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

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F. Lauzier

2017-07-01

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

Active implementation strategy of CONSORT adherence by a dental specialty journal improved randomized clinical trial reporting.

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Pandis, Nikolaos; Shamseer, Larissa; Kokich, Vincent G; Fleming, Padhraig S; Moher, David

2014-09-01

To describe a novel CONsolidated Standards of Reporting Trials (CONSORT) adherence strategy implemented by the American Journal of Orthodontics and Dentofacial Orthopedics (AJO-DO) and to report its impact on the completeness of reporting of published trials. The AJO-DO CONSORT adherence strategy, initiated in June 2011, involves active assessment of randomized clinical trial (RCT) reporting during the editorial process. The completeness of reporting CONSORT items was compared between trials submitted and published during the implementation period (July 2011 to September 2013) and trials published between August 2007 and July 2009. Of the 42 RCTs submitted (July 2011 to September 2013), 23 were considered for publication and assessed for completeness of reporting, seven of which were eventually published. For all published RCTs between 2007 and 2009 (n = 20), completeness of reporting by CONSORT item ranged from 0% to 100% (Median = 40%, interquartile range = 60%). All published trials in 2011-2013, reported 33 of 37 CONSORT (sub) items. Four CONSORT 2010 checklist items remained problematic even after implementation of the adherence strategy: changes to methods (3b), changes to outcomes (6b) after the trial commenced, interim analysis (7b), and trial stopping (14b), which are typically only reported when applicable. Trials published following implementation of the AJO-DO CONSORT adherence strategy completely reported more CONSORT items than those published or submitted previously. Copyright © 2014 Elsevier Inc. All rights reserved.

Adherence of randomized trials within children's surgical specialties published during 2000 to 2009 to standard reporting guidelines.

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Blakely, Martin L; Kao, Lillian S; Tsao, Kuojen; Huang, Eunice Y; Tsai, Anthony; Tanaka, Stacy; Younas, Shiraz; Lu, Zengqi; Lally, Kevin P

2013-09-01

Randomized clinical trials (RCTs) are uncommon in pediatric surgical specialties and the quality of reporting is unknown. Our primary purpose was to analyze published surgical RCTs involving children to measure adherence to the Consolidated Standards of Reporting Trials (CONSORT) guidelines. Published RCTs from January 1, 2000 through December 31, 2009 were reviewed. The trials were evaluated for the presence of 7 CONSORT guidelines and also graded according to the Jadad scale. Two hundred and twenty-eight trials were included. Five trials met all 7 CONSORT criteria (2%) and 53 had a Jadad score of ≥3 (23%). Slightly more than 50% of all trials specified primary outcomes and guidelines for allocation concealment, randomization description, and attrition details was even lower. There were significant differences between surgical specialties with regard to CONSORT adherence to the majority of the guidelines. Pediatric general surgery had the largest number of published RCTs. Pediatric orthopaedic surgery had the highest proportion of trials with a Jadad score ≥3 (40%). Adherence to CONSORT guidelines is low across the spectrum of children's surgical specialties, although significant differences do exist. Future RCTs in children's surgical specialties should specifically focus on areas of low adherence to reporting guidelines. Copyright © 2013 American College of Surgeons. Published by Elsevier Inc. All rights reserved.

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

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Susan A Stoner

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

Interventions to Improve Medication Adherence among Older Adults: Meta-Analysis of Adherence Outcomes among Randomized Controlled Trials

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Conn, Vicki S.; Hafdahl, Adam R.; Cooper, Pamela S.; Ruppar, Todd M.; Mehr, David R.; Russell, Cynthia L.

2009-01-01

Purpose: This study investigated the effectiveness of interventions to improve medication adherence (MA) in older adults. Design and Methods: Meta-analysis was used to synthesize results of 33 published and unpublished randomized controlled trials. Random-effects models were used to estimate overall mean effect sizes (ESs) for MA, knowledge,…

Implementation of a Novel Adherence Monitoring Strategy in a Phase III, Blinded, Placebo-Controlled, HIV-1 Prevention Clinical Trial.

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Husnik, Marla J; Brown, Elizabeth R; Marzinke, Mark; Livant, Edward; Palanee-Phillips, Thesla; Hendrix, Craig W; Matovu Kiweewa, Flavia; Nair, Gonasagrie; Soto-Torres, Lydia E; Schwartz, Katie; Hillier, Sharon L; Baeten, Jared M

2017-11-01

Placebo-controlled HIV-1 prevention trials of pre-exposure prophylaxis (PrEP) have not generally used concurrent measurement of adherence because of the potential risk of unblinding. However, several pre-exposure prophylaxis trials for HIV-1 prevention among women failed to show effectiveness because of low product adherence. Evaluation of product adherence objectively during a study provides the opportunity for strengthening adherence activities at sites having low adherence. During MTN-020/ASPIRE, a phase III, placebo-controlled trial of the dapivirine intravaginal ring, we implemented an adherence monitoring system. Monitoring began in quarter 1 (Q1) 2013 and continued through the conclusion of the trial. Blood plasma was collected quarterly and tested for dapivirine concentrations while maintaining blinding among study team members involved in participant management. Dapivirine concentrations >95 pg/mL, reflecting >8 hours of continuous use, were assessed as signaling product use. Study leadership monitored results on a monthly basis and provided feedback to site investigators. Experiences were shared across sites to motivate staff and counsel participants to strive toward higher adherence levels. An upward trend in adherence was observed (P dapivirine >95 pg/mL increased from 63% in Q1 2013 to 84% by Q1 2015. Ongoing drug level testing as a marker of adherence in MTN-020/ASPIRE demonstrates the feasibility of real-time adherence monitoring while maintaining study blinding at the level of participants, sites, and study leadership. This approach is novel for large-scale effectiveness studies for HIV-1 prevention.

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

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

2011-01-01

Research on the conceptualization of adherence to treatment has not addressed a key question: Is adherence best defined as being a uni-dimensional or multi-dimensional behavioral construct? The primary aim of this study was to test which of these conceptual models best described adherence to a weight management program. This ancillary study was conducted as a part of the POUNDS LOST trial that tested the efficacy of four dietary macro-nutrient compositions for promoting weight loss. A sample of 811 overweight/obese adults was recruited across two clinical sites, and each participant was randomly assigned to one of four macronutrient prescriptions: (1) Low fat (20% of energy), average protein (15% of energy); (2) High fat (40%), average protein (15%); (3) Low fat (20%), high protein (25%); (4) High fat (40%), high protein (25%). Throughout the first 6 months of the study, a computer tracking system collected data on eight indicators of adherence. Computer tracking data from the initial 6 months of the intervention were analyzed using exploratory and confirmatory analyses. Two factors (accounting for 66% of the variance) were identified and confirmed: (1) behavioral adherence and (2) dietary adherence. Behavioral adherence did not differ across the four interventions, but prescription of a high fat diet (vs. a low fat diet) was found to be associated with higher levels of dietary adherence. The findings of this study indicated that adherence to a weight management program was best conceptualized as being multi-dimensional, with two dimensions: behavioral and dietary adherence. PMID:19856202

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

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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

Post-use assay of vaginal rings (VRs) as a potential measure of clinical trial adherence.

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Spence, Patrick; Nel, Annalene; van Niekerk, Neliëtte; Derrick, Tiffany; Wilder, Susan; Devlin, Bríd

2016-06-05

Adherence measurement for microbicide use within the clinical trial setting remains a challenge for the HIV prevention field. This paper describes an assay method used for determining residual dapivirine levels in post-use vaginal rings from clinical trials conducted with the Dapivirine Vaginal Matrix Ring-004 developed by the International Partnership for Microbicides to prevent male to female HIV transmission. Post-use assay results from three Ring-004 clinical trials showed that of the 25mg drug load, approximately 4mg of dapivirine is released from the matrix ring over a 28-day use period. Data obtained by both in vitro and in vivo studies indicate that dapivirine is released according to a diffusion mechanism, as determined by conformance of both data sets to the Higuchi equation. This, coupled with the low variability associated with batch production over two manufacturing sites and 20 batches of material, provides evidence that post-use ring analysis can contribute to the assessment of adherence to ring use. Limitations of this method include the potential of intra-participant and inter-participant variability and uncertainty associated with measuring the low amount of dapivirine actually released relative to the drug load. Therefore, residual drug levels should not serve as the only direct measurement for microbicide adherence in vaginal ring clinical trials but should preferably be used as part of a multi-pronged approach towards understanding and assessing adherence to vaginal ring use. Copyright © 2016 The Authors. Published by Elsevier B.V. All rights reserved.

Riboflavin as an independent and accurate biomarker for adherence in a randomized double-blind and placebo-controlled clinical trial.

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Ramanujam, V-M S; Nayeem, Fatima; Anderson, Karl E; Kuo, Yong-Fang; Chen, Nai-Wei; Ju, Hyunsu; Lu, Lee-Jane W

2017-09-01

Medication adherence is critical for success of clinical trials. To assess oral riboflavin is an adherence marker. Riboflavin was incorporated into active treatment and placebo pills for a clinical trial lasting for 2 years. The accuracy (area under the receiver operating curve) of urinary riboflavin was 0.91 as a binary classifier of adherence, and was similar or better than for two active study ingredients daidzein (0.92) and genistein (0.87) (all p Riboflavin is an accurate and useful biomarker for study pill ingestion.

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

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

2010-02-10

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

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

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Gust, Deborah A; Mosimaneotsile, Barudi; Mathebula, Unami; Chingapane, Balladiah; Gaul, Zaneta; Pals, Sherri L; Samandari, Taraz

2011-04-25

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. 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. 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, reducing barriers, clarifying study expectations, educating

Evaluation of Three Approaches for Assessing Adherence to Vaginal Gel Application in Clinical Trials

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van der Straten, Ariane; Cheng, Helen; Mensch, Barbara; Friedland, Barbara; Katzen, Lauren; Littlefield, Sarah; Buckley, Niall; Espinoza, Lilia; Keller, Marla J.; Herold, Betsy C.; Einstein, Mark H.

2014-01-01

Background: Accurate measurement of adherence to product use is an ongoing challenge in microbicide trials. Methods: We compared adherence estimates using two applicator tests (a dye stain assay [DSA] and an ultraviolet light assay [UVA]), the Wisebag (an applicator container that electronically tracks container openings), and self-reported adherence (ability, frequency, and percent missed doses). Healthy, HIV-negative, non-pregnant US women aged 23 to 45 received a Wisebag and 32 applicators filled with placebo gel, were instructed to insert one applicator daily for 30 days, returned the Wisebag and all applicators, and completed an exit interview. Emptied applicators were tested by UVA and then DSA, and scored by two blinded readers. Positive and negative controls were randomly included in applicator batches. Results: Among 42 women enrolled, 39 completed the study. DSA and UVA yielded similar sensitivity (97% and 95%) and specificity (79% and 79%). Two participants had fully inoperable Wisebags and nine had partially inoperable Wisebags. The proportion of participants considered to have high adherence (≥80%) varied: 43% (Wisebag), 46% (UVA), 49% (DSA), and 62% to 82% (self-reports). For estimating high adherence, Wisebag had a sensitivity of 76% (95% CI, 50% to 93%) and a specificity of 85% (95% CI, 62% to 97%) compared with DSA. Although 28% of participants reported forgetting to open the Wisebag daily, 59% said it helped them remember gel use. Conclusions: DSA and UVA performed similarly. Compared with these tests, self-reports overestimated and Wisebag underestimated adherence. Although Wisebag may encourage gel use, the applicator tests currently appear more useful for measuring use in clinical trials. PMID:24220357

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

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

2016-09-01

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

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

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

2011-01-01

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

One-way versus two-way text messaging on improving medication adherence: meta-analysis of randomized trials.

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Wald, David S; Butt, Shahena; Bestwick, Jonathan P

2015-10-01

Mobile telephone text messaging is a simple potential solution to the failure to take medications as directed. There is uncertainty over the effectiveness of 1-way text messaging (sending text message reminders only) compared with 2-way text messaging (sending reminders and receiving replies confirming whether medication has been taken) as a means of improving medication adherence. A meta-analysis of 8 randomized trials (1994 patients) that tested the effectiveness of text messaging on medication adherence was performed. The trials were divided into 2 groups: trials using 1-way text messaging versus no text messaging and trials using 2-way text messaging versus no text messaging. The summary estimates of the effect of the 2 methods of text messaging (1-way or 2-way) were compared. The summary relative risk estimate was 1.04 (95% confidence interval, 0.97-1.11) for 1-way text messaging and 1.23 (95% confidence interval, 1.13-1.35) for 2-way text messaging. The difference in effect between the 2 methods was statistically significant (P = .007). Two-way text messaging is associated with substantially improved medication adherence compared with 1-way text messaging. This has important implications in the provision of mobile-based messaging in the management of patients taking medication for the prevention of chronic disease. Copyright © 2015 Elsevier Inc. All rights reserved.

Interventions to improve hemodialysis adherence: a systematic review of randomized-controlled trials.

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Matteson, Michelle L; Russell, Cynthia

2010-10-01

Over 485,000 people in the United States have chronic kidney disease, a progressive kidney disease that may lead to hemodialysis. Hemodialysis involves a complex regimen of treatment, medication, fluid, and diet management. In 2005, over 312,000 patients were undergoing hemodialysis in the United States. Dialysis nonadherence rates range from 8.5% to 86%. Dialysis therapy treatment nonadherence, including treatment, medication, fluid, and diet nonadherence, significantly increases the risk of morbidity and mortality. The purpose of this paper is to systematically review randomized-controlled trial intervention studies designed to increase treatment, medication, fluid, and diet adherence in adult hemodialysis patients. A search of Cumulative Index of Nursing and Allied Health Literature (CINAHL) (1982 to May 2008), MEDLINE (1950 to May 2008), PsycINFO (1806 to May 2008), and all Evidence-Based Medicine (EBM) Reviews (Cochran DSR, ACP Journal Club, DARE, and CCTR) was conducted to identify randomized-controlled studies that tested the efficacy of interventions to improve adherence in adult hemodialysis patients. Eight randomized-controlled trials met criteria for inclusion. Six of the 8 studies found statistically significant improvement in adherence with the intervention. Of these 6 intervention studies, all studies had a cognitive component, with 3 studies utilizing cognitive/behavioral intervention strategies. Based on this systematic review, interventions utilizing a cognitive or cognitive/behavioral component appear to show the most promise for future study. © 2010 The Authors. Hemodialysis International © 2010 International Society for Hemodialysis.

Assessing the treatment effect in a randomized controlled trial with extensive non-adherence: the EVOLVE trial.

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Kubo, Yumi; Sterling, Lulu Ren; Parfrey, Patrick S; Gill, Karminder; Mahaffey, Kenneth W; Gioni, Ioanna; Trotman, Marie-Louise; Dehmel, Bastian; Chertow, Glenn M

2015-01-01

Intention-to-treat (ITT) analysis is widely used to establish efficacy in randomized clinical trials. However, in a long-term outcomes study where non-adherence to study drug is substantial, the on-treatment effect of the study drug may be underestimated using the ITT analysis. The analyses presented herein are from the EVOLVE trial, a double-blind, placebo-controlled, event-driven cardiovascular outcomes study conducted to assess whether a treatment regimen including cinacalcet compared with placebo in addition to other conventional therapies reduces the risk of mortality and major cardiovascular events in patients receiving hemodialysis with secondary hyperparathyroidism. Pre-specified sensitivity analyses were performed to assess the impact of non-adherence on the estimated effect of cinacalcet. These analyses included lag-censoring, inverse probability of censoring weights (IPCW), rank preserving structural failure time model (RPSFTM) and iterative parameter estimation (IPE). The relative hazard (cinacalcet versus placebo) of mortality and major cardiovascular events was 0.93 (95% confidence interval 0.85, 1.02) using the ITT analysis; 0.85 (0.76, 0.95) using lag-censoring analysis; 0.81 (0.70, 0.92) using IPCW; 0.85 (0.66, 1.04) using RPSFTM and 0.85 (0.75, 0.96) using IPE. These analyses, while not providing definitive evidence, suggest that the intervention may have an effect while subjects are receiving treatment. The ITT method remains the established method to evaluate efficacy of a new treatment; however, additional analyses should be considered to assess the on-treatment effect when substantial non-adherence to study drug is expected or observed. Copyright © 2015 John Wiley & Sons, Ltd.

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

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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.

Trends and determining factors associated with adherence to antiretroviral therapy (ART in Cameroon: a systematic review and analysis of the CAMPS trial

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Mbuagbaw Lawrence

2012-12-01

Full Text Available Abstract Background The benefits of antiretroviral therapy (ART cannot be experienced if they are not taken as prescribed. Yet, not all causes of non-adherence are dependent on the patient. Having to pay for medication reduces adherence rates. Non- adherence has severe public health implications which must be addressed locally and globally. This paper seeks to describe the trends in adherence rates reported in Cameroon and to investigate the determinants of adherence to ART in the Cameroon Mobile Phone SMS (CAMPS trial. Methods We conducted a systematic review of electronic databases (PubMed, Google Scholar, Web of Science, CINAHL, EMBASE and PSYCINFO for publications on adherence to ART in Cameroon (from January 1999 to May 2012 and described the trend in reported adherence rates and the factors associated with adherence. Data were extracted in duplicate. We used multivariable analyses on the baseline data for 200 participants in the CAMPS trial to determine the factors associated with adherence in four models using different measures of adherence (more than 90% or 95% on the visual analogue scale, no missed doses and a composite measure: 100% on the visual analogue scale, no missed doses and all pills taken on time. Results We identified nine studies meeting our inclusion criteria. Adherence to ART in Cameroon has risen steadily between 2000 and 2010, corresponding to reductions in the cost of medication. The factors associated with adherence to ART in Cameroon are grouped into patient, medication and disease related factors. We also identified factors related to the health system and the patient-provider relationship. In the CAMPS trial, education, side effects experienced and number of reminder methods were found to improve adherence, but only using multiple reminder methods was associated with better adherence in all the regression models (Adjusted Odds Ratio [AOR] 4.11, 95% Confidence Interval [CI] 1.89, 8.93; p Conclusions Reducing the

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

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Prevost A Toby

2010-11-01

Full Text Available Abstract Background The behavioural impact of pharmacogenomics is untested; informing smokers of genetic test results for responsiveness to smoking cessation medication may increase adherence to this medication. The objective of this trial is to estimate the impact upon adherence to nicotine replacement therapy (NRT of informing smokers that their oral dose of NRT has been tailored to a DNA analysis. Hypotheses to be tested are as follows: IAdherence to NRT is greater among smokers informed that their oral dose of NRT is tailored to an analysis of DNA (genotype, compared to one tailored to nicotine dependence questionnaire score (phenotype. II Amongst smokers who fail to quit at six months, motivation to make another quit attempt is lower when informed that their oral dose of NRT was tailored to genotype rather than phenotype. Methods/Design An open label, parallel groups randomised trial in which 630 adult smokers (smoking 10 or more cigarettes daily using National Health Service (NHS stop smoking services in primary care are randomly allocated to one of two groups: i. NRT oral dose tailored by DNA analysis (OPRM1 gene (genotype, or ii. NRT oral dose tailored by nicotine dependence questionnaire score (phenotype The primary outcome is proportion of prescribed NRT consumed in the first 28 days following an initial quit attempt, with the secondary outcome being motivation to make another quit attempt, amongst smokers not abstinent at six months. Other outcomes include adherence to NRT in the first seven days and biochemically validated smoking abstinence at six months. The primary outcome will be collected on 630 smokers allowing sufficient power to detect a 7.5% difference in mean proportion of NRT consumed using a two-tailed test at the 5% level of significance between groups. The proportion of all NRT consumed in the first four weeks of quitting will be compared between arms using an independent samples t-test and by estimating the 95

Treatment Adherence in Child and Adolescent Chronic Migraine Patients: Results From the Cognitive-Behavioral Therapy and Amitriptyline Trial.

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Kroon Van Diest, Ashley M; Ramsey, Rachelle R; Kashikar-Zuck, Susmita; Slater, Shalonda; Hommel, Kevin; Kroner, John W; LeCates, Susan; Kabbouche, Marielle A; O'Brien, Hope L; Kacperski, Joanne; Allen, Janelle R; Peugh, James; Hershey, Andrew D; Powers, Scott W

2017-10-01

To examine treatment adherence among children and adolescents with chronic migraine who volunteered to be in a clinical trial using 3 measures: treatment session attendance, therapy homework completion, and preventive medication use by daily diary. Analyses are secondary from a trial of 135 youth aged 10 to 17 years diagnosed with chronic migraine and with a Pediatric Migraine Disability Score over 20. Participants were randomly assigned to cognitive-behavioral therapy plus amitriptyline (CBT+A, N=64) or headache education plus amitriptyline (HE+A, N=71). Therapists recorded session attendance. Completion of homework/practice between sessions was reported to therapists by patients. Patients reported preventive medication adherence using a daily headache diary. Mean session attendance adherence out of 10 treatment sessions was 95% for CBT+A and 99% for HE+A. CBT+A participants reported completing a mean of 90% of home practice of CBT skills between the 10 sessions. Participants reported taking amitriptyline daily at a mean level of 90% when missing diaries were excluded and 79% when missing diaries were considered as missed doses of medication. Our findings demonstrate that youth with chronic migraine who agree to be a part of a clinical trial do quite well at attending therapy sessions, and report that they are adherent to completing home/practice between sessions and taking medication. These results lend further support to consideration of CBT+A as a first-line treatment for youth with chronic migraine and suggest that measurement of adherence when this treatment is provided in practice will be important.

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

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Haberer, Jessica E; Baeten, Jared M; Campbell, James; Wangisi, Jonathan; Katabira, Elly; Ronald, Allan; Tumwesigye, Elioda; Psaros, Christina; Safren, Steven A; Ware, Norma C; Thomas, Katherine K; Donnell, Deborah; Krows, Meighan; Kidoguchi, Lara; Celum, Connie; Bangsberg, David R

2013-01-01

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 counseling, and HIV testing. A total of 1,147 HIV-uninfected participants were enrolled: 53% were male, median age was 34 years, and median partnership duration was 8.5 years. Fourteen HIV infections occurred among adherence study participants--all of whom were assigned to placebo (PrEP efficacy = 100%, 95% confidence interval 83.7%-100%, pmarriage were associated with >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.

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

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Julia R G Raifman

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

‘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

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MacPhail C

2012-08-01

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

Rationale and design of the Study of a Tele-pharmacy Intervention for Chronic diseases to Improve Treatment adherence (STIC2IT): A cluster randomized pragmatic trial

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Choudhry, Niteesh K.; Isaac, Thomas; Lauffenburger, Julie C.; Gopalakrishnan, Chandrasekar; Khan, Nazleen F.; Lee, Marianne; Vachon, Amy; Iliadis, Tanya L.; Hollands, Whitney; Doheny, Scott; Elman, Sandra; Kraft, Jacqueline M.; Naseem, Samrah; Gagne, Joshua J.; Jackevicius, Cynthia A.; Fischer, Michael A.; Solomon, Daniel H.; Sequist, Thomas D.

2016-01-01

Background Approximately half of patients with chronic cardiometabolic conditions are non-adherent with their prescribed medications. Interventions to improve adherence have been only modestly effective because they often address single barriers to adherence, intervene at single points in time, or are imprecisely targeted to patients who may or may not need adherence assistance. Objective To evaluate the effect of a multi-component, behaviorally-tailored pharmacist-based intervention to improve adherence to medications for diabetes, hypertension, and hyperlipidemia. Trial design The STIC2IT (Study of a Tele-pharmacy Intervention for Chronic diseases To Improve Treatment adherence) trial is a cluster-randomized pragmatic trial testing the impact of a pharmacist-led multi-component intervention that uses behavioral interviewing, text messaging, mailed progress reports and video visits. Targeted patients are those who are non-adherent to glucose-lowering, anti-hypertensive, or statin medications and who also have evidence of poor disease control. The intervention is tailored to patients’ individual health barriers and their level of health activation. We cluster randomized 14 practice sites of a large multi-specialty group practice to receive either the pharmacist-based intervention or usual care. STIC2IT has enrolled 4,076 patients to be followed for 12 months after randomization. The trial’s primary outcome is medication adherence, assessed using pharmacy claims data. Secondary outcomes are disease control and healthcare resource utilization. Conclusion This trial will determine whether a technologically-enabled, behaviorally-targeted pharmacist-based intervention results in improved adherence and disease control. If effective, this strategy could be a scalable method of offering tailored adherence support to those with the greatest clinical need. PMID:27659887

Controller adherence following hospital discharge in high risk children: A pilot randomized trial of text message reminders.

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Kenyon, Chén C; Gruschow, Siobhan M; Quarshie, William O; Griffis, Heather; Leach, Michelle C; Zorc, Joseph J; Bryant-Stephens, Tyra C; Miller, Victoria A; Feudtner, Chris

2018-02-13

To assess the feasibility of a mobile health, inhaled corticosteroid (ICS) adherence reminder intervention and to characterize adherence trajectories immediately following severe asthma exacerbation in high-risk urban children with persistent asthma. Children aged 2-13 with persistent asthma were enrolled in this pilot randomized controlled trial during an asthma emergency department (ED) visit or hospitalization. Intervention arm participants received daily text message reminders for 30 days, and both arms received electronic sensors to measure ICS use. Primary outcomes were feasibility of sensor use and text message acceptability. Secondary outcomes included adherence to prescribed ICS regimen and 30-day adherence trajectories. Group-based trajectory modeling was used to examine adherence trajectories. Forty-one participants (mean age 5.9) were randomized to intervention (n = 21) or control (n = 20). Overall, 85% were Black, 88% had public insurance, and 51% of the caregivers had a high school education or less. Thirty-two participant families (78%) transmitted medication adherence data; of caregivers who completed the acceptability survey, 25 (96%) chose to receive daily reminders beyond that study interval. Secondary outcome analyses demonstrated similar average daily adherence between groups (intervention = 36%; control = 32%, P = 0.73). Three adherence trajectories were identified with none ever exceeding 80% adherence. Within a high-risk pediatric cohort, electronic monitoring of ICS use and adherence reminders delivered via text message were feasible for most participants, but there was no signal of effect. Adherence trajectories following severe exacerbation were suboptimal, demonstrating an important opportunity for asthma care improvement.

Adherence of non-pharmaceutically sponsored oncology trial protocols to the International Conference on Harmonization (ICH) guidelines in an academic institution outside the ICH jurisdictions and the impact of IRB implementation on this adherence

International Nuclear Information System (INIS)

Zeeneldin, A.A.

2013-01-01

Purpose: To assess adherence of non-pharmaceutically sponsored trials (non-PSTs) to ICH protocol structure guidelines and to estimate the effect of implementing Institutional Review Boards (IRB) review on this adherence. Methods: This is a retrospective exploratory study where 60 non-PST clinical trial protocols (CTPs) were reviewed and halved to IRB-reviewed CTPs (IRCTPs) and non-lRB-reviewed CTPs (non-lRCTPs). Adherence score (AS) was calculated as the number of fulfilled items or sub-items divided by their total number. Results: Three adherence patterns were encountered: (1) items consistently present in both groups e.g. general and background information, objectives, inclusion criteria and intervention details, (2) items consistently absent in both groups and included contact information of investigators and trial sites, product accountability, randomization codes management, interim analyses and many other statistical aspects, and (3) items variably present in both groups where the effect of IRB was verifiable. Trial site details, potential benefits, discontinuation and exclusion criteria, and follow up for adverse events were more encountered in IRCTPs than non-IRCTPs. Withdrawal criteria monitoring of treatment compliance showed a reverse pattern (p < 0.05 for all). The total AS, administrative AS and ethics AS for IRCTPs was 43%, 22% and 70% compared to 38%, 16% and 33% for non-IRCTPs (p < 0.003, <0.001, 0.004), respectively. The scientific AS was 54% for both groups (p = 0.87). Conclusions: IRB-implementation at NCl-Egypt improved ethical and administrative sections of academic protocols. However, this improvement is modest and needs further actions including adoption of protocol templates. Scientific sections were as good after IRB-implementation as they were before that

Predictors of adherence to pharmacological and behavioral treatment in a cessation trial among smokers in Aleppo, Syria.

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Ben Taleb, Ziyad; Ward, Kenneth D; Asfar, Taghrid; Bahelah, Raed; Maziak, Wasim

2015-08-01

The development of evidence-based smoking cessation programs is in its infancy in developing countries, which continue to bear the main brunt of the tobacco epidemic. Adherence to treatment recommendations is an important determinant of the success of smoking cessation programs, but little is known about factors influencing adherence to either pharmacological or behavioral treatment in developing countries settings. Our study represents the first attempt to examine the predictors of adherence to cessation treatment in a low-income developing country. Predictors of adherence to pharmacological and behavioral treatment were identified by analyzing data from a multi-site, two-group, parallel-arm, double-blind, randomized, placebo-controlled smoking cessation trial in primary care clinics in Aleppo, Syria. Participants received 3 in-person behavioral counseling sessions plus 5 brief follow-up phone counseling sessions, and were randomized to either 6 weeks of nicotine or placebo patch. Of the 269 participants, 68% adhered to pharmacological treatment, while 70% adhered to behavioral counseling. In logistic regression modeling, lower adherence to pharmacological and behavioral treatment was associated with higher daily smoking at baseline, greater withdrawal symptoms, and perception of receiving placebo instead of active nicotine patch. Women showed lower adherence than men to behavioral treatment, while being assigned to placebo condition and baseline waterpipe use were associated with lower adherence to pharmacological treatment. Adherence to cessation treatment for cigarette smokers in low-income countries such as Syria may benefit from integrated cessation components that provide intensive treatment for subjects with higher nicotine dependence, and address concurrent waterpipe use at all stages. Copyright © 2015 Elsevier Ireland Ltd. All rights reserved.

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

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Kumarasamy Nagalingeswaran

2010-03-01

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

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

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

2009-04-01

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

The efficacy of a brief motivational enhancement education program on CPAP adherence in OSA: a randomized controlled trial.

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Lai, Agnes Y K; Fong, Daniel Y T; Lam, Jamie C M; Weaver, Terri E; Ip, Mary S M

2014-09-01

Poor adherence to CPAP treatment in OSA adversely affects the effectiveness of this therapy. This randomized controlled trial (RCT) examined the efficacy of a brief motivational enhancement education program in improving adherence to CPAP treatment in subjects with OSA. Subjects with newly diagnosed OSA were recruited into this RCT. The control group received usual advice on the importance of CPAP therapy and its care. The intervention group received usual care plus a brief motivational enhancement education program directed at enhancing the subjects' knowledge, motivation, and self-efficacy to use CPAP through the use of a 25-min video, a 20-min patient-centered interview, and a 10-min telephone follow-up. Self-reported daytime sleepiness adherence-related cognitions and quality of life were assessed at 1 month and 3 months. CPAP usage data were downloaded at the completion of this 3-month study. One hundred subjects with OSA (mean ± SD, age 52 ± 10 years; Epworth Sleepiness Scales [ESS], 9 ± 5; median [interquartile range] apnea-hypopnea index, 29 [20, 53] events/h) prescribed CPAP treatment were recruited. The intervention group had better CPAP use (higher daily CPAP usage by 2 h/d [Cohen d = 1.33, P motivational enhancement education in addition to usual care were more likely to show better adherence to CPAP treatment, with greater improvements in treatment self-efficacy and daytime sleepiness. ClinicalTrials.gov; No.: NCT01173406; URL: www.clinicaltrials.gov.

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

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

2016-02-09

We assessed the effect of automated treatment adherence support delivered via mobile phone short message system (SMS) text messages on blood pressure. In this pragmatic, single-blind, 3-arm, randomized trial (SMS-Text Adherence Support [StAR]) undertaken in South Africa, patients treated for high blood pressure were randomly allocated in a 1:1:1 ratio to information only, 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 participants (92%). At 12 months, the mean adjusted change in systolic blood pressure compared with usual care was -2.2 mm Hg (95% confidence interval, -4.4 to -0.04) with information-only SMS and -1.6 mm Hg (95% confidence interval, -3.7 to 0.6) with interactive SMS. Odds ratios for the proportion of participants with a blood pressure high blood pressure, we found a small reduction in systolic blood pressure control compared with usual care at 12 months. There was no evidence that an interactive intervention increased this effect. URL: http://www.clinicaltrials.gov. Unique identifier: NCT02019823. South African National Clinical Trials Register, number SANCTR DOH-27-1212-386; Pan Africa Trial Register, number PACTR201411000724141. © 2016 American Heart Association, Inc.

Randomized feasibility trial to improve hydroxyurea adherence in youth ages 10-18 years through community health workers: The HABIT study.

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Green, Nancy S; Manwani, Deepa; Matos, Sergio; Hicks, April; Soto, Luisa; Castillo, Yina; Ireland, Karen; Stennett, Yvonne; Findley, Sally; Jia, Haomiao; Smaldone, Arlene

2017-12-01

The main therapeutic intervention for sickle cell disease (SCD) is hydroxyurea (HU). The effect of HU is largely through dose-dependent induction of fetal hemoglobin (HbF). Poor HU adherence is common among adolescents. Our 6-month, two-site pilot intervention trial, "HABIT," was led by culturally aligned community health workers (CHWs). CHWs performed support primarily through home visits, augmented by tailored text message reminders. Dyads of youth with SCD ages 10-18 years and a parent were enrolled. A customized HbF biomarker, the percentage decrease from each patients' highest historical HU-induced HbF, "Personal best," was used to qualify for enrollment and assess HU adherence. Two primary outcomes were as follows: (1) intervention feasibility and acceptability and (2) HU adherence measured in three ways: monthly percentage improvement toward HbF Personal best, proportion of days covered (PDC) by HU, and self-report. Twenty-eight dyads were enrolled, of which 89% were retained. Feasibility and acceptability were excellent. Controlling for group assignment and month of intervention, the intervention group improved percentage decrease from Personal best by 2.3% per month during months 0-4 (P = 0.30), with similar improvement in adherence demonstrated using pharmacy records. Self-reported adherence did not correlate. Dyads viewed CHWs as supportive for learning about SCD and HU, living with SCD and making progress in coordinated self-management responsibility to support a daily HU habit. Most parents and youth appreciated text message HU reminders. The HABIT pilot intervention demonstrated feasibility and acceptability with promising effect toward improved medication adherence. Testing in a larger multisite intervention trial is warranted. © 2017 Wiley Periodicals, Inc.

HIV Medication Adherence

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... AIDS Drugs Clinical Trials Apps skip to content HIV Treatment Home Understanding HIV/AIDS Fact Sheets HIV ... 4 p.m. ET) Send us an email HIV Medication Adherence Last Reviewed: January 17, 2018 Key ...

Factors associated to adherence to different treatment schemes with meglumine antimoniate in a clinical trial for cutaneous leishmaniasis.

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Ribeiro, Madelon Novato; Pimentel, Maria Inês Fernandes; Schubach, Armando de Oliveira; Oliveira, Raquel de Vasconcellos Carvalhães de; Teixeira, José Liporage; Leite, Madson Pedro da Silva; Fonseca, Monique; Santos, Ginelza Peres Lima dos; Salgueiro, Mariza Matos; Ferreira e Vasconcellos, Erica de Camargo; Lyra, Marcelo Rosandiski; Saheki, Mauricio Naoto; Valete-Rosalino, Claudia Maria

2014-01-01

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.

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

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Madelon Novato Ribeiro

2014-07-01

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

Safety, Acceptability and Adherence of Dapivirine Vaginal Ring in a Microbicide Clinical Trial Conducted in Multiple Countries in Sub-Saharan Africa

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Nel, Annalene; Bekker, Linda-Gail; Bukusi, Elizabeth; Hellstrӧm, Elizabeth; Kotze, Philip; Louw, Cheryl; Martinson, Francis; Masenga, Gileard; Montgomery, Elizabeth; Ndaba, Nelisiwe; van der Straten, Ariane; van Niekerk, Neliëtte; Woodsong, Cynthia

2016-01-01

Background This was the first microbicide trial conducted in Africa to evaluate an antiretroviral-containing vaginal ring as an HIV prevention technology for women. Objectives The trial assessed and compared the safety, acceptability and adherence to product use of a 4-weekly administered vaginal ring containing the antiretroviral microbicide, dapivirine, with a matching placebo ring among women from four countries in sub-Saharan Africa. Methods 280 Healthy, sexually active, HIV-negative women, aged 18 to 40 years were enrolled with 140 women randomised to a dapivirine vaginal ring (25 mg) and 140 women to a matching placebo ring, inserted 4-weekly and used over a 12-week period. Safety was evaluated by pelvic examination, colposcopy, clinical laboratory assessments, and adverse events. Blood samples for determination of plasma concentrations of dapivirine were collected at Weeks 0, 4 and 12. Residual dapivirine levels in returned rings from dapivirine ring users were determined post-trial. Participant acceptability and adherence to ring use were assessed by self-reports. Results No safety concerns or clinically relevant differences were observed between the dapivirine and placebo ring groups. Plasma dapivirine concentrations immediately prior to ring removal were similar after removal of the first and third ring, suggesting consistent ring use over the 12-week period. No clear relationship was observed between the residual amount of dapivirine in used rings and corresponding plasma concentrations. Self-reported adherence to daily use of the vaginal rings over the 12-week trial period was very high. At the end of the trial, 96% of participants reported that the ring was usually comfortable to wear, and 97% reported that they would be willing to use it in the future if proven effective. Conclusions The dapivirine vaginal ring has a favourable safety and acceptability profile. If proven safe and effective in large-scale trials, it will be an important component of

Use of a goal setting intervention to increase adherence to low back pain rehabilitation: a randomized controlled trial.

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Coppack, Russell J; Kristensen, Jakob; Karageorghis, Costas I

2012-11-01

To examine the effects of a goal setting intervention on self-efficacy, treatment efficacy, adherence and treatment outcome in patients undergoing low back pain rehabilitation. A mixed-model 2 (time) × 3 (group) randomized controlled trial. A residential rehabilitation centre for military personnel. UK military personnel volunteers (N = 48); mean age was 32.9 (SD 7.9) with a diagnosis of non-specific low back pain. Subjects were randomly assigned to either a goal setting experimental group (Exp, n = 16), therapist-led exercise therapy group (C1, n = 16) or non-therapist-led exercise therapy group (C2, n = 16). Treatment duration for all groups was three weeks. Self-efficacy, treatment efficacy and treatment outcome were recorded before and after the treatment period. Adherence was rated during regularly scheduled treatment sessions using the Sports Injury Rehabilitation Adherence Scale (SIRAS). The Biering-Sørensen test was used as the primary measure of treatment outcome. ANCOVA results showed that adherence scores were significantly higher in the experimental group (13.70 ± 1.58) compared with C2 (11.74 ± 1.35), (P goal setting to enhance adherence in clinical rehabilitation.

Improving Adherence to Smoking Cessation Treatment: Smoking Outcomes in a Web-based Randomized Trial.

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Graham, Amanda L; Papandonatos, George D; Cha, Sarah; Erar, Bahar; Amato, Michael S

2018-03-15

Partial adherence in Internet smoking cessation interventions presents treatment and evaluation challenges. Increasing adherence may improve outcomes. To present smoking outcomes from an Internet randomized trial of two strategies to encourage adherence to tobacco dependence treatment components: (i) a social network (SN) strategy to integrate smokers into an online community and (ii) free nicotine replacement therapy (NRT). In addition to intent-to-treat analyses, we used novel statistical methods to distinguish the impact of treatment assignment from treatment utilization. A total of 5,290 current smokers on a cessation website (WEB) were randomized to WEB, WEB + SN, WEB + NRT, or WEB + SN + NRT. The main outcome was 30-day point prevalence abstinence at 3 and 9 months post-randomization. Adherence measures included self-reported medication use (meds), and website metrics of skills training (sk) and community use (comm). Inverse Probability of Retention Weighting and Inverse Probability of Treatment Weighting jointly addressed dropout and treatment selection. Propensity weights were used to calculate Average Treatment effects on the Treated. Treatment assignment analyses showed no effects on abstinence for either adherence strategy. Abstinence rates were 25.7%-32.2% among participants that used all three treatment components (sk+comm +meds).Treatment utilization analyses revealed that among such participants, sk+comm+meds yielded large percentage point increases in 3-month abstinence rates over sk alone across arms: WEB = 20.6 (95% CI = 10.8, 30.4), WEB + SN = 19.2 (95% CI = 11.1, 27.3), WEB + NRT = 13.1 (95% CI = 4.1, 22.0), and WEB + SN + NRT = 20.0 (95% CI = 12.2, 27.7). Novel propensity weighting approaches can serve as a model for establishing efficacy of Internet interventions and yield important insights about mechanisms. NCT01544153.

Effects of a short course of eszopiclone on continuous positive airway pressure adherence: a randomized trial.

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Lettieri, Christopher J; Shah, Anita A; Holley, Aaron B; Kelly, William F; Chang, Audrey S; Roop, Stuart A

2009-11-17

Adherence to short-term continuous positive airway pressure (CPAP) may predict long-term use. Unfortunately, initial CPAP intolerance may lead to poor adherence or abandonment of therapy. To determine whether a short course of eszopiclone at the onset of therapy improves long-term CPAP adherence more than placebo in adults with obstructive sleep apnea. Parallel randomized, placebo-controlled trial from March 2007 to December 2008. Randomization, maintained and concealed centrally by pharmacy personnel, was computer-generated using fixed blocks of 10. Referring physicians, investigators, and patients were blinded to the treatment assignment until after the final data were collected. (ClinicalTrials.gov registration number: NCT00612157). Academic sleep disorder center. 160 adults (mean age, 45.7 years [SD, 7.3]; mean apnea-hypopnea index, 36.9 events/h [SD, 23]) with newly diagnosed obstructive sleep apnea initiating CPAP. Eszopiclone, 3 mg (n = 76), or matching placebo (n = 78) for the first 14 nights of CPAP. Use of CPAP was measured weekly for 24 weeks. Adherence to CPAP (primary outcome) and the rate of CPAP discontinuation and improvements in symptoms (secondary outcomes) were compared. Follow-up at 1, 3, and 6 months was completed by 150, 136, and 120 patients, respectively. Patients in the eszopiclone group used CPAP for 20.8% more nights (95% CI, 7.2% to 34.4%; P = 0.003), 1.3 more hours per night for all nights (CI, 0.4 to 2.2 hours; P = 0.005), and 1.1 more hours per night of CPAP use (CI, 0.2 to 2.1 hours; P = 0.019). The hazard ratio for discontinuation of CPAP was 1.90 (CI, 1.1 to 3.4; P = 0.033) times higher in the placebo group. Side effects were reported in 7.1% of patients and did not differ between groups. Patients had severe obstructive sleep apnea treated at a specialized sleep center with frequent follow-up; results may not be generalizable to different settings. Patients' tolerance to CPAP and their reasons for discontinuation were not assessed

Adherence as a language game.

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Kolberg, Espen Skarstein

2017-04-01

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.

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

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Sutton Stephen

2008-04-01

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

Accurate reporting of adherence to inhaled therapies in adults with cystic fibrosis: methods to calculate normative adherence

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Hoo ZH

2016-05-01

Full Text Available Zhe Hui Hoo,1,2 Rachael Curley,1,2 Michael J Campbell,1 Stephen J Walters,1 Daniel Hind,3 Martin J Wildman1,2 1School of Health and Related Research (ScHARR, University of Sheffield, 2Sheffield Adult Cystic Fibrosis Centre, Northern General Hospital, 3Sheffield Clinical Trials Research Unit, University of Sheffield, Sheffield, UK Background: Preventative inhaled treatments in cystic fibrosis will only be effective in maintaining lung health if used appropriately. An accurate adherence index should therefore reflect treatment effectiveness, but the standard method of reporting adherence, that is, as a percentage of the agreed regimen between clinicians and people with cystic fibrosis, does not account for the appropriateness of the treatment regimen. We describe two different indices of inhaled therapy adherence for adults with cystic fibrosis which take into account effectiveness, that is, “simple” and “sophisticated” normative adherence. Methods to calculate normative adherence: Denominator adjustment involves fixing a minimum appropriate value based on the recommended therapy given a person’s characteristics. For simple normative adherence, the denominator is determined by the person’s Pseudomonas status. For sophisticated normative adherence, the denominator is determined by the person’s Pseudomonas status and history of pulmonary exacerbations over the previous year. Numerator adjustment involves capping the daily maximum inhaled therapy use at 100% so that medication overuse does not artificially inflate the adherence level. Three illustrative cases: Case A is an example of inhaled therapy under prescription based on Pseudomonas status resulting in lower simple normative adherence compared to unadjusted adherence. Case B is an example of inhaled therapy under-prescription based on previous exacerbation history resulting in lower sophisticated normative adherence compared to unadjusted adherence and simple normative adherence

Safety, Acceptability and Adherence of Dapivirine Vaginal Ring in a Microbicide Clinical Trial Conducted in Multiple Countries in Sub-Saharan Africa.

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Annalene Nel

Full Text Available This was the first microbicide trial conducted in Africa to evaluate an antiretroviral-containing vaginal ring as an HIV prevention technology for women.The trial assessed and compared the safety, acceptability and adherence to product use of a 4-weekly administered vaginal ring containing the antiretroviral microbicide, dapivirine, with a matching placebo ring among women from four countries in sub-Saharan Africa.280 Healthy, sexually active, HIV-negative women, aged 18 to 40 years were enrolled with 140 women randomised to a dapivirine vaginal ring (25 mg and 140 women to a matching placebo ring, inserted 4-weekly and used over a 12-week period. Safety was evaluated by pelvic examination, colposcopy, clinical laboratory assessments, and adverse events. Blood samples for determination of plasma concentrations of dapivirine were collected at Weeks 0, 4 and 12. Residual dapivirine levels in returned rings from dapivirine ring users were determined post-trial. Participant acceptability and adherence to ring use were assessed by self-reports.No safety concerns or clinically relevant differences were observed between the dapivirine and placebo ring groups. Plasma dapivirine concentrations immediately prior to ring removal were similar after removal of the first and third ring, suggesting consistent ring use over the 12-week period. No clear relationship was observed between the residual amount of dapivirine in used rings and corresponding plasma concentrations. Self-reported adherence to daily use of the vaginal rings over the 12-week trial period was very high. At the end of the trial, 96% of participants reported that the ring was usually comfortable to wear, and 97% reported that they would be willing to use it in the future if proven effective.The dapivirine vaginal ring has a favourable safety and acceptability profile. If proven safe and effective in large-scale trials, it will be an important component of combination HIV prevention approaches

Safety, Acceptability and Adherence of Dapivirine Vaginal Ring in a Microbicide Clinical Trial Conducted in Multiple Countries in Sub-Saharan Africa.

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Nel, Annalene; Bekker, Linda-Gail; Bukusi, Elizabeth; Hellstrӧm, Elizabeth; Kotze, Philip; Louw, Cheryl; Martinson, Francis; Masenga, Gileard; Montgomery, Elizabeth; Ndaba, Nelisiwe; van der Straten, Ariane; van Niekerk, Neliëtte; Woodsong, Cynthia

2016-01-01

This was the first microbicide trial conducted in Africa to evaluate an antiretroviral-containing vaginal ring as an HIV prevention technology for women. The trial assessed and compared the safety, acceptability and adherence to product use of a 4-weekly administered vaginal ring containing the antiretroviral microbicide, dapivirine, with a matching placebo ring among women from four countries in sub-Saharan Africa. 280 Healthy, sexually active, HIV-negative women, aged 18 to 40 years were enrolled with 140 women randomised to a dapivirine vaginal ring (25 mg) and 140 women to a matching placebo ring, inserted 4-weekly and used over a 12-week period. Safety was evaluated by pelvic examination, colposcopy, clinical laboratory assessments, and adverse events. Blood samples for determination of plasma concentrations of dapivirine were collected at Weeks 0, 4 and 12. Residual dapivirine levels in returned rings from dapivirine ring users were determined post-trial. Participant acceptability and adherence to ring use were assessed by self-reports. No safety concerns or clinically relevant differences were observed between the dapivirine and placebo ring groups. Plasma dapivirine concentrations immediately prior to ring removal were similar after removal of the first and third ring, suggesting consistent ring use over the 12-week period. No clear relationship was observed between the residual amount of dapivirine in used rings and corresponding plasma concentrations. Self-reported adherence to daily use of the vaginal rings over the 12-week trial period was very high. At the end of the trial, 96% of participants reported that the ring was usually comfortable to wear, and 97% reported that they would be willing to use it in the future if proven effective. The dapivirine vaginal ring has a favourable safety and acceptability profile. If proven safe and effective in large-scale trials, it will be an important component of combination HIV prevention approaches for women

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

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Andony, Louise J; Tay, Elaine; Allen, Karina L; Wade, Tracey D; Hay, Phillipa; Touyz, Stephen; McIntosh, Virginia V W; Treasure, Janet; Schmidt, Ulrike H; Fairburn, Christopher G; Erceg-Hurn, David M; Fursland, Anthea; Crosby, Ross D; Byrne, Susan M

2015-12-01

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). 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. 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. 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. The Authors. International Journal of Eating Disorders Published by Wiley Periodicals, Inc.

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.

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De Costa, Ayesha; Shet, Anita; Kumarasamy, Nagalingeswaran; Ashorn, Per; Eriksson, Bo; Bogg, Lennart; Diwan, Vinod K

2010-03-26

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. 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. 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-line antiretrovirals in an Indian context.

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

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

2014-01-01

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

Exercise motivation and adherence in cancer survivors after participation in a randomized controlled trial: an attribution theory perspective.

