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Sample records for adherence intervention trial

  1. Adherence to yoga and exercise interventions in a 6-month clinical trial

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    Haas M

    2007-11-01

    Full Text Available Abstract Background To determine factors that predict adherence to a mind-body intervention in a randomized trial. Design We analyzed adherence data from a 3-arm trial involving 135 generally healthy seniors 65–85 years of age randomized to a 6-month intervention consisting of: an Iyengar yoga class with home practice, an exercise class with home practice, or a wait-list control group. Outcome measures included cognitive function, mood, fatigue, anxiety, health-related quality of life, and physical measures. Adherence to the intervention was obtained by class attendance and biweekly home practice logs. Results The drop-out rate was 13%. Among the completers of the two active interventions, average yoga class attendance was 77% and home practice occurred 64% of all days. Average exercise class attendance was 69% and home exercise occurred 54% of all days. There were no clear effects of adherence on the significant study outcomes (quality of life and physical measures. Class attendance was significantly correlated with baseline measures of depression, fatigue, and physical components of health-related quality of life. Significant differences in baseline measures were also found between study completers and drop-outs in the active interventions. Adherence was not related to age, gender, or education level. Conclusion Healthy seniors have good attendance at classes with a physically active intervention. Home practice takes place over half of the time. Decreased adherence to a potentially beneficial intervention has the potential to decrease the effect of the intervention in a clinical trial because subjects who might sustain the greatest benefit will receive a lower dose of the intervention and subjects with higher adherence rates may be functioning closer to maximum ability before the intervention. Strategies to maximize adherence among subjects at greater risk for low adherence will be important for future trials, especially complementary

  2. Impact of an integrated intervention program on atorvastatin adherence: a randomized controlled trial

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    Goswami NJ

    2013-07-01

    Full Text Available Nilesh J Goswami,1 Mitch DeKoven,2 Andreas Kuznik,3 Jack Mardekian,3 Michelle R Krukas,2 Larry Z Liu,3,4 Patrick Bailey,1 Cynthia Deitrick,5 John Vincent3 1Prairie Heart Cardiovascular Consultants, Springfield, IL, USA; 2Health Economics and Outcomes Research, IMS Health, Alexandria, VA, USA; 3Pfizer Inc, New York, NY, USA; 4Weill Cornell Medical College, Cornell University, New York, NY, USA; 5Prairie Heart Education and Research Cooperative, Springfield, IL, USA Background: This trial evaluated the effectiveness of an integrated intervention program that included a 3-to-5-minute nurse counseling session, copay relief cards, and a monthly newsletter on adherence to atorvastatin treatment. Methods and results: A prospective, integrated (composed of nurse counseling, adherence tip sheet, copay relief card, opportunity to enroll in 12-week cholesterol management program randomized interventional study was designed involving patients >21 years of age who were prescribed atorvastatin at a large single-specialty cardiovascular physician practice in Illinois from March 2010 to May 2011. Data from the practice's electronic medical record were matched/merged to IMS Health's longitudinal data. A total of 500 patients were enrolled (125 in the control arm; 375 in the intervention arm. After data linkage, 53 control patients and 155 intervention patients were included in the analysis. Results: Mean age was 67.8 years (control and 69.5 years (intervention; 67.9% and 58.7%, respectively, were male. The mean 6-month adherence rate was 0.82 in both arms. The mean proportion of days covered for both the new-user control and intervention groups was the same, averaging 0.70 day (standard deviation [SD], 0.27 day; for continuing users, the proportion of days covered for the control group was 0.83 (SD, 0.24 and for the intervention group was 0.84 (SD, 0.22. For continuing users, the control group had mean persistent days of 151.6 (SD, 50.2 compared with 150.9 days

  3. The In Vivo Adherence Intervention For at Risk Adolescents With Asthma: Report of a Randomized Pilot Trial

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    Seid, Michael; D'Amico, Elizabeth J.; Varni, James W; Munafo, Jennifer K.; Britto, Maria T.; Kercsmar, Carolyn M.; Drotar, Dennis; King, Eileen C.; Darbie, Lynn

    2011-01-01

    Objective Low-income and minority adolescents are at high risk for poor asthma outcomes, due in part to adherence. We tested acceptability, feasibility, and effect sizes of an adherence intervention for low socioeconomic status (SES) minority youth with moderate- and severe-persistent asthma. Design and Methods Single-site randomized pilot trial: intervention (n = 12; asthma education, motivational interviewing, problem-solving skills training, 1 month cell-phone with tailored text messaging)...

  4. Efficacy of a brief multifactorial adherence-based intervention on reducing the blood pressure of patients with poor adherence: protocol for a randomized clinical trial

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    Llobera Joan

    2010-09-01

    Full Text Available Abstract Background Lowering of blood pressure by antihypertensive drugs reduces the risks of cardiovascular events, stroke, and total mortality. However, poor adherence to antihypertensive medications reduces their effectiveness and increases the risk of adverse events. In terms of relative risk reduction, an improvement in medication adherence could be as effective as the development of a new drug. Methods/Design The proposed randomized controlled trial will include patients with a low adherence to medication and uncontrolled blood pressure. The intervention group will receive a multifactorial intervention during the first, third, and ninth months, to improve adherence. This intervention will include motivational interviews, pill reminders, family support, blood pressure self-recording, and simplification of the dosing regimen. Measurement The primary outcome is systolic blood pressure. The secondary outcomes are diastolic blood pressure, proportion of patients with adequately controlled blood pressure, and total cost. Discussion The trial will evaluate the impact of a multifactorial adherence intervention in routine clinical practice. Ethical approval was given by the Ethical Committee on Human Research of Balearic islands, Spain (approval number IB 969/08 PI. Trial registration Current controlled trials ISRCTN21229328

  5. Randomized controlled trial of a mobile phone intervention for improving adherence to naltrexone for alcohol use disorders.

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    Susan A Stoner

    Full Text Available Naltrexone is a front-line treatment for alcohol use disorders, but its efficacy is limited by poor medication adherence. This randomized controlled trial evaluated whether a mobile health intervention could improve naltrexone adherence.Treatment-seeking participants with an alcohol use disorder (N = 76 were randomized to intervention and control conditions. All participants received naltrexone (50 mg/day with a medication event monitoring system (MEMS and a prepaid smartphone, and received a daily text message querying medication side effects, alcohol use, and craving. Those in the intervention arm received additional medication reminders and adherence assessment via text message.The primary outcome, proportion of participants with adequate adherence (defined as ≥80% of prescribed doses taken through Week 8, did not differ between groups in intent-to-treat analyses (p = .34. Mean adherence at study midpoint (Week 4 was 83% in the intervention condition and 77% in the control condition (p = .35. Survival analysis found that the intervention group sustained adequate adherence significantly longer (M = 19 days [95% CI = 0.0-44.0] than those in the control group (M = 3 days [95% CI = 0.0-8.1] during the first month of treatment (p = .04. Medication adherence did not predict drinking outcomes.These results suggest that in the context of daily monitoring and assessment via cell phone, additional text message reminders do not further improve medication adherence. Although this initial trial does not provide support for the efficacy of text messaging to improve adherence to pharmacotherapy for alcohol use disorders, additional trials with larger samples and alternate designs are warranted.ClinicalTrials.gov: NCT01349985.

  6. Protocol adherence for continuously titrated interventions in randomized trials: an overview of the current methodology and case study.

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    Lauzier, F; Adhikari, N K; Seely, A; Koo, K K Y; Belley-Côté, E P; Burns, K E A; Cook, D J; D'Aragon, F; Rochwerg, B; Kho, M E; Oczkowksi, S J W; Duan, E H; Meade, M O; Day, A G; Lamontagne, F

    2017-07-17

    The standard definition for protocol adherence is the proportion of all scheduled doses that are delivered. In clinical research, this definition has several limitations when evaluating protocol adherence in trials that study interventions requiring continuous titration. Building upon a specific case study, we analyzed a recent trial of a continuously titrated intervention to assess the impact of different definitions of protocol deviations on the interpretation of protocol adherence. The OVATION pilot trial was an open-label randomized controlled trial of higher (75-80 mmHg) versus lower (60-65 mmHg) mean arterial pressure (MAP) targets for vasopressor therapy in shock. In this trial, potential protocol deviations were defined as MAP values outside the targeted range for >4 consecutive hours during vasopressor therapy without synchronous and consistent adjustments of vasopressor doses. An adjudication committee reviewed each potential deviation to determine if it was clinically-justified or not. There are four reasons for this contextual measurement and reporting of protocol adherence. First, between-arm separation is a robust measure of adherence to complex protocols. Second, adherence assessed by protocol deviations varies in function of the definition of deviations and the frequency of measurements. Third, distinguishing clinically-justified vs. not clinically-justified protocol deviations acknowledges clinically sensible bedside decision-making and offers a clear terminology before the trial begins. Finally, multiple metrics exist to report protocol deviations, which provides different information but complementary information on protocol adherence. In trials of interventions requiring continuous titration, metrics used for defining protocol deviations have a considerable impact on the interpretation of protocol adherence. Definitions for protocol deviations should be prespecified and correlated with between-arm separation, if it can be measured.

  7. A randomized trial of an intervention to improve use and adherence to effective coronary heart disease prevention strategies

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    Sheridan Stacey L

    2011-12-01

    Full Text Available Abstract Background Efficacious strategies for the primary prevention of coronary heart disease (CHD are underused, and, when used, have low adherence. Existing efforts to improve use and adherence to these efficacious strategies have been so intensive that they are impractical for clinical practice. Methods We conducted a randomized trial of a CHD prevention intervention (including a computerized decision aid and automated tailored adherence messages at one university general internal medicine practice. After obtaining informed consent and collecting baseline data, we randomized patients (men and women age 40-79 with no prior history of cardiovascular disease to either the intervention or usual care. We then saw them for two additional study visits over 3 months. For intervention participants, we administered the decision aid at the primary study visit (1 week after baseline visit and then mailed 3 tailored adherence reminders at 2, 4, and 6 weeks. We assessed our outcomes (including the predicted likelihood of angina, myocardial infarction, and CHD death over 10 years (CHD risk and self-reported adherence between groups at 3 month follow-up. Data collection occurred from June 2007 through December 2009. All study procedures were IRB approved. Results We randomized 160 eligible patients (81 intervention; 79 control and followed 96% to study conclusion. Mean predicted CHD risk at baseline was 11.3%. The intervention increased self-reported adherence to chosen risk reducing strategies by 25 percentage points (95% CI 8% to 42%, with the biggest effect for aspirin. It also changed predicted CHD risk by -1.1% (95% CI -0.16% to -2%, with a larger effect in a pre-specified subgroup of high risk patients. Conclusion A computerized intervention that involves patients in CHD decision making and supports adherence to effective prevention strategies can improve adherence and reduce predicted CHD risk. Clinical trials registration number ClinicalTrials

  8. A Multifaceted Prospective Memory Intervention to Improve Medication Adherence: Design of a Randomized Control Trial

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    Insel, Kathie C.; Einstein, Gilles O.; Morrow, Daniel G.; Hepworth, Joseph T.

    2012-01-01

    Adherence to prescribed antihypertensive agents is critical because control of elevated blood pressure is the single most important way to prevent stroke and other end organ damage. Unfortunately, nonadherence remains a significant problem. Previous interventions designed to improve adherence have demonstrated only small benefits of strategies that target single facets such as understanding medication directions. The intervention described here is informed by prospective memory theory and performance of older adults in laboratory-based paradigms and uses a comprehensive, multifaceted approach to improve adherence. It incorporates multiple strategies designed to support key components of prospective remembering involved in taking medication. The intervention is delivered by nurses in the home with an education control group for comparison. Differences between groups in overall adherence following the intervention and 6 months later will be tested. Systolic and diastolic blood pressure levels also will be examined between groups and as it relates to adherence. Intra-individual regression is planned to examine change in adherence over time and its predictors. Finally, we will examine the association between executive function/working memory and adherence, predicting that adherence will be related to executive/working memory in the control group but not in the intervention group. PMID:23010608

  9. Validated adherence scales used in a measurement-guided medication management approach to target and tailor a medication adherence intervention: a randomised controlled trial.

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    Nguyen, Thi-My-Uyen; La Caze, Adam; Cottrell, Neil

    2016-11-30

    To determine if a targeted and tailored intervention based on a discussion informed by validated adherence scales will improve medication adherence. Prospective randomised trial. 2 community pharmacies in Brisbane, Australia. Patients recently initiated on a cardiovascular or oral hypoglycaemic medication within the past 4-12 weeks were recruited from two community pharmacies. Participants identified as non-adherent using the Medication Adherence Questionnaire (MAQ) were randomised into the intervention or control group. The intervention group received a tailored intervention based on a discussion informed by responses to the MAQ, Beliefs about Medicines Questionnaire-Specific and Brief Illness Perception Questionnaire. Adherence was measured using the MAQ at 3 and 6 months following the intervention. A total of 408 patients were assessed for eligibility, from which 152 participants were enrolled into the study. 120 participants were identified as non-adherent using the MAQ and randomised to the 'intervention' or 'control' group. The mean MAQ score at baseline in the intervention and control were similar (1.58: 95% CI (1.38 to 1.78) and 1.60: 95% CI (1.43 to 1.77), respectively). There was a statistically significant improvement in adherence in the intervention group compared to control at 3 months (mean MAQ score 0.42: 95% CI (0.27 to 0.57) vs 1.58: 95% CI (1.42 to 1.75); p<0.001). The significant improvement in MAQ score in the intervention group compared to control was sustained at 6 months (0.48: 95% CI (0.31 to 0.65) vs 1.48: 95% CI (1.27 to 1.69); p<0.001). An intervention that targeted non-adherent participants and tailored to participant-specific reasons for non-adherence was successful at improving medication adherence. ACTRN12613000162718; Results. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/.

  10. Measurement of adherence in a randomised controlled trial of a complex intervention: supported self-management for adults with learning disability and type 2 diabetes.

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    Graham, Liz; Wright, Judy; Walwyn, Rebecca; Russell, Amy M; Bryant, Louise; Farrin, Amanda; House, Allan

    2016-10-06

    Reporting adherence to intervention delivery and uptake is a detailed way of describing what was actually delivered and received, in comparison to what was intended. Measuring and reporting adherence is not routinely done well in complex interventions. The OK Diabetes trial (ISRCTN41897033) aimed to develop and subsequently test the feasibility of implementing a supported self-management intervention in adults with a learning disability and type 2 diabetes. A key study objective was to develop a measure of adherence to the intervention. We conducted a systematic review of published literature, extracting data from included papers using a standardised proforma. We undertook a narrative synthesis of papers to determine the form and content of methods for adherence measurement for self-management interventions in this population that had already been developed. We used the framework and data extraction form developed for the review as the basis for an adherence measurement tool that we applied in the OK Diabetes trial. The literature review found variability in the quality and content of adherence measurement and reporting, with no standardised approach. We were able to develop an adherence measure based upon the review, and populate it with data collected during the OK Diabetes trial. The adherence tool proved satisfactory for recording and measuring adherence in the trial. There remains a need for a standardised approach to adherence measurement in the field of complex interventions. We have shown that it is possible to produce a simple, feasible measure for assessing adherence in the OK Diabetes trial.

  11. Interventions Supporting Long-term Adherence aNd Decreasing cardiovascular events (ISLAND): Pragmatic randomized trial protocol.

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    Ivers, Noah; Schwalm, J-D; Witteman, Holly O; Presseau, Justin; Taljaard, Monica; McCready, Tara; Bosiak, Beth; Cunningham, Jennifer; Smarz, Shelley; Desveaux, Laura; Tu, Jack V; Atzema, Clare; Oakes, Garth; Isaranuwatchai, Wanrudee; Grace, Sherry L; Bhatia, R Sacha; Natarajan, Madhu; Grimshaw, Jeremy M

    2017-08-01

    Guidelines recommend cardiac rehabilitation and long-term use of cardiac medications for most patients who have had a myocardial infarction (MI), but adherence to these secondary prevention treatments is suboptimal. This is a multicenter, pragmatic, 3-arm randomized trial. Eligible patients (n = 2,742) with obstructive coronary artery disease are randomized post-MI to usual care or 1 of 2 intervention arms. Patients in the first intervention arm receive mail-outs sent on behalf of their cardiologist at 4, 8, 20, 32, and 44 weeks post-MI; content is designed to address determinants of adherence and facilitate discussion between the patient and their health care team. Patients in the second intervention arm receive mail-outs plus automated interactive voice response system telephone calls 2 weeks after each letter, as well as a telephone call by trained lay health workers if the interactive voice response system identifies challenges with adherence. Outcomes are assessed 12 months post-MI via patient self-report and administrative data sources. Co-primary outcomes are adherence to cardiac medications and completion of cardiac rehabilitation. Secondary outcomes include cardiovascular events and mortality. An embedded, theory-informed process evaluation will explore the mechanism of action; an economic evaluation is also planned. We describe a complete program evaluation of a highly pragmatic, health-system intervention to support adherence to recommended treatments. Research ethics boards approved waiver of consent for patients enrolled in the trial with provision of multiple opportunities to opt out and a debrief at the time of outcome assessment. The methods used here may provide a model for similar interventions. Copyright © 2017 Elsevier Inc. All rights reserved.

  12. Measurement of adherence in a randomised controlled trial of a complex intervention: supported self-management for adults with learning disability and type 2 diabetes

    Directory of Open Access Journals (Sweden)

    Liz Graham

    2016-10-01

    Full Text Available Abstract Background Reporting adherence to intervention delivery and uptake is a detailed way of describing what was actually delivered and received, in comparison to what was intended. Measuring and reporting adherence is not routinely done well in complex interventions. The OK Diabetes trial (ISRCTN41897033 aimed to develop and subsequently test the feasibility of implementing a supported self-management intervention in adults with a learning disability and type 2 diabetes. A key study objective was to develop a measure of adherence to the intervention. Methods We conducted a systematic review of published literature, extracting data from included papers using a standardised proforma. We undertook a narrative synthesis of papers to determine the form and content of methods for adherence measurement for self-management interventions in this population that had already been developed. We used the framework and data extraction form developed for the review as the basis for an adherence measurement tool that we applied in the OK Diabetes trial. Results The literature review found variability in the quality and content of adherence measurement and reporting, with no standardised approach. We were able to develop an adherence measure based upon the review, and populate it with data collected during the OK Diabetes trial. The adherence tool proved satisfactory for recording and measuring adherence in the trial. Conclusion There remains a need for a standardised approach to adherence measurement in the field of complex interventions. We have shown that it is possible to produce a simple, feasible measure for assessing adherence in the OK Diabetes trial.

  13. Congruence between patient characteristics and interventions may partly explain medication adherence intervention effectiveness: An analysis of 190 randomized controlled trials from a Cochrane systematic review.

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    Allemann, Samuel S; Nieuwlaat, Robby; Navarro, Tamara; Haynes, Brian; Hersberger, Kurt E; Arnet, Isabelle

    2017-08-09

    Due to the negative outcomes of medication non-adherence, interventions to improve adherence have been the focus of countless studies. The congruence between adherence-related patient characteristics and interventions may partly explain the variability of effectiveness in medication adherence studies. In their latest update of a Cochrane review reporting inconsistent effects of adherence interventions, the authors offered access to their database for sub-analysis. We aimed to use this database to assess congruence between adherence-related patient characteristics and interventions and its association with intervention effects. We developed a congruence score consisting of six features related to inclusion criteria, patient characteristics at baseline, and intervention design. Two independent raters extracted and scored items from the 190 studies available in the Cochrane database. We correlated overall congruence score and individual features with intervention effects regarding adherence and clinical outcomes using Kruskal Wallis rank sum test and Fisher's exact test. Interrater-reliability for newly extracted data was almost perfect with a Cohen's Kappa of 0.92 (95% CI 0.89 - 0.94, p non-adherent patients was the single feature significantly associated with effective adherence interventions (p = 0.003). Moreover, effective adherence interventions were significantly associated with improved clinical outcomes (OR = 6.0, CI95% = 3.1 - 12.0, p non-adherence as inclusion criteria", "tailoring of interventions to the inclusion criteria", "reasons for non-adherence assessed at baseline", "adjustment of intervention to individual patient needs", and "theory based interventions") were significantly associated with intervention effects. The presence of only six studies that included non-adherent patients and the inter-dependency of this feature with the remaining five might preclude a conclusive assessment of congruence between patient characteristics and adherence

  14. Low Social Support Level Is Associated with Non-Adherence to Diet at 1 Year in the Family Intervention Trial for Heart Health (FIT Heart)

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    Aggarwal, Brooke; Liao, Ming; Allegrante, John P.; Mosca, Lori

    2010-01-01

    Objective: Evaluate the relationship between low social support (SS) and adherence to diet in a cardiovascular disease (CVD) lifestyle intervention trial. Design: Prospective substudy. Setting and Participants: Blood relatives/cohabitants of hospitalized cardiac patients in a randomized controlled trial (n = 458; 66% female, 35% nonwhite, mean age…

  15. Low Social Support Level Is Associated with Non-Adherence to Diet at 1 Year in the Family Intervention Trial for Heart Health (FIT Heart)

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    Aggarwal, Brooke; Liao, Ming; Allegrante, John P.; Mosca, Lori

    2010-01-01

    Objective: Evaluate the relationship between low social support (SS) and adherence to diet in a cardiovascular disease (CVD) lifestyle intervention trial. Design: Prospective substudy. Setting and Participants: Blood relatives/cohabitants of hospitalized cardiac patients in a randomized controlled trial (n = 458; 66% female, 35% nonwhite, mean age…

  16. Efficacy of a brief multifactorial adherence-based intervention in reducing blood pressure: a randomized clinical trial

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    Leiva A

    2014-12-01

    Full Text Available Alfonso Leiva,1 Antonio Aguiló,2 Marta Fajó-Pascual,3 Lucia Moreno,4 Ma Carmen Martín,5 Elena Marina  Garcia,6 Rosa Elena Duro,7 Francisca Serra,8 Pilar Dagosto,9 Ana Aurelia Iglesias-Iglesias,10 Rosa Maria Company,11 Aina Yañez,12 Joan Llobera13 On behalf of The Adherence Group 1Primary Care Research Unit of Mallorca, Baleares Health Services-IbSalut, Mallorca, 2Research Group on Evidence, Lifestyles and Health, Universitat Illes Balears, Palma, 3Faculty of Health and Sport Sciences, University of Zaragoza, Huesca, 4Son Cladera Health Centre, Baleares Health Services-IbSalut, Mallorca, 5Actur Sur Health Centre, Aragon Health Services-Salud, Aragón, Zaragoza, 6Coll D’en Rabassa Health Centre, Baleares Health Services-IbSalut, Mallorca, 7San Agustín Health Centre, Baleares Health Services-IbSalut, Mallorca, 8Santa María Health Centre, Baleares Health Services-IbSalut, Mallorca, 9Sineu Health Centre, Baleares Health Services-IbSalut, Mallorca, 10Santa Ponça Health Centre, Baleares Health Services-IbSalut, Mallorca, 11Department of Pharmacy, Manacor Hospital-Llevant Sector, Baleares Health Services-IbSalut, Mallorca 12Montuiri Health Centre, Baleares Health Services-IbSalut, Mallorca, 13Fundació d’Investigació Sanitaria Illes Balears (FISIB, Son Espases Hospital, Baleares Health Services-IbSalut, Mallorca, SpainBackground: Lowering blood pressure (BP by antihypertensive (AHT drugs reduces the risks of cardiovascular events, stroke, and total mortality. However, poor adherence to AHT medications reduces their effectiveness and increases the risk of adverse events.Objective: To evaluate the effectiveness of a multifactorial adherence-based intervention in a primary care setting in lowering BP.Methods/design: Multicenter parallel randomized controlled trial. Thirty two nurses in 28 primary care centers of three Spanish regions. Patients aged 18–80 years, taking AHT drugs with uncontrolled BP (n=221 were randomized to a control group

  17. Psychological and Educational Intervention to Improve Tuberculosis Treatment Adherence in Ethiopia Based on Health Belief Model: A Cluster Randomized Control Trial.

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    Habteyes Hailu Tola

    Full Text Available Treatment non-adherence results in treatment failure, prolonged transmission of disease and emergence of drug resistance. Although the problem widely investigated, there remains an information gap on the effectiveness of different methods to improve treatment adherence and the predictors of non-adherence in resource limited countries based on theoretical models. This study aimed to evaluate the impact of psychological counseling and educational intervention on tuberculosis (TB treatment adherence based on Health Belief Model (HBM.A cluster randomized control trial was conducted in Addis Ababa from May to December, 2014. Patients were enrolled into study consecutively from 30 randomly selected Health Centers (HCs (14 HCs intervention and 16 HCs control groups. A total of 698 TB patients, who were on treatment for one month to two months were enrolled. A structured questionnaire was administered to both groups of patients at baseline and endpoint of study. Control participants received routine directly-observed anti-TB therapy and the intervention group additionally received combined psychological counseling and adherence education. Treatment non-adherence level was the main outcome of the study, and multilevel logistic regression was employed to assess the impact of intervention on treatment adherence.At enrollment, the level of non-adherence among intervention (19.4% and control (19.6% groups was almost the same. However, after intervention, non-adherence level decreased among intervention group from 19.4 (at baseline to 9.5% (at endpoint, while it increased among control group from 19.4% (baseline to 25.4% (endpoint. Psychological counseling and educational interventions resulted in significant difference with regard to non-adherence level between intervention and control groups (Adjusted OR = 0.31, 95% Confidence Interval (CI (0.18-0.53, p < 0.001.Psychological counseling and educational interventions, which were guided by HBM, significantly

  18. The (cost-)effectiveness of a patient-tailored intervention programme to enhance adherence to antihypertensive medication in community pharmacies: study protocol of a randomised controlled trial.

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    van der Laan, Danielle M; Elders, Petra J M; Boons, Christel C L M; Bosmans, Judith E; Nijpels, Giel; Hugtenburg, Jacqueline G

    2017-01-19

    Medication non-adherence is a complex health care problem. Due to non-adherence, substantial numbers of cardiovascular patients benefit from their medication to only a limited extent. In order to improve adherence, a variety of pharmacist-led interventions have been developed. However, even the most effective interventions achieved only a modest positive effect. To be effective, interventions should be targeted at underlying barriers to adherence, developed in a systematic manner and tailored to specific features of a target group and setting. The current paper describes the design of the Cardiovascular medication non-Adherence Tailored Intervention (CATI) study aimed to evaluate the (cost-)effectiveness of a patient-tailored intervention programme in patients using antihypertensive medication. The CATI study is a randomised controlled trial that will be performed in 13 community pharmacies. Patients aged 45-75 years using antihypertensive medication and considered non-adherent according to pharmacy dispensing data, as well according to a self-report questionnaire, are eligible to participate. Patients in the intervention condition will receive a patient-tailored, pharmacist-led intervention programme. This programme consists of a structured interview at the pharmacy to identify patients' barriers to adherence and to counsel patients in order to overcome these barriers. The primary outcome is self-reported medication adherence measured with the MARS-5 questionnaire. Secondary outcome measures are blood pressure, illness perceptions, quality of life and societal costs. A cost-effectiveness analysis and process evaluation will also be performed. This study will provide insight into the (cost-)effectiveness of a patient-tailored, pharmacist-led intervention programme in non-adherent patients using antihypertensive medication. This intervention programme allows community pharmacists to support their patients in overcoming barriers to adherence and improving medication

  19. Adherence and success in long-term weight loss diets: the dietary intervention randomized controlled trial (DIRECT).

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    Greenberg, Ilana; Stampfer, Meir J; Schwarzfuchs, Dan; Shai, Iris

    2009-04-01

    Data are limited as to whether participants in diet trials truly adhere to their assigned diet and the factors that affect their adherence. We evaluated success and adherence in a two-year dietary intervention randomized controlled trial (DIRECT) in which 322 moderately obese participants (mean age 52 yrs, mean body-mass-index (BMI) 31 kg/m(2), 86% men) were randomized to one of three groups: low-fat, Mediterranean, or low-carbohydrate diets. Overall compliance at month-24 was 85%, with 90% in low-fat, 85% in Mediterranean, and 78% in low-carbohydrate diet (p = .042 between groups). Attrition was higher in women (29% vs. 14% men, p = .001) and current smokers (25% vs. 14% among maintainers, p = 0.04). In a multivariate model, independent predictors of dropping-out were: higher baseline BMI (OR = 1.11; CI: 1.03-1.21) and less weight loss at month-6 (OR = 1.20; CI: 1.1-1.3). In a multivariate model, greater weight loss achieved at month-6 was the main predictor associated with success in weight loss (> 5%) over 2 years (OR = 1.5; CI: 1.35-1.67). Self-reported complete adherence score to diet was greater on low-carbohydrate diet (p low-fat) until month-6, but dropped overall from 81% at month-1 to 57% at month-24. Holidays were a trigger to a significant decrease in adherence followed by a partial rebound. Changes in diet composition from month-1 to month-12 were more pronounced in the multi-stage low-carbohydrate diet-group (p < .05). Generally, the most irresistible restricted food items were cookies (45% of dieters) and fruits (30%). Among the physically active (n = 107), 44% reported a tendency to eat less after exercising compared to 10% who tended to eat more. Initial 6-month reduction in weight is the main predictor of both long-term retention and success in weight loss. Special attention is needed for women, current smokers, and during holidays. Physical activity is associated with subsequent reduction in energy intake.

  20. Protocol for SAMS (Support and Advice for Medication Study: A randomised controlled trial of an intervention to support patients with type 2 diabetes with adherence to medication

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    Sutton Stephen

    2008-04-01

    Full Text Available Abstract Background Although some interventions have been shown to improve adherence to medication for diabetes, results are not consistent. We have developed a theory-based intervention which we will evaluate in a well characterised population to test efficacy and guide future intervention development and trial design. Methods and Design The SAMS (Supported Adherence to Medication Study trial is a primary care based multi-centre randomised controlled trial among 200 patients with type 2 diabetes and an HbA1c of 7.5% or above. It is designed to evaluate the efficacy of a two-component motivational intervention based on the Theory of Planned Behaviour and volitional action planning to support medication adherence compared with standard care. The intervention is delivered by practice nurses. Nurses were trained using a workshop approach with role play and supervised using assessment of tape-recorded consultations. The trial has a two parallel groups design with an unbalanced three-to-two individual randomisation eight weeks after recruitment with twelve week follow-up. The primary outcome is medication adherence measured using an electronic medication monitor over 12 weeks and expressed as the difference between intervention and control in mean percentage of days on which the correct number of medication doses is taken. Subgroup analyses will explore impact of number of medications taken, age, HbA1c, and self-reported adherence at baseline on outcomes. The study also measures the effect of dispensing medication to trial participants packaged in the electronic medication-monitoring device compared with conventional medication packaging. This will be achieved through one-to-one randomisation at recruitment to these conditions with assessment of the difference between groups in self-report of medication adherence and change in mean HbA1c from baseline to eight weeks. Anonymised demographic data are collected on non-respondents. Central randomisation

  1. Comparing tailored and narrative worksite interventions at increasing colonoscopy adherence in adults 50-75: a randomized controlled trial.

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    Jensen, Jakob D; King, Andy J; Carcioppolo, Nick; Krakow, Melinda; Samadder, N Jewel; Morgan, Susan

    2014-03-01

    Research has identified several communication strategies that could increase adherence to colorectal cancer screening recommendations. Two promising strategies are tailoring and narrative-based approaches. Tailoring is the personalization of information based on individual characteristics. Narrative-based approaches use stories about similar others to counter perceived barriers and cultivate self-efficacy. To compare these two approaches, a randomized controlled trial was carried out at 8 worksites in Indiana. Adults 50-75 (N = 209) received one of four messages about colorectal cancer screening: stock, narrative, tailored, tailored narrative. The primary outcome was whether participants filed a colonoscopy claim in the 18 months following the intervention. Individuals receiving narrative messages were 4 times more likely to screen than those not receiving narrative messages. Tailoring did not increase screening behavior overall. However, individuals with higher cancer information overload were 8 times more likely to screen if they received tailored messages. The results suggest that narrative-based approaches are more effective than tailoring at increasing colorectal cancer screening in worksite interventions. Tailoring may be valuable as a strategy for reaching individuals with high overload, perhaps as a follow-up effort to a larger communication campaign.

  2. Comparison of trial participants and open access users of a web-based physical activity intervention regarding adherence, attrition, and repeated participation.

    Science.gov (United States)

    Wanner, Miriam; Martin-Diener, Eva; Bauer, Georg; Braun-Fahrländer, Charlotte; Martin, Brian W

    2010-02-10

    Web-based interventions are popular for promoting healthy lifestyles such as physical activity. However, little is known about user characteristics, adherence, attrition, and predictors of repeated participation on open access physical activity websites. The focus of this study was Active-online, a Web-based individually tailored physical activity intervention. The aims were (1) to assess and compare user characteristics and adherence to the website (a) in the open access context over time from 2003 to 2009, and (b) between trial participants and open access users; and (2) to analyze attrition and predictors of repeated use among participants in a randomized controlled trial compared with registered open access users. Data routinely recorded in the Active-online user database were used. Adherence was defined as: the number of pages viewed, the proportion of visits during which a tailored module was begun, the proportion of visits during which tailored feedback was received, and the time spent in the tailored modules. Adherence was analyzed according to six one-year periods (2003-2009) and according to the context (trial or open access) based on first visits and longest visits. Attrition and predictors of repeated participation were compared between trial participants and open access users. The number of recorded visits per year on Active-online decreased from 42,626 in 2003-2004 to 8343 in 2008-2009 (each of six one-year time periods ran from April 23 to April 22 of the following year). The mean age of users was between 38.4 and 43.1 years in all time periods and both contexts. The proportion of women increased from 49.5% in 2003-2004 to 61.3% in 2008-2009 (Popen access users. For open access users, adherence was similar during the first and the longest visits; for trial participants, adherence was lower during the first visits and higher during the longest visits. Of registered open access users and trial participants, 25.8% and 67.3% respectively visited Active

  3. An Open Trial of a Smartphone-assisted, Adjunctive Intervention to Improve Treatment Adherence in Bipolar Disorder.

    Science.gov (United States)

    Wenze, Susan J; Armey, Michael F; Weinstock, Lauren M; Gaudiano, Brandon A; Miller, Ivan W

    2016-11-01

    We evaluated the feasibility and acceptability of a novel, 12-week, adjunctive, smartphone-assisted intervention to improve treatment adherence in bipolar disorder. Eight participants completed 4 in-person individual therapy sessions over the course of a month, followed by 60 days of twice-daily ecological momentary intervention (EMI) sessions, with a fifth in-person session after 30 days and a sixth in-person session after 60 days. Perceived credibility of the intervention and expectancy for change were adequate at baseline, and satisfaction on completion of the intervention was very high. Participants demonstrated good adherence to the intervention overall, including excellent adherence to the in-person component and fair adherence to the smartphone-facilitated component. Qualitative feedback revealed very high satisfaction with the in-person sessions and suggested a broad range of ways in which the EMI sessions were helpful. Participants also provided suggestions for improving the intervention, which primarily related to the structure and administration of the EMI (smartphone-administered) sessions. Although this study was not designed to evaluate treatment efficacy, most key outcome variables changed in the expected directions from pretreatment to posttreatment, and several variables changed significantly over the course of the in-person sessions or during the EMI phase. These findings add to the small but growing body of literature suggesting that EMIs are feasible and acceptable for use in populations with bipolar disorder.

  4. Cost effectiveness of medication adherence-enhancing interventions: a systematic review of trial-based economic evaluations

    NARCIS (Netherlands)

    Oberjé, E.J.M.; de Kinderen, R.J.A.; Evers, S.M.A.A.; van Woerkum, C.M.J.; de Bruin, M.

    2013-01-01

    Background In light of the pressure to reduce unnecessary healthcare expenditure in the current economic climate, a systematic review that assesses evidence of cost effectiveness of adherence-enhancing interventions would be timely. Objective Our objective was to examine the cost effectiveness of

  5. An explanatory randomised controlled trial of a nurse-led, consultation-based intervention to support patients with adherence to taking glucose lowering medication for type 2 diabetes

    Directory of Open Access Journals (Sweden)

    Farmer Andrew

    2012-04-01

    Full Text Available Abstract Background Failure to take medication reduces the effectiveness of treatment leading to increased morbidity and mortality. We evaluated the efficacy of a consultation-based intervention to support objectively-assessed adherence to oral glucose lowering medication (OGLM compared to usual care among people with type 2 diabetes. Methods This was a parallel group randomised trial in adult patients with type 2 diabetes and HbA1c≥7.5% (58 mmol/mol, prescribed at least one OGLM. Participants were allocated to a clinic nurse delivered, innovative consultation-based intervention to strengthen patient motivation to take OGLM regularly and support medicine taking through action-plans, or to usual care. The primary outcome was the percentage of days on which the prescribed dose of medication was taken, measured objectively over 12 weeks with an electronic medication-monitoring device (TrackCap, Aardex, Switzerland. The primary analysis was intention-to-treat. Results 211 patients were randomised between July 1, 2006 and November 30, 2008 in 13 British general practices (primary care clinics. Primary outcome data were available for 194 participants (91.9%. Mean (sd percentage of adherent days was 77.4% (26.3 in the intervention group and 69.0% (30.8 in standard care (mean difference between groups 8.4%, 95% confidence interval 0.2% to 16.7%, p = 0.044. There was no significant adverse impact on functional status or treatment satisfaction. Conclusions This well-specified, theory based intervention delivered in a single session of 30 min in primary care increased objectively measured medication adherence, with no adverse effect on treatment satisfaction. These findings justify a definitive trial of this approach to improving medication adherence over a longer period of time, with clinical and cost-effectiveness outcomes to inform clinical practice. Trial registration Current Controlled Trials ISRCTN30522359

  6. Exercise and Motor Training in People with Parkinson's Disease: A Systematic Review of Participant Characteristics, Intervention Delivery, Retention Rates, Adherence, and Adverse Events in Clinical Trials

    Directory of Open Access Journals (Sweden)

    Natalie E. Allen

    2012-01-01

    Full Text Available There is research evidence that exercise and motor training are beneficial for people with Parkinson's disease (PD, and clinicians seek to implement optimal programs. This paper summarizes important factors about the nature and reporting of randomized controlled trials of exercise and/or motor training for people with PD which are likely to influence the translation of research into clinical practice. Searches identified 53 relevant trials with 90 interventions conducted for an average duration of 8.3 (SD 4.2 weeks. Most interventions were fully supervised (74% and conducted at a facility (79%. Retention rates were high with 69% of interventions retaining ≥85% of their participants; however adherence was infrequently reported, and 72% of trials did not report adverse events. Overall, the labor-intensive nature of most interventions tested in these trials and the sparse reporting of adherence and adverse events are likely to pose difficulties for therapists attempting to balance benefits and costs when selecting protocols that translate to sustainable clinical practice for people with PD.

  7. Adherence to self-monitoring via interactive voice response technology in an eHealth intervention targeting weight gain prevention among Black women: randomized controlled trial.

    Science.gov (United States)

    Steinberg, Dori M; Levine, Erica L; Lane, Ilana; Askew, Sandy; Foley, Perry B; Puleo, Elaine; Bennett, Gary G

    2014-04-29

    eHealth interventions are effective for weight control and have the potential for broad reach. Little is known about the use of interactive voice response (IVR) technology for self-monitoring in weight control interventions, particularly among populations disproportionately affected by obesity. This analysis sought to examine patterns and predictors of IVR self-monitoring adherence and the association between adherence and weight change among low-income black women enrolled in a weight gain prevention intervention. The Shape Program was a randomized controlled trial comparing a 12-month eHealth behavioral weight gain prevention intervention to usual care among overweight and obese black women in the primary care setting. Intervention participants (n=91) used IVR technology to self-monitor behavior change goals (eg, no sugary drinks, 10,000 steps per day) via weekly IVR calls. Weight data were collected in clinic at baseline, 6, and 12 months. Self-monitoring data was stored in a study database and adherence was operationalized as the percent of weeks with a successful IVR call. Over 12 months, the average IVR completion rate was 71.6% (SD 28.1) and 52% (47/91) had an IVR completion rate ≥80%. At 12 months, IVR call completion was significantly correlated with weight loss (r =-.22; P=.04) and participants with an IVR completion rate ≥80% had significantly greater weight loss compared to those with an IVR completion rate educated participants were more likely to achieve high IVR call completion. Participants reported positive attitudes toward IVR self-monitoring. Adherence to IVR self-monitoring was high among socioeconomically disadvantaged black women enrolled in a weight gain prevention intervention. Higher adherence to IVR self-monitoring was also associated with greater weight change. IVR is an effective and useful tool to promote self-monitoring and has the potential for widespread use and long-term sustainability. Clinicaltrials.gov NCT00938535; http

  8. A randomized controlled trial to evaluate self-determination theory for exercise adherence and weight control: rationale and intervention description

    Directory of Open Access Journals (Sweden)

    Matos Margarida G

    2008-07-01

    Full Text Available Abstract Background Research on the motivational model proposed by Self-Determination Theory (SDT provides theoretically sound insights into reasons why people adopt and maintain exercise and other health behaviors, and allows for a meaningful analysis of the motivational processes involved in behavioral self-regulation. Although obesity is notoriously difficult to reverse and its recidivism is high, adopting and maintaining a physically active lifestyle is arguably the most effective strategy to counteract it in the long-term. The purposes of this study are twofold: i to describe a 3-year randomized controlled trial (RCT aimed at testing a novel obesity treatment program based on SDT, and ii to present the rationale behind SDT's utility in facilitating and explaining health behavior change, especially physical activity/exercise, during obesity treatment. Methods Study design, recruitment, inclusion criteria, measurements, and a detailed description of the intervention (general format, goals for the participants, intervention curriculum, and main SDT strategies are presented. The intervention consists of a 1-year group behavioral program for overweight and moderately obese women, aged 25 to 50 (and pre-menopausal, recruited from the community at large through media advertisement. Participants in the intervention group meet weekly or bi-weekly with a multidisciplinary intervention team (30 2 h sessions in total, and go through a program covering most topics considered critical for successful weight control. These topics and especially their delivery were adapted to comply with SDT and Motivational Interviewing guidelines. Comparison group receive a general health education curriculum. After the program, all subjects are follow-up for a period of 2 years. Discussion Results from this RCT will contribute to a better understanding of how motivational characteristics, particularly those related to physical activity/exercise behavioral self

  9. A pilot controlled trial to determine the feasibility, acceptability and effectiveness of a PAPA-based online intervention to address practical and perceptual barriers to medication adherence in Inflammatory Bowel Disease.

    Directory of Open Access Journals (Sweden)

    Sarah Chapman

    2015-11-01

    The intervention was effective in addressing perceptual barriers to adherence, as well as having a positive impact on IBD-related illness perceptions: increasing treatment control beliefs, and reducing concerns and emotional response. Fewer episodes of non-adherence were reported in the Intervention Group compared to the Control Group. Satisfaction with information about IBD medication improved following the intervention. However, the number of reported practical barriers was similar between the Intervention and Control groups, suggesting that other support might need to be incorporated into the intervention. Limitations of this study include potential bias due to drop-out, potential lack of generalisability to patient populations not recruited online and a reliance on self-report rather than objective outcome measures. However, this controlled trial suggests that the IBD-Helper intervention may be an effective, feasible and acceptable method of addressing perceptual barriers to adherence.

  10. Adherence to physical and mental activity interventions: Coping plans as a mediator and prior adherence as a moderator.

    NARCIS (Netherlands)

    Evers, A.W.M.; Klusmann, V.; Schwarzer, R.; Heuser, I.

    2012-01-01

    Objective. Adherence to behavioural intervention programmes is a necessary condition for beneficial outcomes to be achieved. This study tested whether social cognitive variables and coping plans predict adherence. Design and methods. Adherence was examined in a randomized controlled trial with healt

  11. A randomized clinical trial of a peri-operative behavioral intervention to improve physical activity adherence and functional outcomes following total knee replacement

    Directory of Open Access Journals (Sweden)

    Zheng Hua

    2011-10-01

    Full Text Available Abstract Background Total knee replacement (TKR is a common and effective surgical procedure to relieve advanced knee arthritis that persists despite comprehensive medical treatment. Although TKR has excellent technical outcomes, significant variation in patient-reported functional improvement post-TKR exists. Evidence suggests that consistent post-TKR exercise and physical activity is associated with functional gain, and that this relationship is influenced by emotional health. The increasing use of TKR in the aging US population makes it critical to find strategies that maximize functional outcomes. Methods/Design This randomized clinical trial (RCT will test the efficacy of a theory-based telephone-delivered Patient Self-Management Support intervention that seeks to enhance adherence to independent exercise and activity among post- TKR patients. The intervention consists of 12 sessions, which begin prior to surgery and continue for approximately 9 weeks post-TKR. The intervention condition will be compared to a usual care control condition using a randomized design and a probabilistic sample of men and women. Assessments are conducted at baseline, eight weeks, and six- and twelve- months. The project is being conducted at a large healthcare system in Massachusetts. The study was designed to provide greater than 80% power for detecting a difference of 4 points in physical function (SF36/Physical Component Score between conditions (standard deviation of 10 at six months with secondary outcomes collected at one year, assuming a loss to follow up rate of no more than 15%. Discussion As TKR use expands, it is important to develop methods to identify patients at risk for sub-optimal functional outcome and to effectively intervene with the goal of optimizing functional outcomes. If shown efficacious, this peri-TKR intervention has the potential to change the paradigm for successful post-TKR care. We hypothesize that Patient Self-Management Support

  12. Patient-focused intervention to improve long-term adherence to evidence-based medications: a randomized trial

    NARCIS (Netherlands)

    Calvert, S.B.; Kramer, J.M.; Anstrom, K.J.; Kaltenbach, L.A.; Stafford, J.A.; Allen LaPointe, N.M.

    2012-01-01

    BACKGROUND: Nonadherence to cardiovascular medications is a significant public health problem. This randomized study evaluated the effect on medication adherence of linking hospital and community pharmacists. METHODS: Hospitalized patients with coronary artery disease discharged on aspirin,

  13. Effectiveness of a group-based intervention to change medication beliefs and improve medication adherence in patients with rheumatoid arthritis: a randomized controlled trial.

    NARCIS (Netherlands)

    Zwikker, H.E.; Ende, C.H. van den; Lankveld, W.G. van; Broeder, A.A. den; Hoogen, F.H. van den; Mosselaar, B. van de; Dulmen, S. van; Bemt, B.J. van den

    2014-01-01

    Objective: To assess the effect of a group-based intervention on the balance between necessity beliefs and concern beliefs about medication and on medication non-adherence in patients with rheumatoid arthritis (RA). Methods: Non-adherent RA patients using disease-modifying anti-rheumatic drugs (DMAR

  14. Microbicide clinical trial adherence: insights for introduction

    Directory of Open Access Journals (Sweden)

    Cynthia Woodsong

    2013-04-01

    Full Text Available After two decades of microbicide clinical trials it remains uncertain if vaginally- delivered products will be clearly shown to reduce the risk of HIV infection in women and girls. Furthermore, a microbicide product with demonstrated clinical efficacy must be used correctly and consistently if it is to prevent infection. Information on adherence that can be gleaned from microbicide trials is relevant for future microbicide safety and efficacy trials, pre-licensure implementation trials, Phase IV post-marketing research, and microbicide introduction and delivery. Drawing primarily from data and experience that has emerged from the large-scale microbicide efficacy trials completed to-date, the paper identifies six broad areas of adherence lessons learned: (1 Adherence measurement in clinical trials, (2 Comprehension of use instructions/Instructions for use, (3 Unknown efficacy and its effect on adherence/Messages regarding effectiveness, (4 Partner influence on use, (5 Retention and continuation and (6 Generalizability of trial participants' adherence behavior. Each is discussed, with examples provided from microbicide trials. For each of these adherence topics, recommendations are provided for using trial findings to prepare for future microbicide safety and efficacy trials, Phase IV post-marketing research, and microbicide introduction and delivery programs.

  15. A MULTI-CENTER CLUSTER-RANDOMIZED TRIAL OF A MULTI-FACTORIAL INTERVENTION TO IMPROVE ANTIHYPERTENSIVE MEDICATION ADHERENCE AND BLOOD PRESSURE CONTROL AMONG PATIENTS AT HIGH CARDIOVASCULAR RISK (The COM99 study)*

    Science.gov (United States)

    Pladevall, Manel; Brotons, Carlos; Gabriel, Rafael; Arnau, Anna; Suarez, Carmen; de la Figuera, Mariano; Marquez, Emilio; Coca, Antonio; Sobrino, Javier; Divine, George; Heisler, Michele; Williams, L Keoki

    2010-01-01

    Background Medication non-adherence is common and results in preventable disease complications. This study assesses the effectiveness of a multifactorial intervention to improve both medication adherence and blood pressure control and to reduce cardiovascular events. Methods and Results In this multi-center, cluster-randomized trial, physicians from hospital-based hypertension clinics and primary care centers across Spain were randomized to receive and provide the intervention to their high-risk patients. Eligible patients were ≥50 years of age, had uncontrolled hypertension, and had an estimated 10-year cardiovascular risk greater than 30%. Physicians randomized to the intervention group counted patients’ pills, designated a family member to support adherence behavior, and provided educational information to patients. The primary outcome was blood pressure control at 6 months. Secondary outcomes included both medication adherence and a composite end-point of all cause mortality and cardiovascular-related hospitalizations. Seventy-nine physicians and 877 patients participated in the trial. The mean duration of follow-up was 39 months. Intervention patients were less likely to have an uncontrolled systolic blood pressure (odds ratio 0.62; 95% confidence interval [CI] 0.50–0.78) and were more likely to be adherent (OR 1.91; 95% CI 1.19–3.05) when compared with control group patients at 6 months. After five years 16% of the patients in the intervention group and 19% in the control group met the composite end-point (hazard ratio 0.97; 95% CI 0.67–1.39). Conclusions A multifactorial intervention to improve adherence to antihypertensive medication was effective in improving both adherence and blood pressure control, but it did not appear to improve long-term cardiovascular events. PMID:20823391

  16. Telephone interventions for adherence to colpocytological examination

    Directory of Open Access Journals (Sweden)

    Thais Marques Lima

    Full Text Available ABSTRACT Objective: to test the effects of behavioral and educational intervention by telephone on adherence of women with inappropriate periodicity to colpocytological examination. Method: quasi-experimental study with a sample of 524 women, selected with the following inclusion criteria: be aged between 25 and 64 years, have initiated sexual activity, have inappropriate periodicity of examination and have mobile or landline phone. The women were divided into two groups for application of behavioral and educational intervention by telephone. It was used an intervention script according to the principles of Motivational Interviewing. Results: on comparing the results before and after the behavioral and educational interventions, it was found that there was a statistically significant change (p = 0.0283 with increase of knowledge of women who participated in the educational intervention. There was no change in the attitude of women of any of the groups and there was an increase of adherence to colpocytological examination in both groups (p < 0.0001, with greater adherence of women participating in the behavioral group (66.8%. Conclusion: the behavioral and educational interventions by phone were effective in the adherence of women to colpocytological examination, representing important strategies for permanent health education and promotion of care for the prevention of cervical cancer.

  17. Clinical pharmacist interventions to support adherence to thrombopreventive therapy

    DEFF Research Database (Denmark)

    Hedegaard, Ulla

    The three papers in the thesis were based on two randomised controlled trials (RCTs) on in-hospital clinical pharmacist interventions for improvement of adherence to thrombopreventive therapy in two different populations: outpatients with hypertension and patients with acute stroke/transient isch......The three papers in the thesis were based on two randomised controlled trials (RCTs) on in-hospital clinical pharmacist interventions for improvement of adherence to thrombopreventive therapy in two different populations: outpatients with hypertension and patients with acute stroke...... targeted patients with hypertension or stroke in a hospital care setting. Thus, the aim of this thesis was to develop and evaluate in-hospital pharmacist interventions including MI to improve adherence to primary and secondary thrombopreventive therapy. The first study was a RCT, which investigated...... the effectiveness of a multifaceted pharmacist intervention in stroke and TIA patients. In the study, 102 stroke or TIA patients receiving the intervention were compared with 101 patients receiving usual care. The 6-month intervention consisted of a focused medication review with recommendations to physicians, a MI...

  18. Cost-effectiveness of a tailored intervention designed to increase breast cancer screening among a non-adherent population: a randomized controlled trial

    Directory of Open Access Journals (Sweden)

    Ishikawa Yoshiki

    2012-09-01

    Full Text Available Abstract Background Although the percentage of women who initiate breast cancer screening is rising, the rate of continued adherence is poor. The purpose of this study was to examine the effectiveness and cost-effectiveness of a tailored print intervention compared with a non-tailored print intervention for increasing the breast cancer screening rate among a non-adherent population. Methods In total, 1859 participants aged 51–59 years (except those aged 55 years were recruited from a Japanese urban community setting. Participants were randomly assigned to receive either a tailored print reminder (tailored intervention group or non-tailored print reminder (non-tailored intervention group. The primary outcome was improvement in the breast cancer screening rate. The screening rates and cost-effectiveness were examined for each treatment group (tailored vs. non-tailored and each intervention subgroup during a follow-up period of five months. All analyses followed the intention-to-treat principle. Results The number of women who underwent a screening mammogram following the reminder was 277 (19.9% in the tailored reminder group and 27 (5.8% in the non-tailored reminder group. A logistic regression model revealed that the odds of a woman who received a tailored print reminder undergoing mammography was 4.02 times those of a women who had received a non-tailored print reminder (95% confidence interval, 2.67–6.06. The cost of one mammography screening increase was 2,544 JPY or 30 USD in the tailored intervention group and 4,366 JPY or 52 USD in the non-tailored intervention group. Conclusions Providing a tailored print reminder was an effective and cost-effective strategy for improving breast cancer screening rates among non-adherent women.

  19. Interventions to Increase Treatment Adherence in Pediatric Atopic Dermatitis: A Systematic Review

    Directory of Open Access Journals (Sweden)

    Alexandria M. Bass

    2015-01-01

    Full Text Available Poor adherence to treatment is a major factor limiting treatment outcomes in patients with atopic dermatitis. The purpose of our systematic review is to identify techniques that have been tested to increase treatment adherence in atopic dermatitis. A MEDLINE search was performed for clinical trials focusing on interventions used to increase adherence in atopic dermatitis. Four articles were retrieved. References of these studies were analyzed yielding three more trials. The seven results were evaluated by comparing the intervention used to improve adherence, how adherence was assessed, and the outcome of the intervention tested. Different approaches to increase adherence such as written eczema action plans, educational workshops, extra office visits, and use of an atopic dermatitis educator were evaluated. All interventions increased adherence rates or decreased severity in patients, except for two. The MEDLINE search yielded limited results due to a lack of studies conducted specifically for atopic dermatitis and adherence was measured using different methods making the studies difficult to compare. Interventions including patient education, eczema action plans, and a quick return for a follow-up visit improve adherence, but based on the lack of clinical trials, developing new techniques to improve adherence could be as valuable as developing new treatments.

  20. Matching Adherence Interventions to Patient Determinants Using the Theoretical Domains Framework.

    Science.gov (United States)

    Allemann, Samuel S; Nieuwlaat, Robby; van den Bemt, Bart J F; Hersberger, Kurt E; Arnet, Isabelle

    2016-01-01

    Introduction: Despite much research, interventions to improve medication adherence report disappointing and inconsistent results. Tailored approaches that match interventions and patient determinants of non-adherence were seldom used in clinical trials. The presence of a multitude of theoretical frameworks and models to categorize interventions and patient determinants complicated the development of common categories shared by interventions and determinants. We retrieved potential interventions and patient determinants from published literature on medication adherence, matched them like locks and keys, and categorized them according to the Theoretical Domains Framework (TDF). Methods: We identified the most relevant literature reviews on interventions and determinants in a pragmatic literature search, extracted all interventions and determinants, grouped similar concepts to umbrella terms and assigned them to TDF categories. All steps were finalized in consensus discussion between the authors. Results: Sixteen articles (5 with determinants, 11 with interventions) were included for analysis. We extracted 103 interventions and 42 determinants that we divided in 26 modifiable and 16 unmodifiable determinants. All interventions and modifiable determinants were matched within 11 categories (Knowledge; Skills; Social/professional role and identity; Beliefs about capabilities; Beliefs about consequences; Intentions; Memory, Attention and decision processes; Environmental context and resources; Social influences; Emotion; and Behavioral regulation). Conclusion: In published trials on medication adherence, the congruence between interventions and determinants can be assessed with matching interventions to determinants. To be successful, interventions in medication adherence should target current modifiable determinants and be tailored to the unmodifiable determinants. Modifiable and unmodifiable determinants need to be assessed at inclusion of intervention studies to

  1. Matching adherence interventions to patient determinants using the Theoretical Domains Framework

    Directory of Open Access Journals (Sweden)

    Samuel Sebastian Allemann

    2016-11-01

    Full Text Available IntroductionDespite much research, interventions to improve medication adherence report disappointing and inconsistent results. Tailored approaches that match interventions and patient determinants of non-adherence were seldom used in clinical trials. The presence of a multitude of theoretical frameworks and models to categorize interventions and patient determinants complicated the development of common categories shared by interventions and determinants. We retrieved potential interventions and patient determinants from published literature on medication adherence, matched them like locks and keys, and categorized them according to the Theoretical Domains Framework (TDF.MethodsWe identified the most relevant literature reviews on interventions and determinants in a pragmatic literature search, extracted all interventions and determinants, grouped similar concepts to umbrella terms and assigned them to TDF categories. All steps were finalized in consensus discussion between the authors.ResultsSixteen articles (5 with determinants, 11 with interventions were included for analysis. We extracted 103 interventions and 42 determinants that we divided in 26 modifiable and 16 unmodifiable determinants. All interventions and modifiable determinants were matched within 11 categories (Knowledge; Skills; Social/professional role and identity; Beliefs about capabilities; Beliefs about consequences; Intentions; Memory, Attention and decision processes; Environmental context and resources; Social influences; Emotion; and Behavioral regulation.ConclusionIn published trials on medication adherence, the congruence between interventions and determinants can be assessed with matching interventions to determinants. To be successful, interventions in medication adherence should target current modifiable determinants and be tailored to the unmodifiable determinants. Modifiable and unmodifiable determinants need to be assessed at inclusion of intervention studies to

  2. Communication style and exercise compliance in physiotherapy (CONNECT. A cluster randomized controlled trial to test a theory-based intervention to increase chronic low back pain patients’ adherence to physiotherapists’ recommendations: study rationale, design, and methods

    Directory of Open Access Journals (Sweden)

    Lonsdale Chris

    2012-06-01

    Full Text Available Abstract Background Physical activity and exercise therapy are among the accepted clinical rehabilitation guidelines and are recommended self-management strategies for chronic low back pain. However, many back pain sufferers do not adhere to their physiotherapist’s recommendations. Poor patient adherence may decrease the effectiveness of advice and home-based rehabilitation exercises. According to self-determination theory, support from health care practitioners can promote patients’ autonomous motivation and greater long-term behavioral persistence (e.g., adherence to physiotherapists’ recommendations. The aim of this trial is to assess the effect of an intervention designed to increase physiotherapists’ autonomy-supportive communication on low back pain patients’ adherence to physical activity and exercise therapy recommendations. Methods/Design This study will be a single-blinded cluster randomized controlled trial. Outpatient physiotherapy centers (N =12 in Dublin, Ireland (population = 1.25 million will be randomly assigned using a computer-generated algorithm to either the experimental or control arm. Physiotherapists in the experimental arm (two hospitals and four primary care clinics will attend eight hours of communication skills training. Training will include handouts, workbooks, video examples, role-play, and discussion designed to teach physiotherapists how to communicate in a manner that promotes autonomous patient motivation. Physiotherapists in the waitlist control arm (two hospitals and four primary care clinics will not receive this training. Participants (N = 292 with chronic low back pain will complete assessments at baseline, as well as 1 week, 4 weeks, 12 weeks, and 24 weeks after their first physiotherapy appointment. Primary outcomes will include adherence to physiotherapy recommendations, as well as low back pain, function, and well-being. Participants will be blinded to treatment allocation, as

  3. Improving diabetes medication adherence: successful, scalable interventions

    Directory of Open Access Journals (Sweden)

    Zullig LL

    2015-01-01

    Full Text Available Leah L Zullig,1,2 Walid F Gellad,3,4 Jivan Moaddeb,2,5 Matthew J Crowley,1,2 William Shrank,6 Bradi B Granger,7 Christopher B Granger,8 Troy Trygstad,9 Larry Z Liu,10 Hayden B Bosworth1,2,7,11 1Center for Health Services Research in Primary Care, Durham Veterans Affairs Medical Center, Durham, NC, USA; 2Department of Medicine, Duke University, Durham, NC, USA; 3Center for Health Equity Research and Promotion, Pittsburgh Veterans Affairs Medical Center, Pittsburgh, PA, USA; 4Division of General Internal Medicine, University of Pittsburgh, Pittsburgh, PA, USA; 5Institute for Genome Sciences and Policy, Duke University, Durham, NC, USA; 6CVS Caremark Corporation; 7School of Nursing, Duke University, Durham, NC, USA; 8Department of Medicine, Division of Cardiology, Duke University School of Medicine, Durham, NC, USA; 9North Carolina Community Care Networks, Raleigh, NC, USA; 10Pfizer, Inc., and Weill Medical College of Cornell University, New York, NY, USA; 11Department of Psychiatry and Behavioral Sciences, Duke University School of Medicine, Durham, NC, USA Abstract: Effective medications are a cornerstone of prevention and disease treatment, yet only about half of patients take their medications as prescribed, resulting in a common and costly public health challenge for the US healthcare system. Since poor medication adherence is a complex problem with many contributing causes, there is no one universal solution. This paper describes interventions that were not only effective in improving medication adherence among patients with diabetes, but were also potentially scalable (ie, easy to implement to a large population. We identify key characteristics that make these interventions effective and scalable. This information is intended to inform healthcare systems seeking proven, low resource, cost-effective solutions to improve medication adherence. Keywords: medication adherence, diabetes mellitus, chronic disease, dissemination research

  4. A Multifactorial Intervention to Enhance Adherence to Medications ...

    African Journals Online (AJOL)

    ... to Enhance Adherence to Medications and Disease-Related Knowledge in ... the intervention group, as evident by a reduction in fasting blood glucose level ... the patients in terms of medication adherence and promotion of healthy lifestyle.

  5. Improving patient adherence to lifestyle advice (IMPALA: a cluster-randomised controlled trial on the implementation of a nurse-led intervention for cardiovascular risk management in primary care (protocol

    Directory of Open Access Journals (Sweden)

    Grol Richard

    2008-01-01

    Full Text Available Abstract Background Many patients at high risk of cardiovascular diseases are managed and monitored in general practice. Recommendations for cardiovascular risk management, including lifestyle change, are clearly described in the Dutch national guideline. Although lifestyle interventions, such as advice on diet, physical exercise, smoking and alcohol, have moderate, but potentially relevant effects in these patients, adherence to lifestyle advice in general practice is not optimal. The IMPALA study intends to improve adherence to lifestyle advice by involving patients in decision making on cardiovascular prevention by nurse-led clinics. The aim of this paper is to describe the design and methods of a study to evaluate an intervention aimed at involving patients in cardiovascular risk management. Methods A cluster-randomised controlled trial in 20 general practices, 10 practices in the intervention arm and 10 in the control arm, starting on October 2005. A total of 720 patients without existing cardiovascular diseases but eligible for cardiovascular risk assessment will be recruited. In both arms, the general practitioners and nurses will be trained to apply the national guideline for cardiovascular risk management. Nurses in the intervention arm will receive an extended training in risk assessment, risk communication, the use of a decision aid and adapted motivational interviewing. This communication technique will be used to support the shared decision-making process about risk reduction. The intervention comprises 2 consultations and 1 follow-up telephone call. The nurses in the control arm will give usual care after the risk estimation, according to the national guideline. Primary outcome measures are self-reported adherence to lifestyle advice and drug treatment. Secondary outcome measures are the patients' perception of risk and their motivation to change their behaviour. The measurements will take place at baseline and after 12 and 52

  6. [e-Health interventions and improvement in treatment adherence].

    Science.gov (United States)

    Sieben, Angelien; Bredie, S J H Bas; van Laarhoven, C J H M Kees; Schoonhoven, Lisette; Burger, David M; van Onzenoort, Hein A W

    2014-01-01

    Poor adherence to medication is one of the most important determinants in the treatment of patients with chronic disorders. e-Health-based interventions may be able to improve treatment adherence. This article gives an overview of the available e-Health interventions and the extent to which they can improve adherence. We searched in the PubMed, Cinahl, PsycInfo, and Embase databases for e-Health interventions that aimed at improving adherence to treatment. Of the 16 included studies, 15 used a website and one used an app. Ten studies showed a significant improvement in treatment adherence by using the intervention. e-Health interventions were generally complex. Simple interventions were the most successful in improving treatment adherence.

  7. Potential Interventions to Support Adherence to HIV Preexposure Prophylaxis (PrEP): A Systematic Review

    Science.gov (United States)

    Marcus, Julia L.; Buisker, Timothy; Horvath, Tara; Amico, K. Rivet; Fuchs, Jonathan D.; Buchbinder, Susan P.; Grant, Robert M.; Liu, Albert Y.

    2014-01-01

    Objectives Adherence is critical for maximizing the effectiveness of preexposure prophylaxis (PrEP) in preventing HIV infection. Strategies for promoting adherence to HIV treatment, and their potential application to PrEP adherence, have received considerable attention. However, adherence promotion strategies for prevention medications have not been well characterized and may be more applicable to PrEP. We aimed to identify adherence support interventions that have been effective in other prevention fields and could be applied in the HIV prevention context to support pill taking among PrEP users. Methods To identify adherence support interventions that could be evaluated and applied in the PrEP context, we conducted a systematic review across the following prevention fields: hypertension, latent tuberculosis infection, hyperlipidemia, oral contraceptives, osteoporosis, malaria prophylaxis, and post-exposure prophylaxis for HIV infection. We included randomized controlled trials that evaluated the efficacy of interventions to improve adherence to daily oral medications prescribed for primary prevention in healthy individuals or for secondary prevention in asymptomatic individuals. Results Our searches identified 585 studies, of which 48 studies met the eligibility criteria and were included in the review; nine evaluated multiple strategies, yielding 64 separately tested interventions. Interventions with the strongest evidence for improving adherence included complex, resource-intensive interventions, which combined multiple adherence support approaches, and low-cost, low-intensity interventions that provided education or telephone calls for adherence support. Conclusions Our review identified adherence interventions with strong evidence of efficacy across prevention fields and provides recommendations for evaluating these interventions in upcoming PrEP studies. PMID:24580813

  8. A systematic review of antiretroviral adherence interventions for HIV-infected people who use drugs.

    Science.gov (United States)

    Binford, Meredith Camp; Kahana, Shoshana Y; Altice, Frederick L

    2012-12-01

    HIV-infected persons who use drugs (PWUDs) are particularly vulnerable for suboptimal combination antiretroviral therapy (cART) adherence. A systematic review of interventions to improve cART adherence and virologic outcomes among HIV-infected PWUDs was conducted. Among the 45 eligible studies, randomized controlled trials suggested directly administered antiretroviral therapy, medication-assisted therapy (MAT), contingency management, and multi-component, nurse-delivered interventions provided significant improved short-term adherence and virologic outcomes, but these effects were not sustained after intervention cessation. Cohort and prospective studies suggested short-term increased cART adherence with MAT. More conclusive data regarding the efficacy on cART adherence and HIV treatment outcomes using cognitive behavioral therapy, motivational interviewing, peer-driven interventions and the integration of MAT into HIV clinical care are warranted. Of great concern was the virtual lack of interventions with sustained post-intervention adherence and virologic benefits. Future research directions, including the development of interventions that promote long-term improvements in adherence and virologic outcomes, are discussed.

  9. Using a tailored health information technology- driven intervention to improve health literacy and medication adherence in a Pakistani population with vascular disease (Talking Rx) - study protocol for a randomized controlled trial.

    Science.gov (United States)

    Kamal, Ayeesha Kamran; Muqeet, Abdul; Farhat, Kashfa; Khalid, Wardah; Jamil, Anum; Gowani, Ambreen; Muhammad, Aliya Amin; Zaidi, Fabiha; Khan, Danyal; Elahi, Touseef; Sharif, Shahrukh; Raz, Sibtain; Zafar, Taha; Bokhari, Syedah Saira; Rahman, Nasir; Sultan, Fateh Ali Tipoo; Sayani, Saleem; Virani, Salim S

    2016-03-05

    Vascular disease, manifesting as myocardial infarction and stroke, is a major cause of morbidity and mortality, especially in low- and middle-income countries. Current estimates are that only one in six patients have good adherence to medications and very few have sufficient health literacy. Our aim is to explore the effectiveness and acceptability of Prescription Interactive Voice Response (IVR) Talking Prescriptions (Talking Rx) and SMS reminders in increasing medication adherence and health literacy in Pakistani patients with vascular disease. This is a randomized, controlled, single center trial. Adult participants, with access to a cell phone and a history of vascular disease, taking multiple risk-modifying medications (inclusive of anti-platelets and statins) will be selected from cerebrovascular and cardiovascular clinics. They will be randomized in a 1:1 ratio via a block design to the intervention or the control arm with both groups having access to a helpline number to address their queries in addition to standard of care as per institutional guidelines. Participants in the intervention group will also have access to Interactive Voice Response (IVR) technology tailored to their respective prescriptions in the native language (Urdu) and will have the ability to hear information about their medication dosage, correct use, side effects, mechanism of action and how and why they should use their medication, as many times as they like. Participants in the intervention arm will also receive scheduled SMS messages reminding them to take their medications. The primary outcome measure will be the comparison of the difference in adherence to anti-platelet and statin medication between baseline and at 3-month follow-up in each group measured by the Morisky Medication Adherence Scale. To ascertain the impact of our intervention on health literacy, we will also compare a local content-validated and modified version of Test of Health Literacy in Adults (TOFHLA) between

  10. mHealth SMS text messaging interventions and to promote medication adherence: an integrative review.

