Sample records for adherence intervention trial

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

    Haas M


    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

    Goswami NJ


    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

    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


    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

    Llobera Joan


    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.

    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 NCT01349985.

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

    Sheridan Stacey L


    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

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

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


    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

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

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


    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…

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

    Leiva A


    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

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

    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

  11. 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

    Sutton Stephen


    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

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

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


    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.

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

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


    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.

  14. 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

    Farmer Andrew


    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

  15. 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

    Natalie E. Allen


    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.

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

    Matos Margarida G


    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

  17. 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.

    Sarah Chapman


    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.

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

    Zheng Hua


    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

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

    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


    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

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

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


    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

  1. Microbicide clinical trial adherence: insights for introduction

    Cynthia Woodsong


    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.


    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


    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

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

    Ishikawa Yoshiki


    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.

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

    Alexandria M. Bass


    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.

  5. 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

    Lonsdale Chris


    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

  6. Clinical pharmacist interventions to support adherence to thrombopreventive therapy

    Hedegaard, Ulla

    individualised interventions and team-based care, e.g. integrating a clinical pharmacist with particular focus on patients’ drug-related problems. One approach with growing evidence of improving medication adherence is motivational interviewing (MI). So far, no clinical pharmacist intervention using MI has...... to the different results in the two trials is that the stroke patients - compared to the hypertension patients - may have been more motivated for taking their medication as they just experienced a serious event. Another factor is that a secondary prevention clinic was established during the stroke study, which may...... by the clinical pharmacists and the patients.  Sensitivity and specificity for the two scales of the adherence questionnaire demonstrating the best agreement with prescription-based measures were about 90% and 30%, and the agreement with refill data was fairly low with kappa values below 0.3, suggesting...

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

    Samuel Sebastian Allemann


    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

  8. Improving diabetes medication adherence: successful, scalable interventions

    Zullig LL


    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

  9. 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

    Grol Richard


    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

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

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


    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.

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

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


    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

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

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


    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.

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

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


    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

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

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


    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.

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

    Kekwaletswe CT


    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

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

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


    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…

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

    Firn Mike


    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

  18. 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

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


    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

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

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


    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.

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

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


    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.

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

    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.


    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

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

    Hogue, Aaron


    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)…

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

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


    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…

  4. 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

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


    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...

  5. Elderly adherence to hypertension treatment and nursing interventions

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


    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...

  6. Telephone interventions for adherence to colpocytological examination 1

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


    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

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

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


    Background 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. Objective 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. Methods 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. Results 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. Conclusions Gamification features have been incorporated into the design of interventions designed to treat CMD and well

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

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


    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

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

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


    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

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

    Taís de Campos Moreira


    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.

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

    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.

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

    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.

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

    Costa E


    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

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

    Farnaz Rahmani


    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.

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

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


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

    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


    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.

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

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


    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...

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

    Prados-Torres Daniel


    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

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

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


    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.

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

    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...... 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...... to the questionnaire, 44.2% of the patients had at least one item indicated an adherence problem. The DRAW©-tool used at the interview, identified 416 problems, 60% medication-related and 40% life style-related. In total 528 actions were taken divided into 8 categories. Motivational interviewing was the most frequent...

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

    Hagen, Anja


    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

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

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


    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.

  3. 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

    Kumarasamy Nagalingeswaran


    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

  4. Nutrition Intervention Trials in Linxian, China

    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

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

    Alfredo D. Oliveira-Filho


    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.

  6. Improving adherence to venous thromoembolism prophylaxis using multiple interventions

    Al-Tawfiq Jaffar


    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.

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

    Xiaoqiu Liu


    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

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

    Vrijens, B; Urquhart, J


    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.

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

    Drawz Paul E


    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.

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


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

    Simco, Russell; McCusker, Jane; Sewitch, Maida


    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…

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

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


    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…

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

    Godfrey Mary


    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

  14. 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).

    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


    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

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

    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: NCT00798772.

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

    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


    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.

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

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


    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

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

    Leila Jahangiry


    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.

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

    Jeffrey Brianne A


    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 NCT00396994

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

    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

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

    Michael H Chung


    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

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

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


    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

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

    Nerat T


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

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


    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

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

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


    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.

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

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


    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.

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

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


    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.

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

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


    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

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

    Nerat, Tomaž; Locatelli, Igor; Kos, Mitja


    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

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

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


    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…

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

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


    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.

  12. ‘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

    MacPhail C


    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

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

    Cox, Lisa E.


    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…

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

    Prevost A Toby


    % 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

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

    Kathleen M MacQueen


    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

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

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


    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.

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

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


    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

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

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


    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.

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

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


    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.

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

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


    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

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

    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 NCT

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

    Garbutt Jane M


    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

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

    Celestino Obua


    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

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

    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

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

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


    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

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

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


    : an adherence questionnaire used in the intervention and a prescription-based measure. METHODS: 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......-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...

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

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


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

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


    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…

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

    Qingyan Ma


    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

  10. 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

    Bouvy Marcel L


    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

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

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


    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.

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

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


    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…

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

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


    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 preinterven......-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...

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

    Ruan Y


    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

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

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


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

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


    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.

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

    Pino Cécile


    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 (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

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

    Bruin, de M.; Viechtbauer, W.


    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

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

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


    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…

  20. Field Trials of Health Interventions, 3rd edition

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


    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...

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

    Williams NJ


    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

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

    Lynda H. Norton


    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.

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

    Zhiyun Wang


    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.

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

    Gravel Karine


    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.

  5. Choosing a control intervention for a randomised clinical trial

    Djulbegovic Benjamin


    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.

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

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


    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.

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

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


    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.

  8. 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

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


    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

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

    Fjeldsoe Brianna S


    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

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

    Lavoie KL


    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

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

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


    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…

  12. Current status and perspectives of interventional clinical trials for glioblastoma - analysis of

    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


    The records of 208.777 (100%) clinical trials registered at 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.

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

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


    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 (

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

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


    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,…

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

    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: NCT01722734.

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

    Haile D


    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


    Madelon Novato Ribeiro


    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.

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

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


    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.

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

    Amico, K Rivet


    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.

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

    Christopher W. T. Miller


    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.

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

    Miller, Christopher W T; Himelhoch, Seth


    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.

  2. 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

    Ivanova Anna


    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.

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

    Richardson C


    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

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

    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


    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.

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

    Gemma Heath


    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.

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


    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...

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

    Cohen Jessica L


    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

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

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


    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.

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

    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)


    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-

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

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


    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

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

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


    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

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

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


    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.

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

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


    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

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

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


    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.

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

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


    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.

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

    W Jack Rejeski


    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

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

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


    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 Identifier: South African National Clinical Trials Register number (SANCTR DOH-27-1212-386); Pan Africa Trial Register (PACTR201411000724141). PMID:26769742

  18. Disproportionate Intrauterine Growth Intervention Trial At Term: DIGITAT

    Huisjes Anjoke JM


    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

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

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


    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.

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

    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

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

    Jade A Pham


    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.

  2. 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.

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


    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.

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

    Broekaert Eric


    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

  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

    Sachin Satpute


    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.

  5. 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

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


    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

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

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


    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.

  7. A pragmatic cluster randomised trial evaluating three implementation interventions

    Rycroft-Malone Jo


    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

  8. [Trials for early intervention in Mie Prefectural Mental Care Center].

    Harada, Masanori; Adachi, Takako; Iwasa, Takashi; Kurita, Kouji; Nakamura, Tomoki; Hama, Yukinobu; Yamamoto, Ayako; Maegawa, Sanae


    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.

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

    Kooij J J Sandra


    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

  10. Reporting Quality of Social and Psychological Intervention Trials: A Systematic Review of Reporting Guidelines and Trial Publications

    Grant, Sean P.; Evan Mayo-Wilson; Melendez-Torres, G. J.; Paul Montgomery


    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 ...

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

    Martin, C. Andrew


    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…

  12. Can Rapid Diagnostic Testing for Malaria Increase Adherence to Artemether-Lumefantrine?: A Randomized Controlled Trial in Uganda.

    Saran, Indrani; Yavuz, Elif; Kasozi, Howard; Cohen, Jessica


    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.

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

    Fenerty SD


    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

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

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


    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...

  15. Malaise, motivation and motherhood: predictors of engagement in behavioral interventions from a randomized controlled trial for HIV+ women in drug abuse recovery.

    Mitrani, Victoria B; Feaster, Daniel J; Weiss-Laxer, Nomi S; McCabe, Brian E


    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.

  16. Effect of exercise on cognitive performance in community-dwelling older adults: review of intervention trials and recommendations for public health practice and research.

    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


    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.

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

    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.

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

    Marcus, B H; Stanton, A L


    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.

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

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


    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.

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

    Jorge Enrique Machado-Alba


    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.

  1. Alzheimer’s disease multiple intervention trial (ADMIT: study protocol for a randomized controlled clinical trial

    Callahan Christopher M


    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

  2. Evaluation of occupational health interventions using a randomized controlled trial: challenges and alternative research designs

    Schelvis, R.M; Oude Hengel, K.M.; Burdorf, A.; Blatter, B.M.; Strijk, J.E.; Beek, A.J. van


    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

  3. Screening and brief intervention targeting risky drinkers in Danish general practice - a pragmatic controlled trial

    Beich, A.; Gannik, D.; Saelan, H.;


    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...

  4. Women, Hypertension, and the Systolic Blood Pressure Intervention Trial.

    Wenger, Nanette K; Ferdinand, Keith C; Bairey Merz, C Noel; Walsh, Mary Norine; Gulati, Martha; Pepine, Carl J


    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.

  5. Reporting quality of social and psychological intervention trials: a systematic review of reporting guidelines and trial publications.

    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

  6. 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

    Duggan Catherine


    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

  7. Efficacy trial of an Internet-based intervention for cancer-related female sexual dysfunction.

    Schover, Leslie R; Yuan, Ying; Fellman, Bryan M; Odensky, Evan; Lewis, Pamela E; Martinetti, Paul


    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.

  8. 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

    Catarina Gomes Cani


    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.

  9. The Effect of Two Educational Methods on Knowledge and Adherence to Treatment in Hemodialysis Patients: Clinical Trial

    Kobra Parvan


    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.

  10. "Did the trial kill the intervention?" experiences from the development, implementation and evaluation of a complex intervention

    Cox Karen


    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.

  11. 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

    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.

  12. Interpreting null findings from trials of alcohol brief interventions.

    Heather, Nick


    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.

  13. Evaluation of lifestyle interventions to treat elevated cardiometabolic risk in primary care (E-LITE: a randomized controlled trial

    Wilson Sandra R


    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

  14. An Open Trial of an Acceptance-Based Behavioral Intervention for Weight Loss

    Forman, Evan M.; Butryn, Meghan L.; Hoffman, Kimberly L.; Herbert, James D.


    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…

  15. 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

    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.


    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

  16. Improving medication adherence in patients with hypertension

    Hedegaard, Ulla; Kjeldsen, Lene Juel; Pottegård, Anton


    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...

  17. Preliminary findings of a randomized trial of non-pharmaceutical interventions to prevent influenza transmission in households.

    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

  18. 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.

    van Loggerenberg, Francois; Grant, Alison D; Naidoo, Kogieleum; Murrman, Marita; Gengiah, Santhanalakshmi; Gengiah, Tanuja N; Fielding, Katherine; Abdool Karim, Salim S


    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.

  19. Randomized trial of DVD, telephone, and usual care for increasing mammography adherence.

    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


    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.

  20. Use of participant focus groups to identify barriers and facilitators to worksite exercise therapy adherence in randomized controlled trials involving firefighters

    Mayer JM


    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

  1. A Multimodal Behavioral Intervention to Impact Adherence and Risk Behavior among Perinatally and Behaviorally HIV-Infected Youth: Description, Delivery, and Receptivity of Adolescent Impact

    Chandwani, Sulachni; Abramowitz, Susan; Koenig, Linda J.; Barnes, William; D'Angelo, Lawrence


    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…

  2. TextTB: A Mixed Method Pilot Study Evaluating Acceptance, Feasibility, and Exploring Initial Efficacy of a Text Messaging Intervention to Support TB Treatment Adherence

    Sarah Iribarren


    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.

  3. Adherence to the Mediterranean diet among employees in South West England: Formative research to inform a web-based, work-place nutrition intervention

    Angeliki Papadaki


    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.

  4. Motivation and Its Relationship to Adherence to Self-Monitoring and Weight Loss in a 16-Week Internet Behavioral Weight Loss Intervention

    Webber, Kelly H.; Tate, Deborah F.; Ward, Dianne S.; Bowling, J. Michael


    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)…

  5. Participant Adherence Indicators Predict Changes in Blood Pressure, Anthropometric Measures, and Self-Reported Physical Activity in a Lifestyle Intervention: HUB City Steps

    Thomson, Jessica L.; Landry, Alicia S.; Zoellner, Jamie M.; Connell, Carol; Madson, Michael B.; Molaison, Elaine Fontenot; Yadrick, Kathy


    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…

  6. A Systematic Review of Ebola Treatment Trials to Assess the Extent to Which They Adhere to Ethical Guidelines


    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

  7. 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.

    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

  8. Complaint-Directed Mini-Interventions for Depressive Complaints: A Randomized Controlled Trial of Unguided Web-Based Self-Help Interventions

    Sommers-Spijkerman, Marion; van der Poel, Agnes; Smit, Filip; Boon, Brigitte


    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; (Archived by WebCite at PMID:28052840

  9. Randomised controlled trial of tailored interventions to improve the management of anxiety and depressive disorders in primary care

    Terluin Berend


    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. 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

    P R Srijithesh


    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.

  11. Is implementing screening for distress an efficient means to recruit patients to a psychological intervention trial?

    van Scheppingen, Corinne; Schroevers, Maya J.; Pool, Grieteke; Smink, Ans; Mul, Veronique E.; Coyne, James C.; Sanderman, Robbert


    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

  12. Influence of reported study design characteristics on intervention effect estimates from randomised controlled trials

    Savović, J; Jones, He; Altman, Dg;


    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...

  13. Identifying effective and feasible interventions to accelerate functional recovery from hospitalization in older adults: A randomized controlled pilot trial.

    Deer, Rachel R; Dickinson, Jared M; Fisher, Steve R; Ju, Hyunsu; Volpi, Elena


    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.

  14. A Cognitive Behavioral Therapy–Based Text Messaging Intervention Versus Medical Management for HIV-Infected Substance Users: Study Protocol for a Pilot Randomized Trial

    Patrick, Kevin; Ybarra, Michele L; Reback, Cathy J; Rawson, Richard A; Chokron Garneau, Helene; Chavez, Kathryn; Venegas, Alexandra


    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

  15. HPTN 071 (PopART: a cluster-randomized trial of the population impact of an HIV combination prevention intervention including universal testing and treatment: mathematical model.

    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

  16. [The Freiburg Intervention Trial for Obesity in Chidren (FITOC)].

    Korsten-Reck, U; Wolfarth, B; Bonk, M; Keul, J; Berg, A


    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

  17. Mindfulness-based stress reduction for people living with HIV/AIDS: preliminary review of intervention trial methodologies and findings.

    Riley, Kristen E; Kalichman, Seth


    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.

  18. Micro-Randomized Trials: An Experimental Design for Developing Just-in-Time Adaptive Interventions

    Klasnja, Predrag; Hekler, Eric B.; Shiffman, Saul; Boruvka, Audrey; Almirall, Daniel; Tewari, Ambuj; Murphy, Susan A.


    Objective This paper presents an experimental design, the micro-randomized trial, developed to support optimization of just-in-time adaptive interventions (JITAIs). JITAIs are mHealth technologies that aim to deliver the right intervention components at the right times and locations to optimally support individuals’ health behaviors. Micro-randomized trials offer a way to optimize such interventions by enabling modeling of causal effects and time-varying effect moderation for individual intervention components within a JITAI. Methods The paper describes the micro-randomized trial design, enumerates research questions that this experimental design can help answer, and provides an overview of the data analyses that can be used to assess the causal effects of studied intervention components and investigate time-varying moderation of those effects. Results Micro-randomized trials enable causal modeling of proximal effects of the randomized intervention components and assessment of time-varying moderation of those effects. Conclusions Micro-randomized trials can help researchers understand whether their interventions are having intended effects, when and for whom they are effective, and what factors moderate the interventions’ effects, enabling creation of more effective JITAIs. PMID:26651463

  19. Design, history and results of the Thiazolidinedione Intervention with vitamin D Evaluation (TIDE) randomised controlled trial

    Punthakee, Z; Bosch, J; Dagenais, G;


    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...... (rosiglitazone and pioglitazone) on cardiovascular outcomes and the effects of vitamin D (cholecalciferol) on cancers and mortality....

  20. Walking the talk: the need for a trial registry for development interventions

    Rasmussen, Ole Dahl; Malchow-Møller, Nikolaj; Andersen, Thomas Barnebeck


    Recent advances in the use of randomised control trials to evaluate the effect of development interventions promise to enhance our knowledge of what works and why. A core argument supporting randomised studies is the claim that they have high internal validity. The authors argue that this claim i...... microfinance, they argue that a trial registry would also enhance external validity and foster innovative research....

  1. A community-based cluster randomised trial of safe storage to reduce pesticide self-poisoning in rural Sri Lanka

    Pearson, Melissa; Konradsen, Flemming; Gunnell, David


    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...

  2. A Trial of an iPad™ Intervention Targeting Social Communication Skills in Children with Autism

    Fletcher-Watson, Sue; Petrou, Alexandra; Scott-Barrett, Juliet; Dicks, Pamela; Graham, Catherine; O'Hare, Anne; Pain, Helen; McConachie, Helen


    This study evaluated a technology-based early intervention for social communication skills in pre-schoolers in a randomised controlled trial. Participants were 54 children aged under 6 years with a diagnosis of autism, assigned to either intervention or control conditions. The app engaged children, who played consistently, regardless of…

  3. Train the Trainer Effectiveness Trials of Behavioral Intervention for Individuals with Autism: A Systematic Review

    Shire, Stephanie Yoshiko; Kasari, Connie


    This systematic review examines train the trainer (TTT) effectiveness trials of behavioral interventions for individuals with autism spectrum disorder (ASD). Published methodological quality scales were used to assess studies including participant description, research design, intervention, outcomes, and analysis. Twelve studies including 9 weak…

  4. Testing Mediators of Intervention Effects in Randomized Controlled Trials: An Evaluation of Three Depression Prevention Programs

    Stice, Eric; Rohde, Paul; Seeley, John R.; Gau, Jeff M.


    Objective: Evaluate a new 5-step method for testing mediators hypothesized to account for the effects of depression prevention programs. Method: In this indicated prevention trial, at-risk teens with elevated depressive symptoms were randomized to a group cognitive-behavioral (CB) intervention, group supportive expressive intervention, CB…

  5. A Randomized Trial of a Multifaceted Intervention to Reduce Falls among Community-Dwelling Adults

    Fox, Patrick J.; Vazquez, Laurie; Tonner, Chris; Stevens, Judy A.; Fineman, Norman; Ross, Leslie K.


    Using a randomized controlled trial, we tested the efficacy of a fall prevention intervention to reduce falls among adults in a community-based health promotion program. Adults aged 65 and older within two counties were recruited (control n = 257; intervention n = 286). After 12 months, there was a significant decrease in the number of falls in…

  6. Brain Research to Ameliorate Impaired Neurodevelopment - Home-based Intervention Trial (BRAIN-HIT

    Mahantshetti Niranjana S


    Full Text Available Abstract Background This randomized controlled trial aims to evaluate the effects of an early developmental intervention program on the development of young children in low- and low-middle-income countries who are at risk for neurodevelopmental disability because of birth asphyxia. A group of children without perinatal complications are evaluated in the same protocol to compare the effects of early developmental intervention in healthy infants in the same communities. Birth asphyxia is the leading specific cause of neonatal mortality in low- and low-middle-income countries and is also the main cause of neonatal and long-term morbidity including mental retardation, cerebral palsy, and other neurodevelopmental disorders. Mortality and morbidity from birth asphyxia disproportionately affect more infants in low- and low-middle-income countries, particularly those from the lowest socioeconomic groups. There is evidence that relatively inexpensive programs of early developmental intervention, delivered during home visit by parent trainers, are capable of improving neurodevelopment in infants following brain insult due to birth asphyxia. Methods/Design This trial is a block-randomized controlled trial that has enrolled 174 children with birth asphyxia and 257 without perinatal complications, comparing early developmental intervention plus health and safety counseling to the control intervention receiving health and safety counseling only, in sites in India, Pakistan, and Zambia. The interventions are delivered in home visits every two weeks by parent trainers from 2 weeks after birth until age 36 months. The primary outcome of the trial is cognitive development, and secondary outcomes include social-emotional and motor development. Child, parent, and family characteristics and number of home visits completed are evaluated as moderating factors. Discussion The trial is supervised by a trial steering committee, and an independent data monitoring

  7. Improving understanding of clinical trial procedures among low literacy populations: an intervention within a microbicide trial in Malawi

    Ndebele Paul M


    Full Text Available Abstract Background The intervention reported in this paper was a follow up to an empirical study conducted in Malawi with the aim of assessing trial participants’ understanding of randomisation, double-blinding and placebo use. In the empirical study, the majority of respondents (61.1%; n=124 obtained low scores (lower than 75% on understanding of all three concepts under study. Based on these findings, an intervention based on a narrative which included all three concepts and their personal implications was designed. The narrative used daily examples from the field of Agriculture because Malawi has an agro-based economy. Methods The intervention was tested using a sample of 36 women who had been identified as low scorers during the empirical study. The 36 low scorers were randomly assigned to control (n=18 and intervention arms (n=18. The control arm went through a session in which they were provided with standard informed consent information for the microbicide trial. The intervention arm went through a session in which they were provided with a narrative in ChiChewa, the local language, with the assistance of a power point presentation which included pictures as well as discussions on justification and personal implications of the concepts under study. Results The findings on the efficacy of the intervention suggest that the 3 scientific concepts and their personal implications can be understood by low literacy populations using simple language and everyday local examples. The findings also suggest that the intervention positively impacted on understanding of trial procedures under study, as 13 of the 18 women in the intervention arm, obtained high scores (above 75% during the post intervention assessment and none of the 18 in the control arm obtained a high score. Using Fischer’s exact test, it was confirmed that the effect of the intervention on understanding of the three procedures was statistically significant (p=0.0001. Conclusions

  8. Therapist adherence in the strong without anorexia nervosa (SWAN) study:A randomized controlled trial of three treatments for adults with anorexia nervosa


    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...

  9. Effects of patient safety culture interventions on incident reporting in general practice : A cluster randomised trial a cluster randomised trial

    Verbakel, Natasha J.; Langelaan, Maaike; Verheij, Theo J M; Wagner, Cordula; Zwart, Dorien L M


    Background: A constructive safety culture is essential for the successful implementation of patient safety improvements. Aim: To assess the effect of two patient safety culture interventions on incident reporting as a proxy of safety culture. Design and setting: A three-arm cluster randomised trial

  10. Development of early mathematical skills with a tablet intervention: a randomized control trial in Malawi

    Nicola ePitchford


    Evaluation of educational interventions is necessary prior to wide-scale rollout. Yet very few rigorous studies have been conducted on the effectiveness of tablet-based interventions, especially in the early years and in developing countries. 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. A total sample of 318 children, spanning Standards 1-3,...

  11. Development of early mathematical skills with a tablet intervention: a randomized control trial in Malawi

    Pitchford, Nicola J.


    Evaluation of educational interventions is necessary prior to wide-scale rollout. Yet very few rigorous studies have been conducted on the effectiveness of tablet-based interventions, especially in the early years and in developing countries. 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. A total sample of 318 children, spanning Standards 1–3,...

  12. A trial of an iPad™ intervention targeting social communication skills in children with autism

    Fletcher-Watson, Susan; Petrou, Alexandra; Scott-Barrett, Juliet; Dicks, Pamela; Graham, Catriona; O'Hare, Anne; Pain, Helen; Mcconachie, Helen


    This study evaluated a technology-based early intervention for social communication skills in pre-schoolers in a randomised controlled trial. Participants were 54 children aged under 6 years old with a diagnosis of autism, assigned to either intervention or control conditions. The app engaged children, who played consistently, regardless of developmental level, and was rated highly by parents. There were no significant group differences in parent-report measures post-intervention, nor in a me...

  13. Therapist adherence in the strong without anorexia nervosa (SWAN) study: A randomized controlled trial of three treatments for adults with anorexia nervosa

    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


    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

  14. The efficacy of a brief intervention to reduce alcohol misuse in patients with HIV in South Africa: study protocol for a randomized controlled trial

    Huis in ’t Veld Diana


    Full Text Available Abstract Background Alcohol abuse comes with risks for increased morbidity and mortality among patients with HIV. This study aims to determine the prevalence of alcohol use and other risk factors in a sample of primary care patients with HIV in South Africa and to assess a brief intervention to reduce the use of alcohol in this group. Methods/Design A single-blinded randomized controlled trial is designed to determine the efficacy of a brief intervention to reduce hazardous alcohol use in patients with HIV. The study will be carried out on out-patients with HIV in two primary healthcare HIV clinics near Pretoria, South Africa. Alcohol use will be assessed with the Alcohol Use Disorder Identification Test questionnaire. Other data that will be collected relate to health-related quality of life, depression, sexual behavior, internalized AIDS stigma, HIV-related information and adherence to antiretroviral therapy (self-reported 7-day recall of missed doses, Visual Analog Scale and pill count. The intervention consists of a brief counseling session to reduce alcohol risk; the control group receives a health education leaflet. Discussion The findings will be important in the public health setting. If the intervention proves to be efficient, it could potentially be incorporated into the HIV care policy of the Ministry of Health. Trial registration Pan African Clinical trial Registry: PACTR201202000355384

  15. OARSI Clinical Trials Recommendations: Design and conduct of clinical trials of rehabilitation interventions for osteoarthritis.

    Fitzgerald, G K; Hinman, R S; Zeni, J; Risberg, M A; Snyder-Mackler, L; Bennell, K L


    A Task Force of the Osteoarthritis Research Society International (OARSI) has previously published a set of guidelines for the conduct of clinical trials in osteoarthritis (OA) of the hip and knee. Limited material available on clinical trials of rehabilitation in people with OA has prompted OARSI to establish a separate Task Force to elaborate guidelines encompassing special issues relating to rehabilitation of OA. The Task Force identified three main categories of rehabilitation clinical trials. The categories included non-operative rehabilitation trials, post-operative rehabilitation trials, and trials examining the effectiveness of devices (e.g., assistive devices, bracing, physical agents, electrical stimulation, etc.) that are used in rehabilitation of people with OA. In addition, the Task Force identified two main categories of outcomes in rehabilitation clinical trials, which include outcomes related to symptoms and function, and outcomes related to disease modification. The guidelines for rehabilitation clinical trials provided in this report encompass these main categories. The report provides guidelines for conducting and reporting on randomized clinical trials. The topics include considerations for entering patients into trials, issues related to conducting trials, considerations for selecting outcome measures, and recommendations for statistical analyses and reporting of results. The focus of the report is on rehabilitation trials for hip, knee and hand OA, however, we believe the content is broad enough that it could be applied to rehabilitation trials for other regions as well.

  16. A pilot randomized controlled trial testing a minimal intervention to prepare breast cancer survivors for recovery

    Sterba, Katherine Regan; Armeson, Kent; Franco, Regina; Harper, Jennifer; Patten, Rebecca; Kindall, Stacey; Bearden, James; Zapka, Jane


    Background Interventions addressing cancer survivors’ post-treatment concerns can be time-intensive and require specialized staff. Research is needed to identify feasible minimal intervention strategies to improve survivors’ quality of life after treatment. Objectives The objectives of this study were to evaluate the feasibility and short-term impact of a minimal clinic intervention on breast cancer survivors’ quality of life, unmet needs, distress and cancer worry. Interventions/Methods In this randomized controlled pilot trial, we enrolled breast cancer survivors at the end of treatment and administered baseline surveys. Participants were randomized to study arm (4-week video plus educational booklet intervention group and usual care group) and completed follow-up surveys at 10 weeks. Linear regression was used to examine intervention effects on quality of life outcomes controlling for clinical and demographic factors. Open-ended questions were used to examine program satisfaction and obtain feedback to improve the intervention. Results We enrolled 92 survivors in the trial. Participants rated the intervention highly and reported feeling less isolated and having more realistic expectations about their recovery after completing the program. Despite positive qualitative findings, no significant intervention effects were observed for quality of life, unmet needs, distress or cancer worry in unadjusted or adjusted analyses. Conclusions Future research is needed to define optimal intervention elements to prepare breast cancer survivors for the post-treatment period. Implications for Practice Effective survivorship interventions may require more intensive components such as clinical input and longer follow-up periods. PMID:24831043

  17. Implementing a complex rehabilitation intervention in a stroke trial: a qualitative process evaluation of AVERT

    Julie A Luker


    Full Text Available Abstract Background The implementation of multidisciplinary stroke rehabilitation interventions is challenging, even when the intervention is evidence-based. Very little is known about the implementation of complex interventions in rehabilitation clinical trials. The aim of study was to better understand how the implementation of a rehabilitation intervention in a clinical trial within acute stroke units is experienced by the staff involved. This qualitative process evaluation was part of a large Phase III stroke rehabilitation trial (AVERT. Methods A descriptive qualitative approach was used. We purposively sampled 53 allied health and nursing staff from 19 acute stroke units in Australia, New Zealand and Scotland. Semi-structured interviews were conducted by phone, voice-internet, or face to face. Digitally recorded interviews were transcribed and analysed by two researchers using rigorous thematic analysis. Results Our analysis uncovered ten important themes that provide insight into the challenges of implementing complex new rehabilitation practices within complex care settings, plus factors and strategies that assisted implementation. Themes were grouped into three main categories: staff experience of implementing the trial intervention, barriers to implementation, and overcoming the barriers. Participation in the trial was challenging but had personal rewards and improved teamwork at some sites. Over the years that the trial ran some staff perceived a change in usual care. Barriers to trial implementation at some sites included poor teamwork, inadequate staffing, various organisational barriers, staff attitudes and beliefs, and patient-related barriers. Participants described successful implementation strategies that were built on interdisciplinary teamwork, education and strong leadership to ‘get staff on board’, and developing different ways of working. Conclusions The AVERT stroke rehabilitation trial required commitment to deliver

  18. Pilot study to test the feasibility of a trial design and complex intervention on PRIoritising MUltimedication in Multimorbidity in general practices (PRIMUMpilot)

    Muth, Christiane; Harder, Sebastian; Uhlmann, Lorenz; Rochon, Justine; Fullerton, Birgit; Güthlin, Corina; Erler, Antje; Beyer, Martin; van den Akker, Marjan; Perera, Rafael; Knottnerus, André; Valderas, Jose M; Gerlach, Ferdinand M; Haefeli, Walter E


    criteria were challenging and potentially inadequate, and should therefore be adjusted. Outcome measures on pain, functionality and self-reported adherence were unfeasible due to frequent missing values, an incorrect manual or potentially invalid results. Conclusions Intervention and trial design were feasible. The pilot study revealed important limitations that influenced the design and conduct of the main study, thus highlighting the value of piloting complex interventions. Trial registration number ISRCTN99691973; Results. PMID:27456328

  19. Assessing adherence factors in patients under topical treatment: development of the Topical Therapy Adherence Questionnaire (TTAQ).

    Zschocke, Ina; Mrowietz, Ulrich; Lotzin, Annett; Karakasili, Eleni; Reich, Kristian


    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.

  20. Unraveling the EXCEL: promises and challenges of the next trial of left main percutaneous coronary intervention.

    Capodanno, Davide; Tamburino, Corrado


    The Evaluation of Xience Prime or Xience V versus Coronary Artery Bypass Surgery for Effectiveness of Left Main Revascularization (EXCEL) trial is a multicenter, ongoing trial conducted in patients with left main disease and SYNTAX score ≤ 32 to establish the presumptive advantage of percutaneous coronary intervention (PCI) versus bypass surgery in patients with less complex coronary artery disease than those enrolled in the Synergy between PCI with Taxus and Cardiac Surgery (SYNTAX) trial. In this article, we aimed at critically discussing key features and issues relevant to design and clinical interpretation of this new contemporary trial of left main PCI.

  1. The influence of wearing schemes and supportive telephone calls on adherence in accelerometry measurement: results of a randomized controlled trial

    van den Berg, Neeltje; Ulbricht, Sabina; Schwaneberg, Thea; Weitmann, Kerstin; Weymar, Franziska; Groß, Stefan; Dörr, Marcus; Hoffmann, Wolfgang


    Background Physical activity (PA) can be assessed by accelerometer monitors. However, a high adherence to wearing this device is essential to obtain valid data. In this study, the influence of different wearing schemes and additional supportive phone calls (SPCs) on adherence was examined. Methods A randomized study with four groups was conducted in the context of a health examination program among participants aged 40–75 years without a history of cardiovascular diseases. Participants were recruited in different settings (general medical practices, job center, and health insurance). The participants were asked to wear an accelerometer for 7 consecutive days according to the wearing scheme “day and night” or “day only” and received or did not receive SPCs. Full adherence was defined as a total wearing time of 98 hours (between 8 am and 10 pm during 7 days). A generalized linear model was used to calculate the difference between the maximum possible and the observed adherence. Results Adherence could be assessed for 249 participants (mean age: 56.40 years; standard deviation [SD] 9.83, 40% males). The mean wearing time was 84.04 hours (SD 20.75). Participants with the wearing scheme day and night were significantly more adherent than participants with the wearing scheme day only (incidence rate ratio [IRR] 0.63; P=0.005). SPCs had no additional effect on adherence (IRR 0.80; P=0.168). Conclusion To assess PA, the wearing scheme day and night provides the best possible adherence in this group of participants. Further studies are necessary to examine adherence and the effects of additional SPCs in other samples or settings.

  2. The impact of monitoring on adherence and persistence with antiresorptive treatment for postmenopausal osteoporosis: a randomized controlled trial.

    Clowes, Jackie A; Peel, Nicola F A; Eastell, Richard


    Long-term adherence and persistence with any therapy are very poor ( approximately 50%). Adherence to therapy is defined as the percentage of prescribed medication taken, and persistence is defined as continuing to take prescribed medication. We examined whether monitoring by nursing staff could enhance adherence and persistence with antiresorptive therapy and whether presenting information on response to therapy provided additional benefit. In addition we evaluated the impact of monitoring on treatment efficacy. Seventy-five postmenopausal women with osteopenia were randomized to 1) no monitoring, 2) nurse-monitoring, or 3) marker-monitoring. All subjects were prescribed raloxifene. At 12, 24, and 36 wk, the nursing staff reviewed subjects in the monitored (nurse-monitoring or marker-monitoring) groups using a predefined protocol. The marker-monitored group were also presented a graph of response to therapy using percentage change in urinary N-telopeptide of type I collagen (uNTX), a bone resorption marker, at each visit. Biological response to therapy at 1 yr was determined using the percent change in bone mineral density (BMD) and uNTX. Treatment adherence and persistence were assessed using electronic monitoring devices. Survival analysis showed that the monitored group increased cumulative adherence to therapy by 57% compared with no monitoring (P = 0.04). There was a trend for the monitored group to persist with therapy for 25% longer compared with no monitoring (P = 0.07). Marker measurements did not improve adherence or persistence to therapy compared with nurse-monitoring alone. Adherence at 1 yr was correlated with percent change in hip (BMD) (r = 0.28; P = 0.01) and percent change in uNTX (r = -0.36; P = 0.002). In conclusion, monitoring of patients increased adherence to therapy by 57% at 1 yr. Increased adherence to therapy increased the effectiveness of raloxifene therapy determined using surrogate end points.