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Courneya, Kerry S; Friedenreich, Christine M; Sela, Rami A; Quinney, H Arthur; Rhodes, Ryan E; Jones, Lee W

2004-01-01

The purpose of this study was to examine postprogram exercise motivation and adherence in cancer survivors who participated in the Group Psychotherapy and Home-Based Physical Exercise (GROUP-HOPE; Courneya, Friedenreich, Sela, Quinney, & Rhodes, 2002) trial. At the completion of the GROUP-HOPE trial, 46 of 51 (90%) participants in the exercise group completed measures of attribution theory constructs. A 5-week follow-up self-report of exercise was then completed by 30 (65%) participants. Correlational analyses indicated that program exercise, perceived success, expected success, and affective reactions were strong predictors of postprogram exercise. In multivariate stepwise regression analyses, program exercise and perceived success were the strongest predictors of postprogram exercise. Additionally, perceived success was more important than objective success in understanding the attribution process, and it interacted with personal control to influence expected success and negative affect. Finally, postprogram quality of life and changes in physical fitness were correlates of perceived success. We concluded that attribution theory may have utility for understanding postprogram exercise motivation and adherence in cancer survivors.

Treatment Adherence and Its Impact on Disease-Free Survival in the Breast International Group 1-98 Trial of Tamoxifen and Letrozole, Alone and in Sequence

DEFF Research Database (Denmark)

Chirgwin, Jacquie H; Giobbie-Hurder, Anita; Coates, Alan S

2016-01-01

PURPOSE: To investigate adherence to endocrine treatment and its relationship with disease-free survival (DFS) in the Breast International Group (BIG) 1-98 clinical trial. METHODS: The BIG 1-98 trial is a double-blind trial that randomly assigned 6,193 postmenopausal women with hormone receptor......-positive early breast cancer in the four-arm option to 5 years of tamoxifen (Tam), letrozole (Let), or the agents in sequence (Let-Tam, Tam-Let). This analysis included 6,144 women who received at least one dose of study treatment. Conditional landmark analyses and marginal structural Cox proportional hazards......). Sequential treatments were associated with higher rates of nonpersistence (Tam-Let, 20.8%; Let-Tam, 20.3%; Tam 16.9%; Let 17.6%). Adverse events were the reason for most trial treatment early discontinuations (82.7%). Apart from sequential treatment assignment, reduced adherence was associated with older age...

Efficacy of a text messaging (SMS) based intervention for adults with hypertension: protocol for the StAR (SMS Text-message Adherence suppoRt trial) randomised controlled trial.

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Bobrow, Kirsty; Brennan, Thomas; Springer, David; Levitt, Naomi S; Rayner, Brian; Namane, Mosedi; Yu, Ly-Mee; Tarassenko, Lionel; Farmer, Andrew

2014-01-11

Interventions to support people with hypertension in attending clinics and taking their medication have potential to improve outcomes, but delivery on a wide scale and at low cost is challenging. Some trials evaluating clinical interventions using short message service (SMS) text-messaging systems have shown important outcomes, although evidence is limited. We have developed a novel SMS system integrated with clinical care for use by people with hypertension in a low-resource setting. We aim to test the efficacy of the system in improving blood pressure control and treatment adherence compared to usual care. The SMS Text-message Adherence suppoRt trial (StAR) is a pragmatic individually randomised three-arm parallel group trial in adults treated for hypertension at a single primary care centre in Cape Town, South Africa. The intervention is a structured programme of clinic appointment, medication pick-up reminders, medication adherence support and hypertension-related education delivered remotely using an automated system with either informational or interactive SMS text-messages. Usual care is supplemented by infrequent non-hypertension related SMS text-messages. Participants are 1:1:1 individually randomised, to usual care or to one of the two active interventions using minimisation to dynamically adjust for gender, age, baseline systolic blood pressure, years with hypertension, and previous clinic attendance. The primary outcome is the change in mean systolic blood pressure at 12-month follow-up from baseline measured with research staff blinded to trial allocation. Secondary outcomes include the proportion of patients with 80% or more of days medication available, proportion of participants achieving a systolic blood pressure less than 140 mmHg and a diastolic blood pressure less than 90 mmHg, hospital admissions, health status, retention in clinical care, satisfaction with treatment and care, and patient related quality of life. Anonymised demographic data

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

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

2017-06-01

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

Communication interventions to improve adherence to infection control precautions: a randomised crossover trial.

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Ong, Mei-Sing; Magrabi, Farah; Post, Jeffrey; Morris, Sarah; Westbrook, Johanna; Wobcke, Wayne; Calcroft, Ross; Coiera, Enrico

2013-02-06

Ineffective communication of infection control requirements during transitions of care is a potential cause of non-compliance with infection control precautions by healthcare personnel. In this study, interventions to enhance communication during inpatient transfers between wards and radiology were implemented, in the attempt to improve adherence to precautions during transfers. Two interventions were implemented, comprising (i) a pre-transfer checklist used by radiology porters to confirm a patient's infectious status; (ii) a coloured cue to highlight written infectious status information in the transfer form. The effectiveness of the interventions in promoting adherence to standard precautions by radiology porters when transporting infectious patients was evaluated using a randomised crossover trial at a teaching hospital in Australia. 300 transfers were observed over a period of 4 months. Compliance with infection control precautions in the intervention groups was significantly improved relative to the control group (p group was 38%. Applying the coloured cue resulted in a compliance rate of 73%. The pre-transfer checklist intervention achieved a comparable compliance rate of 71%. When both interventions were applied, a compliance rate of 74% was attained. Acceptability of the coloured cue was high, but adherence to the checklist was low (40%). Simple measures to enhance communication through the provision of a checklist and the use a coloured cue brought about significant improvement in compliance with infection control precautions by transport personnel during inpatient transfers. The study underscores the importance of effective communication in ensuring compliance with infection control precautions during transitions of care.

Exergames versus self-regulated exercises with instruction leaflets to improve adherence during geriatric rehabilitation: a randomized controlled trial.

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Oesch, Peter; Kool, Jan; Fernandez-Luque, Luis; Brox, Ellen; Evertsen, Gunn; Civit, Anton; Hilfiker, Roger; Bachmann, Stefan

2017-03-23

Improving mobility in elderly persons is a primary goal in geriatric rehabilitation. Self-regulated exercises with instruction leaflets are used to increase training volume but adherence is often low. Exergames may improve adherence. This study therefore compared exergames with self-regulated exercise using instruction leaflets. The primary outcome was adherence. Secondary outcomes were enjoyment, motivation and balance during walking. Design: single center parallel group non-blinded randomized controlled trial with central stratified randomization. center for geriatric inpatient rehabilitation. Included were patients over 65 with mobility restrictions who were able to perform self-regulated exercise. Patients were assigned to self-regulated exercise using a) exergames on Windows Kinect® (exergame group EG) or b) instruction leaflets (conventional group CG). During two 30 min sessions physical therapists instructed self-regulated exercise to be conducted twice daily during thirty minutes during ten working days. Patients reported adherence (primary outcome), enjoyment and motivation daily. Balance during walking was measured blind before and after the treatment phase with an accelerometer. Analysis was by intention to treat. Repeated measures mixed models and Cohen's d effect sizes (ES, moderate if >0.5, large if > 0.8) with 95% CIs were used to evaluate between-group effects over time. Alpha was set at 0.05. From June 2014 to December 2015 217 patients were evaluated and 54 included, 26 in the EG and 28 in the CG. Adverse effects were observed in two patients in the EG who stopped because of pain during exercising. Adherence was comparable at day one (38 min. in the EG and 42 min. in the CG) and significantly higher in the CG at day 10 (54 min. in the CG while decreasing to 28 min. in the EG, p = 0.007, ES 0.94, 0.39-0.151). Benefits favoring the CG were also observed for enjoyment (p = 0.001, ES 0.88, 0.32 - 1.44) and motivation (p = 0

Prospective trial of customized adherence enhancement plus long-acting injectable antipsychotic medication in homeless or recently homeless individuals with schizophrenia or schizoaffective disorder.

Science.gov (United States)

Sajatovic, Martha; Levin, Jennifer; Ramirez, Luis F; Hahn, David Y; Tatsuoka, Curtis; Bialko, Christopher S; Cassidy, Kristin A; Fuentes-Casiano, Edna; Williams, Tiffany D

2013-12-01

Treatment nonadherence in people with schizophrenia is associated with relapse and homelessness. Building on the usefulness of long-acting medication and our work in psychosocial interventions to enhance adherence, we conducted a prospective uncontrolled trial of customized adherence enhancement (CAE) plus long-acting injectable antipsychotic (LAI) using haloperidol decanoate in 30 homeless or recently homeless individuals with DSM-IV-defined schizophrenia or schizoaffective disorder. Participants received monthly CAE and LAI (CAE-L) for 6 months. Primary outcomes were adherence, as measured by the Tablets Routine Questionnaire, and housing status. Secondary outcomes included psychiatric symptoms, functioning, side effects, and hospitalizations. The study was conducted from July 2010 to December 2012. The mean age of participants was 41.8 years (SD = 8.6); they were mainly minorities (90%, n = 27 African-American) and mainly single/never married (70%, n = 21). Most (97%, n = 29) had past or current substance abuse and had been incarcerated (97%, n = 29). Ten individuals (33%) terminated the study prematurely. CAE-L was associated with good adherence to LAI (at 6 months, 76%) and dramatic improvement in oral medication adherence, which changed from missing 46% of medication at study enrollment to missing only 10% at study end (P = .03). There were significant improvements in psychiatric symptoms (P effect with LAI. While interpretation of findings must be tempered by the methodological limitations, CAE-L appears to be associated with improved adherence, symptoms, and functioning in homeless or recently homeless individuals with schizophrenia or schizoaffective disorder. Additional research is needed on effective and practical approaches to improving health outcomes for homeless people with serious mental illness. ClinicalTrials.gov identifier: NCT01152697. © Copyright 2013 Physicians Postgraduate Press, Inc.

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

Directory of Open Access Journals (Sweden)

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

Trials and tribulations with electronic medication adherence monitoring in kidney transplantation.

Science.gov (United States)

Williams, Allison; Low, Jac Kee; Manias, Elizabeth; Dooley, Michael; Crawford, Kimberley

2016-01-01

Medication adherence in kidney transplantation is critical to prevent graft rejection. Testing interventions designed to support patients to take their prescribed medications following a kidney transplant require an accurate measure of medication adherence. In research, the available methods for measuring medication adherence include self-report, pill counts, prescription refill records, surrogate measures of medication adherence and medication bottles with a microchip-embedded cap to record bottle openings. Medication bottles with a microchip-embedded cap are currently regarded as the gold standard measure. This commentary outlines the challenges in measuring medication adherence using electronic medication monitoring of kidney transplant patients recruited from five sites. The challenges included obtaining unanimous stakeholder support for using this method, agreement on an index medication to measure, adequate preparation of the patient and training of pharmacy staff, and how to analyze data when periods of time were not recorded using the electronic adherence measure. Provision of this information will enable hospital and community pharmacists to implement approaches that promote the effective use of this adherence measure for optimal patient outcomes. Copyright © 2015 Elsevier Inc. All rights reserved.

A Review of Recruitment, Adherence and Drop-Out Rates in Omega-3 Polyunsaturated Fatty Acid Supplementation Trials in Children and Adolescents

NARCIS (Netherlands)

Van der Wurff, Inge; Meyer, Barbara; De Groot, Renate

2017-01-01

Introduction: The influence of n-3 long-chain polyunsaturated fatty acids (n-3 LCPUFA) supplementation on health outcomes has been studied extensively with randomized controlled trials (RCT). In many research fields, difficulties with recruitment, adherence and high drop-out rates have been

Biomarkers and biometric measures of adherence to use of ARV-based vaginal rings.

Science.gov (United States)

Stalter, Randy M; Moench, Thomas R; MacQueen, Kathleen M; Tolley, Elizabeth E; Owen, Derek H

2016-01-01

Poor adherence to product use has been observed in recent trials of antiretroviral (ARV)-based oral and vaginal gel HIV prevention products, resulting in an inability to determine product efficacy. The delivery of microbicides through vaginal rings is widely perceived as a way to achieve better adherence but vaginal rings do not eliminate the adherence challenges exhibited in clinical trials. Improved objective measures of adherence are needed as new ARV-based vaginal ring products enter the clinical trial stage. To identify technologies that have potential future application for vaginal ring adherence measurement, a comprehensive literature search was conducted that covered a number of biomedical and public health databases, including PubMed, Embase, POPLINE and the Web of Science. Published patents and patent applications were also searched. Technical experts were also consulted to gather more information and help evaluate identified technologies. Approaches were evaluated as to feasibility of development and clinical trial implementation, cost and technical strength. Numerous approaches were identified through our landscape analysis and classified as either point measures or cumulative measures of vaginal ring adherence. Point measurements are those that give a measure of adherence at a particular point in time. Cumulative measures attempt to measure ring adherence over a period of time. Approaches that require modifications to an existing ring product are at a significant disadvantage, as this will likely introduce additional regulatory barriers to the development process and increase manufacturing costs. From the point of view of clinical trial implementation, desirable attributes would be high acceptance by trial participants, and little or no additional time or training requirements on the part of participants or clinic staff. We have identified four promising approaches as being high priority for further development based on the following measurements

Modeling the impact of increased adherence to asthma therapy.

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Amory Schlender

Full Text Available BACKGROUND: Nonadherence to medications occurs in up to 70% of patients with asthma. The effect of improving adherence is not well quantified. We developed a mathematical model with which to assess the population-level effects of improving medication prescribing and adherence for asthma. METHODS: A mathematical model, calibrated to clinical trial data from the U.S. NHLBI-funded SOCS trial and validated using data from the NHLBI SLIC trial, was used to model the effects of increased prescribing and adherence to asthma controllers. The simulated population consisted of 4,930 individuals with asthma, derived from a sample the National Asthma Survey. Main outcomes were controller use, reliever use, unscheduled doctor visits, emergency department (ED visits, and hospitalizations. RESULTS: For the calibration, simulated outcomes agreed closely with SOCS trial outcomes, with treatment failure hazard ratios [95% confidence interval] of 0.92 [0.58-1.26], 0.97 [0.49-1.45], and 1.01 [0-1.87] for simulation vs. trial in the in placebo, salmeterol, and triamcinolone arms, respectively. For validation, simulated outcomes predicted mid- and end-point treatment failure rates, hazard ratios 1.21 [0.08-2.34] and 0.83 [0.60-1.07], respectively, for patients treated with salmeterol/triamcinolone during the first half of the SLIC study and salmeterol monotherapy during the second half. The model performed less well for patients treated with salmeterol/triamcinolone during the entire study duration, with mid- and end-point hazard ratios 0.83 [0.00-2.12] and 0.37 [0.10-0.65], respectively. Simulation of optimal adherence and prescribing indicated that closing adherence and prescription gaps could prevent as many as nine million unscheduled doctor visits, four million emergency department visits, and one million asthma-related hospitalizations each year in the U.S. CONCLUSIONS: Improvements in medication adherence and prescribing could have a substantial impact on

Adherence to Antihypertensive Treatment and the Blood Pressure-Lowering Effects of Renal Denervation in the Renal Denervation for Hypertension (DENERHTN) Trial.

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Azizi, Michel; Pereira, Helena; Hamdidouche, Idir; Gosse, Philippe; Monge, Matthieu; Bobrie, Guillaume; Delsart, Pascal; Mounier-Véhier, Claire; Courand, Pierre-Yves; Lantelme, Pierre; Denolle, Thierry; Dourmap-Collas, Caroline; Girerd, Xavier; Michel Halimi, Jean; Zannad, Faiez; Ormezzano, Olivier; Vaïsse, Bernard; Herpin, Daniel; Ribstein, Jean; Chamontin, Bernard; Mourad, Jean-Jacques; Ferrari, Emile; Plouin, Pierre-François; Jullien, Vincent; Sapoval, Marc; Chatellier, Gilles

2016-09-20

The DENERHTN trial (Renal Denervation for Hypertension) confirmed the blood pressure-lowering efficacy of renal denervation added to a standardized stepped-care antihypertensive treatment for resistant hypertension at 6 months. We report the influence of adherence to antihypertensive treatment on blood pressure control. One hundred six patients with hypertension resistant to 4 weeks of treatment with indapamide 1.5 mg/d, ramipril 10 mg/d (or irbesartan 300 mg/d), and amlodipine 10 mg/d were randomly assigned to renal denervation plus standardized stepped-care antihypertensive treatment, or the same antihypertensive treatment alone. For standardized stepped-care antihypertensive treatment, spironolactone 25 mg/d, bisoprolol 10 mg/d, prazosin 5 mg/d, and rilmenidine 1 mg/d were sequentially added at monthly visits if home blood pressure was ≥135/85 mm Hg after randomization. We assessed adherence to antihypertensive treatment at 6 months by drug screening in urine/plasma samples from 85 patients. The numbers of fully adherent (20/40 versus 21/45), partially nonadherent (13/40 versus 20/45), or completely nonadherent patients (7/40 versus 4/45) to antihypertensive treatment were not different in the renal denervation and the control groups, respectively (P=0.3605). The difference in the change in daytime ambulatory systolic blood pressure from baseline to 6 months between the 2 groups was -6.7 mm Hg (P=0.0461) in fully adherent and -7.8 mm Hg (P=0.0996) in nonadherent (partially nonadherent plus completely nonadherent) patients. The between-patient variability of daytime ambulatory systolic blood pressure was greater for nonadherent than for fully adherent patients. In the DENERHTN trial, the prevalence of nonadherence to antihypertensive drugs at 6 months was high (≈50%) but not different in the renal denervation and control groups. Regardless of adherence to treatment, renal denervation plus standardized stepped-care antihypertensive treatment resulted in

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

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Williams NJ

2014-03-01

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

The impact of peer support and mp3 messaging on adherence to inhaled corticosteroids in minority adolescents with asthma: a randomized, controlled trial.

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Mosnaim, Giselle; Li, Hong; Martin, Molly; Richardson, DeJuran; Belice, Paula Jo; Avery, Elizabeth; Ryan, Norman; Bender, Bruce; Powell, Lynda

2013-01-01

Poor adherence to inhaled corticosteroids (ICS) is a critical risk factor contributing to asthma morbidity among low-income minority adolescents. This trial tested whether peer support group meetings and peer asthma messages delivered via mp3 players improved adherence to ICS. Low-income African American and/or Hispanic adolescents, ages 11-16 years old, with persistent asthma, and poor (≤ 48%) adherence to prescription ICS during the 3-week run-in were randomized to intervention or attention control groups (ATG) for the 10-week treatment. During treatment, the intervention arm subjects participated in weekly coping peer group support sessions and received mp3 peer-recorded asthma messages that promoted adherence. The ATG participated in weekly meetings with a research assistant and received an equivalent number of mp3 physician-recorded asthma messages. Adherence was measured by using self-report and the Doser CT, an electronic dose counter. The primary outcome was the difference in adherence at 10 weeks between the 2 arms. Thirty-four subjects were randomized to each arm. At 10 weeks, no statistical difference in objectively measured adherence could be detected between the 2 arms when adjusting for baseline adherence (P = .929). Adherence declined in both groups over the course of the active treatment period. In both study arms, self-reported adherence by participants was significantly higher than their objectively measured adherence at week 10 (P mp3-delivered peer asthma messages may not be of sufficient dose to improve outcomes. Copyright © 2013 American Academy of Allergy, Asthma & Immunology. Published by Elsevier Inc. All rights reserved.

Adherence and acceptability in MTN 001: A randomized cross-over trial of daily oral and topical tenofovir for HIV prevention in women

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Minnis, Alexandra M.; Gandham, Sharavi; Richardson, Barbra A.; Guddera, Vijayanand; Chen, Beatrice A.; Salata, Robert; Nakabiito, Clemensia; Hoesley, Craig; Justman, Jessica; Soto-Torres, Lydia; Patterson, Karen; Gomez, Kailazarid; Hendrix, Craig

2012-01-01

We compared adherence to and acceptability of daily topical and oral formulations of tenofovir (TFV) used as pre-exposure prophylaxis (PrEP) for HIV prevention among women in South Africa, Uganda and the United States. 144 sexually active, HIV-uninfected women participated in a cross-over study of three regimens: oral tablet, vaginal gel, or both. We tested for differences in adherence and evaluated product acceptability. Self-reported adherence for all regimens was high (94%), but serum TFV concentrations indicated only 64% of participants used tablets consistently. Most women in the U.S. (72%) favored tablets over gel; while preferences varied at the African sites (42% preferred gel and 40% tablets). Findings indicate a role for oral and vaginal PrEP formulations and highlight the importance of integrating pharmacokinetics-based adherence assessment in future trials. Biomedical HIV prevention interventions should consider geographic and cultural experience with product formulations, partner involvement, and sexual health benefits that ultimately influence use. PMID:23065145

Adherence to Hunger Training over 6 Months and the Effect on Weight and Eating Behaviour: Secondary Analysis of a Randomised Controlled Trial

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Taylor, Rachael W.; Athens, Josie; Brown, Rachel C.

2017-01-01

Monitoring blood glucose prior to eating can teach individuals to eat only when truly hungry, but how adherence to ‘hunger training’ influences weight loss and eating behaviour is uncertain. This exploratory, secondary analysis from a larger randomized controlled trial examined five indices of adherence to ‘hunger training’, chosen a priori, to examine which adherence measure best predicted weight loss over 6 months. We subsequently explored how the best measure of adherence influenced eating behavior in terms of intuitive and emotional eating. Retention was 72% (n = 36/50) at 6 months. Frequency of hunger training booklet entry most strongly predicted weight loss, followed by frequency of blood glucose measurements. Participants who completed at least 60 days of booklet entry (of recommended 63 days) lost 6.8 kg (95% CI: 2.6, 11.0; p hunger training and focusing on simply recording ratings of hunger on a regular basis can produce clinically significant weight loss and clinically relevant improvements in eating behaviour. PMID:29149038

The Use of Cell Phone Support for Non-adherent HIV-Infected Youth and Young Adults: An Initial Randomized and Controlled Intervention Trial

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Belzer, Marvin E.; Naar-King, Sylvie; Olson, Johanna; Sarr, Moussa; Thornton, Sarah; Kahana, Shoshana Y.; Gaur, Aditya H.; Clark, Leslie F.

2014-01-01

This randomized behavioral trial examined whether youth living with HIV (YLH) receiving cell-phone support with study funded phone plans, demonstrated improved adherence and viral control during the 24 week intervention and 24 weeks post-intervention compared to controls. Monday through Friday phone calls confirmed medications were taken, provided problem-solving support, and referred to services to address adherence barriers. Of 37 participants (ages 15–24), 62 % were male and 70 % were African American. Self-reported adherence was significantly higher in the intervention group compared to the control at 24 and 48 weeks for the past month (P = 0.007) and log 10 HIV VL was significantly lower at both 24 weeks (2.82 versus 4.52 P = 0.002) and 48 weeks (3.23 versus 4.23 P = 0.043). Adherence and viral load showed medium to large effect sizes across the 48 week study. This is the first study to demonstrate sustained clinically significant reductions in HIV VL using youth friendly technology. PMID:24271347

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

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David J. Moore

2013-01-01

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 ClinicalTrials.gov NCT01317277.

Referral from primary care to a physical activity programme: establishing long-term adherence? A randomized controlled trial. Rationale and study design

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Puig-Ribera Anna

2009-01-01

Full Text Available Abstract Background Declining physical activity is associated with a rising burden of global disease. There is little evidence about effective ways to increase adherence to physical activity. Therefore, interventions are needed that produce sustained increases in adherence to physical activity and are cost-effective. The purpose is to assess the effectiveness of a primary care physical activity intervention in increasing adherence to physical activity in the general population seen in primary care. Method and design Randomized controlled trial with systematic random sampling. A total of 424 subjects of both sexes will participate; all will be over the age of 18 with a low level of physical activity (according to the International Physical Activity Questionnaire, IPAQ, self-employed and from 9 Primary Healthcare Centres (PHC. They will volunteer to participate in a physical activity programme during 3 months (24 sessions; 2 sessions a week, 60 minutes per session. Participants from each PHC will be randomly allocated to an intervention (IG and control group (CG. The following parameters will be assessed pre and post intervention in both groups: (1 health-related quality of life (SF-12, (2 physical activity stage of change (Prochaska's stages of change, (3 level of physical activity (IPAQ-short version, (4 change in perception of health (vignettes from the Cooperative World Organization of National Colleges, Academies, and Academic Associations of Family Physicians, COOP/WONCA, (5 level of social support for the physical activity practice (Social Support for Physical Activity Scale, SSPAS, and (6 control based on analysis (HDL, LDL and glycated haemoglobin. Participants' frequency of visits to the PHC will be registered over the six months before and after the programme. There will be a follow up in a face to face interview three, six and twelve months after the programme, with the reduced version of IPAQ, SF-12, SSPAS, and Prochaska's stages

Clinical pharmacist interventions to support adherence to thrombopreventive therapy

DEFF Research Database (Denmark)

Hedegaard, Ulla

The three papers in the thesis were based on two randomised controlled trials (RCTs) on in-hospital clinical pharmacist interventions for improvement of adherence to thrombopreventive therapy in two different populations: outpatients with hypertension and patients with acute stroke/transient isch......The three papers in the thesis were based on two randomised controlled trials (RCTs) on in-hospital clinical pharmacist interventions for improvement of adherence to thrombopreventive therapy in two different populations: outpatients with hypertension and patients with acute stroke...... 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...... targeted patients with hypertension or stroke in a hospital care setting. Thus, the aim of this thesis was to develop and evaluate in-hospital pharmacist interventions including MI to improve adherence to primary and secondary thrombopreventive therapy. The first study was a RCT, which investigated...

An Electronic Adherence Measurement Intervention to Reduce Clinical Inertia in the Treatment of Uncontrolled Hypertension: The MATCH Cluster Randomized Clinical Trial.

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Kronish, Ian M; Moise, Nathalie; McGinn, Thomas; Quan, Yan; Chaplin, William; Gallagher, Benjamin D; Davidson, Karina W

2016-11-01

To appropriately manage uncontrolled hypertension, clinicians must decide whether blood pressure (BP) is above goal due to a need for additional medication or to medication nonadherence. Yet, clinicians are poor judges of adherence, and uncertainty about adherence may promote inertia with respect to medication modification. We aimed to determine the effect of sharing electronically-measured adherence data with clinicians on the management of uncontrolled hypertension. This was a cluster randomized trial. Twenty-four primary care providers (12 intervention, 12 usual care; cluster units) and 100 patients with uncontrolled hypertension (65 intervention, 35 usual care) were included in the study. At one visit per patient, clinicians in the intervention group received a report summarizing electronically measured adherence to the BP regimen and recommended clinical actions. Clinicians in the control group did not receive a report. The primary outcome was the proportion of visits with appropriate clinical management (i.e., treatment intensification among adherent patients and adherence counseling among nonadherent patients). Secondary outcomes included patient-rated quality of care and communication during the visit. The proportion of visits with appropriate clinical management was higher in the intervention group than the control group (45 out of 65; 69 %) versus (12 out of 35; 34 %; p = 0.001). A higher proportion of adherent patients in the intervention group had their regimen intensified (p = 0.01), and a higher proportion of nonadherent patients in the intervention group received adherence counseling (p = 0.005). Patients in the intervention group were more likely to give their clinician high ratings on quality of care (p = 0.05), and on measures of patient-centered (p = 0.001) and collaborative communication (p = 0.02). Providing clinicians with electronically-measured antihypertensive adherence reports reduces inertia in the management of

Educational video to improve CPAP use in patients with obstructive sleep apnoea at risk for poor adherence: a randomised controlled trial.

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Guralnick, Amy S; Balachandran, Jay S; Szutenbach, Shane; Adley, Kevin; Emami, Leila; Mohammadi, Meelad; Farnan, Jeanne M; Arora, Vineet M; Mokhlesi, Babak

2017-12-01

Suboptimal adherence to CPAP limits its clinical effectiveness in patients with obstructive sleep apnoea (OSA). Although rigorous behavioural interventions improve CPAP adherence, their labour-intensive nature has limited widespread implementation. Moreover, these interventions have not been tested in patients at risk of poor CPAP adherence. Our objective was to determine whether an educational video will improve CPAP adherence in patients at risk of poor CPAP adherence. Patients referred by clinicians without sleep medicine expertise to an urban sleep laboratory that serves predominantly minority population were randomised to view an educational video about OSA and CPAP therapy before the polysomnogram, or to usual care. The primary outcome was CPAP adherence during the first 30 days of therapy. Secondary outcomes were show rates to sleep clinic (attended appointment) and 30-day CPAP adherence after the sleep clinic visit date. A total of 212 patients met the eligibility criteria and were randomised to video education (n=99) or to usual care (n=113). There were no differences in CPAP adherence at 30 days (3.3, 95% CI 2.8 to 3.8 hours/day video education; vs 3.5, 95% CI 3.1 to 4.0 hours/day usual care; p=0.44) or during the 30 days after sleep clinic visit. Sleep clinic show rate was 54% in the video education group and 59% in the usual care group (p=0.41). CPAP adherence, however, significantly worsened in patients who did not show up to the sleep clinic. In patients at risk for poor CPAP adherence, an educational video did not improve CPAP adherence or show rates to sleep clinic compared with usual care. ClinicalTrials.gov Identifier: NCT02553694. © Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2017. All rights reserved. No commercial use is permitted unless otherwise expressly granted.

Adherence to Hunger Training over 6 Months and the Effect on Weight and Eating Behaviour: Secondary Analysis of a Randomised Controlled Trial.

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Jospe, Michelle R; Taylor, Rachael W; Athens, Josie; Roy, Melyssa; Brown, Rachel C

2017-11-17

Monitoring blood glucose prior to eating can teach individuals to eat only when truly hungry, but how adherence to 'hunger training' influences weight loss and eating behaviour is uncertain. This exploratory, secondary analysis from a larger randomized controlled trial examined five indices of adherence to 'hunger training', chosen a priori, to examine which adherence measure best predicted weight loss over 6 months. We subsequently explored how the best measure of adherence influenced eating behavior in terms of intuitive and emotional eating. Retention was 72% ( n = 36/50) at 6 months. Frequency of hunger training booklet entry most strongly predicted weight loss, followed by frequency of blood glucose measurements. Participants who completed at least 60 days of booklet entry (of recommended 63 days) lost 6.8 kg (95% CI: 2.6, 11.0; p food choice congruence and 0.79 (0.06, 1.51) for eating for physical rather than emotional reasons. Adherent participants also reported significantly lower scores for emotional eating of -0.70 (-1.13, -0.27). Following hunger training and focusing on simply recording ratings of hunger on a regular basis can produce clinically significant weight loss and clinically relevant improvements in eating behaviour.

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

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

2016-01-01

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. 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. 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. 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.

Clustering based on adherence data.

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Kiwuwa-Muyingo, Sylvia; Oja, Hannu; Walker, Sarah A; Ilmonen, Pauliina; Levin, Jonathan; Todd, Jim

2011-03-08

Adherence to a medical treatment means the extent to which a patient follows the instructions or recommendations by health professionals. There are direct and indirect ways to measure adherence which have been used for clinical management and research. Typically adherence measures are monitored over a long follow-up or treatment period, and some measurements may be missing due to death or other reasons. A natural question then is how to describe adherence behavior over the whole period in a simple way. In the literature, measurements over a period are usually combined just by using averages like percentages of compliant days or percentages of doses taken. In the paper we adapt an approach where patient adherence measures are seen as a stochastic process. Repeated measures are then analyzed as a Markov chain with finite number of states rather than as independent and identically distributed observations, and the transition probabilities between the states are assumed to fully describe the behavior of a patient. The patients can then be clustered or classified using their estimated transition probabilities. These natural clusters can be used to describe the adherence of the patients, to find predictors for adherence, and to predict the future events. The new approach is illustrated and shown to be useful with a simple analysis of a data set from the DART (Development of AntiRetroviral Therapy in Africa) trial in Uganda and Zimbabwe.

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

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Michael H Chung

2011-03-01

Full Text Available 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.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.Intensive early adherence counseling at HAART initiation resulted in sustained, significant impact on adherence and

Behavioural graded activity results in better exercise adherence and more physical activity than usual care in people with osteoarthritis: a cluster-randomised trial

NARCIS (Netherlands)

Pisters, M.F.; Veenhof, C.; de Bakker, D.H.; Schellevis, F.G.; Dekker, J.

2010-01-01

Question: Does behavioural graded activity result in better exercise adherence and more physical activity than usual care in people with osteoarthritis of the hip or knee? Design: Analysis of secondary outcomes of a cluster-randomised trial with concealed allocation, assessor blinding, and

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

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Widen Jan H

2008-04-01

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.

Matching Adherence Interventions to Patient Determinants Using the Theoretical Domains Framework

NARCIS (Netherlands)

Allemann, S.S.; Nieuwlaat, R.; Bemt, B.J. van den; Hersberger, K.E.; Arnet, I.

2016-01-01

Introduction: Despite much research, interventions to improve medication adherence report disappointing and inconsistent results. Tailored approaches that match interventions and patient determinants of non-adherence were seldom used in clinical trials. The presence of a multitude of theoretical

Efficacy of shared decision-making on treatment adherence of patients with bipolar disorder: a cluster randomized trial (ShareD-BD).

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Samalin, L; Honciuc, M; Boyer, L; de Chazeron, I; Blanc, O; Abbar, M; Llorca, P M

2018-04-13

Shared decision-making (SDM) is a model of interaction between doctors and patients in which both actors contribute to the medical decision-making process. SDM has raised great interest in mental healthcare over the last decade, as it is considered a fundamental part of patient-centered care. However, there is no research evaluating the efficacy of SDM compared to usual care (CAU), as it relates to quality of care and more specifically treatment adherence, in bipolar disorder (BD). This is a 12-month multi-centre, cluster-randomized controlled trial comparing the efficacy of SDM to CAU. Adult BD patients (n = 300) will be eligible after stabilization for at least 4 weeks following an acute mood episode. The intervention will consist of applying the standardized SDM process as developed by the Ottawa Hospital Research Institute in order to choose the maintenance treatment of BD. A multidisciplinary team developed a decision aid "choose my long-term treatment with my doctor" for BD patients to clarify possible therapeutic options. Primary outcome will assess the patient's level of adherence (based on hetero-evaluation) of ongoing treatment at 12 months. Secondary outcomes will assess the difference between the 2 groups of patients in terms of adherence to maintenance drug therapy based on other measures (self-assessment scale and plasma levels of mood stabilizers). Additionally, other dimensions will be assessed: decisional conflict, satisfaction with care and involvement in decision making, beliefs about treatment, therapeutic relationship, knowledge about information for medical decision and clinical outcomes (depression, mania, functioning and quality of life). The primary endpoint will be analysed without adjustment by comparison of adherence scores between the two groups using Student t-tests or Mann-Whitney tests according to the variable distribution. A set of secondary analyses will be adjusted for covariates of clinical interest using generalized linear

Using daily text messages to improve adherence to infant micronutrient powder (MNP) packets in rural western China: A cluster-randomized controlled trial

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Wang, Xu; Liu, Chengfang; Zhang, Linxiu; Yue, Ai; Medina, Alexis; Rozelle, Scott

2018-01-01

Objective To evaluate the effectiveness of daily text messages as a means to improve caregivers’ adherence to infant micronutrient powder (MNP) in rural Shaanxi Province of China. Methodology 638 infants aged 6–11 months in 234 villages were involved in a cluster-randomized controlled trial (RCT). All caregivers were given free infant MNP packets at baseline in April 2013 and the follow-up survey was in July 2013. We randomly assigned 318 infants in 117 villages to treatment group (receiving daily text message) and 320 infants in the other 117 villages as control group. Results On average, daily text messages increased the number of MNP packets fed (marginal effect = 4.63; 95% confidence interval (CI) = 0.16, 9.10). The text message is more likely to increase the consumption of MNP packets if the primary caregiver was the mother (marginal effect = 12.19; 95% CI = 0.69, 23.68). Receiving the text message appears to significantly increase the likelihood of full adherence when the primary caregiver can either check (odds ratio = 2.93; 95% CI = 1.34, 6.40) or knows how to send (odds ratio = 3.26; 95% CI = 1.53, 6.97) text messages. Conclusion Daily text messages improved the consumption of infant MNP packets. However, the impact was not large enough to increase the probability of caregivers being fully adherent to the feeding instruction, which is to feed 5–7 packets per week as recommended. In addition, when the mother is the caregiver and when the caregiver can check or knows how to send text messages there is greater adherence by the primary caregivers. Trial registration http://www.isrctn.com/ISRCTN44149146 PMID:29352304

Strategies for improving adherence to antiepileptic drug treatment in people with epilepsy.

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Al-Aqeel, Sinaa; Gershuni, Olga; Al-Sabhan, Jawza; Hiligsmann, Mickael

2017-02-03

Poor adherence to antiepileptic medication is associated with increased mortality, morbidity and healthcare costs. In this review, we focus on interventions designed and tested in randomised controlled trials and quasi-randomised controlled trials to assist people with adherence to antiepileptic medication. This is an updated version of the original Cochrane review published in the Cochrane Library, Issue 1, 2010. To determine the effectiveness of interventions aimed at improving adherence to antiepileptic medication in adults and children with epilepsy. For the latest update, on 4 February 2016 we searched the Cochrane Epilepsy Group Specialized Register, the Cochrane Central Register of Controlled Trials (CENTRAL) via the Cochrane Register of Studies Online (CRSO), MEDLINE (Ovid 1946 to 4 February 2016), CINAHL Plus (EBSCOhost 1937 to 4 February 2016), PsycINFO (EBSCOhost 1887 to 4 February 2016), ClinicalTrials.gov, and the WHO International Clinical Trials Registry Platform. We also searched the reference lists of relevant articles. Randomised and quasi-randomised controlled trials of adherence-enhancing interventions aimed at people with a clinical diagnosis of epilepsy (as defined in individual studies), of any age and treated with antiepileptic drugs in a primary care, outpatient or other community setting. All review authors independently assessed lists of potentially relevant citations and abstracts. At least two review authors independently extracted data and performed quality assessment of each study according to the Cochrane tool for assessing risk of bias. We graded the level of evidence for each outcome according to the GRADE working group scale.The studies differed widely according to the type of intervention and measures of adherence; therefore combining data was not appropriate. We included 12 studies reporting data on 1642 participants (intervention = 833, control = 809). Eight studies targeted adults with epilepsy, one study included participants

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

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Alfredo D. Oliveira-Filho

2014-12-01

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

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

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Mayer JM

2013-03-01

Full Text Available John M Mayer,1 James L Nuzzo,1 Simon Dagenais2 1School of Physical Therapy and Rehabilitation Sciences, College of Medicine, University of South Florida, Tampa, FL, 2Palladian Health, West Seneca, NY, USA Background: Firefighters are at increased risk for back injuries, which may be mitigated through exercise therapy to increase trunk muscle endurance. However, long-term adherence to exercise therapy is generally poor, limiting its potential benefits. Focus groups can be used to identify key barriers and facilitators to exercise adherence among study participants. Objective: To explore barriers and facilitators to worksite exercise therapy adherence among firefighters to inform future randomized controlled trials (RCTs. Methods: Participants enrolled in a previous RCT requiring twice-weekly worksite exercise therapy for 24 weeks were asked to take part in moderated focus group discussions centered on eight open-ended questions related to exercise adherence. Responses were analyzed qualitatively using a social ecological framework to identify key intrapersonal, interpersonal, and institutional barriers and potential facilitators to exercise adherence. Results: A total of 27 participants were included in the four focus group discussions, representing 50% of those assigned to a worksite exercise therapy group in the previous RCT, in which only 67% of scheduled exercise therapy sessions were completed. Lack of self-motivation was cited as the key intrapersonal barrier to adherence, while lack of peer support was the key interpersonal barrier reported, and lack of time to exercise during work shifts was the key institutional barrier identified. Conclusion: Focus group discussions identified both key barriers and potential facilitators to increase worksite exercise therapy adherence among firefighters. Future studies should consider educating and reminding participants about the benefits of exercise, providing individual and group incentives based on

A prospective trial of customized adherence enhancement plus long-acting injectable antipsychotic medication in homeless or recently homeless individuals with schizophrenia or schizoaffective disorder

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Sajatovic, Martha; Levin, Jennifer; Ramirez, Luis F.; Hahn, David Y.; Tatsuoka, Curtis; Bialko, Christopher S.; Cassidy, Kristin A.; Fuentes-Casiano, Edna; Williams, Tiffany D.

2014-01-01

Background Treatment non-adherence in people with schizophrenia is associated with relapse and homelessness. Building upon the usefulness of long-acting medication, and our work in psychosocial interventions to enhance adherence, we conducted a prospective uncontrolled trial of customized adherence enhancement (CAE) plus long-acting injectable antipsychotic (LAI) using haloperidol decanoate in 30 homeless or recently homeless individuals with schizophrenia and schizoaffective disorder. Methods Participants received monthly CAE and LAI (CAE-L) for 6 months. Primary outcomes were adherence as measured by the Tablets Routine Questionnaire (TRQ) and housing status. Secondary outcomes included psychiatric symptoms, functioning, side effects, and hospitalizations. Results Mean age of participants was 41.8 years (SD 8.6), mainly minorities (90% African-American) and mainly single/never married (70%). Most (97%) had past or current substance abuse, and had been incarcerated (97%). Ten individuals (33%) terminated the study prematurely. CAE-L was associated with good adherence to LAI (76% at 6 months) and dramatic improvement in oral medication adherence, which changed from missing 46% of medication at study enrollment to missing only 10% at study end (p = 0.03). There were significant improvements in psychiatric symptoms (pschizoaffective disorder. Additional research is needed on effective and practical approaches to improving health outcomes for homeless people with serious mental illness. PMID:24434094

High acceptability of HIV pre-exposure prophylaxis but challenges in adherence and use: qualitative insights from a phase I trial of intermittent and daily PrEP in at-risk populations in Kenya.

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Van der Elst, Elisabeth Maria; Mbogua, Judie; Operario, Don; Mutua, Gaudensia; Kuo, Caroline; Mugo, Peter; Kanungi, Jennifer; Singh, Sagri; Haberer, Jessica; Priddy, Frances; Sanders, Eduard Joachim

2013-07-01

This paper used qualitative methods to explore experiences of men who have sex with men and female sex workers in Nairobi and Mtwapa, Kenya, who used oral pre-exposure prophylaxis (PrEP) for HIV prevention as part of a four-month trial of safety, acceptability and adherence. Fifty-one of 72 volunteers who took part in a randomized, placebo-controlled, blinded trial that compared daily and intermittent dosage of PrEP underwent qualitative assessments after completing the trial. Analyses identified three themes: (i) acceptability of PrEP was high, i.e. side effects were experienced early in the study but diminished over time, however characteristics of pills could improve comfort and use; (ii) social impacts such as stigma, rumors, and relationship difficulties due to being perceived as HIV positive were prevalent; (iii) adherence was challenged by complexities of daily life, in particular post-coital dosing adherence suffered from alcohol use around time of sex, mobile populations, and transactional sex work. These themes resonated across dosing regimens and gender, and while most participants favored the intermittent dosing schedule, those in the intermittent group noted particular challenges in adhering to the post-coital dose. Culturally appropriate and consistent counseling addressing these issues may be critical for PrEP effectiveness.

Matching adherence interventions to patient determinants using the Theoretical Domains Framework

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Samuel Sebastian Allemann

2016-11-01

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

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

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

2016-01-01

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

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

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Ghimire, Saurav; Kyung, Eunjung; Kang, Wonku; Kim, Eunyoung

2012-06-07

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

Measures and predictors of varenicline adherence in the treatment of nicotine dependence.

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Peng, Annie R; Morales, Mark; Wileyto, E Paul; Hawk, Larry W; Cinciripini, Paul; George, Tony P; Benowitz, Neal L; Nollen, Nicole L; Lerman, Caryn; Tyndale, Rachel F; Schnoll, Robert

2017-12-01

While adherence to medication in smoking cessation clinical trials is strongly associated with clinical outcome, very few studies have evaluated the validity of pill count as a measure of adherence relative to a biological assay, and evaluated a broad range of correlates of adherence. In a smoking cessation clinical trial of varenicline, we compared pill counts collected over 4 different time periods to varenicline salivary levels taken after 2weeks of treatment, as well as evaluated predictors of adherence to varenicline. Using a binary measure of adherence based on salivary varenicline levels, adherence was higher among older, white, and more educated participants. Relative to 3, 7, and 14-day pill count, 12-week pill count was the only significant measure able to discriminate adherence as defined by salivary varenicline levels (assessed by area under the receiver operating characteristic curve; AUC=0.59, p=0.004). Seventy-two percent of participants who indicated adherence on 12-week pill count were classified as adherent based on varenicline saliva levels (sensitivity=0.80; specificity=0.40). There was modest variability in the relationship between 12-week pill count and varenicline levels across race and rate of nicotine metabolism. Lastly, General Estimating Equation models demonstrated that longitudinal changes in withdrawal, craving, negative and positive affect, and side effect count and severity were not related to adherence based on salivary varenicline levels. These results indicate that 12-week pill count was the best, albeit a relatively weak, measure of varenicline adherence; additional factors associated with treatment adherence need to be identified. Copyright © 2017 Elsevier Ltd. All rights reserved.

The Effectiveness of a Computer-Tailored E-Learning Program for Practice Nurses to Improve Their Adherence to Smoking Cessation Counseling Guidelines: Randomized Controlled Trial.

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de Ruijter, Dennis; Candel, Math; Smit, Eline Suzanne; de Vries, Hein; Hoving, Ciska

2018-05-22

Improving practice nurses' (PN) adherence to smoking cessation counseling guidelines will benefit the quality of smoking cessation care and will potentially lead to higher smoking abstinence rates. However, support programs to aid PNs in improving their guideline uptake and adherence do not exist yet. The aim of this study was to assess the effects of a novel computer-tailored electronic learning (e-learning) program on PNs' smoking cessation guideline adherence. A Web-based randomized controlled trial (RCT) was conducted in which an intervention group (N=147) with full access to the e-learning program for 6 months was compared with a control group (N=122) without access. Data collection was fully automated at baseline and 6-month follow-up via online questionnaires, assessing PNs' demographics, work-related factors, potential behavioral predictors based on the I-Change model, and guideline adherence. PNs also completed counseling checklists to retrieve self-reported counseling activities for each consultation with a smoker (N=1175). To assess the program's effectiveness in improving PNs' guideline adherence (ie, overall adherence and adherence to individual counseling guideline steps), mixed linear and logistic regression analyses were conducted, thus accommodating for the smokers being nested within PNs. Potential effect moderation by work-related factors and behavioral predictors was also examined. After 6 months, 121 PNs in the intervention group (82.3%, 121/147) and 103 in the control group (84.4%, 103/122) completed the follow-up questionnaire. Mixed linear regression analysis revealed that counseling experience moderated the program's effect on PNs' overall guideline adherence (beta=.589; 95% CI 0.111-1.068; P Holm-Bonferroni =.048), indicating a positive program effect on adherence for PNs with a more than average level of counseling experience. Mixed logistic regression analyses regarding adherence to individual guideline steps revealed a trend toward

100% adherence study: educational workshops vs. video sessions to improve adherence among ART-naïve patients in Salvador, Brazil.

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Sampaio-Sa, Marcia; Page-Shafer, Kimberly; Bangsberg, David R; Evans, Jennifer; Dourado, Maria de Lourdes; Teixeira, Celia; Netto, Eduardo M; Brites, Carlos

2008-07-01

We conducted a randomized trial to test an intervention aimed at increasing adherence to antiretroviral therapy (ART) among HIV-positive, ART-naïve patients in Salvador, Brazil. Participants (N = 107) were randomized to either educational workshops based on the information-motivation-behavioral skills model (n = 52) or a control video session (n = 55). Changes in self-reported ART adherence, viral load, CD4 cell counts and ART pharmacy records were measured periodically over 12 months. After 3-6 months, ART adherence (> or = 95%) was 77.8% in the workshop group and 85.7% in video group (as treated) and 53.8% and 65.5%, respectively, using intention-to-treat (ITT) analysis (both P > 0.05) At 9-12 months, ART adherence decreased to 73.7% in the workshop group and 79.1% in the video group (as treated) and 53.8% and 61.8% using ITT, respectively. No differences were found in self-reported adherence, viral load or pharmacy records between groups. We found that the educational workshop intervention does not increase adherence to ART.

A 2-arm, randomized, controlled trial of a motivational interviewing-based intervention to improve adherence to antiretroviral therapy (ART) among patients failing or initiating ART.

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Golin, Carol E; Earp, Joanne; Tien, Hsiao-Chuan; Stewart, Paul; Porter, Carol; Howie, Lynn

2006-05-01

Motivational interviewing (MI) is a counseling technique that has been used effectively to change a number of health-related behaviors. We sought to assess the impact on patients' antiretroviral therapy (ART) adherence of a multicomponent, MI-based ART adherence intervention compared with that of an HIV informational control program. Two-arm, randomized, controlled trial. One hundred forty adult HIV-infected patients attending a large, academic center infectious diseases clinic who were either failing or newly initiating an ART regimen. STUDY ENDPOINTS: (1) Mean adherence level (% of prescribed doses take in the prior month) at the week 12 visit, (2) change in mean adherence, (3) percentage of patients achieving >95% adherence in the third 4-week block, and (4) change in viral load. The MI group's mean adherence improved by 4.5% compared with a decrease in the control group's adherence by 3.83% (P = 0.10). In the treatment group, 29% achieved >95% adherence compared with only 17% in the control group (P = 0.13). When we controlled for ethnicity, the intervention group had 2.75 times higher odds of achieving more than 95% adherence than did the controls (P = 0.045; 95% confidence interval: 1.023, 7.398). Although a number of mediating variables (beliefs about ART, coping style, social support, and goals set) had statistically significant changes in the expected direction in the MI group compared with controls, in the intent-to-treat analysis, the mean adherence at study exit for the intervention group was 76% (SD = 27%) and 71% (SD = 27%) for the control group (P = 0.62). Although not definitive, this study provides some evidence that MI offers an effective approach to improving adherence. Future studies able to build MI into the intervention for longer than 3 months may have a greater impact.

Adherence to internet-based mobile-supported stress management

DEFF Research Database (Denmark)

Zarski, A C; Lehr, D.; Berking, M.