    Science.gov (United States)

    DeKoekkoek, Tracy; Given, Barbara; Given, Charles W; Ridenour, Kimberly; Schueller, Monica; Spoelstra, Sandra L

    2015-10-01

    This article is an integrative review of the evidence for mobile health Short Message Service text messages as an innovative and emerging intervention to promote medication adherence. Authors completed this review to draw conclusions and implications towards establishing a scientific foundation for use of text messages to promote medication adherence, thus informing clinical practice. The World Health Organization has identified medication adherence as a priority global problem. Text messages are emerging as an effective means of improving health behaviours and in some diseases to promote medication adherence. However, a gap in the literature indicates lack of evidence in guiding theories and content of text messages, which should be synthesised prior to use in clinical practice. Integrative review. Cumulative Index to Nursing and Allied Health Literature, Excerpta Medica dataBASE, Scopus, the Cochrane Library and PubMed were searched for relevant studies between 2004-2014. Inclusion criteria were (1) implementation of a text-message intervention and (2) medication adherence to a prescribed oral medication as a primary outcome. Articles were assessed for quality of methodology and measures of adherence. An integrative review process was used to perform analysis. Thirteen articles meeting the inclusion criteria are included in this review. Nine of 13 studies found adherence rates improved between 15·3-17·8% when using text messages to promote medication adherence. Text messages that were standardised, tailored, one- or two-way and timed either daily to medication regimen, weekly or monthly showed improvement in medication adherence. This review established a scientific basis for text messages as an intervention to improve medication adherence across multiple diseases. Future large rigorous randomised trials are needed to further test text messaging interventions. This review provides clinicians with the state of the science with regard to text messaging

  11. Frailty Intervention Trial (FIT).

    Science.gov (United States)

    Fairhall, Nicola; Aggar, Christina; Kurrle, Susan E; Sherrington, Catherine; Lord, Stephen; Lockwood, Keri; Monaghan, Noeline; Cameron, Ian D

    2008-10-13

    Frailty is a term commonly used to describe the condition of an older person who has chronic health problems, has lost functional abilities and is likely to deteriorate further. However, despite its common use, only a small number of studies have attempted to define the syndrome of frailty and measure its prevalence. The criteria Fried and colleagues used to define the frailty syndrome will be used in this study (i.e. weight loss, fatigue, decreased grip strength, slow gait speed, and low physical activity). Previous studies have shown that clinical outcomes for frail older people can be improved using multi-factorial interventions such as comprehensive geriatric assessment, and single interventions such as exercise programs or nutritional supplementation, but no interventions have been developed to specifically reverse the syndrome of frailty.We have developed a multidisciplinary intervention that specifically targets frailty as defined by Fried et al. We aim to establish the effects of this intervention on frailty, mobility, hospitalisation and institutionalisation in frail older people. A single centre randomised controlled trial comparing a multidisciplinary intervention with usual care. The intervention will target identified characteristics of frailty, functional limitations, nutritional status, falls risk, psychological issues and management of chronic health conditions. Two hundred and thirty people aged 70 and over who meet the Fried definition of frailty will be recruited from clients of the aged care service of a metropolitan hospital. Participants will be followed for a 12-month period. This research is an important step in the examination of specifically targeted frailty interventions. This project will assess whether an intervention specifically targeting frailty can be implemented, and whether it is effective when compared to usual care. If successful, the study will establish a new approach to the treatment of older people at risk of further

  12. Interventional tools to improve medication adherence: review of literature

    Science.gov (United States)

    Costa, Elísio; Giardini, Anna; Savin, Magda; Menditto, Enrica; Lehane, Elaine; Laosa, Olga; Pecorelli, Sergio; Monaco, Alessandro; Marengoni, Alessandra

    2015-01-01

    Medication adherence and persistence is recognized as a worldwide public health problem, particularly important in the management of chronic diseases. Nonadherence to medical plans affects every level of the population, but particularly older adults due to the high number of coexisting diseases they are affected by and the consequent polypharmacy. Chronic disease management requires a continuous psychological adaptation and behavioral reorganization. In literature, many interventions to improve medication adherence have been described for different clinical conditions, however, most interventions seem to fail in their aims. Moreover, most interventions associated with adherence improvements are not associated with improvements in other outcomes. Indeed, in the last decades, the degree of nonadherence remained unchanged. In this work, we review the most frequent interventions employed to increase the degree of medication adherence, the measured outcomes, and the improvements achieved, as well as the main limitations of the available studies on adherence, with a particular focus on older persons. PMID:26396502

  13. Persuasive attributes of medication adherence interventions for older adults: a systematic review.

    Science.gov (United States)

    Xu, Anna; Chomutare, Taridzo; Iyengar, Sriram

    2014-01-01

    Low adherence to prescribed medications leads to serious negative health consequences in older adults. Effective interventions that improve adherence are often labor-intensive and complex. However, most studies do not analyze the separate effects of the components. Persuasive System Design (PSD) is framework that analyzes the motivations that change behavior. In this paper, we aim to apply the model to changing the pill-taking behaviors of the aging population and determine which persuasive elements in interventions drive improvement in medication adherence. Systematic review using the databases Medline (1977 to February 2012), Cochrane library (2000 to June 2013); Cinahl (1975 to June 2013), and Psycinfo (2002 to June 2012). Inclusion criteria were experimental trials with participants' mean age ⩾ 60 years and had medication adherence as a primary or secondary measure. Meta-analysis (40 studies) demonstrated a significant association of tailoring, or one-on-one counseling, with medication adherence. Interventions with simulation (showing the causal relationship between non-adherence and negative effects) and rehearsal (miming medication-taking behavior) also showed evidence for improved adherence. Future medication adherence interventions might be more effective if they were based on persuasive technology.

  14. Frailty Intervention Trial (FIT

    Directory of Open Access Journals (Sweden)

    Lockwood Keri

    2008-10-01

    Full Text Available Abstract Background Frailty is a term commonly used to describe the condition of an older person who has chronic health problems, has lost functional abilities and is likely to deteriorate further. However, despite its common use, only a small number of studies have attempted to define the syndrome of frailty and measure its prevalence. The criteria Fried and colleagues used to define the frailty syndrome will be used in this study (i.e. weight loss, fatigue, decreased grip strength, slow gait speed, and low physical activity. Previous studies have shown that clinical outcomes for frail older people can be improved using multi-factorial interventions such as comprehensive geriatric assessment, and single interventions such as exercise programs or nutritional supplementation, but no interventions have been developed to specifically reverse the syndrome of frailty. We have developed a multidisciplinary intervention that specifically targets frailty as defined by Fried et al. We aim to establish the effects of this intervention on frailty, mobility, hospitalisation and institutionalisation in frail older people. Methods and Design A single centre randomised controlled trial comparing a multidisciplinary intervention with usual care. The intervention will target identified characteristics of frailty, functional limitations, nutritional status, falls risk, psychological issues and management of chronic health conditions. Two hundred and thirty people aged 70 and over who meet the Fried definition of frailty will be recruited from clients of the aged care service of a metropolitan hospital. Participants will be followed for a 12-month period. Discussion This research is an important step in the examination of specifically targeted frailty interventions. This project will assess whether an intervention specifically targeting frailty can be implemented, and whether it is effective when compared to usual care. If successful, the study will establish a

  15. Predictors of adherence to a brief behavioral insomnia intervention: daily process analysis.

    Science.gov (United States)

    Ruiter Petrov, Megan E; Lichstein, Kenneth L; Huisingh, Carrie E; Bradley, Laurence A

    2014-05-01

    Behavioral interventions for insomnia are effective in improving sleep, yet adherence is variable, and predictors of adherence have not been consistently replicated. The relationships between daily variations in state factors at the initiation of treatment and adherence have not been investigated. Using 2-week, self-report online logs, this study determined, among 53 college students with probable insomnia, the associations of pretreatment factors and daily factors during treatment on daily variations in adherence to one session of behavioral treatments for insomnia. These treatments included stimulus control therapy (SCT), sleep restriction therapy (SRT), and sleep hygiene (SH). Low self-efficacy was associated with poorer SCT and SH adherence. Participants with a "bed partner or pet" at least some of the time had better SCT adherence. Greater total sleep time and poorer sleep quality were associated with poor SCT and SRT adherence the following night. Greater sleep efficiency was related to greater next night SCT and SRT adherence. Alcohol consumption was related to poorer SRT and SH adherence the following night. Future studies should test the replicability of these findings. Adherence trials may want to test whether discouraging alcohol intake, enhancing treatment-related self-efficacy, and monitoring and providing feedback on sleep, early in treatment, affects adherence.

  16. Telephone interventions for adherence to colpocytological examination.

    Science.gov (United States)

    Lima, Thais Marques; Nicolau, Ana Izabel Oliveira; Carvalho, Francisco Herlânio Costa; Vasconcelos, Camila Teixeira Moreira; Aquino, Priscila de Souza; Pinheiro, Ana Karina Bezerra

    2017-02-06

    to test the effects of behavioral and educational intervention by telephone on adherence of women with inappropriate periodicity to colpocytological examination. quasi-experimental study with a sample of 524 women, selected with the following inclusion criteria: be aged between 25 and 64 years, have initiated sexual activity, have inappropriate periodicity of examination and have mobile or landline phone. The women were divided into two groups for application of behavioral and educational intervention by telephone. It was used an intervention script according to the principles of Motivational Interviewing. on comparing the results before and after the behavioral and educational interventions, it was found that there was a statistically significant change (p = 0.0283) with increase of knowledge of women who participated in the educational intervention. There was no change in the attitude of women of any of the groups and there was an increase of adherence to colpocytological examination in both groups (p educativa por telefone na adesão das mulheres com periodicidade inadequada ao exame colpocitológico. estudo quase-experimental, com amostra constituída por 524 mulheres selecionadas conforme os critérios de inclusão: estar na faixa etária entre 25 e 64 anos, ter iniciado atividade sexual, estar com a periodicidade do exame inadequada e possuir telefone móvel ou fixo. As mulheres foram divididas em dois grupos para aplicação da intervenção comportamental e educativa por telefone. Utilizou-se um roteiro de intervenção segundo os preceitos da Entrevista Motivacional. ao comparar antes e depois das intervenções comportamental e educativa constatou-se que houve uma mudança estatisticamente significativa (p = 0,0283) no aumento do conhecimento das mulheres que participaram da intervenção educativa; não houve mudança comprovada na atitude das mulheres de nenhum dos grupos e houve um aumento da adesão ao exame colpocitológico nos dois grupos (p

  17. Adherence is a multi-dimensional construct in the POUNDS LOST trial.

    Science.gov (United States)

    Williamson, Donald A; Anton, Stephen D; Han, Hongmei; Champagne, Catherine M; Allen, Ray; LeBlanc, Eric; Ryan, Donna H; McManus, Katherine; Laranjo, Nancy; Carey, Vincent J; Loria, Catherine M; Bray, George A; Sacks, Frank M

    2010-02-01

    Research on the conceptualization of adherence to treatment has not addressed a key question: Is adherence best defined as being a uni-dimensional or multi-dimensional behavioral construct? The primary aim of this study was to test which of these conceptual models best described adherence to a weight management program. This ancillary study was conducted as a part of the POUNDS LOST trial that tested the efficacy of four dietary macronutrient compositions for promoting weight loss. A sample of 811 overweight/obese adults was recruited across two clinical sites, and each participant was randomly assigned to one of four macronutrient prescriptions: (1) Low fat (20% of energy), average protein (15% of energy); (2) High fat (40%), average protein (15%); (3) Low fat (20%), high protein (25%); (4) High fat (40%), high protein (25%). Throughout the first 6 months of the study, a computer tracking system collected data on eight indicators of adherence. Computer tracking data from the initial 6 months of the intervention were analyzed using exploratory and confirmatory analyses. Two factors (accounting for 66% of the variance) were identified and confirmed: (1) behavioral adherence and (2) dietary adherence. Behavioral adherence did not differ across the four interventions, but prescription of a high fat diet (vs. a low fat diet) was found to be associated with higher levels of dietary adherence. The findings of this study indicated that adherence to a weight management program was best conceptualized as being multi-dimensional, with two dimensions: behavioral and dietary adherence.

  18. Alcohol use, antiretroviral therapy adherence, and preferences regarding an alcohol-focused adherence intervention in patients with human immunodeficiency virus

    Directory of Open Access Journals (Sweden)

    Kekwaletswe CT

    2014-03-01

    Full Text Available Connie T Kekwaletswe,1 Neo K Morojele1,21Alcohol and Drug Abuse Research Unit, Medical Research Council, Pretoria, 2School of Public Health, University of the Witwatersrand, Johannesburg, South AfricaBackground: The primary objectives of this study were to determine the association between alcohol and antiretroviral therapy (ART adherence and the perceived appropriateness and acceptability of elements of an adherence counseling program with a focus on alcohol-related ART nonadherence among a sample of ART recipients in human immunodeficiency virus (HIV clinics in Tshwane, South Africa.Methods: We conducted a cross-sectional study with purposive sampling. The sample comprised 304 male and female ART recipients at two President's Emergency Plan For AIDS Relief-supported HIV clinics. Using an interview schedule, we assessed patients' alcohol use (Alcohol Use Disorders Identification Test, other drug use, level of adherence to ART, and reasons for missing ART doses (AIDS Clinical Trials Group adherence instrument. Additionally, patients’ views were solicited on: the likely effectiveness of potential facilitators; the preferred quantity, duration, format, and setting of the sessions; the usefulness of having family members/friends attend sessions along with the patient; and potential skill sets to be imparted.Results: About half of the male drinkers’ and three quarters of the female drinkers’ Alcohol Use Disorders Identification Test scores were suggestive of hazardous or harmful drinking. Average self-reported ART adherence was 89.7%. There was a significant association between level of alcohol use and degree of ART adherence. Overall, participants perceived two clinic-based sessions, each of one hour’s duration, in a group format, and facilitated by a peer or adherence counselor, as most appropriate and acceptable. Participants also had a favorable attitude towards family and friends accompanying them to the sessions. They also favored an

  19. The ENRICH Study to evaluate the effectiveness of a combination intervention package to improve isoniazid preventive therapy initiation, adherence and completion among people living with HIV in Ethiopia: rationale and design of a mixed methods cluster randomized trial.

    Science.gov (United States)

    Howard, Andrea A; Hirsch-Moverman, Yael; Saito, Suzue; Gadisa, Tsigereda; Daftary, Amrita; Melaku, Zenebe

    2017-06-01

    Isoniazid preventive therapy (IPT) prevents tuberculosis among HIV-positive individuals, however implementation is suboptimal. Implementation science studies are needed to identify interventions to address this evidence-to-program gap. The ENRICH Study is a mixed methods cluster randomized trial aimed at evaluating the effectiveness and acceptability of a combination intervention package (CIP) to improve IPT implementation in Ethiopia. Ten health centers were randomized to receive the CIP or standard of care. The CIP includes: nurse training and mentorship using a clinical algorithm, tool to identify IPT-eligible family members, and data review at multidisciplinary team meetings; patient transport reimbursement; and adherence support using peer educators and interactive voice response messages. Routine data were abstracted for all newly-enrolled IPT-eligible HIV-positive patients; anticipated sample size was 1400 individuals. A measurement cohort of patients initiating IPT was recruited; target enrollment was 500 individuals, to be followed for the duration of IPT (6-9 months). Inclusion criteria were: HIV-positive; initiated IPT; age ≥18; Amharic-, Oromiffa-, Harari-, or Somali-speaking; and capable of informed consent. Three groups were recruited from CIP health centers for in-depth interviews: IPT initiators; IPT non-initiators; and health care providers. Primary outcomes are: IPT initiation; and IPT completion. Secondary outcomes include: retention; adherence; change in CD4+ count; adverse events; and acceptability. Follow-up is complete. The ENRICH Study evaluates a CIP targeting barriers to IPT implementation. If the CIP is found effective and acceptable, this study has the potential to inform TB prevention strategies for HIV patients in resource-limited countries in sub-Saharan Africa.

  20. Correlates of Adherence to a Telephone-Based Multiple Health Behavior Change Cancer Preventive Intervention for Teens: The Healthy for Life Program (HELP)

    Science.gov (United States)

    Mays, Darren; Peshkin, Beth N.; Sharff, McKane E.; Walker, Leslie R.; Abraham, Anisha A.; Hawkins, Kirsten B.; Tercyak, Kenneth P.

    2012-01-01

    This study examined factors associated with teens' adherence to a multiple health behavior cancer preventive intervention. Analyses identified predictors of trial enrollment, run-in completion, and adherence (intervention initiation, number of sessions completed). Of 104 teens screened, 73% (n = 76) were trial eligible. White teens were more…

  1. Financial incentives to improve adherence to antipsychotic maintenance medication in non-adherent patients: a cluster randomised controlled trial.

    Science.gov (United States)

    Priebe, Stefan; Bremner, Stephen A; Lauber, Christoph; Henderson, Catherine; Burns, Tom

    2016-09-01

    Poor adherence to long-term antipsychotic injectable (LAI) medication in patients with psychotic disorders is associated with a range of negative outcomes. No psychosocial intervention has been found to be consistently effective in improving adherence. To test whether or not offering financial incentives is effective and cost-effective in improving adherence and to explore patient and clinician experiences with such incentives. A cluster randomised controlled trial with economic and nested qualitative evaluation. The intervention period lasted for 12 months with 24 months' follow-up. The unit of randomisation was mental health teams in the community. Community teams in secondary mental health care. Patients with a diagnosis of schizophrenia, schizoaffective psychosis or bipolar illness, receiving ≤ 75% of their prescribed LAI medication. In total, 73 teams with 141 patients (intervention n = 78 and control n = 63) were included. Participants in the intervention group received £15 for each LAI medication. Patients in the control group received treatment as usual. adherence to LAI medication (the percentage of received out of those prescribed). percentage of patients with at least 95% adherence; clinical global improvement; subjective quality of life; satisfaction with medication; hospitalisation; adverse events; and costs. Qualitative evaluation: semistructured interviews with patients in the intervention group and their clinicians. outcome data were available for 131 patients. Baseline adherence was 69% in the intervention group and 67% in the control group. During the intervention period, adherence was significantly higher in the intervention group than in the control group (85% vs. 71%) [adjusted mean difference 11.5%, 95% confidence interval (CI) 3.9% to 19.0%; p = 0.003]. Secondary outcome: patients in the intervention group showed statistically significant improvement in adherence of at least 95% (adjusted odds ratio 8.21, 95% CI 2.00 to 33

  2. Moving from theory to research to practice. Implementing an effective dyadic intervention to improve antiretroviral adherence for clinic patients.

    Science.gov (United States)

    Remien, Robert H; Stirratt, Michael J; Dognin, Joanna; Day, Emily; El-Bassel, Nabila; Warne, Patricia

    2006-12-01

    There is a dearth of evidence on the relative efficacy of intervention modalities to improve and maintain patient adherence to antiretroviral medications. Although empiric findings from research on HIV/AIDS, other diseases, and chronic medical conditions consistently demonstrate that social support plays an important role in facilitating adherence, few HIV/AIDS interventions have directly targeted this factor. Ewart's social action theory emphasizes the role of social relationships in behavior change and provides a comprehensive and useful guide to the development of interventions for adherence. We describe the development, content, and testing of SMART Couples, an effective antiretroviral adherence intervention that is grounded in social action theory and designed to enhance social support for ART adherence. Finally, we discuss some of the challenges of translating findings from the randomized clinical trial of this intervention into clinical practice and offer recommendations for integration of lessons learned into ongoing clinical care.

  3. Computer-based HIV adherence promotion interventions: a systematic review: Translation Behavioral Medicine.

    Science.gov (United States)

    Claborn, Kasey R; Fernandez, Anne; Wray, Tyler; Ramsey, Susan

    2015-09-01

    Researchers have instituted a range of methodologies to increase access to HIV adherence interventions. This article reviews studies published through January 2014 utilizing computer-based delivery of such interventions to persons living with HIV. A systematic review of five databases identified ten studies (three RCTs, three pilot studies, three feasibility studies, and one single-group trial) that met the inclusion criteria. Descriptions of the interventions' content and characteristics are included. Interventions varied widely in terms of program structure, theoretical framework, and content. Only six studies reported medication adherence outcomes. Of these, four (five RCTS and one single group pre-post test) reported significant improvement in adherence using various measures, and two approached significance. Results suggest that computer-delivered adherence interventions are feasible and acceptable among both HIV-positive adolescents and adults. Definitive conclusions regarding clinical impact cannot be drawn due to the small number of adequately powered randomized trials in this review. Additional randomized controlled research is needed to draw inferences regarding intervention efficacy.

  4. Meta-analyses of Theory use in Medication Adherence Intervention Research

    Science.gov (United States)

    Conn, Vicki S.; Enriquez, Maithe; Ruppar, Todd M.; Chan, Keith C.

    2016-01-01

    Objective This systematic review applied meta-analytic procedures to integrate primary research that examined theory- or model-linked medication adherence interventions. Methods Extensive literature searching strategies were used to locate trials testing interventions with medication adherence behavior outcomes measured by electronic event monitoring, pharmacy refills, pill counts, and self-reports. Random-effects model analysis was used to calculate standardized mean difference effect sizes for medication adherence outcomes. Results Codable data were extracted from 146 comparisons with 19,348 participants. The most common theories and models were social cognitive theory and motivational interviewing. The overall weighted effect size for all interventions comparing treatment and control participants was 0.294. The effect size for interventions based on single-theories was 0.323 and for multiple-theory interventions was 0.214. Effect sizes for individual theories and models ranged from 0.041 to 0.447. The largest effect sizes were for interventions based on the health belief model (0.477) and adult learning theory (0.443). The smallest effect sizes were for interventions based on PRECEDE (0.041) and self-regulation (0.118). Conclusion These findings suggest that theory- and model-linked interventions have a significant but modest effect on medication adherence outcomes. PMID:26931748

  5. Adherence Process Research on Developmental Interventions: Filling in the Middle.

    Science.gov (United States)

    Hogue, Aaron

    2002-01-01

    Presents a framework and some practical examples for using rigorous implementation research to inform program outcomes and foster program development for developmental interventions. Focuses on: (1) role of process research, specifically developing developmental interventions; (2) characteristics of adherence process research; and (3)…

  6. Intervention Adherence for Research and Practice: Necessity or Triage Outcome?

    Science.gov (United States)

    Barnett, David; Hawkins, Renee; Lentz, F. Edward, Jr.

    2011-01-01

    Intervention integrity or adherence describes qualities of carrying out an intervention plan and in research is fundamentally linked to experimental validity questions addressed by measurement of independent and dependent variables. Integrity has been well described in conceptual writing but has been a continuing thorny subject in research and…

  7. Financial incentives to improve adherence to anti-psychotic maintenance medication in non-adherent patients - a cluster randomised controlled trial (FIAT

    Directory of Open Access Journals (Sweden)

    Firn Mike

    2009-09-01

    Full Text Available Abstract Background Various interventions have been tested to achieve adherence to anti-psychotic maintenance medication in non-adherent patients with psychotic disorders, and there is no consistent evidence for the effectiveness of any established intervention. The effectiveness of financial incentives in improving adherence to a range of treatments has been demonstrated; no randomised controlled trial however has tested the use of financial incentives to achieve medication adherence for patients with psychotic disorders living in the community. Methods/Design In a cluster randomised controlled trial, 34 mental health teams caring for difficult to engage patients in the community will be randomly allocated to either the intervention group, where patients will be offered a financial incentive for each anti-psychotic depot medication they receive over a 12 month period, or the control group, where all patients will receive treatment as usual. We will recruit 136 patients with psychotic disorders who use these services and who have problems adhering to antipsychotic depot medication, although all conventional methods to achieve adherence have been tried. The primary outcome will be adherence levels, and secondary outcomes are global clinical improvement, number of voluntary and involuntary hospital admissions, number of attempted and completed suicides, incidents of physical violence, number of police arrests, number of days spent in work/training/education, subjective quality of life and satisfaction with medication. We will also establish the cost effectiveness of offering financial incentives. Discussion The study aims to provide new evidence on the effectiveness and cost effectiveness of offering financial incentives to patients with psychotic disorders to adhere to antipsychotic maintenance medication. If financial incentives improve adherence and lead to better health and social outcomes, they may be recommended as one option to improve the

  8. Effectiveness of an interactive postgraduate educational intervention with patient participation on the adherence to a physiotherapy guideline for hip and knee osteoarthritis: a randomised controlled trial

    NARCIS (Netherlands)

    Peter, W.; Wees, P.J. van der; Verhoef, J.; Jong, Z. de; Bodegom-Vos, L. van; Hilberdink, W.K.; Fiocco, M.; Vlieland, T.P.

    2015-01-01

    PURPOSE: To determine the effectiveness of an interactive educational intervention on a physiotherapy guideline for hip and knee osteoarthritis. METHOD: Physiotherapists were randomly allocated to a 3-h interactive educational course with the collaboration of three patient partners or no interventio

  9. Elderly adherence to hypertension treatment and nursing interventions

    OpenAIRE

    Jênifa Cavalcante dos Santos; Raquel Sampaio Florêncio; Célida Juliana de Oliveira; Thereza Maria Magalhães Moreira

    2016-01-01

    Adherence to the treatment of arterial hypertension is a challenge to health professionals. Thus, this study aimed at verifying adherence to treatment of hypertension of elderly patients followed in a group and describe the possible nursing interventions on the clientele. The descriptive research was developed in two phases: between December/2008 and January/2009, we used data collection instrument to assess compliance to treatment; from February to April/2009, we used the technique Focus Gro...

  10. Medication Adherence in a Comparative Effectiveness Trial for Bipolar Disorder

    Science.gov (United States)

    Sylvia, Louisa G.; Reilly-Harrington, Noreen A.; Leon, Andrew C.; Kansky, Christine I.; Calabrese, Joseph R.; Bowden, Charles L.; Ketter, Terence A.; Friedman, Edward S.; Iosifescu, Dan V.; Thase, Michael E.; Ostacher, Michael J.; Keyes, Michelle; Rabideau, Dustin; Nierenberg, Andrew A.

    2013-01-01

    Objective Psychopharmacology remains the foundation of treatment for bipolar disorder, but medication adherence in this population is low (Range = 20% to 64%). We examined medication adherence in a multi-site, comparative effectiveness study of lithium. Method The Lithium Moderate Dose Use Study (LiTMUS) was a six-month, six-site, randomized effectiveness trial of adjunctive moderate dose lithium therapy compared to optimized treatment in adult outpatients with bipolar I or II disorder (N=283). Medication adherence was measured at each study visit with the Tablet Routine Questionnaire. Results We found that 4.50% of participants reported missing at least 30% of their medications in the past week at baseline and non-adherence remained low throughout the trial (< 7%). Poor medication adherence was associated with more manic symptoms and side effects as well as lower lithium serum levels at mid- and post-treatment, but not with poor quality of life, overall severity of illness, or depressive symptoms. Conclusion Participants in LiTMUS were highly adherent with taking their medications. The lack of association with possible predictors of adherence, such as depression and quality of life, could be explained by the limited variance or other factors as well as by not using an objective measure of adherence. PMID:24117232

  11. Personality and medication non-adherence among older adults enrolled in a six-year trial

    Science.gov (United States)

    Jerant, Anthony; Chapman, Benjamin; Duberstein, Paul; Robbins, John; Franks, Peter

    2011-01-01

    Objectives Personality factors parsimoniously capture the variation in dispositional characteristics that affect behaviours, but their value in predicting medication non-adherence is unclear. We investigated the relationship between five-factor model personality factors (Conscientiousness, Neuroticism, Agreeableness, Extraversion, and Openness) and medication non-adherence among older participants during a six-year randomized placebo-controlled trial (RCT). Design Observational cohort data from 771 subjects aged ≥72 years enrolled in the Ginkgo Evaluation of Memory study, a RCT of Ginkgo biloba for prevention of dementia. Methods Random effects logistic regression analyses examined effects of NEO Five-Factor Inventory scores on medication non-adherence, determined via pill counts every 6 months (median follow-up 6.1 years) and defined as taking personality factor associated with non-adherence: a 1 SD increase was associated with a 3.8% increase in the probability of non-adherence (95% CI [0.4, 7.2]). Lower cognitive function was also associated with non-adherence: a 1 SD decrease in mental status exam score was associated with a 3.0% increase in the probability of non-adherence (95% CI [0.2, 5.9]). Conclusions Neuroticism was associated with medication non-adherence over 6 years of follow-up in a large sample of older RCT participants. Personality measurement in clinical and research settings might help to identify and guide interventions for older adults at risk for medication non-adherence. PMID:21226789

  12. Telephone interventions for adherence to colpocytological examination 1

    Science.gov (United States)

    Lima, Thais Marques; Nicolau, Ana Izabel Oliveira; Carvalho, Francisco Herlânio Costa; Vasconcelos, Camila Teixeira Moreira; Aquino, Priscila de Souza; Pinheiro, Ana Karina Bezerra

    2017-01-01

    ABSTRACT Objective: to test the effects of behavioral and educational intervention by telephone on adherence of women with inappropriate periodicity to colpocytological examination. Method: quasi-experimental study with a sample of 524 women, selected with the following inclusion criteria: be aged between 25 and 64 years, have initiated sexual activity, have inappropriate periodicity of examination and have mobile or landline phone. The women were divided into two groups for application of behavioral and educational intervention by telephone. It was used an intervention script according to the principles of Motivational Interviewing. Results: on comparing the results before and after the behavioral and educational interventions, it was found that there was a statistically significant change (p = 0.0283) with increase of knowledge of women who participated in the educational intervention. There was no change in the attitude of women of any of the groups and there was an increase of adherence to colpocytological examination in both groups (p < 0.0001), with greater adherence of women participating in the behavioral group (66.8%). Conclusion: the behavioral and educational interventions by phone were effective in the adherence of women to colpocytological examination, representing important strategies for permanent health education and promotion of care for the prevention of cervical cancer. PMID:28177055

  13. Patient Education in a 14-month Randomised Trial Fails to Improve Adherence in Ulcerative Colitis: Influence of Demographic and Clinical Parameters on Non-adherence.

    Science.gov (United States)

    Nikolaus, S; Schreiber, S; Siegmund, B; Bokemeyer, B; Bästlein, E; Bachmann, O; Görlich, D; Hofmann, U; Schwab, M; Kruis, W

    2017-09-01

    Recent observational studies document that non-adherence to mesalamine therapy during remission is frequent. We aimed to investigate patient impact of patient education using objective assessments of adherence. A 14-month randomised, prospective clinical trial of adherence to mesalamine was conducted in 248 patients with ulcerative colitis [UC], Colitis Activity Index [CAI] ≤ 9, receiving standard care [n = 122] versus a standardised patient education programme [n = 126]. Primary endpoint was adherence at all visits (5-aminosalicylic acid [5-ASA] urine levels). Secondary endpoints included quality of life (inflammatory bowel disease questionnaise [IBDQ]), disease activity, partial adherence, and self-assessment of adherence. Patient allocation was well balanced. Baseline non-adherence was high in quiescent/mildly active UC [52.4%] without difference between the groups (52.4% of patients in the education group versus 52.5% in the standard care group [p = 0.99]). No difference between the intervention group and standard care was seen in IBDQ, partial adherence, self-assessment of adherence, or therapy satisfaction at all visits. We suggest a model in which individual risks for non-adherence are driven by patients with young age, short disease duration, and low education levels. Non-adherence is frequent in a population with quiescent/mildly active UC. Although more than 25% of the population was not in remission at the various time points, no relationship between disease activity and adherence was seen over the 14-month observation period. Physicians should maximise their efforts to motivate high-risk patients for adherence. Future trials should use objective exposure assessments to examine the impact of continuous education and consultations on the background of individual risks to develop non-adherence.

  14. A cluster randomised controlled trial protocol of an adapted intervention for alcohol use disorders in people living with HIV and AIDS: impact on alcohol use, general functional ability, quality of life and adherence to HAART

    OpenAIRE

    Madhombiro, Munyaradzi; Dube-Marimbe, Bazondlile; Dube, Michelle; Chibanda, Dixon; Zunza, Moleen; Rusakaniko, Simbarashe; Stewart, David; Seedat, Soraya

    2017-01-01

    Background Interventions for alcohol use disorders (AUDs) in HIV infected individuals have been primarily targeted at HIV risk reduction and improved antiretroviral treatment adherence. However, reduction in alcohol use is an important goal. Alcohol use affects other key factors that may influence treatment course and outcome. In this study the authors aim to administer an adapted intervention for AUDs to reduce alcohol use in people living with HIV/AIDS (PLWHA). Methods This study is a clust...

  15. Gamification and Adherence to Web-Based Mental Health Interventions: A Systematic Review.

    Science.gov (United States)

    Brown, Menna; O'Neill, Noelle; van Woerden, Hugo; Eslambolchilar, Parisa; Jones, Matt; John, Ann

    2016-08-24

    Adherence to effective Web-based interventions for common mental disorders (CMDs) and well-being remains a critical issue, with clear potential to increase effectiveness. Continued identification and examination of "active" technological components within Web-based interventions has been called for. Gamification is the use of game design elements and features in nongame contexts. Health and lifestyle interventions have implemented a variety of game features in their design in an effort to encourage engagement and increase program adherence. The potential influence of gamification on program adherence has not been examined in the context of Web-based interventions designed to manage CMDs and well-being. This study seeks to review the literature to examine whether gaming features predict or influence reported rates of program adherence in Web-based interventions designed to manage CMDs and well-being. A systematic review was conducted of peer-reviewed randomized controlled trials (RCTs) designed to manage CMDs or well-being and incorporated gamification features. Seven electronic databases were searched. A total of 61 RCTs met the inclusion criteria and 47 different intervention programs were identified. The majority were designed to manage depression using cognitive behavioral therapy. Eight of 10 popular gamification features reviewed were in use. The majority of studies utilized only one gamification feature (n=58) with a maximum of three features. The most commonly used feature was story/theme. Levels and game leaders were not used in this context. No studies explicitly examined the role of gamification features on program adherence. Usage data were not commonly reported. Interventions intended to be 10 weeks in duration had higher mean adherence than those intended to be 6 or 8 weeks in duration. Gamification features have been incorporated into the design of interventions designed to treat CMD and well-being. Further research is needed to improve understanding

  16. Economic evaluation of mobile phone text message interventions to improve adherence to HIV therapy in Kenya

    Science.gov (United States)

    Patel, Anik R.; Kessler, Jason; Braithwaite, R. Scott; Nucifora, Kimberly A.; Thirumurthy, Harsha; Zhou, Qinlian; Lester, Richard T.; Marra, Carlo A.

    2017-01-01

    Abstract Background: A surge in mobile phone availability has fueled low cost short messaging service (SMS) adherence interventions. Multiple systematic reviews have concluded that some SMS-based interventions are effective at improving antiretroviral therapy (ART) adherence, and they are hypothesized to improve retention in care. The objective of this study was to evaluate the cost-effectiveness of SMS-based adherence interventions and explore the added value of retention benefits. Methods: We evaluated the cost-effectiveness of weekly SMS interventions compared to standard care among HIV+ individuals initiating ART for the first time in Kenya. We used an individual level micro-simulation model populated with data from two SMS-intervention trials, an East-African HIV+ cohort and published literature. We estimated average quality adjusted life years (QALY) and lifetime HIV-related costs from a healthcare perspective. We explored a wide range of scenarios and assumptions in one-way and multivariate sensitivity analyses. Results: We found that SMS-based adherence interventions were cost-effective by WHO standards, with an incremental cost-effectiveness ratio (ICER) of $1,037/QALY. In the secondary analysis, potential retention benefits improved the cost-effectiveness of SMS intervention (ICER = $864/QALY). In multivariate sensitivity analyses, the interventions remained cost-effective in most analyses, but the ICER was highly sensitive to intervention costs, effectiveness and average cohort CD4 count at ART initiation. SMS interventions remained cost-effective in a test and treat scenario where individuals were assumed to initiate ART upon HIV detection. Conclusions: Effective SMS interventions would likely increase the efficiency of ART programs by improving HIV treatment outcomes at relatively low costs, and they could facilitate achievement of the UNAIDS goal of 90% viral suppression among those on ART by 2020. PMID:28207516

  17. Distress tolerance as a predictor of adherence to a yoga intervention: Moderating roles of BMI and body image

    NARCIS (Netherlands)

    Baird, S.O.; Hopkins, L.B.; Medina, J.L.; Rosenfield, D.; Powers, M.B.; Smits, J.A.J.

    2016-01-01

    This study tested whether distress tolerance, body image, and body mass index (BMI) predicted adherence to a yoga intervention. Participants were 27 women who participated in a yoga intervention as part of a randomized controlled trial. Attendance and distress tolerance were assessed weekly, and bod

  18. Distress tolerance as a predictor of adherence to a yoga intervention: Moderating roles of BMI and body image

    NARCIS (Netherlands)

    Baird, S.O.; Hopkins, L.B.; Medina, J.L.; Rosenfield, D.; Powers, M.B.; Smits, J.A.J.

    2016-01-01

    This study tested whether distress tolerance, body image, and body mass index (BMI) predicted adherence to a yoga intervention. Participants were 27 women who participated in a yoga intervention as part of a randomized controlled trial. Attendance and distress tolerance were assessed weekly, and bod

  19. Distress tolerance as a predictor of adherence to a yoga intervention: Moderating roles of BMI and body image

    NARCIS (Netherlands)

    Baird, S.O.; Hopkins, L.B.; Medina, J.L.; Rosenfield, D.; Powers, M.B.; Smits, J.A.J.

    2016-01-01

    This study tested whether distress tolerance, body image, and body mass index (BMI) predicted adherence to a yoga intervention. Participants were 27 women who participated in a yoga intervention as part of a randomized controlled trial. Attendance and distress tolerance were assessed weekly, and

  20. Non-adherence to telemedicine interventions for drug users: systematic review

    Directory of Open Access Journals (Sweden)

    Taís de Campos Moreira

    2014-06-01

    Full Text Available OBJECTIVE To estimate rates of non-adherence to telemedicine strategies aimed at treating drug addiction. METHODS A systematic review was conducted of randomized controlled trials investigating different telemedicine treatment methods for drug addiction. The following databases were consulted between May 18, 2012 and June 21, 2012: PubMed, PsycINFO, SciELO, Wiley (The Cochrane Library, Embase, Clinical trials and Google Scholar. The Grading of Recommendations Assessment, Development and Evaluation was used to evaluate the quality of the studies. The criteria evaluated were: appropriate sequence of data generation, allocation concealment, blinding, description of losses and exclusions and analysis by intention to treat. There were 274 studies selected, of which 20 were analyzed. RESULTS Non-adherence rates varied between 15.0% and 70.0%. The interventions evaluated were of at least three months duration and, although they all used telemedicine as support, treatment methods differed. Regarding the quality of the studies, the values also varied from very poor to high quality. High quality studies showed better adherence rates, as did those using more than one technique of intervention and a limited treatment time. Mono-user studies showed better adherence rates than poly-user studies. CONCLUSIONS Rates of non-adherence to treatment involving telemedicine on the part of users of psycho-active substances differed considerably, depending on the country, the intervention method, follow-up time and substances used. Using more than one technique of intervention, short duration of treatment and the type of substance used by patients appear to facilitate adherence.

  1. Behavioral economics strategies for promoting adherence to sleep interventions.

    Science.gov (United States)

    Stevens, Jack

    2015-10-01

    Cognitive-behavioral treatment for insomnia and continuous positive airway pressure therapy for obstructive sleep apnea are among the most efficacious sleep interventions. Unfortunately, adherence levels are disappointingly low for these interventions. Behavioral economics offers a promising framework for promoting adherence, often through relatively brief and straightforward strategies. The assumptions, goals, and key strategies of behavioral economics will be introduced. These strategies include providing social norms information, changing defaults, using the compromise effect, utilizing commitment devices, and establishing lottery-based systems. Then, this review will highlight specific behavioral economic approaches to promote patient adherence for three major sleep interventions: 1) behavioral treatment for pediatric insomnia, 2) cognitive-behavioral treatment for adult insomnia, and 3) continuous positive airway pressure for obstructive sleep apnea. Next, behavioral economic strategies will be discussed as ways to improve health care provider adherence to clinical practice guidelines regarding appropriate prescribing of hypnotics and ordering sleep-promoting practices for hospitalized inpatients. Finally, possible concerns that readers may have about behavioral economics strategies, including their efficacy, feasibility, and sustainability, will be addressed. Copyright © 2014 Elsevier Ltd. All rights reserved.

  2. Adherence to antiretroviral prophylaxis for HIV prevention: a substudy cohort within a clinical trial of serodiscordant couples in East Africa.

    Directory of Open Access Journals (Sweden)

    Jessica E Haberer

    Full Text Available Randomized clinical trials of oral antiretroviral pre-exposure prophylaxis (PrEP for HIV prevention have widely divergent efficacy estimates, ranging from 0% to 75%. These discrepancies are likely due to differences in adherence. To our knowledge, no studies to date have examined the impact of improving adherence through monitoring and/or intervention, which may increase PrEP efficacy, or reported on objective behavioral measures of adherence, which can inform PrEP effectiveness and implementation.Within the Partners PrEP Study (a randomized placebo-controlled trial of oral tenofovir and emtricitabine/tenofovir among HIV-uninfected members of serodiscordant couples in Kenya and Uganda, we collected objective measures of PrEP adherence using unannounced home-based pill counts and electronic pill bottle monitoring. Participants received individual and couples-based adherence counseling at PrEP initiation and throughout the study; counseling was intensified if unannounced pill count adherence fell to 80% adherence. Study limitations include potential shortcomings of the adherence measures and use of a convenience sample within the substudy cohort.The high PrEP adherence achieved in the setting of active adherence monitoring and counseling support was associated with a high degree of protection from HIV acquisition by the HIV-uninfected partner in heterosexual serodiscordant couples. Low PrEP adherence was associated with sexual behavior, alcohol use, younger age, and length of PrEP use. Please see later in the article for the Editors' Summary.

  3. Adherence in a 1-year whole foods eating pattern intervention with healthy postmenopausal women.

    Science.gov (United States)

    Peters, Nancy Champe; Contento, Isobel R; Kronenberg, Fredi; Coleton, Marci

    2014-12-01

    To determine the degree of dietary adherence or change in eating patterns, and demographic, psychosocial and study characteristics associated with adherence, in the Comparing Healthy Options in Cooking and Eating (CHOICE) Study. Randomized controlled trial where women were randomized to one of three eating patterns: (i) Whole Foods, plant-based, macrobiotic-style (n 22); and Moderate Fat with (ii), and without (iii), 10 g of ground flaxseed added daily, which were combined (n 49). A year-long intervention based on social cognitive theory, consisting of twenty-four class sessions involving hands-on cooking classes and behavioural sessions. Monthly 24 h food recalls were obtained and a psychosocial questionnaire was administered at baseline, 6 and 12 months. Healthy, free-living, postmenopausal women. A non-adherence score measuring all food servings out-of-compliance with eating pattern recommendations was specifically designed for the present study. Non-adherence scores decreased significantly (P < 0·05) in both groups to about 65 % during the adoption phase (first 4 months) and remained so during the 8-month maintenance period. Class attendance of the Moderate Fat group showed a trend towards significance as a predictor of adherence (P = 0·063). None of the other predictors (e.g. demographic and psychosocial factors) in a longitudinal regression model were significant. Postmenopausal women were able to adopt and maintain significant changes in their eating patterns, including those on a demanding, near-vegetarian eating plan, suggesting that behavioural interventions with a healthy free-living population can be effective. The non-adherence score developed for the study provides an example of a means for evaluating eating pattern adherence to a dietary intervention.

  4. Adherence to blood pressure telemonitoring in a cluster-randomized clinical trial

    Science.gov (United States)

    Kerby, Tessa J; Asche, Stephen E; Maciosek, Michael V; O’Connor, Patrick J; Sperl-Hillen, JoAnn M; Margolis, Karen L

    2012-01-01

    Background Hypertension is a leading cause of cardiovascular disease and death worldwide. Advances in technology have added telemedicine as a tool for managing hypertension. The effectiveness of telemedicine depends upon patients’ ability to adhere to schedules of home monitoring and case management. Methods Participants with uncontrolled hypertension in the intervention arm of a randomized trial who had completed 6 months of follow-up were included in this analysis. They were asked to measure their BP a minimum of 6 times per week using a telemonitor that transmitted the readings to their pharmacist case manager. Results Hypertensive patients in this study had high adherence to telemonitoring (73% took at least 6 BP readings per week) and phone visits (88% of expected visits were attended). In a multivariate analysis, older age, male gender, and some college education predicted better telemonitoring adherence. White non-hispanic race/ethnicity predicted better adherence to phone visits with pharmacist case managers. Telemonitoring adherence and phone adherence were highly correlated; participants who did not send readings on schedule were more likely to skip at least one phone visit with their pharmacist case manager. Conclusion The findings from this analysis indicate that hypertensive patients in this study were able to achieve and maintain high adherence to both the telemonitoring and the phone case management visits. PMID:23031143

  5. Adherence to blood pressure telemonitoring in a cluster-randomized clinical trial.

    Science.gov (United States)

    Kerby, Tessa J; Asche, Stephen E; Maciosek, Michael V; O'Connor, Patrick J; Sperl-Hillen, Joann M; Margolis, Karen L

    2012-10-01

    Hypertension is a leading cause of cardiovascular disease and death worldwide. Advances in technology have added telemedicine as a tool for managing hypertension. The effectiveness of telemedicine depends on patients' ability to adhere to schedules of home monitoring and case management. Participants with uncontrolled hypertension in the intervention arm of a randomized trial who completed 6 months of follow-up were included in this analysis. They were asked to measure their blood pressure (BP) a minimum of 6 times per week using a telemonitor that transmitted the readings to their pharmacist case manager. Hypertensive patients in this study had high adherence to telemonitoring (73% took at least 6 BP readings per week) and phone visits (88% of expected visits were attended). In a multivariate analysis, older age, male sex, and some college education predicted better telemonitoring adherence. White non-Hispanic race/ethnicity predicted better adherence to phone visits with pharmacist case managers. Telemonitoring adherence and phone adherence were highly correlated; participants who did not send readings on schedule were more likely to skip at least one phone visit with their pharmacist case manager. The findings from this analysis indicate that hypertensive patients in this study were able to achieve and maintain high adherence to both the telemonitoring and the phone case management visits. © 2012 Wiley Periodicals, Inc.

  6. Effect of a Multi-Dimensional and Inter-Sectoral Intervention on the Adherence of Psychiatric Patients.

    Directory of Open Access Journals (Sweden)

    Anne Pauly

    Full Text Available In psychiatry, hospital stays and transitions to the ambulatory sector are susceptible to major changes in drug therapy that lead to complex medication regimens and common non-adherence among psychiatric patients. A multi-dimensional and inter-sectoral intervention is hypothesized to improve the adherence of psychiatric patients to their pharmacotherapy.269 patients from a German university hospital were included in a prospective, open, clinical trial with consecutive control and intervention groups. Control patients (09/2012-03/2013 received usual care, whereas intervention patients (05/2013-12/2013 underwent a program to enhance adherence during their stay and up to three months after discharge. The program consisted of therapy simplification and individualized patient education (multi-dimensional component during the stay and at discharge, as well as subsequent phone calls after discharge (inter-sectoral component. Adherence was measured by the "Medication Adherence Report Scale" (MARS and the "Drug Attitude Inventory" (DAI.The improvement in the MARS score between admission and three months after discharge was 1.33 points (95% CI: 0.73-1.93 higher in the intervention group compared to controls. In addition, the DAI score improved 1.93 points (95% CI: 1.15-2.72 more for intervention patients.These two findings indicate significantly higher medication adherence following the investigated multi-dimensional and inter-sectoral program.German Clinical Trials Register DRKS00006358.

  7. Effect of a Multi-Dimensional and Inter-Sectoral Intervention on the Adherence of Psychiatric Patients.

    Science.gov (United States)

    Pauly, Anne; Wolf, Carolin; Mayr, Andreas; Lenz, Bernd; Kornhuber, Johannes; Friedland, Kristina

    2015-01-01

    In psychiatry, hospital stays and transitions to the ambulatory sector are susceptible to major changes in drug therapy that lead to complex medication regimens and common non-adherence among psychiatric patients. A multi-dimensional and inter-sectoral intervention is hypothesized to improve the adherence of psychiatric patients to their pharmacotherapy. 269 patients from a German university hospital were included in a prospective, open, clinical trial with consecutive control and intervention groups. Control patients (09/2012-03/2013) received usual care, whereas intervention patients (05/2013-12/2013) underwent a program to enhance adherence during their stay and up to three months after discharge. The program consisted of therapy simplification and individualized patient education (multi-dimensional component) during the stay and at discharge, as well as subsequent phone calls after discharge (inter-sectoral component). Adherence was measured by the "Medication Adherence Report Scale" (MARS) and the "Drug Attitude Inventory" (DAI). The improvement in the MARS score between admission and three months after discharge was 1.33 points (95% CI: 0.73-1.93) higher in the intervention group compared to controls. In addition, the DAI score improved 1.93 points (95% CI: 1.15-2.72) more for intervention patients. These two findings indicate significantly higher medication adherence following the investigated multi-dimensional and inter-sectoral program. German Clinical Trials Register DRKS00006358.

  8. Medication adherence in patients with apparent resistant hypertension: findings from the SYMPATHY trial.

    Science.gov (United States)

    de Jager, R L; van Maarseveen, E M; Bots, M L; Blankestijn, P J

    2017-08-17

    Hypertension is only controlled in approximately 35% of the patients, which could be partially due to non-adherence. Recently, bioanalytical assessment of adherence to blood pressure (BP) lowering drugs has gaining interest. Our aim was to explore possible determinants of non-adherence in treatment resistant hypertension, assessed by objective screening for antihypertensive agents in serum. Secondary aim was to study the effect of adherence on the change in BP. This project was a sub-study of SYMPATHY; an open-label randomized-controlled trial to assess the effect of renal denervation on BP six months after treatment compared to usual care in patients with resistant hypertension. Stored serum samples were screened for antihypertensive agents to assess adherence at baseline and six months after intervention, using liquid chromatography-tandem mass spectrometry. Office and 24-hour BP were measured at the same day blood was sampled. Patients and physicians were unaware of adherence measurements. Ninety-eight baseline and 83 six-month samples were available for analysis. Sixty-eight percent (95%CI 59 to 78) of the patients was non-adherent (n=67). For every 1 pill more prescribed, 0.785 [95%CI 0.529 to 0.891] prescribed pill was less detected in blood. A decrease of 1 pill in adherence between baseline and six months was associated with a significant rise in office systolic BP of 4 (95%CI 0.230 to 8.932) mmHg. Objective measurement of BP lowering drugs in serum, as a tool to assess adherence, showed that non-adherence was very common in patients with apparent resistant hypertension. Furthermore, the assessment results were related to (changes in) blood pressure. Our findings provide direct and objective methodology to help the physician to understand and to improve the condition of apparent resistant hypertension. This article is protected by copyright. All rights reserved.

  9. Effect of pharmacist intervention on improving antidepressant medication adherence and depression symptomology: A systematic review and meta-analysis.

    Science.gov (United States)

    Readdean, Kevin C; Heuer, Albert J; Scott Parrott, J

    2017-05-22

    Depression is a widespread disease with effective pharmacological treatments, but low medication adherence. Pharmacists play a key role in supporting medication adherence in patients with depression given their accessibility to patients. The aim of this review was to systematically evaluate the impact of pharmacist interventions on adherence to antidepressants and clinical symptomology among adult outpatients with depressive disorders. A systematic review of controlled trials (both randomized and non-randomized) was conducted. Studies were obtained through a search of PubMed, Academic Search Premier, and Cochrane Library databases. Studies which included a pharmacist intervention to improve medication adherence in outpatients age 17 and above with a depressive disorder diagnosis and antidepressant treatment were included. Twelve publications met inclusion criteria, representing a total of 15,087 subjects: 1379 (9%) intervention and 13,708 (91%) control. The interventions in each selected publication included some level of in-person counseling and education to promote antidepressant adherence. The pooled odds ratio for medication adherence at 6 months was 2.50 (95% CI 1.62 to 3.86). There were no significant differences noted in subgroup meta-analyses except study location (US, Middle East or Europe) and setting. Only one of the identified studies reported statistically significant impacts of the pharmacist intervention on patient depression symptoms. The findings suggest that pharmacist interventions can enhance patient adherence to antidepressant medication in adult outpatients. However, this review failed to demonstrate a positive effect of these interventions on clinical symptoms. Additional longitudinal research is recommended to investigate the multidimensional relationships between pharmacist interventions, patient adherence, and clinical outcomes. Pharmacists play a key role in supporting medication adherence in patients with depression given their

  10. Interventional tools to improve medication adherence: review of literature

    Directory of Open Access Journals (Sweden)

    Costa E

    2015-09-01

    Full Text Available Elísio Costa,1 Anna Giardini,2 Magda Savin,3 Enrica Menditto,4 Elaine Lehane,5 Olga Laosa,6 Sergio Pecorelli,7,8 Alessandro Monaco,7 Alessandra Marengoni9On behalf of the A1 Action group “Prescription and Adherence to Medical Plans”, European Innovation Partnership on Active and Healthy Ageing1UCIBIO, REQUIMTE, Faculty of Pharmacy, University of Porto, Porto, Portugal; 2Psychology Unit, Salvatore Maugeri Foundation, IRCCS, Scientific Institute of Montescano (PV, Pavia, Italy; 3European Association of Pharmaceutical Full-line Wholesalers, Brussels, Belgium; 4CIRFF/Center of Pharmacoeconomics, School of Pharmacy, University of Naples FedericoII, Nápoles, Italy; 5Catherine McAuley School of Nursing and Midwifery, Brookfield Health Sciences Complex, University College Cork, Cork, Ireland; 6Centro de Investigación Clínica del Anciano Fundación para la Investigación Biomédica, Hospital Universitario de Getafe, Madrid, Spain; 7Italian Medicines Agency – AIFA, Rome, Italy; 8University of Brescia, Brescia, Italy; 9Department of Clinical and Experimental Science, University of Brescia, Brescia, Italy Abstract: Medication adherence and persistence is recognized as a worldwide public health problem, particularly important in the management of chronic diseases. Nonadherence to medical plans affects every level of the population, but particularly older adults due to the high number of coexisting diseases they are affected by and the consequent polypharmacy. Chronic disease management requires a continuous psychological adaptation and behavioral reorganization. In literature, many interventions to improve medication adherence have been described for different clinical conditions, however, most interventions seem to fail in their aims. Moreover, most interventions associated with adherence improvements are not associated with improvements in other outcomes. Indeed, in the last decades, the degree of nonadherence remained unchanged. In this work, we

  11. A randomized controlled trial of the effectiveness of planning strategies in the adherence to medication for coronary artery disease.

    Science.gov (United States)

    Lourenço, Laura Bacelar de Araujo; Rodrigues, Roberta Cunha Matheus; Ciol, Marcia Aparecida; São-João, Thaís Moreira; Cornélio, Marilia Estevam; Dantas, Rosana Aparecida Spadoti; Gallani, Maria-Cecília

    2014-07-01

    To examine the effect of action and coping planning strategies in the adherence to medication among outpatients with coronary artery disease. Action and coping planning strategies are based on implementation intention, which requires self-regulation by the individual, to prioritize intentionally planned responses over learned or habitual ones, from daily routines to stressful situations. Randomized controlled trial. Participants (n = 115) were randomized into intervention (use of action and coping planning strategies, n = 59) or control (usual care, n = 56) groups. The study was conducted between June 2010-May 2011 in two in-person visits: baseline and 2-month follow-up. Participants in the intervention group received telephone reinforcement between baseline and 2-month follow-up. Adherence to medication for cardioprotection and symptoms relief was evaluated by proportion of adherence, global measure of adherence evaluation and Morisky Self-Reported Measure of Medication Adherence Scale at both baseline and 2-month follow-up. When using the measure of global measure of adherence, participants in the intervention group reported adherence to therapy more often than controls (odds ratio = 5.3), but no statistically significant change was observed in the other two outcome measures. This study has shown that individuals who use action and coping planning report higher adherence to drug treatment, when measured by the global adherence evaluation. Further studies with longer follow-ups are needed to assess if the effect of planning strategies has long-term duration. © 2013 John Wiley & Sons Ltd.

  12. Improving antiretroviral therapy adherence in resource-limited settings at scale: a discussion of interventions and recommendations.

    Science.gov (United States)

    Haberer, Jessica E; Sabin, Lora; Amico, K Rivet; Orrell, Catherine; Galárraga, Omar; Tsai, Alexander C; Vreeman, Rachel C; Wilson, Ira; Sam-Agudu, Nadia A; Blaschke, Terrence F; Vrijens, Bernard; Mellins, Claude A; Remien, Robert H; Weiser, Sheri D; Lowenthal, Elizabeth; Stirratt, Michael J; Sow, Papa Salif; Thomas, Bruce; Ford, Nathan; Mills, Edward; Lester, Richard; Nachega, Jean B; Bwana, Bosco Mwebesa; Ssewamala, Fred; Mbuagbaw, Lawrence; Munderi, Paula; Geng, Elvin; Bangsberg, David R

    2017-01-01

    Introduction: Successful population-level antiretroviral therapy (ART) adherence will be necessary to realize both the clinical and prevention benefits of antiretroviral scale-up and, ultimately, the end of AIDS. Although many people living with HIV are adhering well, others struggle and most are likely to experience challenges in adherence that may threaten virologic suppression at some point during lifelong therapy. Despite the importance of ART adherence, supportive interventions have generally not been implemented at scale. The objective of this review is to summarize the recommendations of clinical, research, and public health experts for scalable ART adherence interventions in resource-limited settings. Methods: In July 2015, the Bill and Melinda Gates Foundation convened a meeting to discuss the most promising ART adherence interventions for use at scale in resource-limited settings. This article summarizes that discussion with recent updates. It is not a systematic review, but rather provides practical considerations for programme implementation based on evidence from individual studies, systematic reviews, meta-analyses, and the World Health Organization Consolidated Guidelines for HIV, which include evidence from randomized controlled trials in low- and middle-income countries. Interventions are categorized broadly as education and counselling; information and communication technology-enhanced solutions; healthcare delivery restructuring; and economic incentives and social protection interventions. Each category is discussed, including descriptions of interventions, current evidence for effectiveness, and what appears promising for the near future. Approaches to intervention implementation and impact assessment are then described. Results and discussion: The evidence base is promising for currently available, effective, and scalable ART adherence interventions for resource-limited settings. Numerous interventions build on existing health care

  13. The Effect of Group Psychoeducation Program on Medication Adherence in Patients with Bipolar Mood Disorders: a Randomized Controlled Trial

    Directory of Open Access Journals (Sweden)

    Farnaz Rahmani

    2016-12-01

    Full Text Available Introduction: Medication nonadherence is highly prevalent in patients with bipolar disorders and often results in worsening disease prognosis. The purpose of this study was to investigate the effect of group psychoeducation on medication adherence in female patients with bipolar mood disorder type I. Methods: This randomized controlled trial was conducted on 76 patients with bipolar mood disorder admitted in female psychiatric wards of Razi teaching hospital, Tabriz, Iran. The participants were selected by convenience sampling method and were randomly assigned to experimental and control groups. Patients in experimental group received 10 continuous 90 minutes sessions of psychoeducation, two times a week. Medication adherence was measured using the medicine check list and medication adherence rating scale (MARS before and after intervention. Data analysis was performed with SPSS ver.13. Results: There was no significant difference between two groups regarding medication adherence before the intervention. After the study intervention, the mean scores of medication adherence check list and medication adherence rating scale in the experimental group were significantly higher than the control group. Conclusion: Since group psychoeducation was effective in improving patients' medication adherence, it could be recommended for psychiatric nurses to apply this intervention in the clinical setting.

  14. Displacement of sexual partnerships in trials of sexual behavior interventions: A model-based assessment of consequences.

    Science.gov (United States)

    McCormick, Alethea W; Abuelezam, Nadia N; Fussell, Thomas; Seage, George R; Lipsitch, Marc

    2017-09-01

    We investigated the impact of the displacement of sexual activity from adherent recipients of an intervention to others within or outside a trial population on the results from hypothetical trials of different sexual behavior interventions. A short-term model of HIV-prevention interventions that lead to female rejection of male partnership requests showed the impact of displacement expected at the start of a trial. An agent-based model, with sexual mixing and other South African specific demographics, evaluated consequences of displacement for sexual behavior interventions targeting young females in South Africa. This model measured the cumulative incidence among adherent, non-adherent, control and non-enrolled females in a hypothetical trial of HIV prevention. When males made more than one attempt to seek a partnership, interventions reduced short-term HIV infection risk among adherent females, but increased it among non-adherent females as well as controls, non-enrolled (females eligible for the trial but not chosen to participate) and ineligible females (females that did not qualify for the trial due to age). The impact of displacement depends on the intervention and the adherence. In both models, the risk to individuals who are not members of the adherent intervention group will increase with displacement leading to a biased calculation for the effect estimates for the trial. Likewise, intent-to-treat effect estimates become nonlinear functions of the proportion adherent. Copyright © 2017 The Authors. Published by Elsevier B.V. All rights reserved.

  15. Discontinuing financial incentives for adherence to antipsychotic depot medication: long-term outcomes of a cluster randomised controlled trial

    Science.gov (United States)

    Priebe, Stefan; Bremner, Stephen A; Pavlickova, Hana

    2016-01-01

    Objectives In a cluster randomised controlled trial, offering financial incentives improved adherence to antipsychotic depot medication over a 1-year period. Yet, it is unknown whether this positive effect is sustained once the incentives stop. Methods and analyses Patients in the intervention and control group were followed up for 2 years after the intervention. Primary and secondary outcomes were assessed at 6 months and 24 months post intervention. Assessments were conducted between September 2011 and November 2014. Results After the intervention period, intervention and control groups did not show any statistically significant differences in adherence, neither in the first 6 months (71% and 77%, respectively) nor in the following 18 months (68%, 74%). There were no statistically significant differences in secondary outcomes, that is, adherence ≥95% and untoward incidents either. Conclusions It may be concluded that incentives to improve adherence to antipsychotic maintenance medication are effective only for as long as they are provided. Once they are stopped, adherence returns to approximately baseline level with no sustained benefit. Trial registration number ISRCTN77769281; Results. PMID:27655261

  16. Multifaceted medication adherence intervention for patients with hypertension in secondary care

    DEFF Research Database (Denmark)

    Hedegaard, Ulla; Hallas, Jesper; Nielsen, Lene Ravn-Vestergaard

    Background and Objectives Medication adherence is often suboptimal among patients with hypertension. Non-adherence is a multi-dimensional problem and a successful adherence intervention requires multiple components to address the underlying reason for non-adherence. The objective of the present......-led and included three components: a focused medication review, a patient interview and follow-up telephone calls. Two tools were used to identify and address non-adherence: The DRAW©-tool and an adherence questionnaire. A study carried out at, three out clinics at Odense University Hospital, Denmark was used...... study was to describe the content and process outcomes of an adherence program developed for hypertensive patients in a hospital setting. Methods The intervention development was based on adherence and behavioral theories, and evidence of effective interventions. The intervention was pharmacist...

  17. Efficacy and safety of a multifactor intervention to improve therapeutic adherence in patients with chronic obstructive pulmonary disease (COPD: protocol for the ICEPOC study

    Directory of Open Access Journals (Sweden)

    Prados-Torres Daniel

    2011-02-01

    Full Text Available Abstract Background Low therapeutic adherence to medication is very common. Clinical effectiveness is related to dose rate and route of administration and so poor therapeutic adherence can reduce the clinical benefit of treatment. The therapeutic adherence of patients with chronic obstructive pulmonary disease (COPD is extremely poor according to most studies. The research about COPD adherence has mainly focussed on quantifying its effect, and few studies have researched factors that affect non-adherence. Our study will evaluate the effectiveness of a multifactor intervention to improve the therapeutic adherence of COPD patients. Methods/Design A randomized controlled clinical trial with 140 COPD diagnosed patients selected by a non-probabilistic method of sampling. Subjects will be randomly allocated into two groups, using the block randomization technique. Every patient in each group will be visited four times during the year of the study. Intervention: Motivational aspects related to adherence (beliefs and behaviour: group and individual interviews; cognitive aspects: information about illness; skills: inhaled technique training. Reinforcement of the cognitive-emotional aspects and inhaled technique training will be carried out in all visits of the intervention group. Discussion Adherence to a prescribed treatment involves a behavioural change. Cognitive, emotional and motivational aspects influence this change and so we consider the best intervention procedure to improve adherence would be a cognitive and emotional strategy which could be applied in daily clinical practice. Our hypothesis is that the application of a multifactor intervention (COPD information, dose reminders and reinforcing audiovisual material, motivational aspects and inhalation technique training to COPD patients taking inhaled treatment will give a 25% increase in the number of patients showing therapeutic adherence in this group compared to the control group. We will

  18. A randomized controlled trial examining the efficacy of motivational counseling with observed therapy for antiretroviral therapy adherence.

    Science.gov (United States)

    Goggin, Kathy; Gerkovich, Mary M; Williams, Karen B; Banderas, Julie W; Catley, Delwyn; Berkley-Patton, Jannette; Wagner, Glenn J; Stanford, James; Neville, Sally; Kumar, Vinutha K; Bamberger, David M; Clough, Lisa A

    2013-07-01

    This study determined whether motivational interviewing-based cognitive behavioral therapy (MI-CBT) adherence counseling combined with modified directly observed therapy (MI-CBT/mDOT) is more effective than MI-CBT counseling alone or standard care (SC) in increasing adherence over time. A three-armed randomized controlled 48-week trial with continuous electronic drug monitored adherence was conducted by randomly assigning 204 HIV-positive participants to either 10 sessions of MI-CBT counseling with mDOT for 24 weeks, 10 sessions of MI-CBT counseling alone, or SC. Poisson mixed effects regression models revealed significant interaction effects of intervention over time on non-adherence defined as percent of doses not-taken (IRR = 1.011, CI = 1.000-1.018) and percent of doses not-taken on time (IRR = 1.006, CI = 1.001-1.011) in the 30 days preceding each assessment. There were no significant differences between groups, but trends were observed for the MI-CBT/mDOT group to have greater 12 week on-time and worse 48 week adherence than the SC group. Findings of modest to null impact on adherence despite intensive interventions highlights the need for more effective interventions to maintain high adherence over time.

  19. Effects of eHealth interventions on medication adherence: a systematic review of the literature.

    NARCIS (Netherlands)

    Linn, A.J.; Vervloet, M.; Dijk, L. van; Smit, E.G.; Weert, J.C.M. van

    2011-01-01

    Background: Since medication nonadherence is considered to be an important health risk, numerous interventions to improve adherence have been developed. During the past decade, the use of Internet-based interventions to improve medication adherence has increased rapidly. Internet interventions have

  20. The initial feasibility of a computer-based motivational intervention for adherence for youth newly recommended to start antiretroviral treatment.

    Science.gov (United States)

    Outlaw, Angulique Y; Naar-King, Sylvie; Tanney, Mary; Belzer, Marvin E; Aagenes, Anna; Parsons, Jeffrey T; Merlo, Lisa J

    2014-01-01

    Young people represent the largest number of new HIV infections, thus youth living with HIV (YLH) are likely to be the largest group to initiate antiretroviral treatment (ART). Adherence patterns for behaviorally infected YLH are not adequate to effectively manage the disease; therefore, novel interventions are needed to improve medication adherence. The purpose of the current study, which will precede a randomized controlled trial, was to assess the initial feasibility of an individually tailored computer-based two-session interactive motivational interviewing (MI) intervention for YLH newly recommended to start ART. Intervention development occurred in collaboration with three youth advisory groups. Ten youth (ages 18-24) were recruited to participate in this study. Participants completed the intervention online. Intervention components focused on medication adherence (rating perceived importance and confidence, and goal setting). Retention was 100% for both intervention sessions. All participants (n=10) felt medication adherence was important, but 80% felt confident they could manage their adherence to HIV medications. Ninety percent of participants set the goal of taking their HIV medications exactly as prescribed and reported success achieving this goal at follow-up. Additionally, participants were satisfied with the quality of the sessions and the amount of assistance they received for managing their adherence to HIV medications (90% participants for Session 1; 89% for Session 2). Per exit interview responses, participants felt that the intervention made them think more about their health and was a motivator for them to take better care of their health. In conclusion, the intervention was feasible for YLH enrolled in the study.

  1. Predictors of adherence to a multifaceted podiatry intervention for the prevention of falls in older people

    OpenAIRE

    Landorf Karl B; Wee Elin; Fotoohabadi Mohammad R; Spink Martin J; Hill Keith D; Lord Stephen R; Menz Hylton B

    2011-01-01

    Abstract Background Despite emerging evidence that foot problems and inappropriate footwear increase the risk of falls, there is little evidence as to whether foot-related intervention strategies can be successfully implemented. The aim of this study was to evaluate adherence rates, barriers to adherence, and the predictors of adherence to a multifaceted podiatry intervention for the prevention of falls in older people. Methods The intervention group (n = 153, mean age 74.2 years) of a random...

  2. Feasibility of a Facebook Intervention for Exercise Motivation and Cardiac Rehabilitation Adherence: Study Protocol.

    Science.gov (United States)

    Siegmund, Lee Anne; Ahmed, Haitham M; Crawford, Michael Todd; Bena, James Frank

    2017-08-18

    recruitment goal is 60 cardiac rehabilitation patients. Data collection is anticipated to be complete by July 2018. This pilot study will be the first to examine the effect of a Facebook intervention on patient adherence and motivation for exercise in a cardiac rehabilitation setting. Engagement in the Facebook group and participation in the study will help to determine the feasibility of using Facebook to affect adherence and motivation in cardiac rehabilitation patients, potentially improving outcomes through the use of a unique intervention. ClinicalTrials.gov NCT02971813; https://clinicaltrials.gov/ct2/show/NCT02971813 (Archived by WebCite at http://www.webcitation.org/6sRsz8Zpa).

  3. Cognitive functioning, depression, and HIV medication adherence in India: a randomized pilot trial

    OpenAIRE

    Cook, Ryan; Waldrop-Valverde, Drenna; Sharma, Aman; Vamos, Szonja; Mahajan, Biraaj; Weiss, Stephen M.; Kumar, Mahendra; Nehra, Ritu; Jones, Deborah L

    2014-01-01

    Objective: India is home to the third-largest number of people living with HIV in the world, and no-cost antiretroviral therapy (ART) has been available across the country since 2004. However, rates of adherence to ART are often subpar in India, and interventions to increase adherence are warranted. Cognitive impairment and depression have been associated with ART non-adherence, and may also limit the impact of behavioral interventions designed to improve adherence. Studies have not evaluated...

  4. Interventions for enhancing medication compliance/adherence with benefits in treatment outcomes

    Directory of Open Access Journals (Sweden)

    Hagen, Anja

    2007-01-01

    Full Text Available Scientific background: Poor compliance or adherence in drug therapy can cause increased morbidity, mortality and enormous costs in the healthcare system (in Germany annually approximately 10 billion euros. Different methods are used for enhancing the compliance or adherence. Research questions: The evaluation addresses the questions about existence, efficacy, cost-benefit relation as well as ethical-social and juridical implications of strategies for enhancing compliance or adherence in drug therapy with concomitant improvements in treatment outcomes. Methods: A systematic literature search was conducted in the medical, also health economic relevant, literature databases in January 2007, beginning from 2002. Systematic reviews on the basis of (randomised controlled trials (RCT concerning interventions to enhance compliance or adherence with regard to treatment outcomes as well as systematic reviews of health economic analyses were included in the evaluation. Additionally, it was also searched for publications which primarily considered ethical-social and juridical aspects of these interventions for the German context. Results: One systematic review with data for 57 RCT was included in the medical evaluation and one systematic review with data for six studies into the health economic evaluation. No publication primary concerning ethical-social or juridical implications could be identified. A significant positive effect on the treatment outcome was reported for 22 evaluated interventions. For many interventions the results can be classified as reliable: counseling with providing an information leaflet and compliance diary chart followed by phone consultation for helicobacter pylori positive patients, repeated counseling for patients with acute asthma symptoms, telephone calls to establish the level of compliance and to make recommendations based on that for the therapy of cardiovascular diseases, calls of an automated telephone system with phone

  5. Understanding Patterns of Social Support and Their Relationship to an ART Adherence Intervention Among Adults in Rural Southwestern Uganda.