  3. The OPERA trial: protocol for a randomised trial of an exercise intervention for older people in residential and nursing accommodation

    Taylor Stephanie


    Full Text Available Abstract Background Depression is common in residents of Residential and Nursing homes (RNHs. It is usually undetected and often undertreated. Depression is associated with poor outcomes including increased morbidity and mortality. Exercise has potential to improve depression, and has been shown in existing trials to improve outcomes among younger and older people. Existing evidence comes from trials that are short, underpowered and not from RNH settings. The aim of the OPERA trial is to establish whether exercise is effective in reducing the prevalence of depression among older RNH residents. Method OPERA is a cluster randomised controlled trial. RNHs are randomised to one of two groups with interventions lasting 12 months Intervention group: a depression awareness and physical activity training session for care home staff, plus a whole home physical activation programme including twice weekly physiotherapist-led exercise groups. The intervention lasts for one year from randomisation, or Control group: a depression awareness training session for care home staff. Participants are people aged 65 or over who are free of severe cognitive impairment and willing to participate in the study. Our primary outcome is the prevalence of depressive symptoms, a GDS-15 score of five or more, in all participants at the end of the one year intervention period. Our secondary depression outcomes include remission of depressive symptoms and change in GDS-15 scores in those with depressive symptoms prior to randomisation. Other secondary outcomes include, fear of falling, mobility, fractures, pain, cognition, costs and health related quality of life. We aimed to randomise 77 RNHs. Discussion Home recruitment was completed in May 2010; 78 homes have been randomised. Follow up will finish in May 2011 and results will be available late 2011. Trial Registration [ISRCTN: ISRCTN43769277

  4. Pragmatic randomized trials with new interventions : An ethical analysis

    Kalkman, Shona


    Randomized controlled clinical trials (RCTs) are considered fundamental to the optimization of health care decision-making. Today, the drug development and evaluation process is dominated by so-called explanatory RCTs. Such RCTs are carried out in highly-controlled conditions to deliver the best evi

  5. DeLLITE Depression in late life: an intervention trial of exercise. Design and recruitment of a randomised controlled trial

    Keeling Sally


    Full Text Available Abstract Background Physical activity shows potential in combating the poor outcomes associated with depression in older people. Meta-analyses show gaps in the research with poor trial design compromising certainty in conclusions and few programmes showing sustained effects. Methods/design The Depression in Late Life: an Intervention Trial of Exercise (DeLLITE is a 12 month randomised controlled trial of a physical activity intervention to increase functional status in people aged 75 years and older with depressive symptoms. The intervention involves an individualised activity programme based on goal setting and progression of difficulty of activities delivered by a trained nurse during 8 home visits over 6 months. The control group received time matched home visits to discuss social contacts and networks. Baseline, 6 and 12 months measures were assessed in face to face visits with the primary outcome being functional status (SPPB, NEADL. Secondary outcomes include depressive symptoms (Geriatric Depression Scale, quality of life (SF-36, physical activity (AHS Physical Activity Questionnaire and falls (self report. Discussion Due to report in 2008 the DeLLITE study has recruited 70% of those eligible and tests the efficacy of a home based, goal setting physical activity programme in improving function, mood and quality of life in older people with depressive symptomatology. If successful in improving function and mood this trial could prove for the first time that there are long term health benefit of physical activity, independent of social activity, in this high risk group who consume excess health related costs. Trial registration Australian and New Zealand Clinical Trials Register ACTRN12605000475640

  6. The Nordic Aortic Valve Intervention (NOTION trial comparing transcatheter versus surgical valve implantation: study protocol for a randomised controlled trial

    Thyregod Hans Gustav


    Full Text Available Abstract Background Degenerative aortic valve (AV stenosis is the most prevalent heart valve disease in the western world. Surgical aortic valve replacement (SAVR has until recently been the standard of treatment for patients with severe AV stenosis. Whether transcatheter aortic valve implantation (TAVI can be offered with improved safety and similar effectiveness in a population including low-risk patients has yet to be examined in a randomised setting. Methods/Design This randomised clinical trial will evaluate the benefits and risks of TAVI using the transarterial CoreValve System (Medtronic Inc., Minneapolis, MN, USA (intervention group compared with SAVR (control group in patients with severe degenerative AV stenosis. Randomisation ratio is 1:1, enrolling a total of 280 patients aged 70 years or older without significant coronary artery disease and with a low, moderate, or high surgical risk profile. Trial outcomes include a primary composite outcome of myocardial infarction, stroke, or all-cause mortality within the first year after intervention (expected rates 5% for TAVI, 15% for SAVR. Exploratory safety outcomes include procedure complications, valve re-intervention, and cardiovascular death, as well as cardiac, cerebral, pulmonary, renal, and vascular complications. Exploratory efficacy outcomes include New York Heart Association functional status, quality of life, and valve prosthesis and cardiac performance. Enrolment began in December 2009, and 269 patients have been enrolled up to December 2012. Discussion The trial is designed to evaluate the performance of TAVI in comparison with SAVR. The trial results may influence the choice of treatment modality for patients with severe degenerative AV stenosis. Trial registration NCT01057173

  7. Strong relationship between oral dose and tenofovir hair levels in a randomized trial: hair as a potential adherence measure for pre-exposure prophylaxis (PrEP.

    Albert Y Liu

    Full Text Available Pre-exposure prophylaxis (PrEP trials using tenofovir-based regimens have demonstrated that high levels of adherence are required to evaluate efficacy; the incorporation of objective biomarkers of adherence in trial design has been essential to interpretation, given the inaccuracy of self-report. Antiretroviral measurements in scalp hair have been useful as a marker of long-term exposure in the HIV treatment setting, and hair samples are relatively easy and inexpensive to collect, transport, and store for analysis. To evaluate the relationship between dose and tenofovir concentrations in hair, we examined the dose proportionality of tenofovir in hair in healthy, HIV-uninfected adults.A phase I, crossover pharmacokinetic study was performed in 24 HIV-negative adults receiving directly-observed oral tenofovir tablets administered 2, 4, and 7 doses/week for 6 weeks, with a ≥3-week break between periods. Small samples of hair were collected after each six-week period and analyzed for tenofovir concentrations. Geometric-mean-ratios compared levels between each pair of dosing conditions. Intensive plasma pharmacokinetic studies were performed during the daily-dosing period to calculate areas-under-the-time-concentration curves (AUCs.Over 90% of doses were observed per protocol. Median tenofovir concentrations in hair increased monotonically with dose. A log-linear relationship was seen between dose and hair levels, with an estimated 76% (95% CI 60-93% increase in hair level per 2-fold dose increase. Tenofovir plasma AUCs modestly predicted drug concentrations in hair.This study found a strong linear relationship between frequency of dosing and tenofovir levels in scalp hair. The analysis of quantitative drug levels in hair has the potential to improve adherence measurement in the PrEP field and may be helpful in determining exposure thresholds for protection and explaining failures in PrEP trials. Hair measures for adherence monitoring may also

  8. Improving the adherence of type 2 diabetes mellitus patients with pharmacy care: a systematic review of randomized controlled trials

    Antoine, Sunya-Lee; Pieper, Dawid; Mathes, Tim; Eikermann, Michaela


    Background Oral medication for patients with type 2 diabetes mellitus plays an important role in diabetes care and is associated with a high level self-care behavior and self-management. However, poor adherence to diabetes treatment is common which causes severe health complications and increased mortality. Barriers to adherence may consist of complex treatment regimens often along with long-term multi-therapies, side effects due to the medication as well as insufficient, incomprehensible or ...

  9. Project QUIT (Quit Using Drugs Intervention Trial): A randomized controlled trial of a primary care-based multi-component brief intervention to reduce risky drug use

    Gelberg, Lillian; Andersen, Ronald M.; Afifi, Abdelmonem A.; Leake, Barbara D.; Arangua, Lisa; Vahidi, Mani; Singleton, Kyle; Yacenda-Murphy, Julia; Shoptaw, Steve; Fleming, Michael F.; Baumeister, Sebastian E.


    Aims To assess the effect of a multi-component primary care (PC)-delivered BI for reducing risky drug use (RDU) among patients identified by screening. Design Multicenter single-blind two-arm randomized controlled trial of patients enrolled from February 2011 to November 2012 with 3-month follow-up. Randomization and allocation to trial group were computer-generated. Setting Primary care waiting rooms of 5 federally qualified health centers (FQHCs) in Los Angeles County (LAC), USA. Participants 334 adult primary care patients (171 intervention; 163 control) with RDU scores (4–26) on the WHO Alcohol, Smoking and Substance Involvement Screening Test (ASSIST) self-administered on tablet PCs; 261 (78%) completed follow-up. Mean age was 41.7 years; 63% were male; 38% were Caucasian. Intervention(s) and Measurement Intervention patients received brief (typically 3–4 minutes) clinician advice to quit/reduce their drug use reinforced by a video doctor message, health education booklet, and up to two 20–30 minute follow-up telephone drug use coaching sessions. Controls received usual care and cancer screening information. Primary outcome was patient self-reported use of highest scoring drug (HSD) at follow-up. Findings Intervention and control patients reported equivalent baseline HSD use; at follow-up, after adjustment for covariates in a linear regression model, intervention patients reported using their HSD an average of 2.21 fewer days in the previous month than controls (p0.10). Conclusions A clinician-delivered brief intervention with follow-up counseling calls may decrease drug use among risky users compared with usual care in low-income community health centers of Los Angeles County, USA. PMID:26471159

  10. Endoscopic vs. Surgical Interventions for Painful Chronic Pancreatitis: What is Needed for Future Clinical Trials

    Windsor, John A; Reddy, Nageshwar D


    The treatment of painful chronic pancreatitis remains controversial. The available evidence from two randomized controlled trials favor surgical intervention, whereas an endotherapy-first approach is widely practiced. Chronic pancreatitis is complex disease with different genetic and environmental factors, different pain mechanisms and different treatment modalities including medical, endoscopic, and surgical. The widely practiced step-up approach remains unproven. In designing future clinical trials there are some important pre-requisites including a more comprehensive pain assessment tool, the optimization of conservative medical treatment and interventional techniques. Consideration should be given to the need of a control arm and the optimal timing of intervention. Pending better designed studies, the practical way forward is to identify subgroups of patients who clearly warrant endotherapy or surgery first, and to design the future clinical trials for the remainder. PMID:28079861

  11. Use of peers to improve adherence to antiretroviral therapy: a global network meta-analysis

    Kanters, Steve; Park, Jay JH; Chan, Keith; Ford, Nathan; Forrest, Jamie; Thorlund, Kristian; Nachega, Jean B; Mills, Edward J


    Introduction It is unclear whether using peers can improve adherence to antiretroviral therapy (ART). To construct the World Health Organization's global guidance on adherence interventions, we conducted a systematic review and network meta-analysis to determine the effectiveness of using peers for achieving adequate adherence and viral suppression. Methods We searched for randomized clinical trials of peer-based interventions to promote adherence to ART in HIV populations. We searched six electronic databases from inception to July 2015 and major conference abstracts within the last three years. We examined the outcomes of adherence and viral suppression among trials done worldwide and those specific to low- and middle-income countries (LMIC) using pairwise and network meta-analyses. Results and discussion Twenty-two trials met the inclusion criteria. We found similar results between pairwise and network meta-analyses, and between the global and LMIC settings. Peer supporter+Telephone was superior in improving adherence than standard-of-care in both the global network (odds-ratio [OR]=4.79, 95% credible intervals [CrI]: 1.02, 23.57) and the LMIC settings (OR=4.83, 95% CrI: 1.88, 13.55). Peer support alone, however, did not lead to improvement in ART adherence in both settings. For viral suppression, we found no difference of effects among interventions due to limited trials. Conclusions Our analysis showed that peer support leads to modest improvement in adherence. These modest effects may be due to the fact that in many settings, particularly in LMICs, programmes already include peer supporters, adherence clubs and family disclosures for treatment support. Rather than introducing new interventions, a focus on improving the quality in the delivery of existing services may be a more practical and effective way to improve adherence to ART. PMID:27914185

  12. A randomised, feasibility trial of a tele-health intervention for Acute Coronary Syndrome patients with depression ('MoodCare': Study protocol

    Hare David L


    Full Text Available Abstract Background Coronary heart disease (CHD and depression are leading causes of disease burden globally and the two often co-exist. Depression is common after Myocardial Infarction (MI and it has been estimated that 15-35% of patients experience depressive symptoms. Co-morbid depression can impair health related quality of life (HRQOL, decrease medication adherence and appropriate utilisation of health services, lead to increased morbidity and suicide risk, and is associated with poorer CHD risk factor profiles and reduced survival. We aim to determine the feasibility of conducting a randomised, multi-centre trial designed to compare a tele-health program (MoodCare for depression and CHD secondary prevention, with Usual Care (UC. Methods Over 1600 patients admitted after index admission for Acute Coronary Syndrome (ACS are being screened for depression at six metropolitan hospitals in the Australian states of Victoria and Queensland. Consenting participants are then contacted at two weeks post-discharge for baseline assessment. One hundred eligible participants are to be randomised to an intervention or a usual medical care control group (50 per group. The intervention consists of up to 10 × 30-40 minute structured telephone sessions, delivered by registered psychologists, commencing within two weeks of baseline screening. The intervention focuses on depression management, lifestyle factors (physical activity, healthy eating, smoking cessation, alcohol intake, medication adherence and managing co-morbidities. Data collection occurs at baseline (Time 1, 6 months (post-intervention (Time 2, 12 months (Time 3 and 24 months follow-up for longer term effects (Time 4. We are comparing depression (Cardiac Depression Scale [CDS] and HRQOL (Short Form-12 [SF-12] scores between treatment and UC groups, assessing the feasibility of the program through patient acceptability and exploring long term maintenance effects. A cost-effectiveness analysis of

  13. The matching quality of experimental and control interventions in blinded pharmacological randomised clinical trials

    Bello, Segun; Wei, Maoling; Hilden, Jørgen


    to systematically identify and analyse studies of matching quality in drug trials. Our primary objective was to assess the proportion of studies that concluded that the matching was inadequate; our secondary objective was to describe mechanisms for inadequate matching. Methods: Systematic review. We searched Pub......Background: Blinding is a pivotal method to avoid bias in randomised clinical trials. In blinded drug trials, experimental and control interventions are often designed to be matched, i.e. to appear indistinguishable. It is unknown how often matching procedures are inadequate, so we decided......Med, Google Scholar and Web of Science Citation Index for studies that assessed whether supposedly indistinguishable interventions (experimental and control) in randomized clinical drug trials could be distinguished based on physical properties (e.g. appearance or smell). Two persons decided on study...

  14. The IMEA project: an intervention based on microfinance, entrepreneurship, and adherence to treatment for women with HIV/AIDS living in poverty.

    Arrivillaga, Marcela; Salcedo, Juan Pablo; Pérez, Mauricio


    A number of issues affect adherence to treatment and quality of life among women living with HIV/AIDS. In particular, women living in poverty have a higher risk of mortality due to their vulnerable conditions and socioeconomic exclusion. The objective of this study was to evaluate the effectiveness of an intervention that combines microfinance, entrepreneurship and adherence to treatment (IMEA) for women with HIV/AIDS and living in poverty in Cali, Colombia. A pre-post research design without a control was utilized, and 48 women were included in the study. The evaluation showed effectiveness of the program in the majority of the results (knowledge of HIV and treatment, adherence to treatment, self-efficacy, and the formation of a microenterprise) (p < 0.001); the global indicator increased from 28.3% to 85.5% (p < 0.001). The findings of this study demonstrate that the intervention was partially effective; the health outcomes showed beneficial effects. However, at the end of the study and throughout the follow-up phase, only one third of the participants were able to develop and maintain a legal operating business. It is concluded that the IMEA project should be tested in other contexts and that its consequent results should be analyzed; so it could be converted into a large scale public health program.

  15. Computer-Delivered Screening and Brief Intervention for Alcohol Use in Pregnancy: A Pilot Randomized Trial

    Ondersma, Steven J.; Beatty, Jessica R.; Svikis, Dace S.; Strickler, Ronald C.; Tzilos, Golfo K.; Chang, Grace; Divine, W.; Taylor, Andrew R.; Sokol, Robert J.


    Background Although screening and brief intervention (SBI) for unhealthy alcohol use has demonstrated efficacy in some trials, its implementation has been limited. Technology-delivered approaches are a promising alternative, particularly during pregnancy when the importance of alcohol use is amplified. The present trial evaluated the feasibility and acceptability of an interactive, empathic, video-enhanced, and computer-delivered SBI (e-SBI) plus three separate tailored mailings, and estimated intervention effects. Methods We recruited 48 pregnant women who screened positive for alcohol risk at an urban prenatal care clinic. Participants were randomly assigned to the e-SBI plus mailings or to a control session on infant nutrition, and were reevaluated during their postpartum hospitalization. The primary outcome was 90-day period-prevalence abstinence as measured by timeline follow-back interview. Results Participants rated the intervention as easy to use and helpful (4.7-5.0 on a 5-point scale). Blinded follow-up evaluation at childbirth revealed medium-size intervention effects on 90-day period prevalence abstinence (OR = 3.4); similarly, intervention effects on a combined healthy pregnancy outcome variable (live birth, normal birthweight, and no NICU stay) were also of moderate magnitude in favor of e-SBI participants (OR=3.3). As expected in this intentionally under-powered pilot trial, these effects were non-significant (p = .19 and .09, respectively). Conclusions This pilot trial demonstrated the acceptability and preliminary efficacy of a computer-delivered screening and brief intervention (e-SBI) plus tailored mailings for alcohol use in pregnancy. These findings mirror the promising results of other trials using a similar approach, and should be confirmed in a fully-powered trial. PMID:26010235

  16. A new combined strategy to implement a community occupational therapy intervention: designing a cluster randomized controlled trial

    Adang Eddy


    Full Text Available Abstract Background Even effective interventions for people with dementia and their caregivers require specific implementation efforts. A pilot study showed that the highly effective community occupational therapy in dementia (COTiD program was not implemented optimally due to various barriers. To decrease these barriers and make implementation of the program more effective a combined implementation (CI strategy was developed. In our study we will compare the effectiveness of this CI strategy with the usual educational (ED strategy. Methods In this cluster randomized, single-blinded, controlled trial, each cluster consists of at least two occupational therapists, a manager, and a physician working at Dutch healthcare organizations that deliver community occupational therapy. Forty-five clusters, stratified by healthcare setting (nursing home, hospital, mental health service, have been allocated randomly to either the intervention group (CI strategy or the control group (ED strategy. The study population consists of the professionals included in each cluster and community-dwelling people with dementia and their caregivers. The primary outcome measures are the use of community OT, the adherence of OTs to the COTiD program, and the cost effectiveness of implementing the COTiD program in outpatient care. Secondary outcome measures are patient and caregiver outcomes and knowledge of managers, physicians and OTs about the COTiD program. Discussion Implementation research is fairly new in the field of occupational therapy, making this a unique study. This study does not only evaluate the effects of the CI-strategy on professionals, but also the effects of professionals' degree of implementation on client and caregiver outcomes. Clinical trials registration NCT01117285

  17. Cost-effectiveness of interventions to prevent HIV and STDs among women: a randomized controlled trial.

    Ruger, Jennifer Prah; Abdallah, Arbi Ben; Ng, Nora Y; Luekens, Craig; Cottler, Linda


    Injection drug use is a leading transmission route of HIV and STDs, and disease prevention among drug users is an important public health concern. This study assesses cost-effectiveness of behavioral interventions for reducing HIV and STDs infections among injection drug-using women. Cost-effectiveness analysis was conducted from societal and provider perspectives for randomized trial data and Bernoullian model estimates of infections averted for three increasingly intensive interventions: (1) NIDA's standard intervention (SI); (2) SI plus a well woman exam (WWE); and (3) SI, WWE, plus four educational sessions (4ES). Trial results indicate that 4ES was cost-effective relative to WWE, which was dominated by SI, for most diseases. Model estimates, however, suggest that WWE was cost-effective relative to SI and dominated 4ES for all diseases. Trial and model results agree that WWE is cost-effective relative to SI per hepatitis C infection averted ($109 308 for in trial, $6 016 in model) and per gonorrhea infection averted ($9 461 in trial, $14 044 in model). In sensitivity analysis, trial results are sensitive to 5 % change in WWE effectiveness relative to SI for hepatitis C and HIV. In the model, WWE remained cost-effective or cost-saving relative to SI for HIV prevention across a range of assumptions. WWE is cost-effective relative to SI for preventing hepatitis C and gonorrhea. WWE may have similar effects as the costlier 4ES.

  18. Decision support for evidence-based pharmacotherapy detects adherence problems but does not impact medication use.

    Willis, Janese M; Edwards, Rex; Anstrom, Kevin J; Johnson, Fred S; Del Fiol, Guilherme; Kawamoto, Kensaku; Lapointe, Nancy M Allen; Eisenstein, Eric L; Lobach, David F


    Although evidence-based pharmacotherapies are a principal component of patient care, 30-50% of patients do not take their medications as prescribed. We conducted a randomized trial of two clinical decision support (CDS) interventions in 2219 patients: patient adherence reports to providers (n=744), patient adherence reports to providers + email notices to care managers (n=736), and controls (739). At 18-month follow-up, there were no treatment-related differences in patient medication adherence (overall, by medication class, and by medical condition). There also were no treatment-related differences in patient clinical and economic outcomes. Thus, while this study's CDS information interventions were successfully delivered to providers and care managers, and were effective in identifying medication adherence deficits and in increasing care manager responses to medication adherences issues, these interventions were not able to alter patient medication behavior.

  19. Do Hospitalized Premature Infants Benefit from Music Interventions? A Systematic Review of Randomized Controlled Trials

    Van Der Heijden, Marianne J. E.; Araghi, Sadaf Oliai; Jeekel, Hans; Reiss, Irwin; Hunink, M G M; van Dijk, Monique


    textabstractObjective: Neonatal intensive care units (NICU) around the world increasingly use music interventions. The most recent systematic review of randomized controlled trials (RCT) dates from 2009. Since then, 15 new RCTs have been published. We provide an updated systematic review on the possible benefits of music interventions on premature infants' well-being. Methods: We searched 13 electronic databases and 12 journals from their first available date until August 2016. Included were ...

  20. Psychotherapeutic process of cognitive-behavioral intervention in HIV-infected persons: Results from a controlled, randomized prospective clinical trial

    Znoj, H J; Messerli-Burgy, N; Tschopp, S; Weber, R.; Christen, L; Christen, S; Grawe, K


    The aim of this exploratory study was to examine the possible mechanisms of behavioral change in a cognitive-behavioral intervention supporting medication adherence in HIV-infected persons. A total of 60 persons currently under medical treatment were randomized to psychotherapy or usual care and were compared with a sociodemographically matched group of general psychotherapy clients. Outcome measures included therapy adherence using medication event-monitoring system psychotherapeutic process...

  1. Implementation of a Manualized Communication Intervention for School-Aged Children with Pragmatic and Social Communication Needs in a Randomized Controlled Trial: The Social Communication Intervention Project

    Adams, Catherine; Lockton, Elaine; Gaile, Jacqueline; Earl, Gillian; Freed, Jenny


    Background: Speech-language interventions are often complex in nature, involving multiple observations, variable outcomes and individualization in treatment delivery. The accepted procedure associated with randomized controlled trials (RCT) of such complex interventions is to develop and implement a manual of intervention in order that reliable…

  2. Effect of dietary intervention on serum lignan levels in pregnant women - a controlled trial

    Mäkelä Sari


    Full Text Available Abstract Background Mother's diet during pregnancy is important, since plant lignans and their metabolites, converted by the intestinal microflora to enterolignans, are proposed to possess multiple health benefits. Aim of our study was to investigate whether a dietary intervention affects lignan concentrations in the serum of pregnant women. Methods A controlled dietary intervention trial including 105 first-time pregnant women was conducted in three intervention and three control maternity health clinics. The intervention included individual counseling on diet and on physical activity, while the controls received conventional care. Blood samples were collected on gestation weeks 8-9 (baseline and 36-37 (end of intervention. The serum levels of the plant lignans 7-hydroxymatairesinol, secoisolariciresinol, matairesinol, lariciresinol, cyclolariciresinol, and pinoresinol, and of the enterolignans 7-hydroxyenterolactone, enterodiol, and enterolactone, were measured using a validated method. Results The baseline levels of enterolactone, enterodiol and the sum of lignans were higher in the control group, whereas at the end of the trial their levels were higher in the intervention group. The adjusted mean differences between the baseline and end of the intervention for enterolactone and the total lignan intake were 1.6 ng/ml (p = 0.018, 95% CI 1.1-2.3 and 1.4 ng/mg (p = 0.08, 95% CI 1.0-1.9 higher in the intervention group than in the controls. Further adjustment for dietary components did not change these associations. Conclusion The dietary intervention was successful in increasing the intake of lignan-rich food products, the fiber consumption and consequently the plasma levels of lignans in pregnant women. Trial registration ISRCTN21512277,

  3. Evaluation of an Intervention among Adolescents to Reduce Preventive Misconception in HIV Vaccine Clinical Trials

    Lally, Michelle; Goldsworthy, Richard; Sarr, Moussa; Kahn, Jessica; Brown, Larry; Peralta, Ligia; Zimet, Greg


    Purpose Placebo and randomization are important concepts that must be understood before youth can safely participate in HIV vaccine studies or other biomedical trials for HIV prevention. These concepts are central to the phenomenon of preventive misconception which may be associated with an increase in risk behavior among study participants related to mistaken beliefs. Persuasive messaging, traditionally used in the field of marketing, could enhance educational efforts associated with randomized clinical trials. Methods Two educational brochures were designed to increase knowledge about HIV vaccine clinical trials via 1 and 2-sided persuasive messaging. Through the Adolescent Medicine Trials Network, 120 youth were enrolled, administered a mock HIV vaccine trial consent, and then randomized to receive either no supplemental information or one of the two brochures. Results The 2-sided brochure group in which common clinical trial misconceptions were acknowledgedand then refuted had significantly higher scores on knowledge of randomization and interpretation of side effects than the consent-only control group, and willingness to participate in an HIV vaccine trial was not decreased with the use of this brochure. Conclusion Two sided persuasive messaging improves understanding of the concepts of randomization and placebo among youth who would consider participating in an HIV vaccine trial. Further evaluation of this approach should be considered for at-risk youth participating in an actual trial of a biomedical intervention for HIV prevention. PMID:24613097

  4. CanWalk: a feasibility study with embedded randomised controlled trial pilot of a walking intervention for people with recurrent or metastatic cancer

    Tsianakas, Vicki; Ream, Emma; Van Hemelrijck, Mieke; Purushotham, Arnie; Mucci, Lorelei; Green, James S A; Fewster, Jacquetta; Armes, Jo


    Objectives Walking is an adaptable, inexpensive and accessible form of physical activity. However, its impact on quality of life (QoL) and symptom severity in people with advanced cancer is unknown. This study aimed to assess the feasibility and acceptability of a randomised controlled trial (RCT) of a community-based walking intervention to enhance QoL in people with recurrent/metastatic cancer. Design We used a mixed-methods design comprising a 2-centre RCT and nested qualitative interviews. Participants Patients with advanced breast, prostate, gynaecological or haematological cancers randomised 1:1 between intervention and usual care. Intervention The intervention comprised Macmillan's ‘Move More’ information, a short motivational interview with a recommendation to walk for at least 30 min on alternate days and attend a volunteer-led group walk weekly. Outcomes We assessed feasibility and acceptability of the intervention and RCT by evaluating study processes (rates of recruitment, consent, retention, adherence and adverse events), and using end-of-study questionnaires and qualitative interviews. Patient-reported outcome measures (PROMs) assessing QoL, activity, fatigue, mood and self-efficacy were completed at baseline and 6, 12 and 24 weeks. Results We recruited 42 (38%) eligible participants. Recruitment was lower than anticipated (goal n=60), the most commonly reported reason being unable to commit to walking groups (n=19). Randomisation procedures worked well with groups evenly matched for age, sex and activity. By week 24, there was a 45% attrition rate. Most PROMs while acceptable were not sensitive to change and did not capture key benefits. Conclusions The intervention was acceptable, well tolerated and the study design was judged acceptable and feasible. Results are encouraging and demonstrate that exercise was popular and conveyed benefit to participants. Consequently, an effectiveness RCT is warranted, with some modifications to the

  5. Improvement of pain related self management for oncologic patients through a trans institutional modular nursing intervention: protocol of a cluster randomized multicenter trial

    Thoke-Colberg Anette


    Full Text Available Abstract Background Pain is one of the most frequent and distressing symptoms in cancer patients. For the majority of the patients, sufficient pain relief can be obtained if adequate treatment is provided. However, pain remains often undertreated due to institutional, health care professional and patient related barriers. Patients self management skills are affected by the patients' knowledge, activities and attitude to pain management. This trial protocol is aimed to test the SCION-PAIN program, a multi modular structured intervention to improve self management in cancer patients with pain. Methods 240 patients with diagnosed malignancy and pain > 3 days and average pain ≥ 3/10 will participate in a cluster randomized trial on 18 wards in 2 German university hospitals. Patients from the intervention wards will receive, additionally to standard pain treatment, the SCION-PAIN program consisting of 3 modules: pharmacologic pain management, nonpharmacologic pain management and discharge management. The intervention will be conducted by specially trained oncology nurses and includes components of patient education, skills training and counseling to improve self care regarding pain management beginning with admission followed by booster session every 3rd day and one follow up telephone counseling within 2 to 3 days after discharge. Patients in the control group will receive standard care. Primary endpoint is the group difference in patient related barriers to management of cancer pain (BQII, 7 days after discharge. Secondary endpoints are: pain intensity & interference, adherence, coping and HRQoL. Discussion The study will determine if the acquired self management skills of the patients continue to be used after discharge from hospital. It is hypothesized that patients who receive the multi modular structured intervention will have less patient related barriers and a better self management of cancer pain. Trial Registration ClinicalTrials NCT

  6. Randomized Controlled Trial of the Resilience and Coping Intervention (RCI) with Undergraduate University Students

    Houston, J. Brian; First, Jennifer; Spialek, Matthew L.; Sorenson, Mary E.; Mills-Sandoval, Toby; Lockett, McKenzie; First, Nathan L.; Nitiéma, Pascal; Allen, Sandra F.; Pfefferbaum, Betty


    Objective: The purpose of this pilot study was to evaluate the Resilience and Coping Intervention (RCI) with college students. Participants: College students (aged 18-23) from a large Midwest US university who volunteered for a randomized controlled trial during the 2015 spring semester. Methods: College students were randomly assigned to an…

  7. Mathematical Model for Addiction: Application to Multiple Risk Factor Intervention Trial Data for Smoking.

    Fan, David P.; Elketroussi, Mehdi


    Describes habituation and addiction, both psychological and physiological, using simple equations of mathematical model of ideodynamics, optimized to smoking data from Multiple Risk Factor Intervention Trial (MRFIT) program. With only four constant parameters, it was possible to calculate accurate time trends for recidivism to smoking among…

  8. Fraction Intervention for Students with Mathematics Difficulties: Lessons Learned from Five Randomized Control Trials

    Fuchs, Lynn S.; Malone, Amelia S.; Schumacher, Robin F.; Namkung, Jessica; Wang, Amber


    The purpose of this article was to summarize results from 5 randomized control trials assessing the effects of intervention to improve the fraction performance of 4th-grade students at-risk for difficulty in learning about fractions. We begin by explaining the importance of competence with fractions and why an instructional focus on fractions…

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

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


    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 evaluated the feasibility and preliminary outcomes of the Multimodal Anxiety and Social Skills Intervention (MASSI) program in a sample of 30…

  10. Effectiveness of a Therapeutic Summer Camp for Children with ADHD: Phase I Clinical Intervention Trial

    Hantson, Julie; Wang, Pan Pan; Grizenko-Vida, Michael; Ter-Stepanian, Marina; Harvey, William; Joober, Ridha; Grizenko, Natalie


    Objective: The objective of this study was to evaluate the effectiveness of a 2-week therapeutic summer day camp for children with ADHD, which included a social skills training program and parent psychoeducation and training program. This was an open-label, nonrandomized Phase I Clinical Intervention Trial. Method: Parents completed the Weiss…

  11. Effects of patient safety culture interventions on incident reporting in general practice: a cluster randomised trial.

    Verbakel, N.J.; Langelaan, M.; Verheij, T.J.M.; Wagner, C.; Zwart, D.L.M.


    Background A constructive safety culture is essential for the successful implementation of patient safety improvements. Aim To assess the effect of two patient safety culture interventions on incident reporting as a proxy of safety culture. Design and setting A three-arm cluster randomised trial was

  12. A Randomized Clinical Trial of Alternative Stress Management Interventions in Persons with HIV Infection

    McCain, Nancy L.; Gray, D. Patricia; Elswick, R. K., Jr.; Robins, Jolynne W.; Tuck, Inez; Walter, Jeanne M.; Rausch, Sarah M.; Ketchum, Jessica McKinney


    Research in psychoneuroimmunology suggests that immunosuppression associated with perceived stress may contribute to disease progression in persons with HIV infection. While stress management interventions may enhance immune function, few alternative approaches have yet been tested. This randomized clinical trial was conducted to test effects of…

  13. Do hospitalized premature infants benefit from music interventions? A systematic review of randomized controlled trials

    M.J.E. Van Der Heijden (Marianne J. E.); S.O. Araghi (Sadaf Oliai); J. Jeekel (Hans); I.K.M. Reiss (Irwin); Hunink, M.G.M. (M.G. Myriam); M. Van Dijk (Monique)


    textabstractObjective: Neonatal intensive care units (NICU) around the world increasingly use music interventions. The most recent systematic review of randomized controlled trials (RCT) dates from 2009. Since then, 15 new RCTs have been published. We provide an updated systematic review on the poss

  14. Randomized Controlled Trial of a Preventive Intervention for Perinatal Depression in High-Risk Latinas

    Le, Huynh-Nhu; Perry, Deborah F.; Stuart, Elizabeth A.


    Objective: A randomized controlled trial was conducted to evaluate the efficacy of a cognitive-behavioral (CBT) intervention to prevent perinatal depression in high-risk Latinas. Method: A sample of 217 participants, predominantly low-income Central American immigrants who met demographic and depression risk criteria, were randomized into usual…

  15. A new generation of pragmatic trials of psychosocial interventions is needed.

    Ruggeri, M; Lasalvia, A; Bonetto, C


    This Editorial addresses the crucial issue of which research methodology is most suited for capturing the complexity of psychosocial interventions conducted in 'real world' mental health settings. It first examines conventional randomized controlled trial (RCT) methodology and critically appraises its strengths and weaknesses. It then considers the specificity of mental health care treatments and defines the term 'complex' intervention and its implications for RCT design. The salient features of pragmatic RCTs aimed at generating evidence of psychosocial intervention effectiveness are then described. Subsequently, the conceptualization of pragmatic RCTs, and of their further developments - which we propose to call 'new generation' pragmatic trials - in the broader routine mental health service context, is explored. Helpful tools for planning pragmatic RCTs, such as the CONSORT extension for pragmatic trials, and the PRECIS tool are also examined. We then discuss some practical challenges that are involved in the design and implementation of pragmatic trials based on our own experience in conducting the GET UP PIANO Trial. Lastly, we speculate on the ways in which current ideas on the purpose, scope and ethics of mental health care research may determine further challenges for clinical research and evidence-based practice.

  16. Assessing treatment-as-usual provided to control groups in adherence trials: Exploring the use of an open-ended questionnaire for identifying behaviour change techniques

    Oberjé, E.J.M.; Dima, A.L.; Pijnappel, F.J.; Prins, J.M.; Bruin, M. de


    OBJECTIVE: Reporting guidelines call for descriptions of control group support in equal detail as for interventions. However, how to assess the active content (behaviour change techniques (BCTs)) of treatment-as-usual (TAU) delivered to control groups in trials remains unclear. The objective of this

  17. A simplified combination antiretroviral therapy regimen enhances adherence, treatment satisfaction and quality of life : results of a randomized clinical trial

    Langebeek, N.; Sprenger, H. G.; Gisolf, E. H.; Reiss, P.; Sprangers, M. A. G.; Legrand, J. C.; Richter, C.; Nieuwkerk, P. T.


    Objectives The aim of the study was to investigate the effect of a simplified regimen, in terms of reducing pill burden, dietary requirements and possible adverse effects, on patients' adherence, treatment satisfaction and quality of life (QoL). Methods Antiretroviral-naive patients who achieved a v

  18. Postgraduate education to increase adherence to a Dutch physiotherapy practice guideline for hip and knee OA: a randomized controlled trial

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


    OBJECTIVE: To compare the effectiveness of two educational courses aiming to improve adherence to recommendations in a Dutch physiotherapy practice guideline for hip and knee OA. METHODS: Physiotherapists (PTs) from three regions in The Netherlands were invited to participate in a study comparing an

  19. Brief intervention to reduce risky drinking in pregnancy: study protocol for a randomized controlled trial

    Wilson Graeme B


    Full Text Available Abstract Background Risky drinking in pregnancy by UK women is likely to result in many alcohol-exposed pregnancies. Studies from the USA suggest that brief intervention has promise for alcohol risk reduction in antenatal care. However, further research is needed to establish whether this evidence from the USA is applicable to the UK. This pilot study aims to investigate whether pregnant women can be recruited and retained in a randomized controlled trial of brief intervention aimed at reducing risky drinking in women receiving antenatal care. Methods The trial will rehearse the parallel-group, non-blinded design and procedures of a subsequent definitive trial. Over 8 months, women aged 18 years and over (target number 2,742 attending their booking appointment with a community midwife (n = 31 in north-east England will be screened for alcohol consumption using the consumption questions of the Alcohol Use Disorders Identification Test (AUDIT-C. Those screening positive, without a history of substance use or alcohol dependence, with no pregnancy complication, and able to give informed consent, will be invited to participate in the trial (target number 120. Midwives will be randomized in a 1:1 ratio to deliver either treatment as usual (control or structured brief advice and referral for a 20-minute motivational interviewing session with an alcohol health worker (intervention. As well as demographic and health information, baseline measures will include two 7-day time line follow-back questionnaires and the EuroQoL EQ-5D-3 L questionnaire. Measures will be repeated in telephone follow-ups in the third trimester and at 6 months post-partum, when a questionnaire on use of National Health Service and social care resources will also be completed. Information on pregnancy outcomes and stillbirths will be accessed from central health service records before the follow-ups. Primary outcomes will be rates of eligibility, recruitment, intervention

  20. The Infant Feeding Activity and Nutrition Trial (INFANT an early intervention to prevent childhood obesity: Cluster-randomised controlled trial

    Campbell Karen


    Full Text Available Abstract Background Multiple factors combine to support a compelling case for interventions that target the development of obesity-promoting behaviours (poor diet, low physical activity and high sedentary behaviour from their inception. These factors include the rapidly increasing prevalence of fatness throughout childhood, the instigation of obesity-promoting behaviours in infancy, and the tracking of these behaviours from childhood through to adolescence and adulthood. The Infant Feeding Activity and Nutrition Trial (INFANT aims to determine the effectiveness of an early childhood obesity prevention intervention delivered to first-time parents. The intervention, conducted with parents over the infant's first 18 months of life, will use existing social networks (first-time parent's groups and an anticipatory guidance framework focusing on parenting skills which support the development of positive diet and physical activity behaviours, and reduced sedentary behaviours in infancy. Methods/Design This cluster-randomised controlled trial, with first-time parent groups as the unit of randomisation, will be conducted with a sample of 600 first-time parents and their newborn children who attend the first-time parents' group at Maternal and Child Health Centres. Using a two-stage sampling process, local government areas in Victoria, Australia will be randomly selected at the first stage. At the second stage, a proportional sample of first-time parent groups within selected local government areas will be randomly selected and invited to participate. Informed consent will be obtained and groups will then be randomly allocated to the intervention or control group. Discussion The early years hold promise as a time in which obesity prevention may be most effective. To our knowledge this will be the first randomised trial internationally to demonstrate whether an early health promotion program delivered to first-time parents in their existing social groups

  1. Randomized, controlled intervention trial of male circumcision for reduction of HIV infection risk: the ANRS 1265 Trial.