2016-01-01

of this study was to investigate the influence of different guidance formats (content-focused guidance, adherence-focused guidance, and administrative guidance) on adherence and to identify predictors of nonadherence in an Internet-based mobile-supported stress management intervention (ie, GET.ON Stress......) for employees. Methods: The data from the groups who received the intervention were pooled from three randomized controlled trials (RCTs) that evaluated the efficacy of the same Internet-based mobile-supported stress management intervention (N=395). The RCTs only differed in terms of the guidance format...... of the predictors significantly predicted nonadherence. Conclusions: Guidance has been shown to be an influential factor in promoting adherence to an Internet-based mobile-supported stress management intervention. Adherence-focused guidance, which included email reminders and feedback on demand, was equivalent...

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

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

2011-08-26

Despite emerging evidence that foot problems and inappropriate footwear increase the risk of falls, there is little evidence as to whether foot-related intervention strategies can be successfully implemented. The aim of this study was to evaluate adherence rates, barriers to adherence, and the predictors of adherence to a multifaceted podiatry intervention for the prevention of falls in older people. The intervention group (n = 153, mean age 74.2 years) of a randomised trial that investigated the effectiveness of a multifaceted podiatry intervention to prevent falls was assessed for adherence to the three components of the intervention: (i) foot orthoses, (ii) footwear advice and footwear cost subsidy, and (iii) a home-based foot and ankle exercise program. Adherence to each component and the barriers to adherence were documented, and separate discriminant function analyses were undertaken to identify factors that were significantly and independently associated with adherence to the three intervention components. Adherence to the three components of the intervention was as follows: foot orthoses (69%), footwear (54%) and home-based exercise (72%). Discriminant function analyses identified that being younger was the best predictor of orthoses use, higher physical health status and lower fear of falling were independent predictors of footwear adherence, and higher physical health status was the best predictor of exercise adherence. The predictive accuracy of these models was only modest, with 62 to 71% of participants correctly classified. Adherence to a multifaceted podiatry intervention in this trial ranged from 54 to 72%. People with better physical health, less fear of falling and a younger age exhibited greater adherence, suggesting that strategies need to be developed to enhance adherence in frailer older people who are most at risk of falling. Australian New Zealand Clinical Trials Registry ACTRN12608000065392.

Effect of an interactive text-messaging service on patient retention during the first year of HIV care in Kenya (WelTel Retain): an open-label, randomised parallel-group study.

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van der Kop, Mia Liisa; Muhula, Samuel; Nagide, Patrick I; Thabane, Lehana; Gelmon, Lawrence; Awiti, Patricia Opondo; Abunah, Bonface; Kyomuhangi, Lennie Bazira; Budd, Matthew A; Marra, Carlo; Patel, Anik; Karanja, Sarah; Ojakaa, David I; Mills, Edward J; Ekström, Anna Mia; Lester, Richard Todd

2018-03-01

Retention of patients in HIV care is crucial to ensure timely treatment initiation, viral suppression, and to avert AIDS-related deaths. We did a randomised trial to determine whether a text-messaging intervention improved retention during the first year of HIV care. This unmasked, randomised parallel-group study was done at two clinics in informal settlements in Nairobi, Kenya. Eligible participants were aged 18 years or older, HIV-positive, had their own mobile phone or access to one, and were able to use simple text messaging (or have somebody who could text message on their behalf). Participants were randomly assigned (1:1), with random block sizes of 2, 4, and 6, to the intervention or control group. Participants in the intervention group received a weekly text message from the automated WelTel service for 1 year and were asked to respond within 48 h. Participants in the control group did not receive text messages. Participants in both groups received usual care, which comprised psychosocial support and counselling; patient education; CD4 cell count; treatment; screening for tuberculosis, opportunistic infections, and sexually transmitted infections; prevention of mother-to-child transmission and family planning services; and up to two telephone calls for missed appointments. The primary outcome was retention in care at 12 months (ie, clinic attendance 10-14 months after the first visit). Participants who did not attend this 12-month appointment were traced, and we considered as retained those who were confirmed to be active in care elsewhere. The data analyst and clinic staff were masked to the group assignment, whereas participants and research nurses were not. We analysed the intention-to-treat population. This trial is registered with ClinicalTrials.gov, number NCT01630304. Between April 4, 2013, and June 4, 2015, we screened 1068 individuals, of whom 700 were recruited. 349 people were allocated to the intervention group and 351 to the control group

Improving medication adherence in patients with hypertension

DEFF Research Database (Denmark)

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

2015-01-01

BACKGROUND: and Purpose: In patients with hypertension, medication adherence is often suboptimal, thereby increasing the risk of ischemic heart disease and stroke. In a randomized trial, we investigated the effectiveness of a multifaceted pharmacist intervention in a hospital setting to improve...... medication adherence in hypertensive patients. Motivational interviewing was a key element of the intervention. METHODS: Patients (N=532) were recruited from 3 hospital outpatient clinics and randomized to usual care or a 6-month pharmacist intervention comprising collaborative care, medication review...... for persistence, blood pressure or hospital admission. CONCLUSIONS: A multifaceted pharmacist intervention in a hospital setting led to a sustained improvement in medication adherence for patients with hypertension. The intervention had no significant impact on blood pressure and secondary clinical outcomes....

Self-reported adherence and biomarker levels of CoQ10 and alpha-tocopherol

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Vitolins MZ

2018-04-01

Full Text Available Mara Z Vitolins,1 L Douglas Case,1 Stephen R Rapp,2 Mark O Lively,3 Edward G Shaw,4 Michelle J Naughton,5 Jeffrey Giguere,6 Glenn J Lesser7 1Division of Public Health Sciences, Wake Forest School of Medicine, Winston-Salem, NC, USA; 2Department of Psychiatry and Behavioral Medicine, Wake Forest School of Medicine, Winston-Salem, NC, USA; 3Department of Biochemistry, Wake Forest School of Medicine, Winston-Salem, NC, USA; 4Department of Internal Medicine-Gerontology and Geriatric Medicine, Wake Forest School of Medicine, Winston-Salem, NC, USA; 5Department of Internal Medicine, The Ohio State University, Columbus, OH, USA; 6Greenville Community Oncology Research Program of the Carolinas, Greenville, SC, USA; 7Department of Internal Medicine-Hematology and Oncology, Wake Forest School of Medicine, Medical Center Boulevard, Winston-Salem, NC, USA Purpose: Women with breast cancer were randomized to receive coenzyme Q10 (CoQ10 plus Vitamin E or placebo in a clinical trial. The objective of this evaluation is to examine the association between participant self-reported adherence to the study supplements and changes in plasma biomarker levels.Patients and methods: Correlation coefficients quantified the association between changes in alpha-tocopherol and CoQ10 levels and the association between self-reported adherence and changes in biomarkers. Participants were categorized by self-reported adherence; Kruskal–Wallis tests compared changes in alpha-tocopherol and CoQ10 levels between self-reported adherence groups.Results: Women (N=155 provided baseline and post-treatment biomarkers; 147 completed at least one diary. While changes in alpha-tocopherol and CoQ10 levels were moderately correlated, correlations ranged from 0.40 to 0.48, association between self-reported adherence and plasma alpha-tocopherol or CoQ10 levels was weak; correlations ranged from 0.10 to 0.29 at weeks 8, 16, and 24. Some participants with high self-reported adherence actually

Predictors and outcomes of non-adherence in patients receiving maintenance hemodialysis.

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Tohme, Fadi; Mor, Maria K; Pena-Polanco, Julio; Green, Jamie A; Fine, Michael J; Palevsky, Paul M; Weisbord, Steven D

2017-08-01

Predictors of and outcomes associated with non-adherent behavior among patients on chronic hemodialysis (HD) have been incompletely elucidated. We conducted a post hoc analysis of data from the SMILE trial to identify patient factors associated with non-adherence to dialysis-related treatments and the associations of non-adherence with clinical outcomes. We defined non-adherence as missed HD and abbreviated HD. We used negative binomial regression to model the associations of demographic and clinical factors with measures of non-adherence, and negative binomial and Cox regression to analyze the associations of non-adherence with hospitalizations and mortality, respectively. We followed 286 patients for up to 24 months. Factors independently associated with missing HD included Tuesday/Thursday/Saturday HD schedule [incident rate ratio (IRR) 1.85, p adherence to HD-related treatments, and independent associations of non-adherence with hospitalization and mortality. These findings should inform the development and implementation of interventions to improve adherence and reduce health resource utilization.

An innovative and comprehensive technique to evaluate different measures of medication adherence: The network meta-analysis.

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Tonin, Fernanda S; Wiecek, Elyssa; Torres-Robles, Andrea; Pontarolo, Roberto; Benrimoj, Shalom Charlie I; Fernandez-Llimos, Fernando; Garcia-Cardenas, Victoria

2018-05-19

Poor medication adherence is associated with adverse health outcomes and higher costs of care. However, inconsistencies in the assessment of adherence are found in the literature. To evaluate the effect of different measures of adherence in the comparative effectiveness of complex interventions to enhance patients' adherence to prescribed medications. A systematic review with network meta-analysis was performed. Electronic searches for relevant pairwise meta-analysis including trials of interventions that aimed to improve medication adherence were performed in PubMed. Data extraction was conducted with eligible trials evaluating short-period adherence follow-up (until 3 months) using any measure of adherence: self-report, pill count, or MEMS (medication event monitoring system). To standardize the results obtained with these different measures, an overall composite measure and an objective composite measure were also calculated. Network meta-analyses for each measure of adherence were built. Rank order and surface under the cumulative ranking curve analyses (SUCRA) were performed. Ninety-one trials were included in the network meta-analyses. The five network meta-analyses demonstrated robustness and reliability. Results obtained for all measures of adherence were similar across them and to both composite measures. For both composite measures, interventions comprising economic + technical components were the best option (90% of probability in SUCRA analysis) with statistical superiority against almost all other interventions and against standard care (odds ratio with 95% credibility interval ranging from 0.09 to 0.25 [0.02, 0.98]). The use of network meta-analysis was reliable to compare different measures of adherence of complex interventions in short-periods follow-up. Analyses with longer follow-up periods are needed to confirm these results. Different measures of adherence produced similar results. The use of composite measures revealed reliable alternatives

Low adherence to cervical cancer screening after subtotal hysterectomy

DEFF Research Database (Denmark)

Andersen, Lea Laird; Møller, Lars Mikael Alling; Gimbel, Helga Margrethe

2015-01-01

INTRODUCTION: A reason for not recommending subtotal hysterectomy is the risk of cervical pathology. We aimed to evaluate cervical cancer screening and to describe cervical pathology after subtotal and total hysterectomy for benign indications. METHODS: Data regarding adherence to screening...... Hospital, Rigs-hospitalet and Roskilde Hospital, Denmark. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT01880710....

Adherence to Hunger Training over 6 Months and the Effect on Weight and Eating Behaviour: Secondary Analysis of a Randomised Controlled Trial

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Michelle R. Jospe

2017-11-01

Full Text Available Monitoring blood glucose prior to eating can teach individuals to eat only when truly hungry, but how adherence to ‘hunger training’ influences weight loss and eating behaviour is uncertain. This exploratory, secondary analysis from a larger randomized controlled trial examined five indices of adherence to ‘hunger training’, chosen a priori, to examine which adherence measure best predicted weight loss over 6 months. We subsequently explored how the best measure of adherence influenced eating behavior in terms of intuitive and emotional eating. Retention was 72% (n = 36/50 at 6 months. Frequency of hunger training booklet entry most strongly predicted weight loss, followed by frequency of blood glucose measurements. Participants who completed at least 60 days of booklet entry (of recommended 63 days lost 6.8 kg (95% CI: 2.6, 11.0; p < 0.001 more weight than those who completed fewer days. They also had significantly higher intuitive eating scores than those who completed 30 days or less of booklet entry; a difference (95% CI of 0.73 (0.12, 1.35 in body-food choice congruence and 0.79 (0.06, 1.51 for eating for physical rather than emotional reasons. Adherent participants also reported significantly lower scores for emotional eating of −0.70 (−1.13, −0.27. Following hunger training and focusing on simply recording ratings of hunger on a regular basis can produce clinically significant weight loss and clinically relevant improvements in eating behaviour.

Factors influencing adherence with therapeutic sunlight exposure in older people in intermediate care facilities.

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Durvasula, Seeta; Sambrook, Philip N; Cameron, Ian D

2012-01-01

The purpose of this study was to investigate the factors influencing low adherence with therapeutic sunlight exposure in a randomized controlled trial conducted with older people living in intermediate care facilities. The study involved participants in the FREEDOM (Falls Risk Epidemiology: Effect of vitamin D on skeletal Outcomes and other Measures) study, a randomized controlled trial of therapeutic sun exposure to reduce falls in older people in intermediate care facilities. Semi-structured interviews were conducted with thirty participants in the FREEDOM trial, and with ten sunlight officers who were employed to facilitate the sun exposure. Two focus groups involving 10 participants in the FREEDOM trial were also held at the end of the intervention period. Common themes were derived from the interview and focus group transcripts. The study showed that the perceived health benefits did not influence adherence with the sun exposure. Factors such as socializing with others and being outdoors were more important in encouraging attendance. The main barriers to adherence included the perceived inflexibility and regimentation of daily attendance, clash with other activities, unsuitable timing and heat discomfort. This study showed that providing greater flexibility and autonomy to older people in how and when they receive sun exposure is likely to improve adherence. Copyright © 2011 Elsevier Ireland Ltd. All rights reserved.

The role of mHealth for improving medication adherence in patients with cardiovascular disease: a systematic review.

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Gandapur, Yousuf; Kianoush, Sina; Kelli, Heval M; Misra, Satish; Urrea, Bruno; Blaha, Michael J; Graham, Garth; Marvel, Francoise A; Martin, Seth S

2016-10-01

Cardiovascular disease is a leading cause of morbidity and mortality worldwide, and a key barrier to improved outcomes is medication non-adherence. The aim of this study is to review the role of mobile health (mHealth) tools for improving medication adherence in patients with cardiovascular disease. We performed a systematic search for randomized controlled trials that primarily investigated mHealth tools for improving adherence to cardiovascular disease medications in patients with hypertension, coronary artery disease, heart failure, peripheral arterial disease, and stroke. We extracted and reviewed data on the types of mHealth tools used, preferences of patients and healthcare providers, the effect of the mHealth interventions on medication adherence, and the limitations of trials. We identified 10 completed trials matching our selection criteria, mostly with mHealth tools included text messages, Bluetooth-enabled electronic pill boxes, online messaging platforms, and interactive voice calls. Patients and healthcare providers generally preferred mHealth to other interventions. All 10 studies reported that mHealth interventions improved medication adherence, though the magnitude of benefit was not consistently large and in one study was not greater than a telehealth comparator. Limitations of trials included small sample sizes, short duration of follow-up, self-reported outcomes, and insufficient assessment of unintended harms and financial implications. Current evidence suggests that mHealth tools can improve medication adherence in patients with cardiovascular diseases. However, high-quality clinical trials of sufficient size and duration are needed to move the field forward and justify use in routine care.

Influences on visit retention in clinical trials: insights from qualitative research during the VOICE trial in Johannesburg, South Africa.

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Magazi, Busisiwe; Stadler, Jonathan; Delany-Moretlwe, Sinead; Montgomery, Elizabeth; Mathebula, Florence; Hartmann, Miriam; van der Straten, Ariane

2014-07-28

Although significant progress has been made in clinical trials of women-controlled methods of HIV prevention such as microbicides and Pre-exposure Prophylaxis (PrEP), low adherence to experimental study products remains a major obstacle to being able to establish their efficacy in preventing HIV infection. One factor that influences adherence is the ability of trial participants to attend regular clinic visits at which trial products are dispensed, adherence counseling is administered, and participant safety is monitored. We conducted a qualitative study of the social contextual factors that influenced adherence in the VOICE (MTN-003) trial in Johannesburg, South Africa, focusing on study participation in general, and study visits in particular. The research used qualitative methodologies, including in-depth interviews (IDI), serial ethnographic interviews (EI), and focus group discussions (FGD) among a random sub-sample of 102 female trial participants, 18 to 40 years of age. A socio-ecological framework that explored those factors that shaped trial participation and adherence to study products, guided the analysis. Key codes were developed to standardize subsequent coding and a node search was used to identify texts relating to obstacles to visit adherence. Our analysis includes coded transcripts from seven FGD (N = 40), 41 IDI, and 64 serial EI (N = 21 women). Women's kinship, social, and economic roles shaped their ability to participate in the clinical trial. Although participants expressed strong commitments to attend study visits, clinic visit schedules and lengthy waiting times interfered with their multiple obligations as care givers, wage earners, housekeepers, and students. The research findings highlight the importance of the social context in shaping participation in HIV prevention trials, beyond focusing solely on individual characteristics. This points to the need to focus interventions to improve visit attendance by promoting a culture of

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

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

2010-01-01

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

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

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Usherwood Tim

2010-08-01

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.

MEDication reminder APPs to improve medication adherence in Coronary Heart Disease (MedApp-CHD) Study: a randomised controlled trial protocol.

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Santo, Karla; Chow, Clara K; Thiagalingam, Aravinda; Rogers, Kris; Chalmers, John; Redfern, Julie

2017-10-08

The growing number of smartphone health applications available in the app stores makes these apps a promising tool to help reduce the global problem of non-adherence to long-term medications. However, to date, there is limited evidence that available medication reminder apps are effective. This study aims to determine the impact of medication reminder apps on adherence to cardiovascular medication when compared with usual care for people with coronary heart disease (CHD) and to determine whether an advanced app compared with a basic app is associated with higher adherence. Randomised controlled trial with follow-up at 3 months to evaluate the feasibility and effectiveness of medication reminder apps on medication adherence compared with usual care. An estimated sample size of 156 patients with CHD will be randomised to one of three groups (usual care group, basic medication reminder app group and advanced medication reminder app group). The usual care group will receive standard care for CHD with no access to a medication reminder app. The basic medication reminder app group will have access to a medication reminder app with a basic feature of providing simple daily reminders with no interactivity. The advanced medication reminder app group will have access to a medication reminder app with additional interactive and customisable features. The primary outcome is medication adherence measured by the eight-item Morisky Medication Adherence Scale at 3 months. Secondary outcomes include clinical measurements of blood pressure and cholesterol levels, and medication knowledge. A process evaluation will also be performed to assess the feasibility of the intervention by evaluating the acceptability, utility and engagement with the apps. Ethical approval has been obtained from the Western Sydney Local Health Network Human Research Ethics Committee (AU/RED/HREC/1/WMEAD/3). Study findings will be disseminated via usual scientific forums. ACTRN12616000661471; Pre-results. �

Adherence to Biobehavioral Recommendations in Pediatric Migraine as Measured by Electronic Monitoring: The Adherence in Migraine (AIM) Study.

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Kroon Van Diest, Ashley M; Ramsey, Rachelle; Aylward, Brandon; Kroner, John W; Sullivan, Stephanie M; Nause, Katie; Allen, Janelle R; Chamberlin, Leigh A; Slater, Shalonda; Hommel, Kevin; LeCates, Susan L; Kabbouche, Marielle A; O'Brien, Hope L; Kacperski, Joanne; Hershey, Andrew D; Powers, Scott W

2016-07-01

The purpose of this investigation was to examine treatment adherence to medication and lifestyle recommendations among pediatric migraine patients using electronic monitoring systems. Nonadherence to medical treatment is a significant public health concern, and can result in poorer treatment outcomes, decreased cost-effectiveness of medical care, and increased morbidity. No studies have systematically examined adherence to medication and lifestyle recommendations in adolescents with migraine outside of a clinical trial. Participants included 56 adolescents ages 11-17 who were presenting for clinical care. All were diagnosed with migraine with or without aura or chronic migraine and had at least 4 headache days per month. Medication adherence was objectively measured using electronic monitoring systems (Medication Event Monitoring Systems technology) and daily, prospective self-report via personal electronic devices. Adherence to lifestyle recommendations of regular exercise, eating, and fluid intake were also assessed using daily self-report on personal electronic devices. Electronic monitoring indicates that adolescents adhere to their medication 75% of the time, which was significantly higher than self-reported rates of medication adherence (64%). Use of electronic monitoring of medication detected rates of adherence that were significantly higher for participants taking once daily medication (85%) versus participants taking twice daily medication (59%). Average reported adherence to lifestyle recommendations of consistent noncaffeinated fluid intake (M = 5 cups per day) was below recommended levels of a minimum of 8 cups per day. Participants on average also reported skipping 1 meal per week despite recommendations of consistently eating three meals per day. Results suggest that intervention focused on adherence to preventive treatments (such as medication) and lifestyle recommendations may provide more optimal outcomes for children and adolescents with

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

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Broekaert Eric

2011-05-01

at and beyond eight sessions. Results Individual treatment that included assessment with feedback increased adherence to treatment at and beyond eight sessions (RR = 1.6,95%CI:1.2-2.2. Benefit was also found at and beyond twelve sessions, which was the number of sessions required to complete 90% of the assessments with feedback in practice (RR = 1.6,95%CI:1.2-2.5. Conclusions Assessment with feedback in routine practice improved adherence to treatment. More research is needed to evaluate progress in social functioning and motivation to change in outpatient treatment of substance use disorder, thereby using objective measures Trial registration Current Controlled Trials ISRCTN65456186

A Pilot Randomized Controlled Trial to Promote Immunosuppressant Adherence in Adult Kidney Transplant Recipients.

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Cukor, Daniel; Ver Halen, Nisha; Pencille, Melissa; Tedla, Fasika; Salifu, Moro

2017-01-01

Nonadherence to immunosuppressant medication is a prevalent practice among kidney transplant recipients and has been associated with increased risk for graft failure and economic burden. The aim of this pilot study was to test whether a culturally sensitive cognitive-behavioral adherence promotion program could significantly improve medication adherence to tacrolimus prescription as measured by telephone pill counts among kidney transplant recipients. Thirty-three adult transplant recipients were less than 98% adherent to tacrolimus prescription based on 3 telephone pill counts and were randomized either to the 2-session cognitive-behavioral adherence promotion program or to standard care. The curriculum was developed from an iterative process with transplant recipients into a 2-session group program that provided psychoeducation, addressed barriers to adherence, fostered motivation to improve adherence behavior, and discussed cultural messages on adherence behavior. The intervention group displayed significantly higher levels of adherence when compared to the control group (t = 2.2, p = 0.04) and. similarly, when the amount of change was compared between the groups, the intervention group showed more change than the control condition (F (22,1) = 12.005, p = 0.003). Tacrolimus trough concentration levels were used as a secondary measure of adherence and, while there were no significant between-group differences for mean trough concentration levels, the variability in the trough levels did significantly decrease over time indicating more consistent pill-taking behavior in the intervention group. There is preliminary support for the pilot program as a successful intervention in helping patients with their immunosuppressant medication. © 2016 S. Karger AG, Basel.

Mobile phone reminders and peer counseling improve adherence and treatment outcomes of patients on ART in Malaysia: A randomized clinical trial.

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Abdulrahman, Surajudeen Abiola; Rampal, Lekhraj; Ibrahim, Faisal; Radhakrishnan, Anuradha P; Kadir Shahar, Hayati; Othman, Norlijah

2017-01-01

Adherence to treatment remains the cornerstone of long term viral suppression and successful treatment outcomes among patients receiving Antiretroviral Therapy (ART). Evaluate the effectiveness of mobile phone reminders and peer counseling in improving adherence and treatment outcomes among HIV positive patients on ART in Malaysia. A single-blind, parallel group RCT conducted in Hospital Sungai Buloh, Malaysia in which 242 adult Malaysian patients were randomized to intervention or control groups. Intervention consisted of a reminder module delivered through SMS and telephone call reminders by trained research assistants for 24 consecutive weeks (starting from date of ART initiation), in addition to adherence counseling at every clinic visit. The length of intended follow up for each patient was 6 months. Data on adherence behavior of patients was collected using specialized, pre-validated Adult AIDS Clinical Trial Group (AACTG) adherence questionnaires. Data on weight, clinical symptoms, CD4 count and viral load tests were also collected. Data was analyzed using SPSS version 22 and R software. Repeated measures ANOVA, Friedman's ANOVA and Multivariate regression models were used to evaluate efficacy of the intervention. The response rate after 6 months follow up was 93%. There were no significant differences at baseline in gender, employment status, income distribution and residential location of respondents between the intervention and control group. After 6 months follow up, the mean adherence was significantly higher in the intervention group (95.7; 95% CI: 94.39-96.97) as compared to the control group (87.5; 95% CI: 86.14-88.81). The proportion of respondents who had Good (>95%) adherence was significantly higher in the intervention group (92.2%) compared to the control group (54.6%). A significantly lower frequency in missed appointments (14.0% vs 35.5%) (p = 0.001), lower viral load (p = 0.001), higher rise in CD4 count (p = 0.017), lower incidence of

Mobile phone reminders and peer counseling improve adherence and treatment outcomes of patients on ART in Malaysia: A randomized clinical trial.

Directory of Open Access Journals (Sweden)

Surajudeen Abiola Abdulrahman

Full Text Available Adherence to treatment remains the cornerstone of long term viral suppression and successful treatment outcomes among patients receiving Antiretroviral Therapy (ART.Evaluate the effectiveness of mobile phone reminders and peer counseling in improving adherence and treatment outcomes among HIV positive patients on ART in Malaysia.A single-blind, parallel group RCT conducted in Hospital Sungai Buloh, Malaysia in which 242 adult Malaysian patients were randomized to intervention or control groups. Intervention consisted of a reminder module delivered through SMS and telephone call reminders by trained research assistants for 24 consecutive weeks (starting from date of ART initiation, in addition to adherence counseling at every clinic visit. The length of intended follow up for each patient was 6 months. Data on adherence behavior of patients was collected using specialized, pre-validated Adult AIDS Clinical Trial Group (AACTG adherence questionnaires. Data on weight, clinical symptoms, CD4 count and viral load tests were also collected. Data was analyzed using SPSS version 22 and R software. Repeated measures ANOVA, Friedman's ANOVA and Multivariate regression models were used to evaluate efficacy of the intervention.The response rate after 6 months follow up was 93%. There were no significant differences at baseline in gender, employment status, income distribution and residential location of respondents between the intervention and control group. After 6 months follow up, the mean adherence was significantly higher in the intervention group (95.7; 95% CI: 94.39-96.97 as compared to the control group (87.5; 95% CI: 86.14-88.81. The proportion of respondents who had Good (>95% adherence was significantly higher in the intervention group (92.2% compared to the control group (54.6%. A significantly lower frequency in missed appointments (14.0% vs 35.5% (p = 0.001, lower viral load (p = 0.001, higher rise in CD4 count (p = 0.017, lower incidence of

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

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Taís de Campos Moreira

2014-06-01

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

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

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Zwikker, Hanneke E; van den Ende, Cornelia H; van Lankveld, Wim G; den Broeder, Alfons A; van den Hoogen, Frank H; van de Mosselaar, Birgit; van Dulmen, Sandra; van den Bemt, Bart J

2014-03-01

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). Non-adherent RA patients using disease-modifying anti-rheumatic drugs (DMARDs) were randomized to an intervention or control arm. The intervention consisted, amongst others, of two motivational interviewing-guided group sessions led by the same pharmacist. Control patients received brochures about their DMARDs. Questionnaires were completed up to 12 months follow-up. 123 patients (mean age: 60 years, female: 69%) were randomized. No differences in necessity beliefs and concern beliefs about medication and in medication non-adherence were detected between the intervention and control arm, except at 12 months' follow-up: participants in the intervention arm had less strong necessity beliefs about medication than participants in the control arm (b: -1.0 (95% CI: -2.0, -0.1)). This trial did not demonstrate superiority of our intervention over the control arm in changing beliefs about medication or in improving medication adherence over time. Absent intervention effects might have been due to, amongst others, selection bias and a suboptimal treatment integrity level. Hence, targeting beliefs about medication in clinical practice should not yet be ruled out. Copyright © 2013 Elsevier Ireland Ltd. All rights reserved.

Is the Relationship between Race and Continuous Positive Airway Pressure Adherence Mediated by Sleep Duration?

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Billings, Martha E.; Rosen, Carol L.; Wang, Rui; Auckley, Dennis; Benca, Ruth; Foldvary-Schaefer, Nancy; Iber, Conrad; Zee, Phyllis; Redline, Susan; Kapur, Vishesh K.

2013-01-01

Study Objectives: Black race has been associated with decreased continuous positive airway pressure (CPAP) adherence. Short sleep duration, long sleep latency, and insomnia complaints may affect CPAP adherence as they affect sleep and opportunity to use CPAP. We assessed whether self-reported sleep measures were associated with CPAP adherence and if racial variations in these sleep characteristics may explain racial differences in CPAP adherence. Design: Analysis of data from a randomized controlled trial (HomePAP), which investigated home versus laboratory-based diagnosis and treatment of obstructive sleep apnea. Setting: Seven American Academy of Sleep Medicine-accredited sleep centers in five cities in the United States. Patients or Participants: Enrolled subjects (n = 191) with apnea-hypopnea index ≥ 15 and sleepiness (Epworth Sleepiness Scale > 12). Interventions: N/A. Measurements and Results: Multivariable regression was used to assess if subjective sleep measures and symptoms predicted 3-mo CPAP use. Mediation analysis was used to assess if sleep measures mediated the association of race with CPAP adherence. Black participants reported shorter sleep duration and longer sleep latency at baseline than white and Hispanic participants. Shorter sleep duration and longer sleep latency predicted worse CPAP adherence. Sleep duration mediated the association of black race with lower CPAP adherence. However, insomnia symptoms were not associated with race or CPAP adherence. Conclusions: Among subjects with similar severity of obstructive sleep apnea and sleepiness, baseline self-reported sleep duration and latency, but not perceived insomnia, predicted CPAP adherence over 3 mo. Sleep duration explains some of the observed differences in CPAP use by race. Sleep duration and latency should be considered when evaluating poor CPAP adherence. Clinical Trial Information: Portable Monitoring for Diagnosis and Management of Sleep Apnea (HomePAP) URL: http

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

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

2017-07-01

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

The impact of health coaching on medication adherence in patients with poorly controlled diabetes, hypertension, and/or hyperlipidemia: a randomized controlled trial.

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Thom, David H; Willard-Grace, Rachel; Hessler, Danielle; DeVore, Denise; Prado, Camille; Bodenheimer, Thomas; Chen, Ellen

2015-01-01

Lack of concordance between medications listed in the medical record and taken by the patient contributes to poor outcomes. We sought to determine whether patients who received health coaching by medical assistants improved their medication concordance and adherence. This was a nonblinded, randomized, controlled, pragmatic intervention trial. English- or Spanish-speaking patients, age 18 to 75 years, with poorly controlled type 2 diabetes, hypertension, and/or hyperlipidemia were enrolled from 2 urban safety net clinics and randomized to receive 12 months of health coaching versus usual care. Outcomes included concordance between medications documented in the medical record and those reported by the patient and adherence based on the patient-reported number of days (of the last 7) on which patient took all prescribed medications. The proportion of medications completely concordant increased in the coached group versus the usual care group (difference in change, 10%; P = .05). The proportion of medications listed in the chart but not taken significantly decreased in the coached group compared with the usual care group (difference in change, 17%; P = .013). The mean number of adherent days increased in the coached but not in the usual care group (difference in change, 1.08; P coaching by medical assistants significantly increases medication concordance and adherence. © Copyright 2015 by the American Board of Family Medicine.

Smartphone- and internet-assisted self-management and adherence tools to manage Parkinson's disease (SMART-PD): study protocol for a randomised controlled trial (v7; 15 August 2014).

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Lakshminarayana, Rashmi; Wang, Duolao; Burn, David; Chaudhuri, K Ray; Cummins, Gemma; Galtrey, Clare; Hellman, Bruce; Pal, Suvankar; Stamford, Jon; Steiger, Malcolm; Williams, Adrian

2014-09-25

Nonadherence to treatment leads to suboptimal treatment outcomes and enormous costs to the economy. This is especially important in Parkinson's disease (PD). The progressive nature of the degenerative process, the complex treatment regimens and the high rates of comorbid conditions make treatment adherence in PD a challenge. Clinicians have limited face-to-face consultation time with PD patients, making it difficult to comprehensively address non-adherence. The rapid growth of digital technologies provides an opportunity to improve adherence and the quality of decision-making during consultation. The aim of this randomised controlled trial (RCT) is to evaluate the impact of using a smartphone and web applications to promote patient self-management as a tool to increase treatment adherence and working with the data collected to enhance the quality of clinical consultation. A 4-month multicentre RCT with 222 patients will be conducted to compare use of a smartphone- and internet-enabled Parkinson's tracker smartphone app with treatment as usual for patients with PD and/or their carers. The study investigators will compare the two groups immediately after intervention. Seven centres across England (6) and Scotland (1) will be involved. The primary objective of this trial is to assess whether patients with PD who use the app show improved medication adherence compared to those receiving treatment as usual alone. The secondary objectives are to investigate whether patients who receive the app and those who receive treatment as usual differ in terms of quality of life, quality of clinical consultation, overall disease state and activities of daily living. We also aim to investigate the experience of those receiving the intervention by conducting qualitative interviews with a sample of participants and clinicians, which will be administered by independent researchers. ISRCTN45824264 (registered 5 November 2013).

Therapist adherence in individual cognitive-behavioral therapy for binge-eating disorder: assessment, course, and predictors.

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Brauhardt, Anne; de Zwaan, Martina; Herpertz, Stephan; Zipfel, Stephan; Svaldi, Jennifer; Friederich, Hans-Christoph; Hilbert, Anja

2014-10-01

While cognitive-behavioral therapy (CBT) is the most well-established treatment for binge-eating disorder (BED), little is known about process factors influencing its outcome. The present study sought to explore the assessment of therapist adherence, its course over treatment, and its associations with patient and therapist characteristics, and the therapeutic alliance. In a prospective multicenter randomized-controlled trial comparing CBT to internet-based guided self-help (INTERBED-study), therapist adherence using the newly developed Adherence Control Form (ACF) was determined by trained raters in randomly selected 418 audio-taped CBT sessions of 89 patients (25% of all sessions). Observer-rated therapeutic alliance, interview-based and self-reported patient and therapist characteristics were assessed. Three-level multilevel modeling was applied. The ACF showed adequate psychometric properties. Therapist adherence was excellent. While significant between-therapist variability in therapist adherence was found, within-therapist variability was non-significant. Patient and therapist characteristics did not predict the therapist adherence. The therapist adherence positively predicted the therapeutic alliance. The ACF demonstrated its utility to assess therapist adherence in CBT for BED. The excellent levels of therapist adherence point to the internal validity of the CBT within the INTERBED-study serving as a prerequisite for empirical comparisons between treatments. Variability between therapists should be addressed in therapist trainings and dissemination trials. Copyright © 2014 Elsevier Ltd. All rights reserved.

Behavioral measures to reduce non-adherence in renal transplant recipients: a prospective randomized controlled trial.

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Garcia, Márcia Fátima Faraldo Martinez; Bravin, Ariane Moyses; Garcia, Paula Dalsoglio; Contti, Mariana Moraes; Nga, Hong Si; Takase, Henrique Mochida; de Andrade, Luis Gustavo Modelli

2015-11-01

Solid-organ transplant recipients present a high rate of non-adherence to drug treatment. Few interventional studies have included approaches aimed at increasing adherence. The objective of this study was to evaluate the impact of an educational and behavioral strategy on treatment adherence of kidney transplant recipients. In a randomized prospective study, incident renal transplant patients (n = 111) were divided into two groups: control group (received usual transplant patient education) and treatment group (usual transplant patient education plus ten additional weekly 30-min education/counseling sessions about immunosuppressive drugs and behavioral changes). Treatment adherence was assessed using ITAS adherence questionnaire after 3 months. Renal function at 3, 6, and 12 months, and the incidence of transplant rejection were evaluated. The non-adherence rates were 46.4 and 14.5 % in the control and treatment groups (p = 0.001), respectively. The relative risk for non-adherence was 2.59 times (CI 1.38-4.88) higher in the control group. Multivariate analysis demonstrated a 5.84 times (CI 1.8-18.8, p = 0.003) higher risk of non-adherence in the control group. There were no differences in renal function and rejection rates between groups. A behavioral and educational strategy addressing the patient's perceptions and knowledge about the anti-rejection drugs significantly improved the short-term adherence to immunosuppressive therapy.

Experiences of non-adherence to Internet-delivered cognitive behavior therapy: A qualitative study

OpenAIRE

Johansson, Olof; Michel, Teresa; Andersson, Gerhard; Paxling, Björn

2015-01-01

Many trials on Internet-delivered psychological treatments have had problems with nonadherence, but not much is known about the subjective reasons for non-adhering. The aim of this study was to explore participants' experiences of non-adherence to Internet-delivered psychological treatment. Grounded theory was used to analyze data from seven in-depth interviews with persons who had non-adhered to a study on Internet-delivered cognitive behavioral therapy for generalized anxiety disorder. The ...

Does packaging with a calendar feature improve adherence to self-administered medication for long-term use? A systematic review.

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Zedler, Barbara K; Kakad, Priyanka; Colilla, Susan; Murrelle, Lenn; Shah, Nirav R

2011-01-01

The therapeutic benefit of self-administered medications for long-term use is limited by an average 50% nonadherence rate. Patient forgetfulness is a common factor in unintentional nonadherence. Unit-of-use packaging that incorporates a simple day-and-date feature (calendar packaging) is designed to improve adherence by prompting patients to maintain the prescribed dosing schedule. To review systematically, in accordance with the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) statement, randomized controlled trial evidence of the adherence benefits and harms of calendar blister packaging (CBP) and calendar pill organizers (CPO) for self-administered, long-term medication use. Data sources included the MEDLINE and Web of Science and Cochrane Library databases from their inception to September 2010 and communication with researchers in the field. Key search terms included blister-calendar pack, blister pack, drug packaging, medication adherence, medication compliance, medication compliance devices, medication containers, medication organizers, multicompartment compliance aid, persistence, pill-box organizers, prescription refill, randomized controlled trials, and refill compliance. Selected studies had an English-language title; a randomized controlled design; medication packaged in CBP or CPO; a requirement of solid, oral medication self-administered daily for longer than 1 month in community-dwelling adults; and at least 1 quantitative outcome measure of adherence. Two reviewers extracted data independently on study design, sample size, type of intervention and control, and outcomes. Ten trials with a total of 1045 subjects met the inclusion criteria, and 9 also examined clinical outcomes (seizures, blood pressure, psychiatric symptoms) or health care resource utilization. Substantial heterogeneity among trials precluded meta-analysis. In 3 studies, calendar packaging was part of a multicomponent adherence intervention. Six of 10 trials

The relationship between ART adherence and smoking status among HIV+ individuals.

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Moreno, Jose L; Catley, Delwyn; Lee, Hyoung S; Goggin, Kathy

2015-04-01

Smoking is highly prevalent among HIV+ individuals and studies indicate that it may be associated with poor ART adherence, though the relationship is poorly understood. In addition little is known about interest in quitting among HIV+ smokers who are having adherence difficulties. We examined smoking and ART adherence among 203 HIV+ individuals enrolled in a randomized trial of interventions to increase ART adherence. Prior analyses indicated there were no overall treatment group effects. Smoking status and motivation to quit was assessed at baseline and ART adherence was assessed at week 12, 24, 36, and 48. Longitudinal generalized estimating equation analysis that controlled for treatment group revealed that smoking status was not significantly related to adherence over time. Motivation to quit was high with 58 % intending to quit in the next 6 months and 25 % intending to quit in the next 30 days. Findings suggest that smoking is not associated with adherence among those with adherence difficulties. However it does not diminish importance of addressing both behaviors especially given HIV+ smokers substantial interest in changing smoking behavior.

Improving adherence to Standard Precautions for the control of health care-associated infections.

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Moralejo, Donna; El Dib, Regina; Prata, Rafaela A; Barretti, Pasqual; Corrêa, Ione

2018-02-26

'Standard Precautions' refers to a system of actions, such as using personal protective equipment or adhering to safe handling of needles, that healthcare workers take to reduce the spread of germs in healthcare settings such as hospitals and nursing homes. To assess the effectiveness of interventions that target healthcare workers to improve adherence to Standard Precautions in patient care. We searched CENTRAL, MEDLINE, Embase, CINAHL, LILACS, two other databases, and two trials registers. We applied no language restrictions. The date of the most recent search was 14 February 2017. We included randomised trials of individuals, cluster-randomised trials, non-randomised trials, controlled before-after studies, and interrupted time-series studies that evaluated any intervention to improve adherence to Standard Precautions by any healthcare worker with responsibility for patient care in any hospital, long-term care or community setting, or artificial setting, such as a classroom or a learning laboratory. Two review authors independently screened search results, extracted data from eligible trials, and assessed risk of bias for each included study, using standard methodological procedures expected by Cochrane. Because of substantial heterogeneity among interventions and outcome measures, meta-analysis was not warranted. We used the GRADE approach to assess certainty of evidence and have presented results narratively in 'Summary of findings' tables. We included eight studies with a total of 673 participants; three studies were conducted in Asia, two in Europe, two in North America, and one in Australia. Five studies were randomised trials, two were cluster-randomised trials, and one was a non-randomised trial. Three studies compared different educational approaches versus no education, one study compared education with visualisation of respiratory particle dispersion versus education alone, two studies compared education with additional infection control support versus

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

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Lonsdale Chris

2012-06-01

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

The efficacy and stability of an information and communication technology-based centralized monitoring system of adherence to immunosuppressive medication in kidney transplant recipients: study protocol for a randomized controlled trial.

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Jung, Hee-Yeon; Seong, Sook Jin; Choi, Ji-Young; Cho, Jang-Hee; Park, Sun-Hee; Kim, Chan-Duck; Yoon, Young-Ran; Kim, Hyung-Kee; Huh, Seung; Yoon, Se-Hee; Lee, Jong Soo; Kim, Yong-Lim

2017-10-16

Immunosuppression non-adherence in kidney transplant recipients (KTRs) not only increases the risk of medical intervention due to acute rejection and graft loss but burdens the socioeconomic system in the form of increased healthcare costs. An aggressive preemptive effort by healthcare professionals, geared to ensure adherence to immunosuppressants in KTRs, is significant and imperative. This study was designed as a prospective, open-label, multicenter, randomized controlled study aimed at evaluating the efficacy and stability of an information and communication technology (ICT)-based centralized monitoring system in boosting medication adherence in KTRs. One hundred fourteen KTRs registered throughout the year 2017 to 2018 are randomized into either the ICT-based centralized home monitoring system or to ambulatory follow-up. The planned follow-up duration is 6 months. The ICT-based centralized home monitoring system described consists of a smart pill box equipped with personal identification system, a home monitoring system, an electronic Case Report Form (eCRF) system, and a comprehensive clinical trial management system (CTMS). It alerts both patients and medical staff with texts and pill box alarms if there is a dosage/dosing time error or a missed dose. Medication adherence and transplant outcomes for the follow-up period are compared between the two groups, while patient satisfaction as well as the stability and cost-effectiveness of the ICT-based monitoring system are to be evaluated. This on-going study is expected to determine if consistent use of the ICT-based centralized monitoring system described could maximize mediation adherence and subsequently enhance transplant outcomes in KTRs. Further, it would lay the foundation for successful implementation of this ICT-based monitoring system for effective management of medication adherence in KTRs. ClinicalTrials.gov, Identifier: NCT03136588 . Registered on 20 April 2017.

The patient education - Learning and Coping Strategies - improves adherence in cardiac rehabilitation (LC-REHAB)

DEFF Research Database (Denmark)

Lynggaard, Vibeke; Nielsen, Claus Vinther; Zwisler, Ann-Dorthe

2017-01-01

BACKGROUND: Despite proven benefits of cardiac rehabilitation (CR), adherence to CR remains suboptimal. This trial aimed to assess the impact of the patient education 'Learning and Coping Strategies' (LC) on patient adherence to an eight-week CR program. METHODS: 825 patients with ischaemic heart...... and education. Patients with heart failure, low levels of education and household income appear to benefit most from this adherence promoting intervention. TRIAL REGISTRATION: www.clinicaltrials.gov identifier NCT01668394....... disease or heart failure were open label randomised to either the LC arm (LC plus CR) or the control arm (CR alone) across three hospital units in Denmark. Both arms received same amount of training and education hours. LC consisted of individual clarifying interviews, participation of experienced...

Mobile phone text messaging to improve medication adherence in secondary prevention of cardiovascular disease.

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Adler, Alma J; Martin, Nicole; Mariani, Javier; Tajer, Carlos D; Owolabi, Onikepe O; Free, Caroline; Serrano, Norma C; Casas, Juan P; Perel, Pablo

2017-04-29

Worldwide at least 100 million people are thought to have prevalent cardiovascular disease (CVD). This population has a five times greater chance of suffering a recurrent cardiovascular event than people without known CVD. Secondary CVD prevention is defined as action aimed to reduce the probability of recurrence of such events. Drug interventions have been shown to be cost-effective in reducing this risk and are recommended in international guidelines. However, adherence to recommended treatments remains sub-optimal. In order to influence non-adherence, there is a need to develop scalable and cost-effective behaviour-change interventions. To assess the effects of mobile phone text messaging in patients with established arterial occlusive events on adherence to treatment, fatal and non-fatal cardiovascular events, and adverse effects. We searched CENTRAL, MEDLINE, Embase, the Conference Proceedings Citation Index - Science on Web of Science on 7 November 2016, and two clinical trial registers on 12 November 2016. We contacted authors of included studies for missing information and searched reference lists of relevant papers. We applied no language or date restrictions. We included randomised trials with at least 50% of the participants with established arterial occlusive events. We included trials investigating interventions using short message service (SMS) or multimedia messaging service (MMS) with the aim to improve adherence to medication for the secondary prevention of cardiovascular events. Eligible comparators were no intervention or other modes of communication. We used standard methodological procedures expected by Cochrane. In addition, we attempted to contact all authors on how the SMS were developed. We included seven trials (reported in 13 reports) with 1310 participants randomised. Follow-up ranged from one month to 12 months. Due to heterogeneity in the methods, population and outcome measures, we were unable to conduct meta-analysis on these studies

Effects of a Phone Call Intervention to Promote Adherence to Antiretroviral Therapy and Quality of Life of HIV/AIDS Patients in Baoshan, China: A Randomized Controlled Trial

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Dongsheng Huang

2013-01-01

Full Text Available Background. Suboptimal adherence to antiretroviral therapy (ART is still pervasive. The effect of using a mobile phone call intervention to improve patient adherence is currently not known. Objective. This study aims to investigate the effects of a phone call intervention on adherence to ART and quality of life (QOL of treatment-naive and treatment-experienced patients. Methods. A randomized controlled trial was conducted in the three largest public hospitals. Adherence was measured by self-completed questionnaires. QOL was assessed by the WHOQOL-HIV BREF. Outcomes were assessed at day 15, at 1, 2, and 3 months after start of treatment for treatment-naive patients and at 3 months after study enrollment for treatment-experienced patients. Results. A total of 103 treatment-naive and 93 treatment-experienced HIV/AIDS patients were consecutively recruited. Results show that a phone call intervention could maintain high self-reported adherence among both treatment-naive and treatment-experienced patients. After three months, significant QOL improvements were observed in domains of physical health (P=0.003, level of independence (P=0.018, environment (P=0.002, and spirituality/religion/personal beliefs (P=0.021 among treatment-naive patients. Conclusion. A mobile phone call intervention to patients could maintain high adherence rates although no statistically significant differences were found. A phone call could improve some domains of QOL among treatment-naive patients.

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

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

2016-11-01

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

Predicting the effect of interactive video bikes on exercise adherence: An efficacy trial.

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Rhodes, Ryan E; Warburton, Darren E R; Bredin, Shannon S D

2009-12-01

Exercise games that employ video game technology are increasing in the marketplace but have received scant research attention despite their popularity. The purpose of this study was to evaluate the effect of videobike gaming on the constructs of the theory of planned behavior (TPB) and adherence in comparison to a cycling condition where participants listen to self-selected music. Participants were 29 inactive young men assigned randomly to experimental (n = 16) or comparison (n = 13) conditions. The recommended training regime consisted of moderate intensity activity (60-75% heart rate reserve), 3 days/week for 30 min/day for 6 weeks. At the end of the first session, participants were asked to complete TPB measures and these were subsequently measured 6 weeks later. Attendance was used as the measure of adherence. Results showed that affective attitude and adherence across the 6 weeks significantly favored the videobike condition over the comparison condition. Regression analyses suggested partial mediation of the effect of the videobike condition on adherence via affective attitude. This is the first study to provide evidence that interactive videobikes may improve adherence over traditional cycling because the activity produces higher affective attitudes. The results are promising for expanding to community-based evaluation.

Enhancing adherence in trials promoting change in diet and physical activity in individuals with a diagnosis of colorectal adenoma; a systematic review of behavioural intervention approaches.

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McCahon, Deborah; Daley, Amanda J; Jones, Janet; Haslop, Richard; Shajpal, Arjun; Taylor, Aliki; Wilson, Sue; Dowswell, George

2015-07-07

Little is known about colorectal adenoma patients' ability to adhere to behavioural interventions promoting a change in diet and physical activity. This review aimed to examine health behaviour intervention programmes promoting change in diet and/or physical activity in adenoma patients and characterise interventions to which this patient group are most likely to adhere. Searches of eight databases were restricted to English language publications 2000-2014. Reference lists of relevant articles were also reviewed. All randomised controlled trials (RCTs) of diet and physical activity interventions in colorectal adenoma patients were included. Eligibility and quality were assessed and data were extracted by two reviewers. Data extraction comprised type, intensity, provider, mode and location of delivery of the intervention and data to enable calculation of four adherence outcomes. Data were subject to narrative analysis. Five RCTs with a total of 1932 participants met the inclusion criteria. Adherence to the goals of the intervention ranged from 18 to 86 % for diet and 13 to 47 % for physical activity. Diet interventions achieving ≥ 50 % adherence to the goals of the intervention were clinic based, grounded in cognitive theory, delivered one to one and encouraged social support. The findings of this review indicate that behavioural interventions can encourage colorectal adenoma patients to improve their diet. This review was not however able to clearly characterise effective interventions promoting increased physical activity in this patient group. Further research is required to establish effective interventions to promote adherence to physical activity in this population.