    Science.gov (United States)

    Atukunda, Esther C; Musiimenta, Angella; Musinguzi, Nicholas; Wyatt, Monique A; Ashaba, Justus; Ware, Norma C; Haberer, Jessica E

    2017-02-01

    SMS is a widely used technology globally and may also improve ART adherence, yet SMS notifications to social supporters following real-time detection of missed doses showed no clear benefit in a recent pilot trial. We examine the demographic and social-cultural dynamics that may explain this finding. In the trial, 63 HIV-positive individuals initiating ART received a real-time adherence monitor and were randomized to two types of SMS reminder interventions versus a control (no SMS). SMS notifications were also sent to 45 patient-identified social supporters for sustained adherence lapses. Like participants, social supporters were interviewed at enrollment, following their matched participant's adherence lapse and at exit. Social supporters with regular income (RR = 0.27, P = 0.001) were significantly associated with fewer adherence lapses. Instrumental support was associated with fewer adherence lapses only among social supporters who were food secure (RR = 0.58, P = 0.003). Qualitative interview data revealed diverse and complex economic and relationship dynamics, affecting social support. Resource availability in emotionally positive relationships seemingly facilitated helpful support, while limited resources prevented active provision of support for many. Effective social support appeared subject to social supporters' food security, economic stability and a well-functioning social network dependent on trust and supportive disclosure.

  6. Interventions to improve professional adherence to guidelines for prevention of device-related infections.

    Science.gov (United States)

    Flodgren, Gerd; Conterno, Lucieni O; Mayhew, Alain; Omar, Omar; Pereira, Cresio Romeu; Shepperd, Sasha

    2013-03-28

    Healthcare-associated infections (HAIs) are a major threat to patient safety, and are associated with mortality rates varying from 5% to 35%. Important risk factors associated with HAIs are the use of invasive medical devices (e.g. central lines, urinary catheters and mechanical ventilators), and poor staff adherence to infection prevention practices during insertion and care for the devices when in place. There are specific risk profiles for each device, but in general, the breakdown of aseptic technique during insertion and care for the device, as well as the duration of device use, are important factors for the development of these serious and costly infections. To assess the effectiveness of different interventions, alone or in combination, which target healthcare professionals or healthcare organisations to improve professional adherence to infection control guidelines on device-related infection rates and measures of adherence. We searched the following electronic databases for primary studies up to June 2012: the Cochrane Effective Paractice and Organisation of Care (EPOC) Group Specialised Register, the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, EMBASE, and CINAHL. We searched reference lists and contacted authors of included studies. We also searched the Cochrane Database of Systematic Reviews and Database of Abstracts of Reviews of Effectiveness (DARE) for related reviews. We included randomised controlled trials (RCTs), non-randomised controlled trials (NRCTs), controlled before-after (CBA) studies and interrupted time series (ITS) studies that complied with the Cochrane EPOC Group methodological criteria, and that evaluated interventions to improve professional adherence to guidelines for the prevention of device-related infections. Two review authors independently extracted data and assessed the risk of bias of each included study using the Cochrane EPOC 'Risk of bias' tool. We contacted authors of original papers to obtain

  7. Rationale and design of the Randomized Evaluation to Measure Improvements in Non-adherence from Low-Cost Devices (REMIND) trial.

    Science.gov (United States)

    Choudhry, Niteesh K; Krumme, Alexis A; Ercole, Patrick M; Girdish, Charmaine; Isaman, Danielle L; Matlin, Olga S; Brennan, Troyen A; Shrank, William H; Franklin, Jessica M

    2015-07-01

    Long-term adherence to prescription medications for the treatment of chronic disease remains low. While there are many contributors to suboptimal medication use, simple forgetfulness is widely believed to be central. Relatively simple devices may be a particularly cost-efficient and scalable way to promote adherence, however limited data exists about their ability to improve adherence in real-world settings. The REMIND trial is a prospective, intent-to-treat randomized control trial to evaluate the impact on medication adherence of three simple, low-cost devices (Take-N-Slide(™), the RxTimerCap(™), and a standard pillbox). In March 2014, we enrolled 53,480 individuals 18 to 64 years old taking one to three medications to treat chronic disease whose prescription drug benefits were administered by CVS Caremark. The study's primary outcome is optimal adherence over the 12-month period after randomization. Using a randomization ratio of 1:2 between control and each intervention arm, the study has more than 80% power with an alpha of 5% to detect a 1% difference in the rate of optimal adherence between intervention and control groups and across intervention arms. The REMIND trial is the first randomized study to rigorously evaluate the impact of simple, low-cost reminder devices on medication adherence. The results will inform comparative cost effectiveness studies of reminder systems in improving medication adherence and clinical outcomes. Copyright © 2015 Elsevier Inc. All rights reserved.

  8. Service delivery interventions to improve adolescents' linkage, retention and adherence to antiretroviral therapy and HIV care.

    Science.gov (United States)

    MacPherson, Peter; Munthali, Chigomezgo; Ferguson, Jane; Armstrong, Alice; Kranzer, Katharina; Ferrand, Rashida A; Ross, David A

    2015-08-01

    Adolescents living with HIV face substantial difficulties in accessing HIV care services and have worse treatment outcomes than other age groups. The objective of this review was to evaluate the effectiveness of service delivery interventions to improve adolescents' linkage from HIV diagnosis to antiretroviral therapy (ART) initiation, retention in HIV care and adherence to ART. We systematically searched the Medline, SCOPUS and Web of Sciences databases and conference abstracts from the International AIDS Conference and International Conference on AIDS and STIs in Africa (ICASA). Studies published in English between 1st January 2001 and 9th June 2014 were included. Two authors independently evaluated reports for eligibility, extracted data and assessed methodological quality using the Cochrane risk of bias tool and Newcastle-Ottawa Scale. Eleven studies from nine countries were eligible for review. Three studies were randomised controlled trials. Interventions assessed included individual and group counselling and education; peer support; directly observed therapy; financial incentives; and interventions to improve the adolescent-friendliness of clinics. Most studies were of low to moderate methodological quality. This review identified limited evidence on the effectiveness of service delivery interventions to support adolescents' linkage from HIV diagnosis to ART initiation, retention on ART and adherence to ART. Although recommendations are qualified because of the small numbers of studies and limited methodological quality, offering individual and group education and counselling, financial incentives, increasing clinic accessibility and provision of specific adolescent-tailored services appear promising interventions and warrant further investigation. © 2015 The Authors. Tropical Medicine & International Health Published by John Wiley & Sons Ltd.

  9. Behavioural treatment strategies improve adherence to lifestyle intervention programmes in adults with obesity: a systematic review and meta-analysis.

    Science.gov (United States)

    Burgess, E; Hassmén, P; Welvaert, M; Pumpa, K L

    2017-04-01

    Poor adherence to lifestyle intervention remains a key factor hindering treatment effectiveness and health outcomes for adults with obesity. The aim of this systematic review and meta-analysis is to determine if behavioural treatment strategies (e.g. goal setting, motivational interviewing, relapse prevention, cognitive restructuring etc.) improve adherence to lifestyle intervention programmes in adults with obesity. Randomized controlled trials that investigated the use of behavioural treatment strategies in obesity management were identified by systematically reviewing the literature within Medline, PsycINFO, CINAHL, SPORTDiscus and Web of Science from their inception to August 2016. This meta-analysis shows that behavioural treatment interventions have a significant positive effect on session attendance (percentage) and physical activity (total min/week) in adults with obesity (M = 17.63 (95% confidence interval (CI) = 10.77, 24.50), z =5.0337, P obesity. These strategies should be routinely incorporated into lifestyle intervention, obesity management and weight loss programmes with the aim of improving engagement and adherence. If adherence were improved, treatment effectiveness, health outcomes and the ultimate burden of chronic disease could also be improved.

  10. Improving adherence to venous thromoembolism prophylaxis using multiple interventions

    Directory of Open Access Journals (Sweden)

    Al-Tawfiq Jaffar

    2011-01-01

    Full Text Available Objective : In hospital, deep vein thrombosis (DVT increases the morbidity and mortality in patients with acute medical illness. DVT prophylaxis is well known to be effective in preventing venous thromoembolism (VTE. However, its use remains suboptimal. The objective of this study was to evaluate the impact of quality improvement project on adherence with VTE prophylaxis guidelines and on the incidence of hospital-acquired VTEs in medical patients. Methods : The study was conducted at Saudi Aramco Medical Services Organization from June 2008 to August 2009. Quality improvement strategies included education of physicians, the development of a protocol, and weekly monitoring of compliance with the recommendations for VTE prophylaxis as included in the multidisciplinary rounds. A feedback was provided whenever a deviation from the protocol occurs. Results : During the study period, a total of 560 general internal medicine patients met the criteria for VTE prophylaxis. Of those, 513 (91% patients actually received the recommended VTE prophylaxis. The weekly compliance rate in the initial stage of the intervention was 63% (14 of 22 and increased to an overall rate of 100% (39 of 39 (P = 0.002. Hospital-acquired DVT rate was 0.8 per 1000 discharges in the preintervention period and 0.5 per 1000 discharges in the postintervention period, P = 0.51. However, there was a significant increase in the time-free period of the VTE and we had 11 months with no single DVT. Conclusion : In this study, the use of multiple interventions increased VTE prophylaxis compliance rate.

  11. Persuasive system design does matter: a systematic review of adherence to web-based interventions.

    Science.gov (United States)

    Kelders, Saskia M; Kok, Robin N; Ossebaard, Hans C; Van Gemert-Pijnen, Julia E W C

    2012-11-14

    Although web-based interventions for promoting health and health-related behavior can be effective, poor adherence is a common issue that needs to be addressed. Technology as a means to communicate the content in web-based interventions has been neglected in research. Indeed, technology is often seen as a black-box, a mere tool that has no effect or value and serves only as a vehicle to deliver intervention content. In this paper we examine technology from a holistic perspective. We see it as a vital and inseparable aspect of web-based interventions to help explain and understand adherence. This study aims to review the literature on web-based health interventions to investigate whether intervention characteristics and persuasive design affect adherence to a web-based intervention. We conducted a systematic review of studies into web-based health interventions. Per intervention, intervention characteristics, persuasive technology elements and adherence were coded. We performed a multiple regression analysis to investigate whether these variables could predict adherence. We included 101 articles on 83 interventions. The typical web-based intervention is meant to be used once a week, is modular in set-up, is updated once a week, lasts for 10 weeks, includes interaction with the system and a counselor and peers on the web, includes some persuasive technology elements, and about 50% of the participants adhere to the intervention. Regarding persuasive technology, we see that primary task support elements are most commonly employed (mean 2.9 out of a possible 7.0). Dialogue support and social support are less commonly employed (mean 1.5 and 1.2 out of a possible 7.0, respectively). When comparing the interventions of the different health care areas, we find significant differences in intended usage (p=.004), setup (pdesign a web-based intervention to which patients are more likely to adhere.

  12. Treatment Adherence Intervention Studies in Dermatology and Guidance on How to Support Adherence

    NARCIS (Netherlands)

    Feldman, S.R.; Vrijens, B.; Gieler, U.; Piaserico, S.; Puig, L.; Kerkhof, P. van de

    2017-01-01

    Adequate adherence to prescribed treatment regimens can help to break the cycle of treatment failure, disease progression and subsequent treatment escalation. Unfortunately, adherence in the treatment of skin disorders such as acne, atopic dermatitis/eczema and psoriasis is often inadequate. A revie

  13. Supporting patients : pharmacy based interventions to improve medication adherence

    NARCIS (Netherlands)

    Kooij, M.J.

    2015-01-01

    For many patients it is not easy to adhere to the agreed treatment with medication. Adherence has been defined as “the extent to which a person’s behaviour - taking medication - corresponds with agreed recommendations from a health care provider”. Numerous factors influence this taking behaviour and

  14. Design of a randomized trial to evaluate the influence of mobile phone reminders on adherence to first line antiretroviral treatment in South India - the HIVIND study protocol

    Directory of Open Access Journals (Sweden)

    Kumarasamy Nagalingeswaran

    2010-03-01

    Full Text Available Abstract Background Poor adherence to antiretroviral treatment has been a public health challenge associated with the treatment of HIV. Although different adherence-supporting interventions have been reported, their long term feasibility in low income settings remains uncertain. Thus, there is a need to explore sustainable contextual adherence aids in such settings, and to test these using rigorous scientific designs. The current ubiquity of mobile phones in many resource-constrained settings, make it a contextually appropriate and relatively low cost means of supporting adherence. In India, mobile phones have wide usage and acceptability and are potentially feasible tools for enhancing adherence to medications. This paper presents the study protocol for a trial, to evaluate the influence of mobile phone reminders on adherence to first-line antiretroviral treatment in South India. Methods/Design 600 treatment naïve patients eligible for first-line treatment as per the national antiretroviral treatment guidelines will be recruited into the trial at two clinics in South India. Patients will be randomized into control and intervention arms. The control arm will receive the standard of care; the intervention arm will receive the standard of care plus mobile phone reminders. Each reminder will take the form of an automated call and a picture message. Reminders will be delivered once a week, at a time chosen by the patient. Patients will be followed up for 24 months or till the primary outcome i.e. virological failure, is reached, whichever is earlier. Self-reported adherence is a secondary outcome. Analysis is by intention-to-treat. A cost-effectiveness study of the intervention will also be carried out. Discussion Stepping up telecommunications technology in resource-limited healthcare settings is a priority of the World Health Organization. The trial will evaluate if the use of mobile phone reminders can influence adherence to first

  15. Long-term dietary intervention trials: critical issues and challenges

    Directory of Open Access Journals (Sweden)

    Crichton Georgina E

    2012-07-01

    Full Text Available Abstract Background There are many challenges involved in running randomised controlled dietary intervention trials that investigate health outcomes. The aim of this paper was to evaluate the recruitment process, retention of participants and challenges faced in our dairy intervention trial, and to provide strategies to combat the difficulties of running long-term dietary intervention trials. Methods A 12-month, randomised, two-way crossover study was conducted in overweight adults with habitually low dairy food consumption to assess the effects of a high dairy intake (4 servings of reduced-fat dairy per day compared with a low dairy intake (1 serving of reduced-fat dairy per day on measures of cardiometabolic and cognitive health. On completion of the high dairy intake phase, each participant was interviewed about their experience in the trial and responses were used to evaluate the key issues for study participants. Results Although the recruitment target was achieved, high rates of attrition (49.3% and difficulties maintaining participant compliance (reported by 37.8% of participants were major threats to the viability of the study. Factors that contributed to the high attrition included inability to comply with the dietary requirements of the study protocol (27.0%, health problems or medication changes (24.3% and time commitment (10.8%. Conclusion Attrition and adherence to study requirements present challenges to trials requiring longer-term dietary change. Including a run-in period to further assess the motivation, commitment and availability of participants, maintaining regular contact with participants during control phases, minimising time commitment, providing flexibility with dietary requirements, facilitating positive experiences, and stringent monitoring of diet are some key recommendations for future dietary intervention trials. Trial registration Australia and New Zealand Clinical Trials Registry (ACTRN 12608000538347

  16. Behavioral interventions to enhance adherence to hormonal therapy in breast cancer survivors: A systematic literature review

    Science.gov (United States)

    Hurtado-de-Mendoza, Alejandra; Cabling, Mark L.; Lobo, Tania; Dash, Chiranjeev; Sheppard, Vanessa B.

    2016-01-01

    Adjuvant hormonal therapy contributes to reductions in recurrence and mortality for women with hormone receptor positive breast cancer. However, adherence to hormonal therapy is suboptimal. This is the first systematic literature review examining interventions aimed at improving hormonal therapy adherence. Researchers followed the PRISMA guidelines. PubMed-Medline, CINAHL, PsychInfo, Ovid-Medline, and EMBASE were searched for behavioral interventions that aimed to enhance adherence to adjuvant hormonal therapy in breast cancer survivors. There were 376 manuscripts screened for eligibility. Five articles met criteria. All interventions presented adherence outcomes after one-year follow-up. None significantly enhanced adherence compared to the usual care in the primary analysis (OR ranged from 1.03 to 2.06 for adherence and from 1.11 – 1.18 for persistence). All targeted patients and three only included post-menopausal breast cancer patients. Three tested the same intervention consisting of educational materials. Only one was conducted in the US. Only one reported participants' ethnicity. Overall it was unclear whether the studies contained bias. The use of different terminology and operationalization of adherence made comparisons challenging. Interventions to improve adherence to adjuvant hormonal therapy in US breast cancer populations that includes survivors who are ethnically diverse, premenopausal, and taking tamoxifen are necessary to inform future interventions. Adoption of consistent adherence definitions/measurements will provide a clearer framework to consolidate aggregate findings. Given the limited efficacy of tested interventions, it is important to engage oncologists and academics to develop approaches that target different components associated with hormonal therapy adherence, such as doctor-patient communication or social support. PMID:27133733

  17. Improving Post-Discharge Medication Adherence in Patients with CVD: A Pilot Randomized Trial

    Directory of Open Access Journals (Sweden)

    Alfredo D. Oliveira-Filho

    2014-12-01

    Full Text Available Background: Effective interventions to improve medication adherence are usually complex and expensive. Objective: To assess the impact of a low-cost intervention designed to improve medication adherence and clinical outcomes in post-discharge patients with CVD. Method: A pilot RCT was conducted at a teaching hospital. Intervention was based on the four-item Morisky Medication Adherence Scale (MMAS-4. The primary outcome measure was medication adherence assessed using the eight-item MMAS at baseline, at 1 month post hospital discharge and re-assessed 1 year after hospital discharge. Other outcomes included readmission and mortality rates. Results: 61 patients were randomized to intervention (n = 30 and control (n = 31 groups. The mean age of the patients was 61 years (SD 12.73, 52.5% were males, and 57.4% were married or living with a partner. Mean number of prescribed medications per patient was 4.5 (SD 3.3. Medication adherence was correlated to intervention (p = 0.04 and after 1 month, 48.4% of patients in the control group and 83.3% in the intervention group were considered adherent. However, this difference decreased after 1 year, when adherence was 34.8% and 60.9%, respectively. Readmission and mortality rates were related to low adherence in both groups. Conclusion: The intervention based on a validated patient self-report instrument for assessing adherence is a potentially effective method to improve adherent behavior and can be successfully used as a tool to guide adherence counseling in the clinical visit. However, a larger study is required to assess the real impact of intervention on these outcomes.

  18. Mediterranean diet better adherence by digital intervention (MEDADIS study on overweight and obese patients.

    Directory of Open Access Journals (Sweden)

    Maria Loreto Tarraga Marcos

    2017-03-01

    Full Text Available Objective: To evaluate the impact of based behavioral interventions delivered by digital platform to increase adherence to Mediterranean diet and physical activity in overweight or obese patients detected by laboral health service. Methods: Randomized, controlled, double-blind, parallel clinical trial comparing 2 arms, multicenter study in overweight and obese patients with a 12-month follow-up. Patients were randomized into two groups: Intervention in Primary Care Centers with a Medtep telematic platform support (G2 and a control group that was allowed to evolve under normal conditions (G1.Variables were collected: Weight, height, BMI, waist circumference, lipid parameters, blood pressure and glycemia. Results: 120 patients were included in the study where 60 were randomized to Group 2 and 60 to Group 1. 58.6% of the study population were women and 41.4% were men. In the intervention group, the subjects reduced their weight by an average of 6.5 kg, while the control group increased slightly more than 1`5 kg. It is observed that total cholesterol was reduced in both groups. On the other hand Triglycerides were significantly reduced more in the study group, without achieving significant differences in the control group (p = 0.710. HDL cholesterol was increased in both groups. Conclusion: The group in which no intervention, weight gain normal evolution was made.

  19. Adherence in a pragmatic randomized controlled trial on prophylactic iron supplementation during pregnancy in Maputo, Mozambique.

    Science.gov (United States)

    Nwaru, Bright I; Salomé, Graça; Abacassamo, Fatima; Augusto, Orvalho; Cliff, Julie; Sousa, Cesar; Regushevskaya, Elena; Parkkali, Saara; Hemminki, Elina

    2015-04-01

    Assessing the level of adherence and its determinants is important in appraising the overall effectiveness of trials. The present study aimed to evaluate the extent of adherence and its determinants in a pragmatic randomized controlled trial of Fe prophylaxis during pregnancy in Maputo, Mozambique. A pragmatic randomized controlled trial. Two health centres (1° de Maio and Machava) in Maputo, Mozambique. Pregnant women (≥12 weeks' gestation, ≥18 years old, non-high-risk pregnancy; n 4326) attending prenatal care consultations at two health centres were randomized to receive routine Fe (n 2184; 60 mg ferrous sulfate plus 400 μg folic acid daily throughout pregnancy) or selective Fe (n 2142; screening and treatment for anaemia and daily intake of 1 mg folic acid). The level of adherence was 79% for having two or more visits, 53% for adequate prenatal care and 67% for complete intake of Fe/folic acid tablets during the trial. The correlation between the adherence measures ranged between 0·151 and 0·739. Adherence did not differ by trial arm, but there were centre differences in adequate prenatal visits and intake of tablets. Older women (>20 years) and those with a history of abortion were more likely to achieve greater adherence, whereas an increased number of previous births decreased the likelihood of adherence. HIV positivity decreased the likelihood of adherence in one trial centre and increased it in the other. The variation in adherence by trial centre, women's characteristics and outcome measures suggests that adherence in trials fully depends on participants' behaviour and can be increased by paying attention to contextual factors.

  20. Uptake and adherence to an online intervention for cancer-related distress: older age is not a barrier to adherence but may be a barrier to uptake.

    Science.gov (United States)

    Beatty, Lisa; Kemp, Emma; Binnion, Claire; Turner, Jane; Milne, Donna; Butow, Phyllis; Lambert, Sylvie; Yates, Patsy; Yip, Desmond; Koczwara, Bogda

    2017-06-01

    While online interventions are increasingly explored as an alternative to therapist-based interventions for cancer-related distress, limitations to efficacy potentially include low uptake and adherence. Few predictors of uptake or adherence to online interventions have been consistently identified, particularly in individuals with cancer. This study examined rates and predictors of uptake and adherence to Finding My Way, a RCT of an online intervention versus an information-only online control for cancer-related distress. Participants were adults with cancer treated with curative intent. Adherence was assessed by login frequency, duration and activity level; analyses examined demographic, medical and psychological predictors of uptake and adherence. The study enrolled 191 adults (aged 26-94 years) undergoing active treatment for cancer of any type. Uptake was highest for females and for individuals with ovarian (80%) and breast cancer (49.8%), and lowest for those with melanoma (26.5%). Adherence was predicted by older age and control-group allocation. Baseline distress levels did not predict adherence. High adherers to the full intervention had better emotion regulation and quality of life than low adherers. Uptake of online intervention varies according to age, gender and cancer type. While uptake was higher amongst younger individuals, once enrolled, older individuals were more likely to adhere to online interventions for cancer-related distress.

  1. Persuasive System Design Does Matter: A Systematic Review of Adherence to Web-Based Interventions

    Science.gov (United States)

    Kok, Robin N; Ossebaard, Hans C; Van Gemert-Pijnen, Julia EWC

    2012-01-01

    Background Although web-based interventions for promoting health and health-related behavior can be effective, poor adherence is a common issue that needs to be addressed. Technology as a means to communicate the content in web-based interventions has been neglected in research. Indeed, technology is often seen as a black-box, a mere tool that has no effect or value and serves only as a vehicle to deliver intervention content. In this paper we examine technology from a holistic perspective. We see it as a vital and inseparable aspect of web-based interventions to help explain and understand adherence. Objective This study aims to review the literature on web-based health interventions to investigate whether intervention characteristics and persuasive design affect adherence to a web-based intervention. Methods We conducted a systematic review of studies into web-based health interventions. Per intervention, intervention characteristics, persuasive technology elements and adherence were coded. We performed a multiple regression analysis to investigate whether these variables could predict adherence. Results We included 101 articles on 83 interventions. The typical web-based intervention is meant to be used once a week, is modular in set-up, is updated once a week, lasts for 10 weeks, includes interaction with the system and a counselor and peers on the web, includes some persuasive technology elements, and about 50% of the participants adhere to the intervention. Regarding persuasive technology, we see that primary task support elements are most commonly employed (mean 2.9 out of a possible 7.0). Dialogue support and social support are less commonly employed (mean 1.5 and 1.2 out of a possible 7.0, respectively). When comparing the interventions of the different health care areas, we find significant differences in intended usage (p = .004), setup (p persuasive technology elements, a substantial amount of variance in adherence can be explained. Although there are

  2. Individual and household predictors of adolescents' adherence to a web-based intervention.

    Science.gov (United States)

    Mâsse, Louise C; Watts, Allison W; Barr, Susan I; Tu, Andrew W; Panagiotopoulos, Constadina; Geller, Josie; Chanoine, Jean-Pierre

    2015-06-01

    Adherence to e-health obesity interventions is a significant challenge. We examined the individual and household predictors of adolescents' adherence to a Web-based lifestyle intervention. One hundred sixty overweight/obese adolescents and one of their parents enrolled in the 8-month e-health intervention. Structural equation modeling was used to examine individual factors from the theory of planned behavior and self-determination theory and household factors (food/soda availability, parenting, environment) that predict adolescents' adherence to components of the intervention. We explained 10.8 to 36.9% of the total variance in adherence to components of the intervention. Intrinsic motivation and parenting practices and styles directly predicted adherence. Relatedness and autonomy support indirectly predicted adherence via intrinsic motivation. Finally, household income modulated these effects. Taking a self-regulatory perspective (i.e., accounting for intrinsic motivation) contributes to our understanding of intervention adherence, but the household environment may play a greater role in facilitating adolescent behavior change.

  3. Effectiveness of Electronic Reminders to Improve Medication Adherence in Tuberculosis Patients: A Cluster-Randomised Trial.

    Directory of Open Access Journals (Sweden)

    Xiaoqiu Liu

    2015-09-01

    Full Text Available Mobile text messaging and medication monitors (medication monitor boxes have the potential to improve adherence to tuberculosis (TB treatment and reduce the need for directly observed treatment (DOT, but to our knowledge they have not been properly evaluated in TB patients. We assessed the effectiveness of text messaging and medication monitors to improve medication adherence in TB patients.In a pragmatic cluster-randomised trial, 36 districts/counties (each with at least 300 active pulmonary TB patients registered in 2009 within the provinces of Heilongjiang, Jiangsu, Hunan, and Chongqing, China, were randomised using stratification and restriction to one of four case-management approaches in which patients received reminders via text messages, a medication monitor, combined, or neither (control. Patients in the intervention arms received reminders to take their drugs and reminders for monthly follow-up visits, and the managing doctor was recommended to switch patients with adherence problems to more intensive management or DOT. In all arms, patients took medications out of a medication monitor box, which recorded when the box was opened, but the box gave reminders only in the medication monitor and combined arms. Patients were followed up for 6 mo. The primary endpoint was the percentage of patient-months on TB treatment where at least 20% of doses were missed as measured by pill count and failure to open the medication monitor box. Secondary endpoints included additional adherence and standard treatment outcome measures. Interventions were not masked to study staff and patients. From 1 June 2011 to 7 March 2012, 4,292 new pulmonary TB patients were enrolled across the 36 clusters. A total of 119 patients (by arm: 33 control, 33 text messaging, 23 medication monitor, 30 combined withdrew from the study in the first month because they were reassessed as not having TB by their managing doctor (61 patients or were switched to a different

  4. Methods for measuring, enhancing, and accounting for medication adherence in clinical trials.

    Science.gov (United States)

    Vrijens, B; Urquhart, J

    2014-06-01

    Adherence to rationally prescribed medications is essential for effective pharmacotherapy. However, widely variable adherence to protocol-specified dosing regimens is prevalent among participants in ambulatory drug trials, mostly manifested in the form of underdosing. Drug actions are inherently dose and time dependent, and as a result, variable underdosing diminishes the actions of trial medications by various degrees. The ensuing combination of increased variability and decreased magnitude of trial drug actions reduces statistical power to discern between-group differences in drug actions. Variable underdosing has many adverse consequences, some of which can be mitigated by the combination of reliable measurements of ambulatory patients' adherence to trial and nontrial medications, measurement-guided management of adherence, statistically and pharmacometrically sound analyses, and modifications in trial design. Although nonadherence is prevalent across all therapeutic areas in which the patients are responsible for treatment administration, the significance of the adverse consequences depends on the characteristics of both the disease and the medications.

  5. Adherence to Self-Care Interventions for Depression or Anxiety: A Systematic Review

    Science.gov (United States)

    Simco, Russell; McCusker, Jane; Sewitch, Maida

    2014-01-01

    Objective: The objective of this study was to synthesise and describe adherence to intervention in published studies of supported self-care for depression or anxiety, and to identify participant characteristics associated with higher adherence. Methods: We searched the databases EMBASE, MEDLINE, CINAHL, and PSYCINFO for the period from January…

  6. Nutrition Intervention Trials in Linxian, China

    Science.gov (United States)

    Randomized controlled trials were launched in 1985 to test the effects of multiple vitamin and mineral interventions on total mortality and total and cause-specific cancer mortality in a rural Chinese population

  7. Investigating a TELEmedicine solution to improve MEDication adherence in chronic Heart Failure (TELEMED-HF: study protocol for a randomized controlled trial

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    Widdershoven Jos

    2011-10-01

    Full Text Available Abstract Background Frequent rehospitalisations and poorer survival chances in heart failure (HF patients may partly be explained by poor medication adherence. There are multiple medication-related reasons for suboptimal adherence, but psychological reasons may also be important. A novel TELEmonitoring device may improve MEDication adherence in HF patients (TELEMED-HF. TELEMED-HF is a randomized, controlled clinical intervention trial designed to examine (1 the efficacy and cost-efficiency of an electronic medication adherence support system in improving and monitoring HF patients' medication adherence; (2 the effect of medication adherence on hospitalizations and health care consumption; as well as on (3 clinical characteristics, and Quality of Life (QoL; and (4 clinical, sociodemographic, and psychological determinants of medication adherence. Methods/Design Consecutive patients with chronic, systolic HF presenting to the outpatient clinic of the TweeSteden Hospital, The Netherlands, will be approached for study participation and randomly assigned (1:1 following blocked randomization procedures to the intervention (n = 200 or usual care arm (n = 200. Patients in the intervention arm use the medication support device for six months in addition to usual care. Post-intervention, patients return to usual care only and all patients participate in four follow-up occasions over 12 months. Primary endpoints comprise objective and subjective medication adherence, healthcare consumption, number of hospitalizations, and cost-effectiveness. Secondary endpoints include disease severity, physical functioning, and QoL. Discussion The TELEMED-HF study will provide us a comprehensive understanding of medication adherence in HF patients, and will show whether telemonitoring is effective and cost-efficient in improving adherence and preventing hospitalization in HF patients. Trial registration number NCT01347528.

  8. Refining a personalized mHealth intervention to promote medication adherence among HIV+ methamphetamine users.

    Science.gov (United States)

    Montoya, Jessica L; Georges, Shereen; Poquette, Amelia; Depp, Colin A; Atkinson, J Hampton; Moore, David J

    2014-01-01

    Mobile health (mHealth) interventions to promote antiretroviral therapy (ART) adherence have shown promise; however, among persons living with HIV who abuse methamphetamine (MA), effective tailoring of content to match the expressed needs of this patient population may be necessary. This study aimed (1) to understand patient perspectives of barriers and facilitators of ART adherence among people with HIV who use MA, and (2) to obtain feedback on the thematic content of an mHealth intervention in order to tailor the intervention to this subgroup. Two separate focus groups, each with 10 HIV+/MA+ individuals, were conducted. Transcribed audio recordings were qualitatively analyzed to identify emergent themes. Inter-rater reliability of themes was high (mean Kappa = .97). Adherence barriers included MA use, misguided beliefs about ART adherence, memory and planning difficulties, social barriers and perceived stigma, and mental heath issues. Facilitators of effective ART adherence were cognitive compensatory strategies, promotion of well-being, health-care supports, adherence education, and social support. Additionally, the focus groups generated content for reminder text messages to be used in the medication adherence intervention. This qualitative study demonstrates the feasibility of using focus groups to derive patient-centered intervention content to address the health challenge at hand in targeted populations.

  9. Impact of a chronic kidney disease registry and provider education on guideline adherence – a cluster randomized controlled trial

    Directory of Open Access Journals (Sweden)

    Drawz Paul E

    2012-07-01

    Full Text Available Abstract Background Low adherence to chronic kidney disease (CKD guidelines may be due to unrecognized CKD and lack of guideline awareness on the part of providers. The goal of this study was to evaluate the impact of provider education and access to a CKD registry on guideline adherence. Methods We conducted a cluster randomized controlled trial at the Louis Stokes Cleveland VAMC. One of two primary care clinics was randomized to intervention. Providers from both clinics received a lecture on CKD guidelines at study initiation. Providers in the intervention clinic were given access to and shown how to use a CKD registry, which identifies patients with CKD and is automatically updated daily. Eligible patients had at least one primary care visit in the last year, had CKD based on eGFR, and had not received renal replacement therapy. The primary outcome was parathyroid hormone (PTH adherence, defined by at least one PTH measurement during the 12 month study. Secondary outcomes were measurement of phosphorus, hemoglobin, proteinuria, achievement of goal blood pressure, and treatment with a diuretic or renin-angiotensin system blocker. Results There were 418 and 363 eligible patients seen during the study in the control and intervention clinics, respectively. Compared to pre-intervention, measurement of PTH increased in both clinics (control clinic: 16% to 23%; intervention clinic: 13% to 28%. Patients in the intervention clinic were more likely to have a PTH measured during the study (adjusted odds ratio = 1.53; 95% CI (1.01, 2.30; P = 0.04. However, the intervention was not associated with a consistent improvement in secondary outcomes. Only 5 of the 37 providers in the intervention clinic accessed the registry. Conclusions An intervention that included education on CKD guidelines and access to a CKD patient registry marginally improved guideline adherence over education alone. Adherence to the primary process measure improved in both

  10. A pilot randomized controlled clinical trial to improve antiepileptic drug adherence in young children with epilepsy.

    Science.gov (United States)

    Modi, Avani C; Guilfoyle, Shanna M; Mann, Krista A; Rausch, Joseph R

    2016-03-01

    The primary aim was to examine the preliminary efficacy of a family tailored problem-solving intervention to improve antiepileptic drug (AED) adherence in families of children with new-onset epilepsy. Secondary aims were to assess changes in targeted mechanisms and treatment feasibility and acceptability. Fifty families (M(age) = 7.6 ± 3.0; 80% Caucasian; 42% idiopathic localization related) completed baseline questionnaires and were given an electronic monitor to observe daily AED adherence. If adherence was ≤ 95% in the first 7 months of the study, families were randomized (Supporting Treatment Adherence Regimens (STAR): n = 11; Treatment as Usual (TAU): n = 12). Twenty-one families were not randomized due to adherence being ≥95%. The STAR intervention included four face-to-face and two telephone problem-solving sessions over 8 weeks. Significant group differences in adherence were found during active intervention (weeks 4-6; TAU = -12.0 vs. STAR = 18.1, p < 0.01; and weeks session 6-8: TAU = -9.7 vs. STAR = 15.3, p < 0.05). Children who received the STAR intervention exhibited improved adherence compared to children in the TAU group during active treatment. Significant changes in epilepsy knowledge and management were noted for the STAR group. Families expressed benefitting from the STAR intervention. Future studies should include a larger sample size and booster intervention sessions to maintain treatment effects over time.

  11. Motivational Interviewing (MINT) Improves Continuous Positive Airway Pressure (CPAP) Acceptance and Adherence: A Randomized Controlled Trial

    Science.gov (United States)

    Olsen, Sara; Smith, Simon S.; Oei, Tian P. S.; Douglas, James

    2012-01-01

    Objective: Adherence to continuous positive airway pressure (CPAP) therapy for obstructive sleep apnoea (OSA) is poor. We assessed the effectiveness of a motivational interviewing intervention (motivational interview nurse therapy [MINT]) in addition to best practice standard care to improve acceptance and adherence to CPAP therapy in people with…

  12. Text Messaging and Mobile Phone Apps as Interventions to Improve Adherence in Adolescents With Chronic Health Conditions: A Systematic Review.

    Science.gov (United States)

    Badawy, Sherif M; Barrera, Leonardo; Sinno, Mohamad G; Kaviany, Saara; O'Dwyer, Linda C; Kuhns, Lisa M

    2017-05-15

    The number of adolescents with chronic health conditions (CHCs) continues to increase. Medication nonadherence is a global challenge among adolescents across chronic conditions and is associated with poor health outcomes. While there has been growing interest in the use of mHealth technology to improve medication adherence among adolescents with CHCs, particularly text messaging and mobile phone apps, there has been no prior systematic review of their efficacy. The purpose of this review was to systematically evaluate the most recent evidence for the efficacy of text messaging and mobile phone apps as interventions to promote medication adherence among adolescents with CHCs. PubMed, Embase, CENTRAL, PsycINFO, Web of Science, Google Scholar, and additional databases were searched from 1995 until November 2015. An additional hand search of related themes in the Journal of Medical Internet Research was also conducted. The Preferred Reporting Results of Systematic Reviews and Meta-Analyses guidelines were followed. Two reviewers independently screened titles/abstracts, assessed full-text articles, extracted data from included articles, and assessed their quality using Grades of Recommendation, Assessment, Development, and Evaluation criteria. Included studies were described in original research articles that targeted adherence in adolescents with CHCs (12-24 years-old). Of the 1423 records examined, 15 met predefined criteria: text messaging (n=12) and mobile phone apps (n=3). Most studies were performed in the United States (11/15, 73%), were randomized-controlled trials (8/15, 53%), had a sample size mobile phone app interventions varied across studies. Seven articles (7/15, 47%) reported significant improvement in adherence with moderate to large standardized mean differences. Most of the included studies were of low or moderate quality. Studies varied in sample size, methods of adherence assessment, and definition of adherence, which prohibited performing a meta

  13. Cultural adaptation of a cognitive-behavioural intervention to improve adherence to antiretroviral therapy among people living with HIV/AIDS in Zimbabwe: Nzira Itsva.

    Science.gov (United States)

    Bere, Tarisai; Nyamayaro, Primrose; Magidson, Jessica F; Chibanda, Dixon; Chingono, Alfred; Munjoma, Ronald; Macpherson, Kirsty; Ndhlovu, Chiratidzo Ellen; O'Cleirigh, Conall; Kidia, Khameer; Safren, Steven A; Abas, Melanie

    2016-02-18

    Few evidence-based interventions to improve adherence to antiretroviral therapy have been adapted for use in Africa. We selected, culturally adapted and tested the feasibility of a cognitive-behavioural intervention for adherence and for delivery in a clinic setting in Harare, Zimbabwe. The intervention consisted of a single, 50-minute problem-solving cognitive-behavioural intervention session with four skill-based booster sessions, delivered by four lay adherence counsellors in the context of HIV care. Adaptation followed a theoretically driven approach to intervention adaptation, Assessment-Decision-Administration-Production-Topical Experts-Integration-Training-Testing (ADAPT-ITT), and included modifications to language, session length, tailoring content for delivery by lay counsellors and inclusion of culturally competent probes. The feasibility of the intervention was evaluated using a mixed-methods assessment, including ratings of provider fidelity of intervention delivery, and qualitative assessments of feasibility using individual semi-structured interviews with counsellors (n = 4) and patients (n = 15). The intervention was feasible and acceptable when administered to 42 patients and resulted in improved self-reported adherence in a subset of 15 patients who were followed up after 6 months. Next steps from this study include conducting a randomised control trial to evaluate the adapted intervention compared to standard of care in a larger sample over a long-term follow-up.

  14. Adherence and Attrition in a Web-Based Lifestyle Intervention for People with Metabolic Syndrome.

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    Leila Jahangiry

    2014-09-01

    Full Text Available The aim of this study was to determine adherence and attrition rates in a lifestyle intervention for people with metabolic syndrome.Adherence and attrition data from a randomized controlled trial were collected. Participants were classified as adherence group if they completed assessments at 3 and 6 months follow-up and as attrition group if they did not. Physical activity and quality of life was measured using the International Physical Activity Questionnaire (IPAQ and the Short Form Health Survey (SF-36. Generalized Estimating Equations (GEE was used to explore predictors of attrition.The mean age of participants (n=160 was 44.1 years. Attrition rate in the intervention and control groups at first follow-up were the same (20%. However, the control group had significantly higher attrition rate (%33.7 compared to the intervention group (%20 at 6 months follow up. Results showed that low educated participants were more likely to not stay in the study than better educated participants (OR=2.95,CI:1.39-6.33,P=0.05. According with length of the study, attrition was decreased at six month (OR=0.66,CI:0.52-0.83,P<0.001. Also, some aspects of health-related quality of life contributed to the attrition rate. Those who had higher scores on general health (OR=0.66,CI:0.54-0.97,P=0.023, social functioning (OR=0.44,CI:0.40-0.76,P=0.032, role emotional (OR=0.74,CI:0.54-0.98,P=0.18, vitality (OR=0.55,CI:0.38-0.90,P=0.015 and mental health (OR=0.63,CI:0.45-0.85,P=0.033 were more likely to stay in the study.It remains a concern that Web-based lifestyle programs may fail to reach those who need it most. Participant in the study generally had better quality of life than those who were lost to follow up.

  15. Effect of Reminder Devices on Medication Adherence: The REMIND Randomized Clinical Trial.

    Science.gov (United States)

    Choudhry, Niteesh K; Krumme, Alexis A; Ercole, Patrick M; Girdish, Charmaine; Tong, Angela Y; Khan, Nazleen F; Brennan, Troyen A; Matlin, Olga S; Shrank, William H; Franklin, Jessica M

    2017-05-01

    Forgetfulness is a major contributor to nonadherence to chronic disease medications and could be addressed with medication reminder devices. To compare the effect of 3 low-cost reminder devices on medication adherence. This 4-arm, block-randomized clinical trial involved 53 480 enrollees of CVS Caremark, a pharmacy benefit manager, across the United States. Eligible participants were aged 18 to 64 years and taking 1 to 3 oral medications for long-term use. Participants had to be suboptimally adherent to all of their prescribed therapies (with a medication possession ratio of 30% to 80%) in the 12 months before randomization. Participants were stratified on the basis of the medications they were using at randomization: medications for cardiovascular or other nondepression chronic conditions (the chronic disease stratum) and antidepressants (the antidepressant stratum). In each stratum, randomization occurred within blocks defined by whether all of the patient's targeted medications were dosed once daily. Patients were randomized to receive in the mail a pill bottle strip with toggles, digital timer cap, or standard pillbox. The control group received neither notification nor a device. Data were collected from February 12, 2013, through March 21, 2015, and data analyses were on the intention-to-treat population. The primary outcome was optimal adherence (medication possession ratio ≥80%) to all eligible medications among patients in the chronic disease stratum during 12 months of follow-up, ascertained using pharmacy claims data. Secondary outcomes included optimal adherence to cardiovascular medications among patients in the chronic disease stratum as well as optimal adherence to antidepressants. Of the 53 480 participants, mean (SD) age was 45 (12) years and 56% were female. In the primary analysis, 15.5% of patients in the chronic disease stratum assigned to the standard pillbox, 15.1% assigned to the digital timer cap, 16.3% assigned to the pill bottle

  16. Depression may reduce adherence during CPAP titration trial

    National Research Council Canada - National Science Library

    Law, Mandy; Naughton, Matthew; Ho, Sally; Roebuck, Teanau; Dabscheck, Eli

    2014-01-01

    Depression is a risk factor for medication non-compliance. We aimed to identify if depression is associated with poorer adherence during home-based autotitrating continuous positive airway pressure (autoPAP) titration...

  17. A systematic review of interventions addressing adherence to anti-diabetic medications in patients with type 2 diabetes--impact on adherence.

    Directory of Open Access Journals (Sweden)

    Sujata Sapkota

    Full Text Available The global prevalence of diabetes is increasing. Medications are a recommended strategy to control hyperglycaemia. However, patient adherence can be variable, impacting health outcomes. A range of interventions for patients with type 2 diabetes have focused on improving treatment adherence. This review evaluates the impact of these interventions on adherence to anti-diabetic medications and focuses on the methods and tools used to measure adherence.Medline, Embase, CINAHL, IPA, PUBmed, and PsychINFO were searched for relevant articles published in 2000-2013, using appropriate search terms.Fifty two studies addressing adherence to anti-diabetic medications in patients with type 2 diabetes met the inclusion criteria and were reviewed. Each study was assessed for research design, method(s used for measuring medication adherence, and impact of intervention on medication adherence and glycaemic control. Fourteen studies were published in 2000-2009 and 38 in 2010-2013. Twenty two interventions led to improvements in adherence to anti-diabetic medications, while only nine improved both medication adherence and glycaemic control. A single strategy could not be identified which would be guaranteed to improve anti-diabetic medication adherence consistently. Nonetheless, most interventions were successful in influencing one or more of the outcomes assessed, indicating the usefulness of these interventions under certain circumstances. Self-report, particularly the Summary of Diabetes Self-Care Activities questionnaire was the most commonly used tool to assess medication adherence, although other self-report tools were used in more recent studies. Overall, there was a slight increase in the number of studies that employed multiple methods to assess medication adherence in studies conducted after 2008.The diversity of interventions and adherence measurements prevented a meta-analysis of the impact of interventions on adherence to therapy, highlighting the

  18. A Systematic Review of Completeness of Reporting in Randomized Controlled Trials in Dermatologic Surgery: Adherence to CONSORT 2010 Recommendations.

    Science.gov (United States)

    Alam, Murad; Rauf, Mutahir; Ali, Sana; Patel, Parth; Schlessinger, Daniel I; Schaeffer, Matthew R; Yoo, Simon S; Minkis, Kira; Jiang, Shang I Brian; Maher, Ian A; Sobanko, Joseph F; Cartee, Todd V; Poon, Emily

    2016-12-01

    Randomized controlled trials are the gold standard for comparing safety and effectiveness of surgical interventions. Reporting guidelines are available for conveying the results of such trials. To assess adherence to standard reporting guidelines among randomized controlled trials in dermatologic surgery. Systematic review. Data source was randomized controlled trials in the journal Dermatologic Surgery, per PubMed search, 1995 to 2014. Studies were appraised for the number of the 37 CONSORT 2010 Checklist criteria reported in each. Analysis included comparison of reporting across 4 consecutive periods. Three hundred sixty-three studies were eligible. The mean number of items reported per study increased monotonically from 14.5 in 1995 to 1999 to 16.2 in 2002 to 2004, 17.7 in 2005 to 2009, and 18.0 in 2010 to 2014 (p dermatologic surgery has improved significantly during the preceding 2 decades. Some elements are still reported at lower rates.

  19. Getting inside acupuncture trials - Exploring intervention theory and rationale

    Directory of Open Access Journals (Sweden)

    Godfrey Mary

    2011-03-01

    Full Text Available Abstract Background Acupuncture can be described as a complex intervention. In reports of clinical trials the mechanism of acupuncture (that is, the process by which change is effected is often left unstated or not known. This is problematic in assisting understanding of how acupuncture might work and in drawing together evidence on the potential benefits of acupuncture. Our aim was to aid the identification of the assumed mechanisms underlying the acupuncture interventions in clinical trials by developing an analytical framework to differentiate two contrasting approaches to acupuncture (traditional acupuncture and Western medical acupuncture. Methods Based on the principles of realist review, an analytical framework to differentiate these two contrasting approaches was developed. In order to see how useful the framework was in uncovering the theoretical rationale, it was applied to a set of trials of acupuncture for fatigue and vasomotor symptoms, identified from a wider literature review of acupuncture and early stage breast cancer. Results When examined for the degree to which a study demonstrated adherence to a theoretical model, two of the fourteen selected studies could be considered TA, five MA, with the remaining seven not fitting into any recognisable model. When examined by symptom, five of the nine vasomotor studies, all from one group of researchers, are arguably in the MA category, and two a TA model; in contrast, none of the five fatigue studies could be classed as either MA or TA and all studies had a weak rationale for the chosen treatment for fatigue. Conclusion Our application of the framework to the selected studies suggests that it is a useful tool to help uncover the therapeutic rationale of acupuncture interventions in clinical trials, for distinguishing between TA and MA approaches and for exploring issues of model validity. English language acupuncture trials frequently fail to report enough detail relating to the

  20. The Effects of a Problem Solving-Based Intervention on Depressive Symptoms and HIV Medication Adherence Are Independent

    NARCIS (Netherlands)

    Gross, Robert; Bellamy, Scarlett L.; Chapman, Jennifer; Han, Xiaoyan; O'Duor, Jacqueline; Strom, Brian L.; Houts, Peter S.; Palmer, Steven C.; Coyne, James C.

    2014-01-01

    Depression and depressive symptoms predict poor adherence to medical therapy, but the association is complex, nonspecific, and difficult to interpret. Understanding this association may help to identify the mechanism explaining the results of interventions that improve both medical therapy adherence

  1. Micronutrient deficiency and treatment adherence in a randomized controlled trial of micronutrient supplementation in ART-naive persons with HIV.

    Directory of Open Access Journals (Sweden)

    Louise Balfour

    Full Text Available INTRODUCTION: The MAINTAIN study is an on-going RCT comparing high-dose micronutrient and anti-oxidant supplementation versus recommended daily allowance (RDA vitamins in slowing HIV immune deficiency progression in ART-naïve people with HIV infection. OBJECTIVE: We planned analysis of the first 127 participants to determine the baseline prevalence of serum micronutrient deficiencies and correlates, as well as tolerance and adherence to study interventions. METHODS: Participants receive eight capsules twice daily of 1 high-dose or 2 RDA supplements for two years and are followed-up quarterly for measures of immune deficiency progression, safety and tolerability. Regression analysis was used to identify correlates of micronutrient levels at baseline. Adherence was measured by residual pill count, self-report using the General Treatment Scale (GTS and short-term recall HIV Adherence Treatment Scale (HATS. RESULTS: Prior micronutrient supplementation (within 30 days was 27% at screening and 10% of study population, and was not correlated with baseline micronutrient levels. Low levels were frequent for carotene (24%80% in 75% of participants. CONCLUSION: Micronutrient levels in asymptomatic HIV+ persons are in keeping with population norms, but micronutrient deficiencies are frequent. Adherence levels are high, and will permit a valid evaluation of treatment effects. TRIAL REGISTRATION: ClinicalTrials.gov NCT00798772.

  2. Improving patient adherence to lifestyle advice (IMPALA): a cluster-randomised controlled trial on the implementation of a nurse-led intervention for cardiovascular risk management in primary care (protocol).

    NARCIS (Netherlands)

    Loon, M.S. Koelewijn-van; Steenkiste, B. van; Ronda, G.; Wensing, M.J.P.; Stoffers, H.E.; Elwyn, G.; Grol, R.P.T.M.; Weijden, T.T. van der

    2008-01-01

    BACKGROUND: Many patients at high risk of cardiovascular diseases are managed and monitored in general practice. Recommendations for cardiovascular risk management, including lifestyle change, are clearly described in the Dutch national guideline. Although lifestyle interventions, such as advice on

  3. Type 2 diabetes: cost-effectiveness of medication adherence and lifestyle interventions

    Directory of Open Access Journals (Sweden)

    Nerat T

    2016-10-01

    Full Text Available Tomaž Nerat, Igor Locatelli, Mitja Kos Faculty of Pharmacy, University of Ljubljana, Ljubljana, Slovenia Introduction: Type 2 diabetes is a major burden for the payer, however, with proper medication adherence, diet and exercise regime, complication occurrence rates, and consequently costs can be altered.Aims: The aim of this study was to conduct a cost-effectiveness analysis on real patient data and evaluate which medication adherence or lifestyle intervention is less cost demanding for the payer.Methods: Medline was searched systematically for published type 2 diabetes interventions regarding medication adherence and lifestyle in order to determine their efficacies, that were then used in the cost-effectiveness analysis. For cost-effectiveness analysis-required disease progression simulation, United Kingdom Prospective Diabetes Study Outcomes model 2.0 and Slovenian type 2 diabetes patient cohort were used. The intervention duration was set to 1, 2, 5, and 10 years. Complications and drug costs in euro (EUR were based on previously published type 2 diabetes costs from the Health Care payer perspective in Slovenia.Results: Literature search proved the following interventions to be effective in type 2 diabetes patients: medication adherence, the Mediterranean diet, aerobic, resistance, and combined exercise. The long-term simulation resulted in no payer net savings. The model predicted following quality-adjusted life-years (QALY gained and incremental costs for QALY gained (EUR/QALYg after 10 years of intervention: high-efficacy medication adherence (0.245 QALY; 9,984 EUR/QALYg, combined exercise (0.119 QALY; 46,411 EUR/QALYg, low-efficacy medication adherence (0.075 QALY; 30,967 EUR/QALYg, aerobic exercise (0.069 QALY; 80,798 EUR/QALYg, the Mediterranean diet (0.057 QALY; 27,246 EUR/QALYg, and resistance exercise (0.050 QALY; 111,847 EUR/QALYg.Conclusion: The results suggest that medication adherence intervention is, regarding cost

  4. Piloting behavioral family systems therapy to improve adherence among adolescents with HIV: a case series intervention study.

    Science.gov (United States)

    Gray, Wendy N; Janicke, David M; Fennell, Eileen B; Driscoll, Danielle C; Lawrence, Robert M

    2011-07-01

    Adolescents with HIV are at high risk for suboptimal adherence but have been ignored by the literature. Treatment outcome and feasibility data for the first-known adaptation of Behavioral Family Systems Therapy (BFST) targeting adherence among adolescents with HIV are presented for four adolescents with suboptimal adherence. The intervention was delivered in an alternating home-based and telehealth format and a multi-method adherence assessment approach was used. Adherence improved for three adolescents, viral load decreased for two adolescents, and barriers to adherence declined for all participants. Delivery of an adapted BFST intervention was acceptable to families and may be a promising treatment approach.

  5. Adherence to a physical activity intervention among older adults in a post-transitional middle income country: a quantitative and qualitative analysis

    Science.gov (United States)

    Garmendia, ML; Dangour, AD; Albala, C; Eguiguren, P; Allen, E; Uauy, R

    2017-01-01

    Objectives The effectiveness of community level interventions depends to a great extent on adherence. Currently, information on factors related to adherence in older adults from developing countries is scarce. Our aim was to identify factors associated to adherence to a physical activity intervention in older adults from a post-transitional middle income country. Design, setting and participants Using a combination of quantitative and qualitative methods we studied 996 older Chilean subjects (65-67.9 years at baseline) with low to medium socioeconomic status from 10 health centers randomized to receive a physical activity intervention as part of the CENEX cluster trial (ISRCTN48153354). Measurements Using a multilevel regression model, the relationship between adherence (defined a priori as attendance at a minimum of 24 physical activity classes spread over at least 12 months) and individual, intervention-related and contextual factors was evaluated. We also conducted 40 semi-structured interviews with older adults (n=36) and instructors (n=4). Transcripts of the interviews were analyzed using content analysis to identify barriers and facilitators to adherence. Results Adherence to physical activity intervention was 42.6% (CI 95% 39.5 to 45.6). Depression, diabetes mellitus, percentage of impoverished households and rate of arrests for violent crimes in the neighborhood predicted less adherence (pbenefits attributed to the intervention and the opportunity the classes provided for social interaction with others. Conclusion In order to enhance effectiveness of community exercise interventions, strategies to improve participation should be targeted to older adults from deprived areas and those with psychological and medical conditions. PMID:23636549

  6. Exploring 'generative mechanisms' of the antiretroviral adherence club intervention using the realist approach: a scoping review of research-based antiretroviral treatment adherence theories.

    Science.gov (United States)

    Mukumbang, Ferdinand C; Van Belle, Sara; Marchal, Bruno; van Wyk, Brian

    2017-05-04

    Poor retention in care and non-adherence to antiretroviral therapy (ART) continue to undermine the success of HIV treatment and care programmes across the world. There is a growing recognition that multifaceted interventions - application of two or more adherence-enhancing strategies - may be useful to improve ART adherence and retention in care among people living with HIV/AIDS. Empirical evidence shows that multifaceted interventions produce better results than interventions based on a singular perspective. Nevertheless, the bundle of mechanisms by which multifaceted interventions promote ART adherence are poorly understood. In this paper, we reviewed theories on ART adherence to identify candidate/potential mechanisms by which the adherence club intervention works. We searched five electronic databases (PubMed, EBSCOhost, CINAHL, PsycARTICLES and Google Scholar) using Medical Subject Headings (MeSH) terms. A manual search of citations from the reference list of the studies identified from the electronic databases was also done. Twenty-six articles that adopted a theory-guided inquiry of antiretroviral adherence behaviour were included for the review. Eleven cognitive and behavioural theories underpinning these studies were explored. We examined each theory for possible 'generative causality' using the realist evaluation heuristic (Context-Mechanism-Outcome) configuration, then, we selected candidate mechanisms thematically. We identified three major sets of theories: Information-Motivation-Behaviour, Social Action Theory and Health Behaviour Model, which explain ART adherence. Although they show potential in explaining adherence bebahiours, they fall short in explaining exactly why and how the various elements they outline combine to explain positive or negative outcomes. Candidate mechanisms indentified were motivation, self-efficacy, perceived social support, empowerment, perceived threat, perceived benefits and perceived barriers. Although these candidate

  7. A Narrative Review of Medication Adherence Educational Interventions for Health Professions Students.

    Science.gov (United States)

    Witry, Matthew J; LaFever, Michelle; Gu, Xiaomei

    2017-06-01

    Objective. To review published educational interventions focusing on medication non-adherence. Methods. A literature search was performed of educational articles on the topic of medication adherence. Data on interventions and learning assessments were abstracted for relevant studies meeting search criteria. Results. Twenty studies met inclusion criteria. Sixteen included pill-taking experiences with regimens of candies or placebos and varied in their inclusion of novel elements to highlight issues such as stigma, regimen complexity, and adherence measurement. Three studies involved interacting with the public. Qualitative and quantitative methods were used to assess a variety of learning outcomes. Conclusion. Pill-taking experiences can help future providers appreciate the complex logistics of medication-taking, but are less capable of addressing the psychosocial aspects of adherence. A promising area for learning is to interact with actual medication users to understand their experiences and perspectives.

  8. Self-reported adherence with the use of a device in a clinical trial as validated by electronic monitors: the VIBES study

    Directory of Open Access Journals (Sweden)

    Jeffrey Brianne A

    2012-11-01

    Full Text Available Abstract Background Adherences to treatments that require a behavioral action often rely on self-reported recall, yet it is vital to determine whether real time self reporting of adherence using a simple logbook accurately captures adherence. The purpose of this study was to determine whether real time self-reported adherence is an accurate measurement of device usage during a clinical trial by comparing it to electronic recording. Methods Using data collected from older adult men and women (N=135, mean age 82.3 yrs; range 66 to 98 yrs participating in a clinical trial evaluating a vibrating platform for the treatment of osteoporosis, daily adherence to platform treatment was monitored using both self-reported written logs and electronically recorded radio-frequency identification card usage, enabling a direct comparison of the two methods over one year. Agreement between methods was also evaluated after stratification by age, gender, time in study, and cognition status. Results The two methods were in high agreement (overall intraclass correlation coefficient = 0.96. The agreement between the two methods did not differ between age groups, sex, time in study and cognitive function. Conclusions Using a log book to report adherence to a daily intervention requiring a behavioral action in older adults is an accurate and simple approach to use in clinical trials, as evidenced by the high degree of concordance with an electronic monitor. Trial registration Clinicaltrials.gov NCT00396994

  9. Adherence to dietary recommendations for preschoolers: clinical trial with teenage mothers

    Science.gov (United States)

    Soldateli, Betina; Vigo, Alvaro; Giugliani, Elsa Regina Justo

    2016-01-01

    ABSTRACT OBJECTIVE To assess the effect of educational dietary intervention offered in the child’s first year of life, as well as teenage mothers and grandmothers in carrying out the dietary recommendations at four to seven years. METHODS Randomized clinical trial initiated in 2006, in Porto Alegre, RS, involving 323 teenage mothers and grandmothers who cohabited. The intervention consisted of six counseling sessions on breastfeeding and healthy complementary feeding. The first session occurred in the maternity ward and the other ones in the households of mothers at seven, 15, 30, 60, and 120 days of the child’s life. The information about the child’s diet were obtained on a monthly basis in the first six months, every two months in the second half-year, and at four to seven years, using a food frequency questionnaire. To assess the adequacy of food consumption to the recommendations from the Ministry of Health, we elaborated a score system that would reflect the compliance with the Ten Steps for Healthy Toddlers from 2 to 10 Years. The average scores of intervention and control groups were compared using the t-test. RESULTS Low adherence to recommendations on child nutrition was found in the study population, with no difference in implementation the steps between the groups. The score on the compliance with the steps was similar in both groups (9.6 [SD = 1.63] and 9.3 [SD = 1.60] in the intervention and control groups, respectively) and no influence of the cohabitation with the grandmother was found. CONCLUSIONS Educational dietary intervention in the first four months of the child’s life for teenage mothers and grandmothers had no effect on the compliance with the recommendations at four to seven years of the child’s life. PMID:28099665

  10. The patient education - Learning and Coping Strategies - improves adherence in cardiac rehabilitation (LC-REHAB): A randomised controlled trial.

    Science.gov (United States)

    Lynggaard, Vibeke; Nielsen, Claus Vinther; Zwisler, Ann-Dorthe; Taylor, Rod S; May, Ole

    2017-06-01

    Despite proven benefits of cardiac rehabilitation (CR), adherence to CR remains suboptimal. This trial aimed to assess the impact of the patient education 'Learning and Coping Strategies' (LC) on patient adherence to an eight-week CR program. 825 patients with ischaemic heart disease or heart failure were open label randomised to either the LC arm (LC plus CR) or the control arm (CR alone) across three hospital units in Denmark. Both arms received same amount of training and education hours. LC consisted of individual clarifying interviews, participation of experienced patients as co-educators, situational, reflective and inductive teaching. The control arm received structured deductive teaching. The primary outcomes were patient adherence to at least 75% of the exercise training or education sessions. We tested for subgroup effects on the primary outcomes using interaction terms. The primary outcomes were compared across arms using logistic regression. More patients in the LC arm adhered to at least 75% of the exercise training sessions than control (80% versus 73%, adjusted odds ratio (OR):1.48; 95% CI:1.07 to 2.05, P=0.018) and 75% of education sessions (79% versus 70%, adjusted OR:1.61, 1.17 to 2.22, P=0.003). Some evidence of larger effects of LC on adherence was seen for patients with heart failure, low education and household income. Addition of LC strategies improved adherence in rehabilitation both in terms of exercise training and education. Patients with heart failure, low levels of education and household income appear to benefit most from this adherence promoting intervention. www.clinicaltrials.gov identifier NCT01668394. Copyright © 2017 Elsevier B.V. All rights reserved.

  11. A randomized controlled trial comparing the effects of counseling and alarm device on HAART adherence and virologic outcomes.

    Directory of Open Access Journals (Sweden)

    Michael H Chung

    2011-03-01

    Full Text Available BACKGROUND: Behavioral interventions that promote adherence to antiretroviral medications may decrease HIV treatment failure. Antiretroviral treatment programs in sub-Saharan Africa confront increasing financial constraints to provide comprehensive HIV care, which include adherence interventions. This study compared the impact of counseling and use of an alarm device on adherence and biological outcomes in a resource-limited setting. METHODS AND FINDINGS: A randomized controlled, factorial designed trial was conducted in Nairobi, Kenya. Antiretroviral-naïve individuals initiating free highly active antiretroviral therapy (HAART in the form of fixed-dose combination pills (d4T, 3TC, and nevirapine were randomized to one of four arms: counseling (three counseling sessions around HAART initiation, alarm (pocket electronic pill reminder carried for 6 months, counseling plus alarm, and neither counseling nor alarm. Participants were followed for 18 months after HAART initiation. Primary study endpoints included plasma HIV-1 RNA and CD4 count every 6 months, mortality, and adherence measured by monthly pill count. Between May 2006 and September 2008, 400 individuals were enrolled, 362 initiated HAART, and 310 completed follow-up. Participants who received counseling were 29% less likely to have monthly adherence <80% (hazard ratio [HR] = 0.71; 95% confidence interval [CI] 0.49-1.01; p = 0.055 and 59% less likely to experience viral failure (HIV-1 RNA ≥5,000 copies/ml (HR 0.41; 95% CI 0.21-0.81; p = 0.01 compared to those who received no counseling. There was no significant impact of using an alarm on poor adherence (HR 0.93; 95% CI 0.65-1.32; p = 0.7 or viral failure (HR 0.99; 95% CI 0.53-1.84; p = 1.0 compared to those who did not use an alarm. Neither counseling nor alarm was significantly associated with mortality or rate of immune reconstitution. CONCLUSIONS: Intensive early adherence counseling at HAART initiation resulted

  12. Reproductive health education intervention trial.

    Science.gov (United States)

    Parwej, Saroj; Kumar, Rajesh; Walia, Indarjeet; Aggarwal, Arun K

    2005-04-01

    To measure the effectiveness of a reproductive health education package in improving the knowledge of adolescent girls aged 15-19 years in Chandigarh (India). A reproductive health education package, developed in consultation with parents, teachers and adolescents, was delivered to randomly sampled classes of two senior secondary schools and one school was selected as control. In one school, a nurse conducted 15 sessions for 94 students in three batches using conventional education approach. In another school she conducted sessions for a selected group of 20 adolescents who later disseminated the messages informally to their 84 classmates (peer education). Using a 70-item structured questionnaire the knowledge of 95 adolescents from conventional, 84 from peer, and 94 from control school were assessed before and one month after the last session. Change in the score in intervention and control groups was tested by ANOVA taking age and socio-economic status as covariates. Teachers, parents and students overwhelmingly (88%, 95.5% and 93% respectively) favoured reproductive health education program. Five percent of the respondents reported that someone in their class is having sexual relations, and 13% of the girls approved of pre-marital sexual relations. Reproductive health knowledge scores improved significantly after intervention in conventional education (27.28) and peer education group (20.77) in comparison to the controls (3.64). Post-test scores were not significantly different between peer education group and conventional education group (43.65 and 40.52 respectively) though the time consumed in delivering the peer education intervention was almost one third of the time taken to implement conventional education. Peer education and conventional education strategies were effective in improving the reproductive health knowledge of adolescent girls but peer strategy was less time consuming.

  13. Community Pharmacists Assisting in Total Cardiovascular Health (CPATCH): A Cluster-Randomized, Controlled Trial Testing a Focused Adherence Strategy Involving Community Pharmacies.

    Science.gov (United States)

    Blackburn, David F; Evans, Charity D; Eurich, Dean T; Mansell, Kerry D; Jorgenson, Derek J; Taylor, Jeff G; Semchuk, William M; Shevchuk, Yvonne M; Remillard, Alfred J; Tran, David A; Champagne, Anne P

    2016-10-01

    To test a brief intervention for preventing statin nonadherence among community pharmacy patrons. Prospective, cluster-randomized, controlled trial (the Community Pharmacists Assisting in Total Cardiovascular Health [CPATCH] trial). Thirty community pharmacies in Saskatchewan, Canada. Participating pharmacies were randomized to 15 intervention pharmacies where a brief statin adherence intervention was delivered by pharmacists (intervention group [907 patients]) or 15 usual care pharmacies where no statin adherence intervention was delivered (usual care group [999 patients]) to new users of statins (defined as less than 1 yr of statin therapy). Staff (pharmacy managers, staff pharmacists, and technicians) from intervention pharmacies attended a 2.5-hour workshop on the CPATCH program that prepared pharmacists to deal with the adherence barriers most likely associated with statin use (e.g., safety, cost, patient-provider relationship, and tolerability). Intervention pharmacists screened for new statin users and assessed these adherence barriers. Pharmacists were then instructed to tailor their follow-up plan based on the individual patient's situation. Investigators contacted the intervention pharmacies monthly to assess their compliance with the protocol and to offer additional support to motivate ongoing participation. The primary outcome was mean difference in statin adherence between the intervention and usual care groups. Adherence was measured by the proportion of days covered (PDC) between 6 and 12 months following the original prescription fill date. General estimating equations were used to evaluate the difference in mean adherence between groups. Secondary outcomes included the percentage of new statin users exhibiting optimal adherence (defined as PDC of 80% or higher) and the percentage exhibiting nonpersistence (defined as the cessation of all statin dispensations within 3 mo of the first dispensation). Among 1906 eligible patients, no significant

  14. Evaluating the effectiveness of health belief model interventions in improving adherence: a systematic review.

    Science.gov (United States)

    Jones, Christina Jane; Smith, Helen; Llewellyn, Carrie

    2014-01-01

    Lack of adherence to health-promoting advice challenges the successful prevention and management of many conditions. The Health Belief Model (HBM) was developed in 1966 to predict health-promoting behaviour and has been used in patients with wide variety of disease. The HBM has also been used to inform the development of interventions to improve health behaviours. Several reviews have documented the HBM's performance in predicting behaviour, but no review has addressed its utility in the design of interventions or the efficacy of these interventions. A systematic review was conducted to identify interventional studies which use the HBM as the theoretical basis for intervention design. The HBM has been used continuously in the development of behaviour change interventions for 40 years. Of 18 eligible studies, 14 (78%) reported significant improvements in adherence, with 7 (39%) showing moderate to large effects. However, only six studies used the HBM in its entirety and five different studies measured health beliefs as outcomes. Intervention success appeared to be unrelated to HBM construct addressed challenging the utility of this model as the theoretical basis for adherence-enhancing interventions. Interventions need to be described in full to allow for the identification of effective components and replication of studies.

  15. Type 2 diabetes: cost-effectiveness of medication adherence and lifestyle interventions

    Science.gov (United States)

    Nerat, Tomaž; Locatelli, Igor; Kos, Mitja

    2016-01-01

    Introduction Type 2 diabetes is a major burden for the payer, however, with proper medication adherence, diet and exercise regime, complication occurrence rates, and consequently costs can be altered. Aims The aim of this study was to conduct a cost-effectiveness analysis on real patient data and evaluate which medication adherence or lifestyle intervention is less cost demanding for the payer. Methods Medline was searched systematically for published type 2 diabetes interventions regarding medication adherence and lifestyle in order to determine their efficacies, that were then used in the cost-effectiveness analysis. For cost-effectiveness analysis-required disease progression simulation, United Kingdom Prospective Diabetes Study Outcomes model 2.0 and Slovenian type 2 diabetes patient cohort were used. The intervention duration was set to 1, 2, 5, and 10 years. Complications and drug costs in euro (EUR) were based on previously published type 2 diabetes costs from the Health Care payer perspective in Slovenia. Results Literature search proved the following interventions to be effective in type 2 diabetes patients: medication adherence, the Mediterranean diet, aerobic, resistance, and combined exercise. The long-term simulation resulted in no payer net savings. The model predicted following quality-adjusted life-years (QALY) gained and incremental costs for QALY gained (EUR/QALYg) after 10 years of intervention: high-efficacy medication adherence (0.245 QALY; 9,984 EUR/QALYg), combined exercise (0.119 QALY; 46,411 EUR/QALYg), low-efficacy medication adherence (0.075 QALY; 30,967 EUR/QALYg), aerobic exercise (0.069 QALY; 80,798 EUR/QALYg), the Mediterranean diet (0.057 QALY; 27,246 EUR/QALYg), and resistance exercise (0.050 QALY; 111,847 EUR/QALYg). Conclusion The results suggest that medication adherence intervention is, regarding cost-effectiveness, superior to diet and exercise interventions from the payer perspective. However, the latter could also be utilized

  16. Educational interventions for knowledge on the disease, treatment adherence and control of diabetes mellitus.

    Science.gov (United States)

    Figueira, Ana Laura Galhardo; Boas, Lilian Cristiane Gomes Villas; Coelho, Anna Claudia Martins; Freitas, Maria Cristina Foss de; Pace, Ana Emilia

    2017-04-20

    to assess the effect of educational interventions for knowledge on the disease, medication treatment adherence and glycemic control of diabetes mellitus patients. evaluation research with "before and after" design, developed in a sample of 82 type 2 diabetes mellitus patients. To collect the data, the Brazilian version of the Diabetes Knowledge Scale (DKN-A), the Measure of Adherence to Treatments and the electronic system at the place of study were used. The data were collected before and after the end of the educational interventions. The educational activities were developed within 12 months, mediated by the Diabetes Conversation Maps, using the Cognitive Social Theory to conduct the interventions. the knowledge on the disease (pknowledge about diabetes mellitus, the medication treatment adherence and the glycated hemoglobin rates.