    Full Text Available BACKGROUND: Observational studies suggest that male circumcision may provide protection against HIV-1 infection. A randomized, controlled intervention trial was conducted in a general population of South Africa to test this hypothesis. METHODS AND FINDINGS: A total of 3,274 uncircumcised men, aged 18-24 y, were randomized to a control or an intervention group with follow-up visits at months 3, 12, and 21. Male circumcision was offered to the intervention group immediately after randomization and to the control group at the end of the follow-up. The grouped censored data were analyzed in intention-to-treat, univariate and multivariate, analyses, using piecewise exponential, proportional hazards models. Rate ratios (RR of HIV incidence were determined with 95% CI. Protection against HIV infection was calculated as 1 - RR. The trial was stopped at the interim analysis, and the mean (interquartile range follow-up was 18.1 mo (13.0-21.0 when the data were analyzed. There were 20 HIV infections (incidence rate = 0.85 per 100 person-years in the intervention group and 49 (2.1 per 100 person-years in the control group, corresponding to an RR of 0.40 (95% CI: 0.24%-0.68%; p < 0.001. This RR corresponds to a protection of 60% (95% CI: 32%-76%. When controlling for behavioural factors, including sexual behaviour that increased slightly in the intervention group, condom use, and health-seeking behaviour, the protection was of 61% (95% CI: 34%-77%. CONCLUSION: Male circumcision provides a degree of protection against acquiring HIV infection, equivalent to what a vaccine of high efficacy would have achieved. Male circumcision may provide an important way of reducing the spread of HIV infection in sub-Saharan Africa. (Preliminary and partial results were presented at the International AIDS Society 2005 Conference, on 26 July 2005, in Rio de Janeiro, Brazil..

  2. Lifestyle Intervention on Metabolic Syndrome and its Impact on Quality of Life: A Randomized Controlled Trial

    Saboya, Patrícia Pozas; Bodanese, Luiz Carlos; Zimmermann, Paulo Roberto; Gustavo, Andreia da Silva; Macagnan, Fabricio Edler; Feoli, Ana Pandolfo; Oliveira, Margareth da Silva


    Background Lifestyle intervention programs can reduce the prevalence of metabolic syndrome (MetS) and, therefore, reduce the risk for cardiac disease, one of the main public health problems nowadays. Objective The aim of this study was to compare the effects of three types of approach for lifestyle change programs in the reduction of metabolic parameters, and to identify its impact on the quality of life (QOL) of individuals with MetS. Methods A randomized controlled trial included 72 individuals with MetS aged 30-59 years. Individuals were randomized into three groups of multidisciplinary intervention [Standard Intervention (SI) - control group; Group Intervention (GI); and Individual Intervention (II)] during 12 weeks. The primary outcome was change in the metabolic parameters, and secondarily, the improvement in QOL measures at three moments: baseline, 3 and 9 months. Results Group and individual interventions resulted in a significant reduction in body mass index, waist circumference, systolic blood pressure at 3 months and the improvement of QOL, although it was significantly associated with the physical functioning domain. However, these changes did not remain 6 months after the end of intervention. Depression and anxiety were significantly associated with worse QOL, although they showed no effect on the response to intervention. Conclusion Multidisciplinary intervention, especially in a group, might be an effective and economically feasible strategy in the control of metabolic parameters of MetS and improvement of QOL compared to SI, even in a dose-effect relationship. PMID:27982160

  3. Participant adherence to the Internet-based prevention program StudentBodies™ for eating disorders — A review

    Ina Beintner


    Adherence to StudentBodies™ proved to be high across a number of trials, settings and countries. These findings are promising, but it is likely that adherence will be distinctly lower in the general public than in research settings, and intervention effects will turn out smaller. However, the intervention is readily available at minimal cost per participant, and the public health impact may still be notable.

  4. Models in the delivery of depression care: A systematic review of randomised and controlled intervention trials

    Clack Dannielle


    Full Text Available Abstract Background There is still debate as to which features, types or components of primary care interventions are associated with improved depression outcomes. Previous reviews have focused on components of collaborative care models in general practice settings. This paper aims to determine the effective components of depression care in primary care through a systematic examination of both general practice and community based intervention trials. Methods Fifty five randomised and controlled research trials which focused on adults and contained depression outcome measures were identified through PubMed, PsycInfo and the Cochrane Central Register of Controlled Trials databases. Trials were classified according to the components involved in the delivery of treatment, the type of treatment, the primary focus or setting of the study, detailed features of delivery, and the discipline of the professional providing the treatment. The primary outcome measure was significant improvement on the key depression measure. Results Components which were found to significantly predict improvement were the revision of professional roles, the provision of a case manager who provided direct feedback and delivered a psychological therapy, and an intervention that incorporated patient preferences into care. Nurse, psychologist and psychiatrist delivered care were effective, but pharmacist delivery was not. Training directed to general practitioners was significantly less successful than interventions that did not have training as the most important intervention. Community interventions were effective. Conclusion Case management is important in the provision of care in general practice. Certain community models of care (education programs have potential while others are not successful in their current form (pharmacist monitoring.

  5. Falls Assessment Clinical Trial (FACT: design, interventions, recruitment strategies and participant characteristics

    Lawton Beverley


    Full Text Available Abstract Background Guidelines recommend multifactorial intervention programmes to prevent falls in older adults but there are few randomised controlled trials in a real life health care setting. We describe the rationale, intervention, study design, recruitment strategies and baseline characteristics of participants in a randomised controlled trial of a multifactorial falls prevention programme in primary health care. Methods Participants are patients from 19 primary care practices in Hutt Valley, New Zealand aged 75 years and over who have fallen in the past year and live independently. Two recruitment strategies were used – waiting room screening and practice mail-out. Intervention participants receive a community based nurse assessment of falls and fracture risk factors, home hazards, referral to appropriate community interventions, and strength and balance exercise programme. Control participants receive usual care and social visits. Outcome measures include number of falls and injuries over 12 months, balance, strength, falls efficacy, activities of daily living, quality of life, and physical activity levels. Results 312 participants were recruited (69% women. Of those who had fallen, 58% of people screened in the practice waiting rooms and 40% when screened by practice letter were willing to participate. Characteristics of participants recruited using the two methods are similar (p > 0.05. Mean age of all participants was 81 years (SD 5. On average participants have 7 medical conditions, take 5.5 medications (29% on psychotropics with a median of 2 falls (interquartile range 1, 3 in the previous year. Conclusion The two recruitment strategies and the community based intervention delivery were feasible and successful, identifying a high risk group with multiple falls. Recruitment in the waiting room gave higher response rates but was less efficient than practice mail-out. Testing the effectiveness of an evidence based intervention in a

  6. Spontaneous improvement in randomised clinical trials: meta-analysis of three-armed trials comparing no treatment, placebo and active intervention

    Krogsbøll, Lasse Theis; Hróbjartsson, Asbjørn; Gøtzsche, Peter C


    were psychological in 17 trials, physical in 15 trials, and pharmacological in 5 trials. Overall, across all conditions and interventions, there was a statistically significant change from baseline in all three arms. The standardized mean difference (SMD) for change from baseline was -0.24 (95...... from baseline, and we aimed at quantifying these contributions. METHODS: Systematic review and meta-analysis, based on a Cochrane review of the effect of placebo interventions for all clinical conditions. We selected all trials that had randomised the patients to three arms: no treatment, placebo...

  7. The effect on survival of a multidimensional intervention project (SEAD in HIV/AIDS patients with follow-up and adherence (FUP/ADH barriers

    M Pérez Elías


    Full Text Available Purpose of the study: Irregular FUP/ADH were associated with higher mortality and resource use [1]. SEAD was a multidimensional intervention project, designed from the patient's perspective, to specifically attend patients with poor FUP/ADH in an HIV/AIDS outpatient clinic. Methods: From Jan 2006 to May 2010, patients with poor FUP/ADH were offered SEAD inclusion, all were evaluated by a nurse or a psychologist (adherence collaborators who assessed all the reasons and barriers precluding a correct FUP/ADH. For each identified problem, different interventions were planned, using our own resources or coordinating others. Follow-up was censored in Nov 2011. Time to death after being admitted to SEAD and the effect of SEAD program intervention were assessed with Kaplan-Meier curves, log-Rank test and a Cox regression model. Summary of results: Overall, 215 patients were assessed: mean age 45 years, 24% women, IDU 75%, with baseline ADH >90% in only 23%; median HIV-RNA and CD4 cell count were 377 copies/ml and 326 cell/mcL. Patients entered in SEAD due to poor ADH in 17%, FUP problems in 23%, and both 60%. Main reasons driving poor FUP/ADH were severe bio-psycho-social problems 28%, severe drug and/or alcohol abuse 26%, logistic problems 18%, other psychiatric disorders 13%, oversights 9%, unknown 4% and antiretroviral intolerance 2%. Only 54% of patients received;>50% of planned interventions, due to population complexity. Cocaine/heroin and alcohol abuse were reported by 34% and 17% respectively. Afer a median follow-up of 3.7 [3.31–4.4] years 193 patients received a mean of 8 (2.5–12 interventions/year, achieving virological control in 64%. Probability of survival was 92%, 89% and 86% after 1, 2 and 3 years respectively. In Cox regression model an intervention of SEAD project higher than 50% of planned was an independent predictor of survival HR 0.336 (95% CI 0.156–0.725; p=0.005, after adjusting for age, alcohol or cocaine abuse

  8. Knowledge and adherence to antihypertensive therapy in primary care: results of a randomized trial Conocimiento y adherencia a la terapia antihipertensiva en atención primaria: resultados de un ensayo clínico

    Ester Amado Guirado


    Full Text Available Objectives: To evaluate the efficacy of a healthcare education program for patients with hypertension. Methods: A multicenter, prospective, cluster-randomized trial was conducted. Randomization was by primary care center; 18 of 36 urban primary care centers in Barcelona and its metropolitan area were randomized to the intervention group (IG and 18 to the control group (CG. The study sample consisted of patients with hypertension (n=996; 515 in the IG and 481 in the CG receiving outpatient treatment with antihypertensive drugs. The intervention consisted of personalized information by a trained nurse and written leaflets. Questionnaires on knowledge and awareness of hypertension and its medication, treatment adherence, healthy lifestyle habits, systolic and diastolic blood pressure, and body mass index were assessed at each visit, with a 12-month follow-up. An intention-to-treat analysis was applied. Results: Knowledge of hypertension increased by 27.8% in the IG and by 18.5% in the CG, while that of medication increased by 10.1% in the IG and 5.5% in the CG. Treatment adherence measured by the Morisky-Green test increased by 9.6% (95% CI: 5.5-13.6 in the IG and 8.8% (95% CI: 4.9-12.6 in the CG. There were no differences in adherence on the other tests used. No differences were observed between the IG and CG in clinical variables such as blood pressure or BMI at the end of the trial. Conclusions: The educational intervention had no significant impact on patients´ adherence to the medication.Objetivos: Evaluar la eficacia de un programa de educación sanitaria en pacientes con hipertensión. Métodos: Se diseñó un estudio multicéntrico prospectivo y aleatorizado de conglomerados. La unidad de aleatorización fueron los centros de atención primaria (CAP situados en Barcelona y su área metropolitana, con 18 CAPs urbanos asignados al grupo intervención (GI y 18 al grupo control (GC. La muestra de pacientes hipertensos que recibían tratamiento

  9. Application of balanced scorecard in the evaluation of a complex health system intervention: 12 months post intervention findings from the BHOMA intervention: a cluster randomised trial in Zambia.

    Wilbroad Mutale

    Full Text Available INTRODUCTION: In many low income countries, the delivery of quality health services is hampered by health system-wide barriers which are often interlinked, however empirical evidence on how to assess the level and scope of these barriers is scarce. A balanced scorecard is a tool that allows for wider analysis of domains that are deemed important in achieving the overall vision of the health system. We present the quantitative results of the 12 months follow-up study applying the balanced scorecard approach in the BHOMA intervention with the aim of demonstrating the utility of the balanced scorecard in evaluating multiple building blocks in a trial setting. METHODS: The BHOMA is a cluster randomised trial that aims to strengthen the health system in three rural districts in Zambia. The intervention aims to improve clinical care quality by implementing practical tools that establish clear clinical care standards through intensive clinic implementations. This paper reports the findings of the follow-up health facility survey that was conducted after 12 months of intervention implementation. Comparisons were made between those facilities in the intervention and control sites. STATA version 12 was used for analysis. RESULTS: The study found significant mean differences between intervention(I and control (C sites in the following domains: Training domain (Mean I:C; 87.5.vs 61.1, mean difference 23.3, p = 0.031, adult clinical observation domain (mean I:C; 73.3 vs.58.0, mean difference 10.9, p = 0.02 and health information domain (mean I:C; 63.6 vs.56.1, mean difference 6.8, p = 0.01. There was no gender differences in adult service satisfaction. Governance and motivation scores did not differ between control and intervention sites. CONCLUSION: This study demonstrates the utility of the balanced scorecard in assessing multiple elements of the health system. Using system wide approaches and triangulating data collection methods seems to be

  10. Early intervention in panic: randomized controlled trial and cost-effectiveness analysis

    van Balkom Anton


    Full Text Available Abstract Background Panic disorder (PD is a common, severe and persistent mental disorder, associated with a high degree of distress and occupational and social disability. A substantial proportion of the population experiences subthreshold and mild PD and is at risk of developing a chronic PD. A promising intervention, aimed at preventing panic disorder onset and reducing panic symptoms, is the 'Don't Panic' course. It consists of eight sessions of two hours each. The purpose of this study is to evaluate the effectiveness of this early intervention – based on cognitive behavioural principles – on the reduction of panic disorder symptomatology. We predict that the experimental condition show superior clinical and economic outcomes relative to a waitlisted control group. Methods/design A pragmatic, pre-post, two-group, multi-site, randomized controlled trial of the intervention will be conducted with a naturalistic follow-up at six months in the intervention group. The participants are recruited from the general population and are randomized to the intervention or a waitlist control group. The intervention is offered by community mental health centres. Included are people over 18 years of age with subthreshold or mild panic disorder, defined as having symptoms of PD falling below the cut-off of 13 on the Panic Disorder Severity Scale-Self Report (PDSS-SR. Primary outcomes are panic disorder and panic symptoms. Secondary outcomes are symptoms of agoraphobia, anxiety, cognitive aspects of panic disorder, depressive symptoms, mastery, health-related quality of life, and cost-effectiveness. We will examine the following variables as potential mediators: cognitive aspects of panic disorder, symptoms of agoraphobia, anxiety and mastery. Potential moderating variables are: socio-demographic characteristics, panic disorder, agoraphobia, treatment credibility and mastery. Discussion This study was designed to evaluate the (cost effectiveness of an

  11. The impact of interventions to improve adherence to preventive measures on the incidence of nosocomial infections in ICUs


    Half of all life-threating nosocomial infections occur in intensive care units (ICUs) and, despite the advances in intensive care, the incidence of nosocomial infections is still high. About one third of nosocomial infections are considered preventable. Awareness of risk factors, adherence to preventive measures and collaboration of all members participating in preventive programmes can lead to reduction of the incidence of nosocomial infections and thus can produce a positive impact...

  12. Interventions employing mobile technology for overweight and obesity: an early systematic review of randomized controlled trials

    Bacigalupo, R; Cudd, P; Littlewood, C; Bissell, P; Hawley, M S; Buckley Woods, H


    Summary Obesity is a global epidemic with major healthcare implications and costs. Mobile technologies are potential interventions to promote weight loss. An early systematic review of this rapidly growing area of research was conducted. Electronic databases were searched for articles published between January 1998 and October 2011. Data sources included Medline, Embase and the Cochrane Central Register of Controlled Trials. Ongoing research was searched for using clinical trials databases and registers. Out of 174 articles retrieved, 21 met the inclusion criteria of randomized controlled trials (RCTs) on mobile technology interventions facilitating weight loss in overweight and obese adults with any other comparator. A narrative synthesis was undertaken. Seven articles were included and appraised using the Cochrane risk of bias tool: four presented a low risk of bias and three presented a high risk of bias. There is consistent strong evidence across the included multiple high-quality RCTs that weight loss occurs in the short-term because of mobile technology interventions, with moderate evidence for the medium-term. Recommendations for improving the reporting and quality of future trials are made including reporting weight loss in percent to meet clinical standards, and including features such as long-term follow-up, cost-effectiveness and patient acceptability. PMID:23167478

  13. A randomized, controlled trial to test the effectiveness of a glaucoma patient navigator to improve appointment adherence

    Hark, Lisa A.; Johnson, Deiana M; Berardi,Giuliana; Patel, Neal S.; Zeng, Lichuan; Dai, Yang; Mayro, Eileen L; Waisbourd, Michael; Katz, L Jay


    Purpose Patients with glaucoma who do not keep their follow-up eye care appointments are at risk for developing more severe ocular disease. The primary aim of the current study was to evaluate whether the use of a patient navigator altered adherence to follow-up eye care appointments in community-versus office-based settings. Patients and methods Patients diagnosed with a glaucoma-related condition following a comprehensive eye examination at 43 community sites in Philadelphia, PA, USA, were ...

  14. A randomized, controlled trial to test the effectiveness of a glaucoma patient navigator to improve appointment adherence

    Zeng, Lichuan; Hark, Lisa A.; Johnson,Deiana; Berardi,Giuliana; Patel, Neal; Dai, Yang; Mayro,Eileen; Waisbourd, Michael; Katz, L Jay


    Lisa A Hark, Deiana M Johnson, Giuliana Berardi, Neal S Patel, Lichuan Zeng, Yang Dai, Eileen L Mayro, Michael Waisbourd, L Jay Katz On behalf of the Glaucoma Research Group Wills Eye Hospital Glaucoma Research Center, Philadelphia, PA, USA Purpose: Patients with glaucoma who do not keep their follow-up eye care appointments are at risk for developing more severe ocular disease. The primary aim of the current study was to evaluate whether the use of a patient navigator altered adherence to...

  15. Attrition and Adherence in a Web-Based Distress Management Program for Implantable Cardioverter Defibrillator Patients (WEBCARE): Randomized Controlled Trial

    Habibovic, M.; Cuijpers, P.; Alings, M.;


    Background: WEB-Based Distress Management Program for Implantable CARdioverter defibrillator Patients (WEBCARE) is a Web-based randomized controlled trial, designed to improve psychological well-being in patients with an implantable cardioverter defibrillator (ICD). As in other Web-based trials, ...

  16. Wordless intervention for people with epilepsy and learning disabilities (WIELD): a randomised controlled feasibility trial

    Mengoni, Silvana E; Gates, Bob; Parkes, Georgina; Wellsted, David; Barton, Garry; Ring, Howard; Khoo, Mary Ellen; Monji-Patel, Deela; Friedli, Karin; Zia, Asif; Irvine, Lisa; Durand, Marie-Anne


    Objective To investigate the feasibility of a full-scale randomised controlled trial of a picture booklet to improve quality of life for people with epilepsy and learning disabilities. Trial design A randomised controlled feasibility trial. Randomisation was not blinded and was conducted using a centralised secure database and a blocked 1:1 allocation ratio. Setting Epilepsy clinics in 1 English National Health Service (NHS) Trust. Participants Patients with learning disabilities and epilepsy who had: a seizure within the past 12 months, meaningful communication and a carer with sufficient proficiency in English. Intervention Participants in the intervention group used a picture booklet with a trained researcher, and a carer present. These participants kept the booklet, and were asked to use it at least twice more over 20 weeks. The control group received treatment as usual, and were provided with a booklet at the end of the study. Outcome measures 7 feasibility criteria were used relating to recruitment, data collection, attrition, potential effect on epilepsy-related quality of life (Epilepsy and Learning Disabilities Quality of Life Scale, ELDQOL) at 4-week, 12-week and 20-week follow-ups, feasibility of methodology, acceptability of the intervention and potential to calculate cost-effectiveness. Outcome The recruitment rate of eligible patients was 34% and the target of 40 participants was reached. There was minimal missing data and attrition. An intention-to-treat analysis was performed; data from the outcome measures suggest a benefit from the intervention on the ELDQOL behaviour and mood subscales at 4 and 20 weeks follow-up. The booklet and study methods were positively received, and no adverse events were reported. There was a positive indication of the potential for a cost-effectiveness analysis. Conclusions All feasibility criteria were fully or partially met, therefore confirming feasibility of a definitive trial. Trial registration number ISRCTN

  17. Managing Loss and Change: Grief Interventions for Dementia Caregivers in a CBT-Based Trial.

    Meichsner, Franziska; Schinköthe, Denise; Wilz, Gabriele


    Dementia caregivers often experience loss and grief related to general caregiver burden, physical, and mental health problems. Through qualitative content analysis, this study analyzed intervention strategies applied by therapists in a randomized-controlled trial in Germany to assist caregivers in managing losses and associated emotions. Sequences from 61 therapy sessions that included interventions targeting grief, loss, and change were transcribed and analyzed. A category system was developed deductively, and the intercoder reliability was satisfactory. The identified grief intervention strategies were recognition and acceptance of loss and change,addressing future losses,normalization of grief, and redefinition of the relationship Therapists focused on identifying experienced losses, managing associated feelings, and fostering acceptance of these losses. A variety of cognitive-behavioral therapy-based techniques was applied with each strategy. The findings contribute to understanding how dementia caregivers can be supported in their experience of grief and facilitate the development of a manualized grief intervention.

  18. Video-Feedback Intervention to Promote Positive Parenting Adapted to Autism (VIPP-AUTI): A Randomized Controlled Trial

    Poslawsky, Irina E; Naber, Fabiënne BA; Bakermans-Kranenburg, Marian J; van Daalen, Emma; van Engeland, Herman; van IJzendoorn, Marinus H


    In a randomized controlled trial, we evaluated the early intervention program Video-feedback Intervention to promote Positive Parenting adapted to Autism (VIPP-AUTI) with 78 primary caregivers and their child (16-61 months) with Autism Spectrum Disorder. VIPP-AUTI is a brief attachment-based intervention program, focusing on improving parent-child…

  19. Risk moderation of a parent and student preventive alcohol intervention by adolescent and family factors : A cluster randomized trial

    Verdurmen, Jacqueline E E; Koning, Ina M.; Vollebergh, Wilma A M; van den Eijnden, Regina J J M; Engels, Rutger C M E


    Objective: To examine risk moderation of an alcohol intervention targeting parents and adolescents. Design: A cluster randomized trial including 2937 Dutch early adolescents (m=12.68. years, SD=0.51) and their parents randomized over four conditions: parent intervention, student intervention, combin

  20. A typology of practice narratives during the implementation of a preventive, community intervention trial

    Hawe Penelope


    Full Text Available Abstract Background Traditional methods of process evaluation encompass what components were delivered, but rarely uncover how practitioners position themselves and act relative to an intervention being tested. This could be crucial for expanding our understanding of implementation and its contribution to intervention effectiveness. Methods We undertook a narrative analysis of in-depth, unstructured field diaries kept by nine community development practitioners for two years. The practitioners were responsible for implementing a multi-component, preventive, community-level intervention for mothers of new babies in eight communities, as part of a cluster randomised community intervention trial. We constructed a narrative typology of approaches to practice, drawing on the phenomenology of Alfred Schutz and Max Weber's Ideal Type theory. Results Five types of practice emerged, from a highly 'technology-based' type that was faithful to intervention specifications, through to a 'romantic' type that held relationships to be central to daily operations, with intact relationships being the final arbiter of intervention success. The five types also differed in terms of how others involved in the intervention were characterized, the narrative form (e.g., tragedy, satire and where and how transformative change in communities was best created. This meant that different types traded-off or managed the priorities of the intervention differently, according to the deeply held values of their type. Conclusions The data set constructed for this analysis is unique. It revealed that practitioners not only exercise their agency within interventions, they do so systematically, that is, according to a pattern. The typology is the first of its kind and, if verified through replication, may have value for anticipating intervention dynamics and explaining implementation variation in community interventions.

  1. Measures of clinical malaria in field trials of interventions against Plasmodium falciparum

    Smith Thomas A


    Full Text Available Abstract Background Standard methods for defining clinical malaria in intervention trials in endemic areas do not guarantee that efficacy estimates will be unbiased, and do not indicate whether the intervention has its effect by modifying the force of infection, the parasite density, or the risk of pathology at given parasite density. Methods Three different sets, each of 500 Phase IIb or III malaria vaccine trials were simulated corresponding to each of a pre-erythrocytic, blood stage, and anti-disease vaccine, each in a population with 80% prevalence of patent malaria infection. Simulations considered only the primary effects of vaccination in a homogeneous trial population. The relationships between morbidity and parasite density and the performance of different case definitions for clinical malaria were analysed using conventional likelihood ratio tests to compare incidence of episodes defined using parasite density cut-offs. Bayesian latent class models were used to compare the overall frequencies of clinical malaria episodes in analyses that did not use diagnostic cut-offs. Results The different simulated interventions led to different relationships between clinical symptoms and parasite densities. Consequently, the operating characteristics of parasitaemia cut-offs in general differ between vaccine and placebo arms of the simulated trials, leading to different patterns of bias in efficacy estimates depending on the type of intervention effect. Efficacy was underestimated when low parasitaemia cut-offs were used but the efficacy of an asexual blood stage vaccine was overestimated when a high parasitaemia cut-off was used. The power of a trial may be maximal using case definitions that are associated with substantial bias in efficacy. Conclusion Secondary analyses of the data of malaria intervention trials should consider the relationship between clinical symptoms and parasite density, and attempt to estimate overall numbers of clinical

  2. Psychotherapeutic process of cognitive-behavioral intervention in HIV-infected persons: results from a controlled, randomized prospective clinical trial.

    Znoj, Hans-Jörg; Messerli-Burgy, Nadine; Tschopp, Simone; Weber, Rainer; Christen, Lisanne; Christen, Stephan; Grawe, Klaus


    The aim of this exploratory study was to examine the possible mechanisms of behavioral change in a cognitive-behavioral intervention supporting medication adherence in HIV-infected persons. A total of 60 persons currently under medical treatment were randomized to psychotherapy or usual care and were compared with a sociodemographically matched group of general psychotherapy clients. Outcome measures included therapy adherence using medication event-monitoring system psychotherapeutic processes and changes of experience and behavior. The general psychotherapy group was initially more distressed than HIV psychotherapy patients and reached higher levels of psychotherapeutic effect. In the HIV psychotherapy patients, a significant effect was found for maintaining adherence to medical treatment (Weber et al., 2004). These findings show that psychotherapy is a beneficial intervention for HIV-infected persons, and therapeutic alliance and activation of resources do not differ from a general psychotherapy treatment. Differential effects were detected for specific process variables, namely problem actuation.

  3. Preliminary Evidence for Feasibility, Use, and Acceptability of Individualized Texting for Adherence Building for Antiretroviral Adherence and Substance Use Assessment among HIV-Infected Methamphetamine Users

    David J. Moore


    Full Text Available The feasibility, use, and acceptability of text messages to track methamphetamine use and promote antiretroviral treatment (ART adherence among HIV-infected methamphetamine users was examined. From an ongoing randomized controlled trial, 30-day text response rates of participants assigned to the intervention (individualized texting for adherence building (iTAB, n = 20 were compared to those in the active comparison condition (n = 9. Both groups received daily texts assessing methamphetamine use, and the iTAB group additionally received personalized daily ART adherence reminder texts. Response rate for methamphetamine use texts was 72.9% with methamphetamine use endorsed 14.7% of the time. Text-derived methamphetamine use data was correlated with data from a structured substance use interview covering the same time period (P<0.05. The iTAB group responded to 69.0% of adherence reminder texts; among those responses, 81.8% endorsed taking ART medication. Standardized feedback questionnaire responses indicated little difficulty with the texts, satisfaction with the study, and beliefs that future text-based interventions would be helpful. Moreover, most participants believed the intervention reduced methamphetamine use and improved adherence. Qualitative feedback regarding the intervention was positive. Future studies will refine and improve iTAB for optimal acceptability and efficacy. This trial is registered with NCT01317277.

  4. Effect of Three Interventions on Contact Lens Comfort in Symptomatic Wearers: A Randomized Clinical Trial.

    Maria Navascues-Cornago

    Full Text Available To investigate whether carrying out various interventions part way through the day influences comfort in symptomatic daily disposable (DD contact lens wearers.A subject-masked, randomized, controlled clinical trial was conducted in thirty symptomatic soft lens wearers who wore their habitual DD contact lenses bilaterally for 12 h on two separate days. Five hours after lens application, one of the following three interventions or a control was performed on each eye: replacing the existing lens with a new lens; removing and reapplying the same lens; performing a 'scleral swish'; and no action (control. Comfort scores were recorded using SMS text messages every hour following lens application using a 0 (causes pain to 100 (excellent comfort scale. Comfort scores before lens application, at 6 mins post-application, and at 6 mins post-intervention were also recorded.There was a significant reduction in comfort from pre-lens application to 6 mins post-application for all groups (all p0.05. After the intervention, comfort continued to decline (p<0.0001 with slightly lower mean scores for the control group compared to the new lens group (p = 0.003. Change in comfort relative to pre-intervention (5 h was similar for all groups (p = 0.81. There was no difference in comfort at 12 h between groups (p = 0.83.This work has confirmed that comfort shows a continual and significant decline over a 12-h wearing period in symptomatic DD contact lens wearers. None of the interventions investigated had any significant impact on end-of-day comfort. These data suggest discomfort in lens wearers is more heavily influenced by changes to the ocular environment rather than to the lens ISRCTN10419752

  5. Recruiting older people to a randomised controlled dietary intervention trial - how hard can it be?

    Pockley A Graham


    Full Text Available Abstract Background The success of a human intervention trial depends upon the ability to recruit eligible volunteers. Many trials fail because of unrealistic recruitment targets and flawed recruitment strategies. In order to predict recruitment rates accurately, researchers need information on the relative success of various recruitment strategies. Few published trials include such information and the number of participants screened or approached is not always cited. Methods This paper will describe in detail the recruitment strategies employed to identify older adults for recruitment to a 6-month randomised controlled dietary intervention trial which aimed to explore the relationship between diet and immune function (The FIT study. The number of people approached and recruited, and the reasons for exclusion, will be discussed. Results Two hundred and seventeen participants were recruited to the trial. A total of 7,482 letters were sent to potential recruits using names and addresses that had been supplied by local Family (General Practices. Eight hundred and forty three potential recruits replied to all methods of recruitment (528 from GP letters and 315 from other methods. The eligibility of those who replied was determined using a screening telephone interview, 217 of whom were found to be suitable and agreed to take part in the study. Conclusion The study demonstrates the application of multiple recruitment methods to successfully recruit older people to a randomised controlled trial. The most successful recruitment method was by contacting potential recruits by letter on NHS headed note paper using contacts provided from General Practices. Ninety percent of recruitment was achieved using this method. Adequate recruitment is fundamental to the success of a research project, and appropriate strategies must therefore be adopted in order to identify eligible individuals and achieve recruitment targets. Trial registration number ISRCTN45031464.

  6. Reporting of harm in randomized controlled trials evaluating stents for percutaneous coronary intervention

    Ravaud Philippe


    Full Text Available Abstract Background The aim of this study was to assess the reporting of harm in randomized controlled trials evaluating stents for percutaneous coronary intervention. Methods The study design was a methodological systematic review of randomized controlled trials. The data sources were MEDLINE and the Cochrane Central Register of Controlled Trials. All reports of randomized controlled trials assessing stent treatment for coronary disease published between January 1, 2003, and September 30, 2008 were selected. A standardized abstraction form was used to extract data. Results 132 articles were analyzed. Major cardiac adverse events (death, cardiac death, myocardial infarction or stroke were reported as primary or secondary outcomes in 107 reports (81%. However, 19% of the articles contained no data on cardiac events. The mode of data collection of adverse events was given in 29 reports (22% and a definition of expected adverse events was provided in 47 (36%. The length of follow-up was reported in 95 reports (72%. Assessment of adverse events by an adjudication committee was described in 46 reports (35%, and adverse events were described as being followed up for 6 months in 24% of reports (n = 32, between 7 to 12 months in 42% (n = 55 and for more than 1 year in 4% (n = 5. In 115 reports (87%, numerical data on the nature of the adverse events were reported per treatment arm. Procedural complications were described in 30 articles (23%. The causality of adverse events was reported in only 4 articles. Conclusion Several harm-related data were not adequately accounted for in articles of randomized controlled trials assessing stents for percutaneous coronary intervention. Trials Registration Trials manuscript: 5534201182098351 (T80802P

  7. A systematic review and meta-analysis of clinical trials on physical interventions for lateral epicondylalgia.

    Bisset, L; Paungmali, A; Vicenzino, B; Beller, E


    A systematic review of the literature on the effectiveness of physical interventions for lateral epicondylalgia (tennis elbow) was carried out. Seventy six randomised controlled trials were identified, 28 of which satisfied the minimum criteria for meta-analysis. The evidence suggests that extracorporeal shock wave therapy is not beneficial in the treatment of tennis elbow. There is a lack of evidence for the long term benefit of physical interventions in general. However, further research with long term follow up into manipulation and exercise as treatments is indicated.

  8. Clown intervention to reduce preoperative anxiety in children and parents: a randomized controlled trial.

    Dionigi, Alberto; Sangiorgi, Diego; Flangini, Roberto


    This study investigated whether a clown doctor intervention could reduce preoperative anxiety in children hospitalized for minor surgery and in their parents. A randomized controlled trial was conducted with 77 children and 119 parents: the clown group consisted of 52 children accompanied in the preoperating room by their parents (n = 89) and two clowns while the comparison group consisted of children accompanied by the parents only. The clown intervention significantly reduced the children's preoperative anxiety: children benefited from the clown's presence and showed better adjustment than children in the comparison group. Mothers in Comparison Group showed higher anxiety.

  9. Process and effects of a community intervention on malaria in rural Burkina Faso: randomized controlled trial

    Gustafsson Lars


    Full Text Available Abstract Background In the rural areas of sub-Saharan Africa, the majority of young children affected by malaria have no access to formal health services. Home treatment through mothers of febrile children supported by mother groups and local health workers has the potential to reduce malaria morbidity and mortality. Methods A cluster-randomized controlled effectiveness trial was implemented from 2002–2004 in a malaria endemic area of rural Burkina Faso. Six and seven villages were randomly assigned to the intervention and control arms respectively. Febrile children from intervention villages were treated with chloroquine (CQ by their mothers, supported by local women group leaders. CQ was regularly supplied through a revolving fund from local health centres. The trial was evaluated through two cross-sectional surveys at baseline and after two years of intervention. The primary endpoint of the study was the proportion of moderate to severe anaemia in children aged 6–59 months. For assessment of the development of drug efficacy over time, an in vivo CQ efficacy study was nested into the trial. The study is registered under (ISRCTN 34104704. Results The intervention was shown to be feasible under program conditions and a total of 1.076 children and 999 children were evaluated at baseline and follow-up time points respectively. Self-reported CQ treatment of fever episodes at home as well as referrals to health centres increased over the study period. At follow-up, CQ was detected in the blood of high proportions of intervention and control children. Compared to baseline findings, the prevalence of anaemia (29% vs 16%, p P. falciparum parasitaemia, fever and palpable spleens was lower at follow-up but there were no differences between the intervention and control group. CQ efficacy decreased over the study period but this was not associated with the intervention. Discussion The decreasing prevalence of malaria

  10. Interventions with family caregivers of cancer patients: meta-analysis of randomized trials.

    Northouse, Laurel L; Katapodi, Maria C; Song, Lixin; Zhang, Lingling; Mood, Darlene W


    Family caregivers of cancer patients receive little preparation, information, or support to perform their caregiving role. However, their psychosocial needs must be addressed so they can maintain their own health and provide the best possible care to the patient. The purpose of this article is to analyze the types of interventions offered to family caregivers of cancer patients, and to determine the effect of these interventions on various caregiver outcomes. Meta-analysis was used to analyze data obtained from 29 randomized clinical trials published from 1983 through March 2009. Three types of interventions were offered to caregivers: psychoeducational, skills training, and therapeutic counseling. Most interventions were delivered jointly to patients and caregivers, but they varied considerably with regard to dose and duration. The majority of caregivers were female (64%) and Caucasian (84%), and ranged in age from 18 to 92 years (mean age, 55 years). Meta-analysis indicated that although these interventions had small to medium effects, they significantly reduced caregiver burden, improved caregivers' ability to cope, increased their self-efficacy, and improved aspects of their quality of life. Various intervention characteristics were also examined as potential moderators. Clinicians need to deliver research-tested interventions to help caregivers and patients cope effectively and maintain their quality of life.