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

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Kekwaletswe, Connie T; Morojele, Neo K

2014-01-01

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. 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. 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 alcohol-focused adherence counseling program that employs motivational interviewing and cognitive behavioral therapy-type approaches. The association between alcohol use and ART nonadherence points to a need for alcohol-focused ART adherence

eHealth Technologies as an Intervention to Improve Adherence to Topical Antipsoriatics

DEFF Research Database (Denmark)

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

2018-01-01

BACKGROUND: Topical antipsoriatics are recommended first-line treatment of psoriasis, but rates of adherence are low. Patient support by use of electronic health (eHealth) services is suggested to improve medical adherence. OBJECTIVE: To review randomised controlled trials (RCTs) testing eHealth...... interventions designed to improve adherence to topical antipsoriatics and to review applications for smartphones (apps) incorporating the word psoriasis. MATERIAL AND METHODS: Literature review: Medline, Embase, Cochrane, PsycINFO, and Web of Science were searched using search terms for eHealth, psoriasis....... CONCLUSION: There is a critical need for high-quality RCTs testing if the ubiquitous eHealth technologies, e.g. some of the numerous apps, can improve psoriasis patients' rates of adherence to topical antipsoriatics....

Social Support, Insomnia, and Adherence to Cognitive Behavioral Therapy for Insomnia After Cancer Treatment.

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Kamen, Charles; Garland, Sheila N; Heckler, Charles E; Peoples, Anita R; Kleckner, Ian R; Cole, Calvin L; Perlis, Michael L; Morrow, Gary R; Mustian, Karen M; Roscoe, Joseph A

2017-01-27

While cognitive-behavioral therapy for insomnia (CBT-I) has been shown to be efficacious in treating cancer survivors' insomnia, 30-60% of individuals have difficulty adhering to intervention components. Psychosocial predictors of adherence and response to CBT-I, such as social support, have not been examined in intervention studies for cancer survivors. Data from a randomized placebo-controlled 2 x 2 trial of CBT-I and armodafinil (a wakefulness promoting agent) were used to assess adherence. Ninety-six cancer survivors participated in the trial (mean age 56, 86% female, 68% breast cancer). CBT-I and armodafinil were administered over the course of seven weeks, and participants were assessed at baseline, during intervention, postintervention, and at a three-month follow-up. Social support was assessed using a Functional Assessment of Chronic Illness Therapy subscale, insomnia severity was assessed using the Insomnia Severity Index, and adherence was measured based on CBT-I sleep prescriptions. At baseline, social support was negatively correlated with insomnia severity (r = -0.30, p = 0.002) and associations between social support, CBT-I, and insomnia were maintained through the three-month follow-up. Social support was positively associated with adherence to CBT-I during intervention weeks 3, 4, and 5, and with overall intervention adherence. At postintervention, both social support and treatment with CBT-I independently predicted decreased insomnia severity (p adherence and improved sleep independent of CBT-I. Additional research is needed to determine whether social support can be leveraged to improve adherence and response to CBT-I.

Interventions combining motivational interviewing and cognitive behaviour to promote medication adherence: a literature review.

Science.gov (United States)

Spoelstra, Sandra L; Schueller, Monica; Hilton, Melissa; Ridenour, Kimberly

2015-05-01

This article presents an integrative review of the evidence for combined motivational interviewing and cognitive behavioural interventions that promote medication adherence. We undertook this review to establish a scientific foundation for development of interventions to promote medication adherence and to guide clinical practice. The World Health Organization has designated medication adherence as a global problem. Motivational interviewing and cognitive behaviour interventions have been found to individually promote medication adherence. However, there is a gap in the literature on the effect of combined motivational interviewing and cognitive behavioural approaches to promote medication adherence. Integrative review. COCHRANE, PubMed and CINAHL were searched to access relevant studies between 2004-2014. Inclusion criteria were interventions combining motivational interviewing and cognitive behavioural therapy with medication adherence as the outcome. Articles were assessed for measures of adherence and methodological rigour. Analysis was performed using an integrative review process. Six articles met the inclusion criteria. A randomised controlled trial reported pretreatment missed doses of 5·58 and post-treatment of 0·92 and trended towards significance. Four cohort studies had effect sizes of 0·19-0·35 (p motivational interviewing and cognitive behavioural interventions, five out of six were effective at improving medication adherence. Future studies with large rigorous randomised trials are needed. This review provides clinicians with the state of the science in relation to combined motivational interviewing and cognitive behavioural therapy interventions that promote medication adherence. A summary of intervention components and talking points are provided to aid nurses in informing decision-making and translating evidence into practice. © 2014 John Wiley & Sons Ltd.

Predictors of medication adherence in high risk youth of color living with HIV.

Science.gov (United States)

Macdonell, Karen E; Naar-King, Sylvie; Murphy, Debra A; Parsons, Jeffrey T; Harper, Gary W

2010-07-01

To test predictors of medication adherence in high-risk racial or ethnic minority youth living with HIV (YLH) using a conceptual model of social cognitive predictors including a continuous measure of motivational readiness. Youth were participants in a multi-site clinical trial examining the efficacy of a motivational intervention. Racial-minority YLH (primarily African American) who were prescribed antiretroviral medication were included (N = 104). Data were collected using computer-assisted personal interviewing method via an Internet-based application and questionnaires. Using path analysis with bootstrapping, most youth reported suboptimal adherence, which predicted higher viral load. Higher motivational readiness predicted optimal adherence, and higher social support predicted readiness. Decisional balance was indirectly related to adherence. The model provided a plausible framework for understanding adherence in this population. Culturally competent interventions focused on readiness and social support may be helpful for improving adherence in YLH.

Adherence to the CONSORT Statement in the Reporting of Randomized Controlled Trials on Pharmacological Interventions Published in Iranian Medical Journals

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Pooneh Sarveravan

2017-11-01

Full Text Available Background: Among manuscripts submitted to biomedical journals, randomized controlled trials (RCTs form the backbone of evidence-based medicine. Hence, their protocol should be designed rigorously and their results should be reported clearly. To improve the quality of RCT reporting, researchers developed the CONSORT Statement in 1996 and updated it in 2010. This study was designed to assess the quality of RCT reporting vis-à-vis adherence to CONSORT among articles published in Iranian medical journals (English, Persian, CONSORT-endorsing, and non-CONSORT-endorsing. Methods: In this cross-sectional study, all RCTs published in all Iranian medical journals from September 2012 to September 2013 were retrieved to evaluate their adherence to CONSORT. The journals’ instructions for authors were also reviewed to find out whether or not they endorsed CONSORT. The CONSORT 2010 Checklist was used. Microsoft Excel 2007 was applied to analyze the data, and MedCalc was employed to compare the groups. Results: Totally, 492 pharmacological RCTs that met our inclusion criteria were identified. Twenty-five items were reported in fewer than 50% of the articles. The differences between the articles published in Persian and English language journals were statistically significant in 17 items. The differences between the articles published in the CONSORT-endorsing and non-CONSORT-endorsing journals were significant in 8 items. Conclusion: Our findings showed very weak adherence to CONSORT. Authors, reviewers, and editors should be trained to use standards expressed by the CONSORT Group in reporting RCTs.

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

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Kobra Parvan

2015-03-01

Full Text Available Introduction: Patients with chronic renal disease (CRD deal with many potential problems with hemodialysis for all their life. Regarding the importance of preventing dialysis adverse effects, which are in close connection with lack of knowledge and report on how to train the patients? This study aims at comparing the impact of two methods of face to face training and training pamphlet on complying and informing of hemodialysis treatments. Methods: This clinical trial study was conducted on 58 hemodialysis patients who visited Shahid Rahnemun Teaching hospital, Yazd, Iran, and had required conditions of the research. Data were collected through a questionnaire including personal-social information, several questions to assess the level of compliance and to inform the treatment method. The quantitative analysis of this study used the Statistical Package for Social Sciences SPSS version 13 and descriptive (frequency, mean, standard deviation and inferential (Chi-square, paired t-test, ANOVA, ANCOVA statistics were employed. Results: The mean scores for informing both groups (face to face and training pamphlet were significantly increased. The mean score for adherence to treatments was also significant.Conclusion: In this research, face to face training was found to be more effective than training pamphlet. It seemed to have more strong effect on increasing the level of information and adherence to treatment. To train these people, face to face training should be, thus, preferred.

Financial incentives for improving adherence to maintenance treatment in patients with psychotic disorders (Money for Medication): a multicentre, open-label, randomised controlled trial.

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Noordraven, Ernst L; Wierdsma, André I; Blanken, Peter; Bloemendaal, Anthony F T; Staring, Anton B P; Mulder, Cornelis L

2017-03-01

Provision of financial incentives is a promising intervention for improving adherence in patients taking antipsychotic medication. We aimed to assess the effectiveness of this intervention for improving adherence to antipsychotic depot medication in patients with psychotic disorders, irrespective of their previous compliance. We did this multicentre, open-label, randomised controlled trial at three mental health-care institutions in secondary psychiatric care services in the Netherlands. Eligible patients were aged 18-65 years, had been diagnosed with schizophrenia or another psychotic disorder, had been prescribed antipsychotic depot medication or had an indication to start using depot medication, and were participating in outpatient treatment. Patients were randomly assigned (1:1), via computer-generated randomisation with a block size of four, to receive 12 months of either treatment as usual plus a financial reward for each depot of medication received (€30 per month if fully compliant; intervention group) or treatment as usual alone (control group). Randomisation was stratified by treatment site and suspected prognostic factors: sex, comorbid substance-use disorder (absent vs present), and compliance with antipsychotic medication in the 4 months before baseline (taking antipsychotic medication. We did analysis by intention to treat. This trial is registered with the Nederlands Trial Register, number NTR2350. Between May 21, 2010, and Oct 15, 2014, we randomly assigned 169 patients to the intervention group (n=84) or the control group (n=85). Primary outcome data were available for 155 (92%) patients. At baseline, the mean MPR was 76·0% (SD 28·2%) in the intervention group versus 77·9% (28·5%) in the control group. At 12 months, the mean MPR was higher in the intervention group (94·3% [SD 11·3%]) than in the control group (80·3% [19·1%]), with an adjusted difference of 14·9% (95% CI 8·9-20·9%; pcontrol group (adjusted difference 6·5%, 95% CI 2·0

Two character traits associated with adherence to long term therapies.

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Reach, Gérard

2012-10-01

Adherence is defined as the adequacy between the behaviours of patients and their medical prescriptions. Adherence is a general behaviour, which can explain why patients in the placebo arm of randomised clinical trials have a lower mortality rate when they are adherent. We propose that this behaviour is related to two character traits: patience (capacity to give priority to the future) and, more provocatively, obedience. To support this claim, we bring arguments from the literature and from two published personal studies. We previously showed that type 2 diabetic patients who respond as non-adherers to a questionnaire on adherence to medication and to whom one proposes a fictitious monetary choice between receiving 500 euros today or waiting one year to receive 1500 euros never make the remote choice. We also showed that obese diabetic patients who declare that they do not fasten their seat belt when they are seated in the rear of a car are more often non-adherent concerning medication than those patients who claim that they follow this road safety recommendation. Thus, one of the roles of empowerment and patient education could be to encourage the patients, if they wish it, to replace passive adherence behaviours with conscious active choices. Copyright © 2012 Elsevier Ireland Ltd. All rights reserved.

A Pharmaceutical Care Program to Improve Adherence to Statin Therapy : A Randomized Controlled Trial

NARCIS (Netherlands)

Eussen, Simone R. B. M.; van der Elst, Menno E.; Klungel, Olaf H.; Rompelberg, Cathy J. M.; Garssen, Johan; Oosterveld, Marco H.; de Boer, Anthonius; de Gier, Johan J.; Bouvy, Marcel L.

2010-01-01

BACKGROUND: Despite the well-known beneficial effects of statins, many patients do not adhere to chronic medication regimens. OBJECTIVE: To implement and assess the effectiveness of a community pharmacy based pharmaceutical care program developed to improve patients' adherence to statin therapy.

Correlates of Adherence among Rural Indian Women Living with HIV/AIDS.

Science.gov (United States)

Nyamathi, Adeline; Salem, Benissa; Ernst, E J; Keenan, Colleen; Suresh, P; Sinha, Sanjeev; Ganguly, Kalyan; Ramakrishnan, Padma; Liu, Yihang

2012-01-01

In this prospective, randomized clinical trial, correlates of adherence to antiretroviral therapy (ART) were assessed using a baseline questionnaire among 68 rural women living with AIDS (WLA) in India. Unadjusted analyses revealed positive relationships of ART adherence with Hindu religion, and support from spouses and parents, whereas negative associations were found with depression, poor quality of life, and having ten or more HIV symptoms. Multiple linear regression analysis also revealed that WLA who were Hindu, not depressed, had ART support from spouses and parents, and perceived some benefit from ART were more adherent to ART than their respective counterparts. This study reveals the unique challenges which rural WLA experience and the need to mitigate these challenges early in ART treatment. Further, the findings enable the refinement of an intervention program which will focus on strengthening ART adherence among rural WLA.

A randomised clinical trial of feedback on inhaler adherence and technique in patients with severe uncontrolled asthma.

Science.gov (United States)

Sulaiman, Imran; Greene, Garrett; MacHale, Elaine; Seheult, Jansen; Mokoka, Matshediso; D'Arcy, Shona; Taylor, Terence; Murphy, Desmond M; Hunt, Eoin; Lane, Stephen J; Diette, Gregory B; FitzGerald, J Mark; Boland, Fiona; Sartini Bhreathnach, Aoife; Cushen, Breda; Reilly, Richard B; Doyle, Frank; Costello, Richard W

2018-01-01

In severe asthma, poor control could reflect issues of medication adherence or inhaler technique, or that the condition is refractory. This study aimed to determine if an intervention with (bio)feedback on the features of inhaler use would identify refractory asthma and enhance inhaler technique and adherence.Patients with severe uncontrolled asthma were subjected to a stratified-by-site random block design. The intensive education group received repeated training in inhaler use, adherence and disease management. The intervention group received the same intervention, enhanced by (bio)feedback-guided training. The primary outcome was rate of actual inhaler adherence. Secondary outcomes included a pre-defined assessment of clinical outcome. Outcome assessors were blinded to group allocation. Data were analysed on an intention-to-treat and per-protocol basis.The mean rate of adherence during the third month in the (bio)feedback group (n=111) was higher than that in the enhanced education group (intention-to-treat, n=107; 73% versus 63%; 95% CI 2.8%-17.6%; p=0.02). By the end of the study, asthma was either stable or improved in 54 patients (38%); uncontrolled, but poorly adherent in 52 (35%); and uncontrolled, but adherent in 40 (27%).Repeated feedback significantly improved inhaler adherence. After a programme of adherence and inhaler technique assessment, only 40 patients (27%) were refractory and adherent, and might therefore need add-on therapy. Copyright ©ERS 2018.

Randomized Trial of a Children's Book Versus Brochures for Safe Sleep Knowledge and Adherence in a High-Risk Population.

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Hutton, John S; Gupta, Resmi; Gruber, Rachel; Berndsen, Jennifer; DeWitt, Thomas; Ollberding, Nicholas J; Van Ginkel, Judith B; Ammerman, Robert T

Sleep-related infant deaths have plateaued in the past decade, disproportionately affecting low socioeconomic status (SES) families. Printed materials are widely used for anticipatory guidance, yet none for safe sleep has been studied. We tested the efficacy of a specially designed children's book compared to brochures for safe sleep knowledge and adherence, which we hypothesized would be greater due to superior readability and engagement. This randomized controlled trial involved low-SES mothers (n = 282) enrolled in a home visiting program. Home visitors (n = 56) were randomly assigned to perform safe sleep teaching and assessments during 3 visits: third trimester, 1 week old, and 2 months old, exclusively utilizing a specially designed children's book or brochures, and surveys incorporating the American Academy of Pediatrics' safe sleep recommendations. Outcomes were safe sleep knowledge, adherence, and usefulness of materials, controlling for maternal health literacy. Safe sleep knowledge increased across all time points with no overall group difference, though gains for sleep-evocative and general health items varied. Odds of bed sharing were higher and exclusive crib use lower for the brochure group (P book and mothers in the book group reported more book sharing with their baby. While a specially designed children's book and brochures were equally effective conveying aggregate safe sleep knowledge in low-SES mothers, adherence to exclusive crib use and avoiding bed sharing were greater in the book group, attributable to enhanced dialogue, readability and emotional engagement. Children's books are a promising mode of anticipatory guidance, warranting further investigation. Copyright © 2017 Academic Pediatric Association. Published by Elsevier Inc. All rights reserved.

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

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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.

The Effectiveness of Mobile Phone Text Messaging in Improving Medication Adherence for Patients with Chronic Diseases: A Systematic Review.

Science.gov (United States)

Ershad Sarabi, Roghayeh; Sadoughi, Farahnaz; Jamshidi Orak, Roohangiz; Bahaadinbeigy, Kambiz

2016-05-01

Medication non-adherence is a commonly observed problem in the self-administration of treatment, regardless of the disease type. Text messaging reminders, as electronic reminders, provide an opportunity to improve medication adherence. In this study, we aimed to provide evidence addressing the question of whether text message reminders were effective in improving patients' adherence to medication. We carried out a systematic literature search, using the five electronic bibliographic databases: PubMed, Embase, PsycINFO, CINAHL, and the Cochrane central register of controlled trials. Studies were included on the basis of whether they examined the benefits and effects of short-message service (SMS) interventions on medication adherence. The results of this systematic review indicated that text messaging interventions have improved patients' medication adherence rate (85%, 29.34). Included in the review, those who had problems with adherence, or those whom text messaging was most helpful had HIV, asthma, diabetes, schizophrenia and heart disease (73.5%). The period of intervention varied from 1 week to 14 months. The most common study design was randomized controlled trials (RCTs) (66%) carried out in the developed countries. This study demonstrated the potential of mobile phone text messaging for medication non-adherence problem solving.

Using daily text messages to improve adherence to infant micronutrient powder (MNP) packets in rural western China: A cluster-randomized controlled trial.

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Wang, Xu; Luo, Renfu; Liu, Chengfang; Zhang, Linxiu; Yue, Ai; Medina, Alexis; Rozelle, Scott

2018-01-01

To evaluate the effectiveness of daily text messages as a means to improve caregivers' adherence to infant micronutrient powder (MNP) in rural Shaanxi Province of China. 638 infants aged 6-11 months in 234 villages were involved in a cluster-randomized controlled trial (RCT). All caregivers were given free infant MNP packets at baseline in April 2013 and the follow-up survey was in July 2013. We randomly assigned 318 infants in 117 villages to treatment group (receiving daily text message) and 320 infants in the other 117 villages as control group. On average, daily text messages increased the number of MNP packets fed (marginal effect = 4.63; 95% confidence interval (CI) = 0.16, 9.10). The text message is more likely to increase the consumption of MNP packets if the primary caregiver was the mother (marginal effect = 12.19; 95% CI = 0.69, 23.68). Receiving the text message appears to significantly increase the likelihood of full adherence when the primary caregiver can either check (odds ratio = 2.93; 95% CI = 1.34, 6.40) or knows how to send (odds ratio = 3.26; 95% CI = 1.53, 6.97) text messages. Daily text messages improved the consumption of infant MNP packets. However, the impact was not large enough to increase the probability of caregivers being fully adherent to the feeding instruction, which is to feed 5-7 packets per week as recommended. In addition, when the mother is the caregiver and when the caregiver can check or knows how to send text messages there is greater adherence by the primary caregivers. http://www.isrctn.com/ISRCTN44149146.

Hemodialysis Self-management Intervention Randomized Trial (HED-SMART): A Practical Low-Intensity Intervention to Improve Adherence and Clinical Markers in Patients Receiving Hemodialysis.

Science.gov (United States)

Griva, Konstadina; Nandakumar, Mooppil; Ng, Jo-An H; Lam, Kevin F Y; McBain, Hayley; Newman, Stanton P

2018-03-01

Poor adherence to treatment is common in hemodialysis patients. However, effective interventions for adherence in this population are lacking. Small studies of behavioral interventions have yielded improvements, but clinical effectiveness and long-term effects are unclear. Multicenter parallel (1:1) design, blinded cluster-randomized controlled trial. Patients undergoing maintenance hemodialysis enrolled in 14 dialysis centers. Dialysis shifts of eligible patients were randomly assigned to either an interactive and targeted self-management training program (HED-SMART; intervention; n=134) or usual care (control; n=101). HED-SMART, developed using the principles of problem solving and social learning theory, was delivered in a group format by health care professionals over 4 sessions. Serum potassium and phosphate concentrations, interdialytic weight gains (IDWGs), self-reported adherence, and self-management skills at 1 week, 3 months, and 9 months postintervention. 235 participants were enrolled in the study (response rate, 44.2%), and 82.1% completed the protocol. IDWG was significantly lowered across all 3 assessments relative to baseline (Pmanagement skills, and self-efficacy at all time points. Low proportion of patients with diabetes. HED-SMART provides an effective and practical model for improving health in hemodialysis patients. The observed improvements in clinical markers and self-report adherence, if maintained at the longer follow-up, could significantly reduce end-stage renal disease-related complications. Given the feasibility of this kind of program, it has strong potential for supplementing usual care. Registered at ISRCTN with study number ISRCTN31434033. Copyright © 2017 National Kidney Foundation, Inc. Published by Elsevier Inc. All rights reserved.

A Systematic Review of Antiretroviral Adherence Interventions for HIV-Infected People Who Use Drugs

OpenAIRE

CampBinford, Meredith; Kahana, Shoshana Y.; Altice, Frederick L.

2012-01-01

HIV-infected persons who use drugs (PWUDs) are particularly vulnerable for suboptimal combination antiretroviral therapy (cART) adherence. A systematic review of interventions to improve cART adherence and virologic outcomes among HIV-infected PWUDs was conducted. Among the 45 eligible studies, randomized controlled trials suggested directly administered antiretroviral therapy, medication-assisted therapy (MAT), contingency management, and multi-component, nurse-delivered interventions provid...

Improving adherence to medication in adults with diabetes in the United Arab Emirates.

Science.gov (United States)

Al-Haj Mohd, Mohammed M M; Phung, Hai; Sun, Jing; Morisky, Donald E

2016-08-24

Diabetes is a chronic medical condition and adherence to medication in diabetes is important. Improving medication adherence in adults with diabetes would help prevent the chronic complications associated with diabetes. A case control trial was used to study the effects of an educational session on medication adherence among adults with diabetes as measured by the Morisky Medication adherence scale (MMAS-8©). The study took place at the Dubai Police Health Centre between February 2015 and November 2015. Questionnaires were used to collect socio-demographic, clinical and disease related variables and the primary measure of outcome was adherence levels as measured by the Morisky Medication Adherence Scale (MMAS-8©). The intervention group involved a standardized thirty minute educational session focusing on the importance of adherence to medication. The change in MMAS-8© was measured at 6 months. Four hundred and forty six patients were enrolled. Mean age 61 year +/- 11. 48.4 % were male. The mean time since diagnosis of diabetes was 3.2 years (Range 1-15 years). At baseline two hundred and eighty eight (64.6 %) patients were considered non-adherent (MMAS-8© adherence score strategies should focus on wider educational strategies targeting medication adherence in diabetic patients in the UAE.

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.

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Sarah Chapman

2015-11-01

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

Blood Pressure Treatment Adherence and Control after Participation in the ReHOT

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Nathália Silva de Jesus

Full Text Available Abstract Background: Lack of adherence to pharmacological treatment is one of the main causes of low control rates in hypertension. Objective: To verify treatment adherence and associated factors, as well as blood pressure (BP control in participants of the Resistant Hypertension Optimal Treatment (ReHOT clinical trial. Method: Cross-sectional study including all 109 patients who had completed the ReHOT for at least 6 months. We excluded those participants who failed to respond to the new recruitment after three phone contact attempts. We evaluated the BP control by ambulatory BP monitoring (ABPM; controlled levels: 24-hour systolic and diastolic BP < 130 x 80 mmHg and analyzed the patients' treatment adherence using the Morisky Medication Adherence Scale (MMAS questionnaire validated by Bloch, Melo, and Nogueira (2008. The statistical analysis was performed with the software IBM SPSS statistics 21.0. We tested the normality of the data distribution with kurtosis and skewness. The variables tested in the study are presented with descriptive statistics. Comparisons between treatment adherence and other variables were performed with Student's t test for independent variables and Pearson's chi-square or Fisher's exact test. To conduct analyses among patients considering adherence to treatment and BP control, we created four groups: G0, G1, G2, and G3. We considered a 5% significance level in all tests. Results: During the ReHOT, 80% of the patients had good BP control and treatment adherence. Of 96 patients reevaluated in the present study, only 52.1% had controlled hypertension when assessed by ABPM, while 31.3% were considered adherent by the MMAS. Regarding other ABPM measures, we observed an absence of a nocturnal dip in 64.6% of the patients and a white-coat effect and false BP control in 23% and 12.5%, respectively. Patients' education level showed a trend towards being a determinant factor associated with lack of adherence (p = 0

Experiences of non-adherence to Internet-delivered cognitive behavior therapy: A qualitative study

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Olof Johansson

2015-05-01

Full Text Available Many trials on Internet-delivered psychological treatments have had problems with nonadherence, but not much is known about the subjective reasons for non-adhering. The aim of this study was to explore participants' experiences of non-adherence to Internet-delivered psychological treatment. Grounded theory was used to analyze data from seven in-depth interviews with persons who had non-adhered to a study on Internet-delivered cognitive behavioral therapy for generalized anxiety disorder. The process of non-adherence is described as an interaction between patient factors and treatment factors. A working model theory was generated to illustrate the experience of nonadherence. The model describes a process where treatment features such as workload, text-content complexity and treatment process don't match personal prerequisites regarding daily routines, perceived language skills and treatment expectations respectively, resulting in the decision to nonadhere. Negative effects were also stated as a reason for non-adherence. Several common strategies used for increasing adherence to Internet-delivered therapy in general are by these non-completers regarded as factors directly related to their reason for non-adherence.

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

Directory of Open Access Journals (Sweden)

Kekwaletswe CT

2014-03-01

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

Improving Adherence to Web-Based and Mobile Technologies for People With Psychosis: Systematic Review of New Potential Predictors of Adherence.

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Killikelly, Clare; He, Zhimin; Reeder, Clare; Wykes, Til

2017-07-20

Despite the boom in new technologically based interventions for people with psychosis, recent studies suggest medium to low rates of adherence to these types of interventions. The benefits will be limited if only a minority of service users adhere and engage; if specific predictors of adherence can be identified then technologies can be adapted to increase the service user benefits. The study aimed to present a systematic review of rates of adherence, dropout, and approaches to analyzing adherence to newly developed mobile and Web-based interventions for people with psychosis. Specific predictors of adherence were also explored. Using keywords (Internet or online or Web-based or website or mobile) AND (bipolar disorder or manic depression or manic depressive illness or manic-depressive psychosis or psychosis or schizophr* or psychotic), the following databases were searched: OVID including MedLine, EMBASE and PsychInfo, Pubmed and Web of Science. The objectives and inclusion criteria for suitable studies were defined following PICOS (population: people with psychosis; intervention: mobile or Internet-based technology; comparison group: no comparison group specified; outcomes: measures of adherence; study design: randomized controlled trials (RCT), feasibility studies, and observational studies) criteria. In addition to measurement and analysis of adherence, two theoretically proposed predictors of adherence were examined: (1) level of support from a clinician or researcher throughout the study, and (2) level of service user involvement in the app or intervention development. We provide a narrative synthesis of the findings and followed the preferred reporting items for systematic reviews and meta-analyses (PRISMA) guidelines for reporting systematic reviews. Of the 20 studies that reported a measure of adherence and a rate of dropout, 5 of these conducted statistical analyses to determine predictors of dropout, 6 analyzed the effects of specific adherence

Asthma medication adherence: the role of God and other health locus of control factors.

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Ahmedani, Brian K; Peterson, Edward L; Wells, Karen E; Rand, Cynthia S; Williams, L Keoki

2013-02-01

Medication adherence is an important determinant of disease outcomes, yet medication use on average tends to be low among patients with chronic conditions, including asthma. Although several predictors of non-adherence have been assessed, more research is needed on patients' beliefs about God and how these relate to medication use. To examine the relationship between perceptions about "God's" role in health and other locus of control factors with inhaled corticosteroid (ICS) adherence among asthma patients. Participants were from a clinical trial to improve ICS adherence and were 5-56 years old, had a diagnosis of asthma, and were receiving ICS medication. Baseline adherence was estimated from electronic prescription and pharmacy fill records. Patients were considered to be adherent if ICS use was ≥80% of prescribed. A baseline survey with the Multidimensional Health Locus of Control scale was used to assess five sources (God, doctors, other people, chance, and internal). Medication adherence was low (36%). Patients' who had a stronger belief that God determined asthma control were less likely to be adherent (odds ratio [OR] 0.82, 95% confidence interval [CI] 0.70-0.96). This relationship was stronger among African American (OR 0.68, 95% CI0.47-0.99) compared to white patients (OR 0.89, 95% CI 0.75-1.04), and among adults (OR 0.81, 95% CI 0.69-0.96) compared to children (OR 0.84, 95% CI 0.58-1.22). Patients' belief in God's control of health appears to be a factor in asthma controller use, and therefore should be considered in physician-patient discussions concerning course of treatment. ClinicalTrials.gov: NCT00459368. Copyright © 2013 American College of Allergy, Asthma & Immunology. Published by Elsevier Inc. All rights reserved.

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.

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Lonsdale, Chris; Hall, Amanda M; Williams, Geoffrey C; McDonough, Suzanne M; Ntoumanis, Nikos; Murray, Aileen; Hurley, Deirdre A

2012-06-15

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. 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 they will not be told if their physiotherapist has

MAGIC Study: Aims, Design and Methods using SystemCHANGE™ to Improve Immunosuppressive Medication Adherence in Adult Kidney Transplant Recipients.

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Russell, Cynthia L; Moore, Shirley; Hathaway, Donna; Cheng, An-Lin; Chen, Guoqing; Goggin, Kathy

2016-07-16

Among adult kidney transplant recipients, non-adherence to immunosuppressive medications is the leading predictor of poor outcomes, including rejection, kidney loss, and death. An alarming one-third of kidney transplant patients experience medication non-adherence even though the problem is preventable. Existing adherence interventions have proven marginally effective for those with acute and chronic illnesses and ineffective for adult kidney transplant recipients. Our purpose is to describe the design and methods of the MAGIC (Medication Adherence Given Individual SystemCHANGE™) trial We report the design of a randomized controlled trial with an attention-control group to test an innovative 6-month SystemCHANGE™ intervention designed to enhance immunosuppressive medication adherence in adult non-adherent kidney transplant recipients from two transplant centers. Grounded in the Socio-Ecological Model, SystemCHANGE™ seeks to systematically improve medication adherence behaviors by identifying and shaping routines, involving supportive others in routines, and using medication taking feedback through small patient-led experiments to change and maintain behavior. After a 3-month screening phase of 190 eligible adult kidney transplant recipients, those who are adherent as measured by electronic monitoring, will be randomized into a 6-month SystemCHANGE™ intervention or attention-control phase, followed by a 6-month maintenance phase without intervention or attention. Differences in adherence between the two groups will be assessed at baseline, 6 months (intervention phase) and 12 months (maintenance phase). Adherence mediators (social support, systems-thinking) and moderators (ethnicity, perceived health) are examined. Patient outcomes (creatinine/blood urea nitrogen, infection, acute/chronic rejection, graft loss, death) and cost effectiveness are to be examined. Based on the large effect size of 1.4 found in our pilot study, intervention shows great promise

Feasibility of dialectical behavior therapy with suicidal and self-harming adolescents with multi-problems: training, adherence, and retention.

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Tørmoen, A J; Grøholt, B; Haga, E; Brager-Larsen, A; Miller, A; Walby, F; Stanley, B; Mehlum, L

2014-01-01

We evaluated the feasibility of DBT training, adherence, and retention preparing for a randomized controlled trial of Dialectical Behavior Therapy (DBT) adapted for Norwegian adolescents engaging in self-harming behavior and diagnosed with features of borderline personality disorder. Therapists were intensively trained and evaluated for adherence. Adherence scores, treatment retention, and present and previous self-harm were assessed. Twenty-seven patients were included (mean age 15.7 years), all of them with recent self-harming behaviors and at least 3 features of Borderline Personality Disorder. Therapists were adherent and 21 (78%) patients completed the whole treatment. Three subjects reported self-harm at the end of treatment, and urges to self-harm decreased. At follow up, 7 of 10 subjects reported no self-harm. DBT was found to be well accepted and feasible. Randomized controlled trials are required to test the effectiveness of DBT for adolescents.

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

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

2014-04-29

eHealth interventions are effective for weight control and have the potential for broad reach. Little is known about the use of interactive voice response (IVR) technology for self-monitoring in weight control interventions, particularly among populations disproportionately affected by obesity. This analysis sought to examine patterns and predictors of IVR self-monitoring adherence and the association between adherence and weight change among low-income black women enrolled in a weight gain prevention intervention. The Shape Program was a randomized controlled trial comparing a 12-month eHealth behavioral weight gain prevention intervention to usual care among overweight and obese black women in the primary care setting. Intervention participants (n=91) used IVR technology to self-monitor behavior change goals (eg, no sugary drinks, 10,000 steps per day) via weekly IVR calls. Weight data were collected in clinic at baseline, 6, and 12 months. Self-monitoring data was stored in a study database and adherence was operationalized as the percent of weeks with a successful IVR call. Over 12 months, the average IVR completion rate was 71.6% (SD 28.1) and 52% (47/91) had an IVR completion rate ≥80%. At 12 months, IVR call completion was significantly correlated with weight loss (r =-.22; P=.04) and participants with an IVR completion rate ≥80% had significantly greater weight loss compared to those with an IVR completion rate self-monitoring. Adherence to IVR self-monitoring was high among socioeconomically disadvantaged black women enrolled in a weight gain prevention intervention. Higher adherence to IVR self-monitoring was also associated with greater weight change. IVR is an effective and useful tool to promote self-monitoring and has the potential for widespread use and long-term sustainability. Clinicaltrials.gov NCT00938535; http://www.clinicaltrials.gov/ct2/show/NCT00938535.

Providing physicians with feedback on medication adherence for people with chronic diseases taking long-term medication.

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Zaugg, Vincent; Korb-Savoldelli, Virginie; Durieux, Pierre; Sabatier, Brigitte

2018-01-10

Poor medication adherence decreases treatment efficacy and worsens clinical outcomes, but average rates of adherence to long-term pharmacological treatments for chronic illnesses are only about 50%. Interventions for improving medication adherence largely focus on patients rather than on physicians; however, the strategies shown to be effective are complex and difficult to implement in clinical practice. There is a need for new care models addressing the problem of medication adherence, integrating this problem into the patient care process. Physicians tend to overestimate how well patients take their medication as prescribed. This can lead to missed opportunities to change medications, solve adverse effects, or propose the use of reminders in order to improve patients' adherence. Thus, providing physicians with feedback on medication adherence has the potential to prompt changes that improve their patients' adherence to prescribed medications. To assess the effects of providing physicians with feedback about their patients' medication adherence for improving adherence. We also assessed the effects of the intervention on patient outcomes, health resource use, and processes of care. We conducted a systematic search of the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, and Embase, all from database inception to December 2016 and without any language restriction. We also searched ISI Web of Science, two trials registers, and grey literature. We included randomised trials, controlled before-after studies, and interrupted time series studies that compared the effects of providing feedback to physicians about their patients' adherence to prescribed long-term medications for chronic diseases versus usual care. We included published or unpublished studies in any language. Participants included any physician and any patient prescribed with long-term medication for chronic disease. We included interventions providing the prescribing physician with

Effects of Performance Feedback Reports on Adherence to Evidence-Based Guidelines in Use of CT for Evaluation of Pulmonary Embolism in the Emergency Department: A Randomized Trial.

Science.gov (United States)

Raja, Ali S; Ip, Ivan K; Dunne, Ruth M; Schuur, Jeremiah D; Mills, Angela M; Khorasani, Ramin

2015-11-01

The purpose of this study was to assess whether implementing emergency department (ED) physician performance feedback reports improves adherence to evidence-based guidelines for use of CT for evaluation of pulmonary embolism (PE) beyond that achieved with clinical decision support (CDS) alone. This prospective randomized controlled trial was conducted from January 1, 2012, to December 31, 2013, at an urban level 1 adult trauma center ED. Attending physicians were stratified into quartiles by use of CT for evaluation of PE in 2012 and were randomized to receive quarterly feedback reporting or not, beginning January 2013. Reports consisted of individual and anonymized group data on guideline adherence (using the Wells criteria), use of CT for PE (number of CT examinations for PE per 1000 patients), and yield (percentage of CT examinations for PE with positive findings). We compared guideline adherence (primary outcome) and use and yield (secondary outcomes) of CT for PE between the control and intervention groups in 2013 and with historical imaging data from 2012. Of 109,793 ED patients during the control and intervention periods, 2167 (2.0%) underwent CT for evaluation of PE. In the control group, guideline adherence remained unchanged between 2012 (78.8% [476/604]) and 2013 (77.2% [421/545]) (p = 0.5); in the intervention group, guideline adherence increased 8.8% after feedback report implementation, from 78.3% (426/544) to 85.2% (404/474) (p guidelines for use of CT for evaluation of PE in ED patients, enhancing the impact of CDS alone. These results suggest potentially synergistic effects of traditional performance improvement tools with CDS to improve guideline adherence.

Cost-effectiveness of increasing bisphosphonates adherence for osteoporosis in community pharmacies

NARCIS (Netherlands)

Van Boven, J.F.M.; Oosterhof, P.; Hiddink, E.G.; Stuurman-Bieze, A.G.G.; Postma, M.J.; Vegter, S.

2011-01-01

OBJECTIVES: Increasing real-life adherence to bisphosphonates therapy is important to achieve the clinical benefits of reducing fractures reported in randomized clinical trials (RCTs). The aim of this pharmacoeconomic analysis was to determine the cost-effectiveness of a pharmaceutical care

Perspectives of patients on factors relating to adherence to post-acute coronary syndrome medical regimens

Directory of Open Access Journals (Sweden)

Lambert-Kerzner A

2015-07-01

Full Text Available Anne Lambert-Kerzner,1,2 Edward P Havranek,2,3 Mary E Plomondon,1,2 Katherine M Fagan,1 Marina S McCreight,1 Kelty B Fehling,1 David J Williams,2 Alison B Hamilton,4 Karen Albright,2 Patrick J Blatchford,2 Renee Mihalko-Corbitt,5 Chris L Bryson,6 Hayden B Bosworth,7 Miriam A Kirshner,7 Eric J Del Giacco,5 P Michael Ho1,2 1Department of Cardiology, Veterans Health Administration (VA Eastern Colorado Health Care System, Denver, CO, 2School of Public Health or School of Medicine, University of Colorado, Anschutz Medical Campus, Aurora, CO, 3Cardiology, Denver Health Medical Center, Denver, CO, 4Health Services Research, Veterans Health Administration (VA Greater Los Angeles Healthcare System, Los Angeles, CA, 5Internal Medicine, John L. McClellan Memorial Veterans Hospital, Little Rock, AR, 6Health Services Research, Veterans Health Administration (VA Puget Sound Health Care System, Seattle, WA, 7Health Services Research, Durham Veterans Affairs Medical Center, Durham, NC, USA Purpose: Poor adherence to cardioprotective medications after acute coronary syndrome (ACS hospitalization is associated with increased risk of rehospitalization and mortality. Clinical trials of multifaceted interventions have improved medication adherence with varying results. Patients’ perspectives on interventions could help researchers interpret inconsistent outcomes. Identifying factors that patients believe would improve adherence might inform the design of future interventions and make them more parsimonious and sustainable. The objective of this study was to obtain patients’ perspectives on adherence to medical regimens after experiencing an ACS event and their participation in a medication adherence randomized control trial following their hospitalization. Patients and methods: Sixty-four in-depth interviews were conducted with ACS patients who participated in an efficacious, multifaceted, medication adherence randomized control trial. Interview transcripts were

Cervical cancer screening and adherence to follow-up among Hispanic women study protocol: a randomized controlled trial to increase the uptake of cervical cancer screening in Hispanic women

Directory of Open Access Journals (Sweden)

Duggan Catherine

2012-05-01

Full Text Available Abstract Background In the US, Hispanic women have a higher incidence of, and mortality from, cervical cancer than non-Hispanic white women. The reason for this disparity may be attributable to both low rates of screening and poor adherence to recommended diagnostic follow-up after an abnormal Pap test. The 'Cervical Cancer Screening and Adherence to Follow-up Among Hispanic Women' study is a collaboration between a research institution and community partners made up of members from community based organizations, the Yakima Valley Farm Workers Clinic and the Breast, Cervical, and Colon Health Program of the Yakima District . The study will assess the efficacy of two culturally-appropriate, tailored educational programs designed to increase cervical cancer screening among Hispanic women, based in the Yakima Valley, Washington, US. Methods/design A parallel randomized-controlled trial of 600 Hispanic women aged 21–64, who are non-compliant with Papanicolau (Pap test screening guidelines. Participants will be randomized using block randomization to (1 a control arm (usual care; (2 a low-intensity information program, consisting of a Spanish-language video that educates women on the importance of cervical cancer screening; or (3 a high-intensity program consisting of the video plus a ‘promotora’ or lay-community health educator-led, home based intervention to encourage cervical cancer screening. Participants who attend cervical cancer screening, and receive a diagnosis of an abnormal Pap test will be assigned to a patient navigator who will provide support and information to promote adherence to follow-up tests, and any necessary surgery or treatment. Primary endpoint: Participants will be tracked via medical record review at community-based clinics, to identify women who have had a Pap test within 7 months of baseline assessment. Medical record reviewers will be blinded to randomization arm. Secondary endpoint: An evaluation of the patient

Qualitative evaluation of adherence therapy in Parkinson’s disease: a multidirectional model

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Daley DJ

2015-07-01

Full Text Available David James Daley,1,2 Katherine Helen O’Leary Deane,3 Richard John Gray,4 Rebekah Hill,3 Phyo Kyaw Myint5 1Norwich Medical School, Faculty of Medicine and Health Sciences, University of East Anglia, Norwich Research Park, 2Norfolk and Norwich University Hospital NHS Foundation Trust, 3School of Health Sciences, University of East Anglia, Norwich Research Park, Norwich, UK; 4Hamad Medical Corporation, Doha, Qatar; 5Epidemiology Group, School of Medicine and Dentistry, Institute of Applied Health Sciences, College of Life Sciences and Medicine, University of Aberdeen, Aberdeen, UK Background: Medication can control the symptoms of Parkinson’s disease (PD. Despite this, non-adherence with medication is prevalent in PD. Treatments for improving adherence with medication have been investigated in many chronic conditions, including PD. However, few researchers have evaluated their interventions qualitatively. We investigated the acceptability and potential mechanism of action of adherence therapy (AT in PD patients and their spouse/carers who received the intervention as part of a randomized controlled trial. Methods: Sixteen participants (ten patients and six spouses/carers who had recently completed the trial were purposely selected in order to cover a range of ages and disease severity. Semi-structured interviews were conducted in the participants’ homes. Data were transcribed and analyzed using a thematic approach. A second researcher, naïve to PD and AT, analyzed the data independently to limit bias. Results: The trial showed that AT significantly improved both medication adherence and quality of life in people with PD. Specifically, patients who received AT reported improvements in mobility, activities of daily living, emotional wellbeing, cognition, communication, and body discomfort. General beliefs about medication also significantly improved in those who received AT compared with controls. In the current qualitative evaluation, a

Improved Adherence to Vision Self-monitoring with the Vision and Memory Stimulating (VMS) Journal for Non-neovascular Age-related Macular Degeneration during a Randomized Controlled Trial

OpenAIRE

Bittner, Ava K; Torr-Brown, Sheryl; Arnold, Ellen; Nwankwo, Antonia; Beaton, Patricia; Rampat, Radhika; Dagnelie, Gislin; Roser, Mark

2014-01-01

Objective An educational, interactive journal [Vision and Memory Stimulating (VMS) journal] was developed to boost patient confidence and promote long-term adherence with weekly vision self-monitoring in age-related macular degeneration (AMD) patients at risk for vision loss from new-onset neovascularization. Methods In a multicenter randomized controlled trial, 198 subjects with intermediate stage, non-neovascular AMD received the VMS journal or followed usual care (e.g. their doctor’s instr...

Treatment Adherence, Competence, and Outcome in Individual and Family Therapy for Adolescent Behavior Problems

OpenAIRE

Hogue, Aaron; Henderson, Craig E.; Dauber, Sarah; Barajas, Priscilla C.; Fried, Adam; Liddle, Howard A.

2008-01-01

This study examined the impact of treatment adherence and therapist competence on treatment outcome in a controlled trial of individual cognitive–behavioral therapy (CBT) and multidimensional family therapy (MDFT) for adolescent substance use and related behavior problems. Participants included 136 adolescents (62 CBT, 74 MDFT) assessed at intake, discharge, and 6-month follow-up. Observational ratings of adherence and competence were collected on early and later phases of treatment (192 CBT ...

Adherence to AHA Guidelines When Adapted for Augmented Reality Glasses for Assisted Pediatric Cardiopulmonary Resuscitation: A Randomized Controlled Trial.

Science.gov (United States)

Siebert, Johan N; Ehrler, Frederic; Gervaix, Alain; Haddad, Kevin; Lacroix, Laurence; Schrurs, Philippe; Sahin, Ayhan; Lovis, Christian; Manzano, Sergio

2017-05-29

The American Heart Association (AHA) guidelines for cardiopulmonary resuscitation (CPR) are nowadays recognized as the world's most authoritative resuscitation guidelines. Adherence to these guidelines optimizes the management of critically ill patients and increases their chances of survival after cardiac arrest. Despite their availability, suboptimal quality of CPR is still common. Currently, the median hospital survival rate after pediatric in-hospital cardiac arrest is 36%, whereas it falls below 10% for out-of-hospital cardiac arrest. Among emerging information technologies and devices able to support caregivers during resuscitation and increase adherence to AHA guidelines, augmented reality (AR) glasses have not yet been assessed. In order to assess their potential, we adapted AHA Pediatric Advanced Life Support (PALS) guidelines for AR glasses. The study aimed to determine whether adapting AHA guidelines for AR glasses increased adherence by reducing deviation and time to initiation of critical life-saving maneuvers during pediatric CPR when compared with the use of PALS pocket reference cards. We conducted a randomized controlled trial with two parallel groups of voluntary pediatric residents, comparing AR glasses to PALS pocket reference cards during a simulation-based pediatric cardiac arrest scenario-pulseless ventricular tachycardia (pVT). The primary outcome was the elapsed time in seconds in each allocation group, from onset of pVT to the first defibrillation attempt. Secondary outcomes were time elapsed to (1) initiation of chest compression, (2) subsequent defibrillation attempts, and (3) administration of drugs, as well as the time intervals between defibrillation attempts and drug doses, shock doses, and number of shocks. All these outcomes were assessed for deviation from AHA guidelines. Twenty residents were randomized into 2 groups. Time to first defibrillation attempt (mean: 146 s) and adherence to AHA guidelines in terms of time to other

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

Directory of Open Access Journals (Sweden)

Zheng Hua

2011-10-01

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

Current issues in patient adherence and persistence: focus on anticoagulants for the treatment and prevention of thromboembolism

Directory of Open Access Journals (Sweden)

Patrick P Kneeland

2010-03-01

Full Text Available Patrick P Kneeland, Margaret C FangThe University of California, San Francisco Division of Hospital Medicine, San Francisco, CA, USAAbstract: Warfarin therapy reduces morbidity and mortality related to thromboembolism. Yet adherence to long-term warfarin therapy remains challenging due to the risks of anticoagulantassociated complications and the burden of monitoring. The aim of this paper is to review determinants of adherence and persistence on long-term anticoagulant therapy for atrial fibrillation and venous thromboembolism. We evaluate what the current literature reveals about the impact of warfarin on quality of life, examine warfarin trial data for patterns of adherence, and summarize known risk factors for warfarin discontinuation. Studies suggest only modest adverse effects of warfarin on quality of life, but highlight the variability of individual lifestyle experiences of patients on warfarin. Interestingly, clinical trials comparing anticoagulant adherence to alternatives (such as aspirin show that discontinuation rates on warfarin are not consistently higher than in control arms. Observational studies link a number of risk factors to warfarin non-adherence including younger age, male sex, lower stroke risk, poor cognitive function, poverty, and higher educational attainment. In addition to differentiating the relative impact of warfarin-associated complications (such as bleeding versus the lifestyle burdens of warfarin monitoring on adherence, future investigation should focus on optimizing patient education and enhancing models of physician–patient shared-decision making around anticoagulation.Keywords: anticoagulation, warfarin, adherence, persistence, thromboembolism

Effectiveness and sustainability of a structured group-based educational program (MEDIHEALTH) in improving medication adherence among Malay patients with underlying type 2 diabetes mellitus in Sarawak State of Malaysia: study protocol of a randomized controlled trial.