  17. Adherence in single-parent households in a long-term asthma clinical trial.

    Science.gov (United States)

    Spicher, Mary; Bollers, Nancy; Chinn, Tamara; Hall, Anita; Plunkett, Anne; Rodgers, Denise; Sundström, D A; Wilson, Laura

    2012-01-01

    Adherence of participants in a long-term clinical trial is necessary to assure validity of findings. This article examines adherence differences between single-parent and two-parent families in the Childhood Asthma Management Program (CAMP). Adherence was defined as the percentage of completed daily diary cards and scheduled study visits during the course of the trial. Logistic regression and ordinal logistic regression analyses were used. Children from single-parent families had a lower percentage of completed diary cards (72% vs. 84%) than two-parent families. Single-parent families were also more likely to reschedule visits (62% vs. 45%) and miss more clinic visits (23% vs. 17%) than two-parent families. Suggestions are given for study coordinators to assist participants in completing a long-term clinical trial. Many suggestions may be adapted for nurses in inpatient or outpatient settings for assisting parents of patients with chronic diseases.

  18. Development of a Patient-Centered Antipsychotic Medication Adherence Intervention

    Science.gov (United States)

    Pyne, Jeffrey M.; Fischer, Ellen P.; Gilmore, LaNissa; McSweeney, Jean C.; Stewart, Katharine E.; Mittal, Dinesh; Bost, James E.; Valenstein, Marcia

    2014-01-01

    Objective: A substantial gap exists between patients and their mental health providers about patient's perceived barriers, facilitators, and motivators (BFMs) for taking antipsychotic medications. This article describes how we used an intervention mapping (IM) framework coupled with qualitative and quantitative item-selection methods to…

  19. Interventions to increase medication adherence in African-American and Latino populations: a literature review.

    Science.gov (United States)

    Hu, Daniel; Juarez, Deborah Taira; Yeboah, Michelle; Castillo, Theresa P

    2014-01-01

    The objective of this systematic review was to investigate the effectiveness of interventions to improve medication adherence in ethnic minority populations. A literature search from January 2000 to August 2012 was conducted through PubMed/Medline, Web of Science, The Cochrane Library, and Google Scholar. Search terms used included: medication (MeSH), adherence, medication adherence (MeSH), compliance (MeSH), persistence, race, ethnicity, ethnic groups (MeSH), minority, African-American, Hispanic, Latino, Asian, Pacific Islander, and intervention. Studies which did not have ≥75% of the sample population comprised of individuals of any one ethnic background were excluded, unless the authors performed sub-group analyses by race/ethnicity. Of the 36 studies identified, 20 studies showed significant post-intervention differences. Sample population sizes ranged from 10 to 520, with a median of 126.5. The studies in this review were conducted with patients of mainly African-American and Latino descent. No studies were identified which focused on Asians, Pacific Islanders, or Native Americans. Interventions demonstrating mixed results included motivational interviewing, reminder devices, community health worker (CHW) delivered interventions, and pharmacist-delivered interventions. Directly observed therapy (DOT) was a successful intervention in two studies. Interventions which did not involve human contact with patients were ineffective. In this literature review, studies varied significantly in their methods and design as well as the populations studied. There was a lack of congruence among studies in the way adherence was measured and reported. No single intervention has been seen to be universally successful, particularly for patients from ethnic minority backgrounds.

  20. Standard care quality determines treatment outcomes in control groups of HAART-adherence intervention studies: implications for the interpretation and comparison of intervention effects.

    Science.gov (United States)

    de Bruin, Marijn; Viechtbauer, Wolfgang; Hospers, Harm J; Schaalma, Herman P; Kok, Gerjo

    2009-11-01

    Clinical trials of behavioral interventions seek to enhance evidence-based health care. However, in case the quality of standard care provided to control conditions varies between studies and affects outcomes, intervention effects cannot be directly interpreted or compared. The objective of the present study was to examine whether standard care quality (SCQ) could be reliably assessed, varies between studies of highly active antiretroviral HIV-adherence interventions, and is related to the proportion of patients achieving an undetectable viral load ("success rate"). Databases were searched for relevant articles. Authors of selected studies retrospectively completed a checklist with standard care activities, which were coded to compute SCQ scores. The relationship between SCQ and the success rates was examined using meta-regression. Cronbach's alpha, variability in SCQ, and relation between SCQ and success rate. Reliability of the SCQ instrument was high (Cronbach's alpha = .91). SCQ scores ranged from 3.7 to 27.8 (total range = 0-30) and were highly predictive of success rate (p = .002). Variation in SCQ provided to control groups may substantially influence effect sizes of behavior change interventions. Future trials should therefore assess and report SCQ, and meta-analyses should control for variability in SCQ, thereby producing more accurate estimates of the effectiveness of behavior change interventions. PsycINFO Database Record (c) 2009 APA, all rights reserved.

  1. The impact of supervision on stock management and adherence to treatment guidelines: a randomized controlled trial.

    Science.gov (United States)

    Trap, B; Todd, C H; Moore, H; Laing, R

    2001-09-01

    Ensuring the availability of essential drugs and using them appropriately are crucial if limited resources for health care are to be used optimally. While training of health workers throughout Zimbabwe in drug management (including stock management and rational drug use) resulted in significant improvements in a variety of drug use indicators, these achievements could not be sustained, and a new strategy was introduced based on the supervision of primary health care providers. This was launched in 1995 with a training course in supervisory skills for district pharmacy staff. In order to evaluate the impact of the supervision and the effectiveness of the training programme, adherence to standard treatment guidelines (STG) and stock management protocols was evaluated in a randomized controlled trial. The study compared three different groups of health facilities: those that received supervision for either use of STG (n = 23) or stock management (n = 21) - each facility acting as control for the other area of supervision - and a comparison group of facilities which received no supervision (n = 18). On-the-spot supervision by a specially trained pharmacy staff, based around identified deficiencies, took place at the start of the study and 3 months later. The evaluation compared performance on a variety of drug management indicators at baseline and 6-8 months after the second supervisory visit. The results of the study showed that, following supervision, overall stock management improved significantly when compared with the control and comparison groups. Similar improvements were demonstrated for adherence to STG, although the effect was confounded by other interventions. The study also showed that supervision has a positive effect on improving performance in areas other than those supervised, and demonstrated that pharmacy technicians with limited clinical skills can be trained to influence primary health care workers to positively improve prescribing practices

  2. Adherence to the obesity-related lifestyle intervention targets in the IDEFICS study

    OpenAIRE

    E. Kovács; Siani, A; Konstabel, K; Hadjigeorgiou, C; De Bourdeaudhuij, Ilse; Eiben, G.; Lissner, L.; Gwozdz, W; Reisch, L.; Pala, V.; Moreno, LA; Pigeot, I; Pohlabeln, H; Ahrens, W.; Molnár, D

    2014-01-01

    Background/objectives: To address behaviours associated with childhood obesity, certain target values are recommended that should be met to improve children's health. In the IDEFICS (Identification and prevention of Dietary- and lifestyle-induced health Effects in Children and infantS) study such lifestyle recommendations were conveyed as six key messages. Here, we investigate the adherence of European children to these messages. Methods: The IDEFICS intervention was based on the intervention...

  3. Standard Care Impact on Effects of Highly Active Antiretroviral Therapy Adherence Interventions

    NARCIS (Netherlands)

    Bruin, de M.; Viechtbauer, W.; Schaalma, H.P.; Kok, G.; Abraham, C.; Hospers, H.J.

    2010-01-01

    BACKGROUND: Poor adherence to medication limits the effectiveness of treatment for human immunodeficiency virus. Systematic reviews can identify practical and effective interventions. Meta-analyses that control for variability in standard care provided to control groups may produce more accurate est

  4. Technology and adherence in web-based interventions for weight control: a systematic review

    NARCIS (Netherlands)

    Kelders, Saskia M.; Kok, Robin N.; Gemert-Pijnen, van Julia E.W.C.; Haugtvedt, C.P.; Stibe, A.

    2011-01-01

    While technology based health interventions can be effective, high attrition rates are commonly observed in research and practice and are a major issue in eHealth. Research on adherence has recently gained some scientific attention, but little has been done as to how technology itself engages users.

  5. Participant-Reported Symptoms and Their Effect on Long-Term Adherence in the International Breast Cancer Intervention Study I (IBIS I).

    Science.gov (United States)

    Smith, Samuel George; Sestak, Ivana; Howell, Anthony; Forbes, John; Cuzick, Jack

    2017-08-10

    Purpose To assess the role of participant-reported symptoms on long-term adherence to preventive therapy in the United Kingdom sample of the International Breast Cancer Intervention Study (IBIS-I). IBIS-I was a randomized controlled trial that investigated the effectiveness of tamoxifen in reducing the risk of breast cancer among women at increased risk of the disease. Participants and Methods Women were randomly assigned to tamoxifen versus placebo (20 mg/day; n = 4,279). After 456 exclusions, 3,823 women were included in this analysis. Adherence (adherent for at least 4.5 years (tamoxifen: 65.2% v placebo: 74.0%; P adherence between treatment arms were observed from 12 months onward (all P adherent in both the tamoxifen (odds ratio [OR], 0.57; 95% CI, 0.37 to 0.86; P = .007) and placebo (OR, 0.58; 95% CI, 0.37 to 0.93; P = .023) arms. Headaches were associated with adherence only in the placebo arm (OR, 0.62; 95% CI, 0.42 to 0.91; P = .016), whereas gynecologic symptoms were significant only in the tamoxifen arm (OR, 0.77; 95% CI, 0.62 to 0.97; P = .024). Effect sizes for each symptom on adherence were not significantly different between the treatment groups ( P > .05). In both treatment arms, we observed significant trends for lower adherence with increasing severity for all symptoms ( P adherence. Effects were similar between treatment arms, suggesting that women were attributing age-related symptoms to preventive therapy. Interventions were required to support symptom management.

  6. ‘It’s not about money, it’s about my health’: determinants of participation and adherence among women in an HIV-HSV2 prevention trial in Johannesburg, South Africa

    Directory of Open Access Journals (Sweden)

    MacPhail C

    2012-08-01

    Full Text Available Catherine MacPhail,1 Sinead Delany-Moretlwe,1 Philippe Mayaud21Wits Reproductive Health and HIV Institute, School of Clinical Medicine, Faculty of Health Sciences, University of the Witwatersrand, South Africa; 2Faculty of Infectious and Tropical Diseases, London School of Hygiene and Tropical Medicine, London, UKAbstract: High levels of adherence in clinical trials are essential for producing accurate intervention efficacy estimates. Adherence to clinical trial products and procedures is dependent on the motivations that drive participants. Data are presented to document reasons for trial participation and adherence to daily aciclovir for HSV-2 and HIV-1 genital shedding suppression among 300 HIV-1/HSV-2 seropositive women in South Africa. In-depth interviews after exit from the trial with 31 randomly selected women stratified by age and time since HIV diagnosis confirmed high levels of adherence measured during the trial. Main reasons for trial participation were related to seeking high-quality health care, which explains high levels of adherence in both study arms. Concerns that women would abuse reimbursements, fabricate data, and share or dump pills were not corroborated. Altruism is not a primary motivator in these settings where access to quality services is an issue. This study provides further evidence that good adherence of daily medication is possible in developing countries, particularly where study activities resonate with participants or fill an unmet need.Keywords: adherence, trial, HIV prevention, South Africa

  7. Improving medication adherence with a targeted, technology-driven disease management intervention.

    Science.gov (United States)

    Lawrence, David B; Allison, Wanda; Chen, Joyce C; Demand, Michael

    2008-06-01

    Treatment adherence is critical in managing chronic disease, but achieving it remains an elusive goal across many prevalent conditions. As part of its care management strategy, BlueCross BlueShield of South Carolina (BCBSSC) implemented the Longitudinal Adherence Treatment Evaluation program, a behavioral intervention to improve medication adherence among members with cardiovascular disease and/or diabetes. The objectives of this study were to 1) assess the effectiveness of telephonic intervention in influencing reinitiation of medication therapy, and 2) evaluate the rate and timing of medication reinitiation. BCBSSC applied algorithms against pharmacy claims data to identify patients prescribed targeted medications who were 60 or more days overdue for refills. This information was provided to care managers to address during their next patient contact. Care managers received focused training on techniques for medication behavior change, readiness to change, motivational interviewing, and active listening. Training also addressed common barriers to adherence and available resources, including side effect management, mail order benefits, drug assistance programs, medication organizers, and reminder systems. Overdue refills were tracked for 12 months, with medication reinitiation followed for an additional 3 months. In the intervention group, 94 patients were identified with 123 instances of late medication refills. In the age- and gender-matched comparison group, 61 patients were identified with 76 late refills. The intervention group had a significantly higher rate of medication reinitiation (59.3%) than the control group (42.1%; P management intervention promoting patient behavior change increased the number of patients who reinitiated therapy after a period of nonadherence and decreased the time from nonadherence to adherence.

  8. Predictors of Medication Adherence in an AIDS Clinical Trial: Patient and Clinician Perceptions

    Science.gov (United States)

    Cox, Lisa E.

    2009-01-01

    This article presents data from an AIDS clinical trial that evaluated 238 (60 percent nonwhite) patients infected with HIV and their clinician's perceptions of medication adherence and visit attendance in relationship to lifestyle, psychosocial, and health belief model (HBM) variables. Twelve sites collected data via a prospective, multisite…

  9. An interdisciplinary framework for measuring and supporting adherence in HIV prevention trials of ARV-based vaginal rings

    Directory of Open Access Journals (Sweden)

    Kathleen M MacQueen

    2014-09-01

    Full Text Available Introduction: Product adherence and its measurement have emerged as a critical challenge in the evaluation of new HIV prevention technologies. Long-acting ARV-based vaginal rings may simplify use instructions and require less user behaviour, thereby facilitating adherence. One ARV-based ring is in efficacy trials and others, including multipurpose rings, are in the pipeline. Participant motivations, counselling support and measurement challenges during ring trials must still be addressed. In previous HIV prevention trials, this has been done largely using descriptive and post-hoc methods that are highly variable and minimally evaluated. We outline an interdisciplinary framework for systematically investigating promising strategies to support product uptake and adherence, and to measure adherence in the context of randomized, blinded clinical trials. Discussion: The interdisciplinary framework highlights the dual use of adherence measurement (i.e. to provide feedback during trial implementation and to inform interpretation of trial findings and underscores the complex pathways that connect measurement, adherence support and enacted adherence behaviour. Three inter-related approaches are highlighted: 1 adherence support – sequential efforts to define motivators of study product adherence and to develop, test, refine and evaluate adherence support messages; 2 self-reported psychometric measures – creation of valid and generalizable measures based in easily administered scales that capture vaginal ring use with improved predictive ability at screening, baseline and follow-up that better engage participants in reporting adherence; and 3 more objective measurement of adherence – real-time adherence monitoring and cumulative measurement to correlate adherence with overall product effectiveness through innovative designs, models and prototypes using electronic and biometric technologies to detect ring insertion and/or removal or expulsion

  10. A randomized trial of lottery-based incentives and reminders to improve warfarin adherence: the Warfarin Incentives (WIN2) Trial.

    Science.gov (United States)

    Kimmel, Stephen E; Troxel, Andrea B; French, Benjamin; Loewenstein, George; Doshi, Jalpa A; Hecht, Todd E H; Laskin, Mitchell; Brensinger, Colleen M; Meussner, Chris; Volpp, Kevin

    2016-11-01

    Previous research has suggested that daily lottery incentives could improve medication adherence. Such daily incentives include implicit reminders. However, the comparative effectiveness of reminders alone versus daily incentives has not been tested. A total of 270 patients on warfarin were enrolled in a four-arm, multi-center, randomized controlled trial comparing a daily lottery-based incentive, a daily reminder, and a combination of the two against a control group (usual care). Participants in the reminder group had the lowest percentage of time out of target international normalized ratio (INR) range, the primary outcome, with an adjusted odds of an out-of-range INR 36% lower than among those in the control group, 95%CI [7%, 55%]. No other group had a statistically significant improvement in anticoagulation control relative to the control group or to each other. The only group that had significant improvement in incorrect adherence was the lottery group (incorrect adherence: 12.1% compared with 23.7% in the control group, difference of -7.4% 95%CI [-14%, -0.3%]). However, there was no relationship between changes in adherence and anticoagulation control in the lottery group. Automated reminders led to the largest improvements in anticoagulation control, although without impacting measured adherence. Lottery-based reminders improved measured adherence but did not lead to improved anticoagulation control. Copyright © 2016 John Wiley & Sons, Ltd. Copyright © 2016 John Wiley & Sons, Ltd.

  11. Improving adherence to antiretroviral treatment in Uganda with a low-resource facility-based intervention

    Directory of Open Access Journals (Sweden)

    Celestino Obua

    2014-06-01

    Full Text Available Objective: To assess the effects of facility-based interventions using existing resources to improve overall patient attendance and adherence to antiretroviral therapy (ART at ART-providing facilities in Uganda. Methods: This was an interventional study which tracked attendance and treatment adherence of two distinct cohorts: experienced patients who had been on treatment for at least 12 months prior to the intervention and patients newly initiated on ART before or during the intervention. The interventions included instituting appointment system, fast-tracking, and giving longer prescriptions to experienced stable patients. Mixed-effects models were used to examine intervention effects on the experienced patients, while Cox proportional hazards models were used to determine the intervention effects on time until newly treated patients experienced gaps in medication availability. Results: In all, 1481 patients’ files were selected for follow-up from six facilities – 720 into the experienced cohort, and 761 into the newly treated cohort. Among patients in the experienced cohort, the interventions were associated with a significant reduction from 24.4 to 20.3% of missed appointments (adjusted odds ratio (AOR: 0.67; 95% confidence interval (CI: 0.59–0.77; a significant decrease from 20.2 to 18.4% in the medication gaps of three or more days (AOR: 0.69; 95% CI: 0.60–0.79; and a significant increase from 4.3 to 9.3% in the proportion of patients receiving more than 30 days of dispensed medication (AOR: 2.35; 95% CI: 1.91–2.89. Among newly treated patients, the interventions were associated with significant reductions of 44% (adjusted hazard rate (AHR: 0.56, 95% CI: 0.42–0.74 and 38% (AHR: 0.62; 95% CI: 0.45–0.85 in the hazards of experiencing a medication gap of 7 and 14 days or more, respectively. Conclusions: Patients’ adherence was improved with low-cost and easily implemented interventions using existing health facilities

  12. Trial Protocol: Using genotype to tailor prescribing of nicotine replacement therapy: a randomised controlled trial assessing impact of communication upon adherence

    Directory of Open Access Journals (Sweden)

    Prevost A Toby

    2010-11-01

    % confidence interval for observed between-arm difference in mean NRT consumption (Hypothesis I. Motivation to make another quit attempt will be compared between arms in those failing to quit by six months (Hypothesis II. Discussion This is the first clinical trial evaluating the behavioural impact on adherence of prescribing medication using genetic rather than phenotypic information. Specific issues regarding the choice of design for trials of interventions of this kind are discussed. Trial details Funder: Medical Research Council (MRC Grant number: G0500274 ISRCTN: 14352545 Date trial stated: June 2007 Expected end date: December 2009 Expected reporting date: December 2010

  13. eHealth Technologies as an Intervention to Improve Adherence to Topical Antipsoriatics

    DEFF Research Database (Denmark)

    Svendsen, Mathias Tiedemann; Andersen, Flemming; Andersen, Klaus Ejner

    2017-01-01

    Health interventions designed to improve adherence to topical antipsoriatics and to review applications for smartphones (apps) incorporating the word psoriasis. MATERIAL AND METHODS: Literature review: Medline, Embase, Cochrane, PsycINFO, and Web of Science were searched using search terms for eHealth, psoriasis...... and topical antipsoriatics. General analysis of apps: The operating systems (OS) for smartphones, iOS, Google Play, Microsoft Store, Symbian OS and Blackberry OS were searched for apps containing the word psoriasis. RESULTS: Literature review: Only one RCT was included, reporting on psoriasis patients......' internet-reporting their status of psoriasis over a 12-month period. The rate of adherence was measured by Medication Event Monitoring System (MEMS®). An improvement in medical adherence and reduction of severity of psoriasis were reported. General analysis of apps: 184 apps contained the word psoriasis...

  14. Process- and patient-reported outcomes of a multifaceted medication adherence intervention for hypertensive patients in secondary care.

    Science.gov (United States)

    Hedegaard, Ulla; Hallas, Jesper; Ravn-Nielsen, Lene Vestergaard; Kjeldsen, Lene Juel

    2016-01-01

    Adherence to antihypertensive medications is suboptimal. Hospital pharmacist interventions including motivational interviewing (MI) might assist in improving adherence in patients with hypertension. For an intervention to be useful, it is important to have tools that can easily identify potential adherence problems. To evaluate process outcomes and patient- and pharmacist-reported outcomes of a pharmacist adherence intervention for hypertensive patients treated in hospital outpatient clinics. Secondly, to determine the agreement between two different adherence metrics: an adherence questionnaire used in the intervention and a prescription-based measure. The development of the intervention was based on adherence and behavioral theories and evidence of effective interventions. This included a focused medication review, a patient interview, and follow-up telephone calls. Two tools were used to identify adherence problems: The Drug Adherence Work-up (DRAW) tool and an adherence questionnaire. Process data included drug-related problems (DRPs) with recommendations to the physicians, medication- and lifestyle problems identified at the patient interview, actions taken and time spent on the intervention. In total, 91 DRPs in 8 categories generated recommendations to the physicians; 56 recommendations were generated at the medication review and 35 at the patient interview. At the interview, 421 problems were identified, of which 60% were medication-related and 40% lifestyle-related. In connection with the interview, 528 actions were taken within 8 different categories. MI was a central technique applicable for most problems and was employed in nearly all patients (94%). About half of the patients reported increased focus on lifestyle change, and 21-39% reported increased knowledge, confidence and skills in relation to their medication as well as better quality of life. The pharmacists found that the intervention elements were meaningful pharmacist tasks, and that the DRAW

  15. Mobile Health Medication Adherence and Blood Pressure Control in Renal Transplant Recipients: A Proof-of-Concept Randomized Controlled Trial.

    Science.gov (United States)

    McGillicuddy, John W; Gregoski, Mathew J; Weiland, Anna K; Rock, Rebecca A; Brunner-Jackson, Brenda M; Patel, Sachin K; Thomas, Beje S; Taber, David J; Chavin, Kenneth D; Baliga, Prabhakar K; Treiber, Frank A

    2013-09-04

    Mobile phone based programs for kidney transplant recipients are promising tools for improving long-term graft outcomes and better managing comorbidities (eg, hypertension, diabetes). These tools provide an easy to use self-management framework allowing optimal medication adherence that is guided by the patients' physiological data. This technology is also relatively inexpensive, has an intuitive interface, and provides the capability for real-time personalized feedback to help motivate patient self-efficacy. Automated summary reports of patients' adherence and blood pressure can easily be uploaded to providers' networks helping reduce clinical inertia by reducing regimen alteration time. The aim of this study was to assess the feasibility, acceptability, and preliminary outcomes of a prototype mobile health (mHealth) medication and blood pressure (BP) self-management system for kidney transplant patients with uncontrolled hypertension. A smartphone enabled medication adherence and BP self-management system was developed using a patient and provider centered design. The development framework utilized self-determination theory with iterative stages that were guided and refined based on patient/provider feedback. A 3-month proof-of-concept randomized controlled trial was conducted in 20 hypertensive kidney transplant patients identified as non-adherent to their current medication regimen based on a month long screening using an electronic medication tray. Participants randomized to the mHealth intervention had the reminder functions of their electronic medication tray enabled and received a bluetooth capable BP monitor and a smartphone that received and transmitted encrypted physiological data and delivered reminders to measure BP using text messaging. Controls received standard of care and their adherence continued to be monitored with the medication tray reminders turned off. Providers received weekly summary reports of patient medication adherence and BP readings

  16. Delayed educational reminders for long-term medication adherence in ST-elevation myocardial infarction (DERLA-STEMI: Protocol for a pragmatic, cluster-randomized controlled trial

    Directory of Open Access Journals (Sweden)

    Ivers Noah M

    2012-06-01

    Full Text Available Abstract Background Despite evidence-based recommendations supporting long-term use of cardiac medications in patients post ST-elevation myocardial infarction, adherence is known to decline over time. Discontinuation of cardiac medications in such patients is associated with increased mortality. Methods/design This is a pragmatic, cluster-randomized controlled trial with blinded outcome assessment and embedded qualitative process evaluation. Patients from one health region in Ontario, Canada who undergo a coronary angiogram during their admission for ST-elevation myocardial infarction and who survive their initial hospitalization will be included. Allocation of eligible patients to intervention or usual care will take place within one week after the angiogram using a computer-generated random sequence. To avoid treatment contamination, patients treated by the same family physician will be allocated to the same study arm. The intervention consists of recurrent, personalized, paper-based educational messages and reminders sent via post on behalf of the interventional cardiologist to the patient, family physician, and pharmacist urging long-term adherence to secondary prevention medications. The primary outcome is the proportion of patients who report in a phone interview taking all relevant classes of cardiac medications at twelve months. Secondary outcomes to be measured at three and twelve months include proportions of patients who report: actively taking each cardiac medication class of interest (item-by-item; stopping medications due to side effects; taking one or two or three medication classes concurrently; a perfect Morisky Medication Adherence Score for cardiac medication compliance; and having a discussion with their family physician about long-term adherence to cardiac medications. Self-reported measures of adherence will be validated using administrative data for prescriptions filled. Discussion This intervention is designed to be

  17. Patients' Perception of App-based Educational and Behavioural Interventions for Enhancing Oral Anticancer Medication Adherence.

    Science.gov (United States)

    Ali, Eskinder Eshetu; Leow, Jo Lene; Chew, Lita; Yap, Kevin Yi-Lwern

    2017-07-14

    Well-designed smartphone apps can potentially help in enhancing adherence to oral anticancer medications (OAMs). The objective of this study was to evaluate patients' perception on inclusion of various adherence-enhancing strategies as features of an app and their interest in using such app. A cross-sectional survey was conducted at the National Cancer Centre Singapore. A structured self-administered questionnaire was used to collect data from patients taking OAMs. Final analysis was based on 409 surveys and most of the respondents were female (291, 71.1%), Chinese (332, 81.2%), married (296, 72.4%) and breast cancer patients (211, 51.6%). Close to two-thirds of respondents rated medication information (65.0%), disease information (60.2%) and side effect self-management (60.2%) features as having the highest level of importance in an adherence app. Three hundred thirty-two (81.2%) of the respondents owned a smartphone, among which 92 (27.7%) reported using health-related apps. From respondents with smartphones, 219 (66.0%) were interested in using an app for OAM adherence. Age 65 and older compared to 21-54 years old (adjusted OR = 0.34; 95% CI = 0.15-0.76) and current use of a health app (adjusted OR = 1.91; 95% CI = 1.07-3.41) were significant predictors of interest to adopt an adherence app. In conclusion, patients value the inclusion of educational and behavioural interventions in adherence apps. Developers of adherence apps should consider including tools for side effect self-management and provision of information to educate patients on their medications and disease condition.

  18. Direct Adherence Measurement Using an Ingestible Sensor Compared With Self-Reporting in High-Risk Cardiovascular Disease Patients Who Knew They Were Being Measured: A Prospective Intervention

    Science.gov (United States)

    Thompson, David; Mackay, Teresa; Matthews, Maria; Edwards, Judith; Connolly, Susan B

    2017-01-01

    Background Use of appropriate cardioprotective medication is a cornerstone of cardiovascular disease prevention, but less-than-optimal patient adherence is common. Thus, strategies for improving adherence are recommended to adopt a multifaceted approach. Objective The objective of our study was to test a system comprising a biodegradable, ingestible sensor for direct measurement of medication ingestion in a group of patients at elevated cardiovascular risk attending a cardiac prevention and rehabilitation program. Methods In this prospective intervention trial in a single group of 21 patients running from April 2014 to June 2015, we measured adherence by self-report and adherence determined objectively by the system. The sensor emits a signal when it encounters the acidic environment of the stomach, detectable by an externally worn patch and linked software app. Longitudinal adherence data in the form of daily progress charts for sensed dosing events as compared with scheduled dosing are visible to patients on their tablet computer’s medication dosing app, thus providing patients with continuous medication adherence feedback. We sought feedback on patient acceptability by questionnaire assessment. Participants used the system for the 12-week period of their cardiac prevention and rehabilitation program. Results Only 1 patient at initial assessment and 1 patient at end-of-program assessment reported often missing medication. The remaining patients reported never missing medication or had missing data. Only 12 (57%) of patients overall achieved system-determined adherence of 80% or more, and 3 patients had scores below 40%. Participants reported high levels of acceptability. Conclusions This integrated system was well tolerated in a group of 21 patients over an appreciable time frame. Its ability to measure adherence reveals the sizeable disconnect between patient self-reported adherence and actual medication taking and has promising potential for clinical use as a

  19. A peer adherence support intervention to improve the antiretroviral treatment outcomes of HIV patients in South Africa: the moderating role of family dynamics.

    Science.gov (United States)

    Wouters, Edwin; Masquillier, Caroline; Ponnet, Koen; le Roux Booysen, Frederik

    2014-07-01

    Given the severe shortage of human resources in the healthcare sector in many countries with high HIV prevalence, community-based peer adherence support is being increasingly cited as an integral part of a sustainable antiretroviral treatment (ART) strategy. However, the available scientific evidence on this topic reports discrepant findings on the effectiveness of peer adherence support programmes. These conflicting findings to some extent can be attributed to the lack of attention to the social contexts in which peer adherence support programmes are implemented. This study explores the potential moderating role of family dynamics by assessing the differential impact of peer adherence support in different types of families, based on the theoretical underpinnings of the family functioning framework. These relationships were explored with the aid of multivariate statistical analysis of cross-sectional, post-trial data for a sample of 340 patients interviewed as part of the Effectiveness of Aids Treatment and Support in the Free State (FEATS) study conducted in the public-sector ART programme of the Free State Province of South Africa. The analysis reveals no significant overall differences in CD4 cell count between the intervention group accessing additional peer adherence support and the control group receiving standard care. When controlling for the potential moderating role of family dynamics, however, the outcomes clearly reveal a significant interaction effect between the adherence intervention and the level of family functioning with regard to treatment outcomes. Multi-group analysis demonstrates that peer adherence support has a positive effect on immunological restoration in well-functioning families, while having a negative effect in dysfunctional families. The study outcomes stress the need for peer adherence interventions that are sensitive to the suboptimal contexts in which they are often implemented. Generic, broad-based interventions do not

  20. A Mobile Phone HIV Medication Adherence Intervention: Acceptability and Feasibility Study.

    Science.gov (United States)

    Martin, C Andrew; Upvall, Michele J

    We present the findings of a qualitative pilot study designed to describe the experience of HIV medication adherence using a mobile phone application. Nine semi-structured focus group discussions were conducted over a 3-month period at an AIDS Services Organization in Central Texas. The data were analyzed following the principles of thematic analysis. During analysis, four themes were identified, and relations between these themes were delineated to reflect the experiences of the 23 participants. The mobile phone application, Care4Today™ Mobile Health Manager, was the intervention tool. Collection of focus group discussion outcomes over a 3-month period with baseline versus end-of-study data determined the feasibility and acceptability of this medication adherence intervention. The findings suggest that when individuals are offered the necessary resources, such as a mobile phone medication reminder application, they may have greater success in performing the behavior. Copyright © 2016 Association of Nurses in AIDS Care. Published by Elsevier Inc. All rights reserved.

  1. Video chat technology to remotely quantify dietary, supplement, and medication adherence in clinical trials

    Science.gov (United States)

    Peterson, Courtney M.; Apolzan, John W.; Wright, Courtney; Martin, Corby K.

    2017-01-01

    We conducted a pair of studies to test the validity, reliability, feasibility, and acceptability of using video chat technology as a novel method to quantify dietary and pill-taking (i.e., supplement and medication) adherence. In the first study, we investigated whether video chat technology can accurately quantify adherence to dietary and pill-taking interventions. Mock study participants ate food items and swallowed pills while performing randomized scripted “cheating” behaviors design to mimic non-adherence. Monitoring was conducted in a crossover design, with two monitors watching in-person and two watching remotely by Skype on a smartphone. For the second study, a 22-question online survey was sent to an email listserv with more than 20,000 unique email addresses of past and present study participants to assess the feasibility and acceptability of the technology. For the dietary adherence tests, monitors detected 86% of non-adherent events (sensitivity) in-person versus 78% of events via video chat monitoring (p=0.12), with comparable inter-rater agreement (0.88 vs. 0.85; p=0.62). However, for pill-taking, non-adherence trended towards being more easily detected in-person than by video chat (77% vs. 60%; p=0.08), with non-significantly higher inter-rater agreement (0.85 vs. 0.69; p=0.21). Survey results from the second study (N=1,076 respondents; at least a 5% response rate) indicated that 86.4% of study participants had video chatting hardware, 73.3% were comfortable using the technology; and 79.8% were willing to use it for clinical research. Given the capability of video chat technology to reduce participant burden and to outperform other adherence monitoring methods such as dietary self-report and pill counts, video chatting is a novel and highly promising platform to quantify dietary and pill-taking adherence. PMID:27753427

  2. Video chat technology to remotely quantify dietary, supplement and medication adherence in clinical trials.

    Science.gov (United States)

    Peterson, Courtney M; Apolzan, John W; Wright, Courtney; Martin, Corby K

    2016-11-01

    We conducted two studies to test the validity, reliability, feasibility and acceptability of using video chat technology to quantify dietary and pill-taking (i.e. supplement and medication) adherence. In study 1, we investigated whether video chat technology can accurately quantify adherence to dietary and pill-taking interventions. Mock study participants ate food items and swallowed pills, while performing randomised scripted 'cheating' behaviours to mimic non-adherence. Monitoring was conducted in a cross-over design, with two monitors watching in-person and two watching remotely by Skype on a smartphone. For study 2, a twenty-two-item online survey was sent to a listserv with more than 20 000 unique email addresses of past and present study participants to assess the feasibility and acceptability of the technology. For the dietary adherence tests, monitors detected 86 % of non-adherent events (sensitivity) in-person v. 78 % of events via video chat monitoring (P=0·12), with comparable inter-rater agreement (0·88 v. 0·85; P=0·62). However, for pill-taking, non-adherence trended towards being more easily detected in-person than by video chat (77 v. 60 %; P=0·08), with non-significantly higher inter-rater agreement (0·85 v. 0·69; P=0·21). Survey results from study 2 (n 1076 respondents; ≥5 % response rate) indicated that 86·4 % of study participants had video chatting hardware, 73·3 % were comfortable using the technology and 79·8 % were willing to use it for clinical research. Given the capability of video chat technology to reduce participant burden and outperform other adherence monitoring methods such as dietary self-report and pill counts, video chatting is a novel and promising platform to quantify dietary and pill-taking adherence.

  3. Behavioral Interventions to Enhance Adherence to Hormone Therapy in Breast Cancer Survivors: A Systematic Literature Review.

    Science.gov (United States)

    Hurtado-de-Mendoza, Alejandra; Cabling, Mark L; Lobo, Tania; Dash, Chiranjeev; Sheppard, Vanessa B

    2016-08-01

    Adjuvant hormone therapy contributes to reductions in recurrence and mortality for women with hormone receptor-positive breast cancer. However, adherence to hormone therapy is suboptimal. This is the first systematic literature review examining interventions aimed at improving hormone therapy adherence. Researchers followed the PRISMA guidelines. PubMed-Medline, CINAHL, PsychInfo, Ovid-Medline, and EMBASE were searched for behavioral interventions that aimed to enhance adherence to adjuvant hormone therapy in breast cancer survivors. A total of 376 articles were screened for eligibility. Five articles met the study criteria. All interventions presented adherence outcomes after 1-year follow-up. None significantly enhanced adherence compared to the usual care in the primary analysis (odds ratios ranged from 1.03 to 2.06 for adherence and from 1.11 to 1.18 for persistence). All studies targeted patients, and only 3 studies included postmenopausal breast cancer patients. Three tested the same intervention consisting of educational materials. Only one was conducted in the United States. Only one reported participants' ethnicity. Overall, it was unclear whether the studies contained bias. The use of different terminology and operationalization of adherence made comparisons challenging. Interventions to improve adherence to adjuvant hormone therapy in US breast cancer populations that include survivors who are ethnically diverse, premenopausal, and receiving tamoxifen therapy are necessary to inform future interventions. Adoption of consistent adherence definitions/measurements will provide a clearer framework to consolidate aggregate findings. Given the limited efficacy of tested interventions, it is important to engage oncologists and researchers to develop approaches that target different components associated with hormone therapy adherence, such as doctor-patient communication or social support. Copyright © 2016 Elsevier Inc. All rights reserved.

  4. Cost-effectiveness of a community pharmacist intervention in patients with depression: a randomized controlled trial (PRODEFAR Study.

    Directory of Open Access Journals (Sweden)

    Maria Rubio-Valera

    Full Text Available Non-adherence to antidepressants generates higher costs for the treatment of depression. Little is known about the cost-effectiveness of pharmacist's interventions aimed at improving adherence to antidepressants. The study aimed to evaluate the cost-effectiveness of a community pharmacist intervention in comparison with usual care in depressed patients initiating treatment with antidepressants in primary care.Patients were recruited by general practitioners and randomized to community pharmacist intervention (87 that received an educational intervention and usual care (92. Adherence to antidepressants, clinical symptoms, Quality-Adjusted Life-Years (QALYs, use of healthcare services and productivity losses were measured at baseline, 3 and 6 months.There were no significant differences between groups in costs or effects. From a societal perspective, the incremental cost-effectiveness ratio (ICER for the community pharmacist intervention compared with usual care was €1,866 for extra adherent patient and €9,872 per extra QALY. In terms of remission of depressive symptoms, the usual care dominated the community pharmacist intervention. If willingness to pay (WTP is €30,000 per extra adherent patient, remission of symptoms or QALYs, the probability of the community pharmacist intervention being cost-effective was 0.71, 0.46 and 0.75, respectively (societal perspective. From a healthcare perspective, the probability of the community pharmacist intervention being cost-effective in terms of adherence, QALYs and remission was of 0.71, 0.76 and 0.46, respectively, if WTP is €30,000.A brief community pharmacist intervention addressed to depressed patients initiating antidepressant treatment showed a probability of being cost-effective of 0.71 and 0.75 in terms of improvement of adherence and QALYs, respectively, when compared to usual care. Regular implementation of the community pharmacist intervention is not recommended.ClinicalTrials.gov NCT

  5. Effectiveness of educational or behavioral interventions on adherence to phosphate control in adults receiving hemodialysis: a systematic review.

    Science.gov (United States)

    Milazi, Molly; Bonner, Ann; Douglas, Clint

    2017-04-01

    People with end-stage kidney disease (ESKD) develop impaired excretion of phosphate. Hyperphosphatemia develops in ESKD as a result of the kidney's reduced ability to excrete ingested phosphate load and is characterized by high bone turnover and increased musculoskeletal morbidity including bone pain and muscle weakness. Increased serum phosphate levels are also associated with cardiovascular disease and associated mortality. These effects are significant considering that cardiovascular disease is the leading cause of death in ESKD, making phosphate control a crucial treatment goal. To determine the effectiveness of education or behavioral interventions on adherence to phosphate control in adults with ESKD receiving hemodialysis (HD). Adults aged over 18 years with ESKD undergoing HD, attending dialysis facilities regardless of frequency and duration of treatment sessions per week. Studies with participants receiving hemodiafiltration were excluded. All types of educational and behavioral interventions aimed at improving adherence to dietary phosphate restriction, phosphate binder medication and HD. Randomized controlled trials (RCTs), non-RCTs, before and after and cohort studies. Outcome measures included serum phosphate levels, patient knowledge and adherence to phosphate control methods, chronic kidney disease (CKD) self-management behavior and perceived self-efficacy for CKD related to phosphate control. A search was conducted in CINAHL, MEDLINE, The Cochrane Library, Embase, Web of Science, PsycINFO and ProQuest Dissertations and Theses Global to find published studies between January 2005 and December 2015. Risk of bias was assessed by three reviewers prior to inclusion in the review using standardized critical appraisal instruments from the Joanna Briggs Institute Meta-Analysis of Statistics Assessment and Review Instrument (JBI-MAStARI). Data were extracted using the standardized data extraction tool from JBI-MAStARI. Data were pooled using JBI software

  6. Risk factors for non-adherence and loss to follow-up in a three-year clinical trial in Botswana.

    Directory of Open Access Journals (Sweden)

    Deborah A Gust

    Full Text Available BACKGROUND: Participant non-adherence and loss to follow-up can compromise the validity of clinical trial results. An assessment of these issues was made in a 3-year tuberculosis prevention trial among HIV-infected adults in Botswana. METHODS AND FINDINGS: Between 11/2004-07/2006, 1995 participants were enrolled at eight public health clinics. They returned monthly to receive bottles of medication and were expected to take daily tablets of isoniazid or placebo for three years. Non-adherence was defined as refusing tablet ingestion but agreeing to quarterly physical examinations. Loss to follow-up was defined as not having returned for appointments in ≥60 days. Between 10/2008-04/2009, survey interviews were conducted with 83 participants identified as lost to follow-up and 127 identified as non-adherent. As a comparison, 252 randomly selected adherent participants were also surveyed. Multivariate logistic regression analysis was used to identify associations with selected risk factors. Men had higher odds of being non-adherent (adjusted odds ratio (AOR, 2.24; 95% confidence interval [95%CI] 1.24-4.04 and lost to follow-up (AOR 3.08; 95%CI 1.50-6.33. Non-adherent participants had higher odds of reporting difficulties taking the regimen or not knowing if they had difficulties (AOR 3.40; 95%CI 1.75-6.60 and lower odds associated with each year of age (AOR 0.95; 95%CI 0.91-0.98, but other variables such as employment, distance from clinic, alcohol use, and understanding study requirements were not significantly different than controls. Among participants who were non-adherent or lost to follow-up, 40/210 (19.0% reported that they stopped the medication because of work commitments and 33/210 (15.7% said they thought they had completed the study. CONCLUSIONS: Men had higher odds of non-adherence and loss to follow-up than women. Potential interventions that might improve adherence in trial participants may include:targeting health education for men

  7. The effect of different intervention programs on treatment adherence of HIV-infected children, a retrospective study.

    Science.gov (United States)

    van der Plas, Atie; Scherpbier, Henriette; Kuijpers, Taco; Pajkrt, Dasja

    2013-01-01

    In HIV-infected children, long-term adherence to combination anti-retroviral therapy (cART) is difficult. In this retrospective study, we evaluated the effect of two different treatment adherence programs on treatment adherence (as indicated by cART failures) and the need for additional supportive care measures in a cohort of 31 HIV-infected children between 3 and 18 years of age. In a follow-up period of 6 years, we evaluated the treatment adherence at baseline (before introduction of any treatment adherence program in 2004) and compared this to cART failures during two treatment adherence programs (in respectively 2006 and 2009). The need for additional supportive care measures (the frequency of hospitalizations, daily observed treatment, use of child protection service, attendance of special schools, and placement in foster homes) was also evaluated at these three time points. The first treatment adherence program focused on increasing patient's obedience by imposing negative measures in case of treatment failure, whereas the second program aimed to increase treatment adherence by rewarding optimal medication intake. Prior to start of any treatment adherence intervention program, cART failures were observed in 29% of the pediatric patients. After introduction of the first treatment adherence program, cART failures decreased to 6%. During the second treatment adherence program, the cART failures remained equally low (10%), but the need for some specific additional supportive care measures (the frequency of hospitalizations and placement in foster homes) was importantly reduced. Treatment adherence programs are effective in increasing treatment adherence to cART in HIV-infected children. A novel reward treatment interventional program as an addition to social supportive care programs is a promising new positive enforcement program and can reduce the need for additional supportive care programs. Further prospective studies are needed to evaluate the long

  8. Automated telecommunication interventions to promote adherence to cardio-metabolic medications: meta-analysis of effectiveness and meta-regression of behaviour change techniques.

    Science.gov (United States)

    Kassavou, Aikaterini; Sutton, Stephen

    2017-09-12

    Automated telecommunication interventions, including short message service and interactive voice response, are increasingly being used to promote adherence to medications prescribed for cardio-metabolic conditions. This systematic review aimed to comprehensively assess the effectiveness of such interventions to support medication adherence, and to identify the behaviour change techniques (BCTs) and other intervention characteristics that are positively associated with greater intervention effectiveness. Meta-analysis of 17 randomised controlled trials showed a small but statistically significant effect on medication adherence, OR = 1.89, 95% CI [1.51, 2.36], I(2) = 89%, N = 25,101. Multivariable meta-regression analysis including eight BCTs explained 88% of the observed variance in effect size (ES). The BCTs 'tailored' and 'information about health consequences' were positively and significantly associated with ES. Future studies could explore whether the inclusion of these and/or additional techniques (e.g., 'implementation intentions') would increase the effect of automated telecommunication interventions, using rigorous designs and objective outcome measures.

  9. A Systematic Review of Interventions Addressing Adherence to Anti-Diabetic Medications in Patients with Type 2 Diabetes—Components of Interventions

    Science.gov (United States)

    Sapkota, Sujata; Brien, Jo-anne E.; Greenfield, Jerry R.; Aslani, Parisa

    2015-01-01

    Background Poor adherence to anti-diabetic medications contributes to suboptimal glycaemic control in patients with type 2 diabetes (T2D). A range of interventions have been developed to promote anti-diabetic medication adherence. However, there has been very little focus on the characteristics of these interventions and how effectively they address factors that predict non-adherence. In this systematic review we assessed the characteristics of interventions that aimed to promote adherence to anti-diabetic medications. Method Using appropriate search terms in Medline, Embase, CINAHL, International Pharmaceutical Abstracts (IPA), PUBmed, and PsychINFO (years 2000–2013), we identified 52 studies which met the inclusion criteria. Results Forty-nine studies consisted of patient-level interventions, two provider-level interventions, and one consisted of both. Interventions were classified as educational (n = 7), behavioural (n = 3), affective, economic (n = 3) or multifaceted (a combination of the above; n = 40). One study consisted of two interventions. The review found that multifaceted interventions, addressing several non-adherence factors, were comparatively more effective in improving medication adherence and glycaemic target in patients with T2D than single strategies. However, interventions with similar components and those addressing similar non-adherence factors demonstrated mixed results, making it difficult to conclude on effective intervention strategies to promote adherence. Educational strategies have remained the most popular intervention strategy, followed by behavioural, with affective components becoming more common in recent years. Most of the interventions addressed patient-related (n = 35), condition-related (n = 31), and therapy-related (n = 20) factors as defined by the World Health Organization, while fewer addressed health care system (n = 5) and socio-economic-related factors (n = 13). Conclusion There is a noticeable shift in the literature

  10. Partner randomized controlled trial: study protocol and coaching intervention

    Directory of Open Access Journals (Sweden)

    Garbutt Jane M

    2012-04-01

    Full Text Available Abstract Background Many children with asthma live with frequent symptoms and activity limitations, and visits for urgent care are common. Many pediatricians do not regularly meet with families to monitor asthma control, identify concerns or problems with management, or provide self-management education. Effective interventions to improve asthma care such as small group training and care redesign have been difficult to disseminate into office practice. Methods and design This paper describes the protocol for a randomized controlled trial (RCT to evaluate a 12-month telephone-coaching program designed to support primary care management of children with persistent asthma and subsequently to improve asthma control and disease-related quality of life and reduce urgent care events for asthma care. Randomization occurred at the practice level with eligible families within a practice having access to the coaching program or to usual care. The coaching intervention was based on the transtheoretical model of behavior change. Targeted behaviors included 1 effective use of controller medications, 2 effective use of rescue medications and 3 monitoring to ensure optimal control. Trained lay coaches provided parents with education and support for asthma care, tailoring the information provided and frequency of contact to the parent's readiness to change their child's day-to-day asthma management. Coaching calls varied in frequency from weekly to monthly. For each participating family, follow-up measurements were obtained at 12- and 24-months after enrollment in the study during a telephone interview. The primary outcomes were the mean change in 1 the child's asthma control score, 2 the parent's quality of life score, and 3 the number of urgent care events assessed at 12 and 24 months. Secondary outcomes reflected adherence to guideline recommendations by the primary care pediatricians and included the proportion of children prescribed controller medications

  11. The association of health literacy with adherence in older adults, and its role in interventions : a systematic meta-review

    NARCIS (Netherlands)

    Geboers, Bas; Brainard, Julii S.; Loke, Yoon K.; Jansen, Carel J. M.; Salter, Charlotte; Reijneveld, Sijmen A.; de Winter, Andrea F.

    2015-01-01

    Background: Low health literacy is a common problem among older adults. It is often suggested to be associated with poor adherence. This suggested association implies a need for effective adherence interventions in low health literate people. However, previous reviews show mixed results on the

  12. The Chinese Life-Steps Program: A Cultural Adaptation of a Cognitive-Behavioral Intervention to Enhance HIV Medication Adherence

    Science.gov (United States)

    Shiu, Cheng-Shi; Chen, Wei-Ti; Simoni, Jane; Fredriksen-Goldsen, Karen; Zhang, Fujie; Zhou, Hongxin

    2013-01-01

    China is considered to be the new frontier of the global AIDS pandemic. Although effective treatment for HIV is becoming widely available in China, adherence to treatment remains a challenge. This study aimed to adapt an intervention promoting HIV-medication adherence--favorably evaluated in the West--for Chinese HIV-positive patients. The…

  13. Ethical issues in non-intervention trials for thyroid cancer.

    Science.gov (United States)

    Angelos, P; Hartl, D M; Shah, J P; Nixon, I J; Owen, R P; Rinaldo, A; Rodrigo, J P; Shaha, A R; Silver, C E; Suárez, C; Ferlito, A

    2017-03-16

    In recent years, the increasing numbers of small, apparently indolent thyroid cancers diagnosed in the world have encouraged investigators to consider non-intervention as an alternative to surgical management. In the following pages, the prospect of a non-intervention trial for thyroid cancer is considered with attention to the ethical issues that such a trial might raise. Such a non-intervention trial is analyzed relative to 7 ethical considerations: the social or scientific value of the research, the scientific validity of the trial, the necessity of fair selection of participants, a favorable risk-benefit ratio for trial participants, independent review of the trial, informed consent, and allowing the study participants to withdraw from the trial. A non-intervention trial for thyroid cancer is also considered relative to the central concept of equipoise. Copyright © 2017 Elsevier Ltd, BASO ~ The Association for Cancer Surgery, and the European Society of Surgical Oncology. All rights reserved.

  14. Barriers and facilitators of interventions for improving antiretroviral therapy adherence: a systematic review of global qualitative evidence

    Directory of Open Access Journals (Sweden)

    Qingyan Ma

    2016-10-01

    Full Text Available Introduction: Qualitative research on antiretroviral therapy (ART adherence interventions can provide a deeper understanding of intervention facilitators and barriers. This systematic review aims to synthesize qualitative evidence of interventions for improving ART adherence and to inform patient-centred policymaking. Methods: We searched 19 databases to identify studies presenting primary qualitative data on the experiences, attitudes and acceptability of interventions to improve ART adherence among PLHIV and treatment providers. We used thematic synthesis to synthesize qualitative evidence and the CERQual (Confidence in the Evidence from Reviews of Qualitative Research approach to assess the confidence of review findings. Results: Of 2982 references identified, a total of 31 studies from 17 countries were included. Twelve studies were conducted in high-income countries, 13 in middle-income countries and six in low-income countries. Study populations focused on adults living with HIV (21 studies, n=1025, children living with HIV (two studies, n=46, adolescents living with HIV (four studies, n=70 and pregnant women living with HIV (one study, n=79. Twenty-three studies examined PLHIV perspectives and 13 studies examined healthcare provider perspectives. We identified six themes related to types of interventions, including task shifting, education, mobile phone text messaging, directly observed therapy, medical professional outreach and complex interventions. We also identified five cross-cutting themes, including strengthening social relationships, ensuring confidentiality, empowerment of PLHIV, compensation and integrating religious beliefs into interventions. Our qualitative evidence suggests that strengthening PLHIV social relationships, PLHIV empowerment and developing culturally appropriate interventions may facilitate adherence interventions. Our study indicates that potential barriers are inadequate training and compensation for lay

  15. An innovative peer assessment approach to enhance guideline adherence in physical therapy: single-masked, cluster-randomized controlled trial.

    Science.gov (United States)

    Maas, Marjo J M; van der Wees, Philip J; Braam, Carla; Koetsenruijter, Jan; Heerkens, Yvonne F; van der Vleuten, Cees P M; Nijhuis-van der Sanden, Maria W G

    2015-04-01

    Clinical practice guidelines (CPGs) are not readily implemented in clinical practice. One of the impeding factors is that physical therapists do not hold realistic perceptions of their adherence to CPGs. Peer assessment (PA) is an implementation strategy that aims at improving guideline adherence by enhancing reflective practice, awareness of professional performance, and attainment of personal goals. The purpose of this study was to compare the effectiveness of PA with the usual case discussion (CD) strategy on adherence to CPGs for physical therapist management of upper extremity complaints. A single-masked, cluster-randomized controlled trial with pretest-posttest design was conducted. Twenty communities of practice (n=149 physical therapists) were randomly assigned to groups receiving PA or CD, with both interventions consisting of 4 sessions over 6 months. Both PA and CD groups worked on identical clinical cases relevant to the guidelines. Peer assessment focused on individual performance observed and evaluated by peers; CD focused on discussion. Guideline adherence was measured with clinical vignettes, reflective practice was measured with the Self-Reflection and Insight Scale (SRIS), awareness of performance was measured via the correlation between perceived and assessed improvement, and attainment of personal goals was measured with written commitments to change. The PA groups improved more on guideline adherence compared with the CD groups (effect=22.52; 95% confidence interval [95% CI]=2.38, 42.66; P=.03). The SRIS scores did not differ between PA and CD groups. Awareness of performance was greater for the PA groups (r=.36) than for the CD groups (r=.08) (effect=14.73; 95% CI=2.78, 26.68; P=.01). The PA strategy was more effective than the CD strategy in attaining personal goals (effect=0.50; 95% CI=0.04, 0.96; P=.03). Limited validity of clinical vignettes as a proxy measure of clinical practice was a limitation of the study. Peer assessment was more

  16. How to Increase Reach and Adherence of Web-Based Interventions: A Design Research Viewpoint.

    Science.gov (United States)

    Ludden, Geke D S; van Rompay, Thomas J L; Kelders, Saskia M; van Gemert-Pijnen, Julia E W C

    2015-07-10

    Nowadays, technology is increasingly used to increase people's well-being. For example, many mobile and Web-based apps have been developed that can support people to become mentally fit or to manage their daily diet. However, analyses of current Web-based interventions show that many systems are only used by a specific group of users (eg, women, highly educated), and that even they often do not persist and drop out as the intervention unfolds. In this paper, we assess the impact of design features of Web-based interventions on reach and adherence and conclude that the power that design can have has not been used to its full potential. We propose looking at design research as a source of inspiration for new (to the field) design approaches. The paper goes on to specify and discuss three of these approaches: personalization, ambient information, and use of metaphors. Central to our viewpoint is the role of positive affect triggered by well-designed persuasive features to boost adherence and well-being. Finally, we discuss the future of persuasive eHealth interventions and suggest avenues for follow-up research.

  17. Process- and patient-reported outcomes of a multifaceted medication adherence intervention for hypertensive patients in secondary care

    DEFF Research Database (Denmark)

    Hedegaard, Ulla; Hallas, Jesper; Ravn-Nielsen, Lene Vestergaard

    2016-01-01

    potential adherence problems. OBJECTIVES: To evaluate process outcomes and patient- and pharmacist-reported outcomes of a pharmacist adherence intervention for hypertensive patients treated in hospital outpatient clinics. Secondly, to determine the agreement between two different adherence metrics...... calls. Two tools were used to identify adherence problems: The Drug Adherence Work-up (DRAW) tool and an adherence questionnaire. Process data included drug-related problems (DRPs) with recommendations to the physicians, medication- and lifestyle problems identified at the patient interview, actions......-related and 40% lifestyle-related. In connection with the interview, 528 actions were taken within 8 different categories. MI was a central technique applicable for most problems and was employed in nearly all patients (94%). About half of the patients reported increased focus on lifestyle change, and 21...

  18. Adherence to the obesity-related lifestyle intervention targets in the IDEFICS study.

    Science.gov (United States)

    Kovács, E; Siani, A; Konstabel, K; Hadjigeorgiou, C; de Bourdeaudhuij, I; Eiben, G; Lissner, L; Gwozdz, W; Reisch, L; Pala, V; Moreno, L A; Pigeot, I; Pohlabeln, H; Ahrens, W; Molnár, D

    2014-09-01

    To address behaviours associated with childhood obesity, certain target values are recommended that should be met to improve children's health. In the IDEFICS (Identification and prevention of Dietary- and lifestyle-induced health Effects in Children and infantS) study such lifestyle recommendations were conveyed as six key messages. Here, we investigate the adherence of European children to these messages. The IDEFICS intervention was based on the intervention mapping approach with the following six targets: increase water consumption (to replace sugar-containing beverages), increase fruit/vegetable consumption, reduce daily screen time, increase daily physical activity, improve the quality of family life and ensure adequate sleep duration. Internationally recommended target values were applied to determine the prevalence of children meeting these targets. In a cohort of 18,745 children participating in the IDEFICS baseline survey or newly recruited during follow-up, data on the above lifestyle behaviours were collected for a varying number of 8302 to 17,212 children. Information on all six behaviours was available for 5140 children. Although 52.5% of the cohort was classified in the highest category of water consumption, only 8.8% met the target of an intake of fruits/vegetables five times a day. The prevalence of children adhering to the recommendation regarding total screen time-below 1 h for pre-school children and 2 h for school children-was 51.1%. The recommended amount of at least 60 min of moderate-to-vigorous physical activity per day was fulfilled by 15.2%. Family life of the child measured by various indicators was considered as satisfactory in 22.8%. Nocturnal sleep duration of 11 (10) hours or more in pre-school (school) children was achieved by 37.9%. In general, children in northern countries and younger children showed better adherence to the recommendations. Only 1.1% of the children adhered to at least five of these recommendations. Current

  19. The Completeness of Intervention Descriptions in Randomised Trials of Supervised Exercise Training in Peripheral Arterial Disease.

    Directory of Open Access Journals (Sweden)

    Garry A Tew

    Full Text Available Research supports the use of supervised exercise training as a primary therapy for improving the functional status of people with peripheral arterial disease (PAD. Several reviews have focused on reporting the outcomes of exercise interventions, but none have critically examined the quality of intervention reporting. Adequate reporting of the exercise protocols used in randomised controlled trials (RCTs is central to interpreting study findings and translating effective interventions into practice. The purpose of this review was to evaluate the completeness of intervention descriptions in RCTs of supervised exercise training in people with PAD. A systematic search strategy was used to identify relevant trials published until June 2015. Intervention description completeness in the main trial publication was assessed using the Template for Intervention Description and Replication checklist. Missing intervention details were then sought from additional published material and by emailing authors. Fifty-eight trials were included, reporting on 76 interventions. Within publications, none of the interventions were sufficiently described for all of the items required for replication; this increased to 24 (32% after contacting authors. Although programme duration, and session frequency and duration were well-reported in publications, complete descriptions of the equipment used, intervention provider, and number of participants per session were missing for three quarters or more of interventions (missing for 75%, 93% and 80% of interventions, respectively. Furthermore, 20%, 24% and 26% of interventions were not sufficiently described for the mode of exercise, intensity of exercise, and tailoring/progression, respectively. Information on intervention adherence/fidelity was also frequently missing: attendance rates were adequately described for 29 (38% interventions, whereas sufficient detail about the intensity of exercise performed was presented for only

  20. Acceptability and efficacy of interactive short message service intervention in improving HIV medication adherence in Chinese antiretroviral treatment-naïve individuals

    Directory of Open Access Journals (Sweden)

    Ruan Y

    2017-02-01

    Full Text Available Ye Ruan,1 Xueling Xiao,2 Jia Chen,2 Xianhong Li,2 Ann Bartley Williams,3 Honghong Wang2 1Nursing Department, Second Xiangya Hospital, 2Xiangya School of Nursing, Central South University, Changsha, Hunan, People’s Republic of China; 3School of Nursing, Yale University, West Haven, CT, USA Aim: The aim of this study was to examine the acceptability and efficacy of interactive short message service (SMS in improving medication adherence in antiretroviral treatment (ART-naïve individuals living with HIV/AIDS in Hengyang, Hunan, China.Background: SMS via mobile phone has emerged as a potential tool for improving ART adherence. However, most studies used SMS only as a medication reminder, with few studies exploring the effect of comprehensive, interactive SMS.Patients and methods: In a randomized controlled trial, 100 HIV-positive patients on ART for <3 months were randomized into control or intervention arm. Participants in the control group received routine standard instruction for ART medication in the HIV clinics, while the intervention group received 6 months of an SMS intervention in addition to the standard care. A total of 124 text messages within 6 modules were edited, preinstalled, and sent to participants according to personalized schedules. Knowledge (of HIV and HIV medications, self-reported antiretroviral adherence (Visual Analog Scale [VAS] and Community Programs for Clinical Research on AIDS [CPCRA] Antiretroviral Medication Self-Report, and CD4 count were assessed at baseline and immediate post-intervention. Intervention participants were interviewed after completion of the study about their satisfaction with and acceptability of the SMS intervention.Results: Baseline assessments were comparable between arms. Repeated-measures analysis showed that both HIV-related and ART medication knowledge of the intervention group showed better improvement over time than those of the control group after the intervention (P<0.0001. For the

  1. Improving medication adherence in diabetes type 2 patients through Real Time Medication Monitoring: a Randomised Controlled Trial to evaluate the effect of monitoring patients' medication use combined with short message service (SMS reminders

    Directory of Open Access Journals (Sweden)

    Bouvy Marcel L

    2011-01-01

    Full Text Available Abstract Background Innovative approaches are needed to support patients' adherence to drug therapy. The Real Time Medication Monitoring (RTMM system offers real time monitoring of patients' medication use combined with short message service (SMS reminders if patients forget to take their medication. This combination of monitoring and tailored reminders provides opportunities to improve adherence. This article describes the design of an intervention study aimed at evaluating the effect of RTMM on adherence to oral antidiabetics. Methods/Design Randomised Controlled Trial (RCT with two intervention arms and one control arm involving diabetes type 2 patients with suboptimal levels of adherence to oral antidiabetics (less than 80% based on pharmacy refill data. Patients in the first intervention arm use RTMM including SMS reminders and a personal webpage where they can monitor their medication use. Patients in the second intervention arm use RTMM without SMS reminders or webpage access. Patients in the control arm are not exposed to any intervention. Patients are randomly assigned to one of the three arms. The intervention lasts for six months. Pharmacy refill data of all patients are available from 11 months before, until 11 months after the start of the intervention. Primary outcome measure is adherence to oral antidiabetics calculated from: 1 data collected with RTMM, as a percentage of medication taken as prescribed, and as percentage of medication taken within the correct time interval, 2 refill data, taking the number of days for which oral antidiabetics are dispensed during the study period divided by the total number of days of the study period. Differences in adherence between the intervention groups and control group are studied using refill data. Differences in adherence between the two intervention groups are studied using RTMM data. Discussion The intervention described in this article consists of providing RTMM to patients with

  2. A Pharmacist Telephone Intervention to Identify Adherence Barriers and Improve Adherence Among Nonadherent Patients with Comorbid Hypertension and Diabetes in a Medicare Advantage Plan.

    Science.gov (United States)

    Abughosh, Susan M; Wang, Xin; Serna, Omar; Henges, Chris; Masilamani, Santhi; Essien, Ekere James; Chung, Nancy; Fleming, Marc

    2016-01-01

    Patients with comorbid hypertension (HTN) and diabetes mellitus (DM) are at a high risk of developing macrovascular and microvascular complications of DM. Controlling high blood pressure can greatly reduce these complications. Angiotensin-converting enzyme inhibitors (ACEIs) or angiotensin II receptor blockers (ARBs) are recommended for patients with both DM and HTN by the American Diabetes Association guidelines, and their benefit and efficacy in reducing macrovascular and microvascular complications of DM have been well documented. Poor adherence, however, remains a significant barrier to achieving full effectiveness and optimal outcomes. To examine the effect of a brief pharmacist telephone intervention in identifying adherence barriers and improving adherence to ACEI/ARB medications among nonadherent patients with comorbid HTN and DM who are enrolled in a Medicare Advantage plan. Cigna-HealthSpring's medical claims data was used to identify patients with HTN and DM diagnoses by using ICD-9-CM codes 401 and 250, and at least 2 fills for ACEIs or ARBs between January 2013 and October 2013. Patients who failed to refill their medication for more than 1 day and had a proportion of days covered (PDC) ACEIs/ARBs, defined as PDC during the 6 months following the phone call intervention. The second outcome variable was a categorical outcome of discontinuation versus continuation. Discontinuation was defined as not using ACEIs/ARBs during the 6-month post-intervention period. Patients who disenrolled from the plan in 2014 or were switched to another medication commonly used for treating DM and HTN were excluded from further analysis. Descriptive statistics were conducted to assess the frequency distribution of sample demographic characteristics at baseline. Multiple linear regression was conducted to assess the intervention effect on adherence during the 6 months post-intervention using the first outcome of post-intervention PDC, adjusting for baseline PDC and other

  3. Live Video Diet and Exercise Intervention in Overweight and Obese Youth: Adherence and Cardiovascular Health.

    Science.gov (United States)

    Nourse, Susan E; Olson, Inger; Popat, Rita A; Stauffer, Katie J; Vu, Chau N; Berry, Samuel; Kazmucha, Jeffrey; Ogareva, Olga; Couch, Sarah C; Urbina, Elaine M; Tierney, Elif Seda Selamet

    2015-09-01

    To evaluate adherence of overweight and obese adolescents to a live video lifestyle intervention. The impact on vascular and functional health was also assessed. Twenty adolescents 14.5 ± 2.1 years of age with body mass index z-score 1.94 ± 0.43 were enrolled. The 12-week intervention included 3-times-weekly videoconference sessions with a trainer and weekly diet consultations. Adherence was evaluated by completion rate and percentage of sessions attended. Vascular health indices and traditional cardiovascular risk factors were obtained at baseline and study end. Seventeen participants (85%) completed the intervention. The participants attended 93 ± 11% of scheduled sessions. Reasons for absences included illness/injury (23%), school activities (21%), holidays (18%), forgetting the appointment (8%), Internet connectivity issues (7%), and family emergency (7%). Significant changes were observed in waist-hip ratio (0.87 ± 0.08 vs 0.84 ± 0.08, P = .03), total (159 ± 27 vs 147 ± 23 mg/dL, P = .004) and low-density lipoprotein cholesterol levels (91 ± 20 vs 81 ± 18 mg/dL, P = .004), volume of inspired oxygen per heartbeat at peak exercise (69 ± 16 vs 72 ± 15%, P = .01), and functional movement score (13 ± 2 vs 17 ± 1, P adherence among overweight and obese adolescents and shows promise for improving vascular and functional health. Integrating telehealth into preventive care has the potential to improve cardiovascular health in the youth at risk. Copyright © 2015 Elsevier Inc. All rights reserved.

  4. Implementation of targeted medication adherence interventions within a community chain pharmacy practice: The Pennsylvania Project.

    Science.gov (United States)

    Bacci, Jennifer L; McGrath, Stephanie Harriman; Pringle, Janice L; Maguire, Michelle A; McGivney, Melissa Somma

    2014-01-01

    To identify facilitators and barriers to implementing targeted medication adherence interventions in community chain pharmacies, and describe adaptations of the targeted intervention and organizational structure within each individual pharmacy practice. Qualitative study. Central and western Pennsylvania from February to April 2012. Rite Aid pharmacists staffed at the 118 Pennsylvania Project intervention sites. Qualitative analysis of pharmacists' perceptions of facilitators and barriers experienced, targeted intervention and organizational structure adaptations implemented, and training and preparation prior to implementation. A total of 15 key informant interviews were conducted from February to April 2012. Ten pharmacists from "early adopter" practices and five pharmacists from "traditionalist" practices were interviewed. Five themes emerged regarding the implementation of targeted interventions, including all pharmacists' need to understand the relationship of patient care programs to their corporation's vision; providing individualized, continual support and mentoring to pharmacists; anticipating barriers before implementation of patient care programs; encouraging active patient engagement; and establishing best practices regarding implementation of patient care services. This qualitative analysis revealed that there are a series of key steps that can be taken before the execution of targeted interventions that may promote successful implementation of medication therapy management in community chain pharmacies.

  5. Adherence to a lifestyle program for youth with type 2 diabetes and its association with treatment outcome in the TODAY clinical trial.

    Science.gov (United States)

    Berkowitz, Robert I; Marcus, Marsha D; Anderson, Barbara J; Delahanty, Linda; Grover, Nisha; Kriska, Andrea; Laffel, Lori; Syme, Amy; Venditti, Elizabeth; Van Buren, Dorothy J; Wilfley, Denise E; Yasuda, Patrice; Hirst, Kathryn

    2017-06-30

    To assess the association of proxies of behavioral adherence to the Treatment Options for type 2 Diabetes in Adolescents and Youth (TODAY) lifestyle program with changes in glycemic control and obesity in a multi-ethnic sample of youth with type 2 diabetes. The TODAY clinical trial included an intensive lifestyle intervention to promote weight reduction. Adherence was assessed with measures of attendance at intervention sessions and rates of self-monitoring of diet and physical activity by participants and their caregivers. The relation between participant characteristics and consistency of proxies of adherence were examined across 3 phases of intervention. A total of 234 TODAY youth were randomized to the lifestyle program. Overall rate of session attendance was approximately 60% of planned sessions. Participants with an adequate dose of session attendance (≥75% attended) did not differ from those who attended low and additional analysis was not possible. Rates of session attendance were moderate in a lifestyle program for youth with type 2 diabetes, but levels of self-monitoring, considered a key lifestyle change behavior, were low. Glycemic control was not significantly associated with session attendance but reductions in percent overweight were. Given the salience of program attendance and self-monitoring to lifestyle weight management established in other populations, future research is needed to understand, develop, and promote strategies and interventions targeting weight loss to achieve improved glycemic control in youth diagnosed with type 2 diabetes. © 2017 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd.