  11. Evaluation of a theory-informed implementation intervention for the management of acute low back pain in general medical practice: the IMPLEMENT cluster randomised trial.

    Simon D French

    Full Text Available INTRODUCTION: This cluster randomised trial evaluated an intervention to decrease x-ray referrals and increase giving advice to stay active for people with acute low back pain (LBP in general practice. METHODS: General practices were randomised to either access to a guideline for acute LBP (control or facilitated interactive workshops (intervention. We measured behavioural predictors (e.g. knowledge, attitudes and intentions and fear avoidance beliefs. We were unable to recruit sufficient patients to measure our original primary outcomes so we introduced other outcomes measured at the general practitioner (GP level: behavioural simulation (clinical decision about vignettes and rates of x-ray and CT-scan (medical administrative data. All those not involved in the delivery of the intervention were blinded to allocation. RESULTS: 47 practices (53 GPs were randomised to the control and 45 practices (59 GPs to the intervention. The number of GPs available for analysis at 12 months varied by outcome due to missing confounder information; a minimum of 38 GPs were available from the intervention group, and a minimum of 40 GPs from the control group. For the behavioural constructs, although effect estimates were small, the intervention group GPs had greater intention of practising consistent with the guideline for the clinical behaviour of x-ray referral. For behavioural simulation, intervention group GPs were more likely to adhere to guideline recommendations about x-ray (OR 1.76, 95%CI 1.01, 3.05 and more likely to give advice to stay active (OR 4.49, 95%CI 1.90 to 10.60. Imaging referral was not statistically significantly different between groups and the potential importance of effects was unclear; rate ratio 0.87 (95%CI 0.68, 1.10 for x-ray or CT-scan. CONCLUSIONS: The intervention led to small changes in GP intention to practice in a manner that is consistent with an evidence-based guideline, but it did not result in statistically significant

  12. Do Hospitalized Premature Infants Benefit from Music Interventions? A Systematic Review of Randomized Controlled Trials

    Oliai Araghi, Sadaf; Jeekel, Johannes; Reiss, Irwin K. M; Hunink, M. G. Myriam; van Dijk, Monique


    Objective Neonatal intensive care units (NICU) around the world increasingly use music interventions. The most recent systematic review of randomized controlled trials (RCT) dates from 2009. Since then, 15 new RCTs have been published. We provide an updated systematic review on the possible benefits of music interventions on premature infants’ well-being. Methods We searched 13 electronic databases and 12 journals from their first available date until August 2016. Included were all RCTs published in English with at least 10 participants per group, including infants born prematurely and admitted to the NICU. Interventions were either recorded music interventions or live music therapy interventions. All control conditions were accepted as long as the effects of the music intervention could be analysed separately. A meta-analysis was not possible due to incompleteness and heterogeneity of the data. Results After removal of duplicates the searches retrieved 4893 citations, 20 of which fulfilled the inclusion/exclusion criteria. The 20 included studies encompassed 1128 participants receiving recorded or live music interventions in the NICU between 24 and 40 weeks gestational age. Twenty-six different outcomes were reported which we classified into three categories: physiological parameters; growth and feeding; behavioural state, relaxation outcomes and pain. Live music interventions were shown to improve sleep in three out of the four studies and heart rate in two out of the four studies. Recorded music improved heart rate in two out of six studies. Better feeding and sucking outcomes were reported in one study using live music and in two studies using recorded music. Conclusions Although music interventions show promising results in some studies, the variation in quality of the studies, age groups, outcome measures and timing of the interventions across the studies makes it difficult to draw strong conclusions on the effects of music in premature infants. PMID

  13. Effects of a multifactorial injury prevention intervention in physical education teachers: A randomized controlled trial.

    Vercruysse, Sien; Haerens, Leen; Verhagen, Evert; Goossens, Lennert; De Clercq, Dirk


    Physical education (PE) teachers are at a high risk of musculoskeletal sports or work-related injuries because of the physical activity as inherent part of their profession. Such injuries have a negative impact on work and leisure time activities, and effective injury prevention interventions are needed. The present study aimed at testing the effectiveness of an injury prevention intervention that was developed and optimized according to PE teachers' wishes and values. Fifty-five PE teachers were randomly assigned to intervention or control group. Intervention group teachers engaged in two days of training during which they familiarized with eight injury prevention strategies (seven intrinsic and one extrinsic). A special feature of the intervention was that the way of delivery was based on the self-determination theory in order to stimulate participants' motivation to adhere to the proposed strategies. Prospective registrations during one school year were conducted concerning injuries and preventive behaviours. Results showed that the intervention group teachers had a lower number of injuries per 1000 h time of exposure (TOE) than the controls (INT: 0.49, CON: 1.14 injuries/1000 h TOE, OR: 2.32, 95% CI: 1.06-5.07), and applied a broader variety of strategies including dynamic and static stretching, core stability, balance and strength training, when compared to the controls who mainly engaged in warming-up. In conclusion, with the same amount of time, an injury reduction was found in PE teachers through a more balanced use of provided preventive strategies.

  14. Statistical design of personalized medicine interventions: The Clarification of Optimal Anticoagulation through Genetics (COAG trial

    Gage Brian F


    Full Text Available Abstract Background There is currently much interest in pharmacogenetics: determining variation in genes that regulate drug effects, with a particular emphasis on improving drug safety and efficacy. The ability to determine such variation motivates the application of personalized drug therapies that utilize a patient's genetic makeup to determine a safe and effective drug at the correct dose. To ascertain whether a genotype-guided drug therapy improves patient care, a personalized medicine intervention may be evaluated within the framework of a randomized controlled trial. The statistical design of this type of personalized medicine intervention requires special considerations: the distribution of relevant allelic variants in the study population; and whether the pharmacogenetic intervention is equally effective across subpopulations defined by allelic variants. Methods The statistical design of the Clarification of Optimal Anticoagulation through Genetics (COAG trial serves as an illustrative example of a personalized medicine intervention that uses each subject's genotype information. The COAG trial is a multicenter, double blind, randomized clinical trial that will compare two approaches to initiation of warfarin therapy: genotype-guided dosing, the initiation of warfarin therapy based on algorithms using clinical information and genotypes for polymorphisms in CYP2C9 and VKORC1; and clinical-guided dosing, the initiation of warfarin therapy based on algorithms using only clinical information. Results We determine an absolute minimum detectable difference of 5.49% based on an assumed 60% population prevalence of zero or multiple genetic variants in either CYP2C9 or VKORC1 and an assumed 15% relative effectiveness of genotype-guided warfarin initiation for those with zero or multiple genetic variants. Thus we calculate a sample size of 1238 to achieve a power level of 80% for the primary outcome. We show that reasonable departures from these

  15. A randomized controlled trial of an intervention for infants’ behavioral sleep problems

    Hall, Wendy A.; Hutton, Eileen; Brant, Rollin F.; Collet, Jean Paul; Gregg, Kathy; Saunders, Roy; Ipsiroglu, Osman; Gafni, Amiram; Triolet, Kathy; Tse, Lillian; Bhagat, Radhika; Wooldridge, Joanne


    Background Infant behavioral sleep problems are common, with potential negative consequences. We conducted a randomized controlled trial to assess effects of a sleep intervention comprising a two-hour group teaching session and four support calls over 2 weeks. Our primary outcomes were reduced numbers of nightly wakes or parent report of sleep problem severity. Secondary outcomes included improvement in parental depression, fatigue, sleep, and parent cognitions about infant sleep. Methods Two...

  16. Designing medical and educational intervention studies. A review of some alternatives to conventional randomized controlled trials

    Bradley, Clare


    The advantages and limitations of RCT designs are discussed, and a range of alternative designs for medical and educational intervention studies considered. Designs selected are those that address the much neglected psychological issues involved in the recruitment of patients and allocation of patients to treatments within trials. Designs include Zelen's (18) randomized consent design, Brewin and Bradley's (20) partially randomized patient-centered design, and Korn and Baumrind's (21) partial...

  17. A cognitive behavioural intervention to reduce sexually transmitted infections among gay men: randomised trial

    Imrie, J.; Stephenson, J R; Cowan, F. M.; Wanigaratne, S; Billington, A. J. P.; Copas, A. J.; French, L.; French, P D; Johnson, A. M.; Behav Intervention Gay Men Project


    Objective To determine the effectiveness of a brief cognitive behavioural intervention in reducing the incidence of sexually transmitted infections among gay men.Design Randomised controlled trial with 12 months' follow up.Setting Sexual health clinic in London.Participants 343 gay men with an acute sexually transmitted infection or who reported having had unprotected anal intercourse in the past year.Main outcome measures Number of new sexually transmitted infections diagnosed during follow ...

  18. Ethical challenges in cluster randomized controlled trials: experiences from public health interventions in Africa and Asia.

    Osrin, David; Azad, Kishwar; Fernandez, Armida; Manandhar, Dharma S; Mwansambo, Charles W; Tripathy, Prasanta; Costello, Anthony M


    Public health interventions usually operate at the level of groups rather than individuals, and cluster randomized controlled trials (RCTs) are one means of evaluating their effectiveness. Using examples from six such trials in Bangladesh, India, Malawi and Nepal, we discuss our experience of the ethical issues that arise in their conduct. We set cluster RCTs in the broader context of public health research, highlighting debates about the need to reconcile individual autonomy with the common good and about the ethics of public health research in low-income settings in general. After a brief introduction to cluster RCTs, we discuss particular challenges we have faced. These include the nature of - and responsibility for - group consent, and the need for consent by individuals within groups to intervention and data collection. We discuss the timing of consent in relation to the implementation of public health strategies, and the problem of securing ethical review and approval in a complex domain. Finally, we consider the debate about benefits to control groups and the standard of care that they should receive, and the issue of post-trial adoption of the intervention under test.

  19. Moderators of intervention effects on parenting practices in a randomized controlled trial in early childhood.

    Theise, Rachelle; Huang, Keng-Yen; Kamboukos, Dimitra; Doctoroff, Greta L; Dawson-McClure, Spring; Palamar, Joseph J; Brotman, Laurie Miller


    The current study examined whether parent psychological resources (parenting stress, depression, and social support from friends and family) moderated the effects of early family preventive intervention on parenting among high-risk families. Ninety-two preschool-age children (M age = 3.94 years) at familial risk for conduct problems participated in a randomized controlled trial of a family intervention to prevent conduct problems. The majority of families were African American or Latino and experienced multiple stressors associated with poverty and familial antisocial behavior. Families were randomized to a 22-session group-based intervention or to a no-intervention, assessment-only control condition. Parents reported on their psychological resources (parenting stress, depression and social support from friends and family) at baseline. Parenting (responsive, harsh, stimulation for learning) was assessed through self-report and observational measures four times over 24 months. Previously-reported intervention effects on responsive parenting and stimulation for learning were moderated by depression and social support from friends, respectively, such that benefits were concentrated among those at greatest risk (i.e., depressed, limited support from friends). The intervention effect on harsh parenting was not moderated by any of the parent psychological resources examined, such that parents with high and low resources benefited comparably. Consideration of moderators of preventive intervention effects on parenting provides important information about intervention impact among families experiencing multiple barriers to engagement and effective parenting. Findings suggest that parents with diminished psychological resources are just as likely to benefit. Family-focused, group-based intervention is promising for strengthening parenting among the highest risk families.

  20. Guiding the design and selection of interventions to influence the implementation of evidence-based practice: an experimental simulation of a complex intervention trial.

    Bonetti, Debbie; Eccles, Martin; Johnston, Marie; Steen, Nick; Grimshaw, Jeremy; Baker, Rachel; Walker, Anne; Pitts, Nigel


    A consistent finding in health services research is the report of uneven uptake of research findings. Implementation trials have a variable record of success in effectively influencing clinicians' behaviour. A more systematic approach may be to conduct Intervention Modelling Experiments before service-level trials, examining intervention effects on 'interim endpoints' representing clinical behaviour, derived from empirically supported psychological theories. The objectives were to: (1) Design Intervention Modelling Experiments by backward engineering a 'real-world' randomised controlled trial (NEXUS); (2) examine the applicability of psychological theories to clinical decision-making; (3) explore whether psychological theories can illuminate how interventions achieve their effects. A 2 x 2 factorial randomised controlled trial was designed with pre- and post-intervention data collection by postal questionnaire surveys. The first survey was used to generate feedback data and the interventions were delivered in the second survey. General medical practitioners (GPs) in England and Scotland participated. First survey respondents were randomised twice to receive or not audit and feedback and educational reminder messages. The main outcome measures included behavioural intention (general plan to refer for lumbar X-rays) and simulated behaviour (specific, scenario-based, decisions to refer for lumbar X-ray). Predictors were attitude, subjective norm, perceived behavioural control (theory of planned behaviour), self-efficacy (social cognitive theory) and decision difficulty. Both interventions significantly influenced simulated behaviour, but neither influenced behavioural intention. There were no interaction effects. All theoretically derived cognitions significantly predicted simulated behaviour. Only subjective norm was not predictive of behavioural intention. The effect of audit and feedback on simulated behaviour was mediated through perceived behavioural control. The

  1. Family-based models for childhood-obesity intervention: a systematic review of randomized controlled trials.

    Sung-Chan, P; Sung, Y W; Zhao, X; Brownson, R C


    Effective interventions are needed to address the growing epidemic of childhood obesity. In the past 35 years, family-based approach has gradually developed as a preferred intervention. This review aimed to examine the methodological rigour and treatment effectiveness of family-based interventions according to intervention types and theoretical orientations. A total of 15 randomized controlled trials (RCTs) of family-based lifestyle interventions for children and adolescents aged 2-19 years were included. The adapted Methodological Quality Rating Scales (MQRS) and a four-grade qualitative scoring scheme were adopted to evaluate the methodological rigour and the effectiveness of treatment, respectively. The average MQRS score was 7.93 out of 14 points. Ten of the 15 RCTs had well aligned their research questions with appropriate research methods. The overall short-term outcome of the15 RCTs were satisfactory with an average score of 3.1. Family-based interventions rooted in behaviour theory achieved better results than those theoretically connected to family systems theory in terms of treatment effectiveness. Results suggest future studies to improve the methodological design and continue to explore the potential of the family systems approach.

  2. A Nutrition Education Intervention Trial for Adolescent Girls in Isfahan: Study Design and Protocol

    Morvarid Ghasab Shirazi


    Full Text Available BackgroundNutrition behaviors of adolescent girls is of serious health concerns. Although nutrition education interventions in Iran have met with some success, most of them could not promote nutrition behavioral changes. The aim of our study is to determine a school-based nutrition education intervention to improve adolescents’ nutrition behaviors and behavioral mediators based on the social cognitive theory (SCT.Materials and MethodsThis study is a single-blind randomized controlled trial. Eligible participants will be all student girls in grade 6 and 7, their parents and teachers in Isfahan governmental schools. This multi com­ponent school-based intervention include adolescents’ nutrition education package, parents’ nutrition massages, participatory homework, parents and teachers nutrition education package, supportive group, and collaboration with decision makers. Changing in nutrition behaviors including breakfast, fruit and vegetable, snack and fast food consumption will be examined, as primary outcome. Secondary outcome will be behavioral mediators such as knowledge, self-efficacy, intention, situation, self-regulation, social support, outcome expectations and expectancies, in adolescent girls. The outcomes will be assessed at baseline, and after 3 and 6-month follow-up.DiscussionThis study evaluates a school-based, guided SCT intervention, designed to improve healthy dietary behaviors, nutrition knowledge of adolescent girls. Few behavioral interventions have targeted this high-risk population in Iran. The intervention seems to be promising and has the potential to bridge the gap of the limited program outcomes of nutrition education in Iranian adolescents.

  3. An Intervention to Enhance Obstetric and Newborn Care in India: A cluster randomized-trial

    Goudar, Shivaprasad S.; Derman, Richard J.; Honnungar, Narayan V.; Patil, Kamal P.; Swamy, Mallaiah K.; Moore, Janet; Wallace, Dennis D.; McClure, Elizabeth M.; Kodkany, Bhalchandra S.; Pasha, Omrana; Sloan, Nancy L.; Wright, Linda L.; Goldenberg, Robert L.


    Objectives This study assessed whether community mobilization and interventions to improve emergency obstetric and newborn care (EmONC) reduced perinatal mortality (PMR) and neonatal mortality rates (NMR) in Belgaum, India. Methods The cluster-randomised controlled trial was conducted in Belgaum District, Karnataka State, India. Twenty geographic clusters were randomized to control or the intervention. The intervention engaged and mobilized community and health authorities to leverage support; strengthened community-based stabilization, referral, and transportation; and aimed to improve quality of care at facilities. Results 17,754 intervention births and 15,954 control births weighing ≥1000 g, respectively, were enrolled and analysed. Comparing the baseline period to the last 6 months period, the NMR was lower in the intervention vs. control clusters (OR=0.60, 95% CI 0.34–1.06, p=.076) as was the PMR (OR = 0.74, 95% CI 0.46–1.19, p=.20) although neither reached statistical significance. Rates of facility birth and caesarean section increased among both groups. There was limited influence on quality of care measures. Conclusions The intervention had large but not statistically significant effects on neonatal and perinatal mortality. Community mobilization and increased facility care may ultimately improve neonatal and perinatal survival, and are important in the context of the global transition towards institutional delivery. PMID:26205277

  4. An Intervention To Reduce Postpartum Depressive Symptoms: A Randomized Controlled Trial

    Howell, Elizabeth A; Bodnar-Deren, Susan; Balbierz, Amy; Loudon, Holly; Mora, Pablo A.; Zlotnick, Caron; Wang, Jason; Leventhal, Howard


    Depressive symptoms and depression are a common complication of childbirth and a growing body of literature suggests that there are modifiable factors associated with their occurrence. We developed a behavioral educational intervention targeting these factors and successfully reduced postpartum depressive symptoms in a randomized trial among low-income black and Latina women. We now report results of 540 predominantly white, high income mothers in a second randomized trial. Mothers in the intervention arm received a 2-step intervention that prepared and educated mothers about modifiable factors associated with postpartum depressive symptoms (e.g., physical symptoms, low self-efficacy), bolstered social support, and enhanced management skills. The control arm received enhanced usual care. Participants were surveyed prior to randomization, 3-weeks, 3-months, and 6-months postpartum. Depressive symptoms were assessed using the Edinburgh Postnatal Depression Scale (EPDS of 10 or greater). Prevalence of depressive symptoms postpartum were unexpectedly low precluding detection of difference in rates of depressive symptoms among intervention vs. enhanced usual care post hospitalization: 3-weeks (6.0 % vs. 5.6%, p=.83), 3-months (5.1% vs. 6.5%, p=.53) and 6-months (3.6% vs. 4.6%, p=.53). PMID:24019052

  5. A behavioural intervention increases physical activity in people with subacute spinal cord injury: a randomised trial

    Carla FJ Nooijen


    Full Text Available Questions: For people with subacute spinal cord injury, does rehabilitation that is reinforced with the addition of a behavioural intervention to promote physical activity lead to a more active lifestyle than rehabilitation alone? Design: Randomised, controlled trial with concealed allocation, intention-to-treat analysis, and blinded assessors. Participants: Forty-five adults with subacute spinal cord injury who were undergoing inpatient rehabilitation and were dependent on a manual wheelchair. The spinal cord injuries were characterised as: tetraplegia 33%; motor complete 62%; mean time since injury 150 days (SD 74. Intervention: All participants received regular rehabilitation, including handcycle training. Only the experimental group received a behavioural intervention promoting an active lifestyle after discharge. This intervention involved 13 individual sessions delivered by a coach who was trained in motivational interviewing; it began 2 months before and ended 6 months after discharge from inpatient rehabilitation. Outcome measures: The primary outcome was physical activity, which was objectively measured with an accelerometer-based activity monitor 2 months before discharge, at discharge, and 6 and 12 months after discharge from inpatient rehabilitation. The accelerometry data were analysed as total wheeled physical activity, sedentary time and motility. Self-reported physical activity was a secondary outcome. Results: The behavioural intervention significantly increased wheeled physical activity (overall between-group difference from generalised estimating equation 21 minutes per day, 95% CI 8 to 35. This difference was evident 6 months after discharge (28 minutes per day, 95% CI 8 to 48 and maintained at 12 months after discharge (25 minutes per day, 95% CI 1 to 50. No significant intervention effect was found for sedentary time or motility. Self-reported physical activity also significantly improved. Conclusion: The behavioural

  6. A randomised controlled trial of a smoking cessation intervention delivered by dental hygienists: a feasibility study

    Jenkins William


    Full Text Available Abstract Background Tobacco use continues to be a global public health problem. Helping patients to quit is part of the preventive role of all health professionals. There is now increasing interest in the role that the dental team can play in helping their patients to quit smoking. The aim of this study was to determine the feasibility of undertaking a randomised controlled smoking cessation intervention, utilising dental hygienists to deliver tobacco cessation advice to a cohort of periodontal patients. Methods One hundred and eighteen patients who attended consultant clinics in an outpatient dental hospital department (Periodontology were recruited into a trial. Data were available for 116 participants, 59 intervention and 57 control, and were analysed on an intention-to-treat basis. The intervention group received smoking cessation advice based on the 5As (ask, advise, assess, assist, arrange follow-up and were offered nicotine replacement therapy (NRT, whereas the control group received 'usual care'. Outcome measures included self-reported smoking cessation, verified by salivary cotinine measurement and CO measurements. Self-reported measures in those trial participants who did not quit included number and length of quit attempts and reduction in smoking. Results At 3 months, 9/59 (15% of the intervention group had quit compared to 5/57 (9% of the controls. At 6 months, 6/59 (10% of the intervention group quit compared to 3/57 (5% of the controls. At one year, there were 4/59 (7% intervention quitters, compared to 2/59 (4% control quitters. In participants who described themselves as smokers, at 3 and 6 months, a statistically higher percentage of intervention participants reported that they had had a quit attempt of at least one week in the preceding 3 months (37% and 47%, for the intervention group respectively, compared with 18% and 16% for the control group. Conclusion This study has shown the potential that trained dental hygienists

  7. Context by treatment interactions as the primary object of study in cluster randomized controlled trials of population health interventions.

    Fuller, Daniel; Potvin, Louise


    Cluster randomized controlled trials are increasingly used in population health intervention research. Through randomization, researchers attempt to isolate the treatment effect and remove all other effects, including any effects of social context. In many cases, the constant effect assumption cannot be satisfied in cluster randomized controlled trials. We argue that when studying population health interventions, the effective mechanism of intervention lies in the interaction between the treatment and social context. Researchers should be cognizant that attempts to remove the effect of social context using CRTC may fail. The interaction between the treatment and social context should be the primary object of study in population health intervention research.

  8. An adaptive physical activity intervention for overweight adults: a randomized controlled trial.

    Marc A Adams

    intervention outperformed the static intervention for increasing PA. The adaptive goal and feedback algorithm is a "behavior change technology" that could be incorporated into mHealth technologies and scaled to reach large populations. TRIAL REGISTRATION: NCT01793064.

  9. A randomized controlled intervention trial to relieve and prevent neck/shoulder pain

    Andersen, Lars L; Jørgensen, Marie B; Blangsted, Anne Katrine;


    PURPOSE: The objective of this study is to investigate the effect of three different workplace interventions on long-term compliance, muscle strength gains, and neck/shoulder pain in office workers. METHODS: A 1-yr randomized controlled intervention trial was done with three groups: specific...... in maximal muscle strength, and changes in intensity of neck/shoulder pain (scale 0-9) in those with and without pain at baseline. RESULTS: Regular participation was achieved by 54%, 31%, and 16% of those of the participants who answered the questionnaire in SRT (78%), APE (81%), and REF (80%), respectively......, during the first half of the intervention period, and decreased to 35%, 28% and 9%, respectively, during the second half. Shoulder elevation strength increased 9-11% in SRT and APE (P pain at baseline decreased the intensity of neck pain through SRT, from 5.0 +/- 0...

  10. Programming generality into a performance feedback writing intervention: A randomized controlled trial.

    Hier, Bridget O; Eckert, Tanya L


    Substantial numbers of students in the United States are performing below grade-level expectations in core academic areas, and these deficits are most pronounced in the area of writing. Although performance feedback procedures have been shown to produce promising short-term improvements in elementary-aged students' writing skills, evidence of maintenance and generalization of these intervention effects is limited. The purpose of this study was to examine the immediate, generalized, and sustained effects of incorporating multiple exemplar training into the performance feedback procedures of a writing intervention using a randomized controlled trial (RCT). Results indicated that although the addition of multiple exemplar training did not improve students' writing performance on measures of stimulus and response generalization, it did result in greater maintenance of intervention effects in comparison to students who received performance feedback without generality programming and students who engaged in weekly writing practice alone.

  11. Community-based intervention for blood pressure reduction in Nepal (COBIN trial)

    Neupane, Dinesh; McLachlan, Craig S; Christensen, Bo


    proportion size, 929 individuals for the intervention group and 709 individuals for the control group will participate in the study. Due to the nature of the study, study participants are not compensated or insured. As part of the blood pressure intervention, trained female community health volunteers...... study is to determine the effect of family-based home health education and blood pressure monitoring by trained female community health volunteers. The primary outcome is change in mean systolic blood pressure. A community-based, open-masked, two-armed, cluster-randomized trial will be conducted...... will conduct home visits for health education and blood pressure measurement. The primary outcomes will be modeled by using multiple linear regression analysis. DISCUSSION: This project will be an investigation of a community-based intervention to control blood pressure in countries with limited resources...

  12. A feasibility randomised controlled trial of the DECIDE intervention: dementia carers making informed decisions

    Lord, Kathryn; Livingston, Gill


    Summary Family carers report high levels of decisional conflict when deciding whether their relative with dementia can continue to be cared for in their own home. We tested, in a feasibility randomised controlled trial, the first decision aid (the DECIDE manual) aiming to reduce such conflict. Twenty family carers received the DECIDE intervention, and 21 received usual treatment. The intervention group had reduced decisional conflict compared with controls (mean difference −11.96, 95% confidence interval −20.10 to −3.83, P=0.005). All carers receiving the intervention completed and valued it, despite some still reporting difficulties with family conflict and problems negotiating services. Declaration of interest None. Copyright and usage © The Royal College of Psychiatrists 2017. This is an open access article distributed under the terms of the Creative Commons Non-Commercial, No Derivatives (CC BY-NC-ND) license.

  13. A randomized lifestyle intervention with 5-year follow-up in subjects with impaired glucose tolerance: pronounced short-term impact but long-term adherence problems

    Lindahl, Bernt; Nilssön, Torbjörn K; Borch-Johnsen, Knut;


    AIMS: To compare data on cardiovascular risk factor changes in lipids, insulin, proinsulin, fibrinolysis, leptin and C-reactive protein, and on diabetes incidence, in relation to changes in lifestyle. METHODS: The study was a randomized lifestyle intervention trial conducted in northern Sweden...... with a single counselling session. Follow-up was conducted at 1, 3 and 5 years. RESULTS: At 1-year follow-up, an extensive cardio-metabolic risk factor reduction was demonstrated in the intensive intervention group, along with a 70% decrease of progress to type 2 diabetes. At 5-year follow-up, most...... of these beneficial effects had disappeared. Reported physical activity and fibre intake as well as high-density lipoprotein cholesterol were still increased, and fasting insulin and proinsulin were lower. CONCLUSIONS: The intervention affected several important cardio-metabolic risk variables beneficially...

  14. First-in-Human Trial of MIV-150 and Zinc Acetate Coformulated in a Carrageenan Gel: Safety, Pharmacokinetics, Acceptability, Adherence, and Pharmacodynamics

    Hoesley, Craig J.; Plagianos, Marlena; Hoskin, Elena; Zhang, Shimin; Teleshova, Natalia; Alami, Mohcine; Novak, Lea; Kleinbeck, Kyle R.; Katzen, Lauren L.; Zydowsky, Thomas M.; Fernández-Romero, José A.; Creasy, George W.


    Objective: To evaluate the safety and pharmacokinetics of MIV-150 and zinc acetate in a carrageenan gel (PC-1005). Acceptability, adherence, and pharmacodynamics were also explored. Design: A 3-day open-label safety run-in (n = 5) preceded a placebo-controlled, double-blind trial in healthy, HIV-negative, abstinent women randomized (4:1) to vaginally apply 4 mL of PC-1005 or placebo once daily for 14 days. Methods: Assessments included physical examinations, safety labs, colposcopy, biopsies, cervicovaginal lavages (CVLs), and behavioral questionnaires. MIV-150 (plasma, CVL, tissue), zinc (plasma, CVL), and carrageenan (CVL) concentrations were determined with LC-MS/MS, ICP-MS, and ELISA, respectively. CVL antiviral activity was measured using cell-based assays. Safety, acceptability, and adherence were analyzed descriptively. Pharmacokinetic parameters were calculated using noncompartmental techniques and actual sampling times. CVL antiviral EC50 values were calculated using a dose–response inhibition analysis. Results: Participants (n = 20) ranged from 19–44 years old; 52% were black or African American. Among those completing the trial (13/17, PC-1005; 3/3, placebo), 11/17 reported liking the gel overall; 7 recommended reducing the volume. Adverse events, which were primarily mild and/or unrelated, were comparable between groups. Low systemic MIV-150 levels were observed, without accumulation. Plasma zinc levels were unchanged from baseline. Seven of seven CVLs collected 4-hour postdose demonstrated antiviral (HIV, human papillomavirus) activity. High baseline CVL anti–herpes-simplex virus type-2 (HSV-2) activity precluded assessment of postdose activity. Conclusions: PC-1005 used vaginally for 14 days was well tolerated. Low systemic levels of MIV-150 were observed. Plasma zinc levels were unchanged. Postdose CVLs had anti-HIV and anti–human papillomavirus activity. These data warrant further development of PC-1005 for HIV and sexually transmitted

  15. Low omega-6 vs. low omega-6 plus high omega-3 dietary intervention for Chronic Daily Headache: Protocol for a randomized clinical trial

    Smith Sunyata


    Full Text Available Abstract Background Targeted analgesic dietary interventions are a promising strategy for alleviating pain and improving quality of life in patients with persistent pain syndromes, such as chronic daily headache (CDH. High intakes of the omega-6 (n-6 polyunsaturated fatty acids (PUFAs, linoleic acid (LA and arachidonic acid (AA may promote physical pain by increasing the abundance, and subsequent metabolism, of LA and AA in immune and nervous system tissues. Here we describe methodology for an ongoing randomized clinical trial comparing the metabolic and clinical effects of a low n-6, average n-3 PUFA diet, to the effects of a low n-6 plus high n-3 PUFA diet, in patients with CDH. Our primary aim is to determine if: A both diets reduce n-6 PUFAs in plasma and erythrocyte lipid pools, compared to baseline; and B the low n-6 plus high n-3 diet produces a greater decline in n-6 PUFAs, compared to the low n-6 diet alone. Secondary clinical outcomes include headache-specific quality-of-life, and headache frequency and intensity. Methods Adults meeting the International Classification of Headache Disorders criteria for CDH are included. After a 6-week baseline phase, participants are randomized to a low n-6 diet, or a low n-6 plus high n-3 diet, for 12 weeks. Foods meeting nutrient intake targets are provided for 2 meals and 2 snacks per day. A research dietitian provides intensive dietary counseling at 2-week intervals. Web-based intervention materials complement dietitian advice. Blood and clinical outcome data are collected every 4 weeks. Results Subject recruitment and retention has been excellent; 35 of 40 randomized participants completed the 12-week intervention. Preliminary blinded analysis of composite data from the first 20 participants found significant reductions in erythrocyte n-6 LA, AA and %n-6 in HUFA, and increases in n-3 EPA, DHA and the omega-3 index, indicating adherence. Trial Registration (NCT01157208

  16. Feasibility and Acceptability of a Task-Shifted Intervention to Enhance Adherence to HIV Medication and Improve Depression in People Living with HIV in Zimbabwe, a Low Income Country in Sub-Saharan Africa.

    Abas, Melanie; Nyamayaro, Primrose; Bere, Tarisai; Saruchera, Emily; Mothobi, Nomvuyo; Simms, Victoria; Mangezi, Walter; Macpherson, Kirsty; Croome, Natasha; Magidson, Jessica; Makadzange, Azure; Safren, Steven; Chibanda, Dixon; O'Cleirigh, Conall


    Using a pilot trial design in an HIV care clinic in Zimbabwe, we randomised 32 adults with poor adherence to antiretroviral therapy and at least mild depression to either six sessions of Problem-Solving Therapy for adherence and depression (PST-AD) delivered by an adherence counsellor, or to Enhanced Usual Care (Control). Acceptability of PST-AD was high, as indicated by frequency of session attendance and through qualitative analyses of exit interviews. Fidelity was >80% for the first two sessions of PST-AD but fidelity to the adherence component of PST-AD dropped by session 4. Contamination occurred, in that seven patients in the control arm received one or two PST-AD sessions before follow-up assessment. Routine health records proved unreliable for measuring HIV viral load at follow-up. Barriers to measuring adherence electronically included device failure and participant perception of being helped by the research device. The study was not powered to detect clinical differences, however, promising change at 6-months follow-up was seen in electronic adherence, viral load suppression (PST-AD arm 9/12 suppressed; control arm 4/8 suppressed) and depression (Patient Health Questionnaire-4.7 points in PST-AD arm vs. control, adjusted p value = 0.01). Results inform and justify a future randomised controlled trial of task-shifted PST-AD.

  17. A novel school-based intervention to improve nutrition knowledge in children: cluster randomised controlled trial

    Ong Ken K


    Full Text Available Abstract Background Improving nutrition knowledge among children may help them to make healthier food choices. The aim of this study was to assess the effectiveness and acceptability of a novel educational intervention to increase nutrition knowledge among primary school children. Methods We developed a card game 'Top Grub' and a 'healthy eating' curriculum for use in primary schools. Thirty-eight state primary schools comprising 2519 children in years 5 and 6 (aged 9-11 years were recruited in a pragmatic cluster randomised controlled trial. The main outcome measures were change in nutrition knowledge scores, attitudes to healthy eating and acceptability of the intervention by children and teachers. Results Twelve intervention and 13 control schools (comprising 1133 children completed the trial. The main reason for non-completion was time pressure of the school curriculum. Mean total nutrition knowledge score increased by 1.1 in intervention (baseline to follow-up: 28.3 to 29.2 and 0.3 in control schools (27.3 to 27.6. Total nutrition knowledge score at follow-up, adjusted for baseline score, deprivation, and school size, was higher in intervention than in control schools (mean difference = 1.1; 95% CI: 0.05 to 2.16; p = 0.042. At follow-up, more children in the intervention schools said they 'are currently eating a healthy diet' (39.6% or 'would try to eat a healthy diet' (35.7% than in control schools (34.4% and 31.7% respectively; chi-square test p Conclusions The 'Top Grub' card game facilitated the enjoyable delivery of nutrition education in a sample of UK primary school age children. Further studies should determine whether improvements in nutrition knowledge are sustained and lead to changes in dietary behaviour.