Science.gov (United States)

Ting, Chuo Yew; Ahmad Zaidi Adruce, Shahren; Hassali, Mohamed Azmi; Ting, Hiram; Lim, Chien Joo; Ting, Rachel Sing-Kiat; Abd Jabar, Abu Hassan Alshaari; Osman, Nor Anizah; Shuib, Izzul Syazwan; Loo, Shing Chyi; Sim, Sui Theng; Lim, Su Ee; Morisky, Donald E

2018-06-05

Amidst the high disease burden, non-adherence to medications among patients with type 2 diabetes mellitus (T2DM) has been reported to be common and devastating. Sarawak Pharmaceutical Services Division has formulated a pharmacist-led, multiple-theoretical-grounding, culturally sensitive and structured group-based program, namely "Know Your Medicine - Take if for Health" (MEDIHEALTH), to improve medication adherence among Malay patients with T2DM. However, to date, little is known about the effectiveness and sustainability of the Program. This is a prospective, parallel-design, two-treatment-group randomized controlled trial to evaluate the effectiveness and sustainability of MEDIHEALTH in improving medication adherence. Malay patients who have underlying T2DM, who obtain medication therapy at Petra Jaya Health Clinic and Kota Samarahan Health Clinic, and who have a moderate to low adherence level (8-item Morisky Medication Adherence Scale, Malaysian specific, score sustainability of the Program will be triangulated by findings from semi-structured interviews with five selected participants conducted 1 month after the intervention and in-depth interviews with two main facilitators and two managerial officers in charge of the Program 12 months after the intervention. Statistical analyses of quantitative data were conducted using SPSS version 22 and Stata version 14. Thematic analysis for qualitative data were conducted with the assistance of ATLAS.ti 8. This study provides evidence on the effectiveness and sustainability of a structured group-based educational program that employs multiple theoretical grounding and a culturally sensitive approach in promoting medication adherence among Malays with underlying T2DM. Both the quantitative and qualitative findings of this study could assist in the future development of the Program. National Medical Research Register, NMRR-17-925-35875 (IIR). Registered on 19 May 2017. ClinicalTrials.gov, NCT03228706 . Registered on 25

CHILDREN'S ADHERENCE TO HAART ADHERENCE

African Journals Online (AJOL)

han or equal IQ 2 log" and in 64% of children wirh smaller man 2 log,o decrease in viral load. Secondly, i caregivers are not well prepared for adherence issues before starting HAART, or if regimens are too onerous to follow, treatment is likely to fail. Every effort should be made to see the burden of adherence from the.

Medication Adherence Apps: Review and Content Analysis.

Science.gov (United States)

Ahmed, Imran; Ahmad, Niall Safir; Ali, Shahnaz; Ali, Shair; George, Anju; Saleem Danish, Hiba; Uppal, Encarl; Soo, James; Mobasheri, Mohammad H; King, Dominic; Cox, Benita; Darzi, Ara

2018-03-16

further analyzed to identify strategies used to improve medication adherence. This identified three broad categories of adherence strategies, reminder, behavioral, and educational. A total of 250 apps utilized a single method, 149 apps used two methods, and only 22 apps utilized all three methods. To our knowledge, this is the first study to systematically review all available medication adherence apps on the two largest app repositories. The results demonstrate a concerning lack of HCP involvement in app development and evidence base of effectiveness. More collaboration is required between relevant stakeholders to ensure development of high quality and relevant adherence apps with well-powered and robust clinical trials investigating the effectiveness of these interventions. A sound evidence base will encourage the adoption of effective adherence apps, and thus improve patient welfare in the process. ©Imran Ahmed, Niall Safir Ahmad, Shahnaz Ali, Shair Ali, Anju George, Hiba Saleem Danish, Encarl Uppal, James Soo, Mohammad H Mobasheri, Dominic King, Benita Cox, Ara Darzi. Originally published in JMIR Mhealth and Uhealth (http://mhealth.jmir.org), 16.03.2018.

Protocol for the Osteoporosis Choice trial. A pilot randomized trial of a decision aid in primary care practice

Directory of Open Access Journals (Sweden)

Tulledge-Scheitel Sidna M

2009-12-01

Full Text Available Abstract Background Bisphosphonates can reduce fracture risk in patients with osteoporosis, but many at-risk patients do not start or adhere to these medications. The aims of this study are to: (1 preliminarily evaluate the effect of an individualized 10-year osteoporotic fracture risk calculator and decision aid (OSTEOPOROSIS CHOICE for postmenopausal women at risk for osteoporotic fractures; and (2 assess the feasibility and validity (i.e., absence of contamination of patient-level randomization (vs. cluster randomization in pilot trials of decision aid efficacy. Methods/Design This is a protocol for a parallel, 2-arm, randomized trial to compare an intervention group receiving OSTEOPOROSIS CHOICE to a control group receiving usual primary care. Postmenopausal women with bone mineral density T-scores of STEOPOROSIS CHOICE on five outcomes: (a patient knowledge regarding osteoporosis risk factors and treatment; (b quality of the decision-making process for both the patient and clinician; (c patient and clinician acceptability and satisfaction with the decision aid; (d rate of bisphosphonate use and adherence, and (e trial processes (e.g., ability to recruit participants, collect patient outcomes. To capture these outcomes, we will use patient and clinician surveys following each visit and video recordings of the clinical encounters. These video recordings will also allow us to determine the extent to which clinicians previously exposed to the decision aid were able to recreate elements of the decision aid with control patients (i.e., contamination. Pharmacy prescription profiles and follow-up phone interviews will assess medication start and adherence at 6 months. Discussion This pilot trial will provide evidence of feasibility, validity of patient randomization, and preliminary efficacy of a novel approach -- decision aids -- to improving medication adherence for postmenopausal women at risk of osteoporotic fractures. The results will inform

Do improved patient recall and the provision of memory support enhance treatment adherence?

Science.gov (United States)

Dong, Lu; Lee, Jason Y; Harvey, Allison G

2017-03-01

Patient adherence to psychosocial treatment is an important but understudied topic. The aim of this study was to examine whether better patient recall of treatment contents and therapist use of memory support (MS) were associated with better treatment adherence. Data were drawn from a pilot randomized controlled trial. Participants were 48 individuals (mean age = 44.27 years, 29 females) with Major Depressive Disorder randomized to receive either Cognitive Therapy (CT) with an adjunctive Memory Support Intervention (CT + Memory Support) or CT-as-usual. Therapist and patient ratings of treatment adherence were collected during each treatment session. Patient recall was assessed at mid-treatment. Therapist use of MS was manually coded for a random selection of sessions. Patient recall was significantly associated with better therapist and patient ratings of adherence. Therapist use of Application, a specific MS strategy, predicted higher therapist ratings of adherence. Attention Recruitment, another specific MS strategy, appeared to attenuate the positive impact of session number on patient ratings of adherence. Treatment groups, MS summary scores and other specific MS strategies were not significantly associated with adherence. The measure for treatment adherence is in the process of being formally validated. Results were based on small sample. These results support the importance of patient recall in treatment adherence. Although collectively the effects of MS on treatment adherence were not significant, the results support the use of certain specific MS strategy (i.e., application) as a potential pathway to improve treatment adherence. Larger-scale studies are needed to further examine these constructs. Copyright © 2016 Elsevier Ltd. All rights reserved.

Accurate assessment of adherence: self-report and clinician report vs electronic monitoring of nebulizers.

Science.gov (United States)

Daniels, Tracey; Goodacre, Lynne; Sutton, Chris; Pollard, Kim; Conway, Steven; Peckham, Daniel

2011-08-01

People with cystic fibrosis have a high treatment burden. While uncertainty remains about individual patient level of adherence to medication, treatment regimens are difficult to tailor, and interventions are difficult to evaluate. Self- and clinician-reported measures are routinely used despite criticism that they overestimate adherence. This study assessed agreement between rates of adherence to prescribed nebulizer treatments when measured by self-report, clinician report, and electronic monitoring suitable for long-term use. Seventy-eight adults with cystic fibrosis were questioned about their adherence to prescribed nebulizer treatments over the previous 3 months. Self-report was compared with clinician report and stored adherence data downloaded from the I-Neb nebulizer system. Adherence measures were expressed as a percentage of the prescribed regimen, bias was estimated by the paired difference in mean (95% CI) patient and clinician reported and actual adherence. Agreement between adherence measures was calculated using intraclass correlation coefficients (95% CI), and disagreements for individuals were displayed using Bland-Altman plots. Patient-identified prescriptions matched the medical record prescription. Median self-reported adherence was 80% (interquartile range, 60%-95%), whereas median adherence measured by nebulizer download was 36% (interquartile range, 5%-84.5%). Nine participants overmedicated and underreported adherence. Median clinician report ranged from 50% to 60%, depending on profession. Extensive discrepancies between self-report and clinician report compared with nebulizer download were identified for individuals. Self- and clinician-reporting of adherence does not provide accurate measurement of adherence when compared with electronic monitoring. Using inaccurate measures has implications for treatment burden, clinician prescribing practices, cost, and accuracy of trial data.

Adherence to antidepressants

Directory of Open Access Journals (Sweden)

Abimbola Farinde

2013-01-01

Full Text Available While major depression is considered a frequent mental illness there are ongoing reports of high non-adherence to antidepressant medications which places suffers at high risk for relapse, recurrence, or greater impairment,. The World Health Organization (WHO defines adherence as the extent to which a person′s behavior (e.g. taking medications can align with the agreed recommendations of a health care provider. Unfortunately while patient may recognize the importance of adherence to antidepressant medications the majority of patients do not adhere to their prescribed antidepressants. Some of the factors that may contribute to or lead to non-adherence include knowingly or unknowingly missing doses, taking extra doses, delaying administration times, or taking drug holidays. Pharmacists have the unique ability to deter non-adherence through the performance of continuous assessment and monitoring of adherence in this population given these accessibility. Additionally, pharmacists are able to develop therapeutic alliances with patients that can help to increase the likelihood of achieving positive patient outcomes. Antidepressant non-adherence can be viewed as a significant public health concern so it is important for patients to be educated about the importance of adherence, and health care professionals should be aware of factors or patient characteristics that can serve as barriers to non-adherence.

Mobile technology for medication adherence in people with mood disorders: A systematic review.

Science.gov (United States)

Rootes-Murdy, Kelly; Glazer, Kara L; Van Wert, Michael J; Mondimore, Francis M; Zandi, Peter P

2018-02-01

Medication non-adherence is a critical challenge for many patients diagnosed with mood disorders (Goodwin and Jamison, 1990). There is a need for alternative strategies that improve adherence among patients with mood disorders that are cost-effective, able to reach large patient populations, easy to implement, and that allow for communication with patients outside of in-person visits. Technology-based approaches to promote medication adherence are increasingly being explored to address this need. The aim of this paper is to provide a systematic review of the use of mobile technologies to improve medication adherence in patients with mood disorders. A total of nine articles were identified as describing mobile technology targeting medication adherence in mood disorder populations. Results showed overall satisfaction and feasibility of mobile technology, and reduction in mood symptoms; however, few examined effectiveness of mobile technology improving medication adherence through randomized control trials. Given the limited number of studies, further research is needed to determine long term effectiveness. Mobile technologies has the potential to improve medication adherence and can be further utilized for symptom tracking, side effects tracking, direct links to prescription refills, and provide patients with greater ownership over their treatment progress. Copyright © 2017 Elsevier B.V. All rights reserved.

Defining success with HIV pre-exposure prophylaxis: A prevention-effective adherence paradigm

Science.gov (United States)

Haberer, Jessica E.; Bangsberg, David R.; Baeten, Jared M.; Curran, Kathryn; Koechlin, Florence; Amico, K. Rivet; Anderson, Peter; Mugo, Nelly; Venter, Francois; Goicochea, Pedro; Caceres, Carlos; O’Reilly, Kevin

2015-01-01

Clinical trial data have shown that oral pre-exposure prophylaxis (PrEP) is efficacious when taken as prescribed; however, PrEP adherence is complex and must be understood within the context of variable risk for HIV infection and use of other HIV prevention methods. Different levels of adherence may be needed in different populations to achieve HIV prevention, and the optimal methods for achieving the necessary adherence for both individual and public health benefits are unknown. Guidance for PrEP use must consider these questions to determine the success of PrEP-based HIV prevention programs. In this article, we propose a new paradigm for understanding and measuring PrEP adherence, termed prevention-effective adherence, which incorporates dynamic HIV acquisition risk behaviors and the use of HIV alternative prevention strategies. We discuss the need for daily PrEP use only during periods of risk for HIV exposure, describe key issues for measuring and understanding relevant behaviors, review lessons from another health prevention field (i.e., family planning), and provide guidance for prevention-effective PrEP use. Moreover, we challenge emerging calls for sustained, near perfect PrEP adherence regardless of risk exposure and offer a more practical and public health-focused vision for this prevention intervention. PMID:26103095

The effect of providing feedback on inhaler technique and adherence from an electronic audio recording device, INCA®, in a community pharmacy setting: study protocol for a randomised controlled trial.

Science.gov (United States)

O'Dwyer, Susan Mary; MacHale, Elaine; Sulaiman, Imran; Holmes, Martin; Hughes, Cian; D'Arcy, Shona; Rapcan, Viliam; Taylor, Terence; Boland, Fiona; Bosnic-Anticevich, Sinthia; Reilly, Richard B; Ryder, Sheila A; Costello, Richard W

2016-05-04

time relative to the prescribed interval. Secondary outcomes include exacerbation rates and quality of life measures. Differences in the timing and technique of inhaler use as altered by the interventions will also be assessed. Data will be analysed on an intention-to-treat and a per-protocol basis. Sample size has been calculated with reference to comparisons to be made between the intervention and comparator clusters and indicates 75 participants per cluster. With an estimated 10 % loss to follow-up we will be able to show a 20 % difference between the population means of the intervention and comparator groups with a power of 0.8. The Type I error probability associated with the test of the null hypothesis is 0.05. This clinical trial will establish whether providing personalised feedback to individuals on their inhaler use improves adherence. It may also be possible to enhance the role of pharmacists in clinical care by identifying patients in whom alteration of either therapy or inhaler device is appropriate. ClinicalTrials.gov NCT02203266 .

Treating Depression and Adherence (CBT-AD) in Patients with HIV in Care: A Three-arm Randomized Controlled Trial

Science.gov (United States)

Safren, Steven A.; Bedoya, C. Andres; O’Cleirigh, Conall; Biello, Katie B.; Pinkston, Megan M.; Stein, Michael D.; Traeger, Lara; Kojic, Erna; Robbins, Gregory K.; Lerner, Jonathan A.; Herman, Debra S.; Mimiaga, Matthew J.; Mayer, Kenneth H.

2016-01-01

Summary Background Depression, highly prevalent in HIV, is consistently associated with worse ART adherence. Integrating CBT for depression with adherence counseling using the “Life-Steps” approach (CBT-AD) has an emerging evidence base. The aim of the current study was to test the efficacy of CBT-AD. Methods We conducted a three-arm RCT (N=240 HIV-positive adults with depression), comparing CBT-AD to Life-Steps integrated with information and supportive psychotherapy (ISP-AD) (both 12 sessions), and to ETAU (1 session Life-Steps). Participants were recruited from three sites in New England area, two being hospital settings, and one being a community health center. Randomization was done via a 2:2:1 ratio, using random allocation software by the data manager, in pairs, stratified by three variables: site, whether or not the participant was prescribed antidepressant medications, and history of injection drug use. The primary outcome was adherence assessed via electronic pill caps (MEMs) with correction for “pocketed” doses. Secondary outcomes included depression, plasma HIV RNA and CD4. Follow-ups occurred at 4, 8 and 12 months. We used intent-to treat analyses with ANCOVA for independent-assessor pre-post assessments of depression and mixed effects modeling for longitudinal assessments. Clinical Trial Registration: NCT00951028, https://clinicaltrials.gov/ct2/show/NCT00951028), closed to new participants. Findings The period of recruitment was February 26, 2009 to June 21, 2012, with the 12-month follow-up period extending until April 29, 2013. There were no study-related adverse events. CBT-AD (n=94 randomized, 83 retained) had greater improvements in adherence (Est.=1·00, CI=0·34, 1·66, p=0·003) and depression (CES-D Est.=−0·41, CI=−0·66, −0·16, p=0·001; MADRS Est.=−4·69, CI=−8·09, −1·28, p=0·007; CGI Est.=−0·66, CI=−1·11,-0·21, p=0·005) than ETAU (49 randomized, 46 retained) at post-treatment (4-month). Over follow-ups, CBT

The Effect on Treatment Adherence of Administering Drugs as Fixed-Dose Combinations versus as Separate Pills: Systematic Review and Meta-Analysis

NARCIS (Netherlands)

van Galen, Katy A.; Nellen, Jeannine F.; Nieuwkerk, Pythia T.

2014-01-01

Administering drugs as fixed-dose combinations (FDCs) versus the same active drugs administered as separate pills is assumed to enhance treatment adherence. We synthesized evidence from randomized controlled trials (RCTs) about the effect of FDCs versus separate pills on adherence. We searched

Short- and long-term effects of real-time medication monitoring with short message service (SMS) reminders for missed doses on the refill adherence of people with Type 2 diabetes: evidence from a randomised controlled trial.

NARCIS (Netherlands)

Vervloet, M.; Dijk, L. van; Bakker, D.H. de; Souverein, P.C.; Santen-Reestman, J.; Vlijmen, B. van; Aarle, M.C.W. van; Hoek, L.S. van der; Bouvy, M.L.

2014-01-01

Aims: To investigate short- and long-term effects of real-time monitoring medication use combined with short message service (SMS) reminders for missed doses on refill adherence to oral anti-diabetic medication. Methods: A randomized controlled trial with two intervention groups and one control

Knowledge, Attitudes, and Experiences of HIV Pre-Exposure Prophylaxis (PrEP) Trial Participants in Botswana.

Science.gov (United States)

Toledo, Lauren; McLellan-Lemal, Eleanor; Henderson, Faith L; Kebaabetswe, Poloko M

2015-03-01

Recent clinical trials have shown that a daily dose of oral TDF/FTC pre-exposure prophylaxis (PrEP) is effective in reducing human immunodeficiency (HIV) risk. Understanding trial participants' perspectives about retention and PrEP adherence is critical to inform future PrEP trials and the scale-up and implementation of PrEP programs. We analyzed 53 in-depth interviews conducted in April 2010 with participants in the TDF2 study, a Phase 3, randomized, double-blind, placebo-controlled clinical trial of daily oral TDF/FTC with heterosexual men and women in Francistown and Gaborone, Botswana. We examined participants' knowledge, attitudes, and experiences of the trial, identified facilitators and barriers to enrollment and retention, and compared participant responses by study site, sex, and study drug adherence. Our findings point to several factors to consider for participant retention and adherence in PrEP trials and programs, including conducting pre-enrollment education and myth reduction counseling, providing accurate estimates of participant obligations and side effect symptoms, ensuring participant understanding of the effects of non-adherence, gauging personal commitment and interest in study outcomes, and developing a strong external social support network for participants.

Role for automated communication strategies in medication adherence management.

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Ross, S Michael

2008-11-01

Lack of medication adherence is a prevalent problem that causes a broad range of health-and health-economics-related issues. Adherence management is therefore an important strategy, but it also presents its own set of challenges. Interventional communication from care support teams at managed care organizations and disease management and wellness programs has proved effective at modifying patients' medication adherence and reporting behaviors. However, these communications do not work well from an economic standpoint. It is not economically feasible to scale call centers and the numbers of clinical and professional staff to communicate with the increasing number of patients with chronic diseases who require ongoing medication use. Using communication automation to augment traditional call center outreach can help to mediate patient medication-taking behaviors. Specific design criteria for the automation of this interaction are discussed in this article, offering supporting data from a recent trial of 304 elderly patients with hypertension, and showing the benefits of using such a system for effective blood pressure monitoring, at reduced costs.

Adherence as a predictor of sexual behaviors in people living with HIV/AIDS during the first year of antiretroviral therapy in rural Cameroon: data from Stratall ANRS 12110/ESTHER trial.

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Gilbert Ndziessi

Full Text Available This study aims to investigate the time pattern of inconsistence condom use (ICU during the first year of antiretroviral therapy (ART and its relationship with treatment adherence in naïve HIV-infected adult patients.Data collection was nested within a longitudinal trial on HIV treatment. ICU was defined as reporting to have "never", "sometimes" or "nearly always" used condoms with one's main or casual partner(s--either HIV-negative or of unknown HIV status in the three previous months. Adherence was defined as taking 100% of their ART prescribed doses in the 4 days before the visit and "not having interrupted treatment", even once, for more than two consecutive days during the 4 previous weeks. Mixed logistic regression was used to study the relationship between adherence and ICU.Among the 459 patients enrolled, 212 (46% during 334 visits reported to have had sexual intercourse at least once with their partner(s--either HIV-negative or of unknown HIV status--during the first 12 months of ART. The proportion of ICU was 76%, 50% and 59% at month 0 (M0, month 6 (M6 and month 12 (M12, while 60% and 66% of patients were ART-adherent at M6 and M12, respectively. After adjustment for the frequency of sexual activity, type of sexual partner(s, perceived social class and desire for a child, patients adherent to ART were less likely to report ICU when compared with baseline (AOR [95% CI]: 0.38 [0.19-0.76]; P = 0.006.Adherence to ART is associated with a lower risk of ICU but this result needs to be interpreted carefully. As adherence behaviors are not only determined by problems with the healthcare systems but also by social barriers encountered by patients in their daily life, counseling should not only be ART adherence-centered but also patient-centered, including sexual risk minimization and psychosocial support.

Self-Report and Dry Blood Spot Measurement of Antiretroviral Medications as Markers of Adherence in Pregnant Women in Rural South Africa.

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Alcaide, Maria L; Ramlagan, Shandir; Rodriguez, Violeta J; Cook, Ryan; Peltzer, Karl; Weiss, Stephen M; Sifunda, Sibusiso; Jones, Deborah L

2017-07-01

Antiretroviral (ARV) adherence is essential to prevent mother-to-child transmission of HIV. This study compared self-reported adherence versus ARV detection in dried blood spots (DBS) among N = 392 HIV-infected pregnant women in South Africa (SA). Women completed two self-reported adherence measures [visual analog scale (VAS), AIDS Clinical Trials Group Adherence (ACTG)]. Adherence was 89% (VAS), 80% (ACTG), and 74% (DBS). Self-report measures marginally agreed with DBS (VAS: Kappa = 0.101, Area under the ROC curve (AUROC) = 0.543; ACTG: Kappa  = 0.081, AUROC = 0.538). Self-reported adherence was overestimated and agreement with DBS was poor. Validation of self-reported ARV adherence among pregnant HIV+ women in SA is needed.

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

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Prados-Torres Daniel

2011-02-01

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

Adherence to an Aerobic Exercise Intervention after an Implantable Cardioverter Defibrillator (ICD).

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Dougherty, Cynthia M; Luttrell, Matilda N; Burr, Robert L; Kim, Misun; Haskell, William L

2016-02-01

Exercise adherence is an important element in achieving important exercise outcomes. The purpose of this study was to describe adherence in a home-based aerobic exercise program following an implantable cardioverter defibrillator (ICD), determine effects of adherence on peakVO2 , and outline reasons for nonadherence. A single-blind randomized control trial of home walking compared to usual care in 160 patients with an ICD for primary or secondary prevention was conducted. This report is on adherence in the exercise arm (N = 84). Home walking exercise consisted of 8 weeks of aerobic conditioning (60 minutes/day, 5 days/week) followed by 16 weeks of aerobic maintenance (150 minutes/week, 30 minutes/session) at 60-80% of heart rate reserve. Adherence was tracked using Polar heart rate (HR) monitors, pedometers, home exercise logs, and telephone follow-up. Adherence was defined as performing at least 80% of prescribed exercise. For aerobic conditioning, there was a mean frequency of 3.81 walks/week, duration of 1,873 minutes walked, and 17.5% of exercise was in the target HR (THR) zone. For aerobic maintenance, there was a mean frequency of 2.4 walks/week, duration of 1,872 minutes/walked, and 8.7% of exercise was in the THR zone. Those who were 80% adherent achieved a 3.4 mL/kg/min (P = 0.03) improvement in peakVO2 over those who were exercise ranged from scheduling issues to viral illness and fatigue. Adherence to aerobic exercise frequency and duration was high with few dropouts, resulting in higher peakVO2 . Exercise monitoring equipment encouraged adherence and conferred a sense of safety to exercise. ©2015 Wiley Periodicals, Inc.

Multifaceted Prospective Memory Intervention to Improve Medication Adherence.

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Insel, Kathie C; Einstein, Gilles O; Morrow, Daniel G; Koerner, Kari M; Hepworth, Joseph T

2016-03-01

To test whether a multifaceted prospective memory intervention improved adherence to antihypertensive medications and to assess whether executive function and working memory processes moderated the intervention effects. Two-group longitudinal randomized control trial. Community. Individuals aged 65 and older without signs of dementia or symptoms of severe depression who were self-managing prescribed medication. After 4 weeks of initial adherence monitoring using a medication event monitoring system, individuals with 90% or less adherence were randomly assigned to groups. The prospective memory intervention was designed to provide strategies that switch older adults from relying on executive function and working memory processes (that show effects of cognitive aging) to mostly automatic associative processes (that are relatively spared with normal aging) for remembering to take medications. Strategies included establishing a routine, establishing cues strongly associated with medication taking actions, performing the action immediately upon thinking about it, using a medication organizer, and imagining medication taking to enhance encoding and improve cuing. There was significant improvement in adherence in the intervention group (57% at baseline to 78% after the intervention), but most of these gains were lost after 5 months. The control condition started at 68% and was stable during the intervention, but dropped to 62%. Executive function and working memory moderated the intervention effect, with the intervention producing greater benefit for those with lower executive function and working memory. The intervention improved adherence, but the benefits were not sustained. Further research is needed to determine how to sustain the substantial initial benefits. © 2016, Copyright the Authors Journal compilation © 2016, The American Geriatrics Society.

Perspectives Regarding Adherence to Prescribed Treatment in Highly Adherent HIV-Infected Gay Men.

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Brion, John M; Menke, Edna M

2008-01-01

Focus group methodology was used to describe the medication adherence experience of 24 HIV-infected gay men who reported being adherent to their medication regimens. A conceptualization of medication adherence as an evolving process consisted of challenges to adherence (learning the diagnosis, starting the medications, struggling with the medications, dealing with side effects, coping with stigma) as well as those factors supportive of adherence (believing in medications, finding motivating factors, using reminders, depending on others, owning the disease). Themes associated with challenges to adherence focused on diagnosis and the physical and emotional adjustments individuals made to incorporate antiretroviral medications into their daily lives and move toward medication adherence. The factors supportive of adherence were related to the ongoing behaviors identified with establishing and maintaining adherence behaviors. What can be taken from the study is that adherence is a complex and dynamic process rather than a static behavior.

Interventions to increase adherence in patients taking immunosuppressive drugs after kidney transplantation: a systematic review of controlled trials.

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Mathes, Tim; Großpietsch, Kirsten; Neugebauer, Edmund A M; Pieper, Dawid

2017-11-29

Immunosuppressive drugs have to be taken through the whole duration of kidney transplant survival to avoid rejection. Low adherence can increase the risk of allograft rejection. The objective was to evaluate the effectiveness of adherence-enhancing interventions (AEI) in kidney transplantation recipients taking immunosuppressive drugs. A search was performed in Medline, Embase, CINAHL, and PsycINFO. The search was performed in May 2016. We included comparative studies on AEI for kidney transplant recipients taking immunosuppressive drugs. The primary outcome was medication adherence. All identified articles were screened according to the predefined inclusion criteria. The risk of bias was assessed with the Cochrane risk of bias tool. Study selection and risk of bias assessment were performed by two reviewers independently. Data were extracted in standardized tables. Data extraction was verified by a second reviewer. All discrepancies were resolved through discussion. Data were synthesized in a structured narrative way. There is no registered or published protocol for this systematic review. We identified 12 studies. The number of participants ranged from 24 to 1830. Nine studies included adults, two children, and one adults and children. Risk of bias was high. The main reasons for high risk of bias were inadequate allocation sequence (confounding) and that studies were not blinded. Eleven studies evaluated AEI consisting of educational and/or behavioral components. All these studies showed an effect direction in favor of the intervention. Intervention effect was only moderate. Most adherence measures in studies on educational and behavioral interventions showed statistically significant differences. Studies that combined educational and behavioral intervention components showed larger effects. All studies that were statistically significant were multimodal. Studies that included an individualized component and more intensive interventions showed larger effects. One

MEDICATION ADHERENCE IN ELDERLY WITH POLYPHARMACY LIVING AT HOME: A SYSTEMATIC REVIEW OF EXISTING STUDIES.

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Zelko, Erika; Klemenc-Ketis, Zalika; Tusek-Bunc, Ksenija

2016-04-01

We wanted to systematically review the available evidence to evaluate the drug adherence in elderly with polypharmacy living at home. We performed a literature search using MEDLINE, ISI Web of Science, ProQuest, EMBASE, SCOPUS, Springer Link, Sage Journals and CINAHL. We used the following terms: Medication Adherence, Medication Compliance, Polypharmacy, and Elderly. The search was limited to English-language articles. We included only clinical trials, systematic reviews, meta-analysis and cross-sectional studies. A total of seven articles were included in this systematic review after applying the search strategy. Six studies dealt with the prevalence of medication adherence and its correlates in patients aged 65 years or more with polypharmacy. Two studies dealt with the effect of various interventions on medication adherence in patients aged 65 years or more with polypharmacy. The available literature on the polypharmacy and drug adherence in elderly living at home is scarce and further studies are needed.

A systematic review of immunosuppressant adherence interventions in transplant recipients: Decoding the streetlight effect.

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Duncan, S; Annunziato, R A; Dunphy, C; LaPointe Rudow, D; Shneider, B L; Shemesh, E

2018-02-01

Non-adherence to immunosuppressant medications is an important risk factor for graft dysfunction. To evaluate the effectiveness of adherence-enhancing interventions, we reviewed adherence intervention studies in solid organ transplant recipients (all ages). Using the following databases: PsycINFO, PubMed, Scopus, and ScienceDirect, we identified 41 eligible studies. Only three non-randomized trials showed a possible positive effect on objective indicators of transplant outcomes (such as rejection, liver enzyme levels, kidney function). None of the 21 RCTs showed an improvement in transplant outcomes. Three studies showed a higher rate of adverse events in the intervention group as compared with controls, although this may be related to ascertainment bias. Improvement in adherence as measured indirectly (eg, with electronic monitoring devices) was not aligned with effects on transplant outcomes. We conclude that adherence interventions, to date, have largely been ineffective in improving transplant outcomes. To improve this track record, intervention efforts may wish to concentrate on non-adherent patients (rather than use convenience sampling, which excludes many of the patients who need the intervention), use direct measures of adherence to guide the interventions, and employ strategies that are intensive and yet engaging enough to ensure that non-adherent patients are able to participate. © 2017 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd.

Exergames versus self-regulated exercises with instruction leaflets to improve adherence during geriatric rehabilitation: a randomized controlled trial

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Oesch, Peter; Kool, Jan; Fernandez-Luque, Luis; Brox, Ellen; Evertsen, Gunn; Civit, Anton; Hilfiker, Roger; Bachmann, Stefan

2017-01-01

Background Improving mobility in elderly persons is a primary goal in geriatric rehabilitation. Self-regulated exercises with instruction leaflets are used to increase training volume but adherence is often low. Exergames may improve adherence. This study therefore compared exergames with self-regulated exercise using instruction leaflets. The primary outcome was adherence. Secondary outcomes were enjoyment, motivation and balance during walking. Methods Design: single center parallel group n...

Exergames versus self-regulated exercises with instruction leaflets to improve adherence during geriatric rehabilitation: a randomized controlled trial.

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Oesch, Peter; Kool, Jan; Fernandez-Luque, Luis; Brox, Ellen; Evertsen, Gunn; Civit, Anton; Hilfiker, Roger; Bachmann, Stefan

2017-01-01

BACKGROUND Improving mobility in elderly persons is a primary goal in geriatric rehabilitation. Self-regulated exercises with instruction leaflets are used to increase training volume but adherence is often low. Exergames may improve adherence. This study therefore compared exergames with self-regulated exercise using instruction leaflets. The primary outcome was adherence. Secondary outcomes were enjoyment, motivation and balance during walking. METHODS Design: single center para...

Exercise Intervention: Attrition, Compliance, Adherence, and Progression Following Hematopoietic Stem Cell Transplantation
.

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Peters, Tara; Erdmann, Ruby; Hacker, Eileen Danaher

2018-02-01

Exercise is widely touted as an effective intervention to optimize health and well-being after high-dose chemotherapy and hematopoietic stem cell transplantation. 
. This article reports attrition, compliance, adherence, and progression from the strength training arm of the single-blind randomized, controlled trial Strength Training to Enhance Early Recovery (STEER). 
. 37 patients were randomized to the intervention and participated in a structured strength training program introduced during hospitalization and continued for six weeks after release. Research staff and patients maintained exercise logs to document compliance, adherence, and progression. 
. No patients left the study because of burden. Patients were compliant with completion of exercise sessions, and their adherence was high; they also progressed on their exercise prescription. Because STEER balances intervention effectiveness with patient burden, the findings support the likelihood of successful translation into clinical practice.

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

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Grol Richard

2008-01-01

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

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

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Lavoie KL

2014-11-01

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

Adherence to a Depression Self-Care Intervention among Primary Care Patients with Chronic Physical Conditions: A Randomised Controlled Trial

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McCusker, Jane; Cole, Martin G.; Yaffe, Mark; Strumpf, Erin; Sewitch, Maida; Sussman, Tamara; Ciampi, Antonio; Lavoie, Kim; Belzile, Eric

2016-01-01

Objective: Among primary care patients with chronic physical conditions and comorbid depressive symptoms, to assess (1) the effect of lay telephone coaching on adherence to a psycho-educational intervention for depression, (2) demographic characteristics that predict adherence and (3) the association between adherence and 6-month outcomes. Design:…

Finding the minimal intervention needed for sustained mammography adherence.

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Gierisch, Jennifer M; DeFrank, Jessica T; Bowling, J Michael; Rimer, Barbara K; Matuszewski, Jeanine M; Farrell, David; Skinner, Celette Sugg

2010-10-01

Regular adherence to mammography screening saves lives, yet few women receive regular mammograms. RCT. Participants were recruited through a state employee health plan. All were women aged 40-75 years and had recent mammograms prior to enrollment (n=3547). Data were collected from 2004 to 2009. Trial tested efficacy of a two-step adaptively-designed intervention to increase mammography adherence over 4 years. The first intervention step consisted of three reminder types: enhanced usual care reminders (EUCR); enhanced letter reminders (ELR); both delivered by mail, and automated telephone reminders (ATR). After delivery of reminders, women who became off-schedule in any of the 4 years received a second step of supplemental interventions. Three supplemental intervention arms contained priming letters and telephone counseling: barriers only (BarriCall); barriers plus positive consequences of getting mammograms (BarriConCall+); and barriers plus negative consequences of not getting mammograms (BarriConCall-). Average cumulative number of days non-adherent to mammography over 4 years based on annual screening guidelines (analyses conducted in 2009). All reminders performed equally well in reducing number of days of non-adherence. Women randomized to receive supplemental interventions had significantly fewer days of non-adherence compared to women who received EUCR (p=0.0003). BarrConCall+ and BarrConCall- conditions did not significantly differ in days non-adherent compared to women in the barriers-only condition (BarriCon). The minimal intervention needed for sustained mammography use is a combination of a reminder followed by a priming letter and barrier-specific telephone counseling for women who become off-schedule. Additional costs associated with supplemental interventions should be considered by organizations deciding which interventions to use. NCT01148875. Copyright © 2010 American Journal of Preventive Medicine. Published by Elsevier Inc. All rights reserved.

Meta-analyses of Theory use in Medication Adherence Intervention Research

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

2016-01-01

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

Interventions to Improve Medication Adherence in Hypertensive Patients: Systematic Review and Meta-analysis.

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Conn, Vicki S; Ruppar, Todd M; Chase, Jo-Ana D; Enriquez, Maithe; Cooper, Pamela S

2015-12-01

This systematic review applied meta-analytic procedures to synthesize medication adherence interventions that focus on adults with hypertension. Comprehensive searching located trials with medication adherence behavior outcomes. Study sample, design, intervention characteristics, and outcomes were coded. Random-effects models were used in calculating standardized mean difference effect sizes. Moderator analyses were conducted using meta-analytic analogues of ANOVA and regression to explore associations between effect sizes and sample, design, and intervention characteristics. Effect sizes were calculated for 112 eligible treatment-vs.-control group outcome comparisons of 34,272 subjects. The overall standardized mean difference effect size between treatment and control subjects was 0.300. Exploratory moderator analyses revealed interventions were most effective among female, older, and moderate- or high-income participants. The most promising intervention components were those linking adherence behavior with habits, giving adherence feedback to patients, self-monitoring of blood pressure, using pill boxes and other special packaging, and motivational interviewing. The most effective interventions employed multiple components and were delivered over many days. Future research should strive for minimizing risks of bias common in this literature, especially avoiding self-report adherence measures.

Therapist adherence to manualized cognitive-behavioral therapy for anger management delivered to veterans with PTSD via videoconferencing.

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Morland, Leslie A; Greene, Carolyn J; Grubbs, Kathleen; Kloezeman, Karen; Mackintosh, Margaret-Anne; Rosen, Craig; Frueh, B Christopher

2011-06-01

Therapist adherence to a manualized cognitive-behavioral anger management group treatment (AMT) was compared between therapy delivered via videoconference (VC) and the traditional in-person modality, using data from a large, randomized controlled trial comparing the effectiveness of AMT for veterans with combat-related posttraumatic stress disorder. Therapist adherence was rated for the presence or absence of process and content treatment elements. Secondary analyses were conducted using a repeated measures ANOVA. Overall adherence to the protocol was excellent (M = 96%, SD = 1%). Findings indicate that therapist adherence to AMT is similar across delivery modalities and VC is a viable service delivery strategy that does not compromise a therapist's ability to effectively structure sessions and manage patient care. © 2011 Wiley Periodicals, Inc.

Adherence and Acceptability of a Multidrug Vaginal Ring for HIV Prevention in a Phase I Study in the United States.

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van der Straten, Ariane; Panther, Lori; Laborde, Nicole; Hoesley, Craig J; Cheng, Helen; Husnik, Marla J; Horn, Stephanie; Nel, Annalene; Soto-Torres, Lydia; Chen, Beatrice A

2016-11-01

We evaluated the adherence and acceptability of a vaginal ring containing dapivirine, maraviroc, or both drugs for 28 days during a Phase I placebo-controlled trial in 48 HIV-negative sexually abstinent U.S. women aged 18-40. Adherence was assessed weekly by clinical interview and computer-assisted self-interviewing; acceptability assessment occurred at the last product-use visit. Study retention was 98 % (47/48); 94 % (45/48) reported being fully adherent with ring use during the 28-day period. Two participants experienced the ring partially coming out. Analysis was blinded and behavioral data were combined across study groups. Most women reported being very comfortable having the ring in their vagina; 44 % preferred continuous use, whereas 51 % had no preference compared to episodic use. Although a range of minor ring concerns were expressed, few were actually experienced. High adherence to and acceptability of this vaginal ring in this Phase I trial contributes to its promise as a sustained mechanism for multidrug vaginal microbicide delivery.

Improving adherence to medication in adults with diabetes in the United Arab Emirates

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Mohammed M. M. Al-Haj Mohd

2016-08-01

Full Text Available Abstract Background Diabetes is a chronic medical condition and adherence to medication in diabetes is important. Improving medication adherence in adults with diabetes would help prevent the chronic complications associated with diabetes. A case control trial was used to study the effects of an educational session on medication adherence among adults with diabetes as measured by the Morisky Medication adherence scale (MMAS-8©. Methods The study took place at the Dubai Police Health Centre between February 2015 and November 2015. Questionnaires were used to collect socio-demographic, clinical and disease related variables and the primary measure of outcome was adherence levels as measured by the Morisky Medication Adherence Scale (MMAS-8©. The intervention group involved a standardized thirty minute educational session focusing on the importance of adherence to medication. The change in MMAS-8© was measured at 6 months. Results Four hundred and forty six patients were enrolled. Mean age 61 year +/− 11. 48.4 % were male. The mean time since diagnosis of diabetes was 3.2 years (Range 1–15 years. At baseline two hundred and eighty eight (64.6 % patients were considered non-adherent (MMAS-8© adherence score < 6 while 118 (26.5 % and 40 (9.0 % had low adherence (MMAS-8© adherence score < 6 and medium adherence (MMAS-8© adherence scores of 6 to 7 to their medication respectively. The percentage of patients scoring low adherence MMAS-8 scores in the interventional group dropped from 64.60 % at baseline to 44.80 % at 6-months (p = 0.01. There was no obvious change in the adherence scores at baseline and at 6-months in the control group. Based on the study data, the Wilcoxon signed-rank test showed that at 6 months, the educational 30-min session on diabetes and adherence to medication did elicit a statistically significant change in adherence levels in adults with diabetes enrolled in the intervention arm (Z = −6

Psychosocial Characteristics Associated with Both Antiretroviral Therapy Adherence and Risk Behaviors in Women Living with HIV.

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Holstad, Marcia McDonnell; Spangler, Sydney; Higgins, Melinda; Dalmida, Safiya George; Sharma, Sanjay

2016-05-01

The purpose of this study was to identify key psychosocial characteristics of HIV-infected women who exhibit different levels of both ART adherence and risk behaviors. We analyzed baseline data from 193 predominately African American HIV-infected women participating in a behavioral clinical trial. Women were categorized into high/low groups based on levels of adherence and risky behaviors. There was a significant interaction effect for internal motivation for adherence. Women at high risk for poor health and transmitting HIV (low adherence/high risk group) had the lowest levels of internal motivation and also reported more difficult life circumstances. Gender roles, caretaking and reliance on men for economic and other support may promote external versus internal motivation as well as riskier behaviors in this group. The highest levels of internal motivation were found in those with High Adherence/High Risk behaviors. This group was highly knowledgeable about HIV and had the lowest VL. Compared to others, this group seems to tolerate risky behaviors given their high level of adherence. Adherence and risk reduction behaviors are key to individual and public health. Motivation and risk compensation should be addressed when providing interventions to women living with HIV.

Adherence to Behavioral Interventions for Stress Incontinence: Rates, Barriers, and Predictors

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Burgio, Kathryn L.; Goode, Patricia S.; Ye, Wen; Weidner, Alison C.; Lukacz, Emily S.; Jelovsek, John-Eric; Bradley, Catherine S.; Schaffer, Joseph; Hsu, Yvonne; Kenton, Kimberly; Spino, Cathie

2013-01-01

Background First-line conservative treatment for stress urinary incontinence (SUI) in women is behavioral intervention, including pelvic-floor muscle (PFM) exercise and bladder control strategies. Objective The purposes of this study were: (1) to describe adherence and barriers to exercise and bladder control strategy adherence and (2) to identify predictors of exercise adherence. Design This study was a planned secondary analysis of data from a multisite, randomized trial comparing intravaginal continence pessary, multicomponent behavioral therapy, and combined therapy in women with stress-predominant urinary incontinence (UI). Methods Data were analyzed from the groups who received behavioral intervention alone (n=146) or combined with continence pessary therapy (n=150). Adherence was measured during supervised treatment and at 3, 6, and 12 months post-randomization. Barriers to adherence were surveyed during treatment and at the 3-month time point. Regression analyses were performed to identify predictors of exercise adherence during supervised treatment and at the 3- and 12-month time points. Results During supervised treatment, ≥86% of the women exercised ≥5 days a week, and ≥80% performed at least 30 contractions on days they exercised. At 3, 6, and 12 months post-randomization, 95%, 88%, and 80% of women, respectively, indicated they were still performing PFM exercises. During supervised treatment and at 3 months post-randomization, ≥87% of the women reported using learned bladder control strategies to prevent SUI. In addition, the majority endorsed at least one barrier to PFM exercise, most commonly “trouble remembering to do exercises.” Predictors of exercise adherence changed over time. During supervised intervention, less frequent baseline UI and higher baseline 36-Item Short-Form Health Survey (SF-36) mental scores predicted exercise adherence. At 3 months post-randomization, women who dropped out of the study had weaker PFMs at baseline. At

Epic Allies, a Gamified Mobile Phone App to Improve Engagement in Care, Antiretroviral Uptake, and Adherence Among Young Men Who Have Sex With Men and Young Transgender Women Who Have Sex With Men: Protocol for a Randomized Controlled Trial.

Science.gov (United States)

LeGrand, Sara; Muessig, Kathryn E; Platt, Alyssa; Soni, Karina; Egger, Joseph R; Nwoko, Nkechinyere; McNulty, Tobias; Hightow-Weidman, Lisa B

2018-04-05

In the United States, young men who have sex with men (YMSM) and transgender women who have sex with men (YTWSM) bear a disproportionate burden of prevalent and incident HIV infections. Once diagnosed, many YMSM and YTWSM struggle to engage in HIV care, adhere to antiretroviral therapy (ART), and achieve viral suppression. Computer-based interventions, including those focused on behavior change, are recognized as effective tools for engaging youth. The purpose of the study described in this protocol is to evaluate the efficacy of Epic Allies, a theory-based mobile phone app that utilizes game mechanics and social networking features to improve engagement in HIV care, ART uptake, ART adherence, and viral suppression among HIV-positive YMSM and YTWSM. The study also qualitatively assesses intervention acceptability, perceived impact, and sustainability. This is a two-group, active-control randomized controlled trial of the Epic Allies app. YMSM and YTWSM aged 16 to 24 inclusive, with detectable HIV viral load are randomized 1:1 within strata of new to care (newly entered HIV medical care ≤12 months of baseline visit) or ART-nonadherent (first entered HIV medical care >12 months before baseline visit) to intervention or control conditions. The intervention condition addresses ART adherence barriers through medication reminders and adherence monitoring, tracking of select adherence-related behaviors (eg, alcohol and marijuana use), an interactive dashboard that displays the participant's adherence-related behaviors and provides tailored feedback, encouragement messages from other users, daily HIV/ART educational articles, and gamification features (eg, mini-games, points, badges) to increase motivation for behavior change and app engagement. The control condition features weekly phone-based notifications to encourage participants to view educational information in the control app. Follow-up assessments are administered at 13, 26, and 39 weeks for each arm. The

Better quality of life in patients offered financial incentives for taking anti-psychotic medication: Linked to improved adherence or more money?

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Moran, Katherine; Priebe, Stefan

2016-08-01

In a randomised controlled trial, patients were offered financial incentives to improve their adherence to anti-psychotic maintenance medication. Compared to a control group without the incentives, they had an improved adherence and also better subjective quality of life (SQOL) after 1 year. This paper explores the question as to whether this improvement in SQOL was associated with the amount of money received or with the improved adherence itself. A secondary analysis was performed using data of the experimental group in the trial. Adherence was assessed as the percentage of all prescribed long-acting anti-psychotic injections that were taken by the patient. In regression models, we tested whether changes in medication adherence and/or the amount of incentives received over the 12-month period was associated with SQOL, as rated on the DIALOG scale. Adherence changed from 68.49 % at baseline to 88.23 % (mean difference in adherence = 19.59 %, SD = 17.52 %). The total amount of incentives received within the 1-year study period varied between £75 and £735, depending on the treatment cycle and the number of long-acting injections taken. Improvement in adherence was found to be a significant predictor of better subjective quality of life (β = 0.014, 95 % CI 0.003-0.025, p = 0.014), whilst the amount of incentives received was not (β = 0.0002, 95 % CI -0.002 to 0.002, p = 0.818). Improved medication adherence is associated with a more favourable SQOL. This underlines the clinical relevance of improved adherence in response to financial incentives in this patient group.

A randomized controlled trial with a Canadian electronic pill dispenser used to measure and improve medication adherence in patients with schizophrenia

OpenAIRE

Stip, Emmanuel; Vincent, Philippe D.; Sablier, Juliette; Guevremont, Catherine; Zhornitsky, Simon; Tranulis, Constantin

2013-01-01

Objective: Medication adherence is extremely important in preventing relapse and lowering symptoms in schizophrenic patients. However, estimates show that nearly half of these patients have poor adherence. The Brief Adherence Rating Scale (BARS) seems to be the most reliable tool assessing adherence in schizophrenia and shows that the antipsychotic adherence ratio (AAR) is about 49.5% in schizophrenia. The aim of the study was to test if an electronic pill dispenser named DoPill® improved AAR...

A randomized-controlled trial with a Canadian electronic pill dispenser used to measure and improve medication adherence in patients with schizophrenia

OpenAIRE

Emmanuel eStip; Emmanuel eStip; Emmanuel eStip; Philippe D. Vincent; Philippe D. Vincent; Philippe D. Vincent; Catherine eGuevremont; Simon eZhornitsky; Constantin eTranulis; Constantin eTranulis; Constantin eTranulis; Juliette eSablier; Juliette eSablier

2013-01-01

Objective: Medication adherence is extremely important in preventing relapse and lowering symptoms in schizophrenic patients. However, estimates show that nearly half of these patients have poor adherence. The Brief Adherence Rating Scale (BARS) seems to be the most reliable tool assessing adherence in schizophrenia and shows that the antipsychotic adherence ratio (AAR) is about 49.5 % in schizophrenia. The aim of the study was to test if an electronic pill dispenser named DoPill® improv...

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

Science.gov (United States)

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

2012-01-01

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. © 2012 Wiley Periodicals, Inc.

Self-reported adherence to oral cancer therapy: relationships with symptom distress, depression, and personal characteristics

Directory of Open Access Journals (Sweden)

Berry DL

2015-11-01

Full Text Available Donna L Berry,1–3 Traci M Blonquist,4 Fangxin Hong,4,5 Barbara Halpenny,1 Ann H Partridge2,3 1Phyllis F Cantor Center, Dana-Farber Cancer Institute, 2Medical Oncology, Department of Medicine, Dana-Farber Cancer Institute, 3Department of Medicine, Harvard Medical School, 4Department of Biostatistics and Computational Biology, Dana-Farber Cancer Institute, 5Department of Biostatistics, Harvard School of Public Health, Boston, MA, USA Background: Therapeutic cancer chemotherapy is most successful when complete dosing is achieved. Because many newer therapeutic agents are oral and self-administered by the patient, adherence is a concern. The purpose of our analysis was to explore relationships between adherence, patient characteristics, and barriers to adherence.Methods: This secondary analysis utilized self-reported data from a randomized trial of self-care management conducted at two cancer centers in the US. Symptom distress was measured using the 15-item Symptom Distress Scale (SDS-15 and depression with the Patient Health Questionnaire-9 (PHQ-9. Adherence to oral medication was self-reported using the 8-item Morisky Medication Adherence Scale (MMAS-8. Measures were collected via Web-based, study-specific software ~8 weeks after treatment start date. Odds of low/medium adherence (score <8 were explored using univariate logistic regression. Given the number of factors and possible relationships among factors, a classification tree was built in lieu of a multivariable logistic regression model.Results: Of the eligible participants enrolled, 77 were on oral therapy and 70 had an MMAS score. Forty-nine (70% reported a high adherence score (=8. Higher odds of low/medium adherence were associated with greater symptom distress (P=0.09, more depression (P=0.05, chemotherapy vs hormonal oral medication (P=0.03, being female (P=0.02, and being randomized to the control group in the parent trial (P=0.09. Conversely, high adherence was associated with

Can Telemedicine Improve Adherence to Resuscitation Guidelines for Critically Ill Children at Community Hospitals? A Randomized Controlled Trial Using High-Fidelity Simulation.