  6. The SELF trial: A self-efficacy-based behavioral intervention trial for weight loss maintenance.

    Science.gov (United States)

    Burke, Lora E; Ewing, Linda J; Ye, Lei; Styn, Mindi; Zheng, Yaguang; Music, Edvin; Loar, India; Mancino, Juliet; Imes, Christopher C; Hu, Lu; Goode, Rachel; Sereika, Susan M

    2015-11-01

    The SELF Trial examined the effect of adding individual self-efficacy (SE) enhancement sessions to standard behavioral weight loss treatment (SBT). Participants were randomly assigned to SBT or SBT plus SE sessions (SBT+SE). Outcome measures were weight loss maintenance, quality of life, intervention adherence, and self-efficacy at 12 and 18 months. The sample (N = 130) was female (83.08%) with a mean (SD) body mass index of 33.15 (4.11) kg m(2) . There was a significant time effect for percent weight change (P = 0.002) yet no significant group or group-by-time effects. The weight loss for the SBT+SE group was 8.38% (7.48) at 12 months and 8.00% (7.87) at 18 months, with no significant difference between the two time points (P = 0.06). However, weight loss for the SBT group was 6.95% (6.67) at 12 months and 5.96% (7.35) at 18 months, which was significantly different between the two time points (P = 0.005), indicating that the SBT group had significant weight regain. Both groups achieved clinically significant weight loss. The group receiving an intervention targeting enhanced self-efficacy had greater weight loss maintenance whereas the SBT group demonstrated significant weight regain possibly related to the greater attention provided to the SBT+SE group. © 2015 The Obesity Society.

  7. The effect of dental health education on pregnant women's adherence with toothbrushing and flossing - A randomized control trial.

    Science.gov (United States)

    Al Khamis, Suad; Asimakopoulou, Koula; Newton, Tim; Daly, Blanaid

    2017-10-01

    In a three-arm randomized control trial, this study compared the efficacy of dental health education (DHE) with or without a planning intervention on adherence to oral health-related behaviours. Women (N=154) in their second trimester of pregnancy attending three maternal healthcare clinics in Kuwait completed an assessment of social cognitions and oral health behaviours before a debris and gingival assessment (Plaque Index [PI], Gingival Index [GI]) was undertaken; this was repeated at 1 month. In addition to treatment as usual (TAU), which was a demonstration of OH practices, intervention participants received one of two interventions: (i) DHE, which targeted social cognitions; or (ii) DHE and planning (DHE&P), which targeted social cognitions and intentions to undertake oral health behaviours. The TAU group was given a standard oral hygiene leaflet. At Time one (T1) 154 women were eligible and randomly allocated to the three groups, respectively: treatment as usual (TAU)=53; DHE=53; DHE and planning=48. At Time two (T2), the number of women in each group completing the intervention (N=90) was, respectively, as follows TAU=28; DHE=30; DHE&P=32. There were no demographic differences between the groups at baseline. The mean age of women was 27.80±SD 5.40; 43% (n=38) had a high school level education. A mixed factor ANOVA analysis demonstrated that all women improved their PI (F=94.343 df=1 P=.001) and GI (F=73.138 df=1 P=.001) scores. There were no differences in self-reported oral hygiene and PI and GI by intervention group. The social cognition models (SCM) constructs changed over time in all women (N=90) except barriers to attendance (F=1.067 df=1 P=.305). There were no statistically significant differences in SCM constructs by intervention group at T2. All women reported increasing the frequency of toothbrushing and flossing. The provision of information using a simple leaflet improved the adherence of Kuwaiti pregnant with toothbrushing and flossing advice

  8. Equity in adherence to and effect of prenatal food and micronutrient supplementation on child mortality: results from the MINIMat randomized trial, Bangladesh.

    Science.gov (United States)

    Shaheen, Rubina; Streatfield, Peter Kim; Naved, Ruchira Tabassum; Lindholm, Lars; Persson, Lars Ake

    2014-01-07

    Evidence is often missing on social differentials in effects of nutrition interventions. We evaluated the adherence to and effect of prenatal food and micronutrient supplementations on mortality before the age of five years in different social groups as defined by maternal schooling. Data came from the MINIMat study (Maternal and Infant Nutrition Interventions, Matlab), a randomized trial of prenatal food supplementation (invitation early, about 9 weeks [E], or at usual time, about 20 weeks [U] of pregnancy) and 30 mg or 60 mg iron with 400 μgm folic acid, or multiple micronutrients (Fe30F, Fe60F, MMS) resulting in six randomization groups, EFe30F, UFe30F, EFe60F, UFe60F, EMMS, and UMMS (n = 4436). Included in analysis after omissions (fetal loss and out-migration) were 3625 women and 3659 live births of which 3591 had information on maternal schooling. The study site was rural Matlab, Bangladesh. The main stratifying variable was maternal schooling dichotomized as mortality, but the EMMS supplementation reduced the social difference in mortality risk (using standard program and schooling mortality in children before the age of five years and reduced the gap in child survival chances between social groups. The pattern of adherence to the supplementations was complex; women with less education adhered more to food supplementation while those with more education had higher adherence to micronutrients. ISRCTN16581394.

  9. Dissemination Strategies and Adherence Predictors for Web-Based Interventions--How Efficient Are Patient Education Sessions and Email Reminders?

    Science.gov (United States)

    Schweier, R.; Romppel, M.; Richter, C.; Grande, G.

    2016-01-01

    The Internet offers the potential to efficaciously deliver health interventions at a low cost and with a low threshold across any distance. However, since many web-based interventions are confronted with low use and adherence, proactive dissemination strategies are needed. We, therefore, tested the efficacy of a 1-h patient education session as…

  10. Evaluating a nationwide recreational football intervention: Recruitment, attendance, adherence, exercise intensity, and health effects

    DEFF Research Database (Denmark)

    Fløtum, Liljan av; Ottesen, Laila; Krustrup, Peter

    2016-01-01

    . A preintervention test battery including resting heart rate (RHR), blood pressure, and body mass measurements along with performance tests (Yo-Yo Intermittent Endurance level 1 (Yo-Yo IE1), the Arrowhead Agility Test, and the Flamingo Balance Test) were performed (푛 = 502). Training attendance (푛 = 310) was 1.6 ± 0......-promoting nationwide training intervention for adult participants with an extraordinary recruitment, a high attendance rate, moderate adherence, high exercise intensity, and marked benefits in cardiovascular health profile and fitness.......The present study evaluated a nationwide exercise intervention with Football Fitness in a small-scale society. In all, 741 adult participants (20–72 yrs) were successfully recruited for Football Fitness training in local football clubs, corresponding to 2.1% of the adult population...

  11. Unannounced telephone pill counts for assessing varenicline adherence in a pilot clinical trial

    Directory of Open Access Journals (Sweden)

    Thompson N

    2011-09-01

    Full Text Available Nia Thompson1, Niaman Nazir1, Lisa Sanderson Cox1,2, Babalola Faseru1,2, Kathy Goggin3, Jasjit S Ahluwalia4, Nicole L Nollen1,21University of Kansas School of Medicine, Department of Preventive Medicine and Public Health, Kansas City, KS, USA; 2University of Kansas Cancer Center, Kansas City, KS, USA; 3University of Missouri-Kansas City, Department of Psychology, Kansas City, MO, USA; 4University of Minnesota Medical School, Department of Medicine and Center for Health Equity, Minneapolis, MN, USABackground: Despite consistent evidence linking smoking cessation pharmacotherapy adherence to better outcomes, knowledge about objective adherence measures is lacking and little attention is given to monitoring pharmacotherapy use in smoking cessation clinical trials.Objectives: To examine unannounced telephone pill counts as a method for assessing adherence to smoking cessation pharmacotherapy.Research design: Secondary data analysis of a randomized pilot study.Participants: 46 moderate-to-heavy (>10 cigarettes per day African-American smokers.Main measures: Smokers received 1 month of varenicline (Pfizer Global Pharmaceuticals, New York, NY in a pill box at baseline. Unannounced pill counts were completed by telephone 4 days prior to an in-person pill count conducted at Month 1. At both counts, each compartment of the pill box was opened and the number of remaining pills was recorded.Results: Participants were a mean age of 48 years (SD = 13, predominately female (59%, low income (60% < $1800 monthly family income, and smoked an average of 17 (SD = 7 cigarettes per day. A high degree of concordance was observed between the number of pills counted by phone and in-person (rs = 0.94, P < 0.001. Participants with discordant counts (n = 7 had lower varenicline adherence (mean [SD] = 77% [18%] vs 95% [9%], P < 0.0005, but reported better medication adherence in the past (1.0 [0.8] vs 2.8 [1.0], P < 0.0004 than participants with matching phone and in

  12. Symptoms and QOL as Predictors of Chemoprevention Adherence in NRG Oncology/NSABP Trial P-1

    Science.gov (United States)

    Walcott, Farzana L.; Liu, Qing; Wickerham, D. Lawrence; Costantino, Joseph P.; Ganz, Patricia A.

    2016-01-01

    Background: Tamoxifen provides a 50% reduction in the incidence of breast cancer (BC) among high-risk women, yet many do not adhere to the five-year course of therapy. Using the prospective double-blind National Surgical Adjuvant Breast and Bowel Project P-1 study, we evaluated whether participant-reported outcomes were associated with drug adherence and whether baseline behavioral risk factors modified those associations. Methods: P-1 participants were randomly assigned to placebo vs tamoxifen (20mg/day). Mixed effects logistic regression was used to evaluate whether baseline or three-month SF-36 quality of life (QOL) mental and physical component summaries (MCS, PCS), and participant-reported symptoms (gynecologic, vasomotor, sexual, and other) predicted 12-month drug adherence (76–100% of assigned medication). The evaluation accounted for age, treatment, estimated breast cancer risk, education, baseline smoking, alcohol consumption, and obesity. All statistical tests were two-sided. Results: Participants enrolled at least three years before trial unblinding and without medically indicated discontinuation before 12 months were eligible for the present analyses (n = 10 576). At 12 months, 84.3% were adherent. Statistically significant predictors of adherence were: three-month MCS (odds ratio [OR] = 1.15 per 10 points, 95% confidence interval [CI] = 1.06 to 1.25); three-month gynecologic symptoms among moderate alcohol drinkers (OR = .79, 95% CI = 0.72 to 0.88); baseline vasomotor symptoms among participants assigned tamoxifen (OR = .88, 95% CI = 0.80 to 0.97); and three-month sexual symptoms among younger participants (OR = .89 at age 41 years, 95% CI = 0.80 to 0.99). The strongest association was with three-month other symptoms (OR = .77, 95% CI = 0.63 to 0.93). PCS was not associated with adherence. Symptom and QOL associations were not modified by smoking or obesity. Conclusions: Promoting QOL and managing symptoms early in therapy may be important strategies

  13. Non-adherence to subcutaneous biological medication in patients with rheumatoid arthritis: a multicentre, non-interventional study.

    Science.gov (United States)

    Calvo-Alén, Jaime; Monteagudo, Indalecio; Salvador, Georgina; Vázquez-Rodríguez, Tomás R; Tovar-Beltrán, Juan V; Vela, Paloma; Maceiras, Francisco; Bustabad, Sagrario; Román-Ivorra, José A; Díaz-Miguel, Consuelo; Rosas, José; Raya, Enrique; Carmona, Loreto; Cea-Calvo, Luis; Arteaga, María J; Fernández, Sabela; Marras, Carlos

    2017-01-01

    To evaluate non-adherence to prescribed subcutaneous biologicals in rheumatoid arthritis (RA) patients in Spain. ARCO (Study on Adherence of Rheumatoid Arthritis patients to SubCutaneous and Oral Drugs) was a multicentre, non-interventional retrospective study involving 42 rheumatology clinics from representative hospitals throughout Spain. The primary objective was to assess the percentage of patients (aged ≥18 years with an established RA diagnosis) with non-adherence to prescribed subcutaneous biologicals using clinical records and hospital pharmacy dispensing logs as the primary information sources. Adherence was assessed using the Medication Possession Ratio (MPR). Additionally, patients completed the Morisky-Green Medication Adherence Questionnaire. A total of 364 patients (77.5% females, mean age 54.9 years, median RA duration since diagnosis 7.8 years) were enrolled in ARCO. Non-adherence (MPR ≤80%) was reported in 52/363 evaluable patients (14.3%), and was lower in patients receiving initial monthly drug administration (6.4%) than with weekly (17.4%; p=0.034) or every two weeks (14.4%; p=0.102) administration. By multivariate analysis, non-adherence was positively associated with RA duration above the median and with using induction doses. Monthly administration, compared to weekly administration, was inversely associated with non-adherence. Age, gender, order of administration, and changes in the interval of administration, showed no association with non-adherence. Compared with the MPR, the Morisky-Green questionnaire performed poorly in detecting non-adherence. Non-adherence to the prescribed subcutaneous biological drug occurred in 14.3% of patients with RA. Patients using the most convenient administration period (i.e. monthly) had better adherence than those using more frequent dosing schedules.

  14. A pragmatic trial to improve adherence with scheduled appointments in an inner-city pain clinic by human phone calls in the patient's preferred language.

    Science.gov (United States)

    Andreae, Michael H; Nair, Singh; Gabry, Jonah S; Goodrich, Ben; Hall, Charles; Shaparin, Naum

    2017-08-22

    We investigated if human reminder phone calls in the patient's preferred language increase adherence with scheduled appointments in an inner-city chronic pain clinic. We hypothesized that language and cultural incongruence is the underlying mechanism to explain poor attendance at clinic appointments in underserved Hispanic populations. Pragmatic randomized controlled clinical trial SETTING: Innercity academic chronic pain clinic with a diverse, predominantly African-American and Hispanic population PATIENTS: All (n=963) adult patients with a scheduled first appointment between October 2014 and October 2015 at the Montefiore Pain Center in the Bronx, New York were enrolled. Patients were randomized to receive a human reminder call in their preferred language before their appointment, or no contact. We recorded patients' demographic characteristics and as primary outcome attendance as scheduled, failure to attend and/or cancellation calls. We fit Bayesian and classical multinomial logistic regression models to test if the intervention improved adherence with scheduled appointments. Among the 953 predominantly African American and Hispanic/Latino patients, 475 patients were randomly selected to receive a language-congruent, human reminder call, while 478 were assigned to receive no prior contact, (after we excluded 10 patients, scheduled for repeat appointments). In the experimental group, 275 patients adhered to their scheduled appointment, while 84 cancelled and 116 failed to attend. In the control group, 249 patients adhered to their scheduled appointment, 31 cancelled and 198 failed to attend. Human phone reminders in the preferred language increased adherence (RR 1.89, CI95% [1.42, 1.42], (planguage increased adherence with scheduled appointments. The intervention facilitated access to much needed care in an ethnically diverse, resource poor population, presumably by overcoming language barriers. Copyright © 2017 Elsevier Inc. All rights reserved.

  15. Misreporting of Product Adherence in the MTN-003/VOICE Trial for HIV Prevention in Africa: Participants' Explanations for Dishonesty.

    Science.gov (United States)

    Montgomery, Elizabeth T; Mensch, B; Musara, P; Hartmann, M; Woeber, K; Etima, J; van der Straten, A

    2017-02-01

    Consistent over-reporting of product use limits researchers' ability to accurately measure adherence and estimate product efficacy in HIV prevention trials. While lying is a universal characteristic of the human condition, growing evidence of a stark discrepancy between self-reported product use and biologic or pharmacokinetic evidence demands examination of the reasons research participants frequently misrepresent product use in order to mitigate this challenge in future research. This study (VOICE-D) was an ancillary post-trial study of the vaginal and oral interventions to control the epidemic (VOICE) phase IIb trial (MTN 003). It was conducted in three African countries to elicit candid accounts from former VOICE trial participants about why actual product use was lower than reported. In total 171 participants were enrolled between December 2012 and March 2014 in South Africa (n = 47), Uganda (n = 59) and Zimbabwe (n = 65). Data suggested that participants understood the importance of daily product use and honest reporting, yet acknowledged that research participants typically lie. Participants cited multiple reasons for misreporting adherence, including human nature, self-presentation with study staff, fear of repercussions (study termination resulting in loss of benefits and experience of HIV-related stigma), a permissive environment in which it was easy to get away with misreporting, and avoiding inconvenient additional counseling. Some participants also reported mistrust of the staff and reciprocal dishonesty about the study products. Many suggested real-time blood-monitoring during trials would encourage greater fidelity to product use and honesty in reporting. Participants at all sites understood the importance of daily product use and honesty, while also acknowledging widespread misreporting of product use. Narratives of dishonesty may suggest a wider social context of hiding products from partners and distrust about research, influenced by rumors

  16. Using Randomized Controlled Trials to Evaluate Interventions for Releasing Prisoners

    Science.gov (United States)

    Pettus-Davis, Carrie; Howard, Matthew Owen; Dunnigan, Allison; Scheyett, Anna M.; Roberts-Lewis, Amelia

    2016-01-01

    Randomized controlled trials (RCTs) are rarely used to evaluate social and behavioral interventions designed for releasing prisoners. Objective: We use a pilot RCT of a social support intervention (Support Matters) as a case example to discuss obstacles and strategies for conducting RCT intervention evaluations that span prison and community…

  17. The Meaning of Adherence When Behavioral Risk Patterns Vary: Obscured Use- and Method-Effectiveness in HIV-Prevention Trials

    NARCIS (Netherlands)

    Bruin, de M.; Viechtbauer, W.

    2012-01-01

    Background Recently promising trials of innovative biomedical approaches to prevent HIV transmission have been reported. Participants' non-adherence to the prevention methods complicates the analyses and interpretation of trial results. The influence of variable sexual behaviors within and between p

  18. Impact of a brief patient and provider intervention to improve the quality of communication about medication adherence among HIV patients.

    Science.gov (United States)

    Beach, Mary Catherine; Roter, Debra L; Saha, Somnath; Korthuis, P Todd; Eggly, Susan; Cohn, Jonathan; Sharp, Victoria; Moore, Richard D; Wilson, Ira B

    2015-09-01

    Medication adherence is essential in HIV care, yet provider communication about adherence is often suboptimal. We designed this study to improve patient-provider communication about HIV medication adherence. We randomized 26 providers at three HIV care sites to receive or not receive a one-hour communication skills training based on motivational interviewing principles applied to medication adherence. Prior to routine office visits, non-adherent patients of providers who received the training were coached to discuss adherence with their providers. Patients of providers who did not receive the training providers were not coached. We audio-recorded and coded patient-provider interactions using the roter interaction analysis system (RIAS). There was more dialogue about therapeutic regimen in visits with intervention patients and providers (167 vs 128, respectively, p=.004), with the majority of statements coming from providers. These visits also included more brainstorming solutions to nonadherence (41% vs. 22%, p=0.026). Intervention compared with control visit providers engaged in more positive talk (44 vs. 38 statements, p=0.039), emotional talk (26 vs. 18 statements, ppatient opinion (3 vs. 2 statements, p=0.009). A brief provider training combined with patient coaching sessions, improved provider communication behaviors and increased dialogue regarding medication adherence. Copyright © 2015 Elsevier Ireland Ltd. All rights reserved.

  19. Trials of Intervention Principles: Evaluation Methods for Evolving Behavioral Intervention Technologies.

    Science.gov (United States)

    Mohr, David C; Schueller, Stephen M; Riley, William T; Brown, C Hendricks; Cuijpers, Pim; Duan, Naihua; Kwasny, Mary J; Stiles-Shields, Colleen; Cheung, Ken

    2015-07-08

    In recent years, there has been increasing discussion of the limitations of traditional randomized controlled trial (RCT) methodologies for the evaluation of eHealth and mHealth interventions, and in particular, the requirement that these interventions be locked down during evaluation. Locking down these interventions locks in defects and eliminates the opportunities for quality improvement and adaptation to the changing technological environment, often leading to validation of tools that are outdated by the time that trial results are published. Furthermore, because behavioral intervention technologies change frequently during real-world deployment, even if a tested intervention were deployed in the real world, its shelf life would be limited. We argue that RCTs will have greater scientific and public health value if they focus on the evaluation of intervention principles (rather than a specific locked-down version of the intervention), allowing for ongoing quality improvement modifications to the behavioral intervention technology based on the core intervention principles, while continuously improving the functionality and maintaining technological currency. This paper is an initial proposal of a framework and methodology for the conduct of trials of intervention principles (TIPs) aimed at minimizing the risks of in-trial changes to intervention technologies and maximizing the potential for knowledge acquisition. The focus on evaluation of intervention principles using clinical and usage outcomes has the potential to provide more generalizable and durable information than trials focused on a single intervention technology.

  20. Adherence, Compliance, and Health Risk Factor Changes following Short-Term Physical Activity Interventions

    Directory of Open Access Journals (Sweden)

    Lynda H. Norton

    2015-01-01

    Full Text Available Background. Low physical activity (PA levels are associated with poor health risk factor profiles. Intervention strategies to increase PA and quantify the rate and magnitude of change in risk factors are important. Methods. Interventions were conducted over 40 days to increase PA in 736 insufficiently active (<150 min/wk PA participants using either a pedometer or instructor-led group protocol. There were a further 135 active participants as controls. Major cardiovascular and metabolic risk factors, including fitness parameters, were measured before and after intervention. Results. Adherence to the interventions was higher for the group versus pedometer participants (87.1% versus 79.8% and compliance rates for achieving sufficient levels of PA (≥150 min/wk were also higher for the group participants (95.8% versus 77.6%. Total weekly PA patterns increased by 300 and 435 minutes, for the pedometer and group participants, respectively. Improvements were found for waist girth, total cholesterol, aerobic fitness, and flexibility relative to controls. The change in vigorous PA, but not moderate PA, was a significant predictor of the change in eight of 11 risk factor variables measured. Conclusions. Rapid and dramatic increases in PA among previously insufficiently active adults can result in important health benefits.

  1. Older Australians Can Achieve High Adherence to the Mediterranean Diet during a 6 Month Randomised Intervention; Results from the Medley Study.

    Science.gov (United States)

    Davis, Courtney; Hodgson, Jonathan; Bryan, Janet; Garg, Manohar; Woodman, Richard; Murphy, Karen

    2017-05-24

    Adherence to a Mediterranean diet (MedDiet) is thought to be achievable in non-Mediterranean regions, but this has yet to be investigated. We aimed to determine if an older Australian population could adhere to a MedDiet for six months. We conducted a randomised, parallel dietary intervention trial with two dietary arms: the Mediterranean diet (MedDiet) group and the habitual diet (HabDiet) control group. A 15-point Mediterranean diet adherence score and food and nutrient intakes were estimated from three-day weighed food records collected at baseline, two and four months. Erythrocyte fatty acids, serum carotenoids and urinary metabolites were assessed at baseline, three and six months. We enrolled 166 participants; 152 commenced and 137 completed the study (70 in the MedDiet group, 67 in the HabDiet group). Adherence scores were significantly higher in the MedDiet group at two months (between group difference 2.2, 95% CI 1.3, 2.9) and four months (between group difference 2.6, 95% CI 1.9, 3.3). Consumption of vegetables, fruits, fish, legumes, nuts and olive oil significantly increased in the MedDiet group compared to the control, and discretionary food intake decreased (p Mediterranean diet over a six month period.

  2. Adherence to a web-based intervention program for traumatized persons in mainland China

    Directory of Open Access Journals (Sweden)

    Zhiyun Wang

    2014-12-01

    Full Text Available Background: This paper investigated adherence to a self-help web-based intervention for PTSD (Chinese My Trauma Recovery, CMTR in mainland China and evaluated the association between adherence measures and potential predictors, for example, traumatic symptoms and self-efficacy. Methods: Data from 56 urban and 90 rural trauma survivors were reported who used at least one of the seven recovery modules of CMTR. Results: The results showed that 80% urban users visited CMTR four or less days and 87% rural users visited CMTR for 5 or 6 days. On average, urban users visited 2.54 (SD=1.99 modules on the first visiting day and less from the second day; rural users visited 1.10 (SD=0.54 modules on the first visiting day, and it became stable in the following days. In both samples, depression scores at pre-test were significantly or trend significantly associated with the number of visited web pages in the relaxation and professional help modules (r=0.20–0.26, all p<0.14; traumatic symptom scores at pre-test significantly or trend significantly correlated to the number of visited web pages in the relaxation, professional help, and mastery tools modules (r=0.20–0.26, all p<0.10. Moreover, urban users’ coping self-efficacy scores at pre-test significantly or trend significantly related to the number of visited web pages in the relaxation, professional help, social support, and mastery tool modules (r=0.20–0.33, all p<0.16. Conclusions: These findings suggest that individuals tend to focus on one or two recovery modules when they visit CMTR, and the number of web pages visited during the intervention period relates to users’ traumatic and depressive symptoms and self-efficacy before intervention.

  3. Interventions to enhance adherence to dietary advice for preventing and managing chronic diseases in adults: a study protocol

    Directory of Open Access Journals (Sweden)

    Gravel Karine

    2011-02-01

    Full Text Available Abstract Background Adoption of a healthy diet has been identified as the cornerstone in the prevention and management of chronic diseases. However, non-adherence to lifestyle changes raises an important issue since adherence level to dietary advice is a key determinant of the effectiveness of dietary treatment. Therefore, based on the results of a Cochrane systematic review on interventions for enhancing adherence to dietary advice for preventing and managing chronic diseases in adults, the aim of this study is to assess the importance and applicability of interventions enhancing adherence to dietary advice in the Canadian context. Methods/Design In phase 1, dietitians' opinion will be assessed through a Delphi study regarding the importance and the applicability in the Canadian context of the interventions found the most effective to enhance adherence to dietary advice through a Cochrane systematic review. In phase 2, findings of the Cochrane systematic review assessing the effects of interventions for enhancing adherence to dietary advice will be reported in a practical format on an online knowledge translation tool for dietitians and other health professionals. Discussion In recent years, there has been an increasing recognition of the failure to translate research findings into clinical practice. Therefore, knowledge translation efforts need to prioritize effective interventions that will be the most relevant for practice and end-users by adapting them to the local context. Our study will provide decision makers in the field of dietetic practice with essential knowledge on adherence for elaborating educational activities for academic or professional settings that will respond to dietitians' priorities in terms of importance and applicability to day-to-day practice.

  4. Impact of an electronic monitoring device and behavioral feedback on adherence to multiple sclerosis therapies in youth: results of a randomized trial.

    Science.gov (United States)

    Yeh, E Ann; Grover, Stephanie A; Powell, Victoria E; Alper, Gulay; Banwell, Brenda L; Edwards, Kim; Gorman, Mark; Graves, Jennifer; Lotze, Timothy E; Mah, Jean K; Mednick, Lauren; Ness, Jayne; Obadia, Maya; Slater, Ruth; Waldman, Amy; Waubant, Emmanuelle; Schwartz, Carolyn E

    2017-04-09

    To report the results of a randomized controlled trial using an electronic monitoring device (EM) plus a motivational interviewing (MI) intervention to enhance adherence to disease-modifying therapies (DMT) in pediatric MS. Fifty-two youth with MS (16.03 ± 2.2 years) were randomized to receive either MI (n = 25) (target intervention) or a MS medication video (n = 27) (attention control). Primary endpoint was change in adherence. Secondary outcomes included changes in quality of life, well-being and self-efficacy. Random effects modeling and Cohen's effect size computation evaluated intervention impact. Longitudinal random effect models revealed that the MI group decreased their EM adherence (GroupxTime interaction = -0.19), while increasing frequency of parental DMT reminder (26.01)/administration (11.69). We found decreased EM use in the MI group at 6 months (Cohen's d = -0.61), but increased pharmacy refill adherence (d = 0.23). Parental reminders about medication increased in MI subjects vs controls (d = 0.59 at 3 months; d = 0.70 at 6 months). We found increases in self-reported adherence (d = 0.21) at 3 but not 6 months, fewer barriers to adherence at three (d = -0.58) and six months (d = -0.31), better physical (d = 0.23 at 3 months; d = 0.45 at 6 months), emotional (d = 0.25 at 3 months) and self-efficacy function (d = 0.55 at 3 months; 0.48 at 6 months), but worse well-being, including self-acceptance (d = -0.53 at 6 months) and environmental mastery (d = -0.42 at 3 and 6 months) in intervention as compared to control patients. Participants receiving MI + EM experienced worsening on objective measures of adherence and increased parental involvement, but improved on some self- and parent-reported measures. MI participants reported improvements in quality of life and self-efficacy, but worsened well-being.

  5. Inadequate description of educational interventions in ongoing randomized controlled trials

    Directory of Open Access Journals (Sweden)

    Pino Cécile

    2012-05-01

    Full Text Available Abstract Background The registration of clinical trials has been promoted to prevent publication bias and increase research transparency. Despite general agreement about the minimum amount of information needed for trial registration, we lack clear guidance on descriptions of non-pharmacologic interventions in trial registries. We aimed to evaluate the quality of registry descriptions of non-pharmacologic interventions assessed in ongoing randomized controlled trials (RCTs of patient education. Methods On 6 May 2009, we searched for all ongoing RCTs registered in the 10 trial registries accessible through the World Health Organization International Clinical Trials Registry Platform. We included trials evaluating an educational intervention (that is, designed to teach or train patients about their own health and dedicated to participants, their family members or home caregivers. We used a standardized data extraction form to collect data related to the description of the experimental intervention, the centers, and the caregivers. Results We selected 268 of 642 potentially eligible studies and appraised a random sample of 150 records. All selected trials were registered in 4 registers, mainly ClinicalTrials.gov (61%. The median [interquartile range] target sample size was 205 [100 to 400] patients. The comparator was mainly usual care (47% or active treatment (47%. A minority of records (17%, 95% CI 11 to 23% reported an overall adequate description of the intervention (that is, description that reported the content, mode of delivery, number, frequency, duration of sessions and overall duration of the intervention. Further, for most reports (59%, important information about the content of the intervention was missing. The description of the mode of delivery of the intervention was reported for 52% of studies, the number of sessions for 74%, the frequency of sessions for 58%, the duration of each session for 45% and the overall duration for 63

  6. Developing a Nicotine Patch Adherence Intervention for HIV-positive Latino Smokers

    Science.gov (United States)

    Shadel, William G.; Galvan, Frank H.; Tucker, Joan S.

    2016-01-01

    This paper describes two phases of formative research that were undertaken to develop a smoking cessation treatment module that has the goal of improving adherence with the nicotine patch in HIV-positive Latino smokers. Each research phase (Phase I and II) was conducted independent of the other and used different methods to inform the development of the intervention. Phase I interviewed n=14 smokers who had previous experience using the nicotine patch to gain detailed understanding of how, when, and why they used it; their perceived barriers to using it; and their perspective on ways to improve adherence to it. Phase II provided n=35 smokers with brief smoking cessation treatment and nicotine patches, then interviewed them in “near real time” over a two month period about their use of the patch during a quit attempt (e.g., perceived barriers and facilitators). Authors of the paper conducted a qualitative analysis of the themes emerging from the interview transcripts across these two phases. Results indicated that consistent use of the nicotine patch was associated with maintaining high motivation for use (i.e., not necessarily motivation to quit, but motivation to continue patch use); linking its use with established daily routines (e.g., with taking other medications, with brushing teeth); and maintaining realistic expectations for patch efficacy (e.g., that users may still experience some level of craving and/or withdrawal). This information will used to develop and pilot test a brief treatment module that focuses on improving nicotine patch adherence. PMID:27070097

  7. An economic evaluation of anticipated costs and savings of a behavior change intervention to enhance medication adherence

    Directory of Open Access Journals (Sweden)

    Wiegand PN

    2008-06-01

    Full Text Available Medication adherence across disease states is generally poor. Research has focused on various methods to improve medication adherence, but there is little conclusive evidence regarding specific methods efficacy. The Transtheoretical Model for Behavior Change has been used to modify existing addictive behaviors but not in medication adherence specifically. As a behavioral component is inherently related to medication adherence, it is thought that this model may be applicable. Objective: The purpose of this research is to evaluate the costs and savings of implementing a novel behavioral intervention against the cost of poor medication adherence to determine whether further development is realistic.Methods: The basic tools required to administer this intervention were determined through primary literature review and priced by vendors supplying such materials. Diabetes Mellitus Type 2 (DM2 was used as a vehicle to establish the cost of care for long-term complications of a chronic disease. The primary literature provided information regarding the cost of care for DM2 morbidity and outpatient annual drug therapy expenditure. The total cost of the behavioral intervention components and the cost of care for DM2 morbidity were applied to a theoretical cohort of 1000 patients. By dividing this cost across 1000 patients, a per-patient cost was yielded and multiplied over a 16-year timeframe. Results: It was found that the cost to implement the behavioral intervention and resultant medication costs is USD13,574 per-patient over 16 years. The cost to treat complications of diabetes mellitus is USD 36,528 per patient over the 16 years. The total amount of healthcare dollars potentially saved by utilizing this intervention is USD 22,954 per-patient. Conclusions: It appears that the cost to implement this behavioral intervention is reasonable and permits further evaluation in other chronic conditions with notoriously poor adherence levels.

  8. A Randomized Controlled Trial Protocol to Evaluate the Effectiveness of an Integrated Care Management Approach to Improve Adherence Among HIV-Infected Patients in Routine Clinical Care: Rationale and Design.

    Science.gov (United States)

    Crane, Heidi M; Fredericksen, Rob J; Church, Anna; Harrington, Anna; Ciechanowski, Paul; Magnani, Jennifer; Nasby, Kari; Brown, Tyler; Dhanireddy, Shireesha; Harrington, Robert D; Lober, William B; Simoni, Jane; Safren, Stevan A; Edwards, Todd C; Patrick, Donald L; Saag, Michael S; Crane, Paul K; Kitahata, Mari M

    2016-10-05

    Adherence to antiretroviral medications is a key determinant of clinical outcomes. Many adherence intervention trials investigated the effects of time-intensive or costly interventions that are not feasible in most clinical care settings. We set out to evaluate a collaborative care approach as a feasible intervention applicable to patients in clinical care including those with mental illness and/or substance use issues. We developed a randomized controlled trial (RCT) investigating an integrated, clinic-based care management approach to improve clinical outcomes that could be integrated into the clinical care setting. This is based on the routine integration and systematic follow-up of a clinical assessment of patient-reported outcomes targeting adherence, depression, and substance use, and adapts previously developed and tested care management approaches. The primary health coach or care management role is provided by clinic case managers allowing the intervention to be generalized to other human immunodeficiency virus (HIV) clinics that have case managers. We used a stepped-care approach to target interventions to those at greatest need who are most likely to benefit rather than to everyone to maintain feasibility in a busy clinical care setting. The National Institutes of Health funded this study and had no role in study design, data collection, or decisions regarding whether or not to submit manuscripts for publication. This trial is currently underway, enrollment was completed in 2015, and follow-up time still accruing. First results are expected to be ready for publication in early 2017. This paper describes the protocol for an ongoing clinical trial including the design and the rationale for key methodological decisions. There is a need to identify best practices for implementing evidence-based collaborative care models that are effective and feasible in clinical care. Adherence efficacy trials have not led to sufficient improvements, and there remains

  9. Excessive daytime sleepiness and adherence to antihypertensive medications among Blacks: analysis of the counseling African Americans to control hypertension (CAATCH trial

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    Williams NJ

    2014-03-01

    Full Text Available Natasha J Williams,1 Girardin Jean-Louis,1 Abhishek Pandey,2 Joseph Ravenell,1 Carla Boutin-Foster,3 Gbenga Ogedegbe1 1Center for Healthful Behavior Change, Division of Internal Medicine, NYU Medical Center, New York, 2Department of Family Medicine, SUNY Downstate Medical Center, Brooklyn, 3Center of Excellence in Disparities Research, Weill Cornell Medical College, New York, NY, USA Background: Excessive daytime sleepiness (EDS often occurs as a result of insufficient sleep, sleep apnea, illicit substance use, and other medical and psychiatric conditions. This study tested the hypothesis that blacks exhibiting EDS would have poorer self-reported adherence to hypertensive medication using cross-sectional data from the Counseling African-Americans to Control Hypertension (CAATCH trial. Methods: A total of 1,058 hypertensive blacks (average age 57±12 years participated in CAATCH, a randomized controlled trial evaluating the effectiveness of a multilevel intervention for participants who receive care from community health centers in New York City. Data analyzed in this study included baseline sociodemographics, medical history, EDS, and medication adherence. We used the Epworth Sleepiness Scale, with a cutoff score of ≥10, to define EDS. Medication adherence was measured using an abbreviated Morisky Medication Adherence scale, with a score >0 indicating nonadherence. Results: Of the sample, 71% were female, 72% received at least a high school education, 51% reported a history of smoking, and 33% had a history of alcohol consumption. Overall, 27% of the participants exhibited EDS, and 44% of those who exhibited EDS were classified as adherent to prescribed antihypertensive medications. Multivariable logistic regression analysis, adjusting for effects of age, body mass index, sex, education, and smoking and drinking history indicated that participants who exhibited EDS were more than twice as likely to be nonadherent (odds ratio 2.28, 95

  10. Adherence to a smartphone application for weight loss compared to website and paper diary: pilot randomized controlled trial.

    Science.gov (United States)

    Carter, Michelle Clare; Burley, Victoria Jane; Nykjaer, Camilla; Cade, Janet Elizabeth

    2013-04-15

    There is growing interest in the use of information communication technologies to treat obesity. An intervention delivered by smartphone could be a convenient, potentially cost-effective, and wide-reaching weight management strategy. Although there have been studies of texting-based interventions and smartphone applications (apps) used as adjuncts to other treatments, there are currently no randomized controlled trials (RCT) of a stand-alone smartphone application for weight loss that focuses primarily on self-monitoring of diet and physical activity. The aim of this pilot study was to collect acceptability and feasibility outcomes of a self-monitoring weight management intervention delivered by a smartphone app, compared to a website and paper diary. A sample of 128 overweight volunteers were randomized to receive a weight management intervention delivered by smartphone app, website, or paper diary. The smartphone app intervention, My Meal Mate (MMM), was developed by the research team using an evidence-based behavioral approach. The app incorporates goal setting, self-monitoring of diet and activity, and feedback via weekly text message. The website group used an existing commercially available slimming website from a company called Weight Loss Resources who also provided the paper diaries. The comparator groups delivered a similar self-monitoring intervention to the app, but by different modes of delivery. Participants were recruited by email, intranet, newsletters, and posters from large local employers. Trial duration was 6 months. The intervention and comparator groups were self-directed with no ongoing human input from the research team. The only face-to-face components were at baseline enrollment and brief follow-up sessions at 6 weeks and 6 months to take anthropometric measures and administer questionnaires. Trial retention was 40/43 (93%) in the smartphone group, 19/42 (55%) in the website group, and 20/43 (53%) in the diary group at 6 months. Adherence

  11. Evaluating a Nationwide Recreational Football Intervention: Recruitment, Attendance, Adherence, Exercise Intensity, and Health Effects.

    Science.gov (United States)

    Fløtum, Liljan Av; Ottesen, Laila S; Krustrup, Peter; Mohr, Magni

    2016-01-01

    The present study evaluated a nationwide exercise intervention with Football Fitness in a small-scale society. In all, 741 adult participants (20-72 yrs) were successfully recruited for Football Fitness training in local football clubs, corresponding to 2.1% of the adult population. A preintervention test battery including resting heart rate (RHR), blood pressure, and body mass measurements along with performance tests (Yo-Yo Intermittent Endurance level 1 (Yo-Yo IE1), the Arrowhead Agility Test, and the Flamingo Balance Test) were performed (n = 502). Training attendance (n = 310) was 1.6 ± 0.2 sessions per week (range: 0.6-2.9), corresponding to 28.8 ± 1.0 sessions during the 18 wk intervention period. After 18 wks mean arterial pressure (MAP) was -2.7 ± 0.7 mmHg lower (P 99 mmHg (-5.6 ± 1.5 mmHg; n = 50). RHR was lowered (P Football Fitness was shown to be a successful health-promoting nationwide training intervention for adult participants with an extraordinary recruitment, a high attendance rate, moderate adherence, high exercise intensity, and marked benefits in cardiovascular health profile and fitness.

  12. Online interventions for social marketing health behavior change campaigns: a meta-analysis of psychological architectures and adherence factors.

    Science.gov (United States)

    Cugelman, Brian; Thelwall, Mike; Dawes, Phil

    2011-02-14

    Researchers and practitioners have developed numerous online interventions that encourage people to reduce their drinking, increase their exercise, and better manage their weight. Motivations to develop eHealth interventions may be driven by the Internet's reach, interactivity, cost-effectiveness, and studies that show online interventions work. However, when designing online interventions suitable for public campaigns, there are few evidence-based guidelines, taxonomies are difficult to apply, many studies lack impact data, and prior meta-analyses are not applicable to large-scale public campaigns targeting voluntary behavioral change. This meta-analysis assessed online intervention design features in order to inform the development of online campaigns, such as those employed by social marketers, that seek to encourage voluntary health behavior change. A further objective was to increase understanding of the relationships between intervention adherence, study adherence, and behavioral outcomes. Drawing on systematic review methods, a combination of 84 query terms were used in 5 bibliographic databases with additional gray literature searches. This resulted in 1271 abstracts and papers; 31 met the inclusion criteria. In total, 29 papers describing 30 interventions were included in the primary meta-analysis, with the 2 additional studies qualifying for the adherence analysis. Using a random effects model, the first analysis estimated the overall effect size, including groupings by control conditions and time factors. The second analysis assessed the impacts of psychological design features that were coded with taxonomies from evidence-based behavioral medicine, persuasive technology, and other behavioral influence fields. These separate systems were integrated into a coding framework model called the communication-based influence components model. Finally, the third analysis assessed the relationships between intervention adherence and behavioral outcomes. The

  13. Therapeutic Alliance and Treatment Adherence in Two Interventions for Bulimia Nervosa: A Study of Process and Outcome

    Science.gov (United States)

    Loeb, Katharine L.; Wilson, G. Terence; Labouvie, Erich; Pratt, Elizabeth M.; Hayaki, Jumi; Walsh, B. Timothy; Agras, W. Stewart; Fairburn, Christopher G.

    2005-01-01

    The relationship between therapeutic alliance, therapist adherence to treatment protocol, and outcome was analyzed in a randomized trial of cognitive-behavioral therapy (CBT) and interpersonal psychotherapy for bulimia nervosa. Independent observers rated audiotapes of full-length therapy sessions. Purging frequency was the primary outcome…

  14. Therapeutic Alliance and Treatment Adherence in Two Interventions for Bulimia Nervosa: A Study of Process and Outcome

    Science.gov (United States)

    Loeb, Katharine L.; Wilson, G. Terence; Labouvie, Erich; Pratt, Elizabeth M.; Hayaki, Jumi; Walsh, B. Timothy; Agras, W. Stewart; Fairburn, Christopher G.

    2005-01-01

    The relationship between therapeutic alliance, therapist adherence to treatment protocol, and outcome was analyzed in a randomized trial of cognitive-behavioral therapy (CBT) and interpersonal psychotherapy for bulimia nervosa. Independent observers rated audiotapes of full-length therapy sessions. Purging frequency was the primary outcome…

  15. Maintaining Treatment Fidelity of Mindfulness-Based Relapse Prevention Intervention for Alcohol Dependence: A Randomized Controlled Trial Experience

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    Aleksandra E. Zgierska

    2017-01-01

    Full Text Available Background. Treatment fidelity is essential to methodological rigor of clinical trials evaluating behavioral interventions such as Mindfulness Meditation (MM. However, procedures for monitoring and maintenance of treatment fidelity are inconsistently applied, limiting the strength of such research. Objective. To describe the implementation and findings related to fidelity monitoring of the Mindfulness-Based Relapse Prevention for Alcohol Dependence (MBRP-A intervention in a 26-week randomized controlled trial. Methods. 123 alcohol dependent adults were randomly assigned to MM (MBRP-A and home practice, adjunctive to usual care; N=64 or control (usual care alone; N=59. Treatment fidelity assessment strategies recommended by the National Institutes of Health Behavior Change Consortium for study/intervention design, therapist training, intervention delivery, and treatment receipt and enactment were applied. Results. Ten 8-session interventions were delivered. Therapist adherence and competence, assessed using the modified MBRP Adherence and Competence Scale, were high. Among the MM group participants, 46 attended ≥4 sessions; over 90% reported at-home MM practice at 8 weeks and 72% at 26 weeks. They also reported satisfaction with and usefulness of MM for maintaining sobriety. No adverse events were reported. Conclusions. A systematic approach to assessment of treatment fidelity in behavioral clinical trials allows determination of the degree of consistency between intended and actual delivery and receipt of intervention.

  16. Field Trials of Health Interventions, 3rd edition

    OpenAIRE

    Smith, Peter G; Richard H. Morrow; David A Ross

    2015-01-01

    Before new interventions can be used in disease control programmes, it is essential that they are carefully evaluated in “field trials”, which may be complex and expensive undertakings. Descriptions of the detailed procedures and methods used in trials that have been conducted in the past have generally not been published. As a consequence, those planning such trials have few guidelines available and little access to previously accumulated knowledge. In this book the practical issues of trial...

  17. A randomized controlled trial testing an adherence-optimized Vitamin D regimen to mitigate bone change in adolescents being treated for acute lymphoblastic leukemia.

    Science.gov (United States)

    Orgel, Etan; Mueske, Nicole M; Sposto, Richard; Gilsanz, Vicente; Wren, Tishya A L; Freyer, David R; Butturini, Anna M; Mittelman, Steven D

    2017-10-01

    Adolescents with acute lymphoblastic leukemia (ALL) develop osteopenia early in therapy, potentially exacerbated by high rates of concurrent Vitamin D deficiency. We conducted a randomized clinical trial testing a Vitamin D-based intervention to improve Vitamin D status and reduce bone density decline. Poor adherence to home supplementation necessitated a change to directly observed therapy (DOT) with intermittent, high-dose Vitamin D3 randomized versus standard of care (SOC). Compared to SOC, DOT Vitamin D3 successfully increased trough Vitamin 25(OH)D levels (p = .026) with no residual Vitamin D deficiency, 100% adherence to DOT Vitamin D3, and without associated toxicity. However, neither Vitamin D status nor supplementation impacted bone density. Thus, this adherence-optimized intervention is feasible and effective to correct Vitamin D deficiency in adolescents during ALL therapy. Repletion of Vitamin D and calcium alone did not mitigate osteopenia, however, and new, comprehensive approaches are needed to address treatment-associated osteopenia during ALL therapy.

  18. Online Interventions for Social Marketing Health Behavior Change Campaigns: A Meta-Analysis of Psychological Architectures and Adherence Factors

    Science.gov (United States)

    Thelwall, Mike; Dawes, Phil

    2011-01-01

    Background Researchers and practitioners have developed numerous online interventions that encourage people to reduce their drinking, increase their exercise, and better manage their weight. Motivations to develop eHealth interventions may be driven by the Internet’s reach, interactivity, cost-effectiveness, and studies that show online interventions work. However, when designing online interventions suitable for public campaigns, there are few evidence-based guidelines, taxonomies are difficult to apply, many studies lack impact data, and prior meta-analyses are not applicable to large-scale public campaigns targeting voluntary behavioral change. Objectives This meta-analysis assessed online intervention design features in order to inform the development of online campaigns, such as those employed by social marketers, that seek to encourage voluntary health behavior change. A further objective was to increase understanding of the relationships between intervention adherence, study adherence, and behavioral outcomes. Methods Drawing on systematic review methods, a combination of 84 query terms were used in 5 bibliographic databases with additional gray literature searches. This resulted in 1271 abstracts and papers; 31 met the inclusion criteria. In total, 29 papers describing 30 interventions were included in the primary meta-analysis, with the 2 additional studies qualifying for the adherence analysis. Using a random effects model, the first analysis estimated the overall effect size, including groupings by control conditions and time factors. The second analysis assessed the impacts of psychological design features that were coded with taxonomies from evidence-based behavioral medicine, persuasive technology, and other behavioral influence fields. These separate systems were integrated into a coding framework model called the communication-based influence components model. Finally, the third analysis assessed the relationships between intervention adherence

  19. Effects of The Coach Approach Intervention on Adherence to Exercise in Obese Women: Assessing Mediation of Social Cognitive Theory Factors

    Science.gov (United States)

    Annesi, James J.; Unruh, Jennifer L.; Marti, C. Nathan; Gorjala, Srinivasa; Tennant, Gisele

    2011-01-01

    The link between physical activity and weight loss has precipitated interest in interventions to foster adherence to exercise. It has been suggested that treatment effects, when significant, should be analyzed to determine theory-based mediators. This research assessed possible mediation of changes in Physical Self-Concept, Exercise Self-Efficacy,…

  20. Impact of a care pathway for COPD on adherence to guidelines and hospital readmission: a cluster randomized trial

    Directory of Open Access Journals (Sweden)

    Vanhaecht K

    2016-11-01

    Full Text Available Kris Vanhaecht,1,2 Cathy Lodewijckx,1 Walter Sermeus,1 Marc Decramer,3,4 Svin Deneckere,1,5 Fabrizio Leigheb,6 Paulo Boto,7 Seval Kul,8 Deborah Seys,1 Massimiliano Panella1,6 1Department of Public Health and Primary Care, Leuven Institute for Healthcare Policy, KU Leuven – University of Leuven, 2Department of Quality Management, University Hospitals Leuven, 3Department of Clinical and Experimental Medicine, KU Leuven – University of Leuven, 4University Hospitals Leuven, Leuven, 5Medical Department, Delta Hospitals Roeselare, Roeselare, Belgium; 6Department of Translational Medicine, University of Eastern Piedmont, Vercelli, Italy; 7Department of Health Services Policy and Management, Centro de Investigação em Saúde Pública, Escola Nacional de Saúde Pública, Universidade Nova de Lisboa, Lisbon, Portugal; 8Department of Biostatistics, School of Medicine, University of Gaziantep, Gaziantep, Turkey Purpose: Current in-hospital management of exacerbations of COPD is suboptimal, and patient outcomes are poor. The primary aim of this study was to evaluate whether implementation of a care pathway (CP for COPD improves the 6 months readmission rate. Secondary outcomes were the 30 days readmission rate, mortality, length of stay and adherence to guidelines. Patients and methods: An international cluster randomized controlled trial was performed in Belgium, Italy and Portugal. General hospitals were randomly assigned to an intervention group where a CP was implemented or a control group where usual care was provided. The targeted population included patients with COPD exacerbation. Results: Twenty-two hospitals were included, whereof 11 hospitals (n=174 patients were randomized to the intervention group and 11 hospitals (n=168 patients to the control group. The CP had no impact on the 6 months readmission rate. However, the 30 days readmission rate was significantly lower in the intervention group (9.7%; 15/155 compared to the control group

  1. Choosing a control intervention for a randomised clinical trial

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    Djulbegovic Benjamin

    2003-04-01

    Full Text Available Abstract Background Randomised controlled clinical trials are performed to resolve uncertainty concerning comparator interventions. Appropriate acknowledgment of uncertainty enables the concurrent achievement of two goals : the acquisition of valuable scientific knowledge and an optimum treatment choice for the patient-participant. The ethical recruitment of patients requires the presence of clinical equipoise. This involves the appropriate choice of a control intervention, particularly when unapproved drugs or innovative interventions are being evaluated. Discussion We argue that the choice of a control intervention should be supported by a systematic review of the relevant literature and, where necessary, solicitation of the informed beliefs of clinical experts through formal surveys and publication of the proposed trial's protocol. Summary When clinical equipoise is present, physicians may confidently propose trial enrollment to their eligible patients as an act of therapeutic beneficence.

  2. Protocol for a Randomized Controlled Trial Evaluating Mobile Text Messaging to Promote Retention and Adherence to Antiretroviral Therapy for People Living With HIV in Burkina Faso

    Science.gov (United States)

    Ouedraogo, Denis; Artavia-Mora, Luis; Bedi, Arjun; Thiombiano, Boundia Alexandre

    2016-01-01

    Background Retention in care and adherence to antiretroviral therapy (ART) among people living with human immunodeficiency virus (PLHIV) is a critical challenge in many African countries including Burkina Faso. Delivering text messaging (short message service, SMS) interventions through mobile phones may help facilitate health service delivery and improve patient health. Despite this potential, no evaluations have been delivered for national scale settings to demonstrate the impact of mobile health (mHealth) for PLHIV. Objectives This study aims to test the impact of SMS text messaging reminders for PLHIV in Burkina Faso, who are under ART. The evaluation identifies whether patients who receive SMS text messages are more likely to (1) retain in care (measured as a dichotomous variable), (2) adhere to antiretroviral regimens (measured as the number of doses missed in the past 7 days), and (3) experience slower disease progression (measured with T-lymphocytes cells). The second objective is to assess its effects on the frequency of health center visits, physical and psychosocial health, nutrition and whether the type of message (text vs image) and frequency (weekly vs semiweekly) have differential impacts including the possibility of message fatigue over time. Methods This 24-month, wide-scale intervention implements a randomized controlled trial (RCT) to evaluate the impact of four variants of a mHealth intervention versus a control group. Our sample comprises adult patients (>15 years of age) undergoing antiretroviral therapy with access to mobile phone services. Multivariate regression analysis will be used to analyze the effect of the intervention on the study population. Data collection is done at baseline and three follow-up waves 6, 12, and 24 months after the intervention starts. Results The targeted 3800 patients were recruited between February 2015 and May 2015. But political uncertainty delayed the launch of the intervention until October 2015. Data

  3. Efficacy of brief motivational interviewing to improve adherence to inhaled corticosteroids among adult asthmatics: results from a randomized controlled pilot feasibility trial

    Directory of Open Access Journals (Sweden)

    Lavoie KL

    2014-11-01

    Full Text Available Kim L Lavoie,1–3 Gregory Moullec,1,2,4 Catherine Lemiere,2 Lucie Blais,2 Manon Labrecque,2 Marie-France Beauchesne,2 Veronique Pepin,2,4 André Cartier,2 Simon L Bacon1,2,41Montreal Behavioural Medicine Centre, 2Research Centre, Hôpital du Sacré-Cœur de Montréal – A University of Montreal Affiliated Hospital, Montréal, 3Department of Psychology, University of Quebec at Montreal (UQAM, Succursale Center-Ville, Montreal, 4Department of Exercise Science, Concordia University, Montreal, Quebec, CanadaPurpose: Daily adherence to inhaled corticosteroid (ICS regimens is one of the most important factors linked to achieving optimal asthma control. Motivational interviewing (MI is a client-centered communication style that focuses on enhancing intrinsic motivation to engage in appropriate self-management behaviors. MI has been shown to improve a variety of health behaviors including medication adherence in other disorders, but its efficacy for the improvement of ICS adherence in asthmatics has yet to be examined. This pilot “proof of concept” trial assessed the feasibility of MI to improve daily ICS adherence and asthma control levels in adult asthmatics.Methods: Fifty-four poorly controlled (Asthma Control Questionnaire [ACQ] score ≥1.5, highly nonadherent (filled <50% of ICS medication in the last year adult asthmatics were recruited from the outpatient asthma clinic of a university-affiliated hospital. Participants underwent baseline assessments and were randomly assigned to MI (3×30 minutes sessions within a 6-week period, n=26 or a usual care (UC control group (n=28. ICS adherence (% pharmacy refills and asthma control (ACQ, Asthma Control Test [ACT] were measured at 6 and 12 months postintervention. Mixed model repeated measure analyses for both intent-to-treat and per-protocol were used. Results were adjusted for a priori-defined covariates including baseline adherence. Patients in the MI group also reported their impressions of

  4. Adherence to WHO breastfeeding guidelines among HIV positive mothers in Southern Ethiopia: implication for intervention

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    Haile D

    2015-06-01

    mothers. Seventy-one percent (70.9% of HIV positive mothers practiced “on demand” breastfeeding. Twenty nine percent of infants aged 6–11 months and 47.8% of infants aged ≥12 months were no longer breastfed. The mean (± standard deviation duration of breastfeeding was 7.8 (±3.1 months (95% confidence interval: 6.9–8.7. Conclusion: The 2010 WHO guidelines and recommendations on breastfeeding duration for HIV positive mothers was not adhered to after 6 months of age. Promotion and counseling of optimal breastfeeding practice for HIV positive mothers based on the updated WHO guideline is an appropriate intervention. However, further research is recommended to evaluate the acceptance of the new 2010 WHO guideline by the health professionals and HIV positive mothers. Keywords: HIV-exposed, infants, breastfeeding, initiation

  5. The Impact of Text Messaging on Medication Adherence and Exercise Among Postmyocardial Infarction Patients: Randomized Controlled Pilot Trial.

    Science.gov (United States)

    Pandey, Avinash; Krumme, Alexis; Patel, Tejal; Choudhry, Niteesh

    2017-08-03

    Adherence to evidence-based therapies such as medications and exercise remains poor among patients after a myocardial infarction (MI). Text message reminders have been shown to improve rates of adherence to medication and exercise, but the existing studies have been of short duration. Two single-center randomized controlled pilot trials were conducted to evaluate the impact of text message reminders over 12 months on adherence to cardiac medications and exercise among patients receiving cardiac rehabilitation after hospitalization for MI. In the medication adherence trial, 34 patients were randomized to receive usual care alone or usual care plus daily text message reminders delivered at the time of day at which medications were to be taken. In the exercise adherence trial, 50 patients were randomized to receive usual care alone or usual care plus 4 daily text messages reminding them to exercise as directed. The text message reminders led to a mean 14.2 percentage point improvement in self-reported medication adherence over usual care (Ptext message reminders resulted in an additional 4.2 days (P=.001, 95% CI 1.9-6.4) and 4.0 hours (PText message reminders significantly increased adherence to medication and exercise among post-MI patients receiving care in a structured cardiac rehabilitation program. This technology represents a simple and scalable method to ensure consistent use of evidence-based cardiovascular therapies. Clinicaltrials.gov NCT02783287; https://clinicaltrials.gov/ct2/show/NCT02783287 (Archived by WebCite at http://www.webcitation.org/6sBnvNb05).

  6. Evidence for Technology Interventions to Promote ART Adherence in Adult Populations: a Review of the Literature 2012-2015.

    Science.gov (United States)

    Amico, K Rivet

    2015-12-01

    Leveraging technology to enhance antiretroviral therapy (ART) adherence, and factors associated with it, has tremendous appeal as a low-cost, generalizable strategy to offer high-quality adherence support given an increasingly limited workforce. As the numbers of individuals living with HIV entering care and initiating ART are expected to increase substantially worldwide in the next decade, capacity to support ART adherence is needed and use of computers, internet, and mobile phones has the potential to offer those efficiencies-provided they are effective. This review summarizes recent advances in the evidence base for technology-driven, technology-delivered, or technology-enhanced ART adherence intervention approaches. A PubMed search limited to January 2013 through July 2015 identified 13 qualifying studies evaluating computer-delivered interventions, internet approaches, mobile phone technologies, and electronic dose monitoring with triggered messaging and data-informed counseling. Considerable support for each area has emerged, with the majority of studies reviewed demonstrating significant effects on ART adherence and clinical outcomes. Gaps are identified and recommendations offered.

  7. The impact of behavioural screening on intervention outcomes in a randomised, controlled multiple behaviour intervention trial

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    Fjeldsoe Brianna S

    2011-03-01

    Full Text Available Abstract Background With an increasing research focus on multiple health behaviour change interventions, a methodological issue requiring further investigation is whether or not to employ pre-trial behavioural screening to exclude participants who are achieving a pre-specified level of one or more behaviours. Behavioural screening can be used to direct limited resources to participants most in need of a behaviour change intervention; but may reduce the representativeness of the sample and limit comparability with trials that do not employ pre-trial behavioural screening. Furthermore, the impact of this type of screening on intervention participation and intervention effects is unknown. Methods Data for this study come from the Logan Healthy Living Program, a randomised, controlled telephone counselling lifestyle intervention trial which did not employ behavioural screening prior to randomisation. Screening for physical activity, diet or the combination was simulated using baseline trial data. To examine the impact of behavioural screening on intervention participation (in terms of participant characteristics, intervention dose received and retention, characteristics of participants included an excluded under the various screening scenarios were compared. To examine the impact of behavioural screening on intervention effects, results from the main trial analysis were compared with results obtained from the same analyses performed separately for each of the screened groups. Results Simulated pre-trial behavioural screening impacted minimally on intervention dose received and trial retention rate. Beyond the anticipated effect of reducing baseline levels of the behaviours being screened for, behavioural screening affected baseline levels of behaviours not targeted by screening, and participants' demographic and health-related characteristics. Behavioural screening impacted on intervention effects in ways that were anticipated and positive, but also

  8. Acceptability of Mobile Phone Technology for Medication Adherence Interventions among HIV-Positive Patients at an Urban Clinic

    Directory of Open Access Journals (Sweden)

    Christopher W. T. Miller

    2013-01-01

    Full Text Available Mobile phone technology is increasingly used to overcome traditional barriers limiting access to care. The goal of this study was to evaluate access and willingness to use smart and mobile phone technology for promoting adherence among people attending an urban HIV clinic. One hundred consecutive HIV-positive patients attending an urban HIV outpatient clinic were surveyed. The questionnaire evaluated access to and utilization of mobile phones and willingness to use them to enhance adherence to HIV medication. The survey also included the CASE adherence index as a measure of adherence. The average age was 46.4 (. The majority of participants were males (63%, black (93%, and Hispanic (11.4% and reported earning less than $10,000 per year (67.3%. Most identified themselves as being current smokers (57%. The vast majority reported currently taking HAART (83.5%. Approximately half of the participants reported some difficulty with adherence (CASE < 10. Ninety-six percent reported owning a mobile phone. Among owners of mobile phones 47.4% reported currently owning more than one device. Over a quarter reported owning a smartphone. About 60% used their phones for texting and 1/3 used their phone to search the Internet. Nearly 70% reported that they would use a mobile device to help with HIV adherence. Those who reported being very likely or likely to use a mobile device to improve adherence were significantly more likely to use their phone daily ( and use their phone for text messages (. The vast majority of patients in an urban HIV clinic own mobile phones and would use them to enhance adherence interventions to HIV medication.

  9. Acceptability of Mobile Phone Technology for Medication Adherence Interventions among HIV-Positive Patients at an Urban Clinic.

    Science.gov (United States)

    Miller, Christopher W T; Himelhoch, Seth

    2013-01-01

    Mobile phone technology is increasingly used to overcome traditional barriers limiting access to care. The goal of this study was to evaluate access and willingness to use smart and mobile phone technology for promoting adherence among people attending an urban HIV clinic. One hundred consecutive HIV-positive patients attending an urban HIV outpatient clinic were surveyed. The questionnaire evaluated access to and utilization of mobile phones and willingness to use them to enhance adherence to HIV medication. The survey also included the CASE adherence index as a measure of adherence. The average age was 46.4 (SD = 9.2). The majority of participants were males (63%), black (93%), and Hispanic (11.4%) and reported earning less than $10,000 per year (67.3%). Most identified themselves as being current smokers (57%). The vast majority reported currently taking HAART (83.5%). Approximately half of the participants reported some difficulty with adherence (CASE mobile phone. Among owners of mobile phones 47.4% reported currently owning more than one device. Over a quarter reported owning a smartphone. About 60% used their phones for texting and 1/3 used their phone to search the Internet. Nearly 70% reported that they would use a mobile device to help with HIV adherence. Those who reported being very likely or likely to use a mobile device to improve adherence were significantly more likely to use their phone daily (P = 0.03) and use their phone for text messages (P = 0.002). The vast majority of patients in an urban HIV clinic own mobile phones and would use them to enhance adherence interventions to HIV medication.

  10. Therapeutic Relationship and Study Adherence in a Community Health Worker-Led Intervention.

    Science.gov (United States)

    Mundorf, Christopher; Shankar, Arti; Peng, Terrance; Hassan, Anna; Lichtveld, Maureen Y

    2017-02-01

    Community health workers (CHWs) are increasingly utilized to reach low-resource communities. A critical domain influencing success is the CHWs' ability to create and maintain a therapeutic relationship with the participants they serve. A limited evidence base exists detailing this construct, and evaluating CHW-participant relationships in the context of CHW-led programs. In a longitudinal study design, data on this therapeutic relationship were collected [as captured using The Scale to Assess the Therapeutic Relationship in Community Mental Health Care (STAR)] on 141 participants who had been assigned to a CHW during their perinatal period. Results indicate that therapeutic relationship was associated with the participant's psychosocial health, and independently predicted study adherence in the longitudinal intervention. Changes in therapeutic relationship over the months following birth were strongly associated with changes in anxiety and depression symptoms. A trustful relationship is critical in ensuring CHWs can effectively reach the population they serve. The findings offer additional psychometric evidence of the uses and benefits of STAR outside of the traditional clinical setting in the context of public health research.

  11. The impact of text message reminders on adherence to antimalarial treatment in northern Ghana: a randomized trial.

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    Julia R G Raifman

    Full Text Available BACKGROUND: Low rates of adherence to artemisinin-based combination therapy (ACT regimens increase the risk of treatment failure and may lead to drug resistance, threatening the sustainability of current anti-malarial efforts. We assessed the impact of text message reminders on adherence to ACT regimens. METHODS: Health workers at hospitals, clinics, pharmacies, and other stationary ACT distributors in Tamale, Ghana provided flyers advertising free mobile health information to individuals receiving malaria treatment. The messaging system automatically randomized self-enrolled individuals to the control group or the treatment group with equal probability; those in the treatment group were further randomly assigned to receive a simple text message reminder or the simple reminder plus an additional statement about adherence in 12-hour intervals. The main outcome was self-reported adherence based on follow-up interviews occurring three days after treatment initiation. We estimated the impact of the messages on treatment completion using logistic regression. RESULTS: 1140 individuals enrolled in both the study and the text reminder system. Among individuals in the control group, 61.5% took the full course of treatment. The simple text message reminders increased the odds of adherence (adjusted OR 1.45, 95% CI [1.03 to 2.04], p-value 0.028. Receiving an additional message did not result in a significant change in adherence (adjusted OR 0.77, 95% CI [0.50 to 1.20], p-value 0.252. CONCLUSION: The results of this study suggest that a simple text message reminder can increase adherence to antimalarial treatment and that additional information included in messages does not have a significant impact on completion of ACT treatment. Further research is needed to develop the most effective text message content and frequency. TRIAL REGISTRATION: ClinicalTrials.gov NCT01722734.

  12. FACTORS ASSOCIATED TO ADHERENCE TO DIFFERENT TREATMENT SCHEMES WITH MEGLUMINE ANTIMONIATE IN A CLINICAL TRIAL FOR CUTANEOUS LEISHMANIASIS

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    Madelon Novato Ribeiro

    2014-07-01

    Full Text Available The favorable outcome of the treatment of a disease is influenced by the adherence to therapy. Our objective was to assess factors associated with adherence to treatment of patients included in a clinical trial of equivalence between the standard and alternative treatment schemes with meglumine antimoniate (MA in the treatment of cutaneous leishmaniasis (CL, in the state of Rio de Janeiro. Between 2008 and 2011, 57 patients with CL were interviewed using a questionnaire to collect socioeconomic data. The following methods were used for adherence monitoring: counting of vial surplus, monitoring card, Morisky test and modified Morisky test (without the question regarding the schedule; we observed 82.1% (vial return, 86.0% (monitoring card, 66.7% (Morisky test and 86.0% (modified Morisky test adherence. There was a strong correlation between the method of vial counting and the monitoring card and modified Morisky test. A significant association was observed between greater adherence to treatment and low dose of MA, as well as with a lower number of people sleeping in the same room. We recommend the use of the modified Morisky test to assess adherence to treatment of CL with MA, because it is a simple method and with a good performance, when compared to other methods.

  13. Current status and perspectives of interventional clinical trials for glioblastoma - analysis of ClinicalTrials.gov.

    Science.gov (United States)

    Cihoric, Nikola; Tsikkinis, Alexandros; Minniti, Giuseppe; Lagerwaard, Frank J; Herrlinger, Ulrich; Mathier, Etienne; Soldatovic, Ivan; Jeremic, Branislav; Ghadjar, Pirus; Elicin, Olgun; Lössl, Kristina; Aebersold, Daniel M; Belka, Claus; Herrmann, Evelyn; Niyazi, Maximilian

    2017-01-03

    The records of 208.777 (100%) clinical trials registered at ClinicalTrials.gov were downloaded on the 19th of February 2016. Phase II and III trials including patients with glioblastoma were selected for further classification and analysis. Based on the disease settings, trials were classified into three groups: newly diagnosed glioblastoma, recurrent disease and trials with no differentiation according to disease setting. Furthermore, we categorized trials according to the experimental interventions, the primary sponsor, the source of financial support and trial design elements. Trends were evaluated using the autoregressive integrated moving average model. Two hundred sixteen (0.1%) trials were selected for further analysis. Academic centers (investigator initiated trials) were recorded as primary sponsors in 56.9% of trials, followed by industry 25.9%. Industry was the leading source of monetary support for the selected trials in 44.4%, followed by 25% of trials with primarily academic financial support. The number of newly initiated trials between 2005 and 2015 shows a positive trend, mainly through an increase in phase II trials, whereas phase III trials show a negative trend. The vast majority of trials evaluate forms of different systemic treatments (91.2%). In total, one hundred different molecular entities or biologicals were identified. Of those, 60% were involving drugs specifically designed for central nervous system malignancies. Trials that specifically address radiotherapy, surgery, imaging and other therapeutic or diagnostic methods appear to be rare. Current research in glioblastoma is mainly driven or sponsored by industry, academic medical oncologists and neuro-oncologists, with the majority of trials evaluating forms of systemic therapies. Few trials reach phase III. Imaging, radiation therapy and surgical procedures are underrepresented in current trials portfolios. Optimization in research portfolio for glioblastoma is needed.

  14. Impact of pill organizers and blister packs on adherence to pill taking in two vitamin supplementation trials.

    Science.gov (United States)

    Huang, H Y; Maguire, M G; Miller, E R; Appel, L J

    2000-10-15

    The impact of pill organizers on pill taking was determined in the Trial of Antioxidant Vitamins C and E (TRACE) Study, a factorial trial of vitamin C and vitamin E supplementation in 184 individuals. Participants were recruited in 1996-1997 and randomized to one of two groups (pill organizer or no organizer) and to one of four supplement groups for 2 months. The pill count (observed/expected X 100%) distribution was similar in the organizer and no organizer group for both vitamins. Mean differences in changes in serum vitamin levels between active and placebo groups did not differ by pill organizer use. The impact of pill organizers and blister packs was compared in another trial, the Vitamins, Teachers, and Longevity (VITAL) Study, in 297 individuals randomized in 1993-1994 to receive study pills either in blister packs or in pill organizers and to take one of two supplements. Among those with lower adherence, the pill count distribution in the blister-pack group exceeded that in the organizer group. Mean differences in serum vitamin E levels between active and placebo groups did not differ by types of pill packaging. In summary, use of blister packs, but not pill organizers, improved adherence as measured by pill counts among those with lower adherence. Neither pill delivery system improved adherence as measured by serum vitamin levels.

  15. Developing a Reporting Guideline for Social and Psychological Intervention Trials.

    Science.gov (United States)

    Grant, Sean; Montgomery, Paul; Hopewell, Sally; Macdonald, Geraldine; Moher, David; Mayo-Wilson, Evan

    2013-11-01

    Social and psychological interventions are often complex. Understanding randomized controlled trials (RCTs) of these complex interventions requires a detailed description of the interventions tested and the methods used to evaluate them; however, RCT reports often omit, or inadequately report, this information. Incomplete and inaccurate reporting hinders the optimal use of research, wastes resources, and fails to meet ethical obligations to research participants and consumers. In this article, we explain how reporting guidelines have improved the quality of reports in medicine and describe the ongoing development of a new reporting guideline for RCTs: Consolidated Standards of Reporting Trials-SPI (an extension for social and psychological interventions). We invite readers to participate in the project by visiting our website, in order to help us reach the best-informed consensus on these guidelines (http://tinyurl.com/CONSORT-study).

  16. Masivukeni: development of a multimedia based antiretroviral therapy adherence intervention for counselors and patients in South Africa.