  18. The OPERA trial: a protocol for the process evaluation of a randomised trial of an exercise intervention for older people in residential and nursing accommodation

    Parsons Suzanne


    Full Text Available Abstract Background The OPERA trial is large cluster randomised trial testing a physical activity intervention to address depression amongst people living in nursing and residential homes for older people. A process evaluation was commissioned alongside the trial and we report the protocol for this process evaluation. Challenges included the cognitive and physical ability of the participants, the need to respect the privacy of all home residents, including study non-participants, and the physical structure of the homes. Evaluation activity had to be organised around the structured timetable of homes, leaving limited opportunities for data collection. The aims of this process evaluation are to provide findings that will assist in the interpretation of the clinical trial results, and to inform potential implementation of the physical activity intervention on a wider scale. Methods/design Quantitative data on recruitment of homes and individuals is being collected. For homes in the intervention arm, data on dose and fidelity of the intervention delivered; including individual rates of participation in exercise classes are collected. In the control homes, uptake and delivery of depression awareness training is monitored. These data will be combined with qualitative data from an in-depth study of a purposive sample of eight homes (six intervention and two control. Discussion Although process evaluations are increasingly funded alongside trials, it is still rare to see the findings published, and even rarer to see the protocol for such an evaluation published. Process evaluations have the potential to assist in interpreting and understanding trial results as well as informing future roll-outs of interventions. If such evaluations are funded they should also be reported and reviewed in a similar way to the trial outcome evaluation. Trial Registration ISRCTN No: ISRCTN43769277

  19. Toward Monitoring and Increasing Exercise Adherence in Older Adults by Robotic Intervention: A Proof of Concept Study

    Prathik Gadde


    Full Text Available Socially assistive robots have the potential to improve the quality of life of older adults by encouraging and guiding their performance of rehabilitation exercises while offering cognitive stimulation and companionship. This study focuses on the early stages of developing and testing an interactive personal trainer robot to monitor and increase exercise adherence in older adults. The robot physically demonstrates exercises for the user to follow and monitors the user's progress using a vision-processing unit that detects face and hand movements. When the user successfully completes a move, the robot gives positive feedback and begins the next repetition. The results of usability testing with 10 participants support the feasibility of this approach. Further extensions are planned to evaluate a complete exercise program for improving older adults' physical range of motion in a controlled experiment with three conditions: a personal trainer robot, a personal trainer on-screen character, and a pencil-and-paper exercise plan.

  20. The Breathe Easier through Weight Loss Lifestyle (BE WELL Intervention: A randomized controlled trial

    Buist A


    Full Text Available Abstract Background Obesity and asthma have reached epidemic proportions in the US. Their concurrent rise over the last 30 years suggests that they may be connected. Numerous observational studies support a temporally-correct, dose-response relationship between body mass index (BMI and incident asthma. Weight loss, either induced by surgery or caloric restriction, has been reported to improve asthma symptoms and lung function. Due to methodological shortcomings of previous studies, however, well-controlled trials are needed to investigate the efficacy of weight loss strategies to improve asthma control in obese individuals. Methods/Design BE WELL is a 2-arm parallel randomized clinical trial (RCT of the efficacy of an evidence-based, comprehensive, behavioral weight loss intervention, focusing on diet, physical activity, and behavioral therapy, as adjunct therapy to usual care in the management of asthma in obese adults. Trial participants (n = 324 are patients aged 18 to 70 years who have suboptimally controlled, persistent asthma, BMI between 30.0 and 44.9 kg/m2, and who do not have serious comorbidities (e.g., diabetes, heart disease, stroke. The 12-month weight loss intervention to be studied is based on the principles of the highly successful Diabetes Prevention Program lifestyle intervention. Intervention participants will attend 13 weekly group sessions over a four-month period, followed by two monthly individual sessions, and will then receive individualized counseling primarily by phone, at least bi-monthly, for the remainder of the intervention. Follow-up assessment will occur at six and 12 months. The primary outcome variable is the overall score on the Juniper Asthma Control Questionnaire measured at 12 months. Secondary outcomes include lung function, asthma-specific and general quality of life, asthma medication use, asthma-related and total health care utilization. Potential mediators (e.g., weight loss and change in physical

  1. Safe and effective use of medicines for patients with type 2 diabetes - A randomized controlled trial of two interventions delivered by local pharmacies

    Kjeldsen, Lene Juel; Bjerrum, Lars; Dam, Pernille


    Poor management of chronic medical treatments may result in severe health consequences for patients as well as costs for society. Non-adherence is common among patients with type 2 diabetes. Interventions by community pharmacists may assist in improving adherence and consequently health outcomes ...


    Background. There is no consensus about the level of risk of gastrointestinal illness posed by consumption of drinking water that meets all regulatory requirements. Earlier drinking water intervention trials from Canada suggested that 14% - 40% of such gastrointestinal il...

  3. Development of early mathematical skills with a tablet intervention: a randomized control trial in Malawi

    Nicola ePitchford


    Full Text Available Evaluation of educational interventions is necessary prior to wide-scale rollout. Yet very few rigorous studies have been conducted on the effectiveness of tablet-based interventions, especially in the early years and in developing countries. 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. A total sample of 318 children, spanning Standards 1-3, attending a medium-sized urban primary school, were randomized to one of three groups: maths tablet intervention, non-maths tablet control, and standard face-to-face practice. Children were pre-tested using tablets at the start of the school year on two tests of mathematical knowledge and a range of basic skills related to scholastic progression. Class teachers then delivered the intervention over an 8-week period, for the equivalent of 30-minutes per day. Technical support was provided from the local Voluntary Service Overseas. Children were then post-tested on the same assessments as given at pre-test.A final sample of 283 children from Standards 1-3, present at both pre- and post-test, was analyzed to investigate the effectiveness of the maths tablet intervention. Significant effects of the maths tablet intervention over and above standard face-to-face practice or using tablets without the maths software were found in Standard 2 and 3. In Standard 3 the greater learning gains shown by the maths tablet intervention group compared to both of the control groups on the tablet-based assessments transferred to paper and pencil format, illustrating generalization of knowledge gained. Thus, tablet technology can effectively support early years mathematical skills in developing countries if the software is carefully designed to engage the child in the learning process and the content is grounded in a solid well-constructed curriculum appropriate for the child

  4. Development of early mathematical skills with a tablet intervention: a randomized control trial in Malawi.

    Pitchford, Nicola J


    Evaluation of educational interventions is necessary prior to wide-scale rollout. Yet very few rigorous studies have been conducted on the effectiveness of tablet-based interventions, especially in the early years and in developing countries. 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. A total sample of 318 children, spanning Standards 1-3, attending a medium-sized urban primary school, were randomized to one of three groups: maths tablet intervention, non-maths tablet control, and standard face-to-face practice. Children were pre-tested using tablets at the start of the school year on two tests of mathematical knowledge and a range of basic skills related to scholastic progression. Class teachers then delivered the intervention over an 8-weeks period, for the equivalent of 30-min per day. Technical support was provided from the local Voluntary Service Overseas (VSO). Children were then post-tested on the same assessments as given at pre-test. A final sample of 283 children, from Standards 1-3, present at both pre- and post-test, was analyzed to investigate the effectiveness of the maths tablet intervention. Significant effects of the maths tablet intervention over and above standard face-to-face practice or using tablets without the maths software were found in Standards 2 and 3. In Standard 3 the greater learning gains shown by the maths tablet intervention group compared to both of the control groups on the tablet-based assessments transferred to paper and pencil format, illustrating generalization of knowledge gained. Thus, tablet technology can effectively support early years mathematical skills in developing countries if the software is carefully designed to engage the child in the learning process and the content is grounded in a solid well-constructed curriculum appropriate for the child's developmental

  5. Sticker charts: a method for improving adherence to treatment of chronic diseases in children.

    Luersen, Kara; Davis, Scott A; Kaplan, Sebastian G; Abel, Troy D; Winchester, Woodrow W; Feldman, Steven R


    Poor adherence is a common problem and may be an underlying cause of poor clinical outcomes. In pediatric populations, positive reinforcement techniques such as sticker charts may increase motivation to adhere to treatment regimens. To review the use of sticker charts to improve adherence in children with chronic disease, Medline and PsycINFO searches were conducted using the key words "positive reinforcement OR behavior therapy" and "adherence OR patient compliance" and "child." Randomized controlled retrospective cohort or single-subject-design studies were selected. Studies reporting adherence to the medical treatment of chronic disease in children using positive reinforcement techniques were included in the analysis. The systematic search was supplemented by identifying additional studies identified through the reference lists and authors of the initial articles found. Positive reinforcement techniques such as sticker charts increase adherence to medical treatment regimens. In several studies, this effect was maintained for months after the initial intervention. Better adherence correlated with better clinical outcomes in some, but not all, studies. Few studies examining the use of sticker charts were identified. Although single-subject-design studies are useful in establishing the effect of a behavioral intervention, larger randomized controlled trials would help determine the precise efficacy of sticker chart interventions. Adherence to medical treatments in children can be increased using sticker charts or other positive reinforcement techniques. This may be an effective means to encourage children with atopic dermatitis to apply their medications and improve clinical outcomes.

  6. A physiotherapist-delivered integrated exercise and pain coping skills training intervention for individuals with knee osteoarthritis: a randomised controlled trial protocol

    Bennell Kim L


    the Western Ontario and McMaster Universities Osteoarthritis Index subscale. Secondary outcomes include global rating of change, muscle strength, functional performance, physical activity levels, health related quality of life and psychological factors. Measurements will be taken at baseline and immediately following the intervention (12 weeks as well as at 32 weeks and 52 weeks to examine maintenance of any intervention effects. Specific assessment of adherence to the treatment program will also be made at weeks 22 and 42. Relative cost-effectiveness will be determined from health service usage and outcome data. Discussion The findings from this randomised controlled trial will provide evidence for the efficacy of an integrated PCST and exercise program delivered by physiotherapists in the management of painful and functionally limiting knee OA compared to either program alone. Trial registration Australian New Zealand Clinical Trials Registry reference number: ACTRN12610000533099

  7. Interventions for atopic dermatitis in dogs: a systematic review of randomized controlled trials.

    Olivry, Thierry; Foster, Aiden P; Mueller, Ralf S; McEwan, Neil A; Chesney, Christopher; Williams, Hywel C


    The objective of this systematic review, which was performed following the guidelines of the Cochrane collaboration, was to assess the effects of interventions for treatment of atopic dermatitis (AD) in dogs. Citations identified from three databases (MEDLINE, Thomson's Science Citation Index Expanded and CAB Abstracts) and trials published by December 2007 were selected. Proceedings books from the major veterinary dermatology international congresses were hand searched for relevant citations. The authors selected randomized controlled trials (RCTs), published from January 1980 to December 2007, which reported the efficacy of topical or systemic interventions for treatment or prevention of canine AD. Studies had to report assessments of either pruritus or skin lesions, or both. Studies were selected and data extracted by two reviewers, with discrepancies resolved by a third arbitrator. Missing data were requested from study authors of recently published trials. Pooling of results and meta-analyses were performed for studies reporting similar interventions and outcome measures. A total of 49 RCTs were selected, which had enrolled 2126 dogs. This review found some evidence of efficacy of topical tacrolimus (3 RCTs), topical triamcinolone (1), oral glucocorticoids (5), oral ciclosporin (6), subcutaneous recombinant gamma-interferon (1) and subcutaneous allergen-specific immunotherapy (3) to decrease pruritus and/or skin lesions of AD in dogs. One high-quality RCT showed that an oral essential fatty acid supplement could reduce prednisolone consumption by approximately half. Additional RCTs of high design quality must be performed to remedy previous flaws and to test interventions for prevention of flares of this disease.

  8. Family nurture intervention (FNI: methods and treatment protocol of a randomized controlled trial in the NICU

    Welch Martha G


    Full Text Available Abstract Background The stress that results from preterm birth, requisite acute care and prolonged physical separation in the Neonatal Intensive Care Unit (NICU can have adverse physiological/psychological effects on both the infant and the mother. In particular, the experience compromises the establishment and maintenance of optimal mother-infant relationship, the subsequent development of the infant, and the mother's emotional well-being. These findings highlight the importance of investigating early interventions that are designed to overcome or reduce the effects of these environmental insults and challenges. Methods This study is a randomized controlled trial (RCT with blinded assessment comparing Standard Care (SC with a novel Family Nurture Intervention (FNI. FNI targets preterm infants born 26-34 weeks postmenstrual age (PMA and their mothers in the NICU. The intervention incorporates elements of mother-infant interventions with known efficacy and organizes them under a new theoretical context referred to collectively as calming activities. This intervention is facilitated by specially trained Nurture Specialists in three ways: 1 In the isolette through calming interactions between mother and infant via odor exchange, firm sustained touch and vocal soothing, and eye contact; 2 Outside the isolette during holding and feeding via the Calming Cycle; and 3 through family sessions designed to engage help and support the mother. In concert with infant neurobehavioral and physiological assessments from birth through 24 months corrected age (CA, maternal assessments are made using standard tools including anxiety, depression, attachment, support systems, temperament as well as physiological stress parameters. Quality of mother-infant interaction is also assessed. Our projected enrolment is 260 families (130 per group. Discussion The FNI is designed to increase biologically important activities and behaviors that enhance maternally

  9. What qualitative research can contribute to a randomized controlled trial of a complex community intervention.

    Nelson, Geoffrey; Macnaughton, Eric; Goering, Paula


    Using the case of a large-scale, multi-site Canadian Housing First research demonstration project for homeless people with mental illness, At Home/Chez Soi, we illustrate the value of qualitative methods in a randomized controlled trial (RCT) of a complex community intervention. We argue that quantitative RCT research can neither capture the complexity nor tell the full story of a complex community intervention. We conceptualize complex community interventions as having multiple phases and dimensions that require both RCT and qualitative research components. Rather than assume that qualitative research and RCTs are incommensurate, a more pragmatic mixed methods approach was used, which included using both qualitative and quantitative methods to understand program implementation and outcomes. At the same time, qualitative research was used to examine aspects of the intervention that could not be understood through the RCT, such as its conception, planning, sustainability, and policy impacts. Through this example, we show how qualitative research can tell a more complete story about complex community interventions.

  10. Effectiveness and moderators of the preventive intervention kids in divorce situations: A randomized controlled trial.

    Pelleboer-Gunnink, Hannah A; Van der Valk, Inge E; Branje, Susan J T; Van Doorn, Muriel D; Deković, Maja


    Children of divorced parents have an increased risk of a variety of problems in comparison to children from intact families. Therefore, several intervention programs have been developed directed at children of divorced parents. Yet, empirical data on the effectiveness of these interventions are limited. This study evaluated the school-based, child-directed prevention program Kids In Divorce Situations (KIDS) using a randomized controlled trial. The sample consisted of 156 children randomly assigned at the school level into an experimental (80 children) and control condition (76 children). In addition, 131 mothers and 76 fathers participated in the study. Four assessments took place: a pretest, a posttest, and two follow-up assessments conducted 6 months and 1 year after finishing KIDS. Latent growth analyses demonstrated that the intervention significantly reduced child-reported emotional problems and enhanced child-reported communication with the father and mother-reported communication with the child. The effect sizes ranged from .30-.63. Few moderation effects of gender, time since divorce, or perceived parental conflict on the intervention effects were found. After parental divorce, a limited school-based intervention for children can be efficacious in promoting children's emotional well-being and parent-child communication.

  11. Impact of a Social Work Care Coordination Intervention on Hospital Readmission: A Randomized Controlled Trial.

    Bronstein, Laura R; Gould, Paul; Berkowitz, Shawn A; James, Gary D; Marks, Kris


    This study assessed how a social work-led care coordination intervention would reduce the within-30-day hospital readmission rate among moderate- and high-risk patients age 50 years or older. Authors ran a randomized controlled trial to determine whether there was a significant difference in within-30-day readmission rates between patients receiving usual care post-discharge and those receiving intervention from an MSW intern (one home visit and one to two phone calls). Results were obtained using a sample of hospitalized patients with a LACE index score of 7 or higher (N = 89). Analysis suggests that the intervention improved the likelihood of not being readmitted by some 22 percent (RR = 1.222; 95% CI = 1.063-1.405). The risk improvement with the intervention was highly statistically significant (p = .003). This study shows that a time-efficient care coordination intervention by MSW interns may decrease hospital readmission rates. Replications of this study in other communities, with more diverse populations, and with larger numbers of patients will indicate whether results are generalizable.

  12. Randomized controlled trial of a brief dyadic cognitive-behavioral intervention designed to prevent PTSD

    Alain Brunet


    Full Text Available Background : There is a dearth of effective interventions to prevent the development of post-traumatic stress disorder (PTSD. Method : We evaluated the efficacy of a brief dyadic two-session cognitive-behavioral intervention through a controlled trial involving trauma-exposed individuals recruited at the hospital's emergency room. Participants were randomly assigned to either the dyadic intervention group (n=37 or to a waiting list (assessment only group (n=37. Results : In an intent-to-treat analysis, a time-by-group interaction was found, whereby the treated participants had less PTSD symptoms at the post-treatment but not at the pre-treatment compared to controls. Controlling for the improvement observed in the control participants, the intervention yielded a net effect size of d=0.39. Conclusions : A brief, early, and effective intervention can be provided by nurses or social workers in hospital settings, at a fairly low cost to individuals presenting to the emergency room as the result of trauma exposure.

  13. Short-term effects of an educational intervention on physical restraint use: a cluster randomized trial

    Gulpers Math JM


    Full Text Available Abstract Background Physical restraints are still frequently used in nursing home residents despite growing evidence for the ineffectiveness and negative consequences of these methods. Therefore, reduction in the use of physical restraints in psycho-geriatric nursing home residents is very important. The aim of this study was to investigate the short-term effects of an educational intervention on the use of physical restraints in psycho-geriatric nursing home residents. Methods A cluster randomized trial was applied to 5 psycho-geriatric nursing home wards (n = 167 residents with dementia. The wards were assigned at random to either educational intervention (3 wards or control status (2 wards. The restraint status was observed and residents' characteristics, such as cognitive status, were determined by using the Minimum Data Set (MDS at baseline and 1 month after intervention. Results Restraint use did not change significantly over time in the experimental group (55%–56%, compared to a significant increased use (P Conclusion An educational programme for nurses combined with consultation with a nurse specialist did not decrease the use of physical restraints in psycho-geriatric nursing home residents in the short term. However, the residents in the control group experienced more restraint use during the study period compared to the residents in the experimental group. Whether the intervention will reduce restraint use in the long term could not be inferred from these results. Further research is necessary to gain insight into the long-term effects of this educational intervention.

  14. Effects of Mobility-Enhancing Nursing Intervention in Patients with MS and Stroke: Randomised Controlled Trial.

    Imhof, Lorenz; Suter-Riederer, Susanne; Kesselring, Jürg


    Background. Multiple sclerosis (MS) or stroke causes functional impairment which can have a major impact on patients' life. Objectives. This RCT investigated the effect of a new nursing intervention (Mobility Enhancing Nursing Intervention-MFP) designed to improve rehabilitation outcomes. Method. The study took place in a rehabilitation clinic in Switzerland. One hundred forty participants diagnosed with MS, stroke, and brain injuries were randomly assigned to control group (CG = standard care) or intervention group (IG). The IG combined standard care with 30 days of MFB. MFP placed patients on a mattress on the floor and used tactile-kinaesthetic stimulation to increase spatial orientation and independency. Outcomes were functionality (Extended Barthel Index, EBI), quality of life (WHOQoL), and fall-related self-efficacy (FES-I). Results. There was a significant main effect of the intervention on functionality (EBI-diff/day mean = 0.30, versus mean = 0.16, P = 0.008). There was also a significant main effect on QoL (WHOQoL-diff mean = 13.8, versus mean = 5.4, P = 0.046). No significant effect was observed on fall-related self-efficacy. Conclusions. The positive effect of MFP on rehabilitation outcomes and quality of life suggests that this specialized nursing intervention could become an effective part of rehabilitation programs. The study was approved by the Ethics Committee of St. Gallen (KEK-SG Nr. 09/021) and registered at NCT02198599.

  15. Internet-based guided self-help intervention for chronic pain based on Acceptance and Commitment Therapy: a randomized controlled trial.

    Trompetter, Hester R; Bohlmeijer, Ernst T; Veehof, Martine M; Schreurs, Karlein M G


    Acceptance-based psychological interventions can potentially minimize the burden of chronic pain. This randomized controlled trial evaluated an internet-delivered, guided self-help intervention based on Acceptance and Commitment Therapy (ACT). A total of 238 chronic pain sufferers from the general population were randomly allocated to either ACT (n = 82), an internet-based control condition Expressive Writing (n = 79) or a waiting list condition (n = 77). Participants completed measures at baseline, posttreatment (3 months) and at a 3-month follow-up. At follow-up, ACT participants had improved in pain interference in daily life (primary outcome) compared to participants in Expressive Writing (Cohen's d = .47), but not compared to waiting list participants (p value = .11). Those who adhered to the ACT-intervention (48%) did improve significantly compared to waiting list participants (d = .49). ACT-participants also showed superior improvement on depression, pain intensity, psychological inflexibility and pain catastrophizing (d: .28-.60). Significant clinical improvement was present. Especially, 28% of ACT-participants showed general clinically relevant improvement in pain interference, as well as in pain intensity and depression (vs. Expressive Writing and waiting list 5%). Given these findings, internet-based ACT programs may be a promising treatment modality for chronic pain.

  16. Effectiveness of a cognitive behavioral intervention in patients with medically unexplained symptoms: cluster randomized trial

    López-García-Franco Alberto


    Full Text Available Abstract Background Medically unexplained symptoms are an important mental health problem in primary care and generate a high cost in health services. Cognitive behavioral therapy and psychodynamic therapy have proven effective in these patients. However, there are few studies on the effectiveness of psychosocial interventions by primary health care. The project aims to determine whether a cognitive-behavioral group intervention in patients with medically unexplained symptoms, is more effective than routine clinical practice to improve the quality of life measured by the SF-12 questionary at 12 month. Methods/design This study involves a community based cluster randomized trial in primary healthcare centres in Madrid (Spain. The number of patients required is 242 (121 in each arm, all between 18 and 65 of age with medically unexplained symptoms that had seeked medical attention in primary care at least 10 times during the previous year. The main outcome variable is the quality of life measured by the SF-12 questionnaire on Mental Healthcare. Secondary outcome variables include number of consultations, number of drug (prescriptions and number of days of sick leave together with other prognosis and descriptive variables. Main effectiveness will be analyzed by comparing the percentage of patients that improve at least 4 points on the SF-12 questionnaire between intervention and control groups at 12 months. All statistical tests will be performed with intention to treat. Logistic regression with random effects will be used to adjust for prognostic factors. Confounding factors or factors that might alter the effect recorded will be taken into account in this analysis. Discussion This study aims to provide more insight to address medically unexplained symptoms, highly prevalent in primary care, from a quantitative methodology. It involves intervention group conducted by previously trained nursing staff to diminish the progression to the chronicity

  17. Adherence to recommendations by infectious disease consultants and its influence on outcomes of intravenous antibiotic-treated hospitalized patients

    Fariñas María-Carmen


    Full Text Available Abstract Background Consultation to infectious diseases specialists (ID, although not always performed by treating physicians, is part of hospital’s daily practice. This study analyses adherence by treating physicians to written ID recommendations (inserted in clinical records and its effect on outcome in hospitalized antibiotic-treated patients in a tertiary hospital in Spain. Methods A prospective, randomized, one-year study was performed. Patients receiving intravenous antimicrobial therapy prescribed by treating physicians for 3 days were identified and randomised to intervention (insertion of written ID recommendations in clinical records or non-intervention. Appropriateness of empirical treatments (by treating physicians was classified as adequate, inadequate or unnecessary. In the intervention group, adherence to recommendations was classified as complete, partial or non-adherence. Results A total of 1173 patients were included, 602 in the non-intervention and 571 in the intervention group [199 (34.9% showing complete adherence, 141 (24.7% partial adherence and 231 (40.5% non-adherence to recommendations]. In the multivariate analysis for adherence (R2 Cox=0.065, p=0.009, non-adherence was associated with prolonged antibiotic prophylaxis (p=0.004; OR=0.37, 95%CI=0.19-0.72. In the multivariate analysis for clinical failure (R2 Cox=0.126, p Conclusions Adherence to ID recommendations by treating physicians was associated with favorable outcome, in turn associated with shortened length of hospitalization. This may have important health–economic benefits and stimulates further investigation. Trial registration Current Controlled Trials ISRCTN83234896.


    Risk assessments and intervention trials have been used to inform the EPA on drinking water risks. Seldom are both methods used concurrently. Between 2001 and 2003, illness data from a trial were collected simultaneously with exposure data, providing a unique opportunity to com...

  19. A community intervention trial of multimodal suicide prevention program in Japan: A Novel multimodal Community Intervention program to prevent suicide and suicide attempt in Japan, NOCOMIT-J

    Suzuki Yuriko


    Full Text Available Abstract Background To respond to the rapid surge in the incidence of suicide in Japan, which appears to be an ongoing trend, the Japanese Multimodal Intervention Trials for Suicide Prevention (J-MISP have launched a multimodal community-based suicide prevention program, NOCOMIT-J. The primary aim of this study is to examine whether NOCOMIT-J is effective in reducing suicidal behavior in the community. Methods/DesignThis study is a community intervention trial involving seven intervention regions with accompanying control regions, all with populations of statistically sufficient size. The program focuses on building social support networks in the public health system for suicide prevention and mental health promotion, intending to reinforce human relationships in the community. The intervention program components includes a primary prevention measures of awareness campaign for the public and key personnel, secondary prevention measures for screening of, and assisting, high-risk individuals, after-care for individuals bereaved by suicide, and other measures. The intervention started in July 2006, and will continue for 3.5 years. Participants are Japanese and foreign residents living in the intervention and control regions (a total of population of 2,120,000 individuals. Discussion The present study is designed to evaluate the effectiveness of the community-based suicide prevention program in the seven participating areas. Trial registration UMIN Clinical Trials Registry (UMIN-CTR UMIN000000460.

  20. Obesity and Physical Frailty in Older Adults: A Scoping Review of Intervention Trials

    Porter Starr, Kathryn N.; McDonald, Shelley R.; Bales, Connie W.


    Many frail older adults are thin, weak, and undernourished; this component of frailty remains a critical concern in the geriatric field. However, there is also strong evidence that excessive adiposity contributes to frailty by reducing the ability of older adults to perform physical activities and increasing metabolic instability. Our scoping review explores the impact of being obese on physical frailty in older adults by summarizing the state of the science for both clinical markers of physical function and biomarkers for potential underlying causes of obesity-related decline. We used the five-stage methodological framework of Arksey and O’Malley to conduct a scoping review of randomized trials of weight loss and/or exercise interventions for obesity (BMI ≥ 30 kg/m2) in older adults (aged > 60 yrs), examining the outcomes of inflammation, oxidative stress, and lipid accumulation in muscle, as well as direct measures of physical function. Our initial search yielded 212 articles; exclusion of cross-sectional and observational studies, cell culture and animal studies, disease-specific interventions, and articles published before 2001 led to a final result of 21 articles. Findings of these trials included the following major points: The literature consistently confirmed benefits of lifestyle interventions to physical function assessed at the clinical level. Generally speaking, weight loss alone produced a greater effect than exercise alone and the best outcomes were achieved with a combination of weight loss and exercise, especially exercise programs that combined aerobic, resistance, and flexibility training. Weight loss interventions tended to reduce markers of inflammation and/or oxidative damage when more robust weight reduction was achieved and maintained over time, whereas exercise did not change markers of inflammation. However, participation in a chronic exercise program did reduce the oxidative stress induced by an acute bout of exercise. Weight loss

  1. A controlled trial of an intervention to increase resident choice in long-term care

    Schnelle, John F.; Rahman, Annie; Durkin, Daniel W.; Beuscher, Linda; Choi, Leena; Simmons, Sandra F.


    Objective The purpose of this study was to evaluate an intervention to improve staff offers of choice to nursing home (NH) residents during morning care. Design A controlled trial with a delayed intervention design. Setting Four community, for-profit nursing homes. Participants A total of 169 long-stay NH residents who required staff assistance with morning care and were able to express their care preferences. Intervention Research staff held weekly training sessions with nurse aides (NAs) for 12 consecutive weeks focused on how to offer choice during four targeted morning care areas: when to get out of bed, when to get dressed/what to wear, incontinence care (changing and/or toileting), and where to dine. Training sessions consisted of brief video vignettes illustrating staff-resident interactions followed by weekly feedback about how often choice was being provided based on standardized observations of care conducted weekly by research staff. Measurements Research staff conducted standardized observations during a minimum of 4 consecutive morning hours per participant per week for 12-weeks of baseline and 12-weeks of intervention. Results There was a significant increase in the frequency that choice was offered for three of the four targeted morning care areas from baseline to intervention: (1) out of bed, 21% to 33% (p< .001); dressing, 20% to 32% (p< .001); incontinence care, 18% to 23%, (p< .014). Dining location (8% to 13%) was not significant. There was also a significant increase in the amount of NA staff time to provide care from baseline to intervention (8.01 ± 9.0 to 9.68 ± 9.9 minutes per person, p< .001). Conclusion A staff training intervention improved the frequency with which NAs offered choice during morning care but also required more time. Despite significant improvements, choice was still offered one-third or less of the time during morning care. PMID:23294967

  2. “Smart” RCTs: Development of a Smartphone App for Fully Automated Nutrition-Labeling Intervention Trials

    Volkova, Ekaterina; Li, Nicole; Dunford, Elizabeth; Eyles, Helen; Crino, Michelle; Michie, Jo; Ni Mhurchu, Cliona


    Background There is substantial interest in the effects of nutrition labels on consumer food-purchasing behavior. However, conducting randomized controlled trials on the impact of nutrition labels in the real world presents a significant challenge. Objective The Food Label Trial (FLT) smartphone app was developed to enable conducting fully automated trials, delivering intervention remotely, and collecting individual-level data on food purchases for two nutrition-labeling randomized controlled...

  3. Participatory workplace interventions can reduce sedentary time for office workers--a randomised controlled trial.

    Sharon Parry

    Full Text Available BACKGROUND: Occupational sedentary behaviour is an important contributor to overall sedentary risk. There is limited evidence for effective workplace interventions to reduce occupational sedentary time and increase light activity during work hours. The purpose of the study was to determine if participatory workplace interventions could reduce total sedentary time, sustained sedentary time (bouts >30 minutes, increase the frequency of breaks in sedentary time and promote light intensity activity and moderate/vigorous activity (MVPA during work hours. METHODS: A randomised controlled trial (ANZCTR NUMBER: ACTN12612000743864 was conducted using clerical, call centre and data processing workers (n = 62, aged 25-59 years in 3 large government organisations in Perth, Australia. Three groups developed interventions with a participatory approach: 'Active office' (n = 19, 'Active Workstation' and promotion of incidental office activity; 'Traditional physical activity' (n = 14, pedometer challenge to increase activity between productive work time and 'Office ergonomics' (n = 29, computer workstation design and breaking up computer tasks. Accelerometer (ActiGraph GT3X, 7 days determined sedentary time, sustained sedentary time, breaks in sedentary time, light intensity activity and MVPA on work days and during work hours were measured before and following a 12 week intervention period. RESULTS: For all participants there was a significant reduction in sedentary time on work days (-1.6%, p = 0.006 and during work hours (-1.7%, p = 0.014 and a significant increase in number of breaks/sedentary hour on work days (0.64, p = 0.005 and during work hours (0.72, p = 0.015; there was a concurrent significant increase in light activity during work hours (1.5%, p = 0.012 and MVPA on work days (0.6%, p = 0.012. CONCLUSIONS: This study explored novel ways to modify work practices to reduce occupational sedentary behaviour

  4. A randomised controlled feasibility trial for an educational school-based mental health intervention: study protocol

    Chisholm Katharine


    Full Text Available Abstract Background With the burden of mental illness estimated to be costing the English economy alone around £22.5 billion a year 1, coupled with growing evidence that many mental disorders have their origins in adolescence, there is increasing pressure for schools to address the emotional well-being of their students, alongside the stigma and discrimination of mental illness. A number of prior educational interventions have been developed and evaluated for this purpose, but inconsistency of findings, reporting standards, and methodologies have led the majority of reviewers to conclude that the evidence for the efficacy of these programmes remains inconclusive. Methods/Design A cluster randomised controlled trial design has been employed to enable a feasibility study of 'SchoolSpace', an intervention in 7 UK secondary schools addressing stigma of mental illness, mental health literacy, and promotion of mental health. A central aspect of the intervention involves students in the experimental condition interacting with a young person with lived experience of mental illness, a stigma reducing technique designed to facilitate students' engagement in the project. The primary outcome is the level of stigma related to mental illness. Secondary outcomes include mental health literacy, resilience to mental illness, and emotional well-being. Outcomes will be measured pre and post intervention, as well as at 6 month follow-up. Discussion The proposed intervention presents the potential for increased engagement due to its combination of education and contact with a young person with lived experience of mental illness. Contact as a technique to reduce discrimination has been evaluated previously in research with adults, but has been employed in only a minority of research trials investigating the impact on youth. Prior to this study, the effect of contact on mental health literacy, resilience, and emotional well-being has not been evaluated to the authors

  5. Effects of physiotherapy interventions on balance in multiple sclerosis: a systematic review and meta-analysis of randomized controlled trials

    Paltamaa, Jaana; Sjögren, Tuulikki; Peurala, Sinikka; Heinonen, Ari


    Objective: To determine the effects of physiotherapy interventions on balance in people with multiple sclerosis. Data sources: A systematic literature search was conducted in Medline, Cinahl, Embase, PEDro, both electronically and by manual search up to March 2011. Study selection: Randomized controlled trials of physiotherapy interventions in people with multiple sclerosis, with an outcome measure linked to the International Classification of Functioning, Disability a...

  6. Brief Cognitive-Behavioral Depression Prevention Program for High-Risk Adolescents Outperforms Two Alternative Interventions: A Randomized Efficacy Trial

    Stice, Eric; Rohde, Paul; Seeley, John R.; Gau, Jeff M.


    In this depression prevention trial, 341 high-risk adolescents (mean age = 15.6 years, SD = 1.2) with elevated depressive symptoms were randomized to a brief group cognitive-behavioral (CB) intervention, group supportive-expressive intervention, bibliotherapy, or assessment-only control condition. CB participants showed significantly greater…

  7. Clinical trials to estimate the efficacy of preventive interventions against malaria in paediatric populations: a methodological review

    Reed Zarifah


    Full Text Available Abstract Background Recent years have seen publication of a considerable number of clinical trials of preventive interventions against clinical malaria in children. There has been variability in the specification of end-points, case definitions, analysis methods and reporting and the relative lack of standardization complicates the ability to make comparative evaluations between trials. Methods To prepare for a WHO consultation on design issues in malaria vaccine trials, controlled trials of preventive interventions against malaria in children in endemic countries were identified in which clinical malaria, or death, had been one of the main end-points. Trials were included that evaluated the impact of vaccines, insecticide-treated bed nets (ITN, intermittent presumptive or preventive therapy in infants (IPTi or, in one instance, vitamin A supplementation. Methods that had been used in these trials were summarized and compared in order to identify issues that were directly relevant to the design of malaria vaccine trials. Results 29 controlled trials of preventive malaria interventions were identified, of which eight were vaccine trials. Vaccine trials that were designed to detect an effect on clinical malaria all reported the incidence rate of first episodes of clinical malaria as their primary endpoint. Only one trial of a preventive intervention (of ITN was identified that was designed to detect an effect on severe malaria. A group of larger trials were designed to detect an effect of impregnated bed nets or curtains on all-cause mortality as the primary end-point. Key methodological and reporting differences between trials are noted in the text. Two issues have been identified that are of some concern. Firstly, the choice of primary endpoint is not stated in the reports of a number of the trials and, secondly, the relationship between pre-specified analysis plans and trial reports is rarely made clear. Conclusion This article reports an

  8. Effects of a Web-Based Tailored Intervention to Reduce Alcohol Consumption in Adults: Randomized Controlled Trial

    Daniela N Schulz; Candel, Math JJM; Kremers, Stef PJ; Reinwand, Dominique A; Jander, Astrid; de Vries, Hein


    Background Web-based tailored interventions provide users with information that is adapted to their individual characteristics and needs. Randomized controlled trials assessing the effects of tailored alcohol self-help programs among adults are scarce. Furthermore, it is a challenge to develop programs that can hold respondents’ attention in online interventions. Objective To assess whether a 3-session, Web-based tailored intervention is effective in reducing alcohol intake in high-risk adult...

  9. Patient and provider interventions for managing osteoarthritis in primary care: protocols for two randomized controlled trials

    Allen Kelli D


    Full Text Available Abstract Background Osteoarthritis (OA of the hip and knee are among the most common chronic conditions, resulting in substantial pain and functional limitations. Adequate management of OA requires a combination of medical and behavioral strategies. However, some recommended therapies are under-utilized in clinical settings, and the majority of patients with hip and knee OA are overweight and physically inactive. Consequently, interventions at the provider-level and patient-level both have potential for improving outcomes. This manuscript describes two ongoing randomized clinical trials being conducted in two different health care systems, examining patient-based and provider-based interventions for managing hip and knee OA in primary care. Methods / Design One study is being conducted within the Department of Veterans Affairs (VA health care system and will compare a Combined Patient and Provider intervention relative to usual care among n = 300 patients (10 from each of 30 primary care providers. Another study is being conducted within the Duke Primary Care Research Consortium and will compare Patient Only, Provider Only, and Combined (Patient + Provider interventions relative to usual care among n = 560 patients across 10 clinics. Participants in these studies have clinical and / or radiographic evidence of hip or knee osteoarthritis, are overweight, and do not meet current physical activity guidelines. The 12-month, telephone-based patient intervention focuses on physical activity, weight management, and cognitive behavioral pain management. The provider intervention involves provision of patient-specific recommendations for care (e.g., referral to physical therapy, knee brace, joint injection, based on evidence-based guidelines. Outcomes are collected at baseline, 6-months, and 12-months. The primary outcome is the Western Ontario and McMasters Universities Osteoarthritis Index (self-reported pain, stiffness, and function, and

  10. Completeness of reporting in abstracts from clinical trials of pre-harvest interventions against foodborne pathogens.