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Yang, Chris P; Hunt, Elizabeth A; Shilkofski, Nicole; Dudas, Robert; Egbuta, Chinyere; Schwartz, Jamie M

2017-07-01

Children transferred from community hospitals lacking specialized pediatric care are more seriously ill than those presenting to pediatric centers. Pediatric consultation and adherence to management guidelines improve outcomes. The aims of the study were (1) to assess whether telemedicine consultation in critical situations is feasible and (2) to compare the impact of pediatric critical care medicine (PCCM) consultation via telemedicine versus telephone on community hospital adherence to resuscitation guidelines through a randomized controlled telemedicine trial. In situ, high-fidelity simulation scenarios of critically ill children presenting to a community hospital and progressing to cardiopulmonary arrest were performed. Scenarios were randomized to PCCM consultation via telephone (control) or telemedicine (intervention). Primary outcome measure was proportion of teams who successfully defibrillated in 180 seconds or less from presentation of pulseless ventricular tachycardia. The following 30 scenarios were completed: 15 control and 15 intervention. Only 11 (37%) of 30 teams, defibrillated in 180 seconds or less from presentation of pulseless ventricular tachycardia; control: 6 (40%) of 15 versus intervention: 5 (33%) of 15, P = 0.7. Request for or use of backboard during cardiopulmonary resuscitation occurred in 24 (80%) of 30 scenarios; control: 9 (60%) of 15 versus intervention: 15 (100%) of 15, P = 0.006. Request for or use of stepstool during cardiopulmonary resuscitation occurred in 6 (20%) of 30 scenarios; control: 1 (7%) of 15 versus intervention: 5 (33%) of 15, P = 0.07. This study demonstrates the feasibility of using telemedicine to support acute management of children who present to community hospitals. Neither study arm adhered to current resuscitation guidelines and telemedicine consultation with PCCM experts was not associated with improvement. However, further research on optimizing telemedicine impact on the quality of pediatric care at

Mobile health (mHealth) based medication adherence measurement - a pilot trial using electronic blisters in diabetes patients.

Science.gov (United States)

Brath, Helmut; Morak, Jürgen; Kästenbauer, Thomas; Modre-Osprian, Robert; Strohner-Kästenbauer, Hermine; Schwarz, Mark; Kort, Willem; Schreier, Günter

2013-09-01

The aim of the present study was to evaluate a mobile health (mHealth) based remote medication adherence measurement system (mAMS) in elderly patients with increased cardiovascular risk treated for diabetes, high cholesterol and hypertension. Cardiovascular risk was defined as the presence of at least two out of the three risk factors: type 2 diabetes, hypercholesterolaemia and hypertension. For treatment of diabetes, hypercholesterolaemia and hypertension, four predefined routinely used drugs were selected. Drug adherence was investigated in a controlled randomized doctor blinded study with crossover design. The mAMS was used to measure and improve objectively the adherence by means of closed-loop interactions. The mean age of the 53 patients (30 female) was 69.4 ± 4.8 years. A total of 1654 electronic blisters were handed out. A statistically significant difference (P = 0.04) between the monitoring and the control phase was observed for the diabetes medication only. In a post-study questionnaire twenty-nine patients appreciated that their physician knew if and when they had taken their medications and 13 asked for more or automated communication with their physicians. Only one subject withdrew from the study because of technical complexity. The results indicate that mHealth based adherence management is feasible and well accepted by patients with increased cardiovascular risk. It may help to increase adherence, even in patients with high baseline adherence and, subsequently, lead to improved control of indicators including blood pressure and cholesterol concentrations. Electronic blisters can be used in a multi-medication regimen but need to be carefully designed for day-to-day application. © 2013 The British Pharmacological Society.

Employment-based reinforcement of adherence to depot naltrexone in unemployed opioid-dependent adults: a randomized controlled trial.

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Everly, Jeffrey J; DeFulio, Anthony; Koffarnus, Mikhail N; Leoutsakos, Jeannie-Marie S; Donlin, Wendy D; Aklin, Will M; Umbricht, Annie; Fingerhood, Michael; Bigelow, George E; Silverman, Kenneth

2011-07-01

Naltrexone can be used to treat opioid dependence, but patients refuse to take it. Extended-release depot formulations may improve adherence, but long-term adherence rates to depot naltrexone are not known. This study determined long-term rates of adherence to depot naltrexone and whether employment-based reinforcement can improve adherence. Participants who were inducted onto oral naltrexone were assigned randomly to contingency (n = 18) or prescription (n = 17) groups. Participants were offered six depot naltrexone injections and invited to work at the therapeutic workplace on week days for 26 weeks, where they earned stipends for participating in job skills training. Contingency participants were required to accept naltrexone injections to maintain workplace access and to maintain maximum pay. Prescription participants could work independently of whether they accepted injections. The therapeutic workplace, a model employment-based intervention for drug addiction and unemployment. Opioid-dependent unemployed adults. Depot naltrexone injections accepted and opiate-negative urine samples. Contingency participants accepted significantly more naltrexone injections than prescription participants (81% versus 42%), and were more likely to accept all injections (66% versus 35%). At monthly assessments (with missing urine samples imputed as positive), the groups provided similar percentages of samples negative for opiates (74% versus 62%) and for cocaine (56% versus 54%). Opiate-positive samples were more likely when samples were also positive for cocaine. Employment-based reinforcement can maintain adherence to depot naltrexone. Future research should determine whether persistent cocaine use compromises naltrexone's effect on opiate use. Workplaces may be useful for promoting sustained adherence to depot naltrexone. © 2011 The Authors, Addiction © 2011 Society for the Study of Addiction.

Hematology journals do not sufficiently adhere to reporting guidelines: a systematic review.

Science.gov (United States)

Wayant, C; Smith, C; Sims, M; Vassar, M

2017-04-01

Essentials Reporting guidelines and trial/review registration aim to limit bias in research. We systematically reviewed hematology journals to examine the use of these policies. Forty-eight percent of journals made no use of these policies. Improving the use of reporting guidelines will improve research for all stakeholders. Background Reporting guidelines and trial/review registration policies have been instituted in order to minimize bias and improve research practices. Objective The objective of this study was to investigate the policies of hematology journals concerning reporting guideline adoption and trial/review registration. Methods We performed a web-based data abstraction from the Instructions for Authors of 67 hematology journals catalogued in the Expanded Science Citation Index of the 2014 Journal Citation Reports to identify whether each journal required, recommended or made no mention of the following reporting guidelines: EQUATOR, ICMJE, CONSORT, MOOSE, QUOROM, PRISMA, STARD, STROBE, ARRIVE and CARE. We also extracted whether journals required or recommended trial or systematic review registration. We e-mailed editors three times to determine which types of studies their journal accepts. Results Forty-eight per cent (32/67) of hematology journals do not adhere to any reporting guidelines. For responding journals, the QUOROM statement, MOOSE, CARE and PROSPERO were the least often mentioned, whereas the ICMJE guidelines, CONSORT statement and general trial registration were most often mentioned. Discussion Reporting guidelines are infrequently required or recommended by hematology journals. Furthermore, few require clinical trial or systematic review database registration. A higher rate of adherence to reporting guidelines can prevent bias from entering the literature. Participation from all stakeholders, including authors and journal editors, to improve reporting guideline and policy practices is required. © 2017 International Society on Thrombosis

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

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Brown TA

2010-03-01

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

Tailored nutrition education and food assistance improve adherence to HIV antiretroviral therapy: evidence from Honduras.

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Martinez, Homero; Palar, Kartika; Linnemayr, Sebastian; Smith, Alexandria; Derose, Kathryn Pitkin; Ramírez, Blanca; Farías, Hugo; Wagner, Glenn

2014-10-01

Food insecurity and malnutrition negatively affect adherence to antiretroviral therapy (ART) and are associated with poor HIV clinical outcomes. We examined the effect of providing household food assistance and nutrition education on ART adherence. A 12-month prospective clinical trial compared the effect of a monthly household food basket (FB) plus nutrition education (NE) versus NE alone on ART adherence on 400 HIV patients at four clinics in Honduras. Participants had been receiving ART for an average of 3.7 years and were selected because they had suboptimal adherence. Primary outcome measures were missed clinic appointments, delayed prescription refills, and self-reported missed doses of ART. These three adherence measures improved for both groups over 12 months (p < 0.01), mostly within 6 months. On-time prescription refills improved for the FB plus NE group by 19.6 % more than the group receiving NE alone after 6 months (p < 0.01), with no further change at 12 months. Change in missed appointments and self-reported missed ART doses did not significantly differ by intervention group.

Adherence to guidelines in bleeding oesophageal varices and effects on outcome: comparison between a specialized unit and a community hospital

DEFF Research Database (Denmark)

Hobolth, Lise; Krag, Aleksander; Malchow-Møller, Axel

2010-01-01

OBJECTIVES: Randomized controlled trials have shown beneficial effects of vasoactive drugs, endoscopic treatment and prophylactic antibiotics on the outcome of bleeding oesophageal varices (BOV). However, translating guidelines based on randomized controlled trials into clinical practice is diffi......OBJECTIVES: Randomized controlled trials have shown beneficial effects of vasoactive drugs, endoscopic treatment and prophylactic antibiotics on the outcome of bleeding oesophageal varices (BOV). However, translating guidelines based on randomized controlled trials into clinical practice...... is difficult. Our aims were to compare adherence to evidence-based guidelines in BOV between a specialized unit and a community hospital, and to investigate whether differences in adherence affected the outcome. METHODS: Two cohorts hospitalized during 2000-2007 with a first episode of BOV were retrospectively...... enrolled, one in a community hospital comprising 66 patients and one in a specialized unit comprising 111 patients. Data on treatment, rebleeding and mortality were collected from medical records according to the Baveno III/IV Criteria. RESULTS: Treatments in the specialized unit versus the community...

Providing patients with information about disease-modifying anti-rheumatic drugs: Individually or in groups? A pilot randomized controlled trial comparing adherence and satisfaction.

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Homer, Dawn; Nightingale, Peter; Jobanputra, Paresh

2009-06-01

Communicating information about disease-modifying anti-rheumatic drugs (DMARDs) before patients start treatment is a key role for some rheumatology clinical nurse specialists. This is done in our unit to promote understanding of the risks and benefits of drug therapy and encourage timely and reliable use of DMARDs. Information is routinely provided individually but this can lead to delays in starting treatment because of limited nursing resources. In this randomized trial we tested the feasibility of giving patients, who were about to start on a DMARD, information about the drug in groups and compared this with information given individually. Adults with a clinical diagnosis of rheumatoid arthritis or psoriatic arthritis who were referred to the nursing team for counselling about starting on methotrexate, sulfasalazine or leflunomide were included. Patients who had previously taken a DMARD were not excluded and those consenting were randomized to receive drug information individually or in groups (of three to six patients). We provided all patients with written materials about the relevant drug and discussed the risks and benefits of drug use verbally. Patients allocated to group counselling received this intervention in a teaching room, with a slide presentation. The primary outcome was adherence with medication use, ascertained by pill counts, self-report diaries and prescription dispensation. Secondary outcomes included satisfaction with information about medicines (SIMS) by questionnaire; time taken to provide information; adherence to scheduled hospital appointments and blood monitoring schedules; and DMARD continuation rates at four and twelve months. Of 127 eligible patients referred for counselling about DMARDs, 62 consented to take part: 32 were randomized to receive drug information individually and 30 to receiving it in groups. Patients allocated to the two different interventions were comparable for age and diagnoses at baseline but more patients

Adherence to antiretroviral therapy in Jinja, Uganda: a six-year follow-up study.

Directory of Open Access Journals (Sweden)

Martin Mbonye

Full Text Available INTRODUCTION: We report on the adherence experience of a group of people living with HIV on ART over six years in Uganda. METHODS: Between 2005 and 2009, we followed up 41 participants who were also part of a clinical trial comparing home and facility based delivery of ART in Jinja, eastern Uganda. We conducted qualitative in-depth interviews at enrolment, 3, 6, 18 and 30 months to capture experiences with adherence over time. In 2011 we returned to these participants to find out how they were fairing with long term adherence. We managed to retrace 24 participants and interviewed them about their experience. We thematically analysed the data and compared findings over time. RESULTS: Initially there were few barriers to adherence and many followed the adherence guidance closely. By year six, relaxation of these rules was noticeable although self-reported adherence continued to be high. Alcohol consumption was more common than before. Some relatives of the participants who had died claimed that some deaths were a result of alcohol. While participants reported that ART had allowed them to reclaim independence and return to work the changes in work and social routines created new challenges for adherence. Side effects like lipodystrophy were not only causing some stigma but for some tested their faith in the drugs. Many participants reported resumption of sexual lives but apart from those who selected same status partners, disclosure to new partners was minimal. CONCLUSION: Good adherence practice to ART wanes over the long-term, and people who may have disclosed at initiation find it difficult to do so to new partners once they are healthy. Further adherence interventions and support with disclosure over the course of therapy may need to be considered.

Engagement with Care, Substance Use, and Adherence to Therapy in HIV/AIDS

Directory of Open Access Journals (Sweden)

Patrice K. Nicholas

2014-01-01

Full Text Available Engagement with care for those living with HIV is aimed at establishing a strong relationship between patients and their health care provider and is often associated with greater adherence to therapy and treatment (Flickinger, Saha, Moore, and Beach, 2013. Substance use behaviors are linked with lower rates of engagement with care and medication adherence (Horvath, Carrico, Simoni, Boyer, Amico, and Petroli, 2013. This study is a secondary data analysis using a cross-sectional design from a larger randomized controlled trial (n=775 that investigated the efficacy of a self-care symptom management manual for participants living with HIV. Participants were recruited from countries of Africa and the US. This study provides evidence that substance use is linked with lower self-reported engagement with care and adherence to therapy. Data on substance use and engagement are presented. Clinical implications of the study address the importance of utilizing health care system and policy factors to improve engagement with care.

A randomized trial comparing in person and electronic interventions for improving adherence to oral medications in schizophrenia.

Science.gov (United States)

Velligan, Dawn; Mintz, Jim; Maples, Natalie; Xueying, Li; Gajewski, Stephanie; Carr, Heather; Sierra, Cynthia

2013-09-01

Poor adherence to medication leads to symptom exacerbation and interferes with the recovery process for patients with schizophrenia. Following baseline assessment, 142 patients in medication maintenance at a community mental health center were randomized to one of 3 treatments for 9 months: (1) PharmCAT, supports including pill containers, signs, alarms, checklists and the organization of belongings established in weekly home visits from a PharmCAT therapist; (2) Med-eMonitor (MM), an electronic medication monitor that prompts use of medication, cues the taking of medication, warns patients when they are taking the wrong medication or taking it at the wrong time, record complaints, and, through modem hookup, alerts treatment staff of failures to take medication as prescribed; (3) Treatment as Usual (TAU). All patients received the Med-eMonitor device to record medication adherence. The device was programmed for intervention only in the MM group. Data on symptoms, global functioning, and contact with emergency services and police were obtained every 3 months. Repeated measures analyses of variance for mixed models indicated that adherence to medication was significantly better in both active conditions than in TAU (both p<0.0001). Adherence in active treatments ranged from 90-92% compared to 73% in TAU based on electronic monitoring. In-person and electronic interventions significantly improved adherence to medication, but that did not translate to improved clinical outcomes. Implications for treatment and health care costs are discussed.

Effectiveness of a medication-adherence tool: study protocol for a randomized controlled trial

NARCIS (Netherlands)

Hilbink-Smolders, M.; Lacroix, J.; Bremer-van der Heiden, L.; Halteren, A. van; Teichert, M.; Lieshout, J. van

2016-01-01

BACKGROUND: Research shows that more than half of the people taking medication for a chronic condition are non-adherent. Nonadherence hinders disease control with a burden on patient quality of life and healthcare systems. We developed a tool that provides insight into nonadherence risks and

Effectiveness of a medication-adherence tool : Study protocol for a randomized controlled trial

NARCIS (Netherlands)

Hilbink, Mirrian; Lacroix, Joyca; Bremer-van der Heiden, Linda; van Halteren, Aart; Teichert, Martina; van Lieshout, Jan

2016-01-01

Background: Research shows that more than half of the people taking medication for a chronic condition are non-adherent. Nonadherence hinders disease control with a burden on patient quality of life and healthcare systems. We developed a tool that provides insight into nonadherence risks and

Effect of self-care education on lifestyle modification, medication adherence and blood pressure in hypertensive adults: Randomized controlled clinical trial.

Science.gov (United States)

Golshahi, Jafar; Ahmadzadeh, Hamid; Sadeghi, Masoumeh; Mohammadifard, Noushin; Pourmoghaddas, Ali

2015-01-01

Self-care management has recently been suggested as an effective approach for secondary prevention of hypertension. This study was conducted to examine whether self-care behaviors could modulate blood pressure levels and also comparing the different training methods of self-care on patients' adherence and controlling hypertension. This study was a prospective randomized controlled clinical trial, conducted on 180 hypertensive patients referring to four centers in Isfahan, Iran, between July and December 2013. Block randomization method were applied to divide eligible subjects into four equal groups, including group A in which the patients and their family were educated by cardiology resident about self-care behaviors through eight sessions, group B and group C were obtained self-care education through four pamphlets or eight short message services (SMS), respectively and group D were obtained only usual care of hypertension without any training about self-care management. Increasing vegetable intake and frequency of subject who took antihypertensive medication regularly and the reduction in the frequency of subjects who consumed high salt were significantly more in group A than the others (P = 0.001, P < 0.001 and P < 0.001, respectively). The systolic and diastolic blood pressure had significantly more reduction in the group A than the other groups (-8.18 ± 18.3 and - 3.89 ± 4.1; P < 0.001, respectively). The self-care management education integration into the usual care along with using SMS and other educational materials may improve the efficient and effective adherence strategies.

Efficacy of interventions for adherence to the immunosuppressive therapy in kidney transplant recipients: a meta-analysis and systematic review.

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Zhu, Yichen; Zhou, Yifan; Zhang, Lei; Zhang, Jian; Lin, Jun

2017-10-01

Immunosuppressive treatment regimens are complex and require ongoing self-management. Medication adherence can be difficult to achieve for several reasons. The current meta-analysis and systematic review investigated whether adherence interventions improved immunosuppressive treatment adherence in kidney transplant recipients. Medline, Cochrane, EMBASE, and Google Scholar were searched until October 17, 2016 using the following search terms: kidney transplantation, compliance, adherence, and immunosuppressive therapy. Randomized controlled trials and two-arm prospective, retrospective, and cohort studies were included. The primary outcomes were adherence rate and adherence score. Eight studies were included with a total for 546 patients. Among participants receiving intervention, the adherence rate was significantly higher than the control group (pooled OR=2.366, 95% CI 1.222 to 4.578, p=0.011). Participants in the intervention group had greater adherence scores than those in the control group (pooled standardized difference in means =1.706, 95% CI 0.346 to 3.065, p=0.014). Sensitivity analysis indicated that findings for adherence rate were robust. However, for adherence score, the significance of the association disappeared after removing one of the studies indicating the findings may have been overly influenced by this one study. Intervention programs designed to increase immunosuppressive adherence in patients with kidney transplant improve treatment adherence. Copyright © 2017 American Federation for Medical Research.

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

Science.gov (United States)

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

2016-08-24

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

Type D Personality Predicts Poor Medication Adherence in Patients with Heart Failure in the USA

Science.gov (United States)

Wu, Jia-Rong; Moser, Debra K.

2015-01-01

Background Type D (distressed) personality and medication nonadherence have been associated with poor health outcomes. Type D personality is associated with poor medication adherence in patients with coronary artery disease. However, the relationship between type D personality and medication adherence in patients with heart failure (HF) remains unknown. Purpose Therefore, the goal of this study was to examine the association between type D personality and medication adherence in patients with HF. Method This was a sub-analysis of baseline data from a randomized controlled trial with 84 patients with HF in the USA. Demographic, clinical, and psychological data were collected at baseline by interview, questionnaires, and medical record review. Type D personality was assessed using the Type D Personality Scale (DS14). Medication adherence was measured using both objective (Medication Event Monitoring System, MEMS) and self-reported (Morisky Medication Adherence Scale, MMAS-4) measures. Patients started medication adherence monitoring with the MEMS bottle at baseline and is used continuously for a month. Multiple regressions were used to explore the relationships between type D personality and medication adherence while adjusting for demographic, clinical, and psychological factors. Results Patients with type D personality were more likely to have poor medication adherence. Type D personality was associated with medication adherence before and after adjusting for covariates when it was analyzed as a categorical variable. However, type D personality was not associated with medication adherence when analyzed as a dimensional construct. Negative affectivity, a component of type D personality, was associated with medication adherence. Conclusion As a dimensional construct, type D personality may not reflect the components of the personality associated with poor outcomes. Negative affectivity was associated with medication adherence in patients with HF. Interventions aiming

eHealth Technologies as an intervention to improve adherence to topical antipsoriatics: a systematic review.

Science.gov (United States)

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

2018-03-01

Topical antipsoriatics are recommended first-line treatment of psoriasis, but rates of adherence are low. Patient support by use of electronic health (eHealth) services is suggested to improve medical adherence. To review randomised controlled trials (RCTs) testing eHealth interventions designed to improve adherence to topical antipsoriatics and to review applications for smartphones (apps) incorporating the word psoriasis. Literature review: Medline, Embase, Cochrane, PsycINFO and Web of Science were searched using search terms for eHealth, psoriasis and topical antipsoriatics. General analysis of apps: The operating systems (OS) for smartphones, iOS, Google Play, Microsoft Store, Symbian OS and Blackberry OS were searched for apps containing the word psoriasis. Literature review: Only one RCT was included, reporting on psoriasis patients' Internet reporting their status of psoriasis over a 12-month period. The rate of adherence was measured by Medication Event Monitoring System (MEMS ® ). An improvement in medical adherence and reduction of severity of psoriasis were reported. General analysis of apps: A total 184 apps contained the word psoriasis. There is a critical need for high-quality RCTs testing if the ubiquitous eHealth technologies, for example, some of the numerous apps, can improve psoriasis patients' rates of adherence to topical antipsoriatics.

Alcohol use and non-adherence to antiretroviral therapy in HIV-infected patients in West Africa

Science.gov (United States)

Antoine, Jaquet; Ekouevi Didier, K; Jules, Bashi; Maiga, Aboubakrine; Eugène, Messou; Moussa, Maiga; Alassane, Traore Hamar; Djimon, Zannou Marcel; Calixte, Guehi; Olivier, Ba-Gomis Franck; Albert, Minga; Gérard, Allou; Paul, Eholie Serge; Emmanuel, Bissagnene; Sasco Annie, J; Francois, Dabis

2015-01-01

AIM To investigate the association between alcohol use and adherence to Highly Active Antiretroviral Treatment (HAART) among HIV-infected patients in sub-Saharan Africa. DESIGN and MEASURES Cross sectional survey conducted in eight adult HIV treatment centers from Benin, Côte d’Ivoire and Mali. During a four-week period, health workers administered the Alcohol Use Disorders Identification Test to HAART-treated patients and assessed treatment adherence using the AIDS Clinical Trials Group follow-up questionnaire. RESULTS A total of 2920 patients were enrolled with a median age of 38 years (IQR 32–45 years) and a median duration on HAART of 3 years (IQR 1–4 years). Overall, 91.8% of patients were identified as adherent to HAART. Non-adherence was associated with current drinking (OR 1.4; 95% CI 1.1–2.0), hazardous drinking (OR 4.7; 95% CI 2.6–8.6) and was inversely associated with a history of counseling on adherence (OR 0.7; 95% CI 0.5–0.9). CONCLUSION Alcohol consumption and hazardous drinking is associated with non-adherence to HAART among HIV-infected patients from West Africa. thus providing a framework for developing and reinforcing the necessary prevention and intervention strategies. PMID:20528816

Healthy Beyond Pregnancy, a Web-Based Intervention to Improve Adherence to Postpartum Care: Randomized Controlled Feasibility Trial.

Science.gov (United States)

Himes, Katherine Park; Donovan, Heidi; Wang, Stephanie; Weaver, Carrie; Grove, Jillian Rae; Facco, Francesca Lucia

2017-10-10

During the postpartum visit, health care providers address issues with short- and long-term implications for maternal and child health. Women with Medicaid insurance are less likely to return for a postpartum visit compared with women with private insurance. Behavioral economics acknowledges that people do not make exclusively rational choices, rather immediate gratification, cognitive and psychological biases, and social norms influence decision making. Drawing on insights from decision science, behavioral economists have examined how these biases can be modulated through carefully designed interventions. We have developed a Web-based tool, Healthy Beyond Pregnancy, that incorporates empirically derived concepts of behavioral economics to improve adherence rates to the postpartum visit. The primary objectives of this pilot study were to (1) refine and assess the usability of Healthy Beyond Pregnancy and (2) assess the feasibility of a randomized controlled trial (RCT) of the intervention. We used a multistep process and multidisciplinary team of maternal-fetal medicine physicians, a behavioral economist, and researchers with expertise in behavioral interventions to design Healthy Beyond Pregnancy. We assessed the usability of the program with the Post-Study System Usability Questionnaire (PSSUQ), a validated 7-point scale, and semistructured interviews with postpartum women. We then conducted a feasibility trial to determine the proportion of eligible women who were willing to participate in an RCT of Healthy Beyond Pregnancy and the proportion of women willing to complete the Web-based program. Exploratory outcomes of the pilot trial included attendance at the postpartum visit, uptake of long-acting reversible contraception, and uptake of any contraception. The median PSSUQ score for Healthy Beyond Pregnancy was 6.5 (interquartile range: 6.1-7) demonstrating high usability. Semistructured interviews (n=10) provided in-depth comments about users' experience and

Treatment Adherence, Competence, and Outcome in Individual and Family Therapy for Adolescent Behavior Problems

Science.gov (United States)

Hogue, Aaron; Henderson, Craig E.; Dauber, Sarah; Barajas, Priscilla C.; Fried, Adam; Liddle, Howard A.

2008-01-01

This study examined the impact of treatment adherence and therapist competence on treatment outcome in a controlled trial of individual cognitive-behavioral therapy (CBT) and multidimensional family therapy (MDFT) for adolescent substance use and related behavior problems. Participants included 136 adolescents (62 CBT, 74 MDFT) assessed at intake,…

Cost and clinical consequence of antibiotic non-adherence in acute exacerbations of chronic bronchitis.

Science.gov (United States)

Sorensen, S V; Baker, T; Fleurence, R; Dixon, J; Roberts, C; Haider, S; Hughes, D

2009-08-01

To quantify the impact of non-adherence on the clinical effectiveness of antibiotics for acute exacerbations of chronic bronchitis (AECB) and to estimate the economic consequences for Spain, Italy and the United States. Standard systematic reviewing procedures were followed to identify randomised controlled clinical trials of antibiotic treatment for acute respiratory tract infection for which adherence was reported. A decision-analytic model was then constructed to evaluate the impact of non-adherence to antibiotic treatment on clinical effectiveness and costs per AECB episode. The model compared the total treatment costs, cure rates and incremental costs per cure for a poor compliance group (PCG) against a good compliance group (GCG). Clinical and resource use estimates were from the published literature and physician surveys. Twenty-five articles met the criteria of the systematic review, although only one reported treatment success by adherence status. The relative risk of clinical effectiveness if non-adherent was 0.75 (95%CI 0.73-0.78). Based on this single study, the model predicted that 16-29% more patients would be cured in the GCG vs. the PCG, and payers would save up to euro122, euro179 and US$141 per AECB episode in Spain, Italy and the United States, respectively. Non-adherence to antibiotics for AECB may have an impact on clinical effectiveness, which is associated with increased costs.

Use of automated medication adherence monitoring in bipolar disorder research: pitfalls, pragmatics, and possibilities.

Science.gov (United States)

Levin, Jennifer B; Sams, Johnny; Tatsuoka, Curtis; Cassidy, Kristin A; Sajatovic, Martha

2015-04-01

Medication nonadherence occurs in 20-60% of persons with bipolar disorder (BD) and is associated with serious negative outcomes, including relapse, hospitalization, incarceration, suicide and high healthcare costs. Various strategies have been developed to measure adherence in BD. This descriptive paper summarizes challenges and workable strategies using electronic medication monitoring in a randomized clinical trial (RCT) in patients with BD. Descriptive data from 57 nonadherent individuals with BD enrolled in a prospective RCT evaluating a novel customized adherence intervention versus control were analyzed. Analyses focused on whole group data and did not assess intervention effects. Adherence was assessed with the self-reported Tablets Routine Questionnaire and the Medication Event Monitoring System (MEMS). The majority of participants were women (74%), African American (69%), with type I BD (77%). Practical limitations of MEMS included misuse in conjunction with pill minders, polypharmacy, cost, failure to bring to research visits, losing the device, and the device impacting baseline measurement. The advantages were more precise measurement, less biased recall, and collecting data from past time periods for missed interim visits. Automated devices such as MEMS can assist investigators in evaluating adherence in patients with BD. Knowing the anticipated pitfalls allows study teams to implement preemptive procedures for successful implementation in BD adherence studies and can help pave the way for future refinements as automated adherence assessment technologies become more sophisticated and readily available.

Stepwise strategy to improve Cervical Cancer Screening Adherence (SCAN-CC): automated text messages, phone calls and face-to-face interviews: protocol of a population-based randomised controlled trial.

Science.gov (United States)

Firmino-Machado, João; Mendes, Romeu; Moreira, Amélia; Lunet, Nuno

2017-10-05

Screening is highly effective for cervical cancer prevention and control. Population-based screening programmes are widely implemented in high-income countries, although adherence is often low. In Portugal, just over half of the women adhere to cervical cancer screening, contributing for greater mortality rates than in other European countries. The most effective adherence raising strategies are based on patient reminders, small/mass media and face-to-face educational programmes, but sequential interventions targeting the general population have seldom been evaluated. The aim of this study is to assess the effectiveness of a stepwise approach, with increasing complexity and cost, to improve adherence to organised cervical cancer screening: step 1a-customised text message invitation; step 1b-customised automated phone call invitation; step 2-secretary phone call; step 3-family health professional phone call and face-to-face appointment. A population-based randomised controlled trial will be implemented in Portuguese urban and rural areas. Women eligible for cervical cancer screening will be randomised (1:1) to intervention and control. In the intervention group, women will be invited for screening through text messages, automated phone calls, manual phone calls and health professional appointments, to be applied sequentially to participants remaining non-adherent after each step. Control will be the standard of care (written letter). The primary outcome is the proportion of women adherent to screening after step 1 or sequences of steps from 1 to 3. The secondary outcomes are: proportion of women screened after each step (1a, 2 and 3); proportion of text messages/phone calls delivered; proportion of women previously screened in a private health institution who change to organised screening. The intervention and control groups will be compared based on intention-to-treat and per-protocol analyses. The study was approved by the Ethics Committee of the Northern Health

Age, Stigma, Adherence and Clinical Indicators in HIV-Infected Women.

Science.gov (United States)

McCoy, Katryna; Higgins, Melinda; Zuñiga, Julie Ann; Holstad, Marcia McDonnell

Stigma has become a gendered phenomenon that affects increasing numbers of HIV-infected women worldwide. This study examined the role of age as a possible moderator of the relationship between stigma and antiretroviral therapy adherence, CD4% and viral load among 120 HIV-infected women. A secondary analysis was conducted using data from the Keeping Healthy and Active with Risk Reduction and Medication Adherence (KHARMA) Project, an National Institutes of Health (NIH) funded randomized controlled trial to improve Antiretroviral treatment (ART) adherence and reduce risky behaviors in HIV-infected women at five clinical sites in a South-eastern city from 2005 to 2008. Stigma was measured using the Perceived Personal Stigma of Human Immunodeficiency Virus and Acquired Immune Deficiency Syndrome (HIV/AIDS) scale. Among participants stigma was negatively associated with CD4% (r =-.26, p=.02). For the 30 participants >50 years old, age was not significantly associated with viral load, stigma or CD4%, and there was no significant association between stigma and CD4% (r=.07, p=.70). These findings indicate the need for further study regarding this potential moderating effect and possible interventions to address the susceptibility of younger women to the harmful effects of stigma.

Correlates of Pediatric CPAP Adherence

Science.gov (United States)

Hawkins, Stephen M.M.; Jensen, Emily L.; Simon, Stacey L.; Friedman, Norman R.

2016-01-01

Study Objectives: Obstructive sleep apnea (OSA) is a common pediatric condition characterized by recurrent partial or complete cessation of airflow during sleep, typically due to inadequate upper airway patency. Continuous positive airway pressure (CPAP) is a therapeutic option that reduces morbidity. Despite efforts to promote use, CPAP adherence is poor in both pediatric and adult populations. We sought to determine whether demographics, insurance status, OSA severity, therapeutic pressure, or comorbid conditions were associated with pediatric CPAP adherence. Methods: A retrospective review of adherence download data was performed on all pediatric patients with initiation or adjustment of CPAP treatment over a one-year period with documented in-laboratory CPAP titration. Patients were grouped as CPAP adherent or non-adherent, where adherence was defined as > 70% nightly use and average usage ≥ 4 hours per night. Differences between the groups were analyzed by χ2 test. Results: Overall, nearly half of participants were CPAP adherent (49%, 69/140). Of the demographic data collected (age, ethnicity, sex, insurance status), only female sex was associated with better adherence (60.9% vs 39.5% of males adherent; odds ratio [OR] = 2.41, 95%CI = 1.20–4.85; p = 0.01). Severity of OSA (diagnostic apnea-hypopnea index [AHI] and degree of hypoxemia), therapeutic pressure, and residual AHI did not impact CPAP adherence (p > 0.05). Patients with developmental delay (DD) were more likely to be adherent with CPAP than those without a DD diagnosis (OR = 2.55, 95%CI = 1.27–5.13; p = 0.007). Female patients with trisomy 21 tended to be more adherent, but this did not reach significance or account for the overall increased adherence associated with female sex. Conclusions: Our study demonstrates that adherence to CPAP therapy is poor but suggests that female sex and developmental delay are associated with better adherence. These findings support efforts to understand the

An intervention programme using the ASE-model aimed at enhancing adherence in adolescents with asthma

NARCIS (Netherlands)

van Es, S M; Nagelkerke, A F; Colland, V T; Scholten, R J; Bouter, L M

A randomised controlled trial, involving 112 adolescents with asthma, and a 2-year follow-up was conducted to assess the impact of an intervention programme aimed at enhancing adherence to asthma medication. This programme had a duration of 1 year and consisted of an experimental group which

An intervention programme using the ASE-model aimed at enhancing adherence in adolescents with asthma

NARCIS (Netherlands)

van Es, S.M.; Nagelkerke, A.F.; Colland, V.T.; Scholten, R.J.P.M.; Bouter, L.M.

2001-01-01

A randomised controlled trial, involving 112 adolescents with asthma, and a 2-year follow-up was conducted to assess the impact of an intervention programme aimed at enhancing adherence to asthma medication. This programme had a duration of 1 year and consisted of an experimental group which

Therapist Adherence and Competence with Manualized Cognitive-Behavioral Therapy for PTSD Delivered via Videoconferencing Technology

Science.gov (United States)

Frueh, B. Christopher; Monnier, Jeannine; Grubaugh, Anouk L.; Elhai, Jon D.; Yim, Eunsil; Knapp, Rebecca

2007-01-01

Using secondary analyses from a randomized trial comparing the effectiveness of manualized cognitive-behavioral therapy for posttraumatic stress disorder, we compared ratings of therapist competency and adherence between two service delivery modes: telepsychiatry (TP) and same room (SR). Patients were 38 male treatment-seeking veterans recruited…

Therapist adherence in individual cognitive-behavioral therapy for binge-eating disorder

OpenAIRE

Brauhardt, Anne; de Zwaan, Martina; Herpertz, Stephan; Zipfel, Stephan; Svaldi, Jennifer; Friederich, Hans-Christoph; Hilbert, Anja

2017-01-01

While cognitive-behavioral therapy (CBT) is the most well-established treatment for binge-eating disorder (BED), little is known about process factors influencing its outcome. The present study sought to explore the assessment of therapist adherence, its course over treatment, and its associations with patient and therapist characteristics, and the therapeutic alliance. In a prospective multicenter randomized-controlled trial comparing CBT to internet-based guided self-help (INTERBED-study...

Safety and adherence to intermittent pre-exposure prophylaxis (PrEP) for HIV-1 in African men who have sex with men and female sex workers.

Science.gov (United States)

Mutua, Gaudensia; Sanders, Eduard; Mugo, Peter; Anzala, Omu; Haberer, Jessica E; Bangsberg, David; Barin, Burc; Rooney, James F; Mark, David; Chetty, Paramesh; Fast, Patricia; Priddy, Frances H

2012-01-01

Little is known about safety of and adherence to intermittent HIV PrEP regimens, which may be more feasible than daily dosing in some settings. We present safety and adherence data from the first trial of an intermittent PrEP regimen among Kenyan men who have sex with men (MSM) and female sex workers (FSW). MSM and FSW were randomized to daily oral FTC/TDF or placebo, or intermittent (Monday, Friday and within 2 hours after sex, not to exceed one dose per day) oral FTC/TDF or placebo in a 2:1:2:1 ratio; volunteers were followed monthly for 4 months. Adherence was assessed with the medication event monitoring system (MEMS). Sexual activity data were collected via daily text message (SMS) queries and timeline followback interviews with a one-month recall period. Sixty-seven men and 5 women were randomized into the study. Safety was similar among all groups. Median MEMS adherence rates were 83% [IQR: 63-92] for daily dosing and 55% [IQR:28-78] for fixed intermittent dosing (p = 0.003), while adherence to any post-coital doses was 26% [IQR:14-50]. SMS response rates were low, which may have impaired measurement of post-coital dosing adherence. Acceptability of PrEP was high, regardless of dosing regimen. Adherence to intermittent dosing regimens, fixed doses, and in particular coitally-dependent doses, may be more difficult than adherence to daily dosing. However, intermittent dosing may still be appropriate for PrEP if intracellular drug levels, which correlate with prevention of HIV acquisition, can be attained with less than daily dosing and if barriers to adherence can be addressed. Additional drug level data, qualitative data on adherence barriers, and better methods to measure sexual activity are necessary to determine whether adherence to post-coital PrEP could be comparable to more standard regimens. ClinicalTrials.gov NCT00971230.

Prevalence and correlates of non-adherence to immunosuppressants and to health behaviours in patients after kidney transplantation in Brazil - the ADHERE BRAZIL multicentre study: a cross-sectional study protocol.

Science.gov (United States)

Sanders-Pinheiro, Helady; Colugnati, Fernando Antonio Basile; Marsicano, Elisa Oliveira; De Geest, Sabina; Medina, José Osmar Pestana

2018-02-20

(RedCap) system. Data entry is performed by a trained professional who is part of the transplant team. The data collection began in December 2015. This multicentre study is the first to evaluate multilevel correlates of non-adherence in KT patients and will provide a reliable estimate of non-adherence in Brazilian KT patients. ClinicalTrials.gov on 10/10/2013, NCT02066935 .

In-class Active Video Game Supplementation and Adherence to Cardiac Rehabilitation.

Science.gov (United States)

Ruivo, Jorge Manuel Arsénio Dos Santos; Karim, Kay; OʼShea, Roisin; Oliveira, Rosa Celeste Santos; Keary, Louis; OʼBrien, Claire; Gormley, John Patrick

2017-07-01

The application of active video games (AVGs) during cardiac rehabilitation (CR) sessions could potentially facilitate patient adherence. The feasibility, safety, and efficacy of in-class AVG supplementation as an alternative to conventional phase 2 programs were investigated. A pilot, evaluator-blinded, intention-to-treat, randomized controlled trial recruited 32 low-moderate risk CR participants and allocated them to conventional or AVG-supplemented exercise. Both groups experienced equal exercise loads for 6 weeks. Patients were assessed at baseline, end of the program, and after an 8-week followup. Adherence and safety-related outcomes were the primary endpoints. Secondary outcomes included change in exercise capacity, daily physical activity (PA), energy expenditure (EE), and psychometric profiling. Patients (males 81%; 60 ± 10 years) presented with typical cardiovascular risk factors and similar baseline characteristics. Participants did not perceive an increased risk of injury and were more interactive. At the end of the program, there was a lower tendency for dropping out (6% vs 19%, P > .05), a significant improvement in PA (322 vs 247 arbitrary acceleration units/min, P = .047) and related EE per body weight (13 vs 11 kcal/kg/d, P = .04) among AVG participants compared with controls. No significant differences between groups for adverse medical events, exercise capacity, affect toward exercise, anxiety, depression, or quality-of-life changes were reported. The additional use of AVGs during CR sessions is feasible, safe, and significantly improved daily PA and EE. A dropout reduction trend among its users, which needs to be confirmed in a larger trial, raises awareness to AVG supplementation as a promising strategy to increase CR adherence.

Beyond clinical trials: Cross-sectional associations of combination antiretroviral therapy with reports of multiple symptoms and non-adherence among adolescents in South Africa.

Science.gov (United States)

Natukunda, H P M; Cluver, L D; Toska, E; Musiime, V; Yakubovich, A R

2017-10-31

Studies investigating symptoms associated with combination antiretroviral therapy (cART) use among adolescents in resource-limited settings are rare beyond clinical trials. Identifying adolescents at risk of non-adherence is imperative for HIV/AIDS programming and controlling the epidemic in this key population. To examine which cART regimens were associated with reports of multiple symptoms and past-week non-adherence in a large community-traced sample of HIV-positive adolescents in South Africa (SA). A total of 1 175 HIV-positive ART-experienced adolescents aged 10 - 19 years attending 53 health facilities in the Eastern Cape Province, SA, were interviewed in 2014 - 2015. Ninety percent (n=1 059) were included in the study. Adolescents who reported no medication use and those with unclear or missing data were excluded from further analysis, resulting in a sample for analysis of n=501. Outcomes were reports of multiple symptoms (three or more symptoms in the past 6 months) and past-week ART non-adherence (<95% correct doses in the past week). Multivariable logistic regression analyses controlled for sociodemographic and HIV-related covariates in Stata 13/IC. Of the adolescents included, 54.3% were female. The median age was 14 (interquartile range 12 - 16) years, and 66.5% were vertically infected. The prevalence of multiple symptoms was 59.7% (95% confidence interval (CI) 55.3 - 63.9). Independent of covariates, stavudine (d4T)-containing cART regimens and the fixed-dose combination of tenofovir (TDF) + emtricitabine (FTC) + efavirenz (EFV) were associated with more reports of multiple symptoms (adjusted odds ratio (aOR) 3.38; 95% CI 1.19 - 9.60 and aOR 2.67; 95% CI 1.21 - 5.88, respectively). Lopinavir/ritonavir (LPV/r)-containing regimens were associated with fewer reports of multiple symptoms (aOR 0.47; 95% CI 0.21 - 1.04). For EFV-based regimens, adolescents on d4T + lamivudine (3TC) + EFV were more likely to report multiple symptoms than those on TDF + FTC

A qualitative study of patient motivation to adhere to combination antiretroviral therapy in South Africa.

Science.gov (United States)

van Loggerenberg, Francois; Gray, Debra; Gengiah, Santhanalakshmi; Kunene, Pinky; Gengiah, Tanuja N; Naidoo, Kogieleum; Grant, Alison D

2015-05-01

Taken as prescribed, that is, with high adherence, combination antiretroviral therapy (ART) has changed HIV infection and disease from being a sure predictor of death to a manageable chronic illness. Adherence, however, is difficult to achieve and maintain. The CAPRISA 058 study was conducted between 2007 and 2009 to test the efficacy of individualized motivational counselling to enhance ART adherence in South Africa. As part of the overall trial, a qualitative sub-study was conducted, including 30 individual interviews and four focus group discussions with patients in the first 9 months of ART initiation. Data were inductively analyzed, using thematic analysis, to identify themes central to ART adherence in this context. Four themes emerged that characterize the participants' experiences and high motivation to adhere to ART. Participants in this study were highly motivated to adhere, as they acknowledged that ART was 'life-giving', in the face of a large amount of morbidity and mortality. They were further supported by techniques of routine remembering, and highlighted the importance of good social support and access to supportive healthcare workers, to their continued success in negotiating their treatment. Participants in the current study told us that their adherence motivation is enhanced by free accessible care, approachable and supportive healthcare workers, broad social acceptance of ART, and past first-hand experiences with AIDS-related co-morbidity and mortality. Programs that include specific attention to these aspects of care will likely be successful in the long term.

A test of an adherence-enhancing adjunct to physiotherapy steeped in the protection motivation theory.

Science.gov (United States)

Bassett, Sandra F; Prapavessis, Harry

2011-07-01

The primary aim of this study was to test the effect of a Protection Motivation Theory (PMT)-based patient education intervention on physiotherapy patients' beliefs about their injury and physiotherapy, intentions to adhere, rehabilitation adherence, and ankle function. A secondary aim was to explore the relationships between the patients' injury and physiotherapy beliefs, intentions, adherence behaviours, and ankle function. A randomized controlled trial was undertaken in New Zealand; 71 people with ankle sprains were allocated to either PMT present video information or two control groups (non-PMT information about ankle sprains and no formal information) before commencing their course of physiotherapy. The two information groups watched a video about ankle sprains and physiotherapy before answering the Beliefs about Ankle Sprains and Physiotherapy Scale and behavioural intentions questionnaires that measured the PMT constructs. Adherence was assessed at each treatment and ankle function was measured before and after the physiotherapy program. After viewing the video, the PMT present information group's beliefs about severity, vulnerability, and response efficacy were significantly higher than the other two groups. The groups did not differ significantly on their self-efficacy, intentions, rehabilitation adherence, and post-physiotherapy program ankle function. Significant correlations existed between the patients' PMT-based beliefs and intentions, intentions and adherence, and adherence and post-physiotherapy ankle function. With the exception of self-efficacy, the findings indicate that persuasive information grounded in PMT does enhance physiotherapy patients' beliefs about their injury and treatment.

Impact of mHealth chronic disease management on treatment adherence and patient outcomes: a systematic review.

Science.gov (United States)

Hamine, Saee; Gerth-Guyette, Emily; Faulx, Dunia; Green, Beverly B; Ginsburg, Amy Sarah

2015-02-24

Adherence to chronic disease management is critical to achieving improved health outcomes, quality of life, and cost-effective health care. As the burden of chronic diseases continues to grow globally, so does the impact of non-adherence. Mobile technologies are increasingly being used in health care and public health practice (mHealth) for patient communication, monitoring, and education, and to facilitate adherence to chronic diseases management. We conducted a systematic review of the literature to evaluate the effectiveness of mHealth in supporting the adherence of patients to chronic diseases management ("mAdherence"), and the usability, feasibility, and acceptability of mAdherence tools and platforms in chronic disease management among patients and health care providers. We searched PubMed, Embase, and EBSCO databases for studies that assessed the role of mAdherence in chronic disease management of diabetes mellitus, cardiovascular disease, and chronic lung diseases from 1980 through May 2014. Outcomes of interest included effect of mHealth on patient adherence to chronic diseases management, disease-specific clinical outcomes after intervention, and the usability, feasibility, and acceptability of mAdherence tools and platforms in chronic disease management among target end-users. In all, 107 articles met all inclusion criteria. Short message service was the most commonly used mAdherence tool in 40.2% (43/107) of studies. Usability, feasibility, and acceptability or patient preferences for mAdherence interventions were assessed in 57.9% (62/107) of studies and found to be generally high. A total of 27 studies employed randomized controlled trial (RCT) methods to assess impact on adherence behaviors, and significant improvements were observed in 15 of those studies (56%). Of the 41 RCTs that measured effects on disease-specific clinical outcomes, significant improvements between groups were reported in 16 studies (39%). There is potential for mHealth tools to

The association between adherence and outcome in an Internet intervention for depression.