    Science.gov (United States)

    Remien, Robert H; Mellins, Claude A; Robbins, Reuben N; Kelsey, Ryan; Rowe, Jessica; Warne, Patricia; Chowdhury, Jenifar; Lalkhen, Nuruneesa; Hoppe, Lara; Abrams, Elaine J; El-Bassel, Nabila; Witte, Susan; Stein, Dan J

    2013-07-01

    Effective medical treatment for HIV/AIDS requires patients' optimal adherence to antiretroviral therapy (ART). In resource-constrained settings, lack of adequate standardized counseling for patients on ART remains a significant barrier to adherence. Masivukeni ("Let's Wake Up" in Xhosa) is an innovative multimedia-based intervention designed to help people living with HIV in resource-limited settings achieve and maintain high levels of ART adherence. Adapted from a couples-based intervention tested in the United States (US), Masivukeni was developed through community-based participatory research with US and South African partners and informed by Ewart's Social Action Theory. Innovative computer-based multimedia strategies were used to translate a labor- and training-intensive intervention into one that could be readily and widely used by lay counselors with relatively little training with low-literacy patients. In this paper, we describe the foundations of this new intervention, the process of its development, and the evidence of its high acceptability and feasibility.

  17. Do patients adhere to over-the-counter artemisinin combination therapy for malaria? evidence from an intervention study in Uganda

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    Cohen Jessica L

    2012-03-01

    Full Text Available Abstract Background Increasing affordability of artemisinin combination therapy (ACT in the African retail sector could be critical to expanding access to effective malaria treatment, but must be balanced by efforts to protect the efficacy of these drugs. Previous research estimates ACT adherence rates among public sector patients, but adherence among retail sector purchasers could differ substantially. This study aimed to estimate adherence rates to subsidized, over-the-counter ACT in rural Uganda. Methods An intervention study was conducted with four licensed drug shops in Eastern Uganda in December 2009. Artemether-lumefantrine (AL was made available for sale at a 95% subsidy over-the counter. Customers completed a brief survey at the time of purchase and then were randomly assigned to one of three study arms: no follow-up, follow-up after two days or follow-up after three days. Surveyors recorded the number of pills remaining through blister pack observation or through self-report if the pack was unavailable. The purpose of the three-day follow-up arm was to capture non-adherence in the sense of an incomplete treatment course ("under-dosing". The purpose of the two-day follow-up arm was to capture whether participants completed the full course too soon ("over-dosing". Results Of the 106 patients in the two-day follow-up sample, 14 (13.2% had finished the entire treatment course by the second day. Of the 152 patients in the three-day follow-up sample, 49 (32.2% were definitely non-adherent, three (2% were probably non-adherent and 100 (65.8% were probably adherent. Among the 52 who were non-adherent, 31 (59.6% had more than a full day of treatment remaining. Conclusions Overall, adherence to subsidized ACT purchased over-the-counter was found to be moderate. Further, a non-trivial fraction of those who complete treatment are taking the full course too quickly. Strategies to increase adherence in the retail sector are needed in the context of

  18. A Theory-Based Approach for Developing Interventions to Change Patient Behaviours: A Medication Adherence Example from Paediatric Secondary Care

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    Gemma Heath

    2015-12-01

    Full Text Available In this article we introduce a Health Psychology approach to changing patient behaviour, in order to demonstrate the value of Health Psychology professional practice as applied within healthcare settings. Health Psychologists are experts in understanding, predicting and changing health-related behaviours at the individual, group and population level. They combine psychological theory, research evidence and service-user views to design interventions to solve clinically relevant behavioural problems and improve health outcomes. We provide a pragmatic overview of a theory and evidence-based Intervention Mapping approach for developing, implementing and evaluating interventions to change health-related behaviour. An example of a real behaviour change intervention designed to improve medication adherence in an adolescent patient with poorly controlled asthma is described to illustrate the main stages of the intervention development process.

  19. Improving healthcare worker hand hygiene adherence before patient contact: A multimodal intervention of hand hygiene practice in Three Japanese tertiary care centers.

    Science.gov (United States)

    Sakihama, Tomoko; Honda, Hitoshi; Saint, Sanjay; Fowler, Karen E; Kamiya, Toru; Sato, Yumiko; Iuchi, Ritsuko; Tokuda, Yasuharu

    2016-03-01

    Though hand hygiene is an important method of preventing healthcare-associated infection, we found suboptimal hand hygiene adherence among healthcare workers in 4 diverse Japanese hospitals (adherence rates of 11%-25%). Our goal was to assess multimodal hand hygiene intervention coupled with a contest to improve hand hygiene adherence. A total of 3 to 4 inpatient wards in 3 Japanese hospitals. Pre-post intervention study. The intervention was a multimodal hand hygiene intervention recommended by the World Health Organization that was tailored to each facility. The hospital with the highest adherence after the intervention was given $5000 US dollars and a trophy, provided by an American coinvestigator unaffiliated with any of the Japanese hospitals. We tracked hand hygiene adherence rates before patient contact for each unit and hospital and compared these to pre-intervention adherence rates. We observed 2982 postintervention provider-patient encounters in 10 units across 3 hospitals. Hand hygiene adherence rates were improved overall after the intervention (18% pre- to 33% postintervention; P hand hygiene rates among Japanese healthcare workers. Given the overall low rates, however, further improvement is necessary. © 2015 Society of Hospital Medicine.

  20. Understanding and improving treatment adherence in patients with psychotic disorders: A review and a proposed intervention

    NARCIS (Netherlands)

    A.B.P. Staring (Anton); C.L. Mulder (Niels); M. van der Gaag (Mark); J.-P. Selten; A.J.M. Loonen (Anne); M.W. Hengeveld (Michiel)

    2006-01-01

    textabstractNon-adherence to treatment of patients with psychotic disorders is related to higher rates of relapse, hospitalization, and suicide. Important predictors of non-adherence include poor social structure, cognitive deficits, negative medication attitude, side effects, depression, a sealing-

  1. Did the diabetes check improve drug adherence of Dutch patients with diabetes?: an intervention study.

    NARCIS (Netherlands)

    Hendriks, M.; Vervloet, M.; Dijk, L. van

    2005-01-01

    Background: Poor adherence to treatment of chronic diseases is a worldwide problem. Medicines are often part of therapy and appropriate drug use is important in optimizing health care outcomes. Pharmacies can improve drug adherence by providing information and assistance to their patients. Several i

  2. Core journals that publish clinical trials of physical therapy interventions.

    Science.gov (United States)

    Costa, Leonardo Oliveira Pena; Moseley, Anne M; Sherrington, Catherine; Maher, Christopher G; Herbert, Robert D; Elkins, Mark R

    2010-11-01

    The objective of this study was to identify core journals in physical therapy by identifying those that publish the most randomized controlled trials of physical therapy interventions, provide the highest-quality reports of randomized controlled trials, and have the highest journal impact factors. This study was an audit of a bibliographic database. All trials indexed in the Physiotherapy Evidence Database (PEDro) were analyzed. Journals that had published at least 80 trials were selected. The journals were ranked in 4 ways: number of trials published; mean total PEDro score of the trials published in the journal, regardless of publication year; mean total PEDro score of the trials published in the journal from 2000 to 2009; and 2008 journal impact factor. The top 5 core journals in physical therapy, ranked by the total number of trials published, were Archives of Physical Medicine and Rehabilitation, Clinical Rehabilitation, Spine, British Medical Journal (BMJ), and Chest. When the mean total PEDro score was used as the ranking criterion, the top 5 journals were Journal of Physiotherapy, Journal of the American Medical Association (JAMA), Stroke, Spine, and Clinical Rehabilitation. When the mean total PEDro score of the trials published from 2000 to 2009 was used as the ranking criterion, the top 5 journals were Journal of Physiotherapy, JAMA, Lancet, BMJ, and Pain. The most highly ranked physical therapy-specific journals were Physical Therapy (ranked eighth on the basis of the number of trials published) and Journal of Physiotherapy (ranked first on the basis of the quality of trials). Finally, when the 2008 impact factor was used for ranking, the top 5 journals were JAMA, Lancet, BMJ, American Journal of Respiratory and Critical Care Medicine, and Thorax. There were no significant relationships among the rankings on the basis of trial quality, number of trials, or journal impact factor. Physical therapists who are trying to keep up-to-date by reading the best

  3. Effect of a stewardship intervention on adherence to uncomplicated cystitis and pyelonephritis guidelines in an emergency department setting.

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    Michelle T Hecker

    Full Text Available OBJECTIVE: To evaluate adherence to uncomplicated urinary tract infections (UTI guidelines and UTI diagnostic accuracy in an emergency department (ED setting before and after implementation of an antimicrobial stewardship intervention. METHODS: The intervention included implementation of an electronic UTI order set followed by a 2 month period of audit and feedback. For women age 18-65 with a UTI diagnosis seen in the ED with no structural or functional abnormalities of the urinary system, we evaluated adherence to guidelines, antimicrobial use, and diagnostic accuracy at baseline, after implementation of the order set (period 1, and after audit and feedback (period 2. RESULTS: Adherence to UTI guidelines increased from 44% (baseline to 68% (period 1 to 82% (period 2 (P≤.015 for each successive period. Prescription of fluoroquinolones for uncomplicated cystitis decreased from 44% (baseline to 14% (period 1 to 13% (period 2 (P<.001 and P = .7 for each successive period. Unnecessary antibiotic days for the 200 patients evaluated in each period decreased from 250 days to 119 days to 52 days (P<.001 for each successive period. For 40% to 42% of cases diagnosed as UTI by clinicians, the diagnosis was deemed unlikely or rejected with no difference between the baseline and intervention periods. CONCLUSIONS: A stewardship intervention including an electronic order set and audit and feedback was associated with increased adherence to uncomplicated UTI guidelines and reductions in unnecessary antibiotic therapy and fluoroquinolone therapy for cystitis. Many diagnoses were rejected or deemed unlikely, suggesting a need for studies to improve diagnostic accuracy for UTI.

  4. Psychosocial intervention improves depression, quality of life, and fluid adherence in hemodialysis.

    Science.gov (United States)

    Cukor, Daniel; Ver Halen, Nisha; Asher, Deborah Rosenthal; Coplan, Jeremy D; Weedon, Jeremy; Wyka, Katarzyna E; Saggi, Subodh J; Kimmel, Paul L

    2014-01-01

    Patients with ESRD have high rates of depression, which is associated with diminished quality of life and survival. We determined whether individual cognitive behavioral therapy (CBT) reduces depression in hemodialysis patients with elevated depressive affect in a randomized crossover trial. Of 65 participants enrolled from two dialysis centers in New York, 59 completed the study and were assigned to the treatment-first group (n=33) or the wait-list control group (n=26). In the intervention phase, CBT was administered chairside during dialysis treatments for 3 months; participants were assessed 3 and 6 months after randomization. Compared with the wait-list group, the treatment-first group achieved significantly larger reductions in Beck Depression Inventory II (self-reported, P=0.03) and Hamilton Depression Rating Scale (clinician-reported, Pimprovements in quality of life, assessed with the Kidney Disease Quality of Life Short Form (P=0.04), and interdialytic weight gain (P=0.002) than the wait-list group, although no effect on compliance was evident at follow-up. In summary, CBT led to significant improvements in depression, quality of life, and prescription compliance in this trial, and studies should be undertaken to assess the long-term effects of CBT on morbidity and mortality in patients with ESRD.

  5. A study to assess the feasibility of undertaking a randomized controlled trial of adherence with eye drops in glaucoma patients

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    Richardson C

    2013-10-01

    Full Text Available Cliff Richardson,1 Lisa Brunton,1 Nicola Olleveant,1 David B Henson,1 Mark Pilling,1 Jane Mottershead,2 Cecilia H Fenerty,2 Anne Fiona Spencer,2 Heather Waterman1 1School of Nursing, Midwifery and Social Work, University of Manchester, 2Royal Manchester Eye Hospital, Central Manchester Foundation Trust, Manchester, United Kingdom Background: Adherence with therapy could influence the progression of glaucoma and ultimately affect the onset of visual impairment in some individuals. This feasibility study evaluated the measures to be used for a future randomized controlled trial assessing the effects of group-based education on adherence with eye drops. Methods: People diagnosed with glaucoma within the previous 12 months attending a regional ophthalmology clinic in the North West of England were recruited. A two-session education program delivered one week apart had been devised as part of a previous project. A combined adult learning and health needs approach to education was taken. Outcomes measured were knowledge of glaucoma, self-report of adherence, illness perception, beliefs about medicines, patient enablement, and general health (Short Form-12. Adherence was also measured objectively using a Medical Events Monitoring System device. Results: Twenty-six participants consented to undertake the educational program and 19 produced analyzable data. Knowledge of glaucoma, illness perception, beliefs about medicine, and patient enablement all showed statistically significant improvements after education. Mean adherence with eye drops was maintained above 85% before and for 3 months after attendance at the educational program. Self-report exaggerated adherence by at least 10% when compared with the objective Medical Events Monitoring System data, and in fact the kappa agreement was zero. Conclusion: All questionnaires other than the Short Form-12 were considered to be valuable measures and use of a Medical Events Monitoring System device was

  6. Formative Evaluation of a Text Messaging Intervention to Promote Varenicline Adherence Among Tobacco-Dependent Persons with HIV.

    Science.gov (United States)

    Krebs, Paul; Tseng, Tuo-Yen; Pham, Hieu; Wong, Selena; Sherman, Scott E; Shelley, Donna; Furberg, Robert D; Wolfe, Hannah

    2015-01-01

    Few published studies describe processes in the development of mobile health interventions. This study reports data from a formative evaluation of a text messaging intervention being developed to increase adherence to smoking cessation medication (varenicline) among tobacco-dependent persons with HIV/AIDS. Four focus groups were conducted (N = 29) using a mixed-methods approach to assess: (a) beliefs and preferences regarding the use of varenicline, (b) preferences for receiving tobacco-related texts, and (c) the acceptability of draft text messages. Themes that emerged from the focus groups were that (a) participants were cautious and wanted to discuss varenicline carefully with health care providers, (b) participants preferred simple messages that were positive and encouraging, (c) messages should emphasize tobacco cessation and not varenicline adherence, and (d) texts would serve as a reminder about goals and foster support and connectedness with the health care team. Overall, 47 out of the 100 messages received a grade of C or less (rated on a 5-point grade scale: A, B, C, D, or F), the majority of which focused on medication adherence. All participants reported that they were likely to read the messages. The majority (64%) indicated that they preferred receiving 2 or more messages per day. Gathering systematic participant feedback provides critical input in intervention planning.

  7. Predictors of adherence to physical activity in the Lifestyle Interventions and Independence for Elders pilot study (LIFE-P

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    W Jack Rejeski

    2007-10-01

    Full Text Available W Jack Rejeski1, Michael E Miller2, Abby C King3, Stephanie A Studenski4, Jeffrey A Katula1, Roger A Fielding5, Nancy W Glynn4, Michael P Walkup2, Jamile A Ashmore6, For the LIFE Investigators (20061Department of Health and Exercise Science, Wake Forest University; 2Department of Biostatistics, Wake Forest University; 3Stanford University; 4University of Pittsburgh; 5Tuffs University; 6Cooper Institute Objectives: A prospective design was used to examine predictors of adherence to a physical activity intervention in older adults with compromised function.Methods: The sample included 213 men (31.1% and women (68.9% with an average age of 76.53 years.Results: The predictor variables accounted for 10% of the variance in percent attendance during adoption and transition, respectively. Adding percent attendance during adoption to the prediction of percent attendance during transition increased the explained variance in this phase to 21%. During maintenance, the predictors accounted for 13% of the variance in frequency of physical activity; this estimate increased to 46% when adding in percent attendance from the transition phase.Discussion: These results are encouraging in that the physical activity intervention appears to have been well tolerated by diverse subgroups of older adults. The role of prior behavior in predicting downstream adherence underscores the importance of developing proactive interventions for treating nonadherence in older adult populations.Keywords: Disability, Physical Activity, Older Adults, Adherence

  8. A cluster randomized trial to improve adherence to evidence-based guidelines on diabetes and reduce clinical inertia in primary care physicians in Belgium: study protocol [NTR 1369

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    Ivanova Anna

    2008-10-01

    Full Text Available Abstract Background Most quality improvement programs in diabetes care incorporate aspects of clinician education, performance feedback, patient education, care management, and diabetes care teams to support primary care physicians. Few studies have applied all of these dimensions to address clinical inertia. Aim To evaluate interventions to improve adherence to evidence-based guidelines for diabetes and reduce clinical inertia in primary care physicians. Design Two-arm cluster randomized controlled trial. Participants Primary care physicians in Belgium. Interventions Primary care physicians will be randomly allocated to 'Usual' (UQIP or 'Advanced' (AQIP Quality Improvement Programs. Physicians in the UQIP will receive interventions addressing the main physician, patient, and office system factors that contribute to clinical inertia. Physicians in the AQIP will receive additional interventions that focus on sustainable behavior changes in patients and providers. Outcomes Primary endpoints are the proportions of patients within targets for three clinical outcomes: 1 glycosylated hemoglobin Primary and secondary analysis Statistical analyses will be performed using an intent-to-treat approach with a multilevel model. Linear and generalized linear mixed models will be used to account for the clustered nature of the data, i.e., patients clustered withinimary care physicians, and repeated assessments clustered within patients. To compare patient characteristics at baseline and between the intervention arms, the generalized estimating equations (GEE approach will be used, taking the clustered nature of the data within physicians into account. We will also use the GEE approach to test for differences in evolution of the primary and secondary endpoints for all patients, and for patients in the two interventions arms, accounting for within-patient clustering. Trial Registration number: NTR 1369.

  9. Assessment of adherence to the CONSORT statement for quality of reports on randomized controlled trial abstracts from four high-impact general medical journals

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    Ghimire Saurav

    2012-06-01

    Full Text Available Abstract Background The extended Consolidated Standards of Reporting Trials (CONSORT Statement for Abstracts was developed to improve the quality of reports of randomized controlled trials (RCTs because readers often base their assessment of a trial solely on the abstract. To date, few data exist regarding whether it has achieved this goal. We evaluated the extent of adherence to the CONSORT for Abstract statement for quality of reports on RCT abstracts by four high-impact general medical journals. Methods A descriptive analysis of published RCT abstracts in The New England Journal of Medicine (NEJM, The Lancet, The Journal of American Medical Association (JAMA, and the British Medical Journal (BMJ in the year 2010 was conducted by two reviewers, independently extracting data from a MEDLINE/PubMed search. Results We identified 271 potential RCT abstracts meeting our inclusion criteria. More than half of the abstracts identified the study as randomized in the title (58.7%; 159/271, reported the specific objective/hypothesis (72.7%; 197/271, described participant eligibility criteria with settings for data collection (60.9%; 165/271, detailed the interventions for both groups (90.8%; 246/271, and clearly defined the primary outcome (94.8%; 257/271. However, the methodological quality domains were inadequately reported: allocation concealment (11.8%; 32/271 and details of blinding (21.0%; 57/271. Reporting the primary outcome results for each group was done in 84.1% (228/271. Almost all of the abstracts reported trial registration (99.3%; 269/271, whereas reports of funding and of harm or side effects from the interventions were found in only 47.6% (129/271 and 42.8% (116/271 of the abstracts, respectively. Conclusions These findings show inconsistencies and non-adherence to the CONSORT for abstract guidelines, especially in the methodological quality domains. Improvements in the quality of RCT reports can be expected by adhering to existing

  10. A pilot study of a nurse-delivered cognitive behavioral therapy intervention (Ziphamandla) for adherence and depression in HIV in South Africa.

    Science.gov (United States)

    Andersen, Lena S; Magidson, Jessica F; O'Cleirigh, Conall; Remmert, Jessica E; Kagee, Ashraf; Leaver, Matthew; Stein, Dan J; Safren, Steven A; Joska, John

    2016-04-26

    Depression is prevalent among people living with HIV in South Africa and interferes with adherence to antiretroviral therapy. This study evaluated a nurse-delivered, cognitive behavioral therapy intervention for adherence and depression among antiretroviral therapy users with depression in South Africa (n = 14). Primary outcomes were depression, antiretroviral therapy adherence, feasibility, and acceptability. Findings support robust improvements in mood through a 3-month follow up. Antiretroviral therapy adherence was maintained during the intervention period. Participant retention supports acceptability; however, modest provider fidelity despite intensive supervision warrants additional attention to feasibility. Future effectiveness research is needed to evaluate this nurse-delivered cognitive behavioral therapy intervention for adherence and depression in this context.

  11. The impact of text message reminders on adherence to antimalarial treatment in northern Ghana: a randomized trial.

    Science.gov (United States)

    Raifman, Julia R G; Lanthorn, Heather E; Rokicki, Slawa; Fink, Günther

    2014-01-01

    Low rates of adherence to artemisinin-based combination therapy (ACT) regimens increase the risk of treatment failure and may lead to drug resistance, threatening the sustainability of current anti-malarial efforts. We assessed the impact of text message reminders on adherence to ACT regimens. Health workers at hospitals, clinics, pharmacies, and other stationary ACT distributors in Tamale, Ghana provided flyers advertising free mobile health information to individuals receiving malaria treatment. The messaging system automatically randomized self-enrolled individuals to the control group or the treatment group with equal probability; those in the treatment group were further randomly assigned to receive a simple text message reminder or the simple reminder plus an additional statement about adherence in 12-hour intervals. The main outcome was self-reported adherence based on follow-up interviews occurring three days after treatment initiation. We estimated the impact of the messages on treatment completion using logistic regression. 1140 individuals enrolled in both the study and the text reminder system. Among individuals in the control group, 61.5% took the full course of treatment. The simple text message reminders increased the odds of adherence (adjusted OR 1.45, 95% CI [1.03 to 2.04], p-value 0.028). Receiving an additional message did not result in a significant change in adherence (adjusted OR 0.77, 95% CI [0.50 to 1.20], p-value 0.252). The results of this study suggest that a simple text message reminder can increase adherence to antimalarial treatment and that additional information included in messages does not have a significant impact on completion of ACT treatment. Further research is needed to develop the most effective text message content and frequency. ClinicalTrials.gov NCT01722734.

  12. Improving Blood Pressure Control through a Clinical Pharmacist Outreach Program in Diabetes Patients in Two-High Performing Health Systems: The Adherence and Intensification of Medications (AIM) Cluster Randomized Controlled Pragmatic Trial

    Science.gov (United States)

    Heisler, Michele; Hofer, Timothy P.; Schmittdiel, Julie A.; Selby, Joe V.; Klamerus, Mandi L.; Bosworth, Hayden B.; Bermann, Martin; Kerr, Eve A.

    2013-01-01

    Background Even in high performing health systems, some hypertensive patients with diabetes have persistent poor blood pressure (BP) control. Medication nonadherence and lack of medication intensification contribute to this poor control. We examined whether the Adherence and Intensification of Medications (AIM) intervention, a targeted pharmacist-led intervention that combined state-of-the-art elements found in efficacy studies to lower BP, could improve BP among diabetes patients with persistent hypertension and poor refill adherence or insufficient medication intensification. Methods and Results We conducted a prospective, multi-site cluster randomized pragmatic trial with randomization of 16 primary care teams at five medical centers (3 Veterans Affairs [VA] and 2 Kaiser Permanente [KP]) to the AIM intervention or usual care. The primary outcome was the relative change in systolic blood pressure (SBP) measurements, comparing 1,797 eligible intervention team patients to 2,303 eligible control team patients, between the 6-months preceding and the 6-months following the 14-month intervention period. We examined shorter-term changes in SBP as a secondary outcome. In our primary analysis, the intervention group SBP change from 6-months prior to 6-months after the 14-month intervention period was approximately the same as the control group, declining approximately 9 mm Hg in both groups. SBP lowering occurred more rapidly among eligible intervention team patients, with mean SBPs 2.4 mm Hg lower (95% CI: −3.4 to −1.5; p<.001) immediately after the intervention than those achieved by eligible control patients. Conclusions The AIM program more rapidly lowered SBPs among eligible intervention patients, but there was no significant difference in blood pressure between intervention and control patients 6 months following the intervention period. These findings show the importance of rigorously evaluating in different real-life clinical settings programs found in

  13. Standard Care Quality Determines Treatment Outcomes in Control Groups of HAART-Adherence Intervention Studies: Implications for the Interpretation and Comparison of Intervention Effects

    NARCIS (Netherlands)

    Bruin, de M.; Viechtbauer, W.; Hospers, H.J.; Schaalma, H.P.; Kok, G.

    2009-01-01

    Objective: Clinical trials of behavioral interventions seek to enhance evidence-based health care. However, in case the quality of standard care provided to control conditions varies between studies and affects outcomes, intervention effects cannot be directly interpreted or compared. The objective

  14. Adherence to a lifestyle programme in overweight/obese pregnant women and effect on gestational diabetes mellitus: a randomized controlled trial.

    Science.gov (United States)

    Bruno, Raffaele; Petrella, Elisabetta; Bertarini, Valentina; Pedrielli, Giulia; Neri, Isabella; Facchinetti, Fabio

    2017-07-01

    This study aims to determine whether the prescription of a detailed lifestyle programme in overweight/obese pregnant women influences the occurrence of gestational diabetes (GDM), and if this kind of prescription increases the adherence to a healthier lifestyle in comparison to standard care. The study was designed as a randomized controlled trial, with open allocation, enrolling women at 9-12 weeks of pregnancy with a BMI ≥ 25 kg/m(2) . The women assigned to the Intervention group (I = 96) received a hypocaloric, low-glycaemic, low-saturated fat diet and physical activity recommendations. Those assigned to the Standard Care group (SC = 95) received lifestyle advices regarding healthy nutrition and exercise. Follow-up was planned at the 16(th) , 20(th) , 28(th) and 36(th) weeks. A total of 131 women completed the study (I = 69, SC = 62). The diet adherence was higher in the I (57.9%) than in the SC (38.7%) group. GDM occurred less frequently in the I (18.8%) than in the SC (37.1%, P = 0.019) group. The adherent women from either groups showed a lower GDM rate (12.5% vs. 41.8%, P  4000 g were significantly lower in I group. The incidence of small for gestational age babies was not different. These findings demonstrate that the adherence to a personalized, hypocaloric, low-glycaemic, low-saturated fat diet started early in pregnancy prevents GDM occurrence, in women with BMI ≥ 25 kg/m(2) . © 2016 John Wiley & Sons Ltd.

  15. Hostility in schizophrenia: An integrated analysis of the combined Clinical Antipsychotic Trials of Intervention Effectiveness (CATIE) and the European First Episode Schizophrenia Trial (EUFEST) studies

    Science.gov (United States)

    Volavka, J.; Van Dorn, R.A.; Citrome, L.; Kahn, R.S.; Fleischhacker, W.W.; Czobor, P.

    2016-01-01

    Phase 1 of the Clinical Antipsychotic Trials of Intervention Effectiveness (CATIE) study enrolled a sample of 1493 chronic schizophrenia patients. The European First Episode Schizophrenia Trial (EUFEST) enrolled 498 patients. We have combined these two samples to study the effects of hostility on study discontinuation as well as to examine correlates and predictors of hostility. Individual data from 1154 patients with complete data were used for analyses. Survival analysis demonstrated that higher hostility was associated with earlier all-cause treatment discontinuation. Furthermore, regression analysis indicated that increased hostility was associated with more severe positive symptoms, lower adherence to pharmacological treatment, younger age, impaired insight, and more drug or alcohol consumption. The clinical implications of the results point to the importance of establishing therapeutic alliance while managing patient’s symptoms of hostility with antipsychotics such as olanzapine combined with psychosocial interventions to improve insight and reduce substance use. PMID:26657597

  16. A comparison of usual care, a patient-centred education intervention and motivational interviewing to improve medication adherence and readmissions of adults in an acute-care setting.

    Science.gov (United States)

    Hyrkas, Kristiina; Wiggins, Marjorie

    2014-04-01

    To compare medication adherence and readmissions in patients who received usual care vs. patient-centred interventions. Medication adherence is a complex behaviour that may be improved with patient-centred strategies. A non-concurrent convenience sample of 303 hospitalised patients received either usual care (n = 98) or patient-centred interventions (n = 205). Intervention patients received teach-back and medication tools (n = 137) or motivational interviewing (n = 68). Data were collected at discharge (T1), at 48-72 hours (T2) and 30 days after discharge (T3). No significant differences were found in medication adherence, therapeutic alliance, patients' experience and readmissions between groups. Patients in the motivational interview group reported lower confidence with medication adherence at T1 (P = 0.01) and T2 (P = 0.00) than the patient-centred intervention group. Motivational interviewing was a significant predictor (β = -1.55, P = 0.01, OR 0.21, 95% CI 0.06, 0.72) of fewer readmissions. Overall, patients reported very low levels of non-adherence and very high levels of confidence and importance of medication adherence. Medication adherence continues to be an important area for clinical inquiry. For those patients who lack confidence for medication adherence, comprehensive patient-centred strategies such as motivational interviewing may improve treatment outcomes. © 2014 John Wiley & Sons Ltd.

  17. A longitudinal, qualitative study exploring sustained adherence to a hand exercise programme for Rheumatoid Arthritis evaluated in the SARAH Trial

    OpenAIRE

    2016-01-01

    Purpose:\\ud This study explores the experience of participants taking part in a hand exercise programme for people with rheumatoid arthritis with a focus on adherence. The exercise programme was tested in a randomised controlled trial. This parallel qualitative study will inform future implementation into clinical practice. \\ud \\ud Method:\\ud Twenty-seven semi-structured interviews from 14 participants were undertaken at 2 time points (4 and 12 months after randomisation). We collected data o...

  18. A randomized, controlled study of an educational intervention to improve recall of auxiliary medication labeling and adherence to antibiotics

    Directory of Open Access Journals (Sweden)

    Jade A Pham

    2013-06-01

    Full Text Available Purpose: To evaluate whether medication counseling with emphasis on auxiliary labels improves recall of auxiliary label information and adherence to medication schedules. Methods: A prospective, randomized study of an educational intervention in community pharmacies near Baltimore, Maryland. Fifty literate, English-speaking adults receiving one of the 18 commonly dispensed antibiotics were randomized to receive a counseling session or no counseling. Five to seven days after medication pickup, a structured phone interview was conducted to capture data on recall of auxiliary labels and adherence. Results: A total of 39 subjects completed the phone interview (78%. The rate of correct recall was high: 77% correct recall for all three labels. Among those with incorrect recall, 7 out of 9 subjects received no counseling (p = 0.11. The auxiliary labels incorrectly recalled were all related to dietary restrictions. Conclusion: The findings from this study suggest that medication counseling emphasizing auxiliary label information may lead to improved recall and adherence to antibiotics. Additional studies are required to confirm the preliminary findings and determine whether they correspond to improved adherence. Information most commonly misunderstood were related to dietary restrictions. Additional research focusing on counseling related to dietary restrictions is recommended.

  19. Effect of Expectation of Care on Adherence to Antihypertensive Medications Among Hypertensive Blacks: Analysis of the Counseling African Americans to Control Hypertension (CAATCH) Trial.

    Science.gov (United States)

    Grant, Andrea Barnes; Seixas, Azizi; Frederickson, Keville; Butler, Mark; Tobin, Jonathan N; Jean-Louis, Girardin; Ogedegbe, Gbenga

    2016-07-01

    Novel ideas are needed to increase adherence to antihypertensive medication. The current study used data from the Counseling African Americans to Control Hypertension (CAATCH) study, a sample of 442 hypertensive African Americans, to investigate the mediating effects of expectation of hypertension care, social support, hypertension knowledge, and medication adherence, adjusting for age, sex, number of medications, diabetes, education, income, employment, insurance status, and intervention. Sixty-six percent of patients had an income of $20,000 or less and 56% had a high school education or less, with a mean age of 57 years. Greater expectation of care was associated with greater medication adherence (P=.007), and greater social support was also associated with greater medication adherence (P=.046). Analysis also showed that expectation of care mediated the relationship between hypertension knowledge and medication adherence (PExpectation of care and social support are important factors for developing interventions to increase medication adherence among blacks.

  20. Effect of Expectation of Care on Adherence to Antihypertensive Medications Among Hypertensive Blacks: Analysis of the Counseling African Americans to Control Hypertension (CAATCH) Trial

    Science.gov (United States)

    Grant, Andrea Barnes; Seixas, Azizi; Frederickson, Keville; Butler, Mark; Tobin, Jonathan N.; Jean-Louis, Girardin; Ogedegbe, Gbenga

    2017-01-01

    Novel ideas are needed to increase adherence to antihypertensive medication. The current study used data from the Counseling African Americans to Control Hypertension (CAATCH) study, a sample of 442 hypertensive African Americans, to investigate the mediating effects of expectation of hypertension care, social support, hypertension knowledge, and medication adherence, adjusting for age, sex, number of medications, diabetes, education, income, employment, insurance status, and intervention. Sixty-six percent of patients had an income of $20,000 or less and 56% had a high school education or less, with a mean age of 57 years. Greater expectation of care was associated with greater medication adherence (P=.007), and greater social support was also associated with greater medication adherence (P=.046). Analysis also showed that expectation of care mediated the relationship between hypertension knowledge and medication adherence (P<.05). Expectation of care and social support are important factors for developing interventions to increase medication adherence among blacks. PMID:26593105

  1. Improving the counselling skills of lay counsellors in antiretroviral adherence settings: a cluster randomised controlled trial in the Western Cape, South Africa.

    Science.gov (United States)

    Dewing, Sarah; Mathews, Cathy; Schaay, Nikki; Cloete, Allanise; Simbayi, Leickness; Louw, Johann

    2015-01-01

    Little research has investigated interventions to improve the delivery of counselling in health care settings. We determined the impact of training and supervision delivered as part of the Options: Western Cape project on lay antiretroviral adherence counsellors' practice. Four NGOs employing 39 adherence counsellors in the Western Cape were randomly allocated to receive 53 h of training and supervision in Options for Health, an intervention based on the approach of Motivational Interviewing. Five NGOs employing 52 adherence counsellors were randomly allocated to the standard care control condition. Counselling observations were analysed for 23 intervention and 32 control counsellors. Intervention counsellors' practice was more consistent with a client-centred approach than control counsellors', and significantly more intervention counsellors engaged in problem-solving barriers to adherence (91 vs. 41 %). The Options: Western Cape training and supervision package enabled lay counsellors to deliver counselling for behaviour change in a manner consistent with evidence-based approaches.

  2. Telemonitoring Adherence to Medications in Heart Failure Patients (TEAM-HF): A Pilot Randomized Clinical Trial.

    Science.gov (United States)

    Gallagher, Benjamin D; Moise, Nathalie; Haerizadeh, Mytra; Ye, Siqin; Medina, Vivian; Kronish, Ian M

    2017-04-01

    Medication nonadherence contributes to hospitalizations in recently discharged patients with heart failure (HF). We aimed to test the feasibility of telemonitoring medication adherence in patients with HF. We randomized 40 patients (1:1) hospitalized for HF to 30 days of loop diuretic adherence monitoring with telephonic support or to passive adherence monitoring alone. Eighty-three percent of eligible patients agreed to participate. The median age of patients was 64 years, 25% were female, and 45% were Hispanic. Overall, 67% of patients were nonadherent (percentage of days that the correct number of doses were taken telemonitoring was acceptable to most patients with HF. Diuretic nonadherence was common even when patients knew they were being monitored. Future studies should assess whether adherence telemonitoring can improve adherence and reduce readmissions among patients with HF. Copyright © 2016 Elsevier Inc. All rights reserved.

  3. Diabetes prevention in the real world: effectiveness of pragmatic lifestyle interventions for the prevention of type 2 diabetes and of the impact of adherence to guideline recommendations: a systematic review and meta-analysis.

    Science.gov (United States)

    Dunkley, Alison J; Bodicoat, Danielle H; Greaves, Colin J; Russell, Claire; Yates, Thomas; Davies, Melanie J; Khunti, Kamlesh

    2014-04-01

    OBJECTIVE To summarize the evidence on effectiveness of translational diabetes prevention programs, based on promoting lifestyle change to prevent type 2 diabetes in real-world settings and to examine whether adherence to international guideline recommendations is associated with effectiveness. RESEARCH DESIGN AND METHODS Bibliographic databases were searched up to July 2012. Included studies had a follow-up of ≥12 months and outcomes comparing change in body composition, glycemic control, or progression to diabetes. Lifestyle interventions aimed to translate evidence from previous efficacy trials of diabetes prevention into real-world intervention programs. Data were combined using random-effects meta-analysis and meta-regression considering the relationship between intervention effectiveness and adherence to guidelines. RESULTS Twenty-five studies met the inclusion criteria. The primary meta-analysis included 22 studies (24 study groups) with outcome data for weight loss at 12 months. The pooled result of the direct pairwise meta-analysis shows that lifestyle interventions resulted in a mean weight loss of 2.12 kg (95% CI -2.61 to -1.63; I(2) = 91.4%). Adherence to guidelines was significantly associated with a greater weight loss (an increase of 0.3 kg per point increase on a 12-point guideline-adherence scale). CONCLUSIONS Evidence suggests that pragmatic diabetes prevention programs are effective. Effectiveness varies substantially between programs but can be improved by maximizing guideline adherence. However, more research is needed to establish optimal strategies for maximizing both cost-effectiveness and longer-term maintenance of weight loss and diabetes prevention effects.

  4. Randomized Controlled Trial: Multimodal Anxiety and Social Skill Intervention for Adolescents with Autism Spectrum Disorder

    Science.gov (United States)

    White, Susan W.; Ollendick, Thomas; Albano, Anne Marie; Oswald, Donald; Johnson, Cynthia; Southam-Gerow, Michael A.; Kim, Inyoung; Scahill, Lawrence

    2012-01-01

    Anxiety is common among adolescents with autism spectrum disorders (ASD) and may amplify the core social disability, thus necessitating combined treatment approaches. This pilot, randomized controlled trial (RCT) evaluated the feasibility and preliminary outcomes of the Multimodal Anxiety and Social Skills Intervention (MASSI) program in a sample of 30 adolescents with ASD and anxiety symptoms of moderate or greater severity. The treatment was acceptable to families, subject adherence was high, and therapist fidelity was high. A 16% improvement in ASD social impairment (within-group effect size = 1.18) was observed on a parent-reported scale. Although anxiety symptoms declined by 26%, the change was not statistically significant. These findings suggest MASSI is a feasible treatment program and further evaluation is warranted. PMID:22735897

  5. Mobile Phone Text Messages to Support Treatment Adherence in Adults With High Blood Pressure (StAR): A Single-Blind, Randomized Trial

    Science.gov (United States)

    Bobrow, Kirsten; Farmer, Andrew J; Springer, David; Shanyinde, Milensu; Yu, Ly-Mee; Brennan, Thomas; Rayner, Brian; Namane, Mosedi; Steyn, Krisela; Tarassenko, Lionel; Levitt, Naomi

    2016-01-01

    Background We assessed the effect of automated treatment adherence support delivered via mobile-phone short message system (SMS) text-messages on blood pressure. Methods and Results In this pragmatic single-blind, three-arm randomized trial (StAR), undertaken in South Africa, patients treated for high blood pressure were randomly allocated in a 1:1:1 ratio to information-only or interactive SMS text-messaging, or usual care. The primary outcome was change in systolic blood pressure at 12-months from baseline measured with a validated oscillometric device. All trial staff were masked to treatment allocation. Analyses were intention to treat. Between June 26, 2012 and November 23, 2012, 1372 participants were randomized to receive information-only SMS text-messages (n=457), interactive SMS text-messages (n=458), or usual care (n=457). Primary outcome data were available for 1256 (92%) participants. At 12-months, the mean adjusted change (95% CI) in systolic blood pressure compared to usual care was −2.2 mm Hg (−4.4 to −0.04) with information-only SMS and −1.6 mm Hg (−3.7 to 0.6) with interactive SMS. Odds ratios (95% CI) for the proportion of participants with a blood pressure <140/90mm Hg were for information-only messaging 1.42 (1.03 to 1.95) and for interactive messaging 1.41 (1.02 to 1.95) compared to usual care. Conclusions In this randomized trial of an automated adherence support program delivered by SMS text-message in a general outpatient population of adults with high blood pressure, we found a small, reduction in systolic blood pressure control compared to usual care at 12-months. There was no evidence that an interactive intervention increased this effect. Clinical Trial Registration Information ClinicalTrials.gov. Identifier: South African National Clinical Trials Register number (SANCTR DOH-27-1212-386); Pan Africa Trial Register (PACTR201411000724141). PMID:26769742

  6. Feasibility, acceptability, and adherence of two educational programs for care staff concerning nursing home patients' fecal incontinence: a pilot study preceding a cluster-randomized controlled trial.

    Science.gov (United States)

    Blekken, Lene Elisabeth; Nakrem, Sigrid; Gjeilo, Kari Hanne; Norton, Christine; Mørkved, Siv; Vinsnes, Anne Guttormsen

    2015-05-23

    Fecal incontinence has a high prevalence in the nursing home population which cannot be explained by co-morbidity or anatomic and physiological changes of aging alone. Our hypothesis is that fecal incontinence can be prevented, cured, or ameliorated by offering care staff knowledge of best practice. However, it is not clear which educational model is most effective. To assess the effect of two educational programs for care staff, we planned a three armed cluster-randomized controlled trial. There is a lack of research reporting effects of interventions targeting improved continence care processes in older patients. Thus, to improve the quality of the planned trial, we decided to carry out a pilot study to investigate the feasibility of the planned design, the interventions (educational programs) and the outcome measures, and to enable a power calculation. This paper reports the results from the pilot study. Three nursing homes, representing each arm of the planned trial, were recruited. Criteria for assessing success of feasibility were pre-specified. Methods, outcome measures, acceptability, and adherence of the components of the intervention were evaluated by descriptive statistical analyses and qualitative content analysis of one focus group interview (n = 7) and four individual interviews. The main study is feasible with one major and some minor modifications. Due to challenges with recruitment and indications supporting the assumption that a single intervention with one workshop is not sufficient as an implementation strategy, the main study will be reduced to two arms: a multifaceted education intervention and control. The components of the multifaceted intervention seemed to work well together and need only minor modification. Important barriers to consider were sub-optimal use of skill-mix, problems of communicating important assessments and care plans, and isolated nurses with an indistinct nurse identity. Overall, the main study is feasible. The

  7. Parenting style, parent-youth conflict, and medication adherence in youth with type 2 diabetes participating in an intensive lifestyle change intervention.

    Science.gov (United States)

    Saletsky, Ronald D; Trief, Paula M; Anderson, Barbara J; Rosenbaum, Paula; Weinstock, Ruth S

    2014-06-01

    Parenting behaviors and family conflict relate to type 1 diabetes outcomes in youth. Our purpose was to understand these relationships in parents and youth with type 2 diabetes (T2DM). The TODAY (Treatment Options for Type 2 Diabetes in Adolescents and Youth) trial enrolled youth (10-17 years) with T2DM and parent/guardian. For this ancillary study, we enrolled a sample of youth-parent pairs (N = 137) in 1 study arm (metformin plus lifestyle intervention). They completed questionnaires measuring parenting style related to normative (e.g., completing homework) and diabetes self-care (e.g., testing blood glucose) tasks, and parent-youth verbal conflict (baseline, 6, and 12 months). Parenting style was consistent across normative and diabetes tasks, with gradual increases in autonomy perceived by youth. Conversations were generally calm, with greater conflict regarding normative than diabetes tasks at baseline (youth: p parent: p = .01), 6 months (youth: p = .02, parent: p > .05), and 12 months (youth: p > .05., parent: p = .05). A permissive parenting style toward normative tasks and a less authoritarian style toward diabetes tasks, at baseline, predicted better medication adherence (8-12 months) (normative: adjusted R2 = 0.48, p Parent-youth conflict did not predict medication adherence. Youth with T2DM who perceive more autonomy (less parental control) in day-to-day and diabetes tasks are more likely to adhere to medication regimens. It may be valuable to assess youth perceptions of parenting style and help parents understand youths' needs for autonomy.

  8. Texting and Mobile Phone App Interventions for Improving Adherence to Preventive Behavior in Adolescents: A Systematic Review.

    Science.gov (United States)

    Badawy, Sherif M; Kuhns, Lisa M

    2017-04-19

    Many preventable behaviors contribute to adolescent mortality and morbidity. Non-adherence to preventive measures represents a challenge and has been associated with worse health outcomes in this population. The widespread use of electronic communication technologies by adolescents, particularly the use of text messaging (short message service, SMS) and mobile phones, presents new opportunities to intervene on risk and preventive risk behavior, but little is known about their efficacy. This study aimed to systematically evaluate evidence for the efficacy of text messaging and mobile phone app interventions to improve adherence to preventive behavior among adolescents and describe intervention approaches to inform intervention development. This review covers literature published between 1995 and 2015. Searches included PubMed, Embase, CENTRAL, PsycINFO, CINAHL, INSPEC, Web of Science, Google Scholar, and additional databases. The search strategy sought articles on text messaging and mobile phone apps combined with adherence or compliance, and adolescents and youth. An additional hand search of related themes in the Journal of Medical Internet Research was also conducted. Two reviewers independently screened titles and abstracts, assessed full-text articles, and extracted data from articles that met inclusion criteria. Included studies reflect original research-experimental or preexperimental designs with text messaging or mobile phone app interventions-targeting adherence to preventive behavior among adolescents (12-24 years old). The preferred reporting items of systematic reviews and meta-analyses (PRISMA) guidelines were followed for reporting results, and findings were critically appraised against the Oxford Centre for Evidence-based Medicine criteria. Of 1454 records, 19 met inclusion criteria, including text messaging (n=15) and mobile phone apps (n=4). Studies targeted clinic attendance, contraceptive use, oral health, physical activity and weight management

  9. Adherence to endocrine therapy in breast cancer adjuvant and prevention settings.

    Science.gov (United States)

    Chlebowski, Rowan T; Kim, Jisang; Haque, Reina

    2014-04-01

    Adherence to oral endocrine therapy in adjuvant breast cancer settings is a substantial clinical problem. To provide current perspective on adherence to oral endocrine therapies, a comprehensive literature review was conducted. In adjuvant trials, endocrine therapy adherence is relatively high with greater adherence for aromatase inhibitors compared with tamoxifen. In contrast, adherence to adjuvant therapy in clinical practice is relatively poor, with only about 50% of women successfully completing 5-year therapy. Importantly, good adherence (>80% use) has been associated with lower recurrence risk. Endocrine therapy adherence in primary breast cancer prevention trials parallels that seen in adjuvant trials. Factors associated with nonadherence include low recurrence risk perception, side effects, age extremes, medication cost, suboptimal patient-physician communication, and lack of social support. Few prospective studies have evaluated interventions designed to improve adherence. Interventions currently proposed reflect inferences from clinical trial procedures in which clinical contacts are commonly greater than in usual practice settings. In conclusion, for optimal breast cancer outcome, adherence to endocrine therapy must improve. Although general recommendations likely to improve adherence can be made based on clinical trial results and preliminary prospective trial findings, research specifically targeting this issue is needed to establish effective intervention strategies.

  10. A Structured, Manual-Based Low-Level Intervention vs. Treatment as Usual Evaluated in a Randomized Controlled Trial for Adolescents with Extreme Obesity - the STEREO Trial

    Directory of Open Access Journals (Sweden)

    Yvonne Mühlig

    2017-08-01

    Full Text Available Background: To compare efficacy and safety of a manual-based low-level psychological intervention with treatment as usual (weight loss treatment. Methods: A two-armed randomized controlled trial without blinding and computer-based stratified block randomization included adolescents and young adults (14.0-24.9 years with a BMI ≥ 30 kg/m2 at five German university hospitals. Primary outcomes were adherence (participation rate ≥ 5/6 sessions and quality of life (DISABKIDS-37 6 months after randomization. Secondary outcomes included depression, self-esteem, and perceived stress scores. Results: Of 397 screened adolescents, 119 (mean BMI 40.4 ± 7.0 kg/m2, 49.6% female were randomized to the manual-based low-level intervention (n = 59 or treatment as usual (n = 60. We observed no group difference for adherence (absolute risk reduction 0.4%, 95% CI -14.7% to 15.5%; p = 1.0 or health-related quality of life (score difference 8.1, 95% CI -2.1 to 18.3; p = 0.11. Among all secondary outcomes, we detected explorative evidence for an effect on the DISABKIDS-37 ‘social exclusion' subscale (score difference 15.5; 95% CI 1.6-29.4; p = 0.03. 18/19 adverse events occurred in 26 participants, none were classified as serious. Conclusion: Adherence to a coping-oriented intervention was comparable to weight loss treatment, although it was weak in both interventions. Psychological interventions may help to overcome social isolation; further confirmation is required.

  11. A Structured, Manual-Based Low-Level Intervention vs. Treatment as Usual Evaluated in a Randomized Controlled Trial for Adolescents with Extreme Obesity - the STEREO Trial.

    Science.gov (United States)

    Mühlig, Yvonne; Scherag, André; Bickenbach, Annika; Giesen, Ulrike; Holl, Reinhard; Holle, Rolf; Kiess, Wieland; Lennerz, Belinda; Lütke Brintrup, Diana; Moss, Anja; Neef, Madlen; Ose, Claudia; Reinehr, Thomas; Teuner, Christina M; Wiegand, Susanna; Wolters, Barbara; Wabitsch, Martin; Hebebrand, Johannes

    2017-01-01

    To compare efficacy and safety of a manual-based low-level psychological intervention with treatment as usual (weight loss treatment). A two-armed randomized controlled trial without blinding and computer-based stratified block randomization included adolescents and young adults (14.0-24.9 years) with a BMI ≥ 30 kg/m2 at five German university hospitals. Primary outcomes were adherence (participation rate ≥ 5/6 sessions) and quality of life (DISABKIDS-37) 6 months after randomization. Secondary outcomes included depression, self-esteem, and perceived stress scores. Of 397 screened adolescents, 119 (mean BMI 40.4 ± 7.0 kg/m2, 49.6% female) were randomized to the manual-based low-level intervention (n = 59) or treatment as usual (n = 60). We observed no group difference for adherence (absolute risk reduction 0.4%, 95% CI -14.7% to 15.5%; p = 1.0) or health-related quality of life (score difference 8.1, 95% CI -2.1 to 18.3; p = 0.11). Among all secondary outcomes, we detected explorative evidence for an effect on the DISABKIDS-37 'social exclusion' subscale (score difference 15.5; 95% CI 1.6-29.4; p = 0.03). 18/19 adverse events occurred in 26 participants, none were classified as serious. Adherence to a coping-oriented intervention was comparable to weight loss treatment, although it was weak in both interventions. Psychological interventions may help to overcome social isolation; further confirmation is required. © 2017 The Author(s) Published by S. Karger GmbH, Freiburg.

  12. Disproportionate Intrauterine Growth Intervention Trial At Term: DIGITAT

    Directory of Open Access Journals (Sweden)

    Huisjes Anjoke JM

    2007-07-01

    Full Text Available Abstract Background Around 80% of intrauterine growth restricted (IUGR infants are born at term. They have an increase in perinatal mortality and morbidity including behavioral problems, minor developmental delay and spastic cerebral palsy. Management is controversial, in particular the decision whether to induce labour or await spontaneous delivery with strict fetal and maternal surveillance. We propose a randomised trial to compare effectiveness, costs and maternal quality of life for induction of labour versus expectant management in women with a suspected IUGR fetus at term. Methods/design The proposed trial is a multi-centre randomised study in pregnant women who are suspected on clinical grounds of having an IUGR child at a gestational age between 36+0 and 41+0 weeks. After informed consent women will be randomly allocated to either induction of labour or expectant management with maternal and fetal monitoring. Randomisation will be web-based. The primary outcome measure will be a composite neonatal morbidity and mortality. Secondary outcomes will be severe maternal morbidity, maternal quality of life and costs. Moreover, we aim to assess neurodevelopmental and neurobehavioral outcome at two years as assessed by a postal enquiry (Child Behavioral Check List-CBCL and Ages and Stages Questionnaire-ASQ. Analysis will be by intention to treat. Quality of life analysis and a preference study will also be performed in the same study population. Health technology assessment with an economic analysis is part of this so called Digitat trial (Disproportionate Intrauterine Growth Intervention Trial At Term. The study aims to include 325 patients per arm. Discussion This trial will provide evidence for which strategy is superior in terms of neonatal and maternal morbidity and mortality, costs and maternal quality of life aspects. This will be the first randomised trial for IUGR at term. Trial registration Dutch Trial Register and ISRCTN

  13. A Mobile Phone HIV Medication Adherence Intervention: Care4Today™ Mobile Health Manager

    Science.gov (United States)

    Martin, C. Andrew

    2016-01-01

    This paper presents the findings of a qualitative study designed to describe the experience of HIV medication adherence using a mobile phone application. For the purpose of this qualitative study, nine semi-structured focus group discussions were conducted over a three-month period at an AIDS service organization in Central Texas. The data were…

  14. The Effect of Using Assessment Instruments on Substance-abuse Outpatients' Adherence to Treatment: a Multi-centre Randomised Controlled Trial

    Directory of Open Access Journals (Sweden)

    Broekaert Eric

    2011-05-01

    Full Text Available Abstract Background Drop-out is an important problem in the treatment of substance use disorder. The focus of this study was to investigate the effectiveness of within treatment assessment with feedback directly to patients with multiple substance use disorder on outpatient individual treatment adherence. Feedback consisted of personal resources' and readiness to change status and progress that facilitate or hinder change, thereby using graphical representation. Methods Informed consent was obtained from both the control and experimental groups to be involved in research and follow-up. Following Zelen's single consent design, baseline participants (n = 280 were randomised (sample-size-estimation: 80%power, p=.05, 2-sided and treatment consent was obtained from those allocated to the experiment (n = 142. In both groups, equal numbers of patients did not attend sessions after allocation. So, 227 persons were analyzed according to intention-to-treat analysis (ITT: experiment n = 116;control n = 111. Excluding refusals 211 participants remained for per-protocol analysis (PP: experiment n = 100; control n = 111, The study was conducted in five outpatient treatment-centres of a large network (De Sleutel in Belgium. Participants were people with multiple substance use disorder -abuse and dependence- who had asked for treatment and who had been advised to start individual treatment after a standardised admission assessment with the European Addiction Severity Index. The experimental condition consisted of informing the patient about the intervention and of subsequent assessments plus feedback following a protocol within the first seven sessions. Assessments were made with the Readiness to Change Questionnaire and the Personal Resources Diagnostic System. The control group received the usual treatment without within treatment assessment with feedback. The most important outcome measure in this analysis of the study was the level of adherence to treatment

  15. The feasibility of an exercise intervention in males at risk of oesophageal adenocarcinoma: a randomized controlled trial.

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    Brooke M Winzer

    Full Text Available To investigate the feasibility and safety of a 24-week exercise intervention, compared to control, in males with Barrett's oesophagus, and to estimate the effect of the intervention, compared to control, on risk factors associated with oesophageal adenocarcinoma development.A randomized controlled trial of an exercise intervention (60 minutes moderate-intensity aerobic and resistance exercise five days/week over 24 weeks; one supervised and four unsupervised sessions versus attention control (45 minutes stretching five days/week over 24 weeks; one supervised and four unsupervised sessions in inactive, overweight/obese (25.0-34.9 kg/m2 males with Barrett's oesophagus, aged 18-70 years. Primary outcomes were obesity-associated hormones relevant to oesophageal adenocarcinoma risk (circulating concentrations of leptin, adiponectin, interleukin-6, tumour necrosis factor-alpha, C-reactive protein, and insulin resistance [HOMA]. Secondary outcomes included waist circumference, body composition, fitness, strength and gastro-oesophageal reflux symptoms. Outcomes were measured at baseline and 24-weeks. Intervention effects were analysed using generalised linear models, adjusting for baseline value.Recruitment was difficult in this population with a total of 33 participants recruited (target sample size: n = 80; 97% retention at 24-weeks. Adherence to the exercise protocol was moderate. No serious adverse events were reported. A statistically significant intervention effect (exercise minus control was observed for waist circumference (-4.5 [95% CI -7.5, -1.4] cm; p < 0.01. Effects on primary outcomes were not statistically significant.This small, exploratory trial provides important information to inform future trial development including recruitment rates and estimates of effect sizes on outcomes related to oesophageal adenocarcinoma risk. Future trials should investigate a combined dietary and exercise intervention to achieve greater weight loss in this

  16. Novel ways to explore surgical interventions in randomised controlled trials: applying case study methodology in the operating theatre.

    Science.gov (United States)

    Blencowe, Natalie S; Blazeby, Jane M; Donovan, Jenny L; Mills, Nicola

    2015-12-28

    Multi-centre randomised controlled trials (RCTs) in surgery are challenging. It is particularly difficult to establish standards of surgery and ensure that interventions are delivered as intended. This study developed and tested methods for identifying the key components of surgical interventions and standardising interventions within RCTs. Qualitative case studies of surgical interventions were undertaken within the internal pilot phase of a surgical RCT for obesity (the By-Band study). Each case study involved video data capture and non-participant observation of gastric bypass surgery in the operating theatre and interviews with surgeons. Methods were developed to transcribe and synchronise data from video recordings with observational data to identify key intervention components, which were then explored in the interviews with surgeons. Eight qualitative case studies were undertaken. A novel combination of video data capture, observation and interview data identified variations in intervention delivery between surgeons and centres. Although surgeons agreed that the most critical intervention component was the size and shape of the gastric pouch, there was no consensus regarding other aspects of the procedure. They conceded that evidence about the 'best way' to perform bypass was lacking and, combined with the pragmatic nature of the By-Band study, agreed that strict standardisation of bypass might not be required. This study has developed and tested methods for understanding how surgical interventions are designed and delivered delivered in RCTs. Applying these methods more widely may help identify key components of interventions to be delivered by surgeons in trials, enabling monitoring of key components and adherence to the protocol. These methods are now being tested in the context of other surgical RCTs. Current Controlled Trials ISRCTN00786323 , 05/09/2011.

  17. African American women exhibit similar adherence to intervention but lose less weight due to lower energy requirements.

    Science.gov (United States)

    DeLany, J P; Jakicic, J M; Lowery, J B; Hames, K C; Kelley, D E; Goodpaster, B H

    2014-09-01

    African American (AA) women have been shown to lose less weight than Caucasian women in response to behavioral interventions. Our objective was to examine adherence to intervention and metabolic factors that may explain this difference. We examined longitudinal changes in body weight and energy expenditure (EE), and objective assessment of physical activity (PA) and energy intake (EI) during 6 months of a weight-loss intervention program, including prescribed calorie restriction and increased PA in 66 Caucasian and 39 AA severely obese women. Comparisons were also made in 25 Caucasian and 25 AA women matched for initial body weight. The AA women lost 3.6 kg less weight than Caucasian women. Total daily EE (TDEE) and resting metabolic rate (RMR) adjusted for fat free mass (FFM) were significantly lower in the AA women, whereas the decrease in RMR in response to weight loss was greater in Caucasian women. Adherence to the prescribed PA and change in PA in response to intervention were similar in AA and Caucasian women. Prescribed EI (1794±153 and 1806±153 kcal per day) and measured EI during intervention (2591±371 vs 2630±442 kcal per day) were nearly identical in matched AA and Caucasian women. However, the AA women lost significantly less body weight due to lower energy requirements (2924±279 vs 3116±340 kcal per day; Pweight loss. Therefore, to achieve similar weight loss in AA women, the prescribed caloric restriction cannot be based on weight alone, but must be lower than in Caucasians, to account for lower energy requirements.

  18. Music intervention during daily weaning trials-A 6 day prospective randomized crossover trial.

    Science.gov (United States)

    Liang, Zhan; Ren, Dianxu; Choi, JiYeon; Happ, Mary Beth; Hravnak, Marylyn; Hoffman, Leslie A

    2016-12-01

    To examine the effect of patient-selected music intervention during daily weaning trials for patients on prolonged mechanical ventilation. Using a crossover repeated measures design, patients were randomized to music vs no music on the first intervention day. Provision of music was alternated for 6 days, resulting in 3 music and 3 no music days. During weaning trials on music days, data were obtained for 30min prior to music listening and continued for 60min while patients listened to selected music (total 90min). On no music days, data were collected for 90min. Outcome measures were heart rate (HR), respiratory rate (RR), oxygen saturation (SpO2), blood pressure (BP), dyspnea and anxiety assessed with a visual analog scale (VAS-D, VAS-A) and weaning duration (meanh per day on music and non-music days). Of 31 patients randomized, 23 completed the 6-day intervention. When comparisons were made between the 3 music and 3 no music days, there were significant decreases in RR and VAS-D and a significant increase in daily weaning duration on music days (pmusic days (pmusic during daily weaning trials is a simple, low-cost, potentially beneficial intervention for patients on prolonged mechanical ventilation. Further study is indicated to test ability of this intervention to promote weaning success and benefits earlier in the weaning process. Copyright © 2016 Elsevier Ltd. All rights reserved.

  19. Medication non-adherence in adult patients affected by inflammatory bowel disease: a critical review and update of the determining factors, consequences and possible interventions.

    Science.gov (United States)

    Lenti, Marco Vincenzo; Selinger, Christian P

    2017-03-01

    Achieving adherence to medications can be a serious challenge for patients affected by inflammatory bowel disease (IBD). Medical treatment is fundamental for inducing and maintaining remission, preventing flares and reducing the risk of colorectal cancer. Non-adherence may affect patients' quality of life resulting in unfavourable treatment outcomes, more hospitalizations and higher healthcare-related costs. Recognising and improving adherence is therefore a primary aim for the treatment of IBD. Areas covered: We critically discuss the current knowledge on medication non-adherence in adult patients affected by IBD, also mentioning a few issues concerning the paediatric and adolescent populations. In particular, we reviewed the literature focusing on the definition and detection of non-adherence, on its extent and on the possible non-modifiable and modifiable factors involved (patient-centred, therapy-related, disease-related and physician-related). Furthermore, we analysed the interventional studies performed so far. The literature review was conducted through PubMed addressing medication non-adherence in IBD, using the keywords 'adherence' and related terms and 'IBD, ulcerative colitis or Crohn's disease'. Expert commentary: Adherence to therapy for IBD is a complex yet fundamental issue that cannot be solved by addressing a single aspect only. Future studies should focus on patient-tailored and multidimensional interventions.

  20. Development of a text-messaging intervention to improve treatment adherence and post-treatment review of children with uncomplicated malaria in western Kenya.

    Science.gov (United States)

    Githinji, Sophie; Jones, Caroline; Malinga, Josephine; Snow, Robert W; Talisuna, Ambrose; Zurovac, Dejan

    2015-08-19

    Patients' low adherence to artemisinin-based combination therapy has been reported in areas of Kenya bordering the Lake Victoria region, where the burden of malaria remains high. A randomized controlled trial is underway to determine the efficacy of short message service (SMS) text reminders on adherence to artemether-lumefantrine and post-treatment review of children under the age of five. This paper reports on the iterative process of intervention and delivery system development. An intervention development workshop involving the research team and other stakeholders was held to determine the content of the text messages. Three focus group discussions were conducted to test caregivers' understanding of the messages developed during the workshop. The tested messages were refined and incorporated into an automated SMS distribution system and piloted with 20 caregivers drawn from facilities neighbouring the study sites. The automated SMS distribution system was repeatedly refined following the pilot and implemented at the start of the trial. The content of SMS messages underwent major revisions following the focus group discussions. Technical terms and abbreviations were replaced with simplified general terms. Message sign-off was modified to reflect the name of health facility, removing references to health workers. Day 3 post-treatment review visit reminder was modified to state the purpose of the visit while wording 'day 28' was added to the last post-treatment review visit reminder to help the caregiver recall the appointment date. The unscheduled visit prompt was modified to reflect flexibility and practicality of taking the child back to the facility if unwell. Reception of SMS reminders during the pilot was low with only 169/240 (70%) of scheduled messages delivered to the caregivers. The automated distribution system underwent major refinement and repeated testing following the pilot until effective delivery of all scheduled messages was achieved and

  1. Do psychological interventions reduce depression in hemodialysis patients?: A meta-analysis of randomized controlled trials following PRISMA.

    Science.gov (United States)

    Xing, Lu; Chen, Ruiqi; Diao, Yongshu; Qian, Jiahui; You, Chao; Jiang, Xiaolian

    2016-08-01

    Depression is highly prevalent in hemodialysis patients and results in poor patient outcomes. Although psychological interventions are being developed and used for these patients, there is uncertainty regarding the effectiveness of these interventions. The purpose of this meta-analysis is to evaluate the effects of psychological interventions on depression treatment in hemodialysis patients. All randomized controlled trials (RCTs) relevant to the depression treatment of hemodialysis patients through psychological interventions were retrieved from the following databases: Embase, Pubmed, PsycINFO, the Cochrane Database of Systematic Reviews, and the Cochrane Central Register of Controlled Trials. The reference lists of identified RCTs were also screened. The Cochrane risk of bias tool was used to evaluate the quality of the studies, RevMan (5.3) was used to analyze the data, and the evidence quality of the combined results was evaluated using GRADE (3.6.1). Eight RCTs were included. The combined results showed that psychological interventions significantly reduced the scores of the Beck Depression Inventory (P<0.001) and interdialysis weight gain (P<0.001). However, due to the high heterogeneity, effect size combinations of sleep quality and quality of life were not performed. Psychological interventions may reduce the degree of depression and improve fluid intake restriction adherence. More rigorously designed research is needed.

  2. The effect of reminder systems on patients' adherence to treatment

    Directory of Open Access Journals (Sweden)

    Fenerty SD

    2012-02-01

    Full Text Available Sarah D Fenerty1, Cameron West1, Scott A Davis1, Sebastian G Kaplan3, Steven R Feldman1,2,41Center for Dermatology Research, Department of Dermatology, 2Department of Pathology, 3Department of Psychiatry and Behavioral Medicine, 4Department of Public Health Sciences, Wake Forest University School of Medicine, Winston-Salem, North Carolina, USABackground: Patient adherence is an important component of the treatment of chronic disease. An understanding of patient adherence and its modulating factors is necessary to correctly interpret treatment efficacy and barriers to therapeutic success.Purpose: This meta-analysis aims to systematically review published randomized controlled trials of reminder interventions to assist patient adherence to prescribed medications.Methods: A Medline search was performed for randomized controlled trials published between 1968 and June 2011, which studied the effect of reminder-based interventions on adherence to self-administered daily medications.Results: Eleven published randomized controlled trials were found between 1999 and 2009 which measured adherence to a daily medication in a group receiving reminder interventions compared to controls receiving no reminders. Medication adherence was measured as the number of doses taken compared to the number prescribed within a set period of time. Meta-analysis showed a statistically significant increase in adherence in groups receiving a reminder intervention compared to controls (66.61% versus 54.71%, 95% CI for mean: 0.8% to 22.4%. Self-reported and electronically monitored adherence rates did not significantly differ (68.04% versus 63.67%, P = 1.0. Eight of eleven studies showed a statistically significant increase in adherence for at least one of the reminder group arms compared to the control groups receiving no reminder intervention.Limitations: The data are limited by imperfect measures of adherence due to variability in data collection methods. It is also likely

  3. Assessment of adherence to the statistical components of consolidated standards of reporting trials statement for quality of reports on randomized controlled trials from five pharmacology journals

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    Sachin Satpute

    2016-01-01

    Full Text Available Background: The Consolidated Standards of Reporting Trials (CONSORT statement is a device to standardize reporting and improve the quality of controlled trials. However, little attention is paid to the statistical components in the CONSORT checklist. The present study evaluates the randomized controlled trials [RCTs] published in five high impact pharmacology journals with respect to its statistical methods. Methods: Randomized Controlled Trials [RCTs] published in the years 2013 & 2014 in five pharmacology journals with high impact factor, The Journal of Clinical Pharmacology (JCP, British Journal of Clinical Pharmacology (BJCP, European Journal of Clinical Pharmacology (EJCP, Journal of Pharmacology & Pharmacotherapeutics (JPP and Indian Journal of Pharmacology (IJP were assessed for adherence to the statistical components of CONSORT statement. Results: Of the 174 RCTs analysed, 103 described the method of sample size calculation. Of the five journals, maximum reports in JCP (34/50 and minimum in IJP (13/31 adhered to the CONSORT checklist [item 7a-sample size calculation]. Most reports mentioned the statistical methods used for analysis of data. (171/174 as per the checklist [item 12=statistical methods used]. Analysis of variance (ANOVA was the most commonly used test (88/174. The software used for statistical analysis was mentioned in 111 RCTs and SPSS was used more frequently (58/111. The exact p value was stated in 108 reports. Certain errors in statistical analysis were also noted (40/174. Conclusion: These findings show inconsistencies and non- adherence to the statistical components of the CONSORT statement especially with respect to sample size calculation. Special attention must be paid to the statistical accuracy of the reports.

  4. Assessment of adherence to the statistical components of consolidated standards of reporting trials statement for quality of reports on randomized controlled trials from five pharmacology journals

    Science.gov (United States)

    Satpute, Sachin; Mehta, Manthan; Bhete, Sandeep; Kurle, Dnyneshwar

    2016-01-01

    Background: The Consolidated Standards of Reporting Trials (CONSORT) statement is a device to standardize reporting and improve the quality of controlled trials. However, little attention is paid to the statistical components in the CONSORT checklist. The present study evaluates the randomized controlled trials [RCTs] published in five high impact pharmacology journals with respect to its statistical methods. Methods: Randomized Controlled Trials [RCTs] published in the years 2013 & 2014 in five pharmacology journals with high impact factor, The Journal of Clinical Pharmacology (JCP), British Journal of Clinical Pharmacology (BJCP), European Journal of Clinical Pharmacology (EJCP), Journal of Pharmacology & Pharmacotherapeutics (JPP) and Indian Journal of Pharmacology (IJP) were assessed for adherence to the statistical components of CONSORT statement. Results: Of the 174 RCTs analysed, 103 described the method of sample size calculation. Of the five journals, maximum reports in JCP (34/50) and minimum in IJP (13/31) adhered to the CONSORT checklist [item 7a-sample size calculation]. Most reports mentioned the statistical methods used for analysis of data. (171/174) as per the checklist [item 12=statistical methods used]. Analysis of variance (ANOVA) was the most commonly used test (88/174). The software used for statistical analysis was mentioned in 111 RCTs and SPSS was used more frequently (58/111). The exact p value was stated in 108 reports. Certain errors in statistical analysis were also noted (40/174). Conclusion: These findings show inconsistencies and non- adherence to the statistical components of the CONSORT statement especially with respect to sample size calculation. Special attention must be paid to the statistical accuracy of the reports. PMID:27453829

  5. Predictors and impact of non-adherence in adults with attention-deficit/hyperactivity disorder receiving OROS methylphenidate: results from a randomized, placebo-controlled trial

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    Kooij J J Sandra

    2013-01-01

    be at increased risk of non-adherence. Clinicians and policymakers should therefore pay special attention to these individuals, as non-adherence is a significant predictor of reduced response to treatment. Trial registration EudraCT #: 2007-002111-82

  6. Interventions to improve adherence to first-line antibiotics in respiratory tract infections

    DEFF Research Database (Denmark)

    Llor, Carl; Monedero, María José; García, Guillermo

    2015-01-01

    Background: Many interventions aimed at improving the quality of antibiotic prescribing have been investigated, but more knowledge is needed regarding the impact of different intensity interventions. Objectives: To compare the effect of two interventions, a basic intervention (BI) and intensive....... In the group of GPs following the BI, first-line antibiotics accounted for 23.8% of antibiotics before the intervention and 29.4% after (increase 5.6%, 95% confidence interval (CI): 1.2-10%), while in the group of GPs following the II these figures were 26.2% and 48.6% (increase 22.4%, 95% CI: 18...