    Snedeker, Kate G; Canning, Paisley; Totton, Sarah C; Sargeant, Jan M


    Abstracts are the most commonly read part of a journal article, and play an important role as summaries of the articles, and search and screening tools. However, research on abstracts in human biomedicine has shown that abstracts often do not report key methodological features and results. Little research has been done to examine reporting of such features in abstracts from papers detailing pre-harvest food safety trials. Thus, the objective of this study was to assess the quality of reporting of key factors in abstracts detailing trials of pre-harvest food safety interventions. A systematic search algorithm was used to identify all in vivo trials of pre-harvest interventions against foodborne pathogens in PubMed and CAB Direct published from 1999 to October 2009. References were screened for relevance, and 150 were randomly chosen for inclusion in the study. A checklist based on the CONSORT abstract extension and the REFLECT Statement was used to assess the reporting of methodological features and results. All screening and assessment was performed by two independent reviewers with disagreements resolved by consensus. The systematic search returned 3554 unique citations; 356 were found to be relevant and 150 were randomly selected for inclusion. The abstracts were from 51 different journals, and 13 out of 150 were structured. Of the 124 abstracts that reported whether the trial design was deliberate disease challenge or natural exposure, 113 were deliberate challenge and 11 natural exposure. 103 abstracts detailed studies involving poultry, 20 cattle and 15 swine. Most abstracts reported the production stage of the animals (135/150), a hypothesis or objective (123/150), and results for all treatment groups (136/150). However, few abstracts reported on how animals were grouped in housing (25/150), the location of the study (5/150), the primary outcome (2/126), level of treatment allocation (15/150), sample size (63/150) or whether study units were lost to follow up

  11. A Yoga Intervention for Posttraumatic Stress: A Preliminary Randomized Control Trial.

    Jindani, Farah; Turner, Nigel; Khalsa, Sat Bir S


    Yoga may be effective in the reduction of PTSD symptomology. The purpose of this study was to evaluate the impact of a Kundalini Yoga (KY) treatment on PTSD symptoms and overall wellbeing. To supplement the current field of inquiry, a pilot randomized control trial (RCT) was conducted comparing an 8-session KY intervention with a waitlist control group. 80 individuals with current PTSD symptoms participated. Both groups demonstrated changes in PTSD symptomology but yoga participants showed greater changes in measures of sleep, positive affect, perceived stress, anxiety, stress, and resilience. Between-groups effect sizes were small to moderate (0.09-0.25). KY may be an adjunctive or alternative intervention for PTSD. Findings indicate the need for further yoga research to better understand the mechanism of yoga in relation to mental and physical health, gender and ethnic comparisons, and short- and long-term yoga practice for psychiatric conditions.

  12. A Yoga Intervention for Posttraumatic Stress: A Preliminary Randomized Control Trial

    Farah Jindani


    Full Text Available Yoga may be effective in the reduction of PTSD symptomology. The purpose of this study was to evaluate the impact of a Kundalini Yoga (KY treatment on PTSD symptoms and overall wellbeing. To supplement the current field of inquiry, a pilot randomized control trial (RCT was conducted comparing an 8-session KY intervention with a waitlist control group. 80 individuals with current PTSD symptoms participated. Both groups demonstrated changes in PTSD symptomology but yoga participants showed greater changes in measures of sleep, positive affect, perceived stress, anxiety, stress, and resilience. Between-groups effect sizes were small to moderate (0.09–0.25. KY may be an adjunctive or alternative intervention for PTSD. Findings indicate the need for further yoga research to better understand the mechanism of yoga in relation to mental and physical health, gender and ethnic comparisons, and short- and long-term yoga practice for psychiatric conditions.

  13. Integrating Behavioral HIV Interventions into Biomedical Prevention Trials with Youth: Lessons from Chicago's Project PrEPare.

    Hosek, Sybil G; Green, Keith R; Siberry, George; Lally, Michelle; Balthazar, Christopher; Serrano, Pedro A; Kapogiannis, Bill


    On the heels of several trials demonstrating the efficacy of pre-exposure prophylaxis (PrEP) and the recent approval by the FDA of the supplemental indication for Truvada as PrEP, researchers, advocates, and community providers are calling for the investigation of implementation strategies that combine behavioral interventions with biomedical prevention. This paper describes the modification and integration of an evidence-based group-level intervention into a small PrEP pilot trial with young men who have sex with men (YMSM). The behavioral intervention as well as ongoing risk reduction counseling sessions were found to be highly acceptable among a sample of racially diverse YMSM.

  14. Non-pharmacological interventions in hypertension: A community-based cross-over randomized controlled trial

    Hema Subramanian


    Full Text Available Background: Hypertension is the most prevalent non-communicable disease causing significant morbidity/mortality through cardiovascular, cerebrovascular, and renal complications. Objectives: This community-based study tested the efficacy of non-pharmacological interventions in preventing/controlling hypertension. Materials and Methods: This is a cross-over randomized controlled trial (RCT of the earlier RCT (2007 of non-pharmacological interventions in hypertension, conducted in the urban service area of our Institute. The subjects, prehypertensive and hypertensive young adults (98 subjects: 25, 23, 25, 25 in four groups were randomly allotted into a group that he/she had not belonged to in the earlier RCT: Control (New Group I, Physical Exercise (NG II-brisk walking for 50 to 60 minutes, three to four days/week, Salt Intake Reduction (NG III to at least half of their previous intake, Yoga (NG IV for 30 to 45 minutes/day, five days/week. Blood pressure was measured before and after eight weeks of intervention. Analysis was by ANOVA with a Games-Howell post hoc test. Results: Ninety-four participants (25, 23, 21, 25 completed the study. All three intervention groups showed significant reduction in BP (SBP/DBP mmHg: 5.3/6.0 in NG II, 2.5/2.0 in NG III, and 2.3/2.4 in NG IV, respectively, while the Control Group showed no significant difference. Persistence of significant reduction in BP in the three intervention groups after cross-over confirmed the biological plausibility of these non-pharmacological interventions. This study reconfirmed that physical exercise was more effective than Salt Reduction or Yoga. Salt Reduction, and Yoga were equally effective. Conclusion: Physical exercise, salt intake reduction, and yoga are effective non-pharmacological methods for reducing blood pressure in young pre-hypertensive and hypertensive adults.

  15. Brief interventions to reduce Ecstasy use: a multi-site randomized controlled trial.

    Norberg, Melissa M; Hides, Leanne; Olivier, Jake; Khawar, Laila; McKetin, Rebecca; Copeland, Jan


    Studies examining the ability of motivational enhancement therapy (MET) to augment education provision among ecstasy users have produced mixed results and none have examined whether treatment fidelity was related to ecstasy use outcomes. The primary objectives of this multi-site, parallel, two-group randomized controlled trial were to determine if a single-session of MET could instill greater commitment to change and reduce ecstasy use and related problems more so than an education-only intervention and whether MET sessions delivered with higher treatment fidelity are associated with better outcomes. The secondary objective was to assess participants' satisfaction with their assigned interventions. Participants (N=174; Mage=23.62) at two Australian universities were allocated randomly to receive a 15-minute educational session on ecstasy use (n=85) or a 50-minute session of MET that included an educational component (n=89). Primary outcomes were assessed at baseline, and then at 4-, 16-, and 24-weeks postbaseline, while the secondary outcome measure was assessed 4-weeks postbaseline by researchers blind to treatment allocation. Overall, the treatment fidelity was acceptable to good in the MET condition. There were no statistical differences at follow-up between the groups on the primary outcomes of ecstasy use, ecstasy-related problems, and commitment to change. Both intervention groups reported a 50% reduction in their ecstasy use and a 20% reduction in the severity of their ecstasy-related problems at the 24-week follow up. Commitment to change slightly improved for both groups (9%-17%). Despite the lack of between-group statistical differences on primary outcomes, participants who received a single session of MET were slightly more satisfied with their intervention than those who received education only. MI fidelity was not associated with ecstasy use outcomes. Given these findings, future research should focus on examining mechanisms of change. Such work may

  16. Can Targeted Intervention Mitigate Early Emotional and Behavioral Problems?: Generating Robust Evidence within Randomized Controlled Trials.

    Orla Doyle

    Full Text Available This study examined the impact of a targeted Irish early intervention program on children's emotional and behavioral development using multiple methods to test the robustness of the results. Data on 164 Preparing for Life participants who were randomly assigned into an intervention group, involving home visits from pregnancy onwards, or a control group, was used to test the impact of the intervention on Child Behavior Checklist scores at 24-months. Using inverse probability weighting to account for differential attrition, permutation testing to address small sample size, and quantile regression to characterize the distributional impact of the intervention, we found that the few treatment effects were largely concentrated among boys most at risk of developing emotional and behavioral problems. The average treatment effect identified a 13% reduction in the likelihood of falling into the borderline clinical threshold for Total Problems. The interaction and subgroup analysis found that this main effect was driven by boys. The distributional analysis identified a 10-point reduction in the Externalizing Problems score for boys at the 90th percentile. No effects were observed for girls or for the continuous measures of Total, Internalizing, and Externalizing problems. These findings suggest that the impact of this prenatally commencing home visiting program may be limited to boys experiencing the most difficulties. Further adoption of the statistical methods applied here may help to improve the internal validity of randomized controlled trials and contribute to the field of evaluation science more generally.ISRCTN Registry ISRCTN04631728.

  17. Adherence as a language game.

    Kolberg, Espen Skarstein


    Non-adherence, i.e. medication intake behavior not corresponding with agreed recommendations, is associated with increased morbidity and death, and it has been estimated that as many as 50% of patients in developed countries are not taking their medications as prescribed. But even as efforts in improving medication adherence over the years have increased, results are inconsistent, with only a minority of clinical trials showing any improvement in both adherence and clinical outcome. Since patient education is central to promoting good medication adherence, and language is integral to education, perhaps an exploration of the meaning and use of language, using the philosophy of Ludwig Wittgenstein, is in order.

  18. Efficacy of two educational interventions about inhalation techniques in patients with chronic obstructive pulmonary disease (COPD. TECEPOC: study protocol for a partially randomized controlled trial (preference trial

    Leiva-Fernández Francisca


    Full Text Available Abstract Background Drugs for inhalation are the cornerstone of therapy in obstructive lung disease. We have observed that up to 75 % of patients do not perform a correct inhalation technique. The inability of patients to correctly use their inhaler device may be a direct consequence of insufficient or poor inhaler technique instruction. The objective of this study is to test the efficacy of two educational interventions to improve the inhalation techniques in patients with Chronic Obstructive Pulmonary Disease (COPD. Methods This study uses both a multicenter patients´ preference trial and a comprehensive cohort design with 495 COPD-diagnosed patients selected by a non-probabilistic method of sampling from seven Primary Care Centers. The participants will be divided into two groups and five arms. The two groups are: 1 the patients´ preference group with two arms and 2 the randomized group with three arms. In the preference group, the two arms correspond to the two educational interventions (Intervention A and Intervention B designed for this study. In the randomized group the three arms comprise: intervention A, intervention B and a control arm. Intervention A is written information (a leaflet describing the correct inhalation techniques. Intervention B is written information about inhalation techniques plus training by an instructor. Every patient in each group will be visited six times during the year of the study at health care center. Discussion Our hypothesis is that the application of two educational interventions in patients with COPD who are treated with inhaled therapy will increase the number of patients who perform a correct inhalation technique by at least 25 %. We will evaluate the effectiveness of these interventions on patient inhalation technique improvement, considering that it will be adequate and feasible within the context of clinical practice. Trial registration Current Controlled Trials ISRTCTN15106246

  19. The Cues and Care Trial: A randomized controlled trial of an intervention to reduce maternal anxiety and improve developmental outcomes in very low birthweight infants

    Dunkley David


    Full Text Available Abstract Background Very low birthweight infants are at risk for deficits in cognitive and language development, as well as attention and behaviour problems. Maternal sensitive behaviour (i.e. awareness of infant cues and appropriate responsiveness to those cues in interaction with her very low birthweight infant is associated with better outcomes in these domains; however, maternal anxiety interferes with the mother's ability to interact sensitively with her very low birthweight infant. There is a need for brief, cost-effective and timely interventions that address both maternal psychological distress and interactive behaviour. The Cues and Care trial is a randomized controlled trial of an intervention designed to reduce maternal anxiety and promote sensitive interaction in mothers of very low birthweight infants. Methods and design Mothers of singleton infants born at weights below 1500 g are recruited in the neonatal intensive care units of 2 tertiary care hospitals, and are randomly assigned to the experimental (Cues intervention or to an attention control (Care condition. The Cues intervention teaches mothers to attend to their own physiological, cognitive, and emotional cues that signal anxiety and worry, and to use cognitive-behavioural strategies to reduce distress. Mothers are also taught to understand infant cues and to respond sensitively to those cues. Mothers in the Care group receive general information about infant care. Both groups have 6 contacts with a trained intervener; 5 of the 6 sessions take place during the infant's hospitalization, and the sixth contact occurs after discharge, in the participant mother's home. The primary outcome is maternal symptoms of anxiety, assessed via self-report questionnaire immediately post-intervention. Secondary outcomes include maternal sensitive behaviour, maternal symptoms of posttraumatic stress, and infant development at 6 months corrected age. Discussion The Cues and Care trial will

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

    Kooij, J.J.; Rosler, M.; Philipsen, A.; Wachter, S.; Dejonckheere, J.; Kolk, A. van der; Agthoven, M. van; Schauble, B.


    BACKGROUND: Medication non-adherence has an important impact on treatment efficacy and healthcare burden across a range of conditions and therapeutic areas. The aim of this analysis was to determine predictors of non-adherence and impact of non-adherence on treatment response in adults with attentio

  1. Attempts to Reach the Oldest and Frailest: Recruitment, Adherence, and Retention of Urban Elderly Persons to a Falls Reduction Exercise Program

    Stineman, Margaret G.; Strumpf, Neville; Kurichi, Jibby E.; Charles, Jeremy; Grisso, Jeane Ann; Jayadevappa, Ravishankar


    Purpose of the study: To assess the recruitment, adherence, and retention of urban elderly, predominantly African Americans to a falls reduction exercise program. Design and methods: The randomized controlled trial was designed as an intervention development pilot study. The goal was to develop a culturally sensitive intervention for elderly…

  2. Participation in a mobile health intervention trial to improve retention in HIV care: does gender matter?

    van der Kop, Mia L; Muhula, Samuel; Ekström, Anna M; Jongbloed, Kate; Smillie, Kirsten; Abunah, Bonface; Kinagwi, Koki; Kyomuhangi, Lennie B; Gelmon, Lawrence; Ojakaa, David I; Lester, Richard T; Awiti, Patricia O


    Background To be consistent with the United Nations' sustainable development goals on gender equality, mobile health (mHealth) programmes should aim to use communications technology to promote the empowerment of women. We conducted a pre-trial analysis of data from the WelTel Retain study on retention in HIV care to assess gender-based differences in phone access, phone sharing and concerns about receiving text messages from a healthcare provider. Methods Between April 2013-June 2015, HIV-positive adults were screened for trial participation at two clinics in urban slums in Nairobi, Kenya. Proportions of men and women excluded from the trial due to phone-related criteria were compared using a chi-square test. Gender-based differences in phone sharing patterns and concerns among trial participants were similarly compared. Results Of 1068 individuals screened, there was no difference in the proportion of men ( n = 39/378, 10.3%) and women ( n = 71/690, 10.3%) excluded because of phone-related criteria ( p-value = 0.989). Among those who shared their phone, women ( n = 52/108, 48.1%) were more likely than men ( n = 6/60, 10.0%) to share with other non-household and household members ( p < 0.001). Few participants had concerns about receiving text messages from their healthcare provider; those with concerns were all women ( n = 6/700). Discussion In this study, men and women were equally able to participate in a trial of an mHealth intervention. Equitable access in these urban slums may indicate the 'gender digital divide' is narrowing in some settings; however, gender-specific phone sharing patterns and concerns regarding privacy must be fully considered in the development and scale-up of mHealth programmes.

  3. Non-adherence to antipsychotic medication, relapse and rehospitalisation in recent-onset schizophrenia

    Widen Jan H


    Full Text Available Abstract Background The aims of this study were to describe outcome with respect to persistent psychotic symptoms, relapse of positive symptoms, hospital admissions, and application of treatment by coercion among patients with recent onset schizophrenia being adherent and non-adherent to anti-psychotic medication. Materials and methods The study included 50 patients with recent onset schizophrenia, schizoaffective or schizophreniform disorders. The patients were clinically stable at study entry and had less than 2 years duration of psychotic symptoms. Good adherence to antipsychotic medication was defined as less than one month without medication. Outcomes for poor and good adherence were compared over a 24-month follow-up period. Results The Odds Ratio (OR of having a psychotic relapse was 10.27 and the OR of being admitted to hospital was 4.00 among non-adherent patients. Use of depot-antipsychotics were associated with relapses (OR = 6.44. Conclusion Non-adherence was associated with relapse, hospital admission and having persistent psychotic symptoms. Interventions to increase adherence are needed. Trial registration Current Controlled Trials NCT00184509. Key words: Adherence, schizophrenia, antipsychotic medication, admittances, relapse.

  4. Nutrition education intervention for dependent patients: protocol of a randomized controlled trial

    Arija Victoria


    view: diet, anthropometry and biochemistry in dependent patients at nutritional risk and to assess the effect of a nutritional education intervention. The design with random allocation, inclusion of all patients, validated methods, caregivers’ education and standardization between nurses allows us to obtain valuable information about nutritional status and prevention. Trial Registration number Clinical Trial Registration-URL: Unique identifier: NCT01360775

  5. An Internet-Based Intervention for Depression in Primary Care in Spain: A Randomized Controlled Trial

    Montero-Marín, Jesús; Araya, Ricardo; Mayoral, Fermín; Gili, Margalida; Botella, Cristina; Baños, Rosa; Castro, Adoración; Romero-Sanchiz, Pablo; López-Del-Hoyo, Yolanda; Nogueira-Arjona, Raquel; Vives, Margarita; Riera, Antoni; García-Campayo, Javier


    Background Depression is the most prevalent cause of illness-induced disability worldwide. Face-to-face psychotherapeutic interventions for depression can be challenging, so there is a need for other alternatives that allow these interventions to be offered. One feasible alternative is Internet-based psychological interventions. This is the first randomized controlled trial (RCT) on the effectiveness of an Internet-based intervention on depression in primary health care in Spain. Objective Our aim was to compare the effectiveness of a low-intensity therapist-guided (LITG) Internet-based program and a completely self-guided (CSG) Internet-based program with improved treatment as usual (iTAU) care for depression. Methods Multicenter, three-arm, parallel, RCT design, carried out between November 2012 and January 2014, with a follow-up of 15 months. In total, 296 adults from primary care settings in four Spanish regions, with mild or moderate major depression, were randomized to LITG (n=96), CSG (n=98), or iTAU (n=102). Research completers at follow-up were 63.5%. The intervention was Smiling is Fun, an Internet program based on cognitive behavioral therapy. All patients received iTAU by their general practitioners. Moreover, LITG received Smiling is Fun and the possibility of psychotherapeutic support on request by email, whereas CSG received only Smiling is Fun. The main outcome was the Beck Depression Inventory-II at 3 months from baseline. Mixed-effects multilevel analysis for repeated measures were undertaken. Results There was no benefit for either CSG [(B coefficient=-1.15; P=.444)] or LITG [(B=-0.71; P=.634)] compared to iTAU, at 3 months. There were differences at 6 months [iTAU vs CSG (B=-4.22; P=.007); iTAU vs LITG (B=-4.34; P=.005)] and 15 months [iTAU vs CSG (B=-5.10; P=.001); iTAU vs LITG (B=-4.62; P=.002)]. There were no differences between CSG and LITG at any time. Adjusted and intention-to-treat models confirmed these findings. Conclusions An Internet

  6. Activity monitor intervention to promote physical activity of physicians-in-training: randomized controlled trial.

    Anne N Thorndike

    Full Text Available BACKGROUND: Physicians are expected to serve as role models for healthy lifestyles, but long work hours reduce time for healthy behaviors. A hospital-based physical activity intervention could improve physician health and increase counseling about exercise. METHODS: We conducted a two-phase intervention among 104 medical residents at a large hospital in Boston, Massachusetts. Phase 1 was a 6-week randomized controlled trial comparing daily steps of residents assigned to an activity monitor displaying feedback about steps and energy consumed (intervention or to a blinded monitor (control. Phase 2 immediately followed and was a 6-week non-randomized team steps competition in which all participants wore monitors with feedback. Phase 1 outcomes were: 1 median steps/day and 2 proportion of days activity monitor worn. The Phase 2 outcome was mean steps/day on days monitor worn (≥500 steps/day. Physiologic measurements were collected at baseline and study end. Median steps/day were compared using Wilcoxon rank-sum tests. Mean steps were compared using repeated measures regression analyses. RESULTS: In Phase 1, intervention and control groups had similar activity (6369 vs. 6063 steps/day, p = 0.16 and compliance with wearing the monitor (77% vs. 77% of days, p = 0.73. In Phase 2 (team competition, residents recorded more steps/day than during Phase 1 (CONTROL: 7,971 vs. 7,567, p = 0.002; INTERVENTION: 7,832 vs. 7,739, p = 0.13. Mean compliance with wearing the activity monitor decreased for both groups during Phase 2 compared to Phase 1 (60% vs. 77%, p<0.001. Mean systolic blood pressure decreased (p = 0.004 and HDL cholesterol increased (p<0.001 among all participants at end of study compared to baseline. CONCLUSIONS: Although the activity monitor intervention did not have a major impact on activity or health, the high participation rates of busy residents and modest changes in steps, blood pressure, and HDL suggest that more

  7. Efficacy of musical interventions in dementia: methodological requirements of nonpharmacological trials.

    Samson, Séverine; Clément, Sylvain; Narme, Pauline; Schiaratura, Loris; Ehrlé, Nathalie


    The management of patients with Alzheimer's disease is a significant public health problem given the limited effectiveness of pharmacological therapies combined with iatrogenic effects of drug treatments in dementia. Consequently, the development of nondrug care, such as musical interventions, has become a necessity. The experimental rigor of studies in this area, however, is often lacking. It is therefore difficult to determine the impact of musical interventions on patients with dementia. As part of a series of studies, we carried out randomized controlled trials to compare the effectiveness of musical activities to other pleasant activities on various functions in patients with severe Alzheimer's disease. The data obtained in these trials are discussed in light of the methodological constraints and requirements specific to these clinical studies. Although the results demonstrate the power of music on the emotional and behavioral status of patients, they also suggest that other pleasant activities (e.g., cooking) are also effective, leaving open the question about the specific benefits of music in patients with dementia. All these findings highlight the promising potential for nonpharmacological treatments to improve the well-being of patients living in residential care and to reduce caregiver burden.

  8. Stimulant Reduction Intervention using Dosed Exercise (STRIDE - CTN 0037: Study protocol for a randomized controlled trial

    Morris David W


    Full Text Available Abstract Background There is a need for novel approaches to the treatment of stimulant abuse and dependence. Clinical data examining the use of exercise as a treatment for the abuse of nicotine, alcohol, and other substances suggest that exercise may be a beneficial treatment for stimulant abuse, with direct effects on decreased use and craving. In addition, exercise has the potential to improve other health domains that may be adversely affected by stimulant use or its treatment, such as sleep disturbance, cognitive function, mood, weight gain, quality of life, and anhedonia, since it has been shown to improve many of these domains in a number of other clinical disorders. Furthermore, neurobiological evidence provides plausible mechanisms by which exercise could positively affect treatment outcomes. The current manuscript presents the rationale, design considerations, and study design of the National Institute on Drug Abuse (NIDA Clinical Trials Network (CTN CTN-0037 Stimulant Reduction Intervention using Dosed Exercise (STRIDE study. Methods/Design STRIDE is a multisite randomized clinical trial that compares exercise to health education as potential treatments for stimulant abuse or dependence. This study will evaluate individuals diagnosed with stimulant abuse or dependence who are receiving treatment in a residential setting. Three hundred and thirty eligible and interested participants who provide informed consent will be randomized to one of two treatment arms: Vigorous Intensity High Dose Exercise Augmentation (DEI or Health Education Intervention Augmentation (HEI. Both groups will receive TAU (i.e., usual care. The treatment arms are structured such that the quantity of visits is similar to allow for equivalent contact between groups. In both arms, participants will begin with supervised sessions 3 times per week during the 12-week acute phase of the study. Supervised sessions will be conducted as one-on-one (i.e., individual sessions

  9. A cluster randomised controlled trial of the efficacy of a brief walking intervention delivered in primary care: Study protocol

    Szczepura Ala


    Full Text Available Abstract Background The aim of the present research is to conduct a fully powered explanatory trial to evaluate the efficacy of a brief self-regulation intervention to increase walking. The intervention will be delivered in primary care by practice nurses (PNs and Healthcare Assistants (HCAs to patients for whom increasing physical activity is a particular priority. The intervention has previously demonstrated efficacy with a volunteer population, and subsequently went through an iterative process of refinement in primary care, to maximise acceptability to both providers and recipients. Methods/ Design This two arm cluster randomised controlled trial set in UK general practices will compare two strategies for increasing walking, assessed by pedometer, over six months. Patients attending practices randomised to the self-regulation intervention arm will receive an intervention consisting of behaviour change techniques designed to increase walking self-efficacy (confidence in ability to perform the behaviour, and to help people translate their "good" intentions into behaviour change by making plans. Patients attending practices randomised to the information provision arm will receive written materials promoting walking, and a short unstructured discussion about increasing their walking. The trial will recruit 20 PN/HCAs (10 per arm, who will be trained by the research team to deliver the self-regulation intervention or information provision control intervention, to 400 patients registered at their practices (20 patients per PN/HCA. This will provide 85% power to detect a mean difference of five minutes/day walking between the self-regulation intervention group and the information provision control group. Secondary outcomes include health services costs, and intervention effects in sub-groups defined by age, ethnicity, gender, socio-economic status, and clinical condition. A mediation analysis will investigate the extent to which changes in

  10. Home-Based Intervention Program to Reduce Food Insecurity in Elderly Populations Using a TV App: Study Protocol of the Randomized Controlled Trial Saúde.Come Senior

    Gregório, Maria João; Gein, Pierre; Eusébio, Mónica; Santos, Maria José; de Sousa, Rute Dinis; Coelho, Pedro S; Mendes, Jorge M; Graça, Pedro; Oliveira, Pedro; Branco, Jaime C; Canhão, Helena


    recruit a total of 1,128 subjects considering that 50% of the target individuals are food insecure (based on INFOFAMÍLIA Survey) (567) and about 50% of those will adhere to the study (282). Results The randomized controlled trial with the 12-week home-based intervention with a comprehensive program on healthy eating and physical activity delivery is planned to start recruiting participants at the end of 2017. Conclusions This study will assess the efficacy of this innovative tool (Saúde.Come Senior) for disseminating relevant health information, modifying behaviors, and decreasing food insecurity in an easy, low-cost, and massive way. PMID:28288956

  11. Randomized trial of a DVD intervention to improve readiness to self-manage joint pain.

    Elander, James; Robinson, Georgina; Morris, John


    A DVD (digital video disk) intervention to increase readiness to self-manage joint pain secondary to hemophilia was informed by a 2-phase, motivational-volitional model of readiness to self-manage pain, and featured the personal experiences of individuals with hemophilia. The DVD was evaluated in a randomized controlled trial in which 108 men with hemophilia completed measures of readiness to self-manage pain (Pain Stages of Change Questionnaire) before and 6 months after receiving the DVD plus information booklet (n=57) or just the booklet (n=51). The effect of the DVD was assessed by comparing changes in Pain Stages of Change Questionnaire scores (precontemplation, contemplation, and action/maintenance) between groups. The impact on pain coping, pain acceptance, and health-related quality of life was tested in secondary analyses. Repeated-measures analysis of variance, including all those with complete baseline and follow-up data regardless of use of the intervention, showed a significant, medium-sized, group×time effect on precontemplation, with reductions among the DVD group but not the booklet group. Significant use×time effects showed that benefits in terms of contemplation and action/maintenance were restricted to those who used the interventions at least once. The results show that low-intensity interventions in DVD format can improve the motivational impact of written information, and could be used to help prepare people with chronic pain for more intensive self-management interventions. The findings are consistent with a 2-phase, motivational-volitional model of pain self-management, and provide the first insights to our knowledge of readiness to self-manage pain in hemophilia.

  12. Outcomes of a randomised controlled trial of a complex genetic counselling intervention to improve family communication.

    Hodgson, Jan; Metcalfe, Sylvia; Gaff, Clara; Donath, Susan; Delatycki, Martin B; Winship, Ingrid; Skene, Loane; Aitken, MaryAnne; Halliday, Jane


    When an inherited genetic condition is diagnosed in an individual it has implications for other family members. Privacy legislation and ethical considerations can restrict health professionals from communicating directly with other family members, and so it is frequently the responsibility of the first person in a family to receive the diagnosis (the proband) to share this news. Communication of genetic information is challenging and many at-risk family members remain unaware of important information that may be relevant to their or their children's health. We conducted a randomised controlled trial in six public hospitals to assess whether a specifically designed telephone counselling intervention improved family communication about a new genetic diagnosis. Ninety-five probands/parents of probands were recruited from genetics clinics and randomised to the intervention or control group. The primary outcome measure was the difference between the proportion of at-risk relatives who contacted genetics services for information and/or genetic testing. Audit of the family genetic file after 18 months revealed that 25.6% of intervention group relatives compared with 20.9% of control group relatives made contact with genetic services (adjusted odds ratio (OR) 1.30, 95% confidence interval 0.70-2.42, P=0.40). Although no major difference was detected overall between the intervention and control groups, there was more contact in the intervention group where the genetic condition conferred a high risk to offspring (adjusted OR 24.0, 95% confidence interval 3.4-168.5, P=0.001). The increasing sophistication and scope of genetic testing makes it imperative for health professionals to consider additional ways of supporting families in communicating genetic information.

  13. The nutrition-based comprehensive intervention study on childhood obesity in China (NISCOC: a randomised cluster controlled trial

    Xu Guifa


    Full Text Available Abstract Background Childhood obesity and its related metabolic and psychological abnormalities are becoming serious health problems in China. Effective, feasible and practical interventions should be developed in order to prevent the childhood obesity and its related early onset of clinical cardiovascular diseases. The objective of this paper is to describe the design of a multi-centred random controlled school-based clinical intervention for childhood obesity in China. The secondary objective is to compare the cost-effectiveness of the comprehensive intervention strategy with two other interventions, one only focuses on nutrition education, the other only focuses on physical activity. Methods/Design The study is designed as a multi-centred randomised controlled trial, which included 6 centres located in Beijing, Shanghai, Chongqing, Shandong province, Heilongjiang province and Guangdong province. Both nutrition education (special developed carton style nutrition education handbook and physical activity intervention (Happy 10 program will be applied in all intervention schools of 5 cities except Beijing. In Beijing, nutrition education intervention will be applied in 3 schools and physical activity intervention among another 3 schools. A total of 9750 primary students (grade 1 to grade 5, aged 7-13 years will participate in baseline and intervention measurements, including weight, height, waist circumference, body composition (bioelectrical impendence device, physical fitness, 3 days dietary record, physical activity questionnaire, blood pressure, plasma glucose and plasma lipid profiles. Data concerning investments will be collected in our study, including costs in staff training, intervention materials, teachers and school input and supervising related expenditure. Discussion Present study is the first and biggest multi-center comprehensive childhood obesity intervention study in China. Should the study produce comprehensive results, the

  14. Protocol for the ADDITION-Plus study: a randomised controlled trial of an individually-tailored behaviour change intervention among people with recently diagnosed type 2 diabetes under intensive UK general practice care

    Fanshawe Tom


    Full Text Available Abstract Background The increasing prevalence of type 2 diabetes poses both clinical and public health challenges. Cost-effective approaches to prevent progression of the disease in primary care are needed. Evidence suggests that intensive multifactorial interventions including medication and behaviour change can significantly reduce cardiovascular morbidity and mortality among patients with established type 2 diabetes, and that patient education in self-management can improve short-term outcomes. However, existing studies cannot isolate the effects of behavioural interventions promoting self-care from other aspects of intensive primary care management. The ADDITION-Plus trial was designed to address these issues among recently diagnosed patients in primary care over one year. Methods/Design ADDITION-Plus is an explanatory randomised controlled trial of a facilitator-led, theory-based behaviour change intervention tailored to individuals with recently diagnosed type 2 diabetes. 34 practices in the East Anglia region participated. 478 patients with diabetes were individually randomised to receive (i intensive treatment alone (n = 239, or (ii intensive treatment plus the facilitator-led individual behaviour change intervention (n = 239. Facilitators taught patients key skills to facilitate change and maintenance of key behaviours (physical activity, dietary change, medication adherence and smoking, including goal setting, action planning, self-monitoring and building habits. The intervention was delivered over one year at the participant's surgery and included a one-hour introductory meeting followed by six 30-minute meetings and four brief telephone calls. Primary endpoints are physical activity energy expenditure (assessed by individually calibrated heart rate monitoring and movement sensing, change in objectively measured dietary intake (plasma vitamin C, medication adherence (plasma drug levels, and smoking status (plasma cotinine levels at

  15. Preparing for the unexpected: the pivotal role of social and behavioral sciences in trials of biomedical HIV prevention interventions.

    Koblin, Beryl A; Andrasik, Michele; Austin, Judy


    A range of efficacies have been reported for biomedical HIV prevention interventions, including antiretroviral treatment, male circumcision, preexposure prophylaxis, microbicides, and preventive vaccines. This range of efficacies probably results from the influence of multiple inputs and processes during trials, including the strength and target of the intervention, host factors, target population characteristics, level of HIV exposure, and intervention dose. Expertise in social and behavioral sciences, in conjunction with basic science, clinical research, epidemiology, biostatistics, and community, is needed to understand the influence of these inputs and processes on intervention efficacy, improve trial design and implementation, and enable interpretation of trial results. In particular, social and behavioral sciences provide the means for investigating and identifying populations suitable for recruitment into and retention in trials and for developing and improving measures of HIV exposure and intervention dose, all within the larger sociocultural context. Integration of social and behavioral sciences early in idea generation and study design is imperative for the successful conduct of biomedical trials and for ensuring optimal data collection approaches necessary for the interpretation of findings, particularly in cases of unexpected results.

  16. Infarct size limitation after early intervention with metoprolol in the MIAMI Trial.

    Herlitz, J; Waldenström, J; Hjalmarson, A


    One of the secondary objectives of the MIAMI Trial which evaluated the role of the beta-1-selective blocker metoprolol in suspected acute myocardial infarction was to further assess whether early intervention with beta-blockade can limit infarct size. A total of 5,778 patients from 104 worldwide centres were randomized into the trial. Various enzymes such as aspartate aminotransferase (ASAT), creatine kinase (CK), CK MB, CK B, lactate dehydrogenase (LD) and LD isoenzyme I were analysed. All enzymes were used according to the clinical routine of the respective hospital, except ASAT which was analysed once daily for 3 days in the majority of cases and LD I which was analysed every 12 h for 72 h in a subsample. A consistent observation was the lower serum enzyme activity among patients receiving metoprolol and randomized early after onset of symptoms, whereas no difference between metoprolol and placebo was observed in patients treated later in the course. The results of the MIAMI Trial support previous observations that early institution of metoprolol therapy limits infarct size, as indicated by the maximum serum enzyme activity.