Science.gov (United States)

Fuhr, Kristina; Schröder, Johanna; Berger, Thomas; Moritz, Steffen; Meyer, Björn; Lutz, Wolfgang; Hohagen, Fritz; Hautzinger, Martin; Klein, Jan Philipp

2018-03-15

Adherence to Internet interventions is often reported to be rather low and this might adversely impact the effectiveness of these interventions. We investigated if patient characteristics are associated with adherence, and if adherence is associated with treatment outcome in a large RCT of an Internet intervention for depression, the EVIDENT trial. Patients were randomized to either care as usual (CAU) or CAU plus the Internet intervention Deprexis. A total of 509 participants with mild to moderate depressive symptoms were included in the intervention group and of interest for the present study. We assessed depression symptoms pre and post intervention (12 weeks). Patient characteristics, a self-rating screening for mental disorders, attitudes towards online interventions, and quality of life were assessed before randomization. Adherence in this study was good with on average seven hours of usage time and eight number of sessions spent with the intervention. Some of the patient characteristics (age, sex, depressive symptoms, and confidence in the effectiveness of the program) predicted higher number of sessions in different models (explaining in total between 15 and 25% of variance). Older age (β = .16) and higher depressive symptoms (β = .15) were associated with higher usage duration. Higher adherence to the program predicted a greater symptom reduction in depressive symptoms over 12 weeks (number of sessions: β = .13, usage duration: β = .14), however, this prediction could mostly be explained by receiving guidance (β = .27 and .26). Receiving guidance and symptom severity at baseline were confounded since only participants with a moderate symptom severity at baseline received e-mail support. Therefore no firm conclusions can be drawn from the association we observed between baseline symptom severity and usage intensity. We conclude that older age was associated with adherence and adherence was positively associated with outcome. The effects we have found

Fundamentals of clinical trials

CERN Document Server

Friedman, Lawrence M; DeMets, David L; Reboussin, David M; Granger, Christopher B

2015-01-01

This is the fifth edition of a very successful textbook on clinical trials methodology, written by recognized leaders who have long and extensive experience in all areas of clinical trials. The three authors of the first four editions have been joined by two others who add great expertise.  Most chapters have been revised considerably from the fourth edition.  A chapter on regulatory issues has been included and the chapter on data monitoring has been split into two and expanded.  Many contemporary clinical trial examples have been added.  There is much new material on adverse events, adherence, issues in analysis, electronic data, data sharing, and international trials.  This book is intended for the clinical researcher who is interested in designing a clinical trial and developing a protocol. It is also of value to researchers and practitioners who must critically evaluate the literature of published clinical trials and assess the merits of each trial and the implications for the care and treatment of ...

Treatment Adherence and Quality of Life in Diabetes Mellitus Patients in Indonesia

Directory of Open Access Journals (Sweden)

D. A. Perwitasari

2016-04-01

Full Text Available Adherence to treatment of diabetes mellitus (DM can support successful therapy due to drug consumption over longtime periods. The objectives of this study are to evaluate the treatment adherence in DM as related to the quality of life and to evaluate factors associated with adherence and quality of life. This study used the Brief Medication Questionnaire (BMQ to measure patients’ adherence. The Diabetes Quality of Life Clinical Trial Questionnaire (DQLCTQ was used to measure patients’ quality of life. Subjects of this cross-sectional study were DM patients attending two private hospitals in Yogyakarta and who had been taking DM medications for more than 6 months. Statistical analyses used in this study were student’s t test and regression linear test. We recruited 65 DM patients who met the inclusion criteria. There were no significant differences of BMQ screens and DQLCTQ functions between monotherapy and combination therapy groups (p> .05. The BMQ screens’ score of combination therapy were higher than monotherapy groups. The physical function, health distress, and mental health of combination therapy groups were higher than monotherapy group. The male patients had significantly higher score of regimen domain of BMQ than female patients (0.35 and 0.17, respectively. The older age has the lower score of treatment effect of DQLCTQ (p< .05. The belief, recall, and belief about adverse drug reaction of BMQ have positive correlation with physical function (r = .542, .424, and .640, respectively. Our study concluded that the quality of care, sex, and age may predict patients’ adherence and quality of life. There were positive correlation between patients’ adherence and quality of life.

Impact of food supplementation on weight loss in randomised-controlled dietary intervention trials: a systematic review and meta-analysis.

Science.gov (United States)

Wibisono, Cinthya; Probst, Yasmine; Neale, Elizabeth; Tapsell, Linda

2016-04-01

Dietary trials provide evidence for practice and policy guidelines, but poor adherence may confound results. Food supplementation may improve adherence to dietary interventions, but the impact of supplementation on study outcomes is not known. The aim of this review was to examine the impact of food supplementation on weight loss in dietary intervention trials. The databases Scopus, PubMed and the Cochrane Library were searched for dietary intervention trials published between January 2004 and March 2015 using the following keyword combinations: 'trial' OR 'intervention', 'food' OR 'diet', 'weight loss' and 'adherence' OR 'adherence'. Studies were included if food was provided to at least one study group and both 'weight change' and 'adherence' were reported. Random effects meta-analyses were conducted to assess weighted mean differences (WMD) in body weight (change or final mean values). The included studies formed two groups: trials involving an intervention group supplemented with a food and a control without food supplementation (food v. no food), and trials in which food was provided to all subjects (food v. food) (PROSPERO registration: CRD42015017563). In total, sixteen studies were included. Significant weight reduction was reported in the food v. no food studies (WMD -0·74 kg; 95 % CI -1·40, -0·08; P=0·03, I 2=63 %). A non-significant increase in weight was found among the food v. food studies (WMD 0·84 kg; 95 % CI -0·60, 2·27; P=0·25, I 2=0 %). Food supplementation appeared to result in greater weight loss in dietary trials. Energy restrictions and intensity of interventions were other significant factors influencing weight loss.

Impact of HSCT conditioning and glucocorticoid dose on exercise adherence and response

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Wiskemann, Joachim; Herzog, Benedikt; Kuehl, Rea; Schmidt, Martina E.; Steindorf, Karen; Schwerdtfeger, Rainer; Dreger, Peter; Bohus, Martin

2017-01-01

Abstract: Purpose: Evidence from randomized controlled trials (RCT) that exercise interventions have beneficial effects in patients undergoing allogeneic hematopoietic stem cell transplantation (allo-HSCT) is growing. However, intensive chemotherapy conditioning and glucocorticoid (GC) treatment is always part of an allo-HSCT and possibly affect exercise adherence and training response. Therefore, we aimed to examine whether various conditioning protocols or different doses of GC treatment af...

A randomized controlled trial with a Canadian electronic pill dispenser used to measure and improve medication adherence in patients with schizophrenia.

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Stip, Emmanuel; Vincent, Philippe D; Sablier, Juliette; Guevremont, Catherine; Zhornitsky, Simon; Tranulis, Constantin

2013-01-01

Medication adherence is extremely important in preventing relapse and lowering symptoms in schizophrenic patients. However, estimates show that nearly half of these patients have poor adherence. The Brief Adherence Rating Scale (BARS) seems to be the most reliable tool assessing adherence in schizophrenia and shows that the antipsychotic adherence ratio (AAR) is about 49.5% in schizophrenia. The aim of the study was to test if an electronic pill dispenser named DoPill(®) improved AAR of schizophrenic patients. Furthermore, we compared AAR obtained by the DoPill(®) and the BARS, in order to verify whether the DoPill(®) provides reliable assessment of medication adherence. The DoPill(®) is a smart pill dispenser that beeps and flashes at the appropriate time of the day. Each of its 28 compartments is covered by a plastic lamina that, when taken off, sends a signal to the pharmacist. Patients were randomized to the DoPill(®) or treatment as usual groups for 6 weeks. The BARS was used as a reference measure. Forty-six percent of patients were deemed to be non-adherent with antipsychotic medication. The mean AAR was 67% after 6 weeks. DoPill(®) recorded better AAR than some of those found in the literature and were lower than the BARS estimate we found. These results suggest that DoPill(®) is a valid tool that provides more reliable and objective data for the clinician about their patient's adherence, than existing assessment tools like the BARS. Furthermore, the device may help patients successfully manage their medication regimen.

A cluster randomized trial to determine the effectiveness of a novel, digital pendant and voice reminder platform on increasing infant immunization adherence in rural Udaipur, India.

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Nagar, Ruchit; Venkat, Preethi; Stone, Logan D; Engel, Kyle A; Sadda, Praneeth; Shahnawaz, Mohammed

2017-11-18

Five hundred thousand children under the age of 5 die from vaccine preventable diseases in India every year. More than just improving coverage, increasing timeliness of immunizations is critical to ensuring infant health in the first year of life. Novel, culturally appropriate community engagement strategies are worth exploring to close the immunization gap. In our study, a digital NFC (Near Field Communication) pendant worn on black thread and voice call reminder system was tested for the effectiveness in improving DTP3 adherence within 2 monthly camps from DTP1 administration. A cluster randomized controlled trial was conducted in which 96 village health camps were randomized to 3 arms: NFC sticker, NFC pendant, and NFC pendant with voice call reminder in local dialect. Randomization was done across 5 blocks in the Udaipur District serviced by Seva Mandir from August 2015 to April 2016. In terms of our three primary outcomes related to DTP3 adherence, point estimates show conflicting results. Two outcomes presented adherence in the control. DTP3 completion within two camps after DTP1 showed higher adherence in the Control (Sticker) (74.2%) arm compared to the Pendant (67.2%) and Pendant and Voice arms (69.3%). Likewise, the estimate for DTP3 completion within 180 days of birth in the Control (Sticker) (69.4%) arm was higher than estimates in the Pendant (57.4%) and Pendant and Voice arms (58.7%). However, one outcome displayed higher adherence in the intervention. DTP3 completion within two months from the time of registration was higher in the Pendant (37.7%) and Pendant and Voice arms (38.7%) compared to the Control (Sticker) arm (27.4%). In all primary outcomes, differences in adherence were statistically insignificant both before and after controlling for confounding factors. In terms of secondary outcomes, our results suggest that providing a necklace generated significant community discussion (H = 8.8796, df = 2, p = .0118), had strong

Adherence to guidelines in bleeding oesophageal varices and effects on outcome: comparison between a specialized unit and a community hospital

DEFF Research Database (Denmark)

Hobolth, Lise; Krag, Aleksander; Malchow-Møller, Axel

2010-01-01

is difficult. Our aims were to compare adherence to evidence-based guidelines in BOV between a specialized unit and a community hospital, and to investigate whether differences in adherence affected the outcome. METHODS: Two cohorts hospitalized during 2000-2007 with a first episode of BOV were retrospectively...... rebleeding were not statistically different. CONCLUSION: Our study shows that patients with BOV are more likely to receive therapy according to guidelines when hospitalized in a specialized unit compared with a community hospital. This however did not affect mortality.......OBJECTIVES: Randomized controlled trials have shown beneficial effects of vasoactive drugs, endoscopic treatment and prophylactic antibiotics on the outcome of bleeding oesophageal varices (BOV). However, translating guidelines based on randomized controlled trials into clinical practice...

Sensitivity Analysis of Per-Protocol Time-to-Event Treatment Efficacy in Randomized Clinical Trials

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Gilbert, Peter B.; Shepherd, Bryan E.; Hudgens, Michael G.

2013-01-01

Summary Assessing per-protocol treatment effcacy on a time-to-event endpoint is a common objective of randomized clinical trials. The typical analysis uses the same method employed for the intention-to-treat analysis (e.g., standard survival analysis) applied to the subgroup meeting protocol adherence criteria. However, due to potential post-randomization selection bias, this analysis may mislead about treatment efficacy. Moreover, while there is extensive literature on methods for assessing causal treatment effects in compliers, these methods do not apply to a common class of trials where a) the primary objective compares survival curves, b) it is inconceivable to assign participants to be adherent and event-free before adherence is measured, and c) the exclusion restriction assumption fails to hold. HIV vaccine efficacy trials including the recent RV144 trial exemplify this class, because many primary endpoints (e.g., HIV infections) occur before adherence is measured, and nonadherent subjects who receive some of the planned immunizations may be partially protected. Therefore, we develop methods for assessing per-protocol treatment efficacy for this problem class, considering three causal estimands of interest. Because these estimands are not identifiable from the observable data, we develop nonparametric bounds and semiparametric sensitivity analysis methods that yield estimated ignorance and uncertainty intervals. The methods are applied to RV144. PMID:24187408

Sustainability of professionals’ adherence to clinical practice guidelines in medical care: a systematic review

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Ament, Stephanie M C; de Groot, Jeanny J A; Maessen, José M C; Dirksen, Carmen D; van der Weijden, Trudy; Kleijnen, Jos

2015-01-01

Objectives To evaluate (1) the state of the art in sustainability research and (2) the outcomes of professionals’ adherence to guideline recommendations in medical practice. Design Systematic review. Data sources Searches were conducted until August 2015 in MEDLINE, CINAHL, EMBASE, Cochrane Central Register of Controlled Trials (CENTRAL) and the Guidelines International Network (GIN) library. A snowball strategy, in which reference sections of other reviews and of included papers were searched, was used to identify additional papers. Eligibility criteria Studies needed to be focused on sustainability and on professionals’ adherence to clinical practice guidelines in medical care. Studies had to include at least 2 measurements: 1 before (PRE) or immediately after implementation (EARLY POST) and 1 measurement longer than 1 year after active implementation (LATE POST). Results The search retrieved 4219 items, of which 14 studies met the inclusion criteria, involving 18 sustainability evaluations. The mean timeframe between the end of active implementation and the sustainability evaluation was 2.6 years (minimum 1.5–maximum 7.0). The studies were heterogeneous with respect to their methodology. Sustainability was considered to be successful if performance in terms of professionals’ adherence was fully maintained in the late postimplementation phase. Long-term sustainability of professionals’ adherence was reported in 7 out of 18 evaluations, adherence was not sustained in 6 evaluations, 4 evaluations showed mixed sustainability results and in 1 evaluation it was unclear whether the professional adherence was sustained. Conclusions (2) Professionals’ adherence to a clinical practice guideline in medical care decreased after more than 1 year after implementation in about half of the cases. (1) Owing to the limited number of studies, the absence of a uniform definition, the high risk of bias, and the mixed results of studies, no firm conclusion about the

Depression, patient characteristics, and attachment style: correlates and mediators of medication treatment adherence in a racially diverse primary care sample.

Science.gov (United States)

Hooper, Lisa M; Tomek, Sara; Roter, Debra; Carson, Kathryn A; Mugoya, George; Cooper, Lisa A

2016-03-01

The depth and breadth of problems related to depressive symptomatology and optimal treatment outcomes, including medication treatment adherence, have long been documented in the literature. Missing are clear explanations as to what factors and patient characteristics may account for lack of medication treatment adherence. The two objectives of the current study were to examine the predictive strength of depression, patient characteristics, and patient attachment style regarding medication treatment adherence and to consider the extent to which attachment styles mediate the relation between depression and medication treatment adherence. Participants in the present study were 237 racially diverse American primary care patients with a diagnosis of hypertension who were participants in a clinical trial. Depression, patient characteristics, attachment style, and medication treatment adherence were assessed. Partly consistent with our four hypotheses, the following results were found: (a) Black American, younger, never married, and poorer patients had lower medication treatment adherence (b) depression was significantly associated with lower self-reported medication adherence; (c) insecure-dismissing attachment style was related to lower medication adherence; and (d) insecure-dismissing attachment style mediates the relation between depression and medication treatment adherence by exacerbating the negative association. Physicians and other primary care providers should consider how depressive symptomatology, patient characteristics, and attachment style may inform the treatment plans they put forward and the extent to which patients may adhere to those treatment plans.

A randomized-controlled trial with a Canadian electronic pill dispenser used to measure and improve medication adherence in patients with schizophrenia

Directory of Open Access Journals (Sweden)

Emmanuel eStip

2013-08-01

Full Text Available Objective: Medication adherence is extremely important in preventing relapse and lowering symptoms in schizophrenic patients. However, estimates show that nearly half of these patients have poor adherence. The Brief Adherence Rating Scale (BARS seems to be the most reliable tool assessing adherence in schizophrenia and shows that the antipsychotic adherence ratio (AAR is about 49.5 % in schizophrenia. The aim of the study was to test if an electronic pill dispenser named DoPill® improved AAR of schizophrenic patients. Furthermore, we compared AAR obtained by the DoPill® and the BARS, in order to verify whether the DoPill® provides reliable assessment of medication adherence. Methods: The DoPill® is a smart pill dispenser that beeps and flashes at the appropriate time of the day. Each of its 28 compartments is covered by a plastic lamina that, when taken off, sends a signal to the pharmacist. Patients were randomized to the DoPill® or Treatment As Usual group (TAU for six weeks. The BARS was used as a reference measure. Results: Forty-six percent of patients were deemed to be non-adherent with antipsychotic medication. The mean AAR was 67 % after six weeks. DoPill® recorded better AAR than some of those found in the literature and were lower than the BARS estimate we found. Conclusion: These results suggest that DoPill® is a valid tool that provides more reliable and objective data for the clinician about their patient’s adherence, than existing assessment tools like the BARS. Furthermore, the device may help patients successfully manage their medication regimen.

Mobile Application to Promote Adherence to Oral Chemotherapy and Symptom Management: A Protocol for Design and Development.

Science.gov (United States)

Fishbein, Joel Nathan; Nisotel, Lauren Ellen; MacDonald, James John; Amoyal Pensak, Nicole; Jacobs, Jamie Michele; Flanagan, Clare; Jethwani, Kamal; Greer, Joseph Andrew

2017-04-20

Oral chemotherapy is increasingly used in place of traditional intravenous chemotherapy to treat patients with cancer. While oral chemotherapy includes benefits such as ease of administration, convenience, and minimization of invasive infusions, patients receive less oversight, support, and symptom monitoring from clinicians. Additionally, adherence is a well-documented challenge for patients with cancer prescribed oral chemotherapy regimens. With the ever-growing presence of smartphones and potential for efficacious behavioral intervention technology, we created a mobile health intervention for medication and symptom management. The objective of this study was to develop and evaluate the usability and acceptability of a smartphone app to support adherence to oral chemotherapy and symptom management in patients with cancer. We used a 5-step development model to create a comprehensive mobile app with theoretically informed content. The research and technical development team worked together to develop and iteratively test the app. In addition to the research team, key stakeholders including patients and family members, oncology clinicians, health care representatives, and practice administrators contributed to the content refinement of the intervention. Patient and family members also participated in alpha and beta testing of the final prototype to assess usability and acceptability before we began the randomized controlled trial. We incorporated app components based on the stakeholder feedback we received in focus groups and alpha and beta testing. App components included medication reminders, self-reporting of medication adherence and symptoms, an education library including nutritional information, Fitbit integration, social networking resources, and individually tailored symptom management feedback. We are conducting a randomized controlled trial to determine the effectiveness of the app in improving adherence to oral chemotherapy, quality of life, and burden of

Comparing Mobile Health Strategies to Improve Medication Adherence for Veterans With Coronary Heart Disease (Mobile4Meds): Protocol for a Mixed-Methods Study.

Science.gov (United States)

Park, Linda G; Collins, Eileen G; Shim, Janet K; Whooley, Mary A

2017-07-18

Adherence to antiplatelet medications is critical to prevent life threatening complications (ie, stent thrombosis) after percutaneous coronary interventions (PCIs), yet rates of nonadherence range from 21-57% by 12 months. Mobile interventions delivered via text messaging or mobile apps represent a practical and inexpensive strategy to promote behavior change and enhance medication adherence. The Mobile4Meds study seeks to determine whether text messaging or a mobile app, compared with an educational website control provided to all Veterans, can improve adherence to antiplatelet therapy among patients following acute coronary syndrome (ACS) or PCI. The three aims of the study are to: (1) determine preferences for content and frequency of text messaging to promote medication adherence through focus groups; (2) identify the most patient-centered app that promotes adherence, through a content analysis of all commercially available apps for medication adherence and focus groups centered on usability; and (3) compare adherence to antiplatelet medications in Veterans after ACS/PCI via a randomized clinical trial (RCT). We will utilize a mixed-methods design that uses focus groups to achieve the first and second aims (N=32). Patients will be followed for 12 months after being randomly assigned to one of three arms: (1) customized text messaging, (2) mobile app, or (3) website-control groups (N=225). Medication adherence will be measured with electronic monitoring devices, pharmacy records, and self-reports. Enrollment for the focus groups is currently in progress. We expect to enroll patients for the RCT in the beginning of 2018. Determining the efficacy of mobile technology using a Veteran-designed protocol to promote medication adherence will have a significant impact on Veteran health and public health, particularly for individuals with chronic diseases that require strict medication adherence. ClinicalTrials.gov NCT03022669. ©Linda G Park, Eileen G Collins, Janet K

Increasing daily water intake and fluid adherence in children receiving treatment for retentive encopresis.

Science.gov (United States)

Kuhl, Elizabeth S; Hoodin, Flora; Rice, Jennifer; Felt, Barbara T; Rausch, Joseph R; Patton, Susana R

2010-11-01

To examine the efficacy of an enhanced intervention (EI) compared to standard care (SC) in increasing daily water intake and fluid goal adherence in children seeking treatment for retentive encopresis. Changes in beverage intake patterns and fluid adherence were examined by comparing 7-week diet diary data collected during participation in the EI to achieved data for families who had previously completed the SC. Compared to children in SC (n = 19), children in the EI (n = 18) demonstrated a significantly greater increase in daily water intake from baseline to the conclusion of treatment ( p ≤ .001), and were four and six times more likely to meet fluid targets in Phases 1 (Weeks 3-4) and 2 (Weeks 5-6) of fluid intervention, respectively (both p ≤ .001). Enhanced education and behavioral strategies were efficacious in increasing children's intake of water and improving fluid adherence. Future research should replicate the findings in a prospective randomized clinical trial to discern their effectiveness.

Cognitive Behavioral Therapy for Adherence and Depression (CBT-AD) in HIV-Infected Injection Drug Users: A Randomized Controlled Trial

Science.gov (United States)

Safren, Steven A.; O'Cleirigh, Conall M.; Bullis, Jacqueline R.; Otto, Michael W.; Stein, Michael D.; Pollack, Mark H.

2012-01-01

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…

Considerations in using text messages to improve adherence to highly active antiretroviral therapy: a qualitative study among clients in Yaoundé, Cameroon

Directory of Open Access Journals (Sweden)

Mbuagbaw L

2012-04-01

Full Text Available Lawrence Mbuagbaw1,2, Renée Cécile Bonono-Momnougui1, Lehana Thabane2,31Centre for the Development of Best Practices in Health (CDBPH, Yaoundé Central Hospital, Yaoundé, Cameroon; 2Department of Clinical Epidemiology and Biostatistics, McMaster University, Hamilton, Ontario, Canada; 3Biostatistics Unit, Father Sean O'Sullivan Research Centre, St Joseph's Healthcare, Hamilton, Ontario, CanadaAbstract: Poor adherence to highly active antiretroviral therapy (HAART is a major hindrance to the reduction of mortality and morbidity due to HIV. This qualitative study used focus groups to explore the views and experiences of HIV patients on HAART with adherence reminders, especially the text message (SMS [short message service]. The ethnographic data obtained were used to design a clinical trial to assess the effect of motivational text messages versus usual care to enhance adherence to HAART among HIV patients in Yaoundé, Cameroon. Participants appreciated the idea of a timely SMS reminder, and cited the physician as a role model. They expressed concerns about privacy. Long-term life goals were a motivating factor to adhere. Overall, text messaging was viewed positively as a tool with a dual function of reminder and motivator. Messages coming from the attending physician may have a stronger impact. Trials investigating the use of text messages to improve adherence to HAART need to consider the content and timing of SMS, taking into account technical challenges and privacy.Keywords: focus groups, adherence, highly active antiretroviral therapy (HAART, text message, short message service (SMS, human immunodeficiency virus (HIV

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

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

2005-01-01

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

Effects of Depression Alleviation on ART Adherence and HIV Clinic Attendance in Uganda, and the Mediating Roles of Self-Efficacy and Motivation.

Science.gov (United States)

Wagner, Glenn J; Ghosh-Dastidar, Bonnie; Robinson, Eric; Ngo, Victoria K; Glick, Peter; Mukasa, Barbara; Musisi, Seggane; Akena, Dickens

2017-06-01

With depression known to impede HIV care adherence and retention, we examined whether depression alleviation improves these disease management behaviors. A sample of 1028 depressed HIV clients in Uganda enrolled in a cluster randomized controlled trial of two depression care models, and were surveyed over 12 months. Serial regression analyses examined whether depression alleviation was associated with self-reported antiretroviral therapy (ART) adherence and clinic attendance at month 12, and whether these relationships were mediated by self-efficacy and motivation. Among those with major depression, depression alleviation was associated with better ART adherence and clinic attendance at month 12; these relationships were fully mediated by self-efficacy at month 12, while adherence motivation partially mediated the relationship between depression alleviation and ART adherence. When both mediators were entered simultaneously, only self-efficacy was a significant predictor and still fully mediated the relationship between depression alleviation and adherence. These findings suggest that depression alleviation benefits both ART adherence and clinic attendance, in large part through improved confidence and motivation to engage in these disease management behaviors.

Use of a Novel Artificial Intelligence Platform on Mobile Devices to Assess Dosing Compliance in a Phase 2 Clinical Trial in Subjects With Schizophrenia

Science.gov (United States)

2017-01-01

Background Accurately monitoring and collecting drug adherence data can allow for better understanding and interpretation of the outcomes of clinical trials. Most clinical trials use a combination of pill counts and self-reported data to measure drug adherence, despite the drawbacks of relying on these types of indirect measures. It is assumed that doses are taken, but the exact timing of these events is often incomplete and imprecise. Objective The objective of this pilot study was to evaluate the use of a novel artificial intelligence (AI) platform (AiCure) on mobile devices for measuring medication adherence, compared with modified directly observed therapy (mDOT) in a substudy of a Phase 2 trial of the α7 nicotinic receptor agonist (ABT-126) in subjects with schizophrenia. Methods AI platform generated adherence measures were compared with adherence inferred from drug concentration measurements. Results The mean cumulative pharmacokinetic adherence over 24 weeks was 89.7% (standard deviation [SD] 24.92) for subjects receiving ABT-126 who were monitored using the AI platform, compared with 71.9% (SD 39.81) for subjects receiving ABT-126 who were monitored by mDOT. The difference was 17.9% (95% CI -2 to 37.7; P=.08). Conclusions Using drug levels, this substudy demonstrates the potential of AI platforms to increase adherence, rapidly detect nonadherence, and predict future nonadherence. Subjects monitored using the AI platform demonstrated a percentage change in adherence of 25% over the mDOT group. Subjects were able to use the technology successfully for up to 6 months in an ambulatory setting with early termination rates that are comparable to subjects outside of the substudy. Trial Registration ClinicalTrials.gov NCT01655680 https://clinicaltrials.gov/ct2/show/NCT01655680?term=NCT01655680 PMID:28223265

Placebo HAART Regimen as a Method for Teaching Medication Adherence Issues to Students

OpenAIRE

Sutton, Eliza L; Transue, Emily R; Comes E, Susan; Paauw, Douglas S

2005-01-01

Placebo medication regimens may help educate students about adherence issues. In this randomized trial, 23 third-year medical students took a 2-week placebo regimen mimicking highly active antiretroviral therapy (HAART) during their medicine clerkship; 15 students served as controls. Although no effect was demonstrated from this intervention on an evaluation instrument examining attitudes and beliefs about medication nonadherence, all 23 student-subjects agreed in postintervention interviews ...

Improving Dialysis Adherence for High Risk Patients Using Automated Messaging: Proof of Concept

OpenAIRE

Som, A.; Groenendyk, J.; An, T.; Patel, K.; Peters, R.; Polites, G.; Ross, W. R.

2017-01-01

Comorbidities and socioeconomic barriers often limit patient adherence and self-management with hemodialysis. Missed sessions, often associated with communication barriers, can result in emergency dialysis and avoidable hospitalizations. This proof of concept study explored using a novel digital-messaging platform, EpxDialysis, to improve patient-to-dialysis center communication via widely available text messaging and telephone technology. A randomized controlled trial was conducted through W...

Safety and adherence to intermittent pre-exposure prophylaxis (PrEP for HIV-1 in African men who have sex with men and female sex workers.

Directory of Open Access Journals (Sweden)

Gaudensia Mutua

Full Text Available Little is known about safety of and adherence to intermittent HIV PrEP regimens, which may be more feasible than daily dosing in some settings. We present safety and adherence data from the first trial of an intermittent PrEP regimen among Kenyan men who have sex with men (MSM and female sex workers (FSW.MSM and FSW were randomized to daily oral FTC/TDF or placebo, or intermittent (Monday, Friday and within 2 hours after sex, not to exceed one dose per day oral FTC/TDF or placebo in a 2:1:2:1 ratio; volunteers were followed monthly for 4 months. Adherence was assessed with the medication event monitoring system (MEMS. Sexual activity data were collected via daily text message (SMS queries and timeline followback interviews with a one-month recall period. Sixty-seven men and 5 women were randomized into the study. Safety was similar among all groups. Median MEMS adherence rates were 83% [IQR: 63-92] for daily dosing and 55% [IQR:28-78] for fixed intermittent dosing (p = 0.003, while adherence to any post-coital doses was 26% [IQR:14-50]. SMS response rates were low, which may have impaired measurement of post-coital dosing adherence. Acceptability of PrEP was high, regardless of dosing regimen.Adherence to intermittent dosing regimens, fixed doses, and in particular coitally-dependent doses, may be more difficult than adherence to daily dosing. However, intermittent dosing may still be appropriate for PrEP if intracellular drug levels, which correlate with prevention of HIV acquisition, can be attained with less than daily dosing and if barriers to adherence can be addressed. Additional drug level data, qualitative data on adherence barriers, and better methods to measure sexual activity are necessary to determine whether adherence to post-coital PrEP could be comparable to more standard regimens.ClinicalTrials.gov NCT00971230.

Assessing adherence to the evidence base in the management of poststroke dysphagia.

Science.gov (United States)

Burton, Christopher; Pennington, Lindsay; Roddam, Hazel; Russell, Ian; Russell, Daphne; Krawczyk, Karen; Smith, Hilary A

2006-01-01

To evaluate the reliability and responsiveness to change of an audit tool to assess adherence to evidence of effectiveness in the speech and language therapy (SLT) management of poststroke dysphagia. The tool was used to review SLT practice as part of a randomized study of different education strategies. Medical records were audited before and after delivery of the trial intervention. Seventeen SLT departments in the north-west of England participated in the study. The assessment tool was used to assess the medical records of 753 patients before and 717 patients after delivery of the trial intervention across the 17 departments. A target of 10 records per department per month was sought, using systematic sampling with a random start. Inter- and intra-rater reliability were explored, together with the tool's internal consistency and responsiveness to change. The assessment tool had high face validity, although internal consistency was low (ra = 0.37). Composite scores on the tool were however responsive to differences between SLT departments. Both inter- and intra-rater reliability ranged from 'substantial' to 'near perfect' across all items. The audit tool has high face validity and measurement reliability. The use of a composite adherence score should, however, proceed with caution as internal consistency is low.

Transient improvement of urticaria induces poor adherence as assessed by Morisky Medication Adherence Scale-8.

Science.gov (United States)

Kaneko, Sakae; Masuda, Koji; Hiragun, Takaaki; Inomata, Naoko; Furue, Masutaka; Onozuka, Daisuke; Takeuchi, Satoshi; Murota, Hiroyuki; Sugaya, Makoto; Saeki, Hidehisa; Shintani, Yoichi; Tsunemi, Yuichiro; Abe, Shinya; Kobayashi, Miwa; Kitami, Yuki; Tanioka, Miki; Imafuku, Shinichi; Abe, Masatoshi; Hagihara, Akihito; Morisky, Donald E; Katoh, Norito

2015-11-01

Poor adherence to medication is a major public health challenge. Here, we aimed to determine the adherence to oral and topical medications and to analyze underlying associated factors using the translated Japanese version of Morisky Medication Adherence Scale-8 regarding urticaria treatment. Web-based questionnaires were performed for 3096 registered dermatological patients, along with a subanalysis of 751 registered urticaria patients in this study. The adherence to oral medication was significantly associated with the frequency of hospital visits. Variables that affected the adherence to topical medication included age and experience of drug effectiveness. The rate of responses that "It felt like the symptoms had improved" varied significantly among the dermatological diseases treated with oral medications. Dermatologists should be aware that adherence to the treatment of urticaria is quite low. Regular visits and active education for patients with urticaria are mandatory in order to achieve a good therapeutic outcome by increasing the adherence. © 2015 The Authors. The Journal of Dermatology published by Wiley Publishing Asia Pty Ltd on behalf of Japanese Dermatological Association.

Inhaled antibiotics for the treatment of chronic Pseudomonas aeruginosa infection in cystic fibrosis patients: challenges to treatment adherence and strategies to improve outcomes

Directory of Open Access Journals (Sweden)

Bodnár R

2016-02-01

Full Text Available Réka Bodnár,1,2 Ágnes Mészáros,2 Máté Oláh,2 Tamás Ágh3 1Department of Pediatric Pulmonology, Heim Pál Children’s Hospital, Budapest, Hungary; 2University Pharmacy Department of Pharmacy Administration, Semmelweis University, Budapest, Hungary; 3Syreon Research Institute, Budapest, Hungary Background: Inhaled antibiotics (ABs are recommended for use in the therapy of chronic Pseudomonas aeruginosa infection in patients with cystic fibrosis (CF. The aim of this systematic literature review was to identify level of adherence to inhaled ABs and to determine predictors and consequences of nonadherence in CF. Methods: A systematic literature search of English-language articles was conducted in April 2015 using Medline and Embase. No publication date limit was applied. The literature screening was conducted by two independent reviewers. All of the included studies were assessed for quality. Results: The search yielded 193 publications, of which ten met the inclusion criteria and underwent data extraction. Seven studies focused on inhaled tobramycin, one on inhaled colistimethate, one on inhaled levofloxacin, and one on inhaled aztreonam lysine. Medication adherence to inhaled ABs was analyzed by pharmacy refill history, daily phone diary, parent and child self-reports, vials counting, or electronic monitoring. In randomized controlled trials (n=3, proportion of adherent patients (>75%–80% of required doses taken ranged from 86% to 97%; in prospective cohort studies (n=3, adherence rates ranged between 36% and 92%, and in retrospective studies (n=4 it ranged between 60% and 70%. The adherence to inhaled ABs in CF was found to be associated with the complexity of treatment, time of drug administration, age of patients, treatment burden (adverse events, taste, and patient satisfaction. Conclusion: The high diversity of adherence data was because of the different study designs (randomized controlled trials vs real-world studies and the lack

The Adherence Estimator: a brief, proximal screener for patient propensity to adhere to prescription medications for chronic disease.

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McHorney, Colleen A

2009-01-01

To conceptualize, develop, and provide preliminary psychometric evidence for the Adherence Estimator--a brief, three-item proximal screener for the likelihood of non-adherence to prescription medications (medication non-fulfillment and non-persistence) for chronic disease. Qualitative focus groups with 140 healthcare consumers and two internet-based surveys of adults with chronic disease, comprising a total of 1772 respondents, who were self-reported medication adherers, non-persisters, and non-fulfillers. Psychometric tests were performed on over 150 items assessing 14 patient beliefs and skills hypothesized to be related to medication non-adherence along a proximal-distal continuum. Psychometric tests included, but were not limited to, known-groups discriminant validity at the scale and item level. The psychometric analyses sought to identify: (1) the specific multi-item scales that best differentiated self-reported adherers from self-reported non-adherers (non-fulfillers and non-persisters) and, (2) the single best item within each prioritized multi-item scale that best differentiated self-reported adherers from self-reported non-adherers (non-fulfillers and non-persisters). The two rounds of psychometric testing identified and cross-validated three proximal drivers of self-reported adherence: perceived concerns about medications, perceived need for medications, and perceived affordability of medications. One item from each domain was selected to include in the Adherence Estimator using a synthesis of psychometric results gleaned from classical and modern psychometric test theory. By simple summation of the weights assigned to the category responses of the three items, a total score is obtained that is immediately interpretable and completely transparent. Patients can be placed into one of three segments based on the total score--low, medium, and high risk for non-adherence. Sensitivity was 88%--of the non-adherers, 88% would be accurately classified as medium

The effect of electronic monitoring feedback on medication adherence and clinical outcomes: A systematic review.

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van Heuckelum, Milou; van den Ende, Cornelia H M; Houterman, Anne E J; Heemskerk, Charlotte P M; van Dulmen, Sandra; van den Bemt, Bart J F

2017-01-01

This study aims to assess the efficacy of Electronic Monitoring Feedback (EMF) as an intervention to improve medication adherence (i.e. dose- or full adherence) and clinical outcomes in adult patients. A systematic search was performed in Medline, EMBASE, PsycINFO and Web of Science and reported according to the PRISMA guidelines. Randomised controlled trials (RCTs) comparing EMF with usual care were identified to systematically summarise the evidence for use of EMF in improving medication adherence and clinical outcomes. The GRADE approach was used to assess the quality of the body of evidence. Of 9,993 initially-identified studies, ten studies (four of high-quality and six of low-quality) were included. The sample size of the studies included varied from 18 to 205 patients. Four of the six studies (66.7%) reported a significant positive effect of EMF on mean dose adherence levels, whereas a significant positive effect of EMF on mean full adherence levels was found in all of the included studies (100%, five out of five of the studies included). A significant positive effect of EMF on clinical outcomes was reported in one of the seven studies included. The overall effect of EMF on mean dose- and full adherence was positive and the overall effect of EMF on clinical outcomes was inconclusive. Considering the positive effect of EMF on medication adherence, EMF might be a promising intervention to enhance medication adherence. However, the effect of EMF on clinical outcomes was inconclusive. Prior to implementing EMF in clinical practice, future research with high-quality studies (e.g. adequate sample sizes, follow-up periods and no interfering co-interventions) is required to examine the (long-term) efficacy of EMF.

Patient adherence with COPD therapy

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C. S. Rand

2005-12-01

Full Text Available Although there are very few published studies on adherence to treatment regimens in chronic obstructive pulmonary disease (COPD, the evidence that exists suggests that, as with asthma therapy, adherence is poor. Patient beliefs about COPD, as well as their motivation and expectations about the likelihood of success of medical interventions, can influence adherence rates. Other critical factors include the patient's understanding of their illness and therapy, and the complexity of the prescribed treatment regimen. Incorrect inhaler technique is also a common failing. When prescribing in primary or specialist care, healthcare professionals should address adherence as a vital part of the patient consultation. Improved patient education may also increase adherence rates.

Medication adherence in inflammatory bowel disease

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Webber Chan

2017-10-01

Full Text Available Inflammatory bowel disease (IBD is a chronic idiopathic inflammatory condition with intestinal and extraintestinal manifestations. Medications are the cornerstone of treatment of IBD. However, patients often adhere to medication poorly. Adherence to medications is defined as the process by which patients take their medications as prescribed. Treatment non-adherence is a common problem among chronic diseases, averaging 50% in developed countries and is even poorer in developing countries. In this review, we will examine the adherence data in IBD which vary greatly depending on the study population, route of administration, and methods of adherence measurement used. We will also discuss the adverse clinical outcomes related to non-adherence to medical treatment including increased disease activity, flares, loss of response to anti-tumor necrosis factor therapy, and so forth. There are many methods to measure medication adherence namely direct and indirect methods, each with their advantages and drawbacks. Finally, we will explore different intervention strategies to improve adherence to medications.

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

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

2016-03-05

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

The Effect on Treatment Adherence of Administering Drugs as Fixed-Dose Combinations versus as Separate Pills: Systematic Review and Meta-Analysis.

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van Galen, Katy A; Nellen, Jeannine F; Nieuwkerk, Pythia T

2014-01-01

Administering drugs as fixed-dose combinations (FDCs) versus the same active drugs administered as separate pills is assumed to enhance treatment adherence. We synthesized evidence from randomized controlled trials (RCTs) about the effect of FDCs versus separate pills on adherence. We searched PubMed for RCTs comparing a FDC with the same active drugs administered as separate pills, including a quantitative estimate of treatment adherence, without restriction to medical condition. The odds ratio (OR) of optimal adherence with FDCs versus separate pills was used as common effect size and aggregated into a pooled effect estimate using a random effect model with inverse variance weights. Out of 1258 articles screened, only six studies fulfilled inclusion criteria. Across medical conditions, administering drugs as FDC significantly increased the likelihood of optimal adherence (OR 1.33 (95% CI, 1.03-1.71)). Within subgroups of specific medical conditions, the favourable effect of FDCs on adherence was of borderline statistical significance for HIV infection only (OR 1.46 (95% CI, 1.00-2.13)). We observed a remarkable paucity of RCTs comparing the effect on adherence of administering drugs as FDC versus as separate pills. Administering drugs as FDC improved medication adherence. However, this conclusion is based on a limited number of RCTs only.

Assessment of adherence to visual correction and occlusion therapy in the Infant Aphakia Treatment Study

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Carolyn Drews-Botsch

2016-08-01

Full Text Available Occlusion therapy throughout early childhood is believed to be efficacious in treating deprivation amblyopia but has not been rigorously assessed in clinical trials. Further, tools to assess adherence to such therapy over an extended period of time are lacking. Using data from the Infant Aphakia Treatment Study, a randomized clinical trial of treatment for unilateral congenital cataract, we examined the use of quarterly 48-h recall interviews and annual 7-day prospective diaries to assess reported hours of patching in 114 children throughout the first 5 years of life. Consistency of data reported was assessed using correlation coefficients and intraclass correlation coefficients. Both interview and diary data showed excellent consistency with Cronbach’s Alpha’s ranging from 0.69 to 0.88 for hours of patching and 0.60 to 0.73 for hours of sleep. However, caregivers reported somewhat more adherence in prospective diaries than retrospective interviews. Completion rates, on the other hand, were substantially higher for telephone interviews than prospective diaries. For example, four years after surgery response rates to telephone interviews exceeded 75% versus completion rates of only 54% for diaries. In situations where occlusion dose monitors cannot be used for assessing adherence to occlusion therapy, such as in infants or over an extended period of time, quantitative assessments of occlusion therapy can be obtained by parental report, either as a series of prospective diaries or a series of recall interviews.

Role of male partner involvement in ART retention and adherence in Malawi's Option B+ program.

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Wesevich, Austin; Mtande, Tiwonge; Saidi, Friday; Cromwell, Elizabeth; Tweya, Hannock; Hosseinipour, Mina C; Hoffman, Irving; Miller, William C; Rosenberg, Nora E

2017-11-01

Malawi's Option B+ program provides all HIV-infected pregnant women free lifelong antiretroviral therapy (ART), but challenges remain regarding retention and ART adherence, potentially due to male partner barriers. We explored relationships between male partner involvement and Option B+ retention and adherence. In 2014, a randomized controlled trial in Malawi compared male recruitment strategies for couple HIV testing and counseling (cHTC) at an antenatal clinic. This secondary analysis was conducted among the entire cohort (N = 200) of women, irrespective of randomization status. We assessed whether cHTC attendance, early disclosure of HIV-positive status, and partner ART reminders were associated with retention and adherence at one month after starting treatment. Retention was defined as attending HIV clinic follow-up within one day of running out of pills. Adherence was defined as taking ≥95% of ARTs by pill count. We used binomial regression to calculate adjusted risk ratios (aRR) and 95% confidence intervals (CI). Median female age was 26 years. Most women (79%) were retained; of these, 68% were adherent. Receiving cHTC was associated with improved retention (aRR 1.33, 95% CI 1.12, 1.59). Receiving male partner ART reminders was weakly associated with retention (aRR 1.16, 95% CI 0.96, 1.39). Disclosure within one day was not associated with retention (aRR 1.08, 95% CI: 0.91, 1.28). Among those who were retained, these three behaviors were not associated with improved 95% adherence. CHTC could play an important role in improving Option B+ retention. Increasing cHTC participation and enhancing adherence-related messages within cHTC are important.

The effect of financial incentives on adherence to antipsychotic depot medication: does it change over time?

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

2015-08-01

A recent cluster-randomized controlled trial found that offering financial incentives improves adherence to long-acting injectable antipsychotics (LAIs). The present study investigates whether the impact of incentives diminishes over time and whether the improvement in adherence is linked to the amount of incentives offered. Seventy-three teams with 141 patients with psychotic disorders (using ICD-10) were randomized to the intervention or control group. Over 1 year, patients in the intervention group received £15 (US $23) for each LAI, while control patients received treatment as usual. Adherence levels, ie, the percentage of prescribed LAIs that were received, were calculated for quarterly intervals. The amount of incentives offered was calculated from the treatment cycle at baseline. Multilevel models were used to examine the time course of the effect of incentives and the effect of the amount of incentives offered on adherence. Adherence increased in both the intervention and the control group over time by an average of 4.2% per quarterly interval (95% CI, 2.8%-5.6%; P time and treatment group. Further, a higher total amount of incentives was associated with poorer adherence (βbootstrapped = -0.11; 95% CIbootstrapped, -0.20 to -0.01; P = .023). A substantial effect of financial incentives on adherence to LAIs occurs within the first 3 months of the intervention and is sustained over 1 year. A higher total amount of incentives does not increase the effect. ISRCTN.com identifier: ISRCTN77769281 and UKCRN.org identifier: 7033. © Copyright 2015 Physicians Postgraduate Press, Inc.

A randomized controlled trial of cognitive behavioral therapy for adherence and depression (CBT-AD) in patients with uncontrolled type 2 diabetes.

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Safren, Steven A; Gonzalez, Jeffrey S; Wexler, Deborah J; Psaros, Christina; Delahanty, Linda M; Blashill, Aaron J; Margolina, Aleksandra I; Cagliero, Enrico

2014-01-01

To test cognitive behavioral therapy for adherence and depression (CBT-AD) in type 2 diabetes. We hypothesized that CBT-AD would improve adherence; depression; and, secondarily, hemoglobin A1c (A1C). Eighty-seven adults with unipolar depression and uncontrolled type 2 diabetes received enhanced treatment as usual (ETAU), including medication adherence, self-monitoring of blood glucose (SMBG), and lifestyle counseling; a provider letter documented psychiatric diagnoses. Those randomized to the intervention arm also received 9-11 sessions of CBT-AD. Immediately after acute treatment (4 months), adjusting for baseline, CBT-AD had 20.7 percentage points greater oral medication adherence on electronic pill cap (95% CI -31.14 to -10.22, P = 0.000); 30.2 percentage points greater SMBG adherence through glucometer downloads (95% CI -42.95 to -17.37, P = 0.000); 6.44 points lower depression scores on the Montgomery-Asberg Depression Rating Scale (95% CI 2.33-10.56, P = 0.002); 0.74 points lower on the Clinical Global Impression (95% CI 0.16-1.32, P = 0.01); and 0.72 units lower A1C (95% CI 0.29-1.15, P = 0.001) relative to ETAU. Analyses of 4-, 8-, and 12-month follow-up time points indicated that CBT-AD maintained 24.3 percentage points higher medication adherence (95% CI -38.2 to -10.3, P = 0.001); 16.9 percentage points greater SMBG adherence (95% CI -33.3 to -0.5, P = 0.043); and 0.63 units lower A1C (95% CI 0.06-1.2, P = 0.03) after acute treatment ended. For depression, there was some evidence of continued improvement posttreatment, but no between-group differences. CBT-AD is an effective intervention for adherence, depression, and glycemic control, with enduring and clinically meaningful benefits for diabetes self-management and glycemic control in adults with type 2 diabetes and depression.

System for integrated adherence monitoring: real-time non-adherence risk assessment in pediatric kidney transplantation.

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Pai, Ahna L H; Rausch, Joseph; Tackett, Alayna; Marsolo, Keith; Drotar, Dennis; Goebel, Jens

2012-06-01

This study reports initial results of the development of the SIAM, a non-adherence risk assessment system for tacrolimus and sirolimus for the pediatric kidney transplant population. Forty-eight youths between 10 and 25 yr of age diagnosed with chronic kidney disease or a kidney transplant used an electronic pill bottle (EM; time stamps each bottle opening) to dispense their medication for at least 30 days or until their next clinic appointment. Youth also completed a self-report adherence measure, and standard deviations were calculated for the last four medication serum trough levels obtained for each patient. Estimation models were developed for each medication (i.e., SIAM(TACRO) and SIAM(SIRO) ) to assign weights to these clinically available adherence measures (self-report and trough levels) for the calculation of a non-adherence risk composite score. SIAM(TACRO) models included both self-report and tacrolimus trough levels and significantly predicted EM. For sirolimus, the model predictive of adherence as measured by EM consisted of the standard deviation of sirolimus trough levels only (SIAM(SIRO) ). Non-adherence risk can be effectively assessed using clinically available assessment tools. However, the best methods for using self-report and trough levels to predict non-adherence likely differ based on the medication for which adherence is being assessed. © 2012 John Wiley & Sons A/S.

A single-item self-report medication adherence question predicts hospitalisation and death in patients with heart failure.

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Wu, Jia-Rong; DeWalt, Darren A; Baker, David W; Schillinger, Dean; Ruo, Bernice; Bibbins-Domingo, Kristen; Macabasco-O'Connell, Aurelia; Holmes, George M; Broucksou, Kimberly A; Erman, Brian; Hawk, Victoria; Cene, Crystal W; Jones, Christine DeLong; Pignone, Michael

2014-09-01

To determine whether a single-item self-report medication adherence question predicts hospitalisation and death in patients with heart failure. Poor medication adherence is associated with increased morbidity and mortality. Having a simple means of identifying suboptimal medication adherence could help identify at-risk patients for interventions. We performed a prospective cohort study in 592 participants with heart failure within a four-site randomised trial. Self-report medication adherence was assessed at baseline using a single-item question: 'Over the past seven days, how many times did you miss a dose of any of your heart medication?' Participants who reported no missing doses were defined as fully adherent, and those missing more than one dose were considered less than fully adherent. The primary outcome was combined all-cause hospitalisation or death over one year and the secondary endpoint was heart failure hospitalisation. Outcomes were assessed with blinded chart reviews, and heart failure outcomes were determined by a blinded adjudication committee. We used negative binomial regression to examine the relationship between medication adherence and outcomes. Fifty-two percent of participants were 52% male, mean age was 61 years, and 31% were of New York Heart Association class III/IV at enrolment; 72% of participants reported full adherence to their heart medicine at baseline. Participants with full medication adherence had a lower rate of all-cause hospitalisation and death (0·71 events/year) compared with those with any nonadherence (0·86 events/year): adjusted-for-site incidence rate ratio was 0·83, fully adjusted incidence rate ratio 0·68. Incidence rate ratios were similar for heart failure hospitalisations. A single medication adherence question at baseline predicts hospitalisation and death over one year in heart failure patients. Medication adherence is associated with all-cause and heart failure-related hospitalisation and death in heart

Implementing the PAIN RelieveIt Randomized Controlled Trial in Hospice Care: Mechanisms for Success and Meeting PCORI Methodology Standards.