  7. The Impact of E-Learning on Adherence to Guidelines for Acute Gastroenteritis: A Single-Arm Intervention Study.

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    Emanuele Nicastro

    Full Text Available E-learning is a candidate tool for clinical practice guidelines (CPG implementation due to its versatility, universal access and low costs. We aimed to assess the impact of a five-module e-learning course about CPG for acute gastroenteritis (AGE on physicians' knowledge and clinical practice.This work was conceived as a pre/post single-arm intervention study. Physicians from 11 European countries registered for the online course. Personal data, pre- and post-course questionnaires and clinical data about 3 to 5 children with AGE managed by each physician before and after the course were collected. Primary outcome measures included the proportion of participants fully adherent to CPG and number of patients managed with full adherence.Among the 149 physicians who signed up for the e-learning course, 59 took the course and reported on their case management of 519 children <5 years of age who were referred to their practice because of AGE (281 and 264 children seen before and after the course, respectively. The course improved knowledge scores (pre-course 8.6 ± 2.7 versus post-course 12.8 ± 2.1, P < 0.001, average adherence (from 87.0 ± 7.7% to 90.6 ± 7.1%, P = 0.001 and the number of patients managed in full adherence with the guidelines (from 33.6 ± 31.7% to 43.9 ± 36.1%, P = 0.037.E-learning is effective in increasing knowledge and improving clinical practice in paediatric AGE and is an effective tool for implementing clinical practice guidelines.

  8. Pilot study of a cluster randomised trial of a guided e-learning health promotion intervention for managers based on management standards for the improvement of employee well-being and reduction of sickness absence: GEM Study

    Science.gov (United States)

    Stansfeld, Stephen A; Kerry, Sally; Chandola, Tarani; Russell, Jill; Berney, Lee; Hounsome, Natalia; Lanz, Doris; Costelloe, Céire; Smuk, Melanie; Bhui, Kamaldeep

    2015-01-01

    Objectives To investigate the feasibility of recruitment, adherence and likely effectiveness of an e-learning intervention for managers to improve employees’ well-being and reduce sickness absence. Methods The GEM Study (guided e-learning for managers) was a mixed methods pilot cluster randomised trial. Employees were recruited from four mental health services prior to randomising three services to the intervention and one to no-intervention control. Intervention managers received a facilitated e-learning programme on work-related stress. Main outcomes were Warwick Edinburgh Mental Wellbeing Scale (WEMWBS), 12-item GHQ and sickness absence managers and employees, and additional observational data collected. Results 424 of 649 (65%) employees approached consented, of whom 350 provided WEMWBS at baseline and 284 at follow-up; 41 managers out of 49 were recruited from the three intervention clusters and 21 adhered to the intervention. WEMWBS scores fell from 50.4–49.0 in the control (n=59) and 51.0–49.9 in the intervention (n=225), giving an intervention effect of 0.5 (95% CI −3.2 to 4.2). 120/225 intervention employees had a manager who was adherent to the intervention. HR data on sickness absence (n=393) showed no evidence of effect. There were no effects on GHQ score or work characteristics. Online quiz knowledge scores increased across the study in adherent managers. Qualitative data provided a rich picture of the context within which the intervention took place and managers’ and employees’ experiences of it. Conclusions A small benefit from the intervention on well-being was explained by the mixed methods approach, implicating a low intervention uptake by managers and suggesting that education alone may be insufficient. A full trial of the guided e-learning intervention and economic evaluation is feasible. Future research should include more active encouragement of manager motivation, reflection and behaviour change. Trial Registration number ISRCTN

  9. Evaluation of relapse prevention and reinforcement interventions to promote exercise adherence in sedentary females.

    Science.gov (United States)

    Marcus, B H; Stanton, A L

    1993-12-01

    An experimental design was employed to assess the effectiveness of a relapse prevention program, a reinforcement program, and an exercise-only control group in increasing exercise program adherence and short-term maintenance in 120 previously sedentary female university employees. The subjects participated in an 18-week exercise program composed of stretching, calisthenics, and aerobic dance. Attendance during the first half of the program was significantly higher for subjects in the relapse prevention group than for those in the control group. A nonsignificant trend in this direction emerged during the second half of the program and at 2-month follow-up. For all treatment groups, attrition (attendance at less than two thirds of the exercise sessions) was substantial, averaging 72% at the end of the 18-week program. These findings indicate that relapse prevention and reinforcement programs may not assist previously sedentary females in long-term adherence to an exercise program.

  10. Adherence to prophylactic antibiotic therapy of thoraco-abdominal interventions in Hospital Universitario San Jorge, Pereira

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    Jorge Enrique Machado-Alba

    2013-05-01

    Full Text Available Objective: determine adherence to the protocol of antibiotic prophylaxis in patients undergoingsurgery at Hospital Universitario San Jorge, Pereira. Materials and methods: observational descriptivestudy took information from all patients who underwent surgery between April 1 and June31, 2010. The information was taken from medical records considering the variables age, gender,type of surgery, time, day of week, antimicrobial agents used compared with those recommendedby institutional guidelines. The analysis was done using SPSS 19.0 for Windows. Results: therewere 211 patients, with a predominance of men (52,6% and average age of 45,2 ± 19,9 years.Adherence to guidelines pre-surgical prophylaxis was 44,5% of procedures. The variables malegender (OR 2,2; 95% CI 1,220 to 4,063, p=0,009, emergency surgery (OR 2,1; 95% CI 1,136 to3,889, p=0,018 and weekends surgery (OR 2,3; 95% CI 1,090 to 5,255; p=0,03 were statisticallysignificantly associated with nonadherence. Conclusion: it found low guideline for pre-surgicalantibiotic adherence associated with emergency and weekends surgeries. Should intervene witheducation and feedback the team working in the emergency and surgery department to improvethe level of compliance with guidelines.

  11. Feasibility and Acceptability of a Mobile Intervention to Improve Treatment Adherence in Bipolar Disorder: A Pilot Study.

    Science.gov (United States)

    Wenze, Susan J; Armey, Michael F; Miller, Ivan W

    2014-07-01

    We evaluated the feasibility and acceptability of a 2-week-long ecological momentary intervention (EMI), delivered via personal digital assistants (PDAs), to improve treatment adherence in bipolar disorder. EMIs use mobile technology to deliver treatment as clients engage in their typical daily routines, in their usual settings. Overall, participants (N = 14) stated that EMI sessions were helpful, user-friendly, and engaging, and reported satisfaction with the timing and burden of sessions, as well as the method of delivery. All participants completed the study, and all PDAs were returned undamaged. On average, participants completed 92% of EMI sessions. Although this study was not designed to assess efficacy, depression scores decreased significantly over the study period and data suggest relatively high rates of treatment adherence; missed medication was reported 3% of the time and three participants reported missing a total of six mental health appointments. Negative feedback largely involved technical and logistical issues, many of which are easily addressable. These preliminary findings add to the growing body of literature indicating that mobile-technology-assisted interventions are feasible to implement and acceptable to patients with serious mental illnesses.

  12. Protocol for the ENCODE trial: evaluating a novel online depression intervention for persons with epilepsy.

    Science.gov (United States)

    Meyer, Björn; Weiss, Mario; Holtkamp, Martin; Arnold, Stephan; Brückner, Katja; Schröder, Johanna; Scheibe, Franziska; Nestoriuc, Yvonne

    2017-02-07

    Depression is common among persons with epilepsy (PwE), affecting roughly one in three individuals, and its presence is associated with personal suffering, impaired quality of life, and worse prognosis. Despite the availability of effective treatments, depression is often overlooked and treated inadequately in PwE, in part because of assumed concerns over drug interactions or proconvulsant effects of antidepressants. Internet-administered psychological interventions might complement antidepressant medication or psychotherapy, and preliminary evidence suggests that they can be effective. However, no trial has yet examined whether an Internet intervention designed to meet the needs of PwE can achieve sustained reductions in depression and related symptoms, such as anxiety, when offered as adjunct to treatment as usual. This randomized controlled trial will include 200 participants with epilepsy and a current depressive disorder, along with currently at least moderately elevated depression (Patient Health Questionnaire (PHQ-9) sum score of at least 10). Patients will be recruited via epilepsy treatment centers and other sources, including Internet forums, newspaper articles, flyers, posters, and media articles or advertisements, in German-speaking countries. Main inclusion criteria are: self-reported diagnosis of epilepsy and a depressive disorder, as assessed with a phone-administered structured diagnostic interview, none or stable antidepressant medication, no current psychotherapy, no other major psychiatric disorder, no acute suicidality. Participants will be randomly assigned to either (1) a care-as-usual/waitlist (CAU/WL) control group, in which they receive CAU and are given access to the Internet intervention after 3 months (that is, a CAU/WL control group), or (2) a treatment group that may also use CAU and in addition immediately receives six-month access to the novel, Internet-administered intervention. The primary outcome measure is the PHQ-9, collected

  13. Can Rapid Diagnostic Testing for Malaria Increase Adherence to Artemether-Lumefantrine?: A Randomized Controlled Trial in Uganda.

    Science.gov (United States)

    Saran, Indrani; Yavuz, Elif; Kasozi, Howard; Cohen, Jessica

    2016-04-01

    Most patients with suspected malaria do not receive diagnostic confirmation before beginning antimalarial treatment. We investigated the extent to which uncertainty about malaria diagnosis contributes to patient nonadherence to artemether-lumefantrine (AL) treatment through a randomized controlled trial in central Uganda. Among 1,525 patients purchasing a course of AL at private drug shops, we randomly offered 37.6% a free malaria rapid diagnostic test (RDT) and then assessed adherence through home visits 3 days later. Of these subjects, 68.4% tested positive for malaria and 65.8% adhered overall. Patients who tested positive did not have significantly higher odds of adherence than those who were not offered the test (adjusted odds ratio [OR]: 1.07, 95% confidence interval [CI]: 0.734-1.57,P= 0.719). Patients who received a positive malaria test had 0.488 fewer pills remaining than those not offered the test (95% CI: -1.02 to 0.043,P= 0.072). We found that patients who felt relatively healthy by the second day of treatment had lower odds of completing treatment (adjusted OR: 0.532, 95% CI: 0.394-0.719,Psymptoms have resolved.

  14. A pragmatic cluster randomised trial evaluating three implementation interventions

    Directory of Open Access Journals (Sweden)

    Rycroft-Malone Jo

    2012-08-01

    Full Text Available Abstract Background Implementation research is concerned with bridging the gap between evidence and practice through the study of methods to promote the uptake of research into routine practice. Good quality evidence has been summarised into guideline recommendations to show that peri-operative fasting times could be considerably shorter than patients currently experience. The objective of this trial was to evaluate the effectiveness of three strategies for the implementation of recommendations about peri-operative fasting. Methods A pragmatic cluster randomised trial underpinned by the PARIHS framework was conducted during 2006 to 2009 with a national sample of UK hospitals using time series with mixed methods process evaluation and cost analysis. Hospitals were randomised to one of three interventions: standard dissemination (SD of a guideline package, SD plus a web-based resource championed by an opinion leader, and SD plus plan-do-study-act (PDSA. The primary outcome was duration of fluid fast prior to induction of anaesthesia. Secondary outcomes included duration of food fast, patients’ experiences, and stakeholders’ experiences of implementation, including influences. ANOVA was used to test differences over time and interventions. Results Nineteen acute NHS hospitals participated. Across timepoints, 3,505 duration of fasting observations were recorded. No significant effect of the interventions was observed for either fluid or food fasting times. The effect size was 0.33 for the web-based intervention compared to SD alone for the change in fluid fasting and was 0.12 for PDSA compared to SD alone. The process evaluation showed different types of impact, including changes to practices, policies, and attitudes. A rich picture of the implementation challenges emerged, including inter-professional tensions and a lack of clarity for decision-making authority and responsibility. Conclusions This was a large, complex study and one of the first

  15. [Trials for early intervention in Mie Prefectural Mental Care Center].

    Science.gov (United States)

    Harada, Masanori; Adachi, Takako; Iwasa, Takashi; Kurita, Kouji; Nakamura, Tomoki; Hama, Yukinobu; Yamamoto, Ayako; Maegawa, Sanae

    2013-01-01

    Mie Prefectural Mental Care Center is a public psychiatric hospital that has 400 beds and 250 outpatients a day. The main catchment area is Tsu City (population: 290,000). Our hospital started early intervention in Aug 2008, and opened the Youth Mental Support Center MIE (YMSC MIE) in Oct 2008. This article reports an early intervention trial in a regional area of Japan. The mission of YMSC MIE is the education, consultation, staff training, and intervention for mental health problems and early psychosis of youths. In Jul 2009, we set up the Youth Assist Clinic (YAC) to support youths with mental health problems and early psychoses. Our activities consist of school-based, community-based, and hospital-based approaches. Specific programs are as follows: 1) School-based approaches: Outreach consultation to school. Mental health lessens. Creating mental health textbooks. Education for parents and teachers. 2) Community-based approaches: To enlighten primary physicians and mental clinic psychiatrists about the importance of early psychosis. To survey their concerns regarding early psychosis. Promoting awareness of community staff and the general public. 3) Hospital-based approaches: YAC. Case manager system. Family meetings for the family including the young with mental disorders. Peer group. Looking back over our 3-year trials, especially in school and the community, we find several problems, as follows: 1) Lack of consultation skills of medical staff outside the hospital. 2) Limiting number of schools which have mental support system. 3) Support for school attendance and learning. 4) Lack of concern about early psychosis of primary physicians and mental clinic psychiatrists. 5) Staff training for early intervention. We are now getting close to improving these issues.

  16. Implementing trials of complex interventions in community settings: The USC – Rancho Los Amigos Pressure Ulcer Prevention Study (PUPS)

    Science.gov (United States)

    Clark, Florence; Pyatak, Elizabeth A.; Carlson, Mike; Blanche, Erna Imperatore; Vigen, Cheryl; Hay, Joel; Mallinson, Trudy; Blanchard, Jeanine; Unger, Jennifer B.; Garber, Susan L.; Diaz, Jesus; Florindez, Lucia I.; Atkins, Michal; Rubayi, Salah; Azen, Stanley Paul

    2014-01-01

    Background Randomized trials of complex, non-pharmacologic interventions implemented in home and community settings, such as the University of Southern California (USC)–Rancho Los Amigos National Rehabilitation Center (RLANRC) Pressure Ulcer Prevention Study (PUPS), present unique challenges with respect to: (a) participant recruitment and retention, (b) intervention delivery and fidelity, (c) randomization and assessment, and (d) potential inadvertent treatment effects. Purpose We describe the methods employed to address the challenges confronted in implementing PUPS. In this randomized controlled trial, we are assessing the efficacy of a complex, preventive intervention in reducing the incidence of, and costs associated with, the development of medically serious pressure ulcers in people with spinal cord injury. Method Individuals with spinal cord injury recruited from RLANRC were assigned to either a 12-month preventive intervention group or a standard care control group. The primary outcome is the incidence of serious pressure ulcers with secondary endpoints including ulcer-related surgeries, medical treatment costs, and quality of life. These outcomes are assessed at 12 and 24 months after randomization. Additionally, we are studying the mediating mechanisms that account for intervention outcomes. Results PUPS has been successfully implemented, including recruitment of the target sample size of 170 participants, assurance of the integrity of intervention protocol delivery with an average 90% treatment adherence rate, and enactment of the assessment plan. However, implementation has been replete with challenges. To meet recruitment goals, we instituted a five-pronged approach customized for an underserved, ethnically diverse population. In intervention delivery, we increased staff time to overcome economic and cultural barriers to retention and adherence. To ensure treatment fidelity and replicability, we monitored intervention protocol delivery in accord

  17. Mutual interactions between depression/quality of life and adherence to a multidisciplinary lifestyle intervention in obesity.

    Science.gov (United States)

    Mazzeschi, Claudia; Pazzagli, Chiara; Buratta, Lidia; Reboldi, Gian Paolo; Battistini, Dalila; Piana, Natalia; Pippi, Roberto; Fatone, Cristina; De Feo, Pierpaolo

    2012-12-01

    There is scarce knowledge of the interaction between depression/health-related quality of life (HRQOL) and lifestyle intervention in obesity. The aim of the study was to establish whether baseline mood status or HRQOL affects attendance to educational or exercise sessions and whether attendance to these two components of the intervention affects mood and/or HRQOL in obesity. A total of 282 overweight/obese subjects (body mass index, 33.4 ± 5.9 kg/m(2); 103 males, 179 females; age, 53.8 ± 13.0 yr, mean ± sd) were consecutively enrolled in a multidisciplinary lifestyle intervention program. During the intensive phase of the intervention (3 months) patients were invited to attend eight educational sessions and 26 exercise group sessions. Poor adherence to exercise sessions is predicted by baseline depressive mood (P =0.006) and by low levels of HRQOL (domains of Vitality, Physical Role Functioning, Social Functioning, Mental Composite, Physical Composite Scores) (P obesity.

  18. Interventions targeting absences increase adherence and reduce abandonment of childhood cancer treatment in El Salvador.

    Science.gov (United States)

    Salaverria, Carmen; Rossell, Nuria; Hernandez, Angelica; Fuentes Alabi, Soad; Vasquez, Roberto; Bonilla, Miguel; Lam, Catherine G; Ribeiro, Raul C

    2015-09-01

    In El Salvador, about 200 new cases of pediatric cancer are diagnosed each year, and survival rates approach 70%. Although treatment is available at no cost, abandonment of therapy has remained at a steady yearly rate of 13% during the past decade. A time sensitive adherence tracking procedure (TS-ATP) was recently implemented to detect missed appointments, identify their causes, and intervene promptly. Procedure The study team was informed daily of patient/family failure to attend medical appointments in the pediatric oncology unit; the families were contacted and interviewed to ascertain and address the reasons. Patients who did not return after this initial contact were contacted again through local health clinics and municipalities. Law enforcement was a last resort for patients undergoing frontline treatment with a good prognosis., The system was adapted to clinical urgency: families of patients undergoing induction therapy were contacted within 24 hr, those in other therapy phases, within 48 hr, and those who had completed treatment, within one week. Reasons for absence were obtained by telephone or in person. The annual rate of abandonment was reduced from 13-3% during the 2 years period. There were 1,111 absences reported and 1,472 contacts with caregivers and institutions. The three main reasons for absences were financial needs (165, 23%), unforeseen barriers (116, 16%), and domestic needs (86, 12%). Use of the treatment adherence tracking system to locate and communicate with patients/families after missed appointments and the allocated aid stemming from these interviews substantially reduced abandonment and non-adherence. © 2015 Wiley Periodicals, Inc.

  19. An efficacy trial of brief lifestyle intervention delivered by generalist community nurses (CN SNAP trial

    Directory of Open Access Journals (Sweden)

    Fanaian Mahnaz

    2010-02-01

    Full Text Available Abstract Background Lifestyle risk factors, in particular smoking, nutrition, alcohol consumption and physical inactivity (SNAP are the main behavioural risk factors for chronic disease. Primary health care (PHC has been shown to be an effective setting to address lifestyle risk factors at the individual level. However much of the focus of research to date has been in general practice. Relatively little attention has been paid to the role of nurses working in the PHC setting. Community health nurses are well placed to provide lifestyle intervention as they often see clients in their own homes over an extended period of time, providing the opportunity to offer intervention and enhance motivation through repeated contacts. The overall aim of this study is to evaluate the impact of a brief lifestyle intervention delivered by community nurses in routine practice on changes in clients' SNAP risk factors. Methods/Design The trial uses a quasi-experimental design involving four generalist community nursing services in NSW Australia. Services have been randomly allocated to an 'early intervention' group or 'late intervention' (comparison group. 'Early intervention' sites are provided with training and support for nurses in identifying and offering brief lifestyle intervention for clients during routine consultations. 'Late intervention site' provide usual care and will be offered the study intervention following the final data collection point. A total of 720 generalist community nursing clients will be recruited at the time of referral from participating sites. Data collection consists of 1 telephone surveys with clients at baseline, three months and six months to examine change in SNAP risk factors and readiness to change 2 nurse survey at baseline, six and 12 months to examine changes in nurse confidence, attitudes and practices in the assessment and management of SNAP risk factors 3 semi-structured interviews/focus with nurses, managers and clients

  20. Randomized Trial of a Web-Based Intervention to Address Barriers to Clinical Trials.

    Science.gov (United States)

    Meropol, Neal J; Wong, Yu-Ning; Albrecht, Terrance; Manne, Sharon; Miller, Suzanne M; Flamm, Anne Lederman; Benson, Al Bowen; Buzaglo, Joanne; Collins, Michael; Egleston, Brian; Fleisher, Linda; Katz, Michael; Kinzy, Tyler G; Liu, Tasnuva M; Margevicius, Seunghee; Miller, Dawn M; Poole, David; Roach, Nancy; Ross, Eric; Schluchter, Mark D

    2016-02-10

    Lack of knowledge and negative attitudes have been identified as barriers to participation in clinical trials by patients with cancer. We developed Preparatory Education About Clinical Trials (PRE-ACT), a theory-guided, Web-based, interactive computer program, to deliver tailored video educational content to patients in an effort to overcome barriers to considering clinical trials as a treatment option. A prospective, randomized clinical trial compared PRE-ACT with a control condition that provided general clinical trials information produced by the National Cancer Institute (NCI) in text format. One thousand two hundred fifty-five patients with cancer were randomly allocated before their initial visit with an oncologist to PRE-ACT (n = 623) or control (n = 632). PRE-ACT had three main components: assessment of clinical trials knowledge and attitudinal barriers, values assessment with clarification back to patients, and provision of a video library tailored to address each patient's barriers. Outcomes included knowledge and attitudes and preparation for decision making about clinical trials. Both PRE-ACT and control interventions improved knowledge and attitudes (all P < .001) compared with baseline. Patients randomly allocated to PRE-ACT showed a significantly greater increase in knowledge (P < .001) and a significantly greater decrease in attitudinal barriers (P < .001) than did their control (text-only) counterparts. Participants in both arms significantly increased their preparedness to consider clinical trials (P < .001), and there was a trend favoring the PRE-ACT group (P < .09). PRE-ACT was also associated with greater patient satisfaction than was NCI text alone. These data show that patient education before the first oncologist visit improves knowledge, attitudes, and preparation for decision making about clinical trials. Both text and tailored video were effective. The PRE-ACT interactive video program was more effective than NCI text in improving

  1. Qualitative "trial-sibling" studies and "unrelated" qualitative studies contributed to complex intervention reviews.

    Science.gov (United States)

    Noyes, Jane; Hendry, Margaret; Lewin, Simon; Glenton, Claire; Chandler, Jackie; Rashidian, Arash

    2016-06-01

    To compare the contribution of "trial-sibling" and "unrelated" qualitative studies in complex intervention reviews. Researchers are using qualitative "trial-sibling" studies undertaken alongside trials to provide explanations to understand complex interventions. In the absence of qualitative "trial-sibling" studies, it is not known if qualitative studies "unrelated" to trials are helpful. Trials, "trial-sibling," and "unrelated" qualitative studies looking at three health system interventions were identified. We looked for similarities and differences between the two types of qualitative studies, such as participants, intervention delivery, context, study quality and reporting, and contribution to understanding trial results. Reporting was generally poor in both qualitative study types. We detected no substantial differences in participant characteristics. Interventions in qualitative "trial-sibling" studies were delivered using standardized protocols, whereas interventions in "unrelated" qualitative studies were delivered in routine care. Qualitative "trial-sibling" studies alone provided insufficient data to develop meaningful transferrable explanations beyond the trial context, and their limited focus on immediate implementation did not address all phenomena of interest. Together, "trial-sibling" and "unrelated" qualitative studies provided larger, richer data sets across contexts to better understand the phenomena of interest. Findings support inclusion of "trial-sibling" and "unrelated" qualitative studies to explore complexity in complex intervention reviews. Copyright © 2016 Elsevier Inc. All rights reserved.

  2. The impact of educational intervention on self-care behaviors in overweight hypertensive women: A randomized control trial.

    Science.gov (United States)

    Daniali, Seyedeh Shahrbanoo; Eslami, Ahmad Ali; Maracy, Mohammad Reza; Shahabi, Javad; Mostafavi-Darani, Firoozeh

    2017-01-01

    The improper control of self-care in hypertension imposes a lot of financial burden on the health-care system. On the other hand, the importance of participatory care and high effectiveness of self-management programs have been confirmed. This study was aimed to examine the effect of an educational intervention on self-efficacy, self-care behaviors and blood pressure (BP) of hypertensive obese or overweight women in the primary health-care setting in Isfahan, Iran. This randomized controlled trial was an educational intervention program. It was performed among 146 hypertensive women of 30-65 age range who referred to 6 health care centers of Isfahan that randomly assigned to a control and intervention groups. The interventional group participated in the 6 weekly sessions including exercises, weight control, medication adherence, and home self-monitoring based on goal setting, and promotion of self-efficacy. The control group received routine care from health-care center and any special intervention has been done for the control group. Output variables were analyzed after intervention, and 6-month follow-up. There are no significant differences between age, weight, body mass index and BP and biochemical variables except lipids as well as behavioral factors at the baseline. After 6 months intervention self-efficacy (control group. After 6 months, there was a significant reduction in systolic (P self-care to control disease. Furthermore, since adherence to the treatment of hypertensive patients in our society is low, organizing such courses can teach essential knowledge and skills to lifestyle change and prevention of complications. Performing these courses is recommended for other chronic disease patients in health-care centers to assess self-management programs on self-care behavior.

  3. An internal pilot study for a randomized trial aimed at evaluating the effectiveness of iron interventions in children with non-anemic iron deficiency: the OptEC trial.

    Science.gov (United States)

    Abdullah, Kawsari; Thorpe, Kevin E; Mamak, Eva; Maguire, Jonathon L; Birken, Catherine S; Fehlings, Darcy; Hanley, Anthony J; Macarthur, Colin; Zlotkin, Stanley H; Parkin, Patricia C

    2015-07-14

    The OptEC trial aims to evaluate the effectiveness of oral iron in young children with non-anemic iron deficiency (NAID). The initial sample size calculated for the OptEC trial ranged from 112-198 subjects. Given the uncertainty regarding the parameters used to calculate the sample, an internal pilot study was conducted. The objectives of this internal pilot study were to obtain reliable estimate of parameters (standard deviation and design factor) to recalculate the sample size and to assess the adherence rate and reasons for non-adherence in children enrolled in the pilot study. The first 30 subjects enrolled into the OptEC trial constituted the internal pilot study. The primary outcome of the OptEC trial is the Early Learning Composite (ELC). For estimation of the SD of the ELC, descriptive statistics of the 4 month follow-up ELC scores were assessed within each intervention group. The observed SD within each group was then pooled to obtain an estimated SD (S2) of the ELC. Correlation (ρ) between the ELC measured at baseline and follow-up was assessed. Recalculation of the sample size was performed using analysis of covariance (ANCOVA) method which uses the design factor (1- ρ(2)). Adherence rate was calculated using a parent reported rate of missed doses of the study intervention. The new estimate of the SD of the ELC was found to be 17.40 (S2). The design factor was (1- ρ2) = 0.21. Using a significance level of 5%, power of 80%, S2 = 17.40 and effect estimate (Δ) ranging from 6-8 points, the new sample size based on ANCOVA method ranged from 32-56 subjects (16-28 per group). Adherence ranged between 14% and 100% with 44% of the children having an adherence rate ≥ 86%. Information generated from our internal pilot study was used to update the design of the full and definitive trial, including recalculation of sample size, determination of the adequacy of adherence, and application of strategies to improve adherence. ClinicalTrials.gov Identifier: NCT

  4. Effect of exercise on cognitive performance in community-dwelling older adults: review of intervention trials and recommendations for public health practice and research.

    Science.gov (United States)

    Snowden, Mark; Steinman, Lesley; Mochan, Kara; Grodstein, Francine; Prohaska, Thomas R; Thurman, David J; Brown, David R; Laditka, James N; Soares, Jesus; Zweiback, Damita J; Little, Deborah; Anderson, Lynda A

    2011-04-01

    There is evidence from observational studies that increasing physical activity may reduce the risk of cognitive decline in older adults. Exercise intervention trials have found conflicting results. A systematic review of physical activity and exercise intervention trials on cognition in older adults was conducted. Six scientific databases and reference lists of previous reviews were searched. Thirty studies were eligible for inclusion. Articles were grouped into intervention-outcome pairings. Interventions were grouped as cardiorespiratory, strength, and multicomponent exercises. Cognitive outcomes were general cognition, executive function, memory, reaction time, attention, cognitive processing, visuospatial, and language. An eight-member multidisciplinary panel rated the quality and effectiveness of each pairing. Although there were some positive studies, the panel did not find sufficient evidence that physical activity or exercise improved cognition in older adults. Future research should report exercise adherence, use longer study durations, and determine the clinical relevance of measures used.

  5. Malaise, motivation and motherhood: predictors of engagement in behavioral interventions from a randomized controlled trial for HIV+ women in drug abuse recovery.

    Science.gov (United States)

    Mitrani, Victoria B; Feaster, Daniel J; Weiss-Laxer, Nomi S; McCabe, Brian E

    2011-02-01

    Drug abuse has serious consequences for the wellbeing of persons with HIV/AIDS but suboptimal rates of client engagement limit the efficacy of interventions. The present study examines and compares client characteristics that predicted engagement (defined as attendance at two or more sessions) in a family intervention (SET) and a group intervention within a randomized trial aimed at preventing relapse and improving medication adherence for 126 predominantly African American HIV+ women in drug abuse recovery. Intervention engagement (60% overall) was not significantly different across the two interventions. Fewer physical and mental symptoms (malaise) (P interventions. Results from this study can be used to inform outreach and engagement approaches for women dually affected by drug abuse and HIV/AIDS.

  6. Impact of an Educational Intervention to Improve Physician Adherence to Bronchiolitis Clinical Practice Guidelines: A Pre-Post Intervention Study.

    Science.gov (United States)

    Genies, Marquita C; Kim, Julia M; Pyclik, Kristina; Rossi, Suzanne; Spicyn, Natalie; Serwint, Janet R

    2017-04-01

    Bronchiolitis is the leading cause of infant hospitalizations in the United States. Despite clinical practice guidelines discouraging the utilization of non-evidence-based therapies, there continues to be wide variation in care and resource utilization. A pre-post physician focused educational intervention was conducted with the aims to reduce the use of non-evidence-based medical therapies, including bronchodilators, among patients admitted for bronchiolitis. Among patients meeting inclusion criteria (pre: n = 45; post: n = 47), bronchodilator use decreased by 50% ( P educational intervention highlighting American Academy of Pediatrics clinical practice guidelines resulted in reduced utilization of bronchodilators.

  7. Reporting Quality of Social and Psychological Intervention Trials: A Systematic Review of Reporting Guidelines and Trial Publications

    OpenAIRE

    Grant, Sean P.; Evan Mayo-Wilson; Melendez-Torres, G. J.; Paul Montgomery

    2013-01-01

    BACKGROUND: Previous reviews show that reporting guidelines have improved the quality of trial reports in medicine, yet existing guidelines may not be fully suited for social and psychological intervention trials. OBJECTIVE/DESIGN: We conducted a two-part study that reviewed (1) reporting guidelines for and (2) the reporting quality of social and psychological intervention trials. DATA SOURCES: (1) To identify reporting guidelines, we systematically searched multiple electronic databases and ...

  8. Cigarette smoking, obesity, physical activity, and alcohol use as predictors of chemoprevention adherence in the National Surgical Adjuvant Breast and Bowel Project P-1 Breast Cancer Prevention Trial.

    Science.gov (United States)

    Land, Stephanie R; Cronin, Walter M; Wickerham, D Lawrence; Costantino, Joseph P; Christian, Nicholas J; Klein, William M P; Ganz, Patricia A

    2011-09-01

    The double-blind, prospective, National Surgical Adjuvant Breast and Bowel Project (NSABP) Breast Cancer Prevention Trial (BCPT) showed a 50% reduction in the risk of breast cancer for tamoxifen versus placebo, yet many women at risk of breast cancer do not adhere to the 5-year course. This first report of the rich BCPT drug adherence data examines predictors of adherence. Between June, 1992 and September, 1997 13,338 women at high risk of breast cancer were randomly assigned to 20 mg/d tamoxifen versus placebo; we analyzed the 11,064 enrolled more than 3 years before trial unblinding. Primary endpoint was full drug adherence (100% of assigned pills per staff report, excluding protocol-required discontinuation) at 1 and 36 months; secondary was adequate adherence (76%-100%). Protocol-specified multivariable logistic regression tested lifestyle factors, controlling for demographic and medical predictors. About 13% were current smokers; 60% were overweight/obese; 46% had moderate/heavy physical activity; 21%, 66%, 13% drank 0, 0-1, 1+ drinks per day, respectively; 91% were adequately adherent at 1 month; and 79% were at 3 years. Alcohol use was associated with reduced full adherence at 1 month (P = 0.016; OR = 0.79 1+ vs. 0), as was college education (P adherence. Current smoking (P = 0.003; OR = 0.75), age (P = 0.024, OR = 1.1), college education (P = 0.037; OR = 1.4), tamoxifen assignment (P = 0.031; OR = 0.84), and breast cancer risk (P low) predicted adequate adherence at 36 months. There were no significant associations with obesity or physical activity. Alcohol use and smoking might indicate a need for greater adherence support. ©2011 AACR.

  9. The effect of providing feedback on inhaler technique and adherence from an electronic audio recording device, INCA®, in a community pharmacy setting: study protocol for a randomised controlled trial.

    Science.gov (United States)

    O'Dwyer, Susan Mary; MacHale, Elaine; Sulaiman, Imran; Holmes, Martin; Hughes, Cian; D'Arcy, Shona; Rapcan, Viliam; Taylor, Terence; Boland, Fiona; Bosnic-Anticevich, Sinthia; Reilly, Richard B; Ryder, Sheila A; Costello, Richard W

    2016-05-04

    time relative to the prescribed interval. Secondary outcomes include exacerbation rates and quality of life measures. Differences in the timing and technique of inhaler use as altered by the interventions will also be assessed. Data will be analysed on an intention-to-treat and a per-protocol basis. Sample size has been calculated with reference to comparisons to be made between the intervention and comparator clusters and indicates 75 participants per cluster. With an estimated 10 % loss to follow-up we will be able to show a 20 % difference between the population means of the intervention and comparator groups with a power of 0.8. The Type I error probability associated with the test of the null hypothesis is 0.05. This clinical trial will establish whether providing personalised feedback to individuals on their inhaler use improves adherence. It may also be possible to enhance the role of pharmacists in clinical care by identifying patients in whom alteration of either therapy or inhaler device is appropriate. ClinicalTrials.gov NCT02203266 .

  10. A randomized trial to reduce sugar-sweetened beverage and juice intake in preschool-aged children: description of the Smart Moms intervention trial.

    Science.gov (United States)

    Nezami, Brooke T; Lytle, Leslie A; Tate, Deborah F

    2016-08-19

    Obesity in young children remains a public health concern, and maternal weight is one of the strongest predictors of obesity in early childhood. However, parental adherence in interventions for young children is often low and existing programs have had mixed success. An innovative approach to treatment is needed that increases adherence among mothers and improves weight-related behaviors simultaneously in mothers and children. The objective of the Smart Moms randomized controlled trial (RCT) is to test the efficacy of a 6-month primarily smartphone-delivered program to reduce sugar-sweetened beverage and juice consumption among children ages 3-5 whose mothers are overweight or obese. This paper describes the study design and intervention. Mother-child dyads were eligible if the mother was overweight or obese, owned a smartphone, and if the child was between the ages of 3-5 and consumed 12 oz or more per day of sugar-sweetened beverages (SSBs) and 100 % fruit juice. Participants were randomly assigned to the Smart Moms intervention or a waitlist control group. The intervention consisted of theoretically grounded and evidence-based behavioral strategies delivered through one group session, lessons on a mobile-optimized website, and text messages. Mothers submitted self-monitoring information via text message and received regular tailored feedback emails from interventionists. The primary outcome is change in child SSB and juice consumption and a secondary outcome is change in maternal weight. This Smart Moms study was designed to determine if a low-burden intervention delivered using mobile methods and targeted towards mothers could be effective at changing child sugar-sweetened beverage intake. Results will indicate if mobile-based methods can be a feasible way to engage mothers in family-based studies and will inform successful strategies to prevent childhood obesity through parent-targeted approaches. Clinicaltrials.gov NCT02098902 (Registered March 25, 2014).

  11. Evaluation of mHealth strategies to optimize adherence and efficacy of Option B+ prevention of mother-to-child HIV transmission: Rationale, design and methods of a 3-armed randomized controlled trial.

    Science.gov (United States)

    Drake, Alison L; Unger, Jennifer A; Ronen, Keshet; Matemo, Daniel; Perrier, Trevor; DeRenzi, Brian; Richardson, Barbra A; Kinuthia, John; John-Stewart, Grace

    2017-06-01

    Lifelong antiretroviral therapy (ART) (Option B+) is recommended for all HIV-infected pregnant/postpartum women, but high adherence is required to maximize HIV prevention potential and maintain maternal health. Mobile health (mHealth) interventions may provide treatment adherence support for women during, and beyond, the pregnancy and postpartum periods. We are conducting an unblinded, triple-arm randomized clinical trial (Mobile WACh X) of one-way short message service (SMS) vs. two-way SMS vs. control (no SMS) to improve maternal ART adherence and retention in care by 2years postpartum. We will enroll 825 women from Nairobi and Western Kenya. Women in the intervention arms receive weekly, semi-automated motivational and educational SMS and visit reminders via an interactive, human-computer hybrid communication system. Participants in the two-way SMS arm are also asked to respond to a question related to the message. SMS are based in behavioral theory, are tailored to participant characteristics through SMS tracks, and are timed along the pregnancy/postpartum continuum. After enrollment, follow-up visits are scheduled at 6weeks; 6, 12, 18, and 24months postpartum. The primary outcomes, virological failure (HIV viral load ≥1000copies/mL), maternal retention in care, and infant HIV infection or death, will be compared in an intent to treat analysis. We will also measure ART adherence and drug resistance. Personalized and tailored SMS to support HIV-infected women during and after pregnancy may be an effective strategy to motivate women to adhere to ART and remain in care and improve maternal and infant outcomes. Copyright © 2017 Elsevier Inc. All rights reserved.

  12. STAAR: a randomised controlled trial of electronic adherence monitoring with reminder alarms and feedback to improve clinical outcomes for children with asthma.

    Science.gov (United States)

    Morton, Robert W; Elphick, Heather E; Rigby, Alan S; Daw, William J; King, David A; Smith, Laurie J; Everard, Mark L

    2017-04-01

    Suboptimal adherence to inhaled steroids is common in children with asthma and is associated with poor disease control, reduced quality of life and even death. Previous studies using feedback of electronically monitored adherence data have demonstrated improved adherence, but have not demonstrated a significant impact on clinical outcomes. The aim of this study was to determine whether introduction of this approach into routine practice would result in improved clinical outcomes. Children with asthma aged 6-16 years were randomised to the active intervention consisting of electronic adherence monitoring with daily reminder alarms together with feedback in the clinic regarding their inhaled corticosteroid (ICS) use or to the usual care arm with adherence monitoring alone. All children had poorly controlled asthma at baseline, taking ICS and long-acting β-agonists. Subjects were seen in routine clinics every 3 months for 1 year. The primary outcome was the Asthma Control Questionnaire (ACQ) score. Secondary outcomes included adherence and markers of asthma morbidity. 77 of 90 children completed the study (39 interventions, 38 controls). Adherence in the intervention group was 70% vs 49% in the control group (p≤0.001). There was no significant difference in the change in ACQ, but children in the intervention group required significantly fewer courses of oral steroids (p=0.008) and fewer hospital admissions (p≤0.001). The results indicate that electronic adherence monitoring with feedback is likely to be of significant benefit in the routine management of poorly controlled asthmatic subjects. NCT02451709; pre-result. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/.

  13. Adherence to AHA Guidelines When Adapted for Augmented Reality Glasses for Assisted Pediatric Cardiopulmonary Resuscitation: A Randomized Controlled Trial.

    Science.gov (United States)

    Siebert, Johan N; Ehrler, Frederic; Gervaix, Alain; Haddad, Kevin; Lacroix, Laurence; Schrurs, Philippe; Sahin, Ayhan; Lovis, Christian; Manzano, Sergio

    2017-05-29

    The American Heart Association (AHA) guidelines for cardiopulmonary resuscitation (CPR) are nowadays recognized as the world's most authoritative resuscitation guidelines. Adherence to these guidelines optimizes the management of critically ill patients and increases their chances of survival after cardiac arrest. Despite their availability, suboptimal quality of CPR is still common. Currently, the median hospital survival rate after pediatric in-hospital cardiac arrest is 36%, whereas it falls below 10% for out-of-hospital cardiac arrest. Among emerging information technologies and devices able to support caregivers during resuscitation and increase adherence to AHA guidelines, augmented reality (AR) glasses have not yet been assessed. In order to assess their potential, we adapted AHA Pediatric Advanced Life Support (PALS) guidelines for AR glasses. The study aimed to determine whether adapting AHA guidelines for AR glasses increased adherence by reducing deviation and time to initiation of critical life-saving maneuvers during pediatric CPR when compared with the use of PALS pocket reference cards. We conducted a randomized controlled trial with two parallel groups of voluntary pediatric residents, comparing AR glasses to PALS pocket reference cards during a simulation-based pediatric cardiac arrest scenario-pulseless ventricular tachycardia (pVT). The primary outcome was the elapsed time in seconds in each allocation group, from onset of pVT to the first defibrillation attempt. Secondary outcomes were time elapsed to (1) initiation of chest compression, (2) subsequent defibrillation attempts, and (3) administration of drugs, as well as the time intervals between defibrillation attempts and drug doses, shock doses, and number of shocks. All these outcomes were assessed for deviation from AHA guidelines. Twenty residents were randomized into 2 groups. Time to first defibrillation attempt (mean: 146 s) and adherence to AHA guidelines in terms of time to other

  14. Health behaviour models: a framework for studying adherence in children with atopic dermatitis.

    Science.gov (United States)

    Chisolm, S S; Taylor, S L; Gryzwacz, J G; O'Neill, J L; Balkrishnan, R R; Feldman, S R

    2010-04-01

    Atopic dermatitis (AD) is a common problem of childhood causing considerable distress. Effective topical treatments exist, yet poor adherence often results in poor outcomes. A framework is needed to better understand adherence behaviour. To provide a basis for this framework, we reviewed established models used to describe health behaviour. Structural elements of these models informed the development of an adherence model for AD that can be used to complement empirical AD treatment trials. Health behaviour models provide a means to describe factors that affect adherence and that can mediate the effects of different adherence interventions. Models of adherence behaviour are important for promoting better treatment outcomes for children with AD and their families. These models provide a means to identify new targets to improve adherence and a guide for refining adherence interventions.

  15. Cervical cancer screening and adherence to follow-up among Hispanic women study protocol: a randomized controlled trial to increase the uptake of cervical cancer screening in Hispanic women

    Directory of Open Access Journals (Sweden)

    Duggan Catherine

    2012-05-01

    Full Text Available Abstract Background In the US, Hispanic women have a higher incidence of, and mortality from, cervical cancer than non-Hispanic white women. The reason for this disparity may be attributable to both low rates of screening and poor adherence to recommended diagnostic follow-up after an abnormal Pap test. The 'Cervical Cancer Screening and Adherence to Follow-up Among Hispanic Women' study is a collaboration between a research institution and community partners made up of members from community based organizations, the Yakima Valley Farm Workers Clinic and the Breast, Cervical, and Colon Health Program of the Yakima District . The study will assess the efficacy of two culturally-appropriate, tailored educational programs designed to increase cervical cancer screening among Hispanic women, based in the Yakima Valley, Washington, US. Methods/design A parallel randomized-controlled trial of 600 Hispanic women aged 21–64, who are non-compliant with Papanicolau (Pap test screening guidelines. Participants will be randomized using block randomization to (1 a control arm (usual care; (2 a low-intensity information program, consisting of a Spanish-language video that educates women on the importance of cervical cancer screening; or (3 a high-intensity program consisting of the video plus a ‘promotora’ or lay-community health educator-led, home based intervention to encourage cervical cancer screening. Participants who attend cervical cancer screening, and receive a diagnosis of an abnormal Pap test will be assigned to a patient navigator who will provide support and information to promote adherence to follow-up tests, and any necessary surgery or treatment. Primary endpoint: Participants will be tracked via medical record review at community-based clinics, to identify women who have had a Pap test within 7 months of baseline assessment. Medical record reviewers will be blinded to randomization arm. Secondary endpoint: An evaluation of the patient

  16. Women with pregnancies had lower adherence to 1% tenofovir vaginal gel as HIV preexposure prophylaxis in CAPRISA 004, a phase IIB randomized-controlled trial.

    Science.gov (United States)

    Matthews, Lynn T; Sibeko, Sengeziwe; Mansoor, Leila E; Yende-Zuma, Nonhlanhla; Bangsberg, David R; Karim, Quarraisha Abdool

    2013-01-01

    Antiretroviral prophylaxis may be a critical strategy to reduce periconception HIV transmission. Maximizing the benefit of periconception pharmacologic HIV risk-reduction requires an understanding of the links between pregnancy and adherence to this prevention strategy. We assessed study gel adherence among women with pregnancies compared to women without pregnancies enrolled in the CAPRISA 004 phase IIB trial of 1% vaginal tenofovir gel. Pregnancy was assessed with monthly urine tests. Adherence was measured monthly and defined as proportion of sex acts covered by two returned, used applicators based on pre- and post-coital dosing. High adherence was defined as a median adherence score of >80%, that is, more than 80% of sex acts were covered by two applications of study gel. A multivariate generalized estimating equations (GEE) model with a binomial distribution was used to assess covariates associated with high adherence (>80%) over time. Median adherence before and after pregnancy was compared using Wilcoxon signed rank test. Among 868 women, 53 had at least 1 pregnancy (4.06 per 100 woman years, 95% CI: 3.04, 5.31). Women with pregnancies had lower median adherence compared to women without pregnancies (50% [IQR: 45-83] vs. 60% [IQR: 50-100], p = 0.02). Women with pregnancies also had a 48% lower odds of high adherence compared to women without pregnancies when adjusting for confounders (aOR 0.52, 95%CI: 0.41-0.66, p<0.0001). Among women with pregnancies, adherence before and after pregnancy was not different (50% [IQR: 46-83] vs. 55% [IQR: 20-100], p = 0.68). Women with pregnancies were less likely to have high adherence to study gel compared to women without pregnancies. Understanding these differences may inform findings from HIV prevention trials and future implementation of antiretroviral prophylaxis for at-risk women who choose to conceive. The protocol for the parent trial is registered on ClinicalTrials.gov, NCT00441298, http

  17. Women with pregnancies had lower adherence to 1% tenofovir vaginal gel as HIV preexposure prophylaxis in CAPRISA 004, a phase IIB randomized-controlled trial.

    Directory of Open Access Journals (Sweden)

    Lynn T Matthews

    Full Text Available BACKGROUND: Antiretroviral prophylaxis may be a critical strategy to reduce periconception HIV transmission. Maximizing the benefit of periconception pharmacologic HIV risk-reduction requires an understanding of the links between pregnancy and adherence to this prevention strategy. METHODS: We assessed study gel adherence among women with pregnancies compared to women without pregnancies enrolled in the CAPRISA 004 phase IIB trial of 1% vaginal tenofovir gel. Pregnancy was assessed with monthly urine tests. Adherence was measured monthly and defined as proportion of sex acts covered by two returned, used applicators based on pre- and post-coital dosing. High adherence was defined as a median adherence score of >80%, that is, more than 80% of sex acts were covered by two applications of study gel. A multivariate generalized estimating equations (GEE model with a binomial distribution was used to assess covariates associated with high adherence (>80% over time. Median adherence before and after pregnancy was compared using Wilcoxon signed rank test. RESULTS: Among 868 women, 53 had at least 1 pregnancy (4.06 per 100 woman years, 95% CI: 3.04, 5.31. Women with pregnancies had lower median adherence compared to women without pregnancies (50% [IQR: 45-83] vs. 60% [IQR: 50-100], p = 0.02. Women with pregnancies also had a 48% lower odds of high adherence compared to women without pregnancies when adjusting for confounders (aOR 0.52, 95%CI: 0.41-0.66, p<0.0001. Among women with pregnancies, adherence before and after pregnancy was not different (50% [IQR: 46-83] vs. 55% [IQR: 20-100], p = 0.68. CONCLUSIONS: Women with pregnancies were less likely to have high adherence to study gel compared to women without pregnancies. Understanding these differences may inform findings from HIV prevention trials and future implementation of antiretroviral prophylaxis for at-risk women who choose to conceive. The protocol for the parent trial is registered on ClinicalTrials

  18. Screening and brief intervention targeting risky drinkers in Danish general practice - a pragmatic controlled trial

    DEFF Research Database (Denmark)

    Beich, A.; Gannik, D.; Saelan, H.;

    2007-01-01

    AIMS: Recommendations for routine alcohol screening and brief counselling intervention in primary health care rest on results from intervention efficacy studies. By conducting a pragmatic controlled trial (PCT), we aimed at evaluating the effectiveness of the WHO recommendations for screening...

  19. Evaluation of occupational health interventions using a randomized controlled trial: challenges and alternative research designs

    NARCIS (Netherlands)

    Schelvis, R.M; Oude Hengel, K.M.; Burdorf, A.; Blatter, B.M.; Strijk, J.E.; Beek, A.J. van

    2015-01-01

    Occupational health researchers regularly conduct evaluative intervention research for which a randomized controlled trial (RCT) may not be the most appropriate design (eg, effects of policy measures, organizational interventions on work schedules). This article demonstrates the appropriateness of a

  20. Alzheimer’s disease multiple intervention trial (ADMIT: study protocol for a randomized controlled clinical trial

    Directory of Open Access Journals (Sweden)

    Callahan Christopher M

    2012-06-01

    Full Text Available Abstract Background Given the current lack of disease-modifying therapies, it is important to explore new models of longitudinal care for older adults with dementia that focus on improving quality of life and delaying functional decline. In a previous clinical trial, we demonstrated that collaborative care for Alzheimer’s disease reduces patients’ neuropsychiatric symptoms as well as caregiver stress. However, these improvements in quality of life were not associated with delays in subjects’ functional decline. Trial design Parallel randomized controlled clinical trial with 1:1 allocation. Participants A total of 180 community-dwelling patients aged ≥45 years who are diagnosed with possible or probable Alzheimer’s disease; subjects must also have a caregiver willing to participate in the study and be willing to accept home visits. Subjects and their caregivers are enrolled from the primary care and geriatric medicine practices of an urban public health system serving Indianapolis, Indiana, USA. Interventions All patients receive best practices primary care including collaborative care by a dementia care manager over two years; this best practices primary care program represents the local adaptation and implementation of our prior collaborative care intervention in the urban public health system. Intervention patients also receive in-home occupational therapy delivered in twenty-four sessions over two years in addition to best practices primary care. The focus of the occupational therapy intervention is delaying functional decline and helping both subjects and caregivers adapt to functional impairments. The in-home sessions are tailored to the specific needs and goals of each patient-caregiver dyad; these needs are expected to change over the course of the study. Objective To determine whether best practices primary care plus home-based occupational therapy delays functional decline among patients with Alzheimer’s disease compared

  1. Improvement in medication adherence and self-management of diabetes with a clinical pharmacy program: a randomized controlled trial in patients with type 2 diabetes undergoing insulin therapy at a teaching hospital

    Directory of Open Access Journals (Sweden)

    Catarina Gomes Cani

    2015-02-01

    Full Text Available OBJECTIVE: To evaluate the impact of a clinical pharmacy program on health outcomes in patients with type 2 diabetes undergoing insulin therapy at a teaching hospital in Brazil. METHOD: A randomized controlled trial with a 6-month follow-up period was performed in 70 adults, aged 45 years or older, with type 2 diabetes who were taking insulin and who had an HbA1c level ≥8%. Patients in the control group (CG (n = 36 received standard care, patients in the intervention group (IG (n = 34 received an individualized pharmacotherapeutic care plan and diabetes education. The primary outcome measure was change in HbA1c. Secondary outcomes included diabetes and medication knowledge, adherence to medication, insulin injection and home blood glucose monitoring techniques and diabetes-related quality of life. Outcomes were evaluated at baseline and 6 months using questionnaires. RESULTS: Diabetes knowledge, medication knowledge, adherence to medication and correct insulin injection and home blood glucose monitoring techniques significantly improved in the intervention group but remained unchanged in the control group. At the end of the study, mean HbA1c values in the control group remained unchanged but were significantly reduced in the intervention group. Diabetes-related quality of life significantly improved in the intervention group but worsened significantly in the control group. CONCLUSION: The program improved health outcomes and resulted in better glycemic control in patients with type 2 diabetes undergoing insulin therapy.

  2. Women, Hypertension, and the Systolic Blood Pressure Intervention Trial.

    Science.gov (United States)

    Wenger, Nanette K; Ferdinand, Keith C; Bairey Merz, C Noel; Walsh, Mary Norine; Gulati, Martha; Pepine, Carl J

    2016-10-01

    Hypertension accounts for approximately 1 in 5 deaths in American women and is the major contributor to many comorbid conditions. Although blood pressure lowering reduces cardiovascular disease outcomes, considerable uncertainty remains on best management in women. Specifically, female blood pressure treatment goals have not been established, particularly among older and African American and Hispanic women, for whom hypertension prevalence, related adverse outcomes, and poor control rates are high. The Systolic Blood Pressure Intervention Trial (SPRINT) planned to clarify optimal blood pressure management in both sexes. Although confirming that a lower blood pressure goal is generally better, because female enrollment and event rates were low and follow-up shortened, outcomes differences in women were not statistically significant. Thus optimal blood pressure goals for women have not been established with the highest evidence. This review addresses SPRINT's significance and key remaining knowledge gaps in optimal blood pressure management to improve women's health.

  3. Community-Based Interventions to Improve and Sustain Antiretroviral Therapy Adherence, Retention in HIV Care and Clinical Outcomes in Low- and Middle-Income Countries for Achieving the UNAIDS 90-90-90 Targets

    Science.gov (United States)

    Adetokunboh, Olatunji; Uthman, Olalekan A.; Knowlton, Amy W.; Altice, Frederick L.; Schechter, Mauro; Galárraga, Omar; Geng, Elvin; Peltzer, Karl; Chang, Larry W.; Van Cutsem, Gilles; Jaffar, Shabbar S.; Ford, Nathan; Mellins, Claude A.; Remien, Robert H.; Mills, Edward J.

    2017-01-01

    Little is known about the effect of community versus health facility-based interventions to improve and sustain antiretroviral therapy (ART) adherence, virologic suppression, and retention in care among HIV-infected individuals in low-and middle-income countries (LMICs). We systematically searched four electronic databases for all available randomized controlled trials (RCTs) and comparative cohort studies in LMICs comparing community versus health facility-based interventions. Relative risks (RRs) for pre-defined adherence, treatment engagement (linkage and retention in care), and relevant clinical outcomes were pooled using random effect models. Eleven cohort studies and eleven RCTs (N = 97,657) were included. Meta-analysis of the included RCTs comparing community- versus health facility-based interventions found comparable outcomes in terms of ART adherence (RR = 1.02, 95 % CI 0.99 to 1.04), virologic suppression (RR = 1.00, 95 % CI 0.98 to 1.03), and all-cause mortality (RR = 0.93, 95 % CI 0.73 to 1.18). The result of pooled analysis from the RCTs (RR = 1.03, 95 % CI 1.01 to 1.06) and cohort studies (RR = 1.09, 95 % CI 1.03 to 1.15) found that participants assigned to community-based interventions had statistically significantly higher rates of treatment engagement. Two studies found community-based ART delivery model either cost-saving or cost-effective. Community- versus facility-based models of ART delivery resulted in at least comparable outcomes for clinically stable HIV-infected patients on treatment in LMICs and are likely to be cost-effective. PMID:27475643

  4. Adherence to the Obesity-related Lifestyle Intervention Targets in the IDEFICS Study

    DEFF Research Database (Denmark)

    Kovács, Eva; Siani, Alfonso; Konstabel, Kenn

    2014-01-01

    .1%. The recommended amount of at least 60 min of moderate-to-vigorous physical activity per day was fulfilled by 15.2%. Family life of the child measured by various indicators was considered as satisfactory in 22.8%. Nocturnal sleep duration of 11 (10) hours or more in pre-school (school) children was achieved by 37......-containing beverages), increase fruit/vegetable consumption, reduce daily screen time, increase daily physical activity, improve the quality of family life and ensure adequate sleep duration. Internationally recommended target values were applied to determine the prevalence of children meeting these targets. Results.......5% of the cohort was classified in the highest category of water consumption, only 8.8% met the target of an intake of fruits/vegetables five times a day. The prevalence of children adhering to the recommendation regarding total screen time—below 1 h for pre-school children and 2 h for school children—was 51...

  5. Efficacy trial of an Internet-based intervention for cancer-related female sexual dysfunction.

    Science.gov (United States)

    Schover, Leslie R; Yuan, Ying; Fellman, Bryan M; Odensky, Evan; Lewis, Pamela E; Martinetti, Paul

    2013-11-01

    The recent NCCN Guidelines for Survivorship recommend systematic evaluation and multidisciplinary treatment of cancer-related sexual dysfunctions. However, most oncology professionals fail to routinely assess sexual problems and lack expertise to treat them. An Internet-based intervention was designed to educate female patients and their partners about cancer-related sexual problems, describe medical treatment options and how to find expert care, and provide self-help strategies. A randomized trial assessed efficacy of the intervention when used as self-help versus the same Web access and 3 supplemental counseling sessions. Survivors of localized breast or gynecologic cancers completed online questionnaires at baseline, posttreatment, and 3- and 6-month follow-up, including the Female Sexual Function Index (FSFI), the Menopausal Sexual Interest Questionnaire (MSIQ), the Brief Symptom Inventory-18 (BSI-18) to assess emotional distress, and the Quality of Life in Adult Cancer Survivors (QLACS) scale. Program evaluation ratings were completed posttreatment. Fifty-eight women completed baseline questionnaires (mean age, 53 ± 9 years). Drop-out rates were 22% during treatment and 34% at 6-month follow-up. Linear mixed models for each outcome across time showed improvement in total scores on the FSFI, MSIQ, and QLACS (P<.001) and BSI-18 (P=.001). The counseled group improved significantly more on sexuality measures, but changes in emotional distress and quality of life did not differ between groups. Program content and ease of use were rated positively. Research is needed on how best to integrate this intervention into routine clinical practice, and particularly how to improve uptake and adherence.

  6. The Effect of Two Educational Methods on Knowledge and Adherence to Treatment in Hemodialysis Patients: Clinical Trial

    Directory of Open Access Journals (Sweden)

    Kobra Parvan

    2015-03-01

    Full Text Available Introduction: Patients with chronic renal disease (CRD deal with many potential problems with hemodialysis for all their life. Regarding the importance of preventing dialysis adverse effects, which are in close connection with lack of knowledge and report on how to train the patients? This study aims at comparing the impact of two methods of face to face training and training pamphlet on complying and informing of hemodialysis treatments. Methods: This clinical trial study was conducted on 58 hemodialysis patients who visited Shahid Rahnemun Teaching hospital, Yazd, Iran, and had required conditions of the research. Data were collected through a questionnaire including personal-social information, several questions to assess the level of compliance and to inform the treatment method. The quantitative analysis of this study used the Statistical Package for Social Sciences SPSS version 13 and descriptive (frequency, mean, standard deviation and inferential (Chi-square, paired t-test, ANOVA, ANCOVA statistics were employed. Results: The mean scores for informing both groups (face to face and training pamphlet were significantly increased. The mean score for adherence to treatments was also significant.Conclusion: In this research, face to face training was found to be more effective than training pamphlet. It seemed to have more strong effect on increasing the level of information and adherence to treatment. To train these people, face to face training should be, thus, preferred.

  7. Improving medication adherence in patients with hypertension

    DEFF Research Database (Denmark)

    Hedegaard, Ulla; Kjeldsen, Lene Juel; Pottegård, Anton

    2015-01-01

    BACKGROUND: and Purpose: In patients with hypertension, medication adherence is often suboptimal, thereby increasing the risk of ischemic heart disease and stroke. In a randomized trial, we investigated the effectiveness of a multifaceted pharmacist intervention in a hospital setting to improve...... medication adherence in hypertensive patients. Motivational interviewing was a key element of the intervention. METHODS: Patients (N=532) were recruited from 3 hospital outpatient clinics and randomized to usual care or a 6-month pharmacist intervention comprising collaborative care, medication review......, tailored adherence counselling including motivational interviewing and telephone follow-ups. The primary outcome was composite medication possession ratio (MPR) to antihypertensive and lipid-lowering agents, at one-year follow-up, assessed by analyzing pharmacy records. Secondary outcomes at 12 months...

  8. Facility-level intervention to improve attendance and adherence among patients on anti-retroviral treatment in Kenya--a quasi-experimental study using time series analysis.

    Science.gov (United States)

    Boruett, Patrick; Kagai, Dorine; Njogo, Susan; Nguhiu, Peter; Awuor, Christine; Gitau, Lillian; Chalker, John; Ross-Degnan, Dennis; Wahlström, Rolf; Tomson, Göran

    2013-07-01

    Achieving high rates of adherence to antiretroviral therapy (ART) in resource-poor settings comprises serious, but different, challenges in both the first months of treatment and during the life-long maintenance phase. We measured the impact of a health system-oriented, facility-based intervention to improve clinic attendance and patient adherence. This was a quasi-experimental, longitudinal, controlled intervention study using interrupted time series analysis. The intervention consisted of (1) using a clinic appointment diary to track patient attendance and monitor monthly performance; (2) changing the mode of asking for self-reported adherence; (3) training staff on adherence concepts, intervention methods, and use of monitoring data; (4) conducting visits to support facility teams with the implementation.We conducted the study in 12 rural district hospitals (6 intervention, 6 control) in Kenya and randomly selected 1894 adult patients over 18 years of age in two cohorts: experienced patients on treatment for at least one year, and newly treated patients initiating ART during the study. Outcome measures were: attending the clinic on or before the date of a scheduled appointment, attending within 3 days of a scheduled appointment, reporting perfect adherence, and experiencing a gap in medication supply of more than 14 days. Among experienced patients, the percentage attending the clinic on or before a scheduled appointment increased in both level (average total increase immediately after intervention) (+5.7%; 95% CI=2.1, 9.3) and trend (increase per month) (+1.0% per month; 95% CI=0.6, 1.5) following the intervention, as did the level and trend of those keeping appointments within three days (+4.2%; 95% CI=1.6, 6.7; and +0.8% per month; 95% CI=0.6, 1.1, respectively). The relative difference between the intervention and control groups based on the monthly difference in visit rates increased significantly in both level (+6.5; 95% CI=1.4, 11.6) and trend (1.0% per

  9. Treatment Adherence and Its Impact on Disease-Free Survival in the Breast International Group 1-98 Trial of Tamoxifen and Letrozole, Alone and in Sequence

    Science.gov (United States)

    Giobbie-Hurder, Anita; Coates, Alan S.; Price, Karen N.; Ejlertsen, Bent; Debled, Marc; Gelber, Richard D.; Goldhirsch, Aron; Smith, Ian; Rabaglio, Manuela; Forbes, John F.; Neven, Patrick; Láng, István; Colleoni, Marco; Thürlimann, Beat

    2016-01-01

    Purpose To investigate adherence to endocrine treatment and its relationship with disease-free survival (DFS) in the Breast International Group (BIG) 1-98 clinical trial. Methods The BIG 1-98 trial is a double-blind trial that randomly assigned 6,193 postmenopausal women with hormone receptor–positive early breast cancer in the four-arm option to 5 years of tamoxifen (Tam), letrozole (Let), or the agents in sequence (Let-Tam, Tam-Let). This analysis included 6,144 women who received at least one dose of study treatment. Conditional landmark analyses and marginal structural Cox proportional hazards models were used to evaluate the relationship between DFS and treatment adherence (persistence [duration] and compliance with dosage). Competing risks regression was used to assess demographic, disease, and treatment characteristics of the women who stopped treatment early because of adverse events. Results Both aspects of low adherence (early cessation of letrozole and a compliance score of adherence was associated with older age, smoking, node negativity, or prior thromboembolic event. Conclusion Both persistence and compliance are associated with DFS. Toxicity management and, for sequential treatments, patient and physician awareness, may improve adherence. PMID:27217455

  10. Reporting quality of social and psychological intervention trials: a systematic review of reporting guidelines and trial publications.

    Directory of Open Access Journals (Sweden)

    Sean P Grant

    Full Text Available BACKGROUND: Previous reviews show that reporting guidelines have improved the quality of trial reports in medicine, yet existing guidelines may not be fully suited for social and psychological intervention trials. OBJECTIVE/DESIGN: We conducted a two-part study that reviewed (1 reporting guidelines for and (2 the reporting quality of social and psychological intervention trials. DATA SOURCES: (1 To identify reporting guidelines, we systematically searched multiple electronic databases and reporting guideline registries. (2 To identify trials, we hand-searched 40 journals with the 10 highest impact factors in clinical psychology, criminology, education, and social work. ELIGIBILITY: (1 Reporting guidelines consisted of articles introducing a checklist of reporting standards relevant to social and psychological intervention trials. (2 Trials reported randomised experiments of complex interventions with psychological, social, or health outcomes. RESULTS: (1 We identified 19 reporting guidelines that yielded 147 reporting standards relevant to social and psychological interventions. Social and behavioural science guidelines included 89 standards not found in CONSORT guidelines. However, CONSORT guidelines used more recommended techniques for development and dissemination compared to other guidelines. (2 Our review of trials (n = 239 revealed that many standards were poorly reported, such as identification as a randomised trial in titles (20% reported the information and abstracts (55%; information about blinding (15%, sequence generation (23%, and allocation concealment (17%; and details about actual delivery of experimental (43% and control interventions (34%, participant uptake (25%, and service environment (28%. Only 11 of 40 journals referenced reporting guidelines in "Instructions to Authors." CONCLUSION: Existing reporting guidelines have important limitations in content, development, and/or dissemination. Important details are routinely

  11. Motivation and Its Relationship to Adherence to Self-Monitoring and Weight Loss in a 16-Week Internet Behavioral Weight Loss Intervention

    Science.gov (United States)

    Webber, Kelly H.; Tate, Deborah F.; Ward, Dianne S.; Bowling, J. Michael

    2010-01-01

    Objective: To examine changes in motivation and the relationship of motivation to adherence to self-monitoring and weight loss in a 16-week Internet behavioral weight-loss intervention. Design: Two-group randomized design. Setting: This study was conducted over the Internet. Participants: Sixty-six women, ages 22-65, with a body mass index (BMI)…

  12. Motivation and Its Relationship to Adherence to Self-Monitoring and Weight Loss in a 16-Week Internet Behavioral Weight Loss Intervention

    Science.gov (United States)

    Webber, Kelly H.; Tate, Deborah F.; Ward, Dianne S.; Bowling, J. Michael

    2010-01-01

    Objective: To examine changes in motivation and the relationship of motivation to adherence to self-monitoring and weight loss in a 16-week Internet behavioral weight-loss intervention. Design: Two-group randomized design. Setting: This study was conducted over the Internet. Participants: Sixty-six women, ages 22-65, with a body mass index (BMI)…

  13. Adherence to the Mediterranean diet among employees in South West England: Formative research to inform a web-based, work-place nutrition intervention

    Directory of Open Access Journals (Sweden)

    Angeliki Papadaki

    2015-01-01

    Conclusion: Improvement in the consumption of several Mediterranean diet components is needed to increase adherence in this sample of adults. The findings have the potential to inform the development of a web-based intervention that will focus on these foods to promote the Mediterranean diet in work-place settings in South West England.

  14. A Multimodal Behavioral Intervention to Impact Adherence and Risk Behavior among Perinatally and Behaviorally HIV-Infected Youth: Description, Delivery, and Receptivity of Adolescent Impact

    Science.gov (United States)

    Chandwani, Sulachni; Abramowitz, Susan; Koenig, Linda J.; Barnes, William; D'Angelo, Lawrence

    2011-01-01

    Secondary prevention programs are needed to help HIV-positive youth reduce risk behavior and improve adherence to HIV medications. This article provides an overview of Adolescent Impact, a secondary HIV prevention intervention, including its description, delivery, and receptivity among the two unique groups of participants. Adolescent Impact, a…

  15. TextTB: A Mixed Method Pilot Study Evaluating Acceptance, Feasibility, and Exploring Initial Efficacy of a Text Messaging Intervention to Support TB Treatment Adherence

    Directory of Open Access Journals (Sweden)

    Sarah Iribarren

    2013-01-01

    Full Text Available Objective. To assess a text messaging intervention to promote tuberculosis (TB treatment adherence. Methods. A mixed-methods pilot study was conducted within a public pulmonary-specialized hospital in Argentina. Patients newly diagnosed with TB who were 18 or older, and had mobile phone access were recruited and randomized to usual care plus either medication calendar (n=19 or text messaging intervention (n=18 for the first two months of treatment. Primary outcomes were feasibility and acceptability; secondary outcomes explored initial efficacy. Results. Feasibility was evidenced by high access to mobile phones, familiarity with texting, most phones limited to basic features, a low rate of participant refusal, and many describing suboptimal TB understanding. Acceptability was evidenced by participants indicating feeling cared for, supported, responsible for their treatment, and many self-reporting adherence without a reminder. Participants in the texting group self-reported adherence on average 77% of the days whereas only 53% in calendar group returned diaries. Exploring initial efficacy, microscopy testing was low and treatment outcomes were similar in both groups. Conclusion. The texting intervention was well accepted and feasible with greater reporting of adherence using text messaging than the diary. Further evaluation of the texting intervention is warranted.