  17. Adherence to a Mediterranean-style diet and effects on cognition in adults: A qualitative evaluation of the systematic review of longitudinal and prospective trials

    Roy J Hardman


    Full Text Available The Mediterranean-style diet (MedDiet involves substantial intake of fruits, vegetables, and fish, and a lower consumption of dairy, red meat, and sugars. Over the past 15 years much empirical evidence supports the suggestion that a MedDiet may be beneficial with respect to reducing the incidence of cardiovascular disease, cancer, metabolic syndrome, and dementia. A number of cross-sectional studies that have examined the impact of MedDiet on cognition have yielded largely positive results. The objective of this review is to evaluate longitudinal and prospective trials to gain an understanding of how a MedDiet may impact cognitive processes over time. The included studies were aimed at improving cognition or minimizing of cognitive decline. Studies reviewed included assessments of dietary status using either a food frequency questionnaire or a food diary assessment. Eighteen articles meeting our inclusion criteria were subjected to systematic review. These revealed that higher adherence to a MedDiet is associated with slower rates of cognitive decline, reduced conversion to Alzheimer’s disease (AD and improvements in cognitive function. The specific cognitive domains that were found to benefit with improved Mediterranean Diet Score (MedDietS were memory (delayed recognition, long-term and working memory executive function, and visual constructs. The current review has also considered a number of methodological issues in making recommendations for future research. The utilisation of a dietary pattern such as the Mediterranean style diet will be essential as part of the armamentarium to maintain quality of life and reduce the potential social and economic burden of dementia. Key Words: Nutrition, cognition, Mediterranean diet, clinical trials

  18. Five years of specialised early intervention versus two years of specialised early intervention followed by three years of standard treatment for patients with a first episode psychosis: randomised, superiority, parallel group trial in Denmark (OPUS II)

    Melau, Marianne; Jensen, Heidi; Emborg, Charlotte; Jepsen, Jens Richardt Mollegaard; Fagerlund, Birgitte; Gluud, Christian; Mors, Ole; Hjorthøj, Carsten; Nordentoft, Merete


    Objective To compare the effects of five years of specialised early intervention (SEI) treatment for first episode schizophrenia spectrum disorder with the standard two years of SEI plus three years of treatment as usual. Design Randomised, superiority, parallel group trial with blinded outcome assessment. Randomisation was centralised and computerised with concealed randomisation sequence carried out at an external site. Setting Participants were recruited from six OPUS teams in Denmark between 2009 and 2012. OPUS teams provide SEI treatment to all patients diagnosed with a schizophrenia spectrum disorder in Denmark. Participants 400 participants (51% women) with a mean age of 25.6 (standard deviation 4.3) were randomised to five years of SEI (experimental intervention; n=197) or to two years of SEI plus three years of treatment as usual (control; n=203). Interventions OPUS treatment consists of three core elements—modified assertive community treatment, family involvement, and social skill training—with a patient-case manager ratio of no more than 12:1. For participants randomised to five years of OPUS treatment, the treatment was largely unchanged. Participants randomised to the control group were mostly referred to community health centres after two years of SEI treatment. Main outcomes Follow-up assessments were conducted five years after start of OPUS treatment. Primary outcome was negative symptoms measured on the scale for assessment of negative symptoms (avolition-apathy, anhedonia, alogia, and affective blunting). Secondary outcomes were remission of both negative and psychotic symptoms, psychotic symptoms, suicidal ideation, substance abuse, compliance with medical treatment, adherence with treatment, client satisfaction, days in hospital care, and labour market affiliation. Results Levels of negative symptoms did not differ between the intervention group and control group (1.72 v 1.81 points; estimated mean difference −0.10 (95% confidence

  19. Comparison of a one-time educational intervention to a teach-to-goal educational intervention for self-management of heart failure: design of a randomized controlled trial

    DeWalt Darren A


    Full Text Available Abstract Background Heart failure (HF is common, costly and associated with significant morbidity and poor quality of life, particularly for patients with low socioeconomic status. Self-management training has been shown to reduce HF related morbidity and hospitalization rates, but there is uncertainty about how best to deliver such training and what patients benefit. This study compares a single session self-management HF training program against a multiple session training intervention and examines whether their effects differ by literacy level. Methods/Design In this randomized controlled multi-site trial, English and Spanish-speaking patients are recruited from university-affiliated General Internal Medicine and Cardiology clinics at 4 sites across the United States. Eligible patients have HF with New York Heart Association class II-IV symptoms and are prescribed a loop diuretic. Baseline data, including literacy level, are collected at enrollment and follow-up surveys are conducted at 1, 6 and 12 months Upon enrollment, both the control and intervention groups receive the same 40 minute, literacy-sensitive, in-person, HF education session covering the 4 key self-management components of daily self assessment and having a plan, salt avoidance, exercise, and medication adherence. All participants also receive a literacy-sensitive workbook and a digital bathroom scale. After the baseline education was completed, patients are randomly allocated to return to usual care or to receive ongoing education and training. The intervention group receives an additional 20 minutes of education on weight and symptom-based diuretic self-adjustment, as well as periodic follow-up phone calls from the educator over the course of 1 year. These phone calls are designed to reinforce the education, assess participant knowledge of the education and address barriers to success. The primary outcome is the combined incidence of all cause hospitalization and death

  20. Smartphone application for multi-phasic interventional trials in psychiatry: Technical design of an automated smart server.

    Zhang, Melvyn W B; Ho, Roger C M


    Smartphones and their accompanying applications are currently widely utilized in various healthcare interventions. Prior to the deployment of these tools for healthcare intervention, typically, proof of concept feasibility studies, as well as randomized trials are conducted to determine that these tools are efficacious prior to their actual implementation. In the field of psychiatry, most of the current interventions seek to compare smartphone based intervention against conventional care. There remains a paucity of research evaluating different forms of interventions using a single smartphone application. In the field of nutrition, there has been recent pioneering research demonstrating how a multi-phasic randomized controlled trial could be conducted using a single smartphone application. Despite the innovativeness of the previous smartphone conceptualization, there remains a paucity of technical information underlying the conceptualization that would support a multi-phasic interventional trial. It is thus the aim of the current technical note to share insights into an innovative server design that would enable the delivery of multi-phasic trials.

  1. Weight loss intervention for young adults using mobile technology: design and rationale of a randomized controlled trial – Cell phone Intervention for You (CITY)

    Batch, Bryan C.; Tyson, Crystal; Bagwell, Jacqueline; Corsino, Leonor; Intille, Stephen; Lin, Pao-Hwa; Lazenka, Tony; Bennett, Gary; Bosworth, Hayden B.; Voils, Corrine; Grambow, Steven; Sutton, Aziza; Bordogna, Rachel; Pangborn, Matthew; Schwager, Jenifer; Pilewski, Kate; Caccia, Carla; Burroughs, Jasmine; Svetkey, Laura P.


    Background The obesity epidemic has spread to young adults, leading to significant public health implications later in adulthood. Intervention in early adulthood may be an effective public health strategy for reducing the long-term health impact of the epidemic. Few weight loss trials have been conducted in young adults. It is unclear what weight loss strategies are beneficial in this population. Purpose To describe the design and rationale of the NHLBI-sponsored Cell Phone Intervention for You (CITY) study, which is a single center, randomized three-arm trial that compares the impact on weight loss of 1) a behavioral intervention that is delivered almost entirely via cell phone technology (Cell Phone group); and 2) a behavioral intervention delivered mainly through monthly personal coaching calls enhanced by self-monitoring via cell phone (Personal Coaching group), each compared to; 3) a usual care, advice-only control condition. Methods A total of 365 community-dwelling overweight/obese adults aged 18–35 years were randomized to receive one of these three interventions for 24 months in parallel group design. Study personnel assessing outcomes were blinded to group assignment. The primary outcome is weight change at 12 months. We hypothesize that each active intervention will cause more weight loss than the usual care condition. Study completion is anticipated in 2014. Conclusions If effective, implementation of the CITY interventions could mitigate the alarming rates of obesity in young adults through promotion of weight loss. PMID:24462568

  2. OARSI Clinical Trials Recommendations

    Katz, J N; Losina, E; Lohmander, L S


    relating to obsolescence, fidelity of intervention delivery, and adherence and crossover. Assessment and analysis raise questions regarding blinding and clustering of observations. This paper describes methodological problems in the design and conduct of surgical randomized trials and proposes strategies......To highlight methodological challenges in the design and conduct of randomized trials of surgical interventions and to propose strategies for addressing these challenges. This paper focuses on three broad areas: enrollment; intervention; and assessment including implications for analysis. For each...... challenge raised in the paper, we propose potential solutions. Enrollment poses challenges in maintaining investigator equipoise, managing conflict of interest and anticipating that patient preferences for specific treatments may reduce enrollment. Intervention design and implementation pose challenges...

  3. Enhancing Father Engagement and Interparental Teamwork in an Evidence-Based Parenting Intervention: A Randomized-Controlled Trial of Outcomes and Processes.

    Frank, Tenille J; Keown, Louise J; Sanders, Matthew R


    This study examined the outcomes and process in a positive parenting program adapted to enhance father engagement and teamwork. A randomized control trial of the Group Triple P Program with additional father-relevant content was conducted with 42 families of children with conduct problems aged between 3 to 8years. Families were allocated to either the intervention or waitlist condition. Assessments of child behavior, self- and partner-reported parenting, and the interparental relationship were conducted at T1 (pre), T2 (post), and T3 (6-month follow-up). Observations were used to examine fathers' and mothers' unique and shared contributions to group process during participation in parenting group sessions. Following program completion (T2) intervention group fathers and mothers reported significantly fewer child behavior problems, dysfunctional parenting practices, and interparental conflict about child-rearing than waitlist parents. Intervention group mothers also reported increased parenting confidence and rated their partners as showing significantly fewer dysfunctional parenting practices. Intervention effects were maintained at 6-month follow-up. Observational data showed that fathers and mothers made similar contributions during the group sessions. The most frequent types of contributions were asking questions and sharing information with other parents about implementing parenting strategies. The key differences between parents were fathers' more frequent use of humor and mothers' more frequent sharing of personal stories and reporting co-parenting cooperation. The levels of session attendance and program satisfaction were high for both fathers and mothers. Findings highlight the potential benefits of efforts to engage both fathers and mothers for program adherence, satisfaction, and effectiveness.

  4. Rationale and design for the blood pressure intervention of the Action to Control Cardiovascular Risk in Diabetes (ACCORD) trial.

    Cushman, William C; Grimm, Richard H; Cutler, Jeffrey A; Evans, Gregory W; Capes, Sarah; Corson, Marshall A; Sadler, Laurie S; Alderman, Michael H; Peterson, Kevin; Bertoni, Alain; Basile, Jan N


    The Action to Control Cardiovascular Disease in Diabetes (ACCORD) blood pressure trial is an unmasked, open-label, randomized trial with a sample size of 4,733 participants. This report describes the rationale, design, and methods of the blood pressure interventions in ACCORD. Participants eligible for the blood pressure trial are randomized to 1 of 2 groups with different treatment goals: systolic blood pressure <120 mm Hg for the more intensive goal and systolic blood pressure <140 mm Hg for the less intensive goal. The primary outcome measure for the trial is the first occurrence of a major cardiovascular disease (CVD) event, specifically nonfatal myocardial infarction or stroke, or cardiovascular death during a follow-up period ranging from 4-8 years. The ACCORD blood pressure trial should provide the first definitive clinical trial data on the possible benefit of treating to a more aggressive systolic blood pressure goal in reducing CVD events in patients with diabetes mellitus.

  5. The Diabetes Manual trial protocol – a cluster randomized controlled trial of a self-management intervention for type 2 diabetes [ISRCTN06315411

    Dale Jeremy


    Full Text Available Abstract Background The Diabetes Manual is a type 2 diabetes self-management programme based upon the clinically effective 'Heart Manual'. The 12 week programme is a complex intervention theoretically underpinned by self-efficacy theory. It is a one to one intervention meeting United Kingdom requirements for structured diabetes-education and is delivered within routine primary care. Methods/design In a two-group cluster randomized controlled trial, GP practices are allocated by computer minimisation to an intervention group or a six-month deferred intervention group. We aim to recruit 250 participants from 50 practices across central England. Eligibility criteria are adults able to undertake the programme with type 2 diabetes, not taking insulin, with HbA1c over 8% (first 12 months and following an agreed protocol change over 7% (months 13 to 18. Following randomisation, intervention nurses receive two-day training and delivered the Diabetes Manual programme to participants. Deferred intervention nurses receive the training following six-month follow-up. Primary outcome is HbA1c with total and HDL cholesterol; blood pressure, body mass index; self-efficacy and quality of life as additional outcomes. Primary analysis is between-group HbA1c differences at 6 months powered to give 80% power to detect a difference in HbA1c of 0.6%. A 12 month cohort analysis will assess maintenance of effect and assess relationship between self-efficacy and outcomes, and a qualitative study is running alongside. Discussion This trial incorporates educational and psychological diabetes interventions into a single programme and assesses both clinical and psychosocial outcomes. The trial will increase our understanding of intervention transferability between conditions, those diabetes related health behaviours that are more or less susceptible to change through efficacy enhancing mechanisms and how this impacts on clinical outcomes.

  6. A cognitive behavioral based group intervention for children with a chronic illness and their parents: a multicentre randomized controlled trial

    Schuengel Carlo


    Full Text Available Abstract Background Coping with a chronic illness (CI challenges children's psychosocial functioning and wellbeing. Cognitive-behavioral intervention programs that focus on teaching the active use of coping strategies may prevent children with CI from developing psychosocial problems. Involvement of parents in the intervention program may enhance the use of learned coping strategies in daily life, especially on the long-term. The primary aim of the present study is to examine the effectiveness of a cognitive behavioral based group intervention (called 'Op Koers' 1 for children with CI and of a parallel intervention for their parents. A secondary objective is to investigate why and for whom this intervention works, in order to understand the underlying mechanisms of the intervention effect. Methods/design This study is a multicentre randomized controlled trial. Participants are children (8 to 18 years of age with a chronic illness, and their parents, recruited from seven participating hospitals in the Netherlands. Participants are randomly allocated to two intervention groups (the child intervention group and the child intervention combined with a parent program and a wait-list control group. Primary outcomes are child psychosocial functioning, wellbeing and child disease related coping skills. Secondary outcomes are child quality of life, child general coping skills, child self-perception, parental stress, quality of parent-child interaction, and parental perceived vulnerability. Outcomes are evaluated at baseline, after 6 weeks of treatment, and at a 6 and 12-month follow-up period. The analyses will be performed on the basis of an intention-to-treat population. Discussion This study evaluates the effectiveness of a group intervention improving psychosocial functioning in children with CI and their parents. If proven effective, the intervention will be implemented in clinical practice. Strengths and limitations of the study design are discussed

  7. A pilot evaluation of the efficacy of a couple-tailored print intervention on colorectal cancer screening practices among non-adherent couples.

    Manne, Sharon L; Kashy, Deborah A; Weinberg, David S; Boscarino, Joseph A; Bowen, Deborah J; Worhach, Sara


    The objective of this study was to evaluate the efficacy of a couple-tailored print (CTP) intervention on colorectal cancer screening (CRCS), CRCS intentions, and on knowledge and attitudes among couples in which neither partner is on schedule with regard to CRCS. A total of 168 married couples with both members non-adherent with CRCS were randomly assigned to receive either a CTP pamphlet accompanied by a generic print (GP) pamphlet or a GP pamphlet only. Couples completed measures of CRCS, intentions, relational perspective on CRCS, discussions about CRCS, spouse support for CRCS, spouse influence strategies, CRC knowledge, perceived CRC risk, and CRCS benefits and barriers. Results indicated there was no significant benefit of CTP vs. GP on CRCS, but there was a significant increase in CRCS intentions in CTP compared with GP. There was also a significant increase in relationship perspective on CRCS, a significant increase in husbands' support of their wives' CRCS, and a significant increase in CRCS benefits in CTP. In summary, CTP did not increase CRCS practices but increased intentions and perceived benefits of CRCS as well as improving couples' ability to view CRCS as having benefit for the marital relationship.

  8. A two-session psychological intervention for siblings of pediatric cancer patients: a randomized controlled pilot trial

    Prchal Alice


    Full Text Available Abstract Background Since siblings of pediatric cancer patients are at risk for emotional, behavioral, and social problems, there is considerable interest in development of early psychological interventions. This paper aimed at evaluating the effectiveness of a two-session psychological intervention for siblings of newly diagnosed pediatric cancer patients. Methods Thirty siblings age 6-17 years were randomly assigned to an intervention group or an active control group with standard psychosocial care. The manualized intervention provided to siblings in the first 2 months after the cancer diagnosis of the ill child included medical information, promotion of coping skills, and a psychoeducational booklet for parents. At 4 to 6 weeks, 4 months, and 7 months after the diagnosis, all siblings and their parents completed measures (from standardized instruments of social support, quality of life, medical knowledge, posttraumatic stress symptoms, and anxiety. Results At follow-up siblings in the intervention group showed better psychological well-being, had better medical knowledge, and reported receiving social support from more people. However, the intervention had no effects on posttraumatic stress symptoms and anxiety. Conclusions The results of this pilot trial suggest that a two-session sibling intervention can improve siblings' adjustment, particularly psychological well-being, in the early stage after a cancer diagnosis. Trial Registration NCT00296907

  9. Methadone induction in primary care (ANRS-Methaville: a phase III randomized intervention trial

    Roux Perrine


    Full Text Available Abstract Background In France, the rapid scale-up of buprenorphine, an opioid maintenance treatment (OMT, in primary care for drug users has led to an impressive reduction in HIV prevalence among injecting drug users (IDU but has had no major effect on Hepatitis C incidence. To date, patients willing to start methadone can only do so in a methadone clinic (a medical centre for drug and alcohol dependence (CSAPA or a hospital setting and are referred to primary care physicians after dose stabilization. This study aims to assess the effectiveness of methadone in patients who initiated treatment in primary care compared with those who initiated it in a CSAPA, by measuring abstinence from street opioid use after one year of treatment. Methods/Design The ANRS-Methaville study is a randomized multicenter non-inferiority control trial comparing methadone induction (lasting approximately 2 weeks in primary care and in CSAPA. The model of care chosen for methadone induction in primary care was based on study-specific pre-training of all physicians, exclusion criteria and daily supervision of methadone during the initiation phase. Between January 2009 and January 2011, 10 sites each having one CSAPA and several primary care physicians, were identified to recruit patients to be randomized into two groups, one starting methadone in primary care (n = 147, the other in CSAPA (n = 48. The primary outcome of the study is the proportion of participants abstinent from street opioids after 1 year of treatment i.e. non-inferiority of primary care model in terms of the proportion of patients not using street opioids compared with the proportion observed in those starting methadone in a CSAPA. Discussion The ANRS-Methaville study is the first in France to use an interventional trial to improve access to OMT for drug users. Once the non-inferiority results become available, the Ministry of Health and agency for the safety of health products may change the the

  10. Improving the Dictation in Attention Deficit Hyperactivity Disorder by Using Computer Based Interventions: A Clinical Trial

    Mahdi Tehranidoost


    Full Text Available Objective: The aim of the current study was to assess the impact of computer games and computer-assisted type instruction on dictation scores of elementary school children with attention deficit – hyperactivity disorder (ADHD. Method: In this single-blind clinical trial, 37 elementary school children with ADHD, selected by convenience sampling and divided into group I (n=17 and group II (n=20, underwent eight one-hour sessions (3 sessions per week of intervention by computer games versus computer-assisted type instruction, respectively. 12 school dictation scores were considered: 4 scores preintervention, 4 scores during interventions, and 4 scores post-intervention. Dictation test was taken during each session. Data was analyzed using repeated measure ANOVA. Results: Two groups were matched for age, gender, school grade, medication, IQ, parent’s and teacher’s Conners’ scale scores, having computer at home, history of working with computer, and mean dictation scores. There was no significant difference in dictation scores before and after interventions and also between the study groups. The improvement in school dictation scores had no significant correlation with age, gender, Ritalin use, owning a computer at home and past history of computer work, baseline dictation scores, Ritalin dose, educational status, IQ, and the total score of parent’s and teacher’s Conners’ rating scale. Conclusion: Absence of significant improvement in dictation scores in study groups may be due to the confounding effect of other variables with known impact on dictation scores. Further studies in this field should also assess the change of attention and memory.

  11. Can Early Intervention Improve Maternal Well-Being? Evidence from a Randomized Controlled Trial

    Doyle, Orla; Delaney, Liam; O’Farrelly, Christine; Fitzpatrick, Nick; Daly, Michael


    Objective This study estimates the effect of a targeted early childhood intervention program on global and experienced measures of maternal well-being utilizing a randomized controlled trial design. The primary aim of the intervention is to improve children’s school readiness skills by working directly with parents to improve their knowledge of child development and parenting behavior. One potential externality of the program is well-being benefits for parents given its direct focus on improving parental coping, self-efficacy, and problem solving skills, as well as generating an indirect effect on parental well-being by targeting child developmental problems. Methods Participants from a socio-economically disadvantaged community are randomly assigned during pregnancy to an intensive 5-year home visiting parenting program or a control group. We estimate and compare treatment effects on multiple measures of global and experienced well-being using permutation testing to account for small sample size and a stepdown procedure to account for multiple testing. Results The intervention has no impact on global well-being as measured by life satisfaction and parenting stress or experienced negative affect using episodic reports derived from the Day Reconstruction Method (DRM). Treatment effects are observed on measures of experienced positive affect derived from the DRM and a measure of mood yesterday. Conclusion The limited treatment effects suggest that early intervention programs may produce some improvements in experienced positive well-being, but no effects on negative aspects of well-being. Different findings across measures may result as experienced measures of well-being avoid the cognitive biases that impinge upon global assessments. PMID:28095505

  12. On-line randomized controlled trial of an internet based psychologically enhanced intervention for people with hazardous alcohol consumption.

    Paul Wallace

    Full Text Available BACKGROUND: Interventions delivered via the Internet have the potential to address the problem of hazardous alcohol consumption at minimal incremental cost, with potentially major public health implications. It was hypothesised that providing access to a psychologically enhanced website would result in greater reductions in drinking and related problems than giving access to a typical alcohol website simply providing information on potential harms of alcohol. DYD-RCT Trial registration: ISRCTN 31070347. METHODOLOGY/PRINCIPAL FINDINGS: A two-arm randomised controlled trial was conducted entirely on-line through the Down Your Drink (DYD website. A total of 7935 individuals who screened positive for hazardous alcohol consumption were recruited and randomized. At entry to the trial, the geometric mean reported past week alcohol consumption was 46.0 (SD 31.2 units. Consumption levels reduced substantially in both groups at the principal 3 month assessment point to an average of 26.0 (SD 22.3 units. Similar changes were reported at 1 month and 12 months. There were no significant differences between the groups for either alcohol consumption at 3 months (intervention: control ratio of geometric means 1.03, 95% CI 0.97 to 1.10 or for this outcome and the main secondary outcomes at any of the assessments. The results were not materially changed following imputation of missing values, nor was there any evidence that the impact of the intervention varied with baseline measures or level of exposure to the intervention. CONCLUSIONS/SIGNIFICANCE: Findings did not provide support for the hypothesis that access to a psychologically enhanced website confers additional benefit over standard practice and indicate the need for further research to optimise the effectiveness of Internet-based behavioural interventions. The trial demonstrates a widespread and potentially sustainable demand for Internet based interventions for people with hazardous alcohol consumption

  13. Adolescent type 1 Diabetes cardio-renal Intervention Trial (AdDIT


    Full Text Available Abstract Background The prognosis for young people diagnosed with diabetes during childhood remains poor and this is mainly related to the long-term risk of developing vascular complications. Microalbuminuria identifies subjects at risk for diabetic nephropathy (DN and cardiovascular disease (CVD. It is often detected in adolescence but is rarely treated before the age of 18 years, as at the end of puberty albumin excretion may decline and in some subjects will return into the normal range. However, evidence indicates that subjects with both transient and persistent microalbuminuria have experienced renal damage during puberty and thus reno-protection to prevent long-term complications is warranted. In adults with diabetes and microalbuminuria, the use of angiotensin converting enzyme inhibitors (ACEI and Statins is increasing, and in order to determine whether these agents are of value in the adolescent population a large randomized controlled clinical trial is needed. Methods/Design The Adolescent type 1 Diabetes cardio-renal Intervention Trial (AdDIT is a multi-center, randomized, double-blind, placebo-controlled trial of ACEI and Statin therapy in adolescents with type 1 diabetes. 500 high-risk adolescents, defined on the basis of their albumin excretion, are randomized to receive either ACEI (Quinapril or Statins (Atorvastatin or combination therapy or placebo for 3-4 years. There will also be a parallel open observational study, based on the follow-up of 400 low-risk non-randomized adolescents. The major endpoint of the study is the change in albumin excretion; secondary endpoints include markers of CVD, renal function, retinopathy, quality of life combined with assessment of compliance and potential health economic benefits. Discussion AdDIT will provide important data on the potential renal and cardiovascular protective effects of ACEI and Statins in high-risk adolescents. Long-term follow-up of the randomized subjects will provide

  14. Effectiveness of acupuncture intervention for neck pain caused by cervical spondylosis: study protocol for a randomized controlled trial


    Background Neck pain caused by cervical spondylosis has become a common health problem worldwide among >40-year-old adults. Acupuncture intervention is one of the most popular treatment measures for this disorder. However, evidence for its efficacy in relieving neck pain and recovering neck physiological function has not been established in randomized, placebo-controlled trials. The primary aim of this trial is to assess the efficacy and safety of active acupuncture compared with sham acupunc...

  15. Prevention through Activity in Kindergarten Trial (PAKT: A cluster randomised controlled trial to assess the effects of an activity intervention in preschool children

    Lenz Dorothea


    Full Text Available Abstract Background Physical activity and motor skills acquisition are of high importance for health-related prevention and a normal development in childhood. However, few intervention studies exist in preschool children focussing on an increase in physical activity and motor skills. Proof of positive effects is available but not consistent. Methods/Design The design, curriculum, and evaluation strategy of a cluster randomised intervention study in preschool children are described in this manuscript. In the Prevention through Activity in Kindergarten Trial (PAKT, 41 of 131 kindergartens of Wuerzburg and Kitzingen, Germany, were randomised into an intervention and a control group by a random number table stratified for the location of the kindergarten in an urban (more than 20.000 inhabitants or rural area. The aims of the intervention were to increase physical activity and motor skills in the participating children, and to reduce health risk factors as well as media use. The intervention was designed to involve children, parents and teachers, and lasted one academic year. It contained daily 30-min sessions of physical education in kindergarten based on a holistic pedagogic approach termed the "early psychomotor education". The sessions were instructed by kindergarten teachers under regular supervision by the research team. Parents were actively involved by physical activity homework cards. The kindergarten teachers were trained in workshops and during the supervision. Assessments were performed at baseline, 3-5 months into the intervention, at the end of the intervention and 2-4 months after the intervention. The primary outcomes of the study are increases in physical activity (accelerometry and in motor skills performance (composite score of obstacle course, standing long jump, balancing on one foot, jumping sidewise to and fro between baseline and the two assessments during the intervention. Secondary outcomes include decreases in body

  16. The effectiveness of behavioural interventions in the primary prevention of Hepatitis C amongst injecting drug users: a randomised controlled trial and lessons learned

    Tibbs Christopher


    Full Text Available Abstract Aim To develop and evaluate the comparative effectiveness of behavioural interventions of enhanced prevention counselling (EPC and simple educational counselling (SEC in reducing hepatitis C viral (HCV infection in sero-negative injecting drug users (IDU. Design Randomised controlled trial (RCT of EPC intervention in comparison with simple educational counselling (SEC. Setting Specialised Drug services in London and Surrey, United Kingdom. Participants and Measurements Ninety five IDUs were recruited and randomised to receive EPC (n = 43 or SEC (n = 52. Subjects were assessed at baseline using the Addiction Severity Index (ASI, the Injecting Risk Questionnaire (IRQ, and Drug Injecting Confidence Questionnaire (DICQ. The primary outcome was measured by the rate of sero-conversion at 6 months and 12 months from baseline and by the ASI, IRQ and DICQ at 6 months from baseline. Hepatitis C testing was undertaken by the innovative test of the dried blood spot (DBS test which increased the rate of testing by 4 fold compared to routine blood testing. Findings Seventy Eighty two subjects (82% out of the 95 recruited were followed up at 6 months and 62 (65% were followed up at 12 months. On the primary outcome measure of the rate of seroconversion, 8 out of 62 patients followed-up at twelve months seroconverted, three in the EPC group and five in the SEC group, indicating incidence rates of 9.1 per 100 person years for the EPC group, 17.2 per 100 person years for the SEC group, and 12.9 per 100 person years for the cohort as a whole. Analysis of the secondary outcome measures on alcohol use, risk behaviour, psychological measures, quality of life, showed no significant differences between the EPC and the SEC groups. However, there were significant changes on a number of measures from baseline values indicating positive change for both groups. Conclusion We were not able to prove the efficacy of EPC in comparison with SEC in the prevention of

  17. Interventions for the prevention of overweight and obesity in preschool children: a systematic review of randomized controlled trials.

    Monasta, L; Batty, G D; Macaluso, A; Ronfani, L; Lutje, V; Bavcar, A; van Lenthe, F J; Brug, J; Cattaneo, A


    The objective of this study was to analyse interventions for the prevention of overweight and obesity in children under 5 years of age. We carried out a systematic review focusing exclusively on randomized controlled trials (RCTs). Data sources include Medline, Cochrane Library, EMBASE, CINHAL, PsychInfo and Web of Science. Data were extracted from seventeen articles describing seven RCTs identified through electronic search, screening of references in systematic reviews, own files and contact with authors. RCTs were assessed with the Jadad scale. Four trials were carried out in preschool settings, one with an exclusive educational component, two with an exclusive physical activity component and one with both. Two trials were family-based, with education and counselling for parents and children. The remaining trial was carried out in maternity hospitals, with a training intervention on breastfeeding. None of the interventions had an effect in preventing overweight and obesity. The failure to show an effect may be due to the choice of outcomes, the quality of the RCTs, the suboptimal implementation of the interventions, the lack of focus on social and environmental determinants. More rigorous research is needed on interventions and on social and environmental factors that could impact on lifestyle.

  18. A randomized controlled trial of a theoretically-based behavioral nutrition intervention for community elders: lessons learned from the Behavioral Nutrition Intervention for Community Elders Study.

    Locher, Julie L; Vickers, Kristin S; Buys, David R; Ellis, Amy; Lawrence, Jeannine C; Newton, Laura Elizabeth; Roth, David L; Ritchie, Christine S; Bales, Connie W


    Older adults with multiple comorbidities are often undernourished or at high risk for becoming so, especially after a recent hospitalization. Randomized controlled trials of effective, innovative interventions are needed to support evidence-based approaches for solving nutritional problems in this population. Self-management approaches where participants select their own behavioral goals can enhance success of interventions. The purpose of this study was to evaluate the feasibility and efficacy of a multilevel self-management intervention to improve nutritional status in a group of high-risk older adults. The Behavioral Nutrition Intervention for Community Elders (B-NICE) trial used a prospective randomized controlled design to determine whether the intervention, compared to standard care, maintained or increased caloric intake (depending on baseline body mass index) and, consequently, stabilized or increased body weight. Participants were 34 Medicare-eligible, age 65 years old or older, homebound adults who were consuming insufficient calories and/or had a history of weight loss ≥2.5% over 6 months. The intervention took place within participants' homes. Outcome measures, including energy intake (based on collection of three 24-hour dietary recalls) and body weights were assessed at baseline and at 60 days post randomization. The primary analyses included analyses of covariance and Pearson's χ(2). We hypothesized that the intervention would result in increased caloric intake and weight gain in underweight older adults and increased or stabilized caloric intake and weight for everyone else. The intervention was feasible; however, it did not result in differences between groups for desired outcomes of either caloric intake or body weight. Future interventions might either deliberately involve caregivers or reduce burden for both patients and caregivers.

  19. Using the Medical Research Council Framework for the Development and Evaluation of Complex Interventions in a Theory-Based Infant Feeding Intervention to Prevent Childhood Obesity: The Baby Milk Intervention and Trial

    Rajalakshmi Lakshman


    Full Text Available Introduction. We describe our experience of using the Medical Research Council framework on complex interventions to guide the development and evaluation of an intervention to prevent obesity by modifying infant feeding behaviours. Methods. We reviewed the epidemiological evidence on early life risk factors for obesity and interventions to prevent obesity in this age group. The review suggested prevention of excess weight gain in bottle-fed babies and appropriate weaning as intervention targets; hence we undertook systematic reviews to further our understanding of these behaviours. We chose theory and behaviour change techniques that demonstrated evidence of effectiveness in altering dietary behaviours. We subsequently developed intervention materials and evaluation tools and conducted qualitative studies with mothers (intervention recipients and healthcare professionals (intervention deliverers to refine them. We developed a questionnaire to assess maternal attitudes and feeding practices to understand the mechanism of any intervention effects. Conclusions. In addition to informing development of our specific intervention and evaluation materials, use of the Medical Research Council framework has helped to build a generalisable evidence base for early life nutritional interventions. However, the process is resource intensive and prolonged, and this should be taken into account by public health research funders. This trial is registered with ISRTCN: 20814693 Baby Milk Trial.

  20. Rationale and design of the Kanyini guidelines adherence with the polypill (Kanyini-GAP study: a randomised controlled trial of a polypill-based strategy amongst Indigenous and non Indigenous people at high cardiovascular risk

    Usherwood Tim


    Full Text Available Abstract Background The Kanyini Guidelines Adherence with the Polypill (Kanyini-GAP Study aims to examine whether a polypill-based strategy (using a single capsule containing aspirin, a statin and two blood pressure-lowering agents amongst Indigenous and non-Indigenous people at high risk of experiencing a cardiovascular event will improve adherence to guideline-indicated therapies, and lower blood pressure and cholesterol levels. Methods/Design The study is an open, randomised, controlled, multi-centre trial involving 1000 participants at high risk of cardiovascular events recruited from mainstream general practices and Aboriginal Medical Services, followed for an average of 18 months. The participants will be randomised to one of two versions of the polypill, the version chosen by the treating health professional according to clinical features of the patient, or to usual care. The primary study outcomes will be changes, from baseline measures, in serum cholesterol and systolic blood pressure and self-reported current use of aspirin, a statin and at least two blood pressure lowering agents. Secondary study outcomes include cardiovascular events, renal outcomes, self-reported barriers to indicated therapy, prescription of indicated therapy, occurrence of serious adverse events and changes in quality-of-life. The trial will be supplemented by formal economic and process evaluations. Discussion The Kanyini-GAP trial will provide new evidence as to whether or not a polypill-based strategy improves adherence to effective cardiovascular medications amongst individuals in whom these treatments are indicated. Trial Registration This trial is registered with the Australian New Zealand Clinical Trial Registry ACTRN126080005833347.

  1. Patients' interpretations of a counselling intervention for low back pain

    Angel, Sanne; Jensen, Lone Donbæk; Gonge, Birgitte Krøis


    persist. A Danish randomised controlled trial identified an effective counselling intervention on low back pain patients' physical function, bodily pain and sick leave. Counselling addressed experienced workplace barriers and physical activity. OBJECTIVE: The objective of the present study was to achieve...... of status interviews performed during the randomised controlled trial's intervention. ANALYSIS: Between two individual counselling sessions, all 110 participants were interviewed about their perspectives on adhering to their individual plans for reaching specific goals for adjustments at their workplace...

  2. Multifaceted Intervention to Prevent Venous Thromboembolism in Patients Hospitalized for Acute Medical Illness: A Multicenter Cluster-Randomized Trial.

    Pierre-Marie Roy

    Full Text Available Misuse of thromboprophylaxis may increase preventable complications for hospitalized medical patients.To assess the net clinical benefit of a multifaceted intervention in emergency wards (educational lectures, posters, pocket cards, computerized clinical decision support systems and, where feasible, electronic reminders for the prevention of venous thromboembolism.Prospective cluster-randomized trial in 27 hospitals. After a pre-intervention period, centers were randomized as either intervention (n = 13 or control (n = 14. All patients over 40 years old, admitted to the emergency room, and hospitalized in a medical ward were included, totaling 1,402 (712 intervention and 690 control and 15,351 (8,359 intervention and 6,992 control in the pre-intervention and intervention periods, respectively.Symptomatic venous thromboembolism or major bleeding (primary outcome occurred at 3 months in 3.1% and 3.2% of patients in the intervention and control groups, respectively (adjusted odds ratio: 1.02 [95% confidence interval: 0.78-1.34]. The rates of thromboembolism (1.9% vs. 1.9%, major bleedings (1.2% vs. 1.3%, and mortality (11.3% vs. 11.1% did not differ between the groups. Between the pre-intervention and intervention periods, the proportion of patients who received prophylactic anticoagulant treatment more steeply increased in the intervention group (from 35.0% to 48.2%: +13.2% than the control (40.7% to 44.1%: +3.4%, while the rate of adequate thromboprophylaxis remained stable in both groups (52.4% to 50.9%: -1.5%; 49.1% to 48.8%: -0.3%.Our intervention neither improved adequate prophylaxis nor reduced the rates of clinical events. New strategies are required to improve thromboembolism prevention for hospitalized medical NCT01212393.

  3. Indicated school-based intervention to improve depressive symptoms among at risk Chilean adolescents: a randomized controlled trial

    Gaete, Jorge; Martinez, Vania; Fritsch, Rosemarie; Rojas, Graciela; Montgomery, Alan A.; Araya, Ricardo


    Background Depression is a disabling condition affecting people of all ages, but generally starting during adolescence. Schools seem to be an excellent setting where preventive interventions may be delivered. This study aimed to test the effectiveness of an indicated school-based intervention to reduce depressive symptoms among at-risk adolescents from low-income families. Methods A two-arm, parallel, randomized controlled trial was conducted in 11 secondary schools in vulnerable socioeconomi...

  4. Can simply answering research questions change behaviour? Systematic review and meta analyses of brief alcohol intervention trials.