  16. Participant Adherence Indicators Predict Changes in Blood Pressure, Anthropometric Measures, and Self-Reported Physical Activity in a Lifestyle Intervention: HUB City Steps

    Science.gov (United States)

    Thomson, Jessica L.; Landry, Alicia S.; Zoellner, Jamie M.; Connell, Carol; Madson, Michael B.; Molaison, Elaine Fontenot; Yadrick, Kathy

    2015-01-01

    The objective of this secondary analysis was to evaluate the utility of several participant adherence indicators for predicting changes in clinical, anthropometric, dietary, fitness, and physical activity (PA) outcomes in a lifestyle intervention, HUB City Steps, conducted in a southern, African American cohort in 2010. HUB City Steps was a…

  17. A Non-Inferiority Trial of an Evidence-Based Secondary HIV Prevention Behavioral Intervention Compared to an Adapted, Abbreviated Version: Rationale and Intervention Description

    Science.gov (United States)

    Shrestha, Roman; Krishnan, Archana; Altice, Frederick L.; Copenhaver, Michael

    2015-01-01

    Background Real-world clinical settings like addiction treatment programs are ill-equipped to deploy and sustain the existing-resource-demanding evidence-based interventions (EBIs) that target HIV-infected people who use drugs (PWUDs), and this has left a critical void in current HIV prevention efforts. In response to this unmet need, we have conducted formative research in addiction treatment settings that has resulted in Holistic Health for HIV (3H+) – an empirically adapted, substantially abbreviated version of Holistic Health Recovery Program (HHRP+), a CDC-recommended EBI targeting HIV-infected PWUDs. Methods Using a non-inferiority randomized controlled trial design, we will determine whether the abbreviated 3H+ intervention is comparable (i.e., within a 10% margin) and cost-effective relative to the original HHRP+ intervention in terms of reducing HIV risk behaviors and improving antiretroviral therapy (ART) adherence among HIV-infected PWUDs in addiction treatment who report drug- or sex-related HIV risk behaviors. Conclusions This article provides a description of the development and adaptation of the 3H+ intervention, the innovative non-inferiority comparative experimental design for testing the 3H+ to the HHRP+. Furthermore, it provides empirical evidence from a formal cost-effectiveness analysis justifying the cost-effectiveness of the 3H+ intervention when compared to the HHRP+ intervention. If confirmed to be comparable and more cost-effective, as hypothesized, the 3H+ intervention has the potential to be readily and immediately integrated within common clinical settings where large numbers of HIV-infected PWUDs receive clinical services. PMID:26253181

  18. "Did the trial kill the intervention?" experiences from the development, implementation and evaluation of a complex intervention

    Directory of Open Access Journals (Sweden)

    Cox Karen

    2011-03-01

    Full Text Available Abstract Background The development, implementation and evaluation of any new health intervention is complex. This paper uses experiences from the design, implementation and evaluation of a rehabilitation programme to shed light on, and prompt discussion around, some of the complexities involved in such an undertaking. Methods Semi-structured interviews were conducted with 15 trial participants and five members of staff at the conclusion of a trial evaluating a rehabilitation programme aimed at promoting recovery after stem cell transplantation. Results This study identified a number of challenges relating to the development and evaluation of complex interventions. The difficulty of providing a standardised intervention that was acceptable to patients was highlighted in the participant interviews. Trial participants and some members of staff found the concept of equipoise and randomisation challenging and there was discord between the psychosocial nature of the intervention and the predominant bio-medical culture in which the research took place. Conclusions A lack of scientific evidence as to the efficacy of an intervention does not preclude staff and patients holding strong views about the benefits of an intervention. The evaluation of complex interventions should, where possible, facilitate not restrict that complexity. Within the local environment where the trial is conducted, acquiescence from those in positions of authority is insufficient; commitment to the trial is required.

  19. Applying Theory to Understand and Modify Nurse Intention to Adhere to Recommendations regarding the Use of Filter Needles: An Intervention Mapping Approach

    Directory of Open Access Journals (Sweden)

    Julianne Cassista

    2014-01-01

    Full Text Available The manipulation of glass ampoules involves risk of particle contamination of parenteral medication, and the use of filter needles has often been recommended in order to reduce the number of particles in these solutions. This study aims to develop a theory-based intervention to increase nurse intention to use filter needles according to clinical guideline recommendations produced by a large university medical centre in Quebec (Canada. Using the Intervention Mapping framework, we first identified the psychosocial determinants of nurse intention to use filter needles according to these recommendations. Second, we developed and implemented an intervention targeting nurses from five care units in order to increase their intention to adhere to recommendations on the use of filter needles. We also assessed nurse satisfaction with the intervention. In total, 270 nurses received the intervention and 169 completed the posttest questionnaire. The two determinants of intention, that is, attitude and perceived behavioral control, were significantly higher after the intervention, but only perceived behavioral control remained a predictor of intention. In general, nurses were highly satisfied with the intervention. This study provides support for the use of Intervention Mapping to develop, implement, and evaluate theory-based interventions in order to improve healthcare professional adherence to clinical recommendations.

  20. Effectiveness of a healthy lifestyle intervention for low back pain and osteoarthritis of the knee: protocol and statistical analysis plan for two randomised controlled trials

    Directory of Open Access Journals (Sweden)

    Kate M. O’Brien

    Full Text Available ABSTRACT Background These trials are the first randomised controlled trials of telephone-based weight management and healthy lifestyle interventions for low back pain and knee osteoarthritis. This article describes the protocol and statistical analysis plan. Method These trials are parallel randomised controlled trials that investigate and compare the effect of a telephone-based weight management and healthy lifestyle intervention for improving pain intensity in overweight or obese patients with low back pain or knee osteoarthritis. The analysis plan was finalised prior to initiation of analyses. All data collected as part of the trial were reviewed, without stratification by group, and classified by baseline characteristics, process of care and trial outcomes. Trial outcomes were classified as primary and secondary outcomes. Appropriate descriptive statistics and statistical testing of between-group differences, where relevant, have been planned and described. Conclusions A protocol for standard analyses was developed for the results of two randomised controlled trials. This protocol describes the data, and the pre-determined statistical tests of relevant outcome measures. The plan demonstrates transparent and verifiable use of the data collected. This a priori protocol will be followed to ensure rigorous standards of data analysis are strictly adhered to.

  1. Individualised motivational counselling to enhance adherence to antiretroviral therapy is not superior to didactic counselling in South African patients: findings of the CAPRISA 058 randomised controlled trial.

    Science.gov (United States)

    van Loggerenberg, Francois; Grant, Alison D; Naidoo, Kogieleum; Murrman, Marita; Gengiah, Santhanalakshmi; Gengiah, Tanuja N; Fielding, Katherine; Abdool Karim, Salim S

    2015-01-01

    Concerns that standard didactic adherence counselling may be inadequate to maximise antiretroviral therapy (ART) adherence led us to evaluate more intensive individualised motivational adherence counselling. We randomised 297 HIV-positive ART-naïve patients in Durban, South Africa, to receive either didactic counselling, prior to ART initiation (n = 150), or an intensive motivational adherence intervention after initiating ART (n = 147). Study arms were similar for age (mean 35.8 years), sex (43.1 % male), CD4+ cell count (median 121.5 cells/μl) and viral load (median 119,000 copies/ml). Virologic suppression at 9 months was achieved in 89.8 % of didactic and 87.9 % of motivational counselling participants (risk ratio [RR] 0.98, 95 % confidence interval [CI] 0.90-1.07, p = 0.62). 82.9 % of didactic and 79.5 % of motivational counselling participants achieved >95 % adherence by pill count at 6 months (RR 0.96, 95 % CI 0.85-1.09, p = 0.51). Participants receiving intensive motivational counselling did not achieve higher treatment adherence or virological suppression than those receiving routinely provided didactic adherence counselling. These data are reassuring that less resource intensive didactic counselling was adequate for excellent treatment outcomes in this setting.

  2. A Review of Recruitment, Adherence and Drop-Out Rates in Omega-3 Polyunsaturated Fatty Acid Supplementation Trials in Children and Adolescents

    NARCIS (Netherlands)

    Van der Wurff, Inge; Meyer, Barbara; De Groot, Renate

    2017-01-01

    Introduction: The influence of n-3 long-chain polyunsaturated fatty acids (n-3 LCPUFA) supplementation on health outcomes has been studied extensively with randomized controlled trials (RCT). In many research fields, difficulties with recruitment, adherence and high drop-out rates have been

  3. An Open Trial of an Acceptance-Based Behavioral Intervention for Weight Loss

    Science.gov (United States)

    Forman, Evan M.; Butryn, Meghan L.; Hoffman, Kimberly L.; Herbert, James D.

    2009-01-01

    Innovative approaches are urgently needed to improve behavioral treatment for weight loss. The weight regain that is so common after treatment may be a result of an environment that makes it challenging to adhere, long-term, to a dietary and physical activity regimen. This study was designed to test, via a 12-week open trial, the preliminary…

  4. An Open Trial of an Acceptance-Based Behavioral Intervention for Weight Loss

    Science.gov (United States)

    Forman, Evan M.; Butryn, Meghan L.; Hoffman, Kimberly L.; Herbert, James D.

    2009-01-01

    Innovative approaches are urgently needed to improve behavioral treatment for weight loss. The weight regain that is so common after treatment may be a result of an environment that makes it challenging to adhere, long-term, to a dietary and physical activity regimen. This study was designed to test, via a 12-week open trial, the preliminary…

  5. Evaluation of lifestyle interventions to treat elevated cardiometabolic risk in primary care (E-LITE: a randomized controlled trial

    Directory of Open Access Journals (Sweden)

    Wilson Sandra R

    2009-11-01

    Full Text Available Abstract Background Efficacy research has shown that intensive individual lifestyle intervention lowers the risk for developing type 2 diabetes mellitus and the metabolic syndrome. Translational research is needed to test real-world models of lifestyle interventions in primary care settings. Design E-LITE is a three-arm randomized controlled clinical trial aimed at testing the feasibility and potential effectiveness of two lifestyle interventions: information technology-assisted self-management, either alone or in combination with care management by a dietitian and exercise counselor, in comparison to usual care. Overweight or obese adults with pre-diabetes and/or metabolic syndrome (n = 240 recruited from a community-based primary care clinic are randomly assigned to one of three treatment conditions. Treatment will last 15 months and involves a three-month intensive treatment phase followed by a 12-month maintenance phase. Follow-up assessment occurs at three, six, and 15 months. The primary outcome is change in body mass index. The target sample size will provide 80% power for detecting a net difference of half a standard deviation in body mass index at 15 months between either of the self-management or care management interventions and usual care at a two-sided α level of 0.05, assuming up to a 20% rate of loss to 15-month follow-up. Secondary outcomes include glycemic control, additional cardiovascular risk factors, and health-related quality of life. Potential mediators (e.g., treatment adherence, caloric intake, physical activity level and moderators (e.g., age, gender, race/ethnicity, baseline mental status of the intervention's effect on weight change also will be examined. Discussion This study will provide objective evidence on the extent of reductions in body mass index and related cardiometabolic risk factors from two lifestyle intervention programs of varying intensity that could be implemented as part of routine health care

  6. Use of participant focus groups to identify barriers and facilitators to worksite exercise therapy adherence in randomized controlled trials involving firefighters

    Directory of Open Access Journals (Sweden)

    Mayer JM

    2013-03-01

    Full Text Available John M Mayer,1 James L Nuzzo,1 Simon Dagenais2 1School of Physical Therapy and Rehabilitation Sciences, College of Medicine, University of South Florida, Tampa, FL, 2Palladian Health, West Seneca, NY, USA Background: Firefighters are at increased risk for back injuries, which may be mitigated through exercise therapy to increase trunk muscle endurance. However, long-term adherence to exercise therapy is generally poor, limiting its potential benefits. Focus groups can be used to identify key barriers and facilitators to exercise adherence among study participants. Objective: To explore barriers and facilitators to worksite exercise therapy adherence among firefighters to inform future randomized controlled trials (RCTs. Methods: Participants enrolled in a previous RCT requiring twice-weekly worksite exercise therapy for 24 weeks were asked to take part in moderated focus group discussions centered on eight open-ended questions related to exercise adherence. Responses were analyzed qualitatively using a social ecological framework to identify key intrapersonal, interpersonal, and institutional barriers and potential facilitators to exercise adherence. Results: A total of 27 participants were included in the four focus group discussions, representing 50% of those assigned to a worksite exercise therapy group in the previous RCT, in which only 67% of scheduled exercise therapy sessions were completed. Lack of self-motivation was cited as the key intrapersonal barrier to adherence, while lack of peer support was the key interpersonal barrier reported, and lack of time to exercise during work shifts was the key institutional barrier identified. Conclusion: Focus group discussions identified both key barriers and potential facilitators to increase worksite exercise therapy adherence among firefighters. Future studies should consider educating and reminding participants about the benefits of exercise, providing individual and group incentives based on

  7. An Adaptive Treatment to Improve Positive Airway Pressure (PAP) Adherence in Patients With Obstructive Sleep Apnea: A Proof of Concept Trial.

    Science.gov (United States)

    Cvengros, Jamie A; Rodríguez, Vivian M; Snyder, Sarah; Hood, Megan M; Crawford, Megan; Park, Margaret

    2017-01-01

    Despite the benefits of positive airway pressure (PAP) treatment, rates of adherence to treatment are suboptimal. This proof-of-concept study assessed the feasibility, acceptability, and clinical significance of an adaptive treatment strategy to improve adherence to PAP. All participants first completed a brief educational intervention. Those who did not show at least a 25% increase in PAP use were randomized to receive a second, more intensive intervention, either motivational enhancement treatment or self-management treatment. Results suggested adequate feasibility and acceptability. In addition, participants demonstrated significant increases in objective PAP use, improvements in sleep quality, and decreases in daytime sleepiness. This study represents a first step in the development and validation of an adaptive treatment strategy to improve PAP adherence.

  8. Interpreting null findings from trials of alcohol brief interventions

    Directory of Open Access Journals (Sweden)

    Nick eHeather

    2014-07-01

    Full Text Available The effectiveness of alcohol brief intervention (ABI has been established by a succession of meta-analyses but, because the effects of ABI are small, null findings from randomized controlled trials are often reported and can sometimes lead to skepticism regarding the benefits of ABI in routine practice. This article first explains why null findings are likely to occur under null hypothesis significance testing (NHST due to the phenomenon known as ‘the dance of the p-values’. A number of misconceptions about null findings are then described, using as an example the way in which the results of the primary care arm of a recent cluster randomized trial of ABI in England (the SIPS project have been misunderstood. These misinterpretations include the fallacy of ‘proving the null hypothesis’ that lack of a significant difference between the means of sample groups can be taken as evidence of no difference between their population means, and the possible effects of this and related misunderstandings of the SIPS findings are examined. The mistaken inference that reductions in alcohol consumption seen in control groups from baseline to follow-up are evidence of real effects of control group procedures is then discussed and other possible reasons for such reductions, including regression to the mean, research participation effects, historical trends, and assessment reactivity, are described. From the standpoint of scientific progress, the chief problem about null findings under the conventional NHST approach is that it is not possible to distinguish ‘evidence of absence’ from ‘absence of evidence’. By contrast, under a Bayesian approach, such a distinction is possible and it is explained how this approach could classify ABIs in particular settings or among particular populations as either truly ineffective or as of unknown effectiveness, thus accelerating progress in the field of ABI research.

  9. Interpreting null findings from trials of alcohol brief interventions.

    Science.gov (United States)

    Heather, Nick

    2014-01-01

    The effectiveness of alcohol brief intervention (ABI) has been established by a succession of meta-analyses but, because the effects of ABI are small, null findings from randomized controlled trials are often reported and can sometimes lead to skepticism regarding the benefits of ABI in routine practice. This article first explains why null findings are likely to occur under null hypothesis significance testing (NHST) due to the phenomenon known as "the dance of the p-values." A number of misconceptions about null findings are then described, using as an example the way in which the results of the primary care arm of a recent cluster-randomized trial of ABI in England (the SIPS project) have been misunderstood. These misinterpretations include the fallacy of "proving the null hypothesis" that lack of a significant difference between the means of sample groups can be taken as evidence of no difference between their population means, and the possible effects of this and related misunderstandings of the SIPS findings are examined. The mistaken inference that reductions in alcohol consumption seen in control groups from baseline to follow-up are evidence of real effects of control group procedures is then discussed and other possible reasons for such reductions, including regression to the mean, research participation effects, historical trends, and assessment reactivity, are described. From the standpoint of scientific progress, the chief problem about null findings under the conventional NHST approach is that it is not possible to distinguish "evidence of absence" from "absence of evidence." By contrast, under a Bayesian approach, such a distinction is possible and it is explained how this approach could classify ABIs in particular settings or among particular populations as either truly ineffective or as of unknown effectiveness, thus accelerating progress in the field of ABI research.

  10. Preliminary findings of a randomized trial of non-pharmaceutical interventions to prevent influenza transmission in households.

    Directory of Open Access Journals (Sweden)

    Benjamin J Cowling

    Full Text Available BACKGROUND: There are sparse data on whether non-pharmaceutical interventions can reduce the spread of influenza. We implemented a study of the feasibility and efficacy of face masks and hand hygiene to reduce influenza transmission among Hong Kong household members. METHODOLOGY/PRINCIPAL FINDINGS: We conducted a cluster randomized controlled trial of households (composed of at least 3 members where an index subject presented with influenza-like-illness of <48 hours duration. After influenza was confirmed in an index case by the QuickVue Influenza A+B rapid test, the household of the index subject was randomized to 1 control or 2 surgical face masks or 3 hand hygiene. Households were visited within 36 hours, and 3, 6 and 9 days later. Nose and throat swabs were collected from index subjects and all household contacts at each home visit and tested by viral culture. The primary outcome measure was laboratory culture confirmed influenza in a household contact; the secondary outcome was clinically diagnosed influenza (by self-reported symptoms. We randomized 198 households and completed follow up home visits in 128; the index cases in 122 of those households had laboratory-confirmed influenza. There were 21 household contacts with laboratory confirmed influenza corresponding to a secondary attack ratio of 6%. Clinical secondary attack ratios varied from 5% to 18% depending on case definitions. The laboratory-based or clinical secondary attack ratios did not significantly differ across the intervention arms. Adherence to interventions was variable. CONCLUSIONS/SIGNIFICANCE: The secondary attack ratios were lower than anticipated, and lower than reported in other countries, perhaps due to differing patterns of susceptibility, lack of significant antigenic drift in circulating influenza virus strains recently, and/or issues related to the symptomatic recruitment design. Lessons learnt from this pilot have informed changes for the main study in 2008

  11. Cervical cancer screening and adherence to follow-up among Hispanic women study protocol: a randomized controlled trial to increase the uptake of cervical cancer screening in Hispanic women.

    Science.gov (United States)

    Duggan, Catherine; Coronado, Gloria; Martinez, Javiera; Byrd, Theresa L; Carosso, Elizabeth; Lopez, Cathy; Benavides, Maria; Thompson, Beti

    2012-05-06

    In the US, Hispanic women have a higher incidence of, and mortality from, cervical cancer than non-Hispanic white women. The reason for this disparity may be attributable to both low rates of screening and poor adherence to recommended diagnostic follow-up after an abnormal Pap test. The 'Cervical Cancer Screening and Adherence to Follow-up Among Hispanic Women' study is a collaboration between a research institution and community partners made up of members from community based organizations, the Yakima Valley Farm Workers Clinic and the Breast, Cervical, and Colon Health Program of the Yakima District . The study will assess the efficacy of two culturally-appropriate, tailored educational programs designed to increase cervical cancer screening among Hispanic women, based in the Yakima Valley, Washington, US. A parallel randomized-controlled trial of 600 Hispanic women aged 21-64, who are non-compliant with Papanicolau (Pap) test screening guidelines. Participants will be randomized using block randomization to (1) a control arm (usual care); (2) a low-intensity information program, consisting of a Spanish-language video that educates women on the importance of cervical cancer screening; or (3) a high-intensity program consisting of the video plus a 'promotora' or lay-community health educator-led, home based intervention to encourage cervical cancer screening. Participants who attend cervical cancer screening, and receive a diagnosis of an abnormal Pap test will be assigned to a patient navigator who will provide support and information to promote adherence to follow-up tests, and any necessary surgery or treatment. Primary endpoint: Participants will be tracked via medical record review at community-based clinics, to identify women who have had a Pap test within 7 months of baseline assessment. Medical record reviewers will be blinded to randomization arm. Secondary endpoint: An evaluation of the patient navigator program as a method to improve adherence and

  12. A yoga intervention for type 2 diabetes risk reduction: a pilot randomized controlled trial

    Science.gov (United States)

    2014-01-01

    Background Type 2 diabetes is a major health problem in many countries including India. Yoga may be an effective type 2 diabetes prevention strategy in India, particularly given its cultural familiarity. Methods This was a parallel, randomized controlled pilot study to collect feasibility and preliminary efficacy data on yoga for diabetes risk factors among people at high risk of diabetes. Primary outcomes included: changes in BMI, waist circumference, fasting blood glucose, postprandial blood glucose, insulin, insulin resistance, blood pressure, and cholesterol. We also looked at measures of psychological well-being including changes in depression, anxiety, positive and negative affect and perceived stress. Forty-one participants with elevated fasting blood glucose in Bangalore, India were randomized to either yoga (n = 21) or a walking control (n = 20). Participants were asked to either attend yoga classes or complete monitored walking 3–6 days per week for eight weeks. Randomization and allocation was performed using computer-generated random numbers and group assignments delivered in sealed, opaque envelopes generated by off-site study staff. Data were analyzed based on intention to treat. Results This study was feasible in terms of recruitment, retention and adherence. In addition, yoga participants had significantly greater reductions in weight, waist circumference and BMI versus control (weight −0.8 ± 2.1 vs. 1.4 ± 3.6, p = 0.02; waist circumference −4.2 ± 4.8 vs. 0.7 ± 4.2, p yoga intervention and walking control over the course of the study. Conclusion Among Indians with elevated fasting blood glucose, we found that participation in an 8-week yoga intervention was feasible and resulted in greater weight loss and reduction in waist circumference when compared to a walking control. Yoga offers a promising lifestyle intervention for decreasing weight-related type 2 diabetes risk factors and potentially increasing

  13. Registration practices for observational studies on ClinicalTrials.gov indicated low adherence.

    Science.gov (United States)

    Boccia, Stefania; Rothman, Kenneth J; Panic, Nikola; Flacco, Maria Elena; Rosso, Annalisa; Pastorino, Roberta; Manzoli, Lamberto; La Vecchia, Carlo; Villari, Paolo; Boffetta, Paolo; Ricciardi, Walter; Ioannidis, John P A

    2016-02-01

    The study aims to assess the status of registration of observational studies. We identified studies on cancer research with prospective recruitment of participants that were registered from February 2000 to December 2011 in ClinicalTrials.gov. We recorded the dates of registration and start of recruitment, outcomes, and description of statistical method. We searched for publications corresponding to the registered studies through May 31, 2014. One thousand one hundred nine registered studies were eligible. Primary and secondary outcomes were reported in 809 (73.0%) and 464 (41.8%) of them. The date of registration preceded the month of the study start in 145 (13.8%) and coincided in 205 (19.5%). A total of 151 publications from 120 (10.8%) registered studies were identified. In 2 (33.3%) of the 6 publications where ClinicalTrials.gov reported that the study started recruitment after registration, and in 9 (50.0%) of 18 publications where ClinicalTrials.gov reported the same date for registration and start of recruitment, the articles showed that the study had actually started recruiting before registration. During the period reviewed, few observational studies have been registered. Registration usually occurred after the study started, and prespecification of outcomes and statistical analysis rarely occurred. Copyright © 2016 Elsevier Inc. All rights reserved.

  14. Randomized trial of DVD, telephone, and usual care for increasing mammography adherence.

    Science.gov (United States)

    Champion, Victoria L; Rawl, Susan M; Bourff, Sara A; Champion, Kristen M; Smith, Lisa G; Buchanan, Adam H; Fish, Laura J; Monahan, Patrick O; Stump, Timothy E; Springston, Jeffery K; Gathirua-Mwangi, Wambui G; Skinner, Celette Sugg

    2016-06-01

    The purpose of this study was to test an intervention to increase mammography screening in women 51-75 years of age who had not received a mammogram in the last 15 months. A total of 1681 women were randomized to (1) a mailed tailored interactive DVD, (2) a computer-tailored telephone counseling, or (3) usual care. Women with income below US$75,000 who were in the interactive DVD group had significantly more mammograms than women in usual care. Women with income above US$75,000 had significantly fewer mammograms than women with income less than US$75,000 regardless of group. Further investigation is needed to understand why women with income above US$75,000 did not show the same benefit of the intervention.

  15. Treatment Adherence and Its Impact on Disease-Free Survival in the Breast International Group 1-98 Trial of Tamoxifen and Letrozole, Alone and in Sequence

    DEFF Research Database (Denmark)

    Chirgwin, Jacquie H; Giobbie-Hurder, Anita; Coates, Alan S

    2016-01-01

    PURPOSE: To investigate adherence to endocrine treatment and its relationship with disease-free survival (DFS) in the Breast International Group (BIG) 1-98 clinical trial. METHODS: The BIG 1-98 trial is a double-blind trial that randomly assigned 6,193 postmenopausal women with hormone receptor......-positive early breast cancer in the four-arm option to 5 years of tamoxifen (Tam), letrozole (Let), or the agents in sequence (Let-Tam, Tam-Let). This analysis included 6,144 women who received at least one dose of study treatment. Conditional landmark analyses and marginal structural Cox proportional hazards...... models were used to evaluate the relationship between DFS and treatment adherence (persistence [duration] and compliance with dosage). Competing risks regression was used to assess demographic, disease, and treatment characteristics of the women who stopped treatment early because of adverse events...

  16. Assessment effects in educational and psychosocial intervention trials: an important but often-overlooked problem.

    Science.gov (United States)

    Song, Mi-Kyung; Ward, Sandra E

    2015-06-01

    Baseline assessments and repeated measures are an essential part of educational and psychosocial intervention trials, but merely measuring an outcome of interest can modify that outcome, either by the measurement process alone or by interacting with the intervention to strengthen or weaken the intervention effects. Assessment effects can result in biased estimates of intervention effects and may not be controlled by the usual two-group randomized controlled trial design. In this paper, we review the concept of assessment effects and other related phenomena, briefly describe study designs that estimate assessment effects separately from intervention effects and discuss their strengths and limitations, review evidence regarding the strength of assessment effects in intervention trials targeting behavior change, and discuss implications for intervention research. © 2015 Wiley Periodicals, Inc.

  17. Rationale and design of a randomized controlled trial evaluating Community Health Worker (CHW) based interventions for the secondary prevention of acute coronary syndromes in India (SPREAD)

    Science.gov (United States)

    Kamath, Deepak Y; Xavier, Denis; Gupta, Rajeev; Devereaux, P.J.; Sigamani, Alben; Hussain, Tanvir; Umesh, Sowmya; Xavier, Freeda; Girish, Preeti; George, Nisha; Thomas, Tinku; Chidambaram, N.; Joshi, Rajnish; Pais, Prem; Yusuf, Salim

    2014-01-01

    Background There is a need to evaluate & implement cost-effective strategies to improve adherence to treatments in Coronary Heart Disease (CHD). There are no studies from Low Middle Income Countries (LMICs) evaluating trained Community Health Worker (CHW) based interventions for the secondary prevention of CHD. Methods We designed a hospital-based, open randomized trial of CHW based interventions versus standard care. Patients after an Acute Coronary Syndrome (ACS) were randomized to an intervention group (a CHW based intervention package, comprising education tools to enhance self-care and adherence, and regular follow-up by the CHW) or to standard care for 12 months during which study outcomes were recorded. The CHWs were trained over a period of 6 months. The primary outcome measure was medication adherence. The secondary outcomes were differences in adherence to lifestyle modification, physiological parameters (BP, body weight, BMI, heart rate, lipids) and major adverse cardiovascular events. Results We recruited 806 patients stabilized after an ACS from 14 hospitals in 13 Indian cities. The mean age was 56.4 (+/−11.32) and 17.2% were females. A high prevalence of risk factors -hypertension (43.4%), diabetes (31.9%), tobacco consumption (35.4%) and inadequate physical activity (70.5%) were documented. A little over half had ST elevation myocardial infarction (STEMI, 53.7%) and 46.3% had non-ST elevation myocardial infarction (NSTEMI) or unstable angina. Conclusion The CHW interventions and training for SPREAD have been developed and adapted for local use. The results and experience of this study will be important to counter the burden of Cardiovascular Diseases (CVD) in LMICs. PMID:25440797

  18. Psychosocial predictors of non-adherence and treatment failure in a large scale multi-national trial of antiretroviral therapy for HIV: data from the ACTG A5175/PEARLS trial.

    Directory of Open Access Journals (Sweden)

    Steven A Safren

    Full Text Available PEARLS, a large scale trial of antiretroviral therapy (ART for HIV (n = 1,571, 9 countries, 4 continents, found that a once-daily protease inhibitor (PI based regimen (ATV+DDI+FTC, but not a once-daily non-nucleoside reverse transcriptase inhibitor/nucleoside reverse transcriptase inhibitor (NNRTI/NRTI regimen (EFV+FTC/TDF, had inferior efficacy compared to a standard of care twice-daily NNRTI/NRTI regimen (EFV+3TC/ZDV. The present study examined non-adherence in PEARLS.Outcomes: non-adherence assessed by pill count and by self-report, and time to treatment failure. Longitudinal predictors: regimen, quality of life (general health perceptions  =  QOL-health, mental health  =  QOL-mental health, social support, substance use, binge drinking, and sexual behaviors. "Life-Steps" adherence counseling was provided.In both pill-count and self-report multivariable models, both once-a-day regimens had lower levels of non-adherence than the twice-a-day standard of care regimen; although these associations attenuated with time in the self-report model. In both multivariable models, hard-drug use was associated with non-adherence, living in Africa and better QOL-health were associated with less non-adherence. According to pill-count, unprotected sex was associated with non-adherence. According to self-report, soft-drug use was associated with non-adherence and living in Asia was associated with less non-adherence. Both pill-count (HR = 1.55, 95% CI: 1.15, 2.09, p<.01 and self-report (HR = 1.13, 95% CI: 1.08, 1.13, p<.01 non-adherence were significant predictors of treatment failure over 72 weeks. In multivariable models (including pill-count or self-report nonadherence, worse QOL-health, age group (younger, and region were also significant predictors of treatment failure.In the context of a large, multi-national, multi-continent, clinical trial there were variations in adherence over time, with more simplified regimens generally being

  19. Cricothyrotomy training increases adherence to the ASA difficult airway algorithm in a simulated crisis: a randomized controlled trial.

    Science.gov (United States)

    You-Ten, Kong Eric; Bould, M Dylan; Friedman, Zeev; Riem, Nicole; Sydor, Devin; Boet, Sylvain

    2015-05-01

    Non-adherence to airway guidelines in a 'cannot intubate-cannot oxygenate' (CICO) crisis situation is associated with adverse patient outcomes. This study investigated the effects of hands-on training in cricothyrotomy on adherence to the American Society of Anesthesiologists difficult airway algorithm (ASA-DAA) during a simulated CICO scenario. A total of 21 postgraduate second-year anesthesia residents completed a pre-test teaching session during which they reviewed the ASA-DAA, became familiarized with the Melker cricothyrotomy kit, and watched a video on cricothyrotomy. Participants were randomized to either the intervention 'Trained' group (n = 10) (taught and practiced cricothyrotomy) or the control 'Non-Trained' group (n = 11) (no extra training). After two to three weeks, performances of the groups were assessed in a simulated CICO scenario. The primary outcome measure was major deviation from the ASA-DAA. Secondary outcome measures were (1) performance of the four categories of non-technical behaviours using the validated Anaesthetists' Non-Technical Skills scale (ANTS) and (2) time to perform specific tasks. Significantly more non-trained than trained participants (6/11 vs 0/10, P = 0.012) committed at least one major ASA-DAA deviation, including failure to insert an oral airway, failure to call for help, bypassing the laryngeal mask airway, and attempting fibreoptic intubation. ANTS scores for all four categories of behaviours, however, were similar between the groups. Trained participants called for help faster [26 (2) vs 63 (48) sec, P = 0.012] but delayed opening of the cricothyrotomy kit [130 (50) vs 74 (36) sec, P = 0.014]. Hands-on training in cricothyrotomy resulted in fewer major ASA-DAA deviations in a simulated CICO scenario. Training in cricothyrotomy may play an important role in complying with the ASA-DAA in a CICO situation but does not appear to affect non-technical behaviours such as decision-making.

  20. The relationship between persuasive technology principles, adherence and effect of web-Based interventions for mental health: A meta-analysis.

    Science.gov (United States)

    Wildeboer, Gina; Kelders, Saskia M; van Gemert-Pijnen, Julia E W C

    2016-12-01

    Research has shown that web-based interventions concerning mental health can be effective, although there is a broad range in effect sizes. Why some interventions are more effective than others is not clear. Persuasive technology is one of the aspects which has a positive influence on changing attitude and/or behavior, and can contribute to better outcomes. According to the Persuasive Systems Design Model there are various principles that can be deployed. It is unknown whether the number and combinations of principles used in a web-based intervention affect the effectiveness. Another issue in web-based interventions is adherence. Little is known about the relationship of adherence on the effectiveness of web-based interventions. This study examines whether there is a relationship between the number and combinations of persuasive technology principles used in web-based interventions and the effectiveness. Also the influence of adherence on effectiveness of web-based interventions is investigated. This study elaborates on the systematic review by [37] and therefore the articles were derived from that study. Only web-based interventions were included that were intended to be used on more than one occasion and studies were excluded when no information on adherence was provided. 48 interventions targeted at mental health were selected for the current study. A within-group (WG) and between-group (BG) meta-analysis were performed and subsequently subgroup analyses regarding the relationship between the number and combinations of persuasive technology principles and effectiveness. The influence of adherence on the effectiveness was examined through a meta-regression analysis. For the WG meta-analysis 40 treatment groups were included. The BG meta-analysis included 19 studies. The mean pooled effect size in the WG meta-analysis was large and significant (Hedges' g=0.94), while for the BG meta-analysis this was moderate to large and significant (Hedges' g=0.78) in favor of

  1. A randomized controlled trial of a transdiagnostic Internet intervention for individuals with panic and phobias - One size fits all.

    Science.gov (United States)

    Schröder, Johanna; Jelinek, Lena; Moritz, Steffen

    2017-03-01

    Many individuals with anxiety disorders do not receive professional treatment. Internet interventions have shown to be effective in the treatment of anxiety. The present randomized controlled trial was designed to examine the effectiveness of a short-term (4-week) Internet intervention in treating panic disorder, agoraphobia, social anxiety disorder, and specific phobias ('ConfID'). We addressed the questions of whether this transdiagnostic program would affect these disorders to varying degrees and whether there would be moderators of effectiveness. Adults who were recruited in online forums for anxiety underwent an online baseline assessment (N = 179) and were randomized either to the intervention group (ConfID) or the control group (care as usual). Online post-assessment took place 4 weeks later. The primary outcome was assessed with the Beck Anxiety Inventory (BAI); the secondary outcomes targeted the disorder-specific symptoms, depression, and somatization. Participants in the intervention group showed a significantly stronger anxiety reduction compared to participants receiving care as usual (small-to-medium effect size between groups in intention-to-treat analysis). The treatment effect was similar for the different disorders and was moderated by participants' attitudes towards Internet interventions. Secondary outcomes yielded effect sizes in the medium range. Moderate treatment adherence, lack of measures beyond online self-reports, and unavailability of long-term results. The study provides further evidence that transdiagnostic Internet interventions are promising in reducing the existing treatment gap in individuals with panic disorder and phobias. Results extend previous findings by showing that significant effects can also be reached by comprehensive short-term programs and that the effects might be moderated by participants' attitudes towards Internet interventions. Copyright © 2016 Elsevier Ltd. All rights reserved.

  2. Endovascular Interventions for Acute Ischemic Stroke: A Review of Recent Trials.

    Science.gov (United States)

    Bishop, Bryan M

    2016-03-01

    To review recent endovascular intervention trials for acute ischemic stroke. Recent, randomized controlled trials of endovascular interventions for acute ischemic stroke were identified. The search terms "endovascular" AND "stroke" were used and filter for "randomized controlled trial" was applied; the period searched was January 1, 2013, to October 31, 2015. Randomized controlled trials of endovascular interventions in acute ischemic stroke published within the past 3 years (2013-2015). A total of 8 trials are reviewed: 3 trials published in 2013 demonstrated neutral results for endovascular interventions, and 5 trials published in 2015 demonstrated positive results for endovascular interventions. Potential reasons for the change in outcomes include better patient selection and improvement indevice technology. Patient selection improvements included selecting patients with salvageable brain tissue with an identifiable thrombus on perfusion imaging. The major improvement in device technology was the introduction of the Solitaire Flow Restoration stent retriever and the Trevo stent retriever, both of which have improved recanalization rates compared with earlier devices. Adjunctive medication considerations include the mode of sedation (general or conscious), intraprocedural anticoagulation with heparin, and intra-arterial tissue plasminogen activator. The use of endovascular devices for treating acute ischemic stroke is likely to increase as more centers become capable of integrating them into their stroke programs. It is important for pharmacists to understand the trials that evaluated endovascular interventions because differences exist with respect to device, adjunctive medication, and patient selection, all of which affect patient outcomes. © The Author(s) 2015.

  3. Intervention Efficacy in Trials Targeting Cannabis Use Disorders in Patients with Comorbid Psychosis

    DEFF Research Database (Denmark)

    Hjorthoj, Carsten Rygaard; Baker, Amanda; Fohlmann, Allan

    2014-01-01

    Introduction: Cannabis use disorders are highly prevalent in patients with schizophrenia and other psychoses, and are probably associated with a range of poor outcomes. Several trials have been conducted on this population, the results of which have been summarized in several systematic reviews...... with schizophrenia spectrum disorders. We extracted information on intervention types, efficacy, trial characteristics, and risk of bias. Results: There was no evidence of an effect on frequency of cannabis use, but intervention effects of motivational intervention with or without cognitive behavior therapy were...... observed on quantity of use and on positive symptoms of schizophrenia. Psychosocial intervention did not have an appreciable effect on negative symptoms. Longer interventions appear to be more efficacious, and efficacy may be better in trials with comparatively few women. Larger trials may be better...

  4. A Systematic Review of Ebola Treatment Trials to Assess the Extent to Which They Adhere to Ethical Guidelines

    Science.gov (United States)

    2017-01-01

    Background Objective: To determine to what extent each trial met criteria specified in three research frameworks for ethical trial conduct. Design: Systematic review and narrative analysis Methods and findings Data sources: MEDBASE and EMBASE databases were searched using a specific search strategy. The Cochrane database for systematic reviews, the PROSPERO database and trial registries were examined. A grey literature search and citation search were also carried out. Eligibility criteria for selecting studies: Studies were included where the intervention was being used to treat Ebola in human subjects regardless of study design, comparator or outcome measured. Studies were eligible if they had taken place after the 21st March 2014. Unpublished as well as published studies were included. Included studies: Sixteen studies were included in the data synthesis. Data was extracted on study characteristics as well as any information relating to ten ethical areas of interest specified in the three research frameworks for ethical trial conduct and an additional criterion of whether the study received ethics approval from a research ethics committee. Synthesis of results: Eight studies were judged to fully comply with all eleven criteria. The other eight studies all had at least one criteria where there was not enough information available to draw any conclusions. In two studies there were ethical concerns regarding the information provided in relation to at least one ethical criteria. Description of the effect: One study did not receive ethical approval as the authors argued that treating approximately one hundred patients consecutively for compassionate reasons did not constitute a clinical trial. Furthermore, after the patients were treated, physicians in Sierra Leone did not release reports of treatment results and so study conclusions had to be made based on unpublished observations. In another study the risk-benefit ratio of the trial drug does not appear to be

  5. A culturally adapted telecommunication system to improve physical activity, diet quality, and medication adherence among hypertensive African-Americans: a randomized controlled trial.

    Science.gov (United States)

    Migneault, Jeffrey P; Dedier, Julien J; Wright, Julie A; Heeren, Timothy; Campbell, Marci Kramish; Morisky, Donald E; Rudd, Peter; Friedman, Robert H

    2012-02-01

    Hypertension is more prevalent and clinically severe among African-Americans than whites. Several health behaviors influence blood pressure (BP) control, but effective, accessible, culturally sensitive interventions that target multiple behaviors are lacking. We evaluated a culturally adapted, automated telephone system to help hypertensive, urban African-American adults improve their adherence to their antihypertensive medication regimen and to evidence-based guidelines for dietary behavior and physical activity. We randomized 337 hypertensive primary care patients to an 8-month automated, multi-behavior intervention or to an education-only control. Medication adherence, diet, physical activity, and BP were assessed at baseline and every 4 months for 1 year. Data were analyzed using longitudinal modeling. The intervention was associated with improvements in a measure of overall diet quality (+3.5 points, p telecommunications systems can promote self-management of diet and energy balance in urban African-Americans.

  6. Effect of text messages to improve health literacy on medication adherence in patients with type 2 diabetes mellitus: A randomized controlled pilot trial.

    Science.gov (United States)

    Sugita, Hideki; Shinohara, Ryoji; Yokomichi, Hiroshi; Suzuki, Kohta; Yamagata, Zentaro

    2017-08-01

    It has been suggested that low health literacy (HL) is associated with poor medication adherence. This study aimed to examine the effect of a text message-based HL intervention to promote medication adherence, compared with text messages that only sent medication reminders, in patients with type 2 diabetes. This was a single-center, open-label, randomized (1:1) controlled pilot study. The study period was 6 months. Intervention group was sent HL related text messages, compared to the reminder messages that were sent to the control group. The primary outcome was the difference in the change rate of scores on the Morisky Eight-Item Medication Adherence Scale (MMAS-8). Forty-one participants were randomized into the intervention (n = 21) and control (n = 20) groups and completed the 6-month follow-up. Although almost participants read and understood the information provided in the messages, no significant difference was observed between groups for the primary outcome (p = 0.78). Our results suggested that medication adherence at 6 months after discharge in patients with type 2 diabetes did not significantly change by text messages, which aimed to improve their HL levels.

  7. Can You Teach a Teen New Tricks? Problem Solving Skills Training Improves Oral Medication Adherence in Pediatric Patients with Inflammatory Bowel Disease Participating in a Randomized Trial.

    Science.gov (United States)

    Greenley, Rachel N; Gumidyala, Amitha P; Nguyen, Eve; Plevinsky, Jill M; Poulopoulos, Natasha; Thomason, Molly M; Walter, Jennifer G; Wojtowicz, Andrea A; Blank, Ellen; Gokhale, Ranjana; Kirschner, Barbara S; Miranda, Adrian; Noe, Joshua D; Stephens, Michael C; Werlin, Steven; Kahn, Stacy A

    2015-11-01

    Medication nonadherence is associated with higher disease activity, greater health care utilization, and lower health-related quality of life in pediatric inflammatory bowel diseases (IBD). Problem solving skills training (PSST) is a useful tool to improve adherence in patients with chronic diseases but has not been fully investigated in IBD. This study assessed feasibility, acceptability, and preliminary efficacy of PSST in pediatric IBD. Recruitment occurred during outpatient clinic appointments. After completion of baseline questionnaires, families were randomized to a treatment group or wait-list comparison group. The treatment group received either 2 or 4 PSST sessions. Youth health-related quality of life was assessed at 3 time points, and electronic monitoring of oral medication adherence occurred for the study duration. Seventy-six youth (ages 11-18 years) on an oral IBD maintenance medication participated. High retention (86%) and treatment fidelity rates (95%) supported feasibility. High satisfaction ratings (mean values ≥4.2 on 1-5 scale) supported intervention acceptability. Modest increases in adherence occurred after 2 PSST sessions among those with imperfect baseline adherence (d = 0.41, P 0.05). Phone-delivered PSST was feasible and acceptable. Efficacy estimates were similar to those of lengthier interventions conducted in other chronic illness populations. Older adolescents benefited more from the intervention than their younger counterparts.

  8. Complaint-Directed Mini-Interventions for Depressive Complaints: A Randomized Controlled Trial of Unguided Web-Based Self-Help Interventions

    Science.gov (United States)

    Sommers-Spijkerman, Marion; van der Poel, Agnes; Smit, Filip; Boon, Brigitte

    2017-01-01

    the 3-month intervention period (median 3, range 0-166). After 3 months, there was a significant reduction in depressive symptomatology for participants in the intervention group compared to participants in the wait-list control group (reduction in depression: mean –4.47, 95% CI –6.54 to –2.40; Cohen d=–0.70). Furthermore, significant effects were observed for sleep problems, worry, anxiety, and well-being, with effect sizes ranging from –0.29 to –0.40. The intervention did not significantly reduce stress. At 6-month follow-up, the improvements in the intervention group were generally sustained. Conclusions This study shows that the online self-help CDMIs have a positive impact on various mental health outcomes. Future research should focus on which specific strategies may boost adherence, and increase the reach of the CDMIs among people with low socioeconomic status. ClinicalTrial Netherlands Trial Register (NTR): NTR4612; http://www.trialregister.nl/trialreg/admin/rctview.asp?TC=4612 (Archived by WebCite at http://www.webcitation.org/6n4PVYddM) PMID:28052840

  9. Randomised controlled trial of tailored interventions to improve the management of anxiety and depressive disorders in primary care

    Directory of Open Access Journals (Sweden)

    Terluin Berend

    2011-07-01

    Full Text Available Abstract Background Anxiety and depressive disorders are highly prevalent disorders and are mostly treated in primary care. The management of these disorders by general practitioners is not always consistent with prevailing guidelines because of a variety of factors. Designing implementation strategies tailored to prospectively identified barriers could lead to more guideline-recommended care. Although tailoring of implementation strategies is promoted in practice, little is known about the effect on improving the quality of care for the early recognition, diagnosis, and stepped care treatment allocation in patients with anxiety or depressive disorders in general practice. This study examines whether the tailored strategy supplemented with training and feedback is more effective than providing training and feedback alone. Methods In this cluster randomised controlled trial, a total of 22 general practices will be assigned to one of two conditions: (1 training, feedback, and tailored interventions and (2 training and feedback. The primary outcome measure is the proportion of patients who have been recognised to have anxiety and/or depressive disorder. The secondary outcome measures in patients are severity of anxiety and depressive symptoms, level of functioning, expectation towards and experience with care, quality of life, and economic costs. Measures are taken after the start of the intervention at baseline and at three- and six-month follow-ups. Secondary outcome measures in general practitioners are adherence to guideline-recommended care in care that has been delivered, the proportion of antidepressant prescriptions, and number of referrals to specialised mental healthcare facilities. Data will be gathered from the electronic medical patient records from the patients included in the study. In a process evaluation, the identification of barriers to change and the relations between prospectively identified barriers and improvement

  10. The effectiveness of interventions using electronic reminders to improve adherence to chronic medication: a systematic review of the literature

    NARCIS (Netherlands)

    Vervloet, M.; Linn, A.J.; van Weert, J.C.M.; de Bakker, D.H.; Bouvy, M.L.; van Dijk, L.

    2012-01-01

    Background: Many patients experience difficulties in adhering to long-term treatment. Although patients' reasons for not being adherent are diverse, one of the most commonly reported barriers is forgetfulness. Reminding patients to take their medication may provide a solution. Electronic reminders (

  11. The effectiveness of interventions using electronic reminders to improve adherence to chronic medication: a systematic review of the literature.

    NARCIS (Netherlands)

    Vervloet, M.; Linn, A.J.; Weert, J.C.M. van; Bakker, D.H. de; Bouvy, M.L.; Dijk, L. van

    2012-01-01

    Background: Many patients experience difficulties in adhering to long-term treatment. Although patients’ reasons for not being adherent are diverse, one of the most commonly reported barriers is forgetfulness. Reminding patients to take their medication may provide a solution. Electronic reminders (

  12. The Happy Life Club™ study protocol: A cluster randomised controlled trial of a type 2 diabetes health coach intervention

    Directory of Open Access Journals (Sweden)

    Yang Hui

    2011-02-01

    Full Text Available Abstract Background The Happy Life Club™ is an intervention that utilises health coaches trained in behavioural change and motivational interviewing techniques to assist with the management of type 2 diabetes mellitus (T2DM in primary care settings in China. Health coaches will support participants to improve modifiable risk factors and adhere to effective self-management treatments associated with T2DM. Methods/Design A cluster randomised controlled trial involving 22 Community Health Centres (CHCs in Fengtai District of Beijing, China. CHCs will be randomised into a control or intervention group, facilitating recruitment of at least 1320 individual participants with T2DM into the study. Participants in the intervention group will receive a combination of both telephone and face-to-face health coaching over 18 months, in addition to usual care received by the control group. Health coaching will be performed by CHC doctors and nurses certified in coach-assisted chronic disease management. Outcomes will be assessed at baseline and again at 6, 12 and 18 months by means of a clinical health check and self-administered questionnaire. The primary outcome measure is HbA1c level. Secondary outcomes include metabolic, physiological and psychological variables. Discussion This cluster RCT has been developed to suit the Chinese health care system and will contribute to the evidence base for the management of patients with T2DM. With a strong focus on self-management and health coach support, the study has the potential to be adapted to other chronic diseases, as well as other regions of China. Trial Registration Current Controlled Trials ISRCTN01010526

  13. Design, history and results of the Thiazolidinedione Intervention with vitamin D Evaluation (TIDE) randomised controlled trial

    DEFF Research Database (Denmark)

    Punthakee, Z; Bosch, J; Dagenais, G

    2012-01-01

    AIMS/OBJECTIVE: Conflicting data regarding cardiovascular effects of thiazolidinediones (TZDs) and extra-skeletal effects of vitamin D supported the need for a definitive trial. The Thiazolidinedione Intervention with vitamin D Evaluation (TIDE) trial aimed to assess the effects of TZDs (rosiglit...... (rosiglitazone and pioglitazone) on cardiovascular outcomes and the effects of vitamin D (cholecalciferol) on cancers and mortality.......AIMS/OBJECTIVE: Conflicting data regarding cardiovascular effects of thiazolidinediones (TZDs) and extra-skeletal effects of vitamin D supported the need for a definitive trial. The Thiazolidinedione Intervention with vitamin D Evaluation (TIDE) trial aimed to assess the effects of TZDs...

  14. A Cognitive Behavioral Therapy-Based Text Messaging Intervention Versus Medical Management for HIV-Infected Substance Users: Study Protocol for a Pilot Randomized Trial.

    Science.gov (United States)

    Glasner-Edwards, Suzette; Patrick, Kevin; Ybarra, Michele L; Reback, Cathy J; Rawson, Richard A; Chokron Garneau, Helene; Chavez, Kathryn; Venegas, Alexandra

    2016-06-24

    Evidence-based psychosocial interventions for addictions and related conditions such as cognitive behavioral therapy (CBT) are underutilized. Obstacles to implementation of CBT in clinical settings include limited availability of quality training, supervision, and certification in CBT for clinicians; high rates of clinician turnover and high caseloads; and limited qualifications of the workforce to facilitate CBT expertise. Mobile phone-based delivery of CBT, if demonstrated to be feasible and effective, could be transformative in broadening its application and improving the quality of addiction treatment. No experimental interventions that deliver CBT targeting both drug use and medication adherence using text messaging have been previously reported; as such, the objective of this study is to develop and test an SMS-based treatment program for HIV-positive adults with comorbid substance use disorders. With user input, we developed a 12-week CBT-based text messaging intervention (TXT-CBT) targeting antiretroviral (ART) adherence, risk behaviors, and drug use in a population of HIV-infected substance users. The intervention has been developed and is presently being tested in a pilot randomized clinical trial. Results will be reported later this year. This investigation will yield valuable knowledge about the utility of a cost-effective, readily deployable text messaging behavioral intervention for HIV-infected drug users.

  15. A Cognitive Behavioral Therapy–Based Text Messaging Intervention Versus Medical Management for HIV-Infected Substance Users: Study Protocol for a Pilot Randomized Trial

    Science.gov (United States)

    Patrick, Kevin; Ybarra, Michele L; Reback, Cathy J; Rawson, Richard A; Chokron Garneau, Helene; Chavez, Kathryn; Venegas, Alexandra

    2016-01-01

    Background Evidence-based psychosocial interventions for addictions and related conditions such as cognitive behavioral therapy (CBT) are underutilized. Obstacles to implementation of CBT in clinical settings include limited availability of quality training, supervision, and certification in CBT for clinicians; high rates of clinician turnover and high caseloads; and limited qualifications of the workforce to facilitate CBT expertise. Objective Mobile phone–based delivery of CBT, if demonstrated to be feasible and effective, could be transformative in broadening its application and improving the quality of addiction treatment. No experimental interventions that deliver CBT targeting both drug use and medication adherence using text messaging have been previously reported; as such, the objective of this study is to develop and test an SMS-based treatment program for HIV-positive adults with comorbid substance use disorders. Methods With user input, we developed a 12-week CBT-based text messaging intervention (TXT-CBT) targeting antiretroviral (ART) adherence, risk behaviors, and drug use in a population of HIV-infected substance users. Results The intervention has been developed and is presently being tested in a pilot randomized clinical trial. Results will be reported later this year. Conclusions This investigation will yield valuable knowledge about the utility of a cost-effective, readily deployable text messaging behavioral intervention for HIV-infected drug users. PMID:27341852

  16. Assessing adherence factors in patients under topical treatment: development of the Topical Therapy Adherence Questionnaire (TTAQ).

    Science.gov (United States)

    Zschocke, Ina; Mrowietz, Ulrich; Lotzin, Annett; Karakasili, Eleni; Reich, Kristian

    2014-04-01

    Medication adherence rates strongly depend on favorable disease outcomes. It is known that medication adherence rates are lower for topical treatment than for systemic treatment. However, to date no validated instrument for the assessment of adherence factors in topical treatment is available. The aim of this study was to develop a new questionnaire to assess adherence risk factors in topical treatment. The development of the Topical Therapy Adherence Questionnaire (TTAQ) and Patient Preference Questionnaire (PPQ) was based on a systematic literature review, and qualitative patient focus interviews and expert focus groups' input. The psychometric properties and comprehensibility of the TTAQ and PPQ were assessed in a feasibility study with 59 psoriasis patients. Our first preliminary results indicate that the TTAQ and PPQ are psychometrically sound and reliable measures for the assessment of factors influencing topical treatment adherence. The questionnaires are currently being further developed and various parameters (e.g., time point of assessment) are currently being tested in an exploratory pilot study with ca. 2,000 psoriasis patients receiving topical treatment in a European clinical trial. The use of the final versions of TTAQ and PPQ in clinical practice may facilitate the early identification of specific non-adherence factors in patients under topical treatment, which could enable designing and applying adherence-enhancing interventions according to the patient's individual needs.

  17. Identifying effective and feasible interventions to accelerate functional recovery from hospitalization in older adults: A randomized controlled pilot trial.

    Science.gov (United States)

    Deer, Rachel R; Dickinson, Jared M; Fisher, Steve R; Ju, Hyunsu; Volpi, Elena

    2016-07-01

    Hospitalization induces functional decline in older adults. Many geriatric patients fail to fully recover physical function after hospitalization, which increases the risk of frailty, disability, dependence, re-hospitalization, and mortality. There is a lack of evidence-based therapies that can be implemented following hospitalization to accelerate functional improvements. The aims of this Phase I clinical trial are to determine 1) the effect size and variability of targeted interventions in accelerating functional recovery from hospitalization and 2) the feasibility of implementing such interventions in community-dwelling older adults. Older patients (≥65years, n=100) will be recruited from a single site during hospitalization for an acute medical condition. Subjects will be randomized to one of five interventions initiated immediately upon discharge: 1. protein supplementation, 2. in-home rehabilitation plus placebo supplementation, 3. in-home rehabilitation plus protein supplementation, 4. single testosterone injection, or 5. isocaloric placebo supplementation. Testing will occur during hospitalization (baseline) and at 1 and 4weeks post-discharge. Each testing session will include measures of muscle strength, physical function/performance, body composition, and psychological function. Physical activity levels will be continuously monitored throughout study participation. Feasibility will be determined through collection of the number of eligible, contacted, and enrolled patients; intervention adherence and compliance; and reasons for declining enrollment and study withdrawal. This research will determine the feasibility of post-hospitalization strategies to improve physical function in older adults. These results will also provide a foundation for performing larger, multi-site clinical trials to improve physical function and reduce readmissions in geriatric patents.

  18. Engaging Latina cancer survivors, their caregivers, and community partners in a randomized controlled trial: Nueva Vida intervention.

    Science.gov (United States)

    Rush, Christina L; Darling, Margaret; Elliott, Maria Gloria; Febus-Sampayo, Ivis; Kuo, Charlene; Muñoz, Juliana; Duron, Ysabel; Torres, Migdalia; Galván, Claudia Campos; Gonzalez, Florencia; Caicedo, Larisa; Nápoles, Anna; Jensen, Roxanne E; Anderson, Emily; Graves, Kristi D

    2015-05-01

    Few studies have evaluated interventions to improve quality of life (QOL) for Latina breast cancer survivors and caregivers. Following best practices in community-based participatory research (CBPR), we established a multi-level partnership among Latina survivors, caregivers, community-based organizations (CBOs), clinicians, and researchers to evaluate a survivor-caregiver QOL intervention. A CBO in the mid-Atlantic region, Nueva Vida, developed a patient-caregiver program called Cuidando a mis Cuidadores (Caring for My Caregivers), to improve outcomes important to Latina cancer survivors and their families. Together with an academic partner, Nueva Vida and three CBOs established a multi-level team of researchers, clinicians, Latina cancer survivors, and caregivers to conduct a national randomized trial to compare the patient-caregiver program to usual care. Incorporating team feedback and programmatic considerations, we adapted the prior patient-caregiver program into an 8-session patient- and caregiver-centered intervention that includes skill-building workshops such as managing stress, communication, self-care, social well-being, and impact of cancer on sexual intimacy. We will measure QOL domains with the patient-reported outcomes measurement information system, dyadic communication between the survivor and caregiver, and survivors' adherence to recommended cancer care. To integrate the intervention within each CBO, we conducted interactive training on the protection of human subjects, qualitative interviewing, and intervention delivery. The development and engagement process for our QOL intervention study is innovative because it is both informed by and directly impacts underserved Latina survivors and caregivers. The CBPR-based process demonstrates successful multi-level patient engagement through collaboration among researchers, clinicians, community partners, survivors, and caregivers.

  19. 'The phone reminder is important, but will others get to know about my illness?' Patient perceptions of an mHealth antiretroviral treatment support intervention in the HIVIND trial in South India.

    Science.gov (United States)

    Rodrigues, Rashmi; Poongulali, S; Balaji, Kavitha; Atkins, Salla; Ashorn, Per; De Costa, Ayesha

    2015-11-02

    The recent explosion of mHealth applications in the area of HIV care has led to the development of mHealth interventions to support antiretroviral treatment adherence. Several of these interventions have been tested for effectiveness, but few studies have explored patient perspectives of such interventions. Exploring patient perspectives enhances the understanding of how an intervention works or why it does not. We therefore studied perceptions regarding an mHealth adherence intervention within the HIVIND trial in South India. The study was conducted at three clinics in South India. The intervention comprised an automated interactive voice response (IVR) call and a pictorial short messaging service (SMS), each delivered weekly. Sixteen purposively selected participants from the intervention arm in the HIVIND trial were interviewed. All participants had completed at least 84 weeks since enrollment in the trial. Perceptions on the usefulness and perceived benefits and risks of receiving the intervention were sought. The interviews were transcribed and analysed using the framework approach to qualitative data analysis. Despite varying perceptions of the intervention, most participants found it useful. The intervention was perceived as a sign of 'care' from the clinic. The IVR call was preferred to the SMS reminder. Two-way communication was preferred to automated calls. Participants also perceived a risk of unintentional disclosure of their HIV status and stigma thereof via the intervention and took initiatives to mitigate this risk. Targeting reminders at those with poor adherence and those in need of social support was suggested. mHealth adherence interventions go beyond their intended role to provide a sense of care and support to the recipient. Although automated interventions are impersonal, they could be a solution for scale up. Interventions that engage both the recipient and the healthcare provider have greater potential for success. Personalising m

  20. HPTN 071 (PopART: a cluster-randomized trial of the population impact of an HIV combination prevention intervention including universal testing and treatment: mathematical model.

    Directory of Open Access Journals (Sweden)

    Anne Cori

    Full Text Available BACKGROUND: The HPTN 052 trial confirmed that antiretroviral therapy (ART can nearly eliminate HIV transmission from successfully treated HIV-infected individuals within couples. Here, we present the mathematical modeling used to inform the design and monitoring of a new trial aiming to test whether widespread provision of ART is feasible and can substantially reduce population-level HIV incidence. METHODS AND FINDINGS: The HPTN 071 (PopART trial is a three-arm cluster-randomized trial of 21 large population clusters in Zambia and South Africa, starting in 2013. A combination prevention package including home-based voluntary testing and counseling, and ART for HIV positive individuals, will be delivered in arms A and B, with ART offered universally in arm A and according to national guidelines in arm B. Arm C will be the control arm. The primary endpoint is the cumulative three-year HIV incidence. We developed a mathematical model of heterosexual HIV transmission, informed by recent data on HIV-1 natural history. We focused on realistically modeling the intervention package. Parameters were calibrated to data previously collected in these communities and national surveillance data. We predict that, if targets are reached, HIV incidence over three years will drop by >60% in arm A and >25% in arm B, relative to arm C. The considerable uncertainty in the predicted reduction in incidence justifies the need for a trial. The main drivers of this uncertainty are possible community-level behavioral changes associated with the intervention, uptake of testing and treatment, as well as ART retention and adherence. CONCLUSIONS: The HPTN 071 (PopART trial intervention could reduce HIV population-level incidence by >60% over three years. This intervention could serve as a paradigm for national or supra-national implementation. Our analysis highlights the role mathematical modeling can play in trial development and monitoring, and more widely in evaluating the

  1. HIV Medication Adherence

    Science.gov (United States)

    ... AIDS Drugs Clinical Trials Apps skip to content HIV Treatment Home Understanding HIV/AIDS Fact Sheets HIV ... 4 p.m. ET) Send us an email HIV Medication Adherence Last Reviewed: March 2, 2017 Key ...

  2. Is implementing screening for distress an efficient means to recruit patients to a psychological intervention trial?

    NARCIS (Netherlands)

    van Scheppingen, Corinne; Schroevers, Maya J.; Pool, Grieteke; Smink, Ans; Mul, Veronique E.; Coyne, James C.; Sanderman, Robbert

    2014-01-01

    ObjectivesPsychological interventions show greater efficacy when evaluated with distressed patients. We report on the feasibility of implementing screening for recruiting distressed cancer patients to a randomized controlled trial of problem-solving therapy (PST), characteristics associated with enr

  3. Influence of reported study design characteristics on intervention effect estimates from randomised controlled trials

    DEFF Research Database (Denmark)

    Savović, J; Jones, He; Altman, Dg

    2012-01-01

    The design of randomised controlled trials (RCTs) should incorporate characteristics (such as concealment of randomised allocation and blinding of participants and personnel) that avoid biases resulting from lack of comparability of the intervention and control groups. Empirical evidence suggests...

  4. Is implementing screening for distress an efficient means to recruit patients to a psychological intervention trial?

    NARCIS (Netherlands)

    van Scheppingen, Corinne; Schroevers, Maya J.; Pool, Grieteke; Smink, Ans; Mul, Veronique E.; Coyne, James C.; Sanderman, Robbert

    2014-01-01

    ObjectivesPsychological interventions show greater efficacy when evaluated with distressed patients. We report on the feasibility of implementing screening for recruiting distressed cancer patients to a randomized controlled trial of problem-solving therapy (PST), characteristics associated with enr

  5. Development of early mathematical skills with a tablet intervention: a randomized control trial in Malawi

    National Research Council Canada - National Science Library

    Pitchford, Nicola J

    2015-01-01

    .... This study reports a randomized control trial to evaluate the effectiveness of a tablet intervention for supporting the development of early mathematical skills in primary school children in Malawi...

  6. Mindfulness-based stress reduction for people living with HIV/AIDS: preliminary review of intervention trial methodologies and findings.

    Science.gov (United States)

    Riley, Kristen E; Kalichman, Seth

    2015-01-01

    In the context of successful antiretroviral therapy (ART) for the management of HIV infection, the harmful effects of stress remain a significant threat. Stress may increase viral replication, suppress immune response, and impede adherence to ART. Stressful living conditions of poverty, facing a chronic life-threatening illness and stigma all exacerbate chronic stress in HIV-affected populations. Stress-reduction interventions are urgently needed for the comprehensive care of people living with HIV. Mindfulness-based stress reduction (MBSR) is one approach that has shown promise as an intervention for patients facing other medical conditions for reducing disease progression, psychological distress and maladaptive behaviours. In this systematic review, we identified 11 studies that have examined MBSR as an intervention for HIV-positive populations. Of the studies, six were randomised designs, one was a quasi-experimental design, and the remaining four were pre- and post-test designs. The preliminary outcomes support MBSR to decrease emotional distress with mixed evidence for impact on disease progression. Effect sizes were generally small to moderate in magnitude. The early findings from this emerging literature must be considered preliminary and support moving forward with more rigorous controlled trials, evaluated with objective assessments in longer-term follow-ups to determine the efficacy of MBSR for people living with HIV.

  7. A community-based cluster randomised trial of safe storage to reduce pesticide self-poisoning in rural Sri Lanka

    DEFF Research Database (Denmark)

    Pearson, Melissa; Konradsen, Flemming; Gunnell, David

    2011-01-01

    partnership between provincial health services, local and international researchers, and local communities. We discuss issues in relation to randomisation and contamination, engaging control villages, the intervention, and strategies to improve adherence. Trial Registritation The trial is registered...

  8. Homogeneity and the outcome of clinical trials: An appraisal of the outcome of recent clinical trials on endovascular intervention in acute ischemic stroke

    Directory of Open Access Journals (Sweden)

    Shakir Husain

    2016-01-01

    Full Text Available Clinical trials that allow significant heterogeneity of population or interventions often result in uncertain outcomes. In this paper, we review the outcomes of five recent trials of endovascular interventions in acute ischemic stroke in the context of the neutral results of previous large clinical trials on the subject.

  9. Therapist adherence in the strong without anorexia nervosa (SWAN) study:A randomized controlled trial of three treatments for adults with anorexia nervosa

    OpenAIRE

    2015-01-01

    Objective To develop a psychotherapy rating scale to measure therapist adherence in the Strong Without Anorexia Nervosa (SWAN) study, a multi-center randomized controlled trial comparing three different psychological treatments for adults with anorexia nervosa. The three treatments under investigation were Enhanced Cognitive Behavioural Therapy (CBT-E), the Maudsley Anorexia Nervosa Treatment for Adults (MANTRA), and Specialist Supportive Clinical Management (SSCM). Method The SWAN Psychother...

  10. Facility-level intervention to improve attendance and adherence among patients on anti-retroviral treatment in Kenya—a quasi-experimental study using time series analysis

    Science.gov (United States)

    2013-01-01

    Background Achieving high rates of adherence to antiretroviral therapy (ART) in resource-poor settings comprises serious, but different, challenges in both the first months of treatment and during the life-long maintenance phase. We measured the impact of a health system-oriented, facility-based intervention to improve clinic attendance and patient adherence. Methods This was a quasi-experimental, longitudinal, controlled intervention study using interrupted time series analysis. The intervention consisted of (1) using a clinic appointment diary to track patient attendance and monitor monthly performance; (2) changing the mode of asking for self-reported adherence; (3) training staff on adherence concepts, intervention methods, and use of monitoring data; (4) conducting visits to support facility teams with the implementation. We conducted the study in 12 rural district hospitals (6 intervention, 6 control) in Kenya and randomly selected 1894 adult patients over 18 years of age in two cohorts: experienced patients on treatment for at least one year, and newly treated patients initiating ART during the study. Outcome measures were: attending the clinic on or before the date of a scheduled appointment, attending within 3 days of a scheduled appointment, reporting perfect adherence, and experiencing a gap in medication supply of more than 14 days. Results Among experienced patients, the percentage attending the clinic on or before a scheduled appointment increased in both level (average total increase immediately after intervention) (+5.7%; 95% CI = 2.1, 9.3) and trend (increase per month) (+1.0% per month; 95% CI = 0.6, 1.5) following the intervention, as did the level and trend of those keeping appointments within three days (+4.2%; 95% CI = 1.6, 6.7; and +0.8% per month; 95% CI = 0.6, 1.1, respectively). The relative difference between the intervention and control groups based on the monthly difference in visit rates increased significantly in both

  11. [The Freiburg Intervention Trial for Obesity in Chidren (FITOC)].

    Science.gov (United States)

    Korsten-Reck, U; Wolfarth, B; Bonk, M; Keul, J; Berg, A

    2000-09-01

    Freiburg Intervention Trial for Obese Children (FITOC) is an interdisciplinary treatment program for obese children, which is established in Freiburg since 1987. Obese children at the age of 8-11 are treated in an eight months intensive period and a follow-up period of 4 months or more. Since 1990 data from 283 children coming out of 15 treatment groups (about 2 groups per year) were collected and analyzed. The program consists of regular physical training (3 times a week), comprehensive nutrition and behaviour training (overall 7 parents evenings each 4 to 6 weeks and 7 cookery courses for the kids in the same time scale). The parents evenings are filled with theoretical and practical information about nutrition as well as background information about the psychological and physiological problems in obese children. In the first examination and the regular control examinations anthropometric, biochemical and exercise physiology data are investigated. In addition, questionnaires for nutrition and behaviour are analysed on a regular basis. At each examination, depending on the progress in therapy, a new orientation with adapted goals will be discussed with the child and the parents. For the growing children a moderate reduction or long term stabilisation of weight will lead to success. Teaching goal for the children in the intensive period is to control themselves and, depending on their specific situation, to establish individual recommendations on a long term basis. The sports program should lead to an increase in self-esteem and a raise in daily energy expenditure. The team includes a physician, a nutritionist, a psychologist and a sports teacher. From 1997 the program was spread to institutions in the surroundings of Freiburg. Training for the external teams is provided for in continuous seminars. Teaching material includes a manual, forms and transparencies. The major goal is to secure quality by continuous training and close interaction between the institutions

  12. Therapist adherence in the strong without anorexia nervosa (SWAN) study: A randomized controlled trial of three treatments for adults with anorexia nervosa

    Science.gov (United States)

    Andony, Louise J; Tay, Elaine; Allen, Karina L; Wade, Tracey D; Hay, Phillipa; Touyz, Stephen; McIntosh, Virginia VW; Treasure, Janet; Schmidt, Ulrike H; Fairburn, Christopher G; Erceg-Hurn, David M; Fursland, Anthea; Crosby, Ross D; Byrne, Susan M

    2015-01-01

    Objective To develop a psychotherapy rating scale to measure therapist adherence in the Strong Without Anorexia Nervosa (SWAN) study, a multi-center randomized controlled trial comparing three different psychological treatments for adults with anorexia nervosa. The three treatments under investigation were Enhanced Cognitive Behavioural Therapy (CBT-E), the Maudsley Anorexia Nervosa Treatment for Adults (MANTRA), and Specialist Supportive Clinical Management (SSCM). Method The SWAN Psychotherapy Rating Scale (SWAN-PRS) was developed, after consultation with the developers of the treatments, and refined. Using the SWAN-PRS, two independent raters initially rated 48 audiotapes of treatment sessions to yield inter-rater reliability data. One rater proceeded to rate a total of 98 audiotapes from 64 trial participants. Results The SWAN-PRS demonstrated sound psychometric properties, and was considered a reliable measure of therapist adherence. The three treatments were highly distinguishable by independent raters, with therapists demonstrating significantly more behaviors consistent with the actual allocated treatment compared to the other two treatment modalities. There were no significant site differences in therapist adherence observed. Discussion The findings provide support for the internal validity of the SWAN study. The SWAN-PRS was deemed suitable for use in other trials involving CBT-E, MANTRA, or SSCM. © 2015 The Authors. International Journal of Eating Disorders Published by Wiley Periodicals, Inc. (Int J Eat Disord 2015; 48:1170–1175) PMID:26769445

  13. Influence of trial design, heterogeneity and regulatory environment on the results of clinical trials: An appraisal in the context of recent trials on acute stroke intervention

    Directory of Open Access Journals (Sweden)

    P R Srijithesh

    2014-01-01

    Full Text Available The outcome of randomized controlled trials can vary depending on the eligibility criteria of the patients entering into the trial, as well as the heterogeneity of the eligible population and/or the interventions. If the subject population and/or interventions are heterogeneous, the final outcome of the trial depends on the degree of concordance of effects of the subgroups of interventions on the subgroups of the subject population. The considerations that go into the calculation of sample size and determination of the study stopping rules also would affect the nature of the outcome of the study. In this paper we try to examine these phenomena with respect to the recent trials on endovascular therapy in acute ischemic stroke.

  14. Disparities in the use of a mHealth medication adherence promotion intervention for low-income adults with type 2 diabetes.

    Science.gov (United States)

    Nelson