    Jim McCambridge

    Full Text Available BACKGROUND: Participant reports of their own behaviour are critical for the provision and evaluation of behavioural interventions. Recent developments in brief alcohol intervention trials provide an opportunity to evaluate longstanding concerns that answering questions on behaviour as part of research assessments may inadvertently influence it and produce bias. The study objective was to evaluate the size and nature of effects observed in randomized manipulations of the effects of answering questions on drinking behaviour in brief intervention trials. METHODOLOGY/PRINCIPAL FINDINGS: Multiple methods were used to identify primary studies. Between-group differences in total weekly alcohol consumption, quantity per drinking day and AUDIT scores were evaluated in random effects meta-analyses. Ten trials were included in this review, of which two did not provide findings for quantitative study, in which three outcomes were evaluated. Between-group differences were of the magnitude of 13.7 (-0.17 to 27.6 grams of alcohol per week (approximately 1.5 U.K. units or 1 standard U.S. drink and 1 point (0.1 to 1.9 in AUDIT score. There was no difference in quantity per drinking day. CONCLUSIONS/SIGNIFICANCE: Answering questions on drinking in brief intervention trials appears to alter subsequent self-reported behaviour. This potentially generates bias by exposing non-intervention control groups to an integral component of the intervention. The effects of brief alcohol interventions may thus have been consistently under-estimated. These findings are relevant to evaluations of any interventions to alter behaviours which involve participant self-report.

  5. The Effects of Perioperative Music Interventions in Pediatric Surgery: A Systematic Review and Meta-Analysis of Randomized Controlled Trials

    Van Der Heijden, Marianne J. E.; Sadaf Oliai Araghi; Monique van Dijk; Johannes Jeekel; M G Myriam Hunink


    Objective Music interventions are widely used, but have not yet gained a place in guidelines for pediatric surgery or pediatric anesthesia. In this systematic review and meta-analysis we examined the effects of music interventions on pain, anxiety and distress in children undergoing invasive surgery. Data Sources We searched 25 electronic databases from their first available date until October 2014. Study Selection Included were all randomized controlled trials with a parallel group, crossove...

  6. Male partner antenatal attendance and HIV testing in eastern Uganda: a randomized facility-based intervention trial

    Byamugisha Robert


    Full Text Available Abstract Background The objective of the study was to evaluate the effect of a written invitation letter to the spouses of new antenatal clinic attendees on attendance by couples and on male partner acceptance of HIV testing at subsequent antenatal clinic visits. Methods The trial was conducted with 1060 new attendees from October 2009 to February 2010 in an antenatal clinic at Mbale Regional Referral Hospital, Mbale District, eastern Uganda. The intervention comprised an invitation letter delivered to the spouses of new antenatal attendees, while the control group received an information letter, a leaflet, concerning antenatal care. The primary outcome measure was the proportion of pregnant women who attended antenatal care with their male partners during a follow-up period of four weeks. Eligible pregnant women were randomly assigned to the intervention or non-intervention groups using a randomization sequence, which was computer generated utilizing a random sequence generator (RANDOM ORG that employed a simple randomization procedure. Respondents, health workers and research assistants were masked to group assignments. Results The trial was completed with 530 women enrolled in each group. Participants were analyzed as originally assigned (intention to treat. For the primary outcome, the percentage of trial participants who attended the antenatal clinic with their partners were 16.2% (86/530 and 14.2% (75/530 in the intervention and non-intervention groups, respectively (OR = 1.2; 95% CI: 0.8, 1.6. For the secondary outcome, most of the 161 male partners attended the antenatal clinic; 82 of 86 (95% in the intervention group and 68 of 75 (91% in the non-intervention group were tested for HIV (OR = 2.1; 95% CI: 0.6 to 7.5. Conclusions The effect of the intervention and the control on couple antenatal attendance was similar. In addition, the trial demonstrated that a simple intervention, such as a letter to the spouse, could increase couple

  7. Who Follows eHealth Interventions as Recommended? A Study of Participants' Personal Characteristics From the Experimental Arm of a Randomized Controlled Trial

    Reinwand, Dominique A; Schulz, Daniela Nadine; Crutzen, Rik; Kremers, Stef PJ; de Vries, Hein


    Background Computer-tailored eHealth interventions to improve health behavior have been demonstrated to be effective and cost-effective if they are used as recommended. However, different subgroups may use the Internet differently, which might also affect intervention use and effectiveness. To date, there is little research available depicting whether adherence to intervention recommendations differs according to personal characteristics. Objective The aim was to assess which personal charact...

  8. Adherence: a review of education, research, practice, and policy in the United States

    Brown TA


    Full Text Available Objective: To describe the education, research, practice, and policy related to pharmacist interventions to improve medication adherence in community settings in the United States.Methods: Authors used MEDLINE and International Pharmaceutical Abstracts (since 1990 to identify community and ambulatory pharmacy intervention studies which aimed to improve medication adherence. The authors also searched the primary literature using Ovid to identify studies related to the pharmacy teaching of medication adherence. The bibliographies of relevant studies were reviewed in order to identify additional literature. We searched the tables of content of three US pharmacy education journals and reviewed the American Association of Colleges of Pharmacy website for materials on teaching adherence principles. Policies related to medication adherence were identified based on what was commonly known to the authors from professional experience, attendance at professional meetings, and pharmacy journals.Results: Research and Practice: 29 studies were identified: 18 randomized controlled trials; 3 prospective cohort studies; 2 retrospective cohort studies; 5 case-controlled studies; and one other study. There was considerable variability in types of interventions and use of adherence measures. Many of the interventions were completed by pharmacists with advanced clinical backgrounds and not typical of pharmacists in community settings. The positive intervention effects had either decreased or not been sustained after interventions were removed. Although not formally assessed, in general, the average community pharmacy did not routinely assess and/or intervene on medication adherence. Education: National pharmacy education groups support the need for pharmacists to learn and use adherence-related skills. Educational efforts involving adherence have focused on students’ awareness of adherence barriers and communication skills needed to engage patients in behavioral

  9. Rating the quality of trials in systematic reviews of physical therapy interventions.

    Elkins, Mark R; Herbert, Robert D; Moseley, Anne M; Sherrington, Catherine; Maher, Chris


    Physical therapists seeking to use evidence to guide their practice may have limited time to read research reports. One way to reduce the time required to identify and read about the research that is relevant to a particular clinical question is to read a systematic review that summarizes multiple studies. This paper explains the process that is used to conduct systematic reviews, which includes the establishment of a protocol, comprehensive searching, appraisal of the quality of the included studies, data extraction and metaanalysis, and consideration of the clinical and research implications of the findings. We also consider how the reader of a systematic review can determine whether the review is likely to provide an unbiased (believable) estimate of the treatment effect. A systematic review of randomized trials of a cardiopulmonary physical therapy intervention is used as an example. The issue of appraisal of quality is then discussed further, with a demonstration of how one validated tool for quality appraisal-the PEDro scale-can be used to evaluate a randomized trial in cardiopulmonary physical therapy.

  10. Pilot randomised trial of a healthy eating behavioural intervention in uncontrolled asthma.

    Ma, Jun; Strub, Peg; Lv, Nan; Xiao, Lan; Camargo, Carlos A; Buist, A Sonia; Lavori, Philip W; Wilson, Sandra R; Nadeau, Kari C; Rosas, Lisa G


    Rigorous research on the benefit of healthy eating patterns for asthma control is lacking.We randomised 90 adults with objectively confirmed uncontrolled asthma and a low-quality diet (Dietary Approaches to Stop Hypertension (DASH) scores Asthma Control Questionnaire scores (-0.2 (-0.5, 0) versus 0 (-0.3, 0.3); difference -0.2 (-0.5, 0.1)) at 6 months. The mean group differences in changes in Mini Asthma Quality of Life Questionnaire overall and subdomain scores consistently favoured the intervention over the control group: overall 0.4 (95% CI 0, 0.8), symptoms 0.5 (0, 0.9), environment 0.4 (-0.1, 1.0), emotions 0.4 (-0.2, 0.9) and activities 0.3 (0, 0.7). These differences were modest, but potentially clinical significant.The DASH behavioural intervention improved diet quality with promising clinical benefits for better asthma control and functional status among adults with uncontrolled asthma. A full-scale efficacy trial is warranted.

  11. A lifestyle intervention for primary care patients with depression and anxiety: A randomised controlled trial.

    Forsyth, Adrienne; Deane, Frank P; Williams, Peter


    This study aimed to evaluate the efficacy of a diet and exercise lifestyle intervention on mental health outcomes for patients currently being treated for depression and/or anxiety in primary care. Patients (n=119) referred by general practitioners to the 12-week randomised controlled trial were assigned to either an intervention of six visits to a dual qualified dietitian/exercise physiologist (DEP) where motivational interviewing and activity scheduling were used to engage patients in individually-tailored lifestyle change (focussed on diet and physical activity), or an attention control with scheduled telephone contact. Assessments conducted at baseline (n=94) and 12 weeks (n=60) were analysed with an intent-to-treat approach using linear mixed modelling. Significant improvement was found for both groups on Depression, Anxiety and Stress Scale (DASS) scores, measures of nutrient intake and total Australian modified Healthy Eating Index (Aust-HEI) scores. Significant differences between groups over time were found only for iron intake and body mass index. Patients participating in individual consultations with a dietitian were more likely to maintain or improve diet quality than those participating in an attention control. This study provides initial evidence to support the role of dietitians in the management of patients with depression and/or anxiety.

  12. Promoting first relationships: randomized trial of a relationship-based intervention for toddlers in child welfare.

    Spieker, Susan J; Oxford, Monica L; Kelly, Jean F; Nelson, Elizabeth M; Fleming, Charles B


    We conducted a community-based, randomized control trial with intent-to-treat analyses of Promoting First Relationships (PFR) to improve parenting and toddler outcomes for toddlers in state dependency. Toddlers (10-24 months; N = 210) with a recent placement disruption were randomized to 10-week PFR or a comparison condition. Community agency providers were trained to use PFR in the intervention for caregivers. From baseline to postintervention, observational ratings of caregiver sensitivity improved more in the PFR condition than in the comparison condition, with an effect size for the difference in adjusted means postintervention of d = .41. Caregiver understanding of toddlers' social emotional needs and caregiver reports of child competence also differed by intervention condition postintervention (d = .36 and d = .42) with caregivers in the PFR condition reporting more understanding of toddlers and child competence. Models of PFR effects on within-individual change were significant for caregiver sensitivity and understanding of toddlers. At the 6-month follow-up, only 61% of original sample dyads were still intact and there were no significant differences on caregiver or child outcomes.

  13. A pragmatic cluster randomized controlled trial of early intervention for chronic obstructive pulmonary disease by practice nurse-general practitioner teams: Study Protocol

    Bunker Jeremy M


    Full Text Available Abstract Background Chronic Obstructive Pulmonary Disease (COPD is a leading cause of disability, hospitalization, and premature mortality. General practice is well placed to diagnose and manage COPD, but there is a significant gap between evidence and current practice, with a low level of awareness and implementation of clinical practice guidelines. Under-diagnosis of COPD is a world-wide problem, limiting the benefit that could potentially be achieved through early intervention strategies such as smoking cessation, dietary advice, and exercise. General practice is moving towards more structured chronic disease management, and the increasing involvement of practice nurses in delivering chronic care. Design A pragmatic cluster randomised trial will test the hypothesis that intervention by a practice nurse-general practitioner (GP team leads to improved health-related quality of life and greater adherence with clinical practice guidelines for patients with newly-diagnosed COPD, compared with usual care. Forty general practices in greater metropolitan Sydney Australia will be recruited to identify patients at risk of COPD and invite them to attend a case finding appointment. Practices will be randomised to deliver either practice nurse-GP partnership care, or usual care, to patients newly-diagnosed with COPD. The active intervention will involve the practice nurse and GP working in partnership with the patient in developing and implementing a care plan involving (as appropriate, smoking cessation, immunisation, pulmonary rehabilitation, medication review, assessment and correction of inhaler technique, nutritional advice, management of psycho-social issues, patient education, and management of co-morbidities. The primary outcome measure is health-related quality of life, assessed with the St George’s Respiratory Questionnaire 12 months after diagnosis. Secondary outcome measures include validated disease-specific and general health related

  14. Screening and brief interventions for hazardous alcohol use in accident and emergency departments: a randomised controlled trial protocol

    Myles Judy


    Full Text Available Abstract Background There is a wealth of evidence regarding the detrimental impact of excessive alcohol consumption on the physical, psychological and social health of the population. There also exists a substantial evidence base for the efficacy of brief interventions aimed at reducing alcohol consumption across a range of healthcare settings. Primary research conducted in emergency departments has reinforced the current evidence regarding the potential effectiveness and cost-effectiveness. Within this body of evidence there is marked variation in the intensity of brief intervention delivered, from very minimal interventions to more intensive behavioural or lifestyle counselling approaches. Further the majority of primary research has been conducted in single centre and there is little evidence of the wider issues of generalisability and implementation of brief interventions across emergency departments. Methods/design The study design is a prospective pragmatic factorial cluster randomised controlled trial. Individual Emergency Departments (ED (n = 9 are randomised with equal probability to a combination of screening tool (M-SASQ vs FAST vs SIPS-PAT and an intervention (Minimal intervention vs Brief advice vs Brief lifestyle counselling. The primary hypothesis is that brief lifestyle counselling delivered by an Alcohol Health Worker (AHW is more effective than Brief Advice or a minimal intervention delivered by ED staff. Secondary hypotheses address whether short screening instruments are more acceptable and as efficient as longer screening instruments and the cost-effectiveness of screening and brief interventions in ED. Individual participants will be followed up at 6 and 12 months after consent. The primary outcome measure is performance using a gold-standard screening test (AUDIT. Secondary outcomes include; quantity and frequency of alcohol consumed, alcohol-related problems, motivation to change, health related quality of life and

  15. Multicomponent interdisciplinary group intervention for self-management of fibromyalgia: a mixed-methods randomized controlled trial.

    Patricia Bourgault

    Full Text Available This study evaluated the efficacy of the PASSAGE Program, a structured multicomponent interdisciplinary group intervention for the self-management of FMS.A mixed-methods randomized controlled trial (intervention (INT vs. waitlist (WL was conducted with patients suffering from FMS. Data were collected at baseline (T0, at the end of the intervention (T1, and 3 months later (T2. The primary outcome was change in pain intensity (0-10. Secondary outcomes were fibromyalgia severity, pain interference, sleep quality, pain coping strategies, depression, health-related quality of life, patient global impression of change (PGIC, and perceived pain relief. Qualitative group interviews with a subset of patients were also conducted. Complete data from T0 to T2 were available for 43 patients.The intervention had a statistically significant impact on the three PGIC measures. At the end of the PASSAGE Program, the percentages of patients who perceived overall improvement in their pain levels, functioning and quality of life were significantly higher in the INT Group (73%, 55%, 77% respectively than in the WL Group (8%, 12%, 20%. The same differences were observed 3 months post-intervention (Intervention group: 62%, 43%, 38% vs Waitlist Group: 13%, 13%, 9%. The proportion of patients who reported ≥ 50% pain relief was also significantly higher in the INT Group at the end of the intervention (36% vs 12% and 3 months post-intervention (33% vs 4%. Results of the qualitative analysis were in line with the quantitative findings regarding the efficacy of the intervention. The improvement, however, was not reflected in the primary outcome and other secondary outcome measures.The PASSAGE Program was effective in helping FMS patients gain a sense of control over their symptoms. We suggest including PGIC in future clinical trials on FMS as they appear to capture important aspects of the patients' experience.International Standard Randomized Controlled Trial Number

  16. Time-Based Physical Activity Interventions for Weight Loss: A Randomized Trial

    Jakicic, John M.; Rickman, Amy D.; Lang, Wei; Davis, Kelliann K.; Gibbs, Bethany Barone; Neiberg, Rebecca; Marcus, Marsha D.


    Purpose To examine whether enhancing standard behavior weight loss interventions (SBWP) with additional strategies at the initiation of the intervention (ADOPT) or providing the additional strategies at predetermined times over the intervention period (MAINTAIN) enhances 18 month weight loss. Methods This was a clinical trial with participants (n=195; age= 43.2±8.6 yrs; BMI= 33.0±3.4 kg/m2) randomized to SBWP, ADOPT, or MAINTAIN. All were prescribed an energy restricted diet and physical activity, with group intervention sessions delivered over 18 months. ADOPT received additional phone contact (months 1–3), supervised exercise (months 1–6), and behavior campaigns (months 4–9). MAINTAIN received additional phone contact (months 4–6), supervised exercise (months 7–12), and behavior campaigns (months 13–18). Results There was a significant Group X Time interaction for weight loss (p=0.0032). SBWP lost 9.3±0.9, 7.8±1.1, and 5.9±1.2 kg at 6, 12, and 18 months, respectively. ADOPT lost 8.9±0.9, 7.6±1.2, and 5.8±1.2 kg, and MAINTAIN lost 9.7±0.9, 11.0±1.2, and 9.0±1.2 kg at 6, 12, and 18 months, respectively. The Group X Time interaction for SBWP vs. MAINTAIN (p=0.0033) and ADOPT vs. MAINTAIN (p=0.0075) was significant. There was a significant Group X Time interaction for change in fitness (p=0.0060). The Group X Time interaction for MAINTAIN vs. ADOPT (p=0.0018) was significant with a trend for MAINTAIN vs. SBWP (p=0.0525). Conclusions MAINTAIN improved 18-month weight loss compared to SBWP and ADOPT, with statistical trends that MAINTAIN resulted in greater improvements in fitness. These results suggest that time-based strategies emphasizing physical activity conferred greater benefits when delivered later and over the full course of intervention. This provides valuable information for the implementation of time-based strategies to improve long-term weight loss and fitness in overweight and obese adults. PMID:25160843

  17. Cognitive Behavioral Therapy for Adherence and Depression (CBT-AD) in HIV-Infected Injection Drug Users: A Randomized Controlled Trial

    Safren, Steven A.; O'Cleirigh, Conall M.; Bullis, Jacqueline R.; Otto, Michael W.; Stein, Michael D.; Pollack, Mark H.


    Objective: Depression and substance use, the most common comorbidities with HIV, are both associated with poor treatment adherence. Injection drug users comprise a substantial portion of individuals with HIV in the United States and globally. The present study tested cognitive behavioral therapy for adherence and depression (CBT-AD) in patients…

  18. The influence of cognition, anxiety and psychiatric disorders over treatment adherence in uncontrolled hypertensive patients.

    Úrsula Jacobs

    Full Text Available BACKGROUND: Poor adherence is estimated to cause 125 thousand deaths per year and is linked to 10% of all hospital stays in the U.S. Up to one third of elderly hypertensive patients don't have adherence, which is responsible for high proportion of hospitalizations. Hypertension is also related to poor performance in tests that assess cognitive functions. On the other hand, poor cognitive performance is associated with low adherence to treatment. OBJECTIVE: To assess the association between cognitive function, anxiety and psychiatric disorders with adherence to drug treatment in patients with hypertension. METHODOLOGY AND PRINCIPAL FINDINGS: This a cohort studies with 56 adult patients with uncontrolled hypertension who participated of all meetings of a pharmaceutical intervention in a randomized clinical trial of pharmaceutical care. Cognitive function was measured by the Mini Mental State Examination (Mini-mental. The memory was measured by digit and word spans, tower and church shadow test, short story test and metamemory. Anxiety and psychiatric disorders were evaluated by the State Trace Anxiety Inventory and the Self-Report Questionnaire, respectively. The participants were classified as adherent or non-adherent to the drug treatment, according to the identification of plasma levels of hydrochlorothiazide. All non-adherent patients (n = 12 and 35 out 44 (79.5% patients with adherence to treatment had at least one memory test with an altered score (P = 0.180. Participants with an unsatisfactory score in the Mini-mental had six-fold higher risk of non-adherence to treatment when compared to those with a normal score (RR = 5.8; CI 95%: 1.6-20.8; P = 0.007. The scores of anxiety and psychiatric disorders were not associated with adherence to the pharmacological treatment. CONCLUSION: Cognitive deficit impairs adherence to drug therapy and should be screened as part of a program of pharmaceutical care to improve adherence to

  19. Mindfulness Training Improves Attentional Task Performance in Incarcerated Youth: A Group Randomized Controlled Intervention Trial

    Noelle R Leonard


    Full Text Available We investigated the impact of cognitive behavioral therapy and mindfulness training (CBT/MT on attentional task performance in incarcerated adolescents. Attention is a cognitive system necessary for managing cognitive demands and regulating emotions. Yet persistent and intensive demands, such as those experienced during high-stress intervals like incarceration and the events leading to incarceration, may deplete attention resulting in cognitive failures, emotional disturbances, and impulsive behavior. We hypothesized that CBT/MT may mitigate these deleterious effects of high stress and protect against degradation in attention over the high-stress interval of incarceration. Using a group randomized controlled trial design, we randomly assigned dormitories of incarcerated youth, ages 16 to 18, to a CBT/MT intervention (youth n = 147 or an active control intervention (youth n = 117. Both arms received approximately 750 minutes of intervention in a small-group setting over a 3-5 week period. Youth in the CBT/MT arm also logged the amount of out-of-session time spent practicing MT exercises. The Attention Network Test was used to index attentional task performance at baseline and 4 months post-baseline. Overall, task performance degraded over time in all participants. The magnitude of performance degradation was significantly less in the CBT/MT vs. control arm. Further, within the CBT/MT arm, performance degraded over time in those with no outside-of-class practice time, but remained stable over time in those who practiced mindfulness exercises outside of the session meetings. Thus, these findings suggest that sufficient CBT/MT practice may protect against functional attentional impairments associated with high-stress intervals. Keywords: adolescent development, incarcerated adolescents, detained adolescents, stress, attention, mindfulness meditation.

  20. Effects of self-management intervention on health outcomes of patients with heart failure: a systematic review of randomized controlled trials

    Holroyd-Leduc Jayna M


    Full Text Available Abstract Background Heart failure is the most common cause of hospitalization among adults over 65. Over 60% of patients die within 10 years of first onset of symptoms. The objective of this study is to determine the effectiveness of self-management interventions on hospital readmission rates, mortality, and health-related quality of life in patients diagnosed with heart failure. Methods The study is a systematic review of randomized controlled trials. The following data sources were used: MEDLINE (1966-11/2005, EMBASE (1980-11/2005, CINAHL (1982-11/2005, the ACP Journal Club database (to 11/2005, the Cochrane Central Trial Registry and the Cochrane Database of Systematic Reviews (to 11/2005; article reference lists; and experts in the field. We included randomized controlled trials of self-management interventions that enrolled patients 18 years of age or older who were diagnosed with heart failure. The primary outcomes of interest were all-cause hospital readmissions, hospital readmissions due to heart failure, and mortality. Secondary outcomes were compliance with treatment and quality of life scores. Three reviewers independently assessed the quality of each study and abstracted the results. For each included study, we computed the pooled odds ratios (OR for all-cause hospital readmission, hospital readmission due to heart failure, and death. We used a fixed effects model to quantitatively synthesize results. We were not able to pool effects on health-related quality of life and measures of compliance with treatment, but we summarized the findings from the relevant studies. We also summarized the reported cost savings. Results From 671 citations that were identified, 6 randomized trials with 857 patients were included in the review. Self-management decreased all-cause hospital readmissions (OR 0.59; 95% confidence interval (CI 0.44 to 0.80, P = 0.001 and heart failure readmissions (OR 0.44; 95% CI 0.27 to 0.71, P = 0.001. The effect on

  1. Psychosocial Syndemics are Additively Associated with Worse ART Adherence in HIV-Infected Individuals.

    Blashill, Aaron J; Bedoya, C Andres; Mayer, Kenneth H; O'Cleirigh, Conall; Pinkston, Megan M; Remmert, Jocelyn E; Mimiaga, Matthew J; Safren, Steven A


    Adherence to antiretroviral therapy (ART) among HIV-infected individuals is necessary to both individual and public health, and psychosocial problems have independently been associated with poor adherence. To date, studies have not systematically examined the effect of multiple, co-occurring psychosocial problems (i.e., "syndemics") on ART adherence. Participants included 333 HIV-infected individuals who completed a comprehensive baseline evaluation, as part of a clinical trial to evaluate an intervention to treat depression and optimize medication adherence. Participants completed self-report questionnaires, and trained clinicians completed semi-structured diagnostic interviews. ART non-adherence was objectively measured via an electronic pill cap (i.e., MEMS). As individuals reported a greater number of syndemic indicators, their odds of non-adherence increased. Co-occurring psychosocial problems have an additive effect on the risk for poor ART adherence. Future behavioral medicine interventions are needed that address these problems comprehensively, and/or the core mechanisms that they share.

  2. Developing a Video-Based eHealth Intervention for HIV-Positive Gay, Bisexual, and Other Men Who Have Sex with Men: Study Protocol for a Randomized Controlled Trial

    Downing Jr, Martin J; Parsons, Jeffrey T; Grov, Christian; Gordon, Rachel J; Houang, Steven T; Scheinmann, Roberta; Sullivan, Patrick S; Yoon, Irene S; Anderson, Ian; Chiasson, Mary Ann


    Background Gay, bisexual, and other men who have sex with men (GBMSM) accounted for 67% of new US human immunodeficiency virus (HIV) infections in 2012; however, less than 40% of HIV-positive GBMSM are virally suppressed. Preventing transmission from virally unsuppressed men who have condomless anal sex (CAS) with serodiscordant partners is a public health imperative. New HIV infections in GBMSM are attributed in part to online access to sex partners; therefore, low-cost eHealth interventions are a unique opportunity to reach men where they meet partners. Objective To describe the protocol of a randomized controlled trial evaluating whether video-based messaging delivered online may lead to reductions in serodiscordant CAS and increased HIV disclosure. Methods Sex Positive![+] is a two-arm, phase III, video-based randomized controlled trial delivered online to GBMSM living with HIV. Participants in the intervention arm receive 10 video vignettes grounded in social learning and social cognitive theories that are designed to elicit critical thinking around issues of HIV transmission and disclosure. Participants in the attention control arm receive 10 video vignettes that focus on healthy living. All videos are optimized for mobile viewing. The study protocol includes five online assessments conducted over a 1-year period among 1500 US white, black, or Hispanic/Latino GBMSM living with HIV who report suboptimal antiretroviral therapy (ART) adherence or a detectable viral load in the past 12 months and recent CAS (past 6 months) with HIV-negative or unknown status male partners. Compared to the control arm, we hypothesize that men who watch the intervention videos will report at 12-month follow-up significantly fewer serodiscordant CAS partners, increased HIV disclosure, and improved social cognition (eg, condom use self-efficacy, perceived responsibility). Results Participant recruitment began in June 2015 and ended in December 2015. Conclusions This protocol

  3. Implementation of physical coordination training and cognitive behavioural training interventions at cleaning workplaces - secondary analyses of a randomised controlled trial

    Jørgensen, Marie B; Faber, Anne; Jespersen, Tobias;


    This study evaluates the implementation of physical coordination training (PCT) and cognitive behavioural training (CBTr) interventions in a randomised controlled trial at nine cleaners' workplaces. Female cleaners (n = 294) were randomised into a PCT, a CBTr or a reference (REF) group. Both 12-w....... However, thorough consideration should be given to feasibility in the design of interventions. The optimal intervention should be tailored to closely match the implementation context and be robust and flexible to minimise susceptibility to changes in work organisation....

  4. A Positive Psychology Intervention for Patients with an Acute Coronary Syndrome: Treatment Development and Proof-of-Concept Trial.

    Huffman, Jeff C; Millstein, Rachel A; Mastromauro, Carol A; Moore, Shannon V; Celano, Christopher M; Bedoya, C Andres; Suarez, Laura; Boehm, Julia K; Januzzi, James L


    Positive psychological constructs are associated with superior outcomes in cardiac patients, but there has been minimal study of positive psychology (PP) interventions in this population. Our objective was to describe the intervention development and pilot testing of an 8-week phone-based PP intervention for patients following an acute coronary syndrome (ACS). Initial intervention development and single-arm proof-of-concept trial, plus comparison of the PP intervention to a subsequently-recruited treatment as usual (TAU) cohort. PP development utilized existing literature, expert input, and qualitative interview data in ACS patients. In the proof-of-concept trial, the primary outcomes were feasibility and acceptability, measured by rates of exercise completion and participant ratings of exercise ease/utility. Secondary outcomes were pre-post changes in psychological outcomes and TAU comparisons, measured using effect sizes (Cohen's d). The PP intervention and treatment manual were successfully created. In the proof-of-concept trial, 17/23 PP participants (74 %) completed at least 5 of 8 exercises. Participants rated the ease (M = 7.4/10; SD = 2.1) and utility (M = 8.1/10, SD = 1.6) of PP exercises highly. There were moderate pre-post improvements (ds = .46-.69) in positive affect, anxiety, and depression, but minimal effects on dispositional optimism (d = .08). Compared to TAU participants (n = 22), PP participants demonstrated greater improvements in positive affect, anxiety, and depression (ds = . 47-.71), but not optimism. A PP intervention was feasible, well-accepted, and associated with improvements in most psychological measures among cardiac patients. These results provide support for a larger trial focusing on behavioral outcomes.

  5. Rationale, design and conduct of a randomised controlled trial evaluating a primary care-based complex intervention to improve the quality of life of heart failure patients: HICMan (Heidelberg Integrated Case Management

    Muth Christiane


    Full Text Available Abstract Background Chronic congestive heart failure (CHF is a complex disease with rising prevalence, compromised quality of life (QoL, unplanned hospital admissions, high mortality and therefore high burden of illness. The delivery of care for these patients has been criticized and new strategies addressing crucial domains of care have been shown to be effective on patients' health outcomes, although these trials were conducted in secondary care or in highly organised Health Maintenance Organisations. It remains unclear whether a comprehensive primary care-based case management for the treating general practitioner (GP can improve patients' QoL. Methods/Design HICMan is a randomised controlled trial with patients as the unit of randomisation. Aim is to evaluate a structured, standardized and comprehensive complex intervention for patients with CHF in a 12-months follow-up trial. Patients from intervention group receive specific patient leaflets and documentation booklets as well as regular monitoring and screening by a prior trained practice nurse, who gives feedback to the GP upon urgency. Monitoring and screening address aspects of disease-specific self-management, (nonpharmacological adherence and psychosomatic and geriatric comorbidity. GPs are invited to provide a tailored structured counselling 4 times during the trial and receive an additional feedback on pharmacotherapy relevant to prognosis (data of baseline documentation. Patients from control group receive usual care by their GPs, who were introduced to guideline-oriented management and a tailored health counselling concept. Main outcome measurement for patients' QoL is the scale physical functioning of the SF-36 health questionnaire in a 12-month follow-up. Secondary outcomes are the disease specific QoL measured by the Kansas City Cardiomyopathy questionnaire (KCCQ, depression and anxiety disorders (PHQ-9, GAD-7, adherence (EHFScBS and SANA, quality of care measured by an adapted

  6. Evaluation of effects of nutrition intervention on healing of pressure ulcers and nutritional states (randomized controlled trial).

    Ohura, Takehiko; Nakajo, Toshio; Okada, Shingo; Omura, Kenji; Adachi, Kayoko


    The objective of this study was to evaluate the effects of nutrition intervention on nutritional states and healing of pressure ulcers by standardizing or unified factors including nursing, care and treatment in a multicenter open randomized trial. Tube-fed patients with Stage III-IV pressure ulcers were selected. The control group (30 patients) received the same nutrition management as before participating in this trial, whereas the intervention group (30 patients) was given calories in the range of Basal Energy Expenditure (BEE) × 1.1 × 1.3 to 1.5. The intervention period was 12 weeks. The efficacy and safety were evaluated based on the nutritional states and the sizes of ulcers (length × width), and on the incidence of adverse events related to the study, respectively. The calories administered to the control and intervention groups were 29.1 ± 4.9 and 37.9 ± 6.5 kcal/kg/day, respectively. Significant interactions between the presence or absence of the intervention and the intervention period were noted for nutritional states (pnutrition intervention could directly enhance the healing process in pressure ulcer patients.

  7. Lifestyle intervention can reduce the risk of gestational diabetes: a meta-analysis of randomized controlled trials.

    Song, C; Li, J; Leng, J; Ma, R C; Yang, X


    This study aimed to examine the effect of lifestyle intervention on the risk of gestational diabetes mellitus (GDM). We searched PubMed, Springer and other databases to retrieve articles published in English and Chinese up to 30 September 2015. The inclusion criteria were randomized controlled trials evaluating the effects of lifestyle intervention on risk of GDM. Exclusion criteria were studies with prepregnancy diabetes mellitus or interventions with nutrient supplements. Random-effect and fixed-effect model analyses were used to obtain pooled relative risks and 95% confidence intervals (CIs) of diet and physical activity on the risk of GDM. Subgroup analyses were performed to check the consistency of effect sizes across groups where appropriate. We identified 29 randomized controlled trials with 11,487 pregnant women, addressing the effect of lifestyle intervention on the risk of GDM. In the pooled analysis, either diet or physical activity resulted in an 18% (95%CI 5-30%) reduction in the risk of GDM (P = 0.0091). Subgroup analysis showed that such intervention was effective among women with intervention before the 15th gestational week (relative risk: 0.80, 95%CI 0.66-0.97), but not among women receiving the intervention afterwards. We conclude that lifestyle modification during pregnancy, especially before the 15th gestational week, can reduce the risk of GDM. © 2016 World Obesity.

  8. Extended Follow-Up of a Randomized Controlled Trial of the Lidcombe Program of Early Stuttering Intervention

    Jones, Mark; Onslow, Mark; Packman, Ann; O'Brian, Sue; Hearne, Anna; Williams, Shelley; Ormond, Tika; Schwarz, Ilsa


    Background: In the Lidcombe Program of Early Stuttering Intervention, parents present verbal contingencies for stutter-free and stuttered speech in everyday situations. A previous randomized controlled trial of the programme with preschool-age children from 2005, conducted in two public speech clinics in New Zealand, showed that the odds of…

  9. Randomized Trial Outcomes of a TTM-Tailored Condom Use and Smoking Intervention in Urban Adolescent Females

    Redding, Colleen A.; Prochaska, James O.; Armstrong, Kay; Rossi, Joseph S.; Hoeppner, Bettina B.; Sun, Xiaowu; Kobayashi, Hisanori; Yin, Hui-Qing; Coviello, Donna; Evers, Kerry; Velicer, Wayne F.


    Smoking and sexual risk behaviors in urban adolescent females are prevalent and problematic. Family planning clinics reach those who are at most risk. This randomized effectiveness trial evaluated a transtheoretical model (TTM)-tailored intervention to increase condom use and decrease smoking. At baseline, a total of 828 14- to 17-year-old females…

  10. Comparing patient characteristics, type of intervention, control, and outcome (PICO) queries with unguided searching: a randomized controlled crossover trial

    Hoogendam, A.; Vries Robbé, P.F. de; Overbeke, A.J.P.M.


    BACKGROUND: Translating a question into a query using patient characteristics, type of intervention, control, and outcome (PICO) should help answer therapeutic questions in PubMed searches. The authors performed a randomized crossover trial to determine whether the PICO format was useful for quick s

  11. Percutaneous coronary intervention versus bypass surgery for left main coronary artery disease: A meta-analysis of randomised trials

    G. Ferrante (Giuseppe); P. Presbitero (Patrizia); M. Valgimigli (Marco); M-C. Morice (Marie-Claude); P. Pagnotta (Paolo); G. Belli (Guido); E. Corrada (Elena); Y. Onuma (Yoshinobu); P. Barlis (Peter); D. Locca (Didier); E. Eeckhout; C. di Mario (Carlo); P.W.J.C. Serruys (Patrick)


    textabstractAims: We performed a meta-analysis of randomised trials comparing percutaneous coronary intervention (PCI) with stent implantation to coronary artery bypass grafting (CABG) for the treatment of unprotected left main coronary artery stenosis (ULMCA). Methods and results: Pubmed and other

  12. High School Students with Reading Comprehension Difficulties: Results of a Randomized Control Trial of a Two-Year Reading Intervention

    Vaughn, Sharon; Roberts, Greg; Wexler, Jade; Vaughn, Michael G.; Fall, Anna-Mária; Schnakenberg, Jennifer B.


    A 2-year, randomized control trial with 9th to 10th grade students with significant reading problems was provided for 50 minutes a day in small groups. Comparison students were provided an elective class and treatment students the reading intervention. Students were identified as demonstrating reading difficulties through failure on their state…

  13. A cluster randomized control field trial of the ABRACADABRA web-based literacy intervention: Replication and extension of basic findings.

    Noella Angele Piquette


    Full Text Available The present paper reports a cluster randomized control trial evaluation of teaching using ABRACADABRA (ABRA, an evidence-based and web-based literacy intervention ( with 107 kindergarten and 96 grade 1 children in 24 classes (12 intervention 12 control classes from all 12 elementary schools in one school district in Canada. Children in the intervention condition received 10-12 hours of whole class instruction using ABRA between pre- and post-test. Hierarchical linear modeling of post-test results showed significant gains in letter-sound knowledge for intervention classrooms over control classrooms. In addition, medium effect sizes were evident for three of five outcome measures favoring the intervention: letter-sound knowledge (d = +.66, phonological blending (d = +.52, and word reading (d = +.52, over effect sizes for regular teachin