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Ezenwa, Miriam O; Suarez, Marie L; Carrasco, Jesus D; Hipp, Theresa; Gill, Anayza; Miller, Jacob; Shea, Robert; Shuey, David; Zhao, Zhongsheng; Angulo, Veronica; McCurry, Timothy; Martin, Joanna; Yao, Yingwei; Molokie, Robert E; Wang, Zaijie Jim; Wilkie, Diana J

2017-07-01

This purpose of this article is to describe how we adhere to the Patient-Centered Outcomes Research Institute's (PCORI) methodology standards relevant to the design and implementation of our PCORI-funded study, the PAIN RelieveIt Trial. We present details of the PAIN RelieveIt Trial organized by the PCORI methodology standards and components that are relevant to our study. The PAIN RelieveIt Trial adheres to four PCORI standards and 21 subsumed components. The four standards include standards for formulating research questions, standards associated with patient centeredness, standards for data integrity and rigorous analyses, and standards for preventing and handling missing data. In the past 24 months, we screened 2,837 cancer patients and their caregivers; 874 dyads were eligible; 223.5 dyads consented and provided baseline data. Only 55 patients were lost to follow-up-a 25% attrition rate. The design and implementation of the PAIN RelieveIt Trial adhered to PCORI's methodology standards for research rigor.

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

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

2013-01-01

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

Adherence with Preventive Medication in Childhood Asthma

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Scott Burgess

2011-01-01

Full Text Available Suboptimal adherence with preventive medication is common and often unrecognised as a cause of poor asthma control. A number of risk factors for nonadherence have emerged from well-conducted studies. Unfortunately, patient report a physician's estimation of adherence and knowledge of these risk factors may not assist in determining whether non-adherence is a significant factor. Electronic monitoring devices are likely to be more frequently used to remind patients to take medication, as a strategy to motivate patients to maintain adherence, and a tool to evaluate adherence in subjects with poor disease control. The aim of this paper is to review non-adherence with preventive medication in childhood asthma, its impact on asthma control, methods of evaluating non-adherence, risk factors for suboptimal adherence, and strategies to enhance adherence.

Clarifying the Concept of Adherence to eHealth Technology: Systematic Review on When Usage Becomes Adherence.

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Sieverink, Floor; Kelders, Saskia M; van Gemert-Pijnen, Julia Ewc

2017-12-06

In electronic health (eHealth) evaluations, there is increasing attention for studying the actual usage of a technology in relation to the outcomes found, often by studying the adherence to the technology. On the basis of the definition of adherence, we suggest that the following three elements are necessary to determine adherence to eHealth technology: (1) the ability to measure the usage behavior of individuals; (2) an operationalization of intended use; and (3) an empirical, theoretical, or rational justification of the intended use. However, to date, little is known on how to operationalize the intended usage of and the adherence to different types of eHealth technology. The study aimed to improve eHealth evaluations by gaining insight into when, how, and by whom the concept of adherence has been used in previous eHealth evaluations and finding a concise way to operationalize adherence to and intended use of different eHealth technologies. A systematic review of eHealth evaluations was conducted to gain insight into how the use of the technology was measured, how adherence to different types of technologies was operationalized, and if and how the intended use of the technology was justified. Differences in variables between the use of the technology and the operationalization of adherence were calculated using a chi-square test of independence. In total, 62 studies were included in this review. In 34 studies, adherence was operationalized as "the more use, the better," whereas 28 studies described a threshold for intended use of the technology as well. Out of these 28, only 6 reported a justification for the intended use. The proportion of evaluations of mental health technologies reporting a justified operationalization of intended use is lagging behind compared with evaluations of lifestyle and chronic care technologies. The results indicated that a justification of intended use does not require extra measurements to determine adherence to the technology. The

Adherence of Lactobacillus crispatus to vaginal epithelial cells from women with or without a history of recurrent urinary tract infection.

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Kwok, Louisa; Stapleton, Ann E; Stamm, Walter E; Hillier, Sharon L; Wobbe, Cheryl L; Gupta, Kalpana

2006-11-01

Lactobacillus crispatus strain CTV-05 is a vaginal probiotic proposed for use in women with recurrent urinary tract infection to reduce vaginal colonization with Escherichia coli and the risk of urinary tract infection. However, the ability of this probiotic strain to adhere to the target mucosa, vaginal epithelial cells, has not been assessed in women with recurrent urinary tract infection. We measured the adherence of L. crispatus strain CTV-05 to vaginal epithelial cells collected from more than 100 premenopausal women with (cases) and without (controls) a history of recurrent urinary tract infection. We also examined the effects of relevant host factors on bacterial adherence. Bacterial adherence assays were performed by combining L. crispatus CTV-05 with exfoliated vaginal epithelial cells collected from 51 case women and 51 controls. L. crispatus CTV-05 adhered in high numbers to vaginal epithelial cells from women with recurrent urinary tract infection (mean adherence of 50.5 lactobacilli per vaginal epithelial cell) and controls (mean adherence of 39.4 lactobacilli per vaginal epithelial cell). Adherence was significantly higher using vaginal epithelial cells from women with a maternal history of urinary tract infection (p = 0.036) and a nonsecretor phenotype (p urinary tract infection. These data strongly support further evaluation of this probiotic in clinical trials of women with recurrent urinary tract infection.

Interventions to improve medication adherence in adult kidney transplant recipients: a systematic review.

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Low, Jac Kee; Williams, Allison; Manias, Elizabeth; Crawford, Kimberley

2015-05-01

In kidney transplantation, adherence to immunosuppressive therapy is paramount for long-term graft survival. This systematic review aimed to assess the effectiveness of interventions to improve medication adherence in adult kidney transplantation. Eight electronic databases were searched from inception to November 2013. Only primary intervention studies, which reported measurement of adherence to immunosuppressive medications after kidney transplantation, were included. The quality of all studies was assessed using the Consolidated Standards of Reporting Trials and Transparent Reporting of Evaluations with Non-randomized Designs checklists. A synthesis was undertaken to tease out the domains targeted by interventions: (i) educational/cognitive, (ii) counselling/behavioural, (iii) psychologic/affective and (iv) financial support. For each study, key information, such as population, location, methods of measurements, comparison group, type of intervention and outcomes, were extracted and tabulated. Twelve intervention studies were identified. Quality of studies ranged from 16.0 to 80.5%. Effective interventions were implemented for 3, 6 and 12 months. Medication adherence rates were greatly enhanced when multidimensional interventions were implemented whereas one-off feedback from a nurse and financial assistance programmes offered little improvement. Dose administration aids when used in conjunction with self-monitoring also improved adherence. The number of patients who had a drug holiday (at least 1-day interval without a dose) was higher in a once-daily regimen than a twice-daily regimen. The findings of this review suggest an intervention targeting behavioural risk factors or a combination of behavioural, educational and emotional changes is effective in enhancing medication adherence. Effectiveness of an intervention may be further enhanced if patients are encouraged to participate in the development process. © The Author 2014. Published by Oxford University

Quality assurance in clinical trials : a multi-disciplinary approach

International Nuclear Information System (INIS)

Cornes, D.

2001-01-01

Full text: Multi-disciplinary groups, such as medical physicists and radiation therapists, which work effectively together, can ensure continued improvements in radiation therapy quality. The same is also true for clinical trials, which have the added complication of requiring multi-institutional participation to collate sufficient data to effectively assess treatment benefits. It can be difficult to manage quality across all aspects of a multi-disciplinary and multi-institutional trial. A planned system of quality assurance is necessary to provide support for participating centres and facilitate a collaborative approach. To ensure protocol compliance a good relationship between the clinical trial group and treatment centre is idea with definition of mutual goals and objectives before and during the trial, and ongoing consultation and feedback throughout the trial process. To ensure good quality data and maximise the validity of results the study protocol must be strictly adhered to. Because of the need for meticulous attention to detail, both in treatment delivery and standards of documentation, clinical trials are often seen to further complicate the process of delivery of radiation therapy treatment. The Declaration of Helsinki and Good Clinical Practise Guidelines (adopted in May 1996, ICH) provide 'international ethical and scientific standards for designing, conducting, recording and reporting clinical research' and multi-disciplinary groups in each participating centre should also adhere to these guidelines. Copyright (2001) Australasian College of Physical Scientists and Engineers in Medicine

Current strategies for improving access and adherence to antiretroviral therapies in resource-limited settings

Directory of Open Access Journals (Sweden)

Scanlon ML

2013-01-01

Full Text Available Michael L Scanlon,1,2 Rachel C Vreeman1,21Department of Pediatrics, Indiana University School of Medicine, Indianapolis, IN, USA; 2USAID, Academic Model Providing Access to Healthcare (AMPATH Partnership, Eldoret, KenyaAbstract: The rollout of antiretroviral therapy (ART significantly reduced human immunodeficiency virus (HIV-related morbidity and mortality, but good clinical outcomes depend on access and adherence to treatment. In resource-limited settings, where over 90% of the world’s HIV-infected population resides, data on barriers to treatment are emerging that contribute to low rates of uptake in HIV testing, linkage to and retention in HIV care systems, and suboptimal adherence rates to therapy. A review of the literature reveals limited evidence to inform strategies to improve access and adherence with the majority of studies from sub-Saharan Africa. Data from observational studies and randomized controlled trials support home-based, mobile and antenatal care HIV testing, task-shifting from doctor-based to nurse-based and lower level provider care, and adherence support through education, counseling and mobile phone messaging services. Strategies with more limited evidence include targeted HIV testing for couples and family members of ART patients, decentralization of HIV care, including through home- and community-based ART programs, and adherence promotion through peer health workers, treatment supporters, and directly observed therapy. There is little evidence for improving access and adherence among vulnerable groups such as women, children and adolescents, and other high-risk populations and for addressing major barriers. Overall, studies are few in number and suffer from methodological issues. Recommendations for further research include health information technology, social-level factors like HIV stigma, and new research directions in cost-effectiveness, operations, and implementation. Findings from this review make a

Sustainability of professionals' adherence to clinical practice guidelines in medical care: a systematic review.

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Ament, Stephanie M C; de Groot, Jeanny J A; Maessen, José M C; Dirksen, Carmen D; van der Weijden, Trudy; Kleijnen, Jos

2015-12-29

To evaluate (1) the state of the art in sustainability research and (2) the outcomes of professionals' adherence to guideline recommendations in medical practice. Systematic review. Searches were conducted until August 2015 in MEDLINE, CINAHL, EMBASE, Cochrane Central Register of Controlled Trials (CENTRAL) and the Guidelines International Network (GIN) library. A snowball strategy, in which reference sections of other reviews and of included papers were searched, was used to identify additional papers. Studies needed to be focused on sustainability and on professionals' adherence to clinical practice guidelines in medical care. Studies had to include at least 2 measurements: 1 before (PRE) or immediately after implementation (EARLY POST) and 1 measurement longer than 1 year after active implementation (LATE POST). The search retrieved 4219 items, of which 14 studies met the inclusion criteria, involving 18 sustainability evaluations. The mean timeframe between the end of active implementation and the sustainability evaluation was 2.6 years (minimum 1.5-maximum 7.0). The studies were heterogeneous with respect to their methodology. Sustainability was considered to be successful if performance in terms of professionals' adherence was fully maintained in the late postimplementation phase. Long-term sustainability of professionals' adherence was reported in 7 out of 18 evaluations, adherence was not sustained in 6 evaluations, 4 evaluations showed mixed sustainability results and in 1 evaluation it was unclear whether the professional adherence was sustained. (2) Professionals' adherence to a clinical practice guideline in medical care decreased after more than 1 year after implementation in about half of the cases. (1) Owing to the limited number of studies, the absence of a uniform definition, the high risk of bias, and the mixed results of studies, no firm conclusion about the sustainability of professionals' adherence to guidelines in medical practice can be drawn

Impact of written information on control and adherence in type 2 diabetes.

Science.gov (United States)

Caetano, Inês Rosendo Carvalho E Silva; Santiago, Luiz Miguel; Marques, Margarida

2018-02-01

Diabetes therapeutic education and information by leaflets is important. This study aimed to understand the effectiveness of written information to diabetic patients, after six months, in the control of diabetes and medication adherence. Non-pharmacological clinical trial. Randomized sample of diabetic patients of 65 volunteer doctors, distributed among the five health regions in Portugal. At the first appointment, patients were randomized in four groups (three intervention with validated leaflets and one control), leaflet reading being reinforced at the follow-up appointments in a 6-months period. Variables collected: HbA1c, home blood glucose, weight, waist circumference, blood pressure, cigarettes smoked, physical activity level, adherence to medication, medication, height, diabetes progression, age, sex and educational background. Descriptive and inferential statistics. From the 709 patients recruited, 702 were studied in this 6-months period with no statistical differences in the baseline variables studied. After six months of intervention, the adherence to medication improved in the leaflet group (p=0.034). This was noticed in those under 65 years of age (p=0.027), with diabetes for ≤ 5 years (p=0.010), with educational background up to 4 years (p=0.030) and 9 years (p=0.006) and with HbA1c ≥ 7% at the beginning of the study. Interventions with leaflets handed in primary healthcare to people with diabetes type 2 can bring benefits in what concerns adherence to therapeutics, namely in younger people with a less studies.

Information and communication technologies for adherence to antiretroviral treatment in adults with HIV/AIDS.

Science.gov (United States)

Lima, Ivana Cristina Vieira de; Galvão, Marli Teresinha Gimeniz; Alexandre, Herta de Oliveira; Lima, Francisca Elisângela Teixeira; Araújo, Thelma Leite de

2016-08-01

Information and communication technologies support interventions directed at the prevention of HIV transmission and patient monitoring by promoting improved accessibility and quality of care. To evaluate the efficacy of information and communication technologies in the adherence to antiretroviral treatment in adults with HIV/AIDS. Systematic review conducted from March to May of 2015 in three databases-the Cumulative Index to Nursing and Allied Health Literature (CINAHL); the Latin-American and Caribbean Literature in Health Sciences (LILACS/BIREME) and SCOPUS; and the Cochrane library and the Medical Literature Analysis and Retrieval System Online portal (MEDLINE/PubMed). The sample consisted of nine randomized clinical trials based on the use of information and communication technologies for adherence to antiretroviral treatment in adults with HIV/AIDS. Three studies analysed the use of a short message service - SMS - two phone calls, two alarm devices, one web-enabled Hand-held device and one web electronic intervention. Improvements in the levels of adherence in the group subjected to the intervention were identified in seven studies. The phone was the type of information and communication technology with proven efficacy with respect to adherence. It was used to make calls, as well as to send alert messages and reminders about taking medications. Pagers were not considered to be effective regarding adherence to antiretroviral therapy. The integrated use of information and communication technologies with standard care promotes increased access to care, strengthening the relationship between patients and health services, with the possibility of mitigating the difficulties experienced by people with HIV in achieving optimal levels of adherence to drug therapy. Copyright © 2016 Elsevier Ireland Ltd. All rights reserved.

Determinants of adherence to methylphenidate and the impact of poor adherence on maternal and family measures.

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Gau, Susan S F; Shen, Hsin-Yi; Chou, Miao-Churn; Tang, Ching-Shu; Chiu, Yen-Nan; Gau, Churn-Shiouh

2006-06-01

The aim of this study was to examine the association between adherence to immediate-release methylphenidate (IR MPH) and maternal psychological distress, parenting style, parent- child relationship, and perceived family support. The sample consisted of 307 children with attention-deficit hyperactivity disorder (ADHD) (271 boys and 36 girls), 6-17 years of age, who had been treated with IR MPH for the past 6 months. The measures included the Chinese Health Questionnaire, Parental Bonding Instrument, Family APGAR, and Home Behaviors of the Social Adjustment Inventory for Children and Adolescents. Reasons for poor adherence (n = 79; 25.7%) included forgetting medication (72.7%), the medication having no effect (20.0%), and refusing medication (12.7%). Increased age and three-times-daily administration were the major predictors for poor adherence to IR MPH. Poor adherence was associated with increased degree of maternal psychological distress, indifferent parenting, maternal overprotection/control, poor family support, decreased interaction with parents, and increased problems at home. Findings indicate that multiple daily dosing of MPH increases the likelihood of poor adherence, particularly in adolescents, and that poor adherence is associated with impaired maternal/family process. Once-daily administration of MPH is necessary to improve adherence and to decrease the possible exacerbation of tense parent-child relationships caused by poor drug adherence.

Suboptimal adherence to doxycycline and treatment outcomes among men with non-gonococcal urethritis: a prospective cohort study.

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Khosropour, Christine M; Manhart, Lisa E; Colombara, Danny V; Gillespie, Catherine W; Lowens, M Sylvan; Totten, Patricia A; Golden, Matthew R; Simoni, Jane

2014-02-01

Doxycycline, one of two recommended therapies for non-gonococcal urethritis (NGU), consists of a 7-day course of therapy (100 mg BID). Since suboptimal adherence may contribute to poor treatment outcomes, we examined the association between self-reported imperfect adherence to doxycycline and clinical and microbiologic failure among men with NGU. Men aged ≥16 years with NGU attending a Seattle, WA, sexually transmitted diseases clinic were enrolled in a double-blind, parallel-group superiority trial from January 2007 to July 2011. Men were randomised to active doxycycline/placebo azithromycin or placebo doxycycline/active azithromycin. Imperfect adherence was defined as missing ≥1 dose in 7 days. Urine was tested for Chlamydia trachomatis (CT), Mycoplasma genitalium (MG), and Ureaplasma urealyticum-biovar 2 (UU-2) using nucleic acid amplification tests. Clinical failure (symptoms and ≥5 PMNs/HPF or discharge) and microbiologic failure (positive tests for CT, MG, and/or UU-2) were determined after 3 weeks. 184 men with NGU were randomised to active doxycycline and provided data on adherence. Baseline prevalence of CT, MG and UU-2 was 26%, 13% and 27%, respectively. 28% of men reported imperfect adherence, and this was associated with microbiologic failure among men with CT (aRR=9.33; 95% CI 1.00 to 89.2) and UU-2 (aRR=3.08; 95% CI 1.31 to 7.26) but not MG. Imperfect adherence was not significantly associated with clinical failure overall or for any specific pathogens, but it was more common among imperfectly adherent men with CT (aRR=2.63; 0.93-7.41, p=0.07). Adherence may be important for microbiologic cure of select pathogens. Factors other than adherence should be considered for CT-negative men with persistent NGU.

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

NARCIS (Netherlands)

Tola, Habteyes Hailu; Shojaeizadeh, Davoud; Tol, Azar; Garmaroudi, Gholamreza; Yekaninejad, Mir Saeed; Kebede, Abebaw; Ejeta, Luche Tadesse; Kassa, Desta; Klinkenberg, Eveline

2016-01-01

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

Adherence of Pseudomonas aeruginosa to contact lenses

International Nuclear Information System (INIS)

Miller, M.J.

1988-01-01

The purpose of this research was to examined the interactions of P. aeruginosa with hydrogel contact lenses and other substrata, and characterize adherence to lenses under various physiological and physicochemical conditions. Isolates adhered to polystyrene, glass, and hydrogel lenses. With certain lens types, radiolabeled cells showed decreased adherence with increasing water content of the lenses, however, this correlation with not found for all lenses. Adherence to rigid gas permeable lenses was markedly greater than adherence to hydrogels. Best adherence occurred near pH 7 and at a sodium chloride concentration of 50 mM. Passive adhesion of heat-killed cells to hydrogels was lower than the adherence obtained of viable cells. Adherence to hydrogels was enhanced by mucin, lactoferrin, lysozyme, IgA, bovine serum albumin, and a mixture of these macromolecules. Adherence to coated and uncoated lenses was greater with a daily-wear hydrogel when compared with an extended-wear hydrogel of similar polymer composition. Greater adherence was attributed to a higher concentration of adsorbed macromolecules on the 45% water-content lens in comparison to the 55% water-content lens

[Do commercial sex workers who discuss treatment with family and friends adhere to it better?].

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Sanon, A; Traoré, I; Diallo, R; Ouédraogo, A; Andonaba, J; Konate, I; Berthe, A; Huet, C; Msellati, P; Visier, L; Mayaud, P; Nagot, N

2009-01-01

The number of HIV trials in Africa is increasing, and they target population groups with high HIV incidence, such as sex workers. Little information, however, is available about the adherence to long-term therapy among such marginalized groups with few economic resources and poor social and family support. A project called "Yerelon" ("know herself" in the Dioula language) began in 1998 in Bobo-Dioulasso to improve the health of women involved in commercial sex through STI/HIV prevention and care adapted to them. This study was conducted before introducing long-term treatment to the population, to assess the effect of communication with those around them on the capacity of these vulnerable women to adhere to drug prescriptions. The study was based on interviews conducted during the pilot phase of a 3-month trial of vitamins with potential participants. It concerned two groups of women: one group was infected with HIV (N = 22), the other was not (N = 20); all women in both groups were infected by HSV-2, however. For 5 weeks, the two psychologists of the study team in charge of adherence assessment carried out weekly in-depth interviews with the participants. The qualitative data analysis was organised around several themes. The data were related to aspects of communication with family and friends, serologic results, and adherence. According to our definition of communication about treatment, 20 participants communicated with their family and friends; adherence was good for all but three of them. Women who reported that they were married or living with someone (7/42) nearly all spoke about the study treatment (06/07) with him. Of 16 participants living in a family, 10 communicated with them about the treatment. On the other hand, as seems logical, single women who lived alone spoke less often about the treatment with family and friends (04/19). Talking about the treatment did not appear to involve the family or friends in the treatment; no one reminded any participant

Adherence to low-carbohydrate and low-fat diets in relation to weight loss and cardiovascular risk factors.

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Hu, Tian; Yao, Lu; Reynolds, Kristi; Niu, Tianhua; Li, Shengxu; Whelton, Paul K; He, Jiang; Steffen, Lyn M; Bazzano, Lydia A

2016-03-01

A low-carbohydrate diet can reduce body weight and some cardiovascular disease (CVD) risk factors more than a low-fat diet, but differential adherence may play a role in these effects. Data were used from 148 adults who participated in a 12-month clinical trial examining the effect of a low-carbohydrate diet (fat diet (fat, fat) on weight and CVD risk factors. We compared attendance at counseling sessions, deviation from nutrient goals, urinary ketone presence, and composite scores representing the overall adherence based on the distribution of these individual indicators between two interventions. Composite scores were similar between the two groups. A one-interquartile-range increase in composite score representing better adherence to a low-carbohydrate diet was associated with 2.2 kg or 2.3 % greater weight loss, 1.1 greater reduction in percent fat mass, and 1.3 greater increase in proportion of lean mass. Indicators of adherence to a low-fat diet was not associated with changes in weight, fat mass or lean mass. Despite comparable adherence between groups, a low-carbohydrate diet was associated with greater reductions in body weight and improvement in body composition, while a low-fat diet was not associated with weight loss.

Current treatment for anorexia nervosa: efficacy, safety, and adherence

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Lindsay P Bodell

2010-10-01

Full Text Available Lindsay P Bodell, Pamela K KeelDepartment of Psychology, Florida State University, Tallahassee, FL, USAAbstract: Anorexia nervosa (AN is a serious psychiatric illness associated with significant medical and psychiatric morbidity, psychosocial impairment, increased risk of death, and chronicity. Given the severity of the disorder, the establishment of safe and effective treatments is necessary. Several treatments have been tried in AN, but few favorable results have emerged. This paper reviews randomized controlled trials in AN, and provides a synthesis of existing data regarding the efficacy, safety, and adherence associated with pharmacologic and psychological interventions. Randomized controlled trials for the treatment of AN published in peer-reviewed journals were identified by electronic and manual searches. Overall, pharmacotherapy has limited benefits in the treatment of AN, with some promising preliminary findings associated with olanzapine, an antipsychotic agent. No single psychological intervention has demonstrated clear superiority in treating adults with AN. In adolescents with AN, the evidence base is strongest for the use of family therapy over alternative individual psychotherapies. Results highlight challenges in both treating individuals with AN and in studying the effects of those treatments, and further emphasize the importance of continued efforts to develop novel interventions. Treatment trials currently underway and areas for future research are discussed.Keywords: anorexia nervosa, treatment, pharmacotherapy, psychotherapy, randomized controlled trials

Using a smartphone-based self-management platform to support medication adherence and clinical consultation in Parkinson's disease.

Science.gov (United States)

Lakshminarayana, Rashmi; Wang, Duolao; Burn, David; Chaudhuri, K Ray; Galtrey, Clare; Guzman, Natalie Valle; Hellman, Bruce; Ben James; Pal, Suvankar; Stamford, Jon; Steiger, Malcolm; Stott, R W; Teo, James; Barker, Roger A; Wang, Emma; Bloem, Bastiaan R; van der Eijk, Martijn; Rochester, Lynn; Williams, Adrian

2017-01-01

The progressive nature of Parkinson's disease, its complex treatment regimens and the high rates of comorbid conditions make self-management and treatment adherence a challenge. Clinicians have limited face-to-face consultation time with Parkinson's disease patients, making it difficult to comprehensively address non-adherence. Here we share the results from a multi-centre (seven centres) randomised controlled trial conducted in England and Scotland to assess the impact of using a smartphone-based Parkinson's tracker app to promote patient self-management, enhance treatment adherence and quality of clinical consultation. Eligible Parkinson's disease patients were randomised using a 1:1 ratio according to a computer-generated random sequence, stratified by centre and using blocks of variable size, to intervention Parkinson's Tracker App or control (Treatment as Usual). Primary outcome was the self-reported score of adherence to treatment (Morisky medication adherence scale -8) at 16 weeks. Secondary outcomes were Quality of Life (Parkinson's disease questionnaire -39), quality of consultation for Parkinson's disease patients ( Patient-centred questionnaire for Parkinson's disease ), impact on non-motor symptoms (Non-motor symptoms questionnaire), depression and anxiety (Hospital anxiety and depression scale) and beliefs about medication (Beliefs about Medication Questionnaire) at 16 weeks. Primary and secondary endpoints were analysed using a generalised linear model with treatment as the fixed effect and baseline measurement as the covariate. 158 patients completed the study (Parkinson's tracker app = 68 and TAU = 90). At 16 weeks Parkinson's tracker app significantly improved adherence, compared to treatment as usual (mean difference: 0.39, 95%CI 0.04-0.74; p  = 0.0304) with no confounding effects of gender, number of comorbidities and age. Among secondary outcomes, Parkinson's tracker app significantly improved patients' perception of quality of

Influence of Spirituality and Religion on Adherence to Highly Active Antiretroviral Therapy in Adult HIV/AIDS Patients in Calabar, Nigeria

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Agam Ebaji Ayuk

2017-07-01

Full Text Available The emergence of a chronic medical illness such as Human Immune Deficiency Virus and Acquired Immunodeficiency Syndrome (HIV/AIDS may be the time when people turn to the Sacred through spirituality and religion. HIV is a chronic illness that requires strict adherence to medication regimens that may be influenced by spirituality/religion. This study was aimed at finding the association between spirituality/religion and adherence to highly active antiretroviral therapy (HAART in adult HIV/AIDS patients. This is a cross-sectional descriptive study of 370 patients. Adherence was measured using an adapted adult AIDS clinical trial group (AACTG and visual analogue scale (VAS tools. Spirituality was assessed using Functional Assessment of Chronic Illness Therapy-Spirituality Expanded (FACIT-Sp-Ex scale, religiosity with Duke University Religion index (DUREL, and religious coping with Brief Religious Coping (RCOPE scale. Adherence rates were 86.2 and 43.8% using AACTG and VAS tools, respectively. Statistical significant correlation was found between spirituality and adherence to HAART (r = 0.265; p = 0.00. Also, significant correlation was found between positive religious coping and adherence (r = 0.15, p = 0.003. Odds ratio indicated that female respondents were 1.6 times more likely to be adherent, compared with males. Similarly, every unit rise in spirituality score yielded a 1.3 times increased likelihood of adherence to HAART on multiple logistic regression of adherence to HAART with relevant predictors. Both spirituality and positive religious coping have positive influence on optimal adherence. Therefore, the training of health care personnel to assess and provide spiritual care and involvement of chaplains/religious leaders is advocated for improved adherence.

Medication adherence among adult patients on hemodialysis

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Abdulmalik M Alkatheri

2014-01-01

Full Text Available Medication adherence was assessed in 89 patients on hemodialysis (HD at the King Abdul Aziz Medical City using an Arabic version of the Morisky Medication Adherence Scale (MASS-8. The results of the study revealed that 31.46% and 40.45% of the participants showed low and medium adherence, respectively, while 28.09% showed high medication adherence. Accordingly, 71.91% of the patients visiting the dialysis unit were considered medication non-adherent. While being of older age (P = 0.012, being married (P = 0.012 increased the level of adherence, being of medium level of education (P = 0.024 decreased adherence levels. On the other hand, gender, presence of a care-giver, number of members in the household and employment status seems to have no effect on the level of medication adherence. These results call upon the practitioners in HD units to develop intervention programs that can increase the level of medication adherence.

Adherence to a behavioral weight loss treatment program enhances weight loss and improvements in biomarkers

Directory of Open Access Journals (Sweden)

Sushama D Acharya

2009-06-01

Full Text Available Sushama D Acharya3, Okan U Elci3, Susan M Sereika1,2,3, Edvin Music3, Mindi A Styn3, Melanie Warziski Turk3, Lora E Burke2,31Department of Biostatistics, Graduate School of Public Health, 2Department of Epidemiology, Graduate School of Public Health, 3School of Nursing, University of Pittsburgh, Pittsburgh, PA, USAObjectives: To describe participants’ adherence to multiple components (attendance, energy intake, fat gram, exercise goals, and self-monitoring eating and exercise behaviors of a standard behavioral treatment program (SBT for weight loss and how adherence to these components may influence weight loss and biomarkers (triglycerides, low density lipoproteins [LDL], high density lipoprotein, and insulin during the intensive and less-intensive intervention phases. Methods: A secondary analysis of a randomized clinical trial consisting of a SBT with either fat-restricted standard or lacto-ovo vegetarian diet. The 12-month intervention was delivered in 33 group sessions. The first six months reflected the intensive phase; the second six months, the less-intensive intervention phase. We conducted the analysis without regard to treatment assignment. Eligible participants included overweight/obese adults (N = 176; mean body mass index = 34.0 kg/m2. The sample was 86.9% female, 70.5% White, and 44.4 ± 8.6 years old. The outcome measures included weight and biomarkers. Results: There was a significant decline in adherence to each treatment component over time (P < 0.0001. In the first six months, adherence to attendance, self-monitoring and the energy goal were significantly associated with greater weight loss (P < 0.05. Adherence to attendance and exercise remained significantly associated with weight loss in the second six months (P < 0.05. Adherence to attendance, self-monitoring and exercise had indirect effects through weight loss on LDL, triglycerides, and insulin (P < 0.05.Conclusions: We observed a decline in adherence to each

The relationship of gender and gender identity to treatment adherence among individuals with bipolar disorder.

Science.gov (United States)

Sajatovic, Martha; Micula-Gondek, Weronika; Tatsuoka, Curtis; Bialko, Christopher

2011-08-01

men with BD differed from general population norms and appeared to be related to adherence. Treatment approaches that are intended to optimize adherence need to consider the construct of gender identity or gender role. ClinicalTrials.gov ID: NCT00183495. Copyright © 2011 Elsevier HS Journals, Inc. All rights reserved.

Probiotics: Prevention of Severe Pneumonia and Endotracheal Colonization Trial-PROSPECT: a pilot trial.

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Cook, Deborah J; Johnstone, Jennie; Marshall, John C; Lauzier, Francois; Thabane, Lehana; Mehta, Sangeeta; Dodek, Peter M; McIntyre, Lauralyn; Pagliarello, Joe; Henderson, William; Taylor, Robert W; Cartin-Ceba, Rodrigo; Golan, Eyal; Herridge, Margaret; Wood, Gordon; Ovakim, Daniel; Karachi, Tim; Surette, Michael G; Bowdish, Dawn M E; Lamarche, Daphnee; Verschoor, Chris P; Duan, Erick H; Heels-Ansdell, Diane; Arabi, Yaseen; Meade, Maureen

2016-08-02

Probiotics are live microorganisms that may confer health benefits when ingested. Randomized trials suggest that probiotics significantly decrease the incidence of ventilator-associated pneumonia (VAP) and the overall incidence of infection in critically ill patients. However, these studies are small, largely single-center, and at risk of bias. The aim of the PROSPECT pilot trial was to determine the feasibility of conducting a larger trial of probiotics to prevent VAP in mechanically ventilated patients in the intensive care unit (ICU). In a randomized blinded trial, patients expected to be mechanically ventilated for ≥72 hours were allocated to receive either 1 × 10(10) colony-forming units of Lactobacillus rhamnosus GG or placebo, twice daily. Patients were excluded if they were at increased risk of L. rhamnosus GG infection or had contraindications to enteral medication. Feasibility objectives were: (1) timely recruitment; (2) maximal protocol adherence; (3) minimal contamination; and (4) estimated VAP rate ≥10 %. We also measured other infections, diarrhea, ICU and hospital length of stay, and mortality. Overall, in 14 centers in Canada and the USA, all feasibility goals were met: (1) 150 patients were randomized in 1 year; (2) protocol adherence was 97 %; (3) no patients received open-label probiotics; and (4) the VAP rate was 19 %. Other infections included: bloodstream infection (19.3 %), urinary tract infections (12.7 %), and skin and soft tissue infections (4.0 %). Diarrhea, defined as Bristol type 6 or 7 stools, occurred in 133 (88.7 %) of patients, the median length of stay in ICU was 12 days (quartile 1 to quartile 3, 7-18 days), and in hospital was 26 days (quartile 1 to quartile 3, 14-44 days); 23 patients (15.3 %) died in the ICU. The PROSPECT pilot trial supports the feasibility of a larger trial to investigate the effect of L. rhamnosus GG on VAP and other nosocomial infections in critically ill patients. Clinicaltrials

The Interaction of Motivation and Therapist Adherence Predicts Outcome in Cognitive Behavioral Therapy for Panic Disorder: Preliminary Findings

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Huppert, Jonathan D.; Barlow, David H.; Gorman, Jack M.; Shear, M. Katherine; Woods, Scott W.

2006-01-01

This report is a post-hoc, exploratory examination of the relationships among patient motivation, therapist protocol adherence, and panic disorder outcome in patients treated with cognitive behavioral therapy within the context of a randomized clinical trial for the treatment of panic disorder (Barlow, Gorman, Shear, & Woods, 2000). Results…

Effect on adherence to nicotine replacement therapy of informing smokers their dose is determined by their genotype: a randomised controlled trial.

Directory of Open Access Journals (Sweden)

Theresa M Marteau

Full Text Available BACKGROUND: The behavioural impact of pharmacogenomics is untested. We tested two hypotheses concerning the behavioural impact of informing smokers their oral dose of NRT is tailored to analysis of DNA. METHODS AND FINDINGS: We conducted an RCT with smokers in smoking cessation clinics (N = 633. In combination with NRT patch, participants were informed that their doses of oral NRT were based either on their mu-opioid receptor (OPRM1 genotype, or their nicotine dependence questionnaire score (phenotype. The proportion of prescribed NRT consumed in the first 28 days following quitting was not significantly different between groups: (68.5% of prescribed NRT consumed in genotype vs 63.6%, phenotype group, difference = 5.0%, 95% CI -0.9,10.8, p = 0.098. Motivation to make another quit attempt among those (n = 331 not abstinent at six months was not significantly different between groups (p = 0.23. Abstinence at 28 days was not different between groups (p = 0.67; at six months was greater in genotype than phenotype group (13.7% vs 7.9%, difference = 5.8%, 95% CI 1.0,10.7, p = 0.018. CONCLUSIONS: Informing smokers their oral dose of NRT was tailored to genotype not phenotype had a small, statistically non-significant effect on 28-day adherence to NRT. Among those still smoking at six months, there was no evidence that saying NRT was tailored to genotype adversely affected motivation to make another quit attempt. Higher abstinence rate at six months in the genotype arm requires investigation. TRIAL REGISTRATION: Controlled-Trials.com ISRCTN14352545.

Adherence to Pre-Exposure Prophylaxis for HIV Prevention in a Clinical Setting.

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Madeline C Montgomery

Full Text Available The HIV epidemic in the United States (US disproportionately affects gay, bisexual, and other men who have sex with men (MSM. Pre-exposure prophylaxis (PrEP using co-formulated tenofovir disoproxil fumarate (TDF and emtricitabine (FTC has demonstrated high efficacy in reducing HIV incidence among MSM. However, low adherence was reported in major efficacy trials and may present a substantial barrier to successful PrEP implementation. Rates of adherence to PrEP in "real-world" clinical settings in the US remain largely unknown.We reviewed demographic and clinical data for the first 50 patients to enroll in a clinical PrEP program in Providence, Rhode Island. We analyzed self-reported drug adherence as well as drug concentrations in dried blood spots (DBS from patients who attended either a three- or six-month follow-up appointment. We further assessed drug concentrations and the resistance profile of a single patient who seroconverted while taking PrEP.Of the first 50 patients to be prescribed PrEP, 62% attended a follow-up appointment at three months and 38% at six months. Of those who attended an appointment at either time point (70%, n = 35, 92% and 95% reported taking ±4 doses/week at three and six months, respectively. Drug concentrations were performed on a random sample of 20 of the 35 patients who attended a follow-up appointment. TDF levels consistent with ±4 doses/week were found in 90% of these patients. There was a significant correlation between self-reported adherence and drug concentrations (r = 0.49, p = 0.02. One patient who had been prescribed PrEP seroconverted at his three-month follow-up visit. The patient's drug concentrations were consistent with daily dosing. Population sequencing and ultrasensitive allele-specific PCR detected the M184V mutation, but no other TDF- or FTC-associated mutations, including those present as minor variants.In this clinical PrEP program, adherence was high, and self-reported drug adherence

Adherence to Pre-Exposure Prophylaxis for HIV Prevention in a Clinical Setting.

Science.gov (United States)

Montgomery, Madeline C; Oldenburg, Catherine E; Nunn, Amy S; Mena, Leandro; Anderson, Peter; Liegler, Teri; Mayer, Kenneth H; Patel, Rupa; Almonte, Alexi; Chan, Philip A

2016-01-01

The HIV epidemic in the United States (US) disproportionately affects gay, bisexual, and other men who have sex with men (MSM). Pre-exposure prophylaxis (PrEP) using co-formulated tenofovir disoproxil fumarate (TDF) and emtricitabine (FTC) has demonstrated high efficacy in reducing HIV incidence among MSM. However, low adherence was reported in major efficacy trials and may present a substantial barrier to successful PrEP implementation. Rates of adherence to PrEP in "real-world" clinical settings in the US remain largely unknown. We reviewed demographic and clinical data for the first 50 patients to enroll in a clinical PrEP program in Providence, Rhode Island. We analyzed self-reported drug adherence as well as drug concentrations in dried blood spots (DBS) from patients who attended either a three- or six-month follow-up appointment. We further assessed drug concentrations and the resistance profile of a single patient who seroconverted while taking PrEP. Of the first 50 patients to be prescribed PrEP, 62% attended a follow-up appointment at three months and 38% at six months. Of those who attended an appointment at either time point (70%, n = 35), 92% and 95% reported taking ±4 doses/week at three and six months, respectively. Drug concentrations were performed on a random sample of 20 of the 35 patients who attended a follow-up appointment. TDF levels consistent with ±4 doses/week were found in 90% of these patients. There was a significant correlation between self-reported adherence and drug concentrations (r = 0.49, p = 0.02). One patient who had been prescribed PrEP seroconverted at his three-month follow-up visit. The patient's drug concentrations were consistent with daily dosing. Population sequencing and ultrasensitive allele-specific PCR detected the M184V mutation, but no other TDF- or FTC-associated mutations, including those present as minor variants. In this clinical PrEP program, adherence was high, and self-reported drug adherence accurately

Reasons for non-adherence to the dapivirine vaginal ring: results of the MTN-032/ AHA study.

Science.gov (United States)

Montgomery, Elizabeth T; Stadler, Jonathan; Naidoo, Sarita; Katz, Ariana; Laborde, Nicole; Garcia, Morgan; Reddy, Krishnaveni; Mansoor, Leila; Etima, Juliane; Zimba, Chifundo; Chitukuta, Miria; Soto-Torres, Lydia

2018-05-11

METHODS:: Former ASPIRE participants were stratified by age group (18-21; 22-45) and randomly selected at seven sites in Malawi, South Africa, Uganda and Zimbabwe, 12-17 months after trial exit. Using in-depth interviews or focus group discussions, ring use barriers were explored using structured guides and visual tools including individual-level depictions of dapivirine levels detected in plasma and returned rings. 187 were enrolled; 37% were 18-21 when they began ASPIRE. Most (75%) had drug-level results suggesting inconsistent ring use throughout ASPIRE. Participants viewed themselves as adherent, while simultaneously describing regular instances and reasons for ring removal (e.g. for sex or menses). Less adherent women reported fears that partners would oppose the ring or feel it during sex. High adherers expressed altruistic motivations for ring use. Women of all ages attributed young women's non-adherence to their tendency to be less "serious" about the future, HIV prevention and the study; motivated predominantly by benefits; more fearful of fertility-related consequences; and to having less relationship control. When presented with objective adherence data, participants provided reasons for intermittent ring use, while simultaneously portraying themselves as consistent ring users. Further research is needed to understand how women could use the ring in a way that fits into the context of their relationships and their lives while still conferring adequate HIV prophylaxis.

EEG Neurofeedback for ADHD: Double-Blind Sham-Controlled Randomized Pilot Feasibility Trial

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Arnold, L. Eugene; Lofthouse, Nicholas; Hersch, Sarah; Pan, Xueliang; Hurt, Elizabeth; Bates, Bethany; Kassouf, Kathleen; Moone, Stacey; Grantier, Cara

2013-01-01

Objective: Preparing for a definitive randomized clinical trial (RCT) of neurofeedback (NF) for ADHD, this pilot trial explored feasibility of a double-blind, sham-controlled design and adherence/palatability/relative effect of two versus three treatments/week. Method: Unmedicated 6- to 12-year-olds with "Diagnostic and Statistical Manual of…

The science of being a study participant: FEM-PrEP participants' explanations for overreporting adherence to the study pills and for the whereabouts of unused pills.

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Corneli, Amy L; McKenna, Kevin; Perry, Brian; Ahmed, Khatija; Agot, Kawango; Malamatsho, Fulufhelo; Skhosana, Joseph; Odhiambo, Jacob; Van Damme, Lut

2015-04-15

FEM-PrEP was unable to determine whether once-daily, oral emtricitabine/tenofovir disoproxil fumarate reduces the risk of HIV acquisition among women because of low adherence. Self-reported adherence was high, and pill-count data suggested good adherence. Yet, drug concentrations revealed limited pill use. We conducted a follow-up study with former participants in Bondo, Kenya, and Pretoria, South Africa, to understand factors that had influenced overreporting of adherence and to learn the whereabouts of unused pills. Qualitative, semistructured interviews were conducted with 88 participants, and quantitative, audio computer-assisted self-interviews were conducted with 224 participants. We used thematic analysis and descriptive statistics to analyze the qualitative and quantitative data, respectively. In audio computer-assisted self-interviews, 31% (n = 70) said they had overreported adherence; the main reason was the belief that nonadherence would result in trial termination (69%, n = 48). A considerable percentage (35%, n = 78) acknowledged discarding unused pills. Few acknowledged giving their pills to someone else (4%, n = 10), and even fewer acknowledged giving them to someone with HIV (2%, n = 5). Many participants in the semistructured interviews said other participants had counted and removed pills from their bottles to appear adherent. Despite repeated messages that nonadherence would not upset staff, participants acknowledged several perceived negative consequences of reporting nonadherence, which made it difficult to report accurately. Uneasiness continued in the follow-up study, as many said they had not overreported during the trial. Efforts to improve self-reported measures should include identifying alternative methods for creating supportive environments that allow participants to feel comfortable reporting actual adherence.

Medicine non-adherence in kidney transplantation.

Science.gov (United States)

Williams, Allison Fiona; Manias, Elizabeth; Gaskin, Cadeyrn J; Crawford, Kimberley

2014-06-01

The increasing prevalence of chronic kidney disease, the relative shortage of kidney donors and the economic- and health-related costs of kidney transplant rejection make the prevention of adverse outcomes following transplantation a healthcare imperative. Although strict adherence to immunosuppressant medicine regimens is key to preventing kidney rejection, evidence suggests that adherence is sub-optimal. Strategies need to be developed to help recipients of kidney transplants adhere to their prescribed medicines. This review has found that a number of factors contribute to poor adherence, for example, attitudes towards medicine taking and forgetfulness. Few investigations have been conducted, however, on strategies to enhance medicine adherence in kidney transplant recipients. Strategies that may improve adherence include pharmacist-led interventions (incorporating counselling, medicine reviews and nephrologist liaison) and nurse-led interventions (involving collaboratively working with recipients to understand their routines and offering solutions to improve adherence). Strategies that have shown to have limited effectiveness include supplying medicines free of charge and providing feedback on a participant's medicine adherence without any educational or behavioural interventions. Transplantation is the preferred treatment option for people with end-stage kidney disease. Medicine non-adherence in kidney transplantation increases the risk of rejection, kidney loss and costly treatments. Interventions are needed to help the transplant recipient take all their medicines as prescribed to improve general well-being, medicine safety and reduce healthcare costs. © 2014 European Dialysis and Transplant Nurses Association/European Renal Care Association.

Effects of a Patient-Provider, Collaborative, Medication-Planning Tool: A Randomized, Controlled Trial

Directory of Open Access Journals (Sweden)

James F. Graumlich

2016-01-01

Full Text Available Among patients with various levels of health literacy, the effects of collaborative, patient-provider, medication-planning tools on outcomes relevant to self-management are uncertain. Objective. Among adult patients with type II diabetes mellitus, we tested the effectiveness of a medication-planning tool (Medtable™ implemented via an electronic medical record to improve patients’ medication knowledge, adherence, and glycemic control compared to usual care. Design. A multicenter, randomized controlled trial in outpatient primary care clinics. 674 patients received either the Medtable tool or usual care and were followed up for up to 12 months. Results. Patients who received Medtable had greater knowledge about indications for medications in their regimens and were more satisfied with the information about their medications. Patients’ knowledge of drug indication improved with Medtable regardless of their literacy status. However, Medtable did not improve patients’ demonstrated medication use, regimen adherence, or glycemic control (HbA1c. Conclusion. The Medtable tool supported provider/patient collaboration related to medication use, as reflected in patient satisfaction with communication, but had limited impact on patient medication knowledge, adherence, and HbA1c outcomes. This trial is registered with ClinicalTrials.gov NCT01296633.

Immunosuppressive medication adherence in kidney transplant patients.

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Lalić, Jelena; Veličković-Radovanović, Radmila; Mitić, Branka; Paunović, Goran; Cvetković, Tatjana

2014-01-01

To assess the degree of immunosuppressive medication adherence in kidney transplant patients (KTPs) and to determine if there is a difference in the rate of adherence to tacrolimus (Tac), cyclosporine (CsA) and sirolimus (Sir). From a total of 63 KTPs treated at the Clinic of Nephrology, Clinical Centre Niš, Serbia, 60 participated in the study by responding to questionnaires. They were divided into the adherence group (n = 43) and the nonadherence group (n = 17) according to their degree of adherence which was measured using a validated survey form, the simplified medication adherence questionnaire. The KTP adherence to the different immunosuppressive regimens (Tac, CsA and Sir) was compared. Statistical analysis was performed using the Student t test. Adherence was observed in 43 (71.7%) patients, and only 17 (28.3%) did not follow the prescribed therapy. The estimated glomerular filtration rate was significantly lower in the nonadherence group (38.52 ± 18.22 ml/min) than in the adherence group (52.43 ± 16.91 ml/min, p adherers and the nonadherers (6.30 ± 2.06 vs. 5.0 ± 1.52 ng/ml, p adherence. Nonadherence was associated with worse graft function and a lower Tac level. Knowledge about the degree of adherence could help the early identification of nonadherent patients and the development of strategies to improve this. © 2014 S. Karger AG, Basel

Patient non-adherence: an interpretative phenomenological analysis.

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Dalvi, Vidya; Mekoth, Nandakumar

2017-04-18

Purpose While interpretative phenomenological analysis (IPA) has been used in health psychology research, it has so far not been applied to seek deeper insights into the patients' experiences about treatment. The purpose of this paper is to address this gap by using IPA to understand patient non-adherence. Design/methodology/approach In total, 18 patients with chronic conditions seeking healthcare services in Goa and Karnataka, India, were selected by using the snowball sampling method. In-depth interviews were conducted face to face. A semi-structured questionnaire developed by the researchers was used to collect the data. IPA was used to explore the themes to predict patient non-adherence. Findings The study results indicate that economic factors, health system related factors, social factors and psychological factors impact patient non-adherence. Patient non-adherence includes medication non-adherence and lifestyle modification non-adherence. Research limitations/implications Being cross sectional in design, the results may not be as appropriate as the results derived from a longitudinal study given that non-adherence occurs over time. Practical implications Patient non-adherence is a global health issue. Multidisciplinary approach to enhance patient adherence to treatment should form part of public healthcare policy. Social implications Exploring the factors influencing patient non-adherence will help the health-care industry stakeholders to reduce healthcare cost and improve patient's quality of life. Originality/value Although there is extensive quantitative research on the prevalence of non-adherence, qualitative research is limited. This paper addresses this gap by using IPA to understand patient non-adherence and its factors and dimensions.

Can an app supporting psoriasis patients improve adherence to topical treatment?

DEFF Research Database (Denmark)

Svendsen, Mathias Tiedemann; Andersen, Flemming; Andersen, Kirsten Hammond

2018-01-01

of applications (apps) for smartphones is suggested to improve medical adherence. METHODS/DESIGN: Design: An investigator-initiated, single-center, single-blind, parallel-group, phase-4 clinical superiority randomized controlled trial (RCT). PARTICIPANTS: 134 patients 18 to 75 years of age with mild...... that pop-up on the smartphone screen with a short alert sound. The app synchronizes through Bluetooth® to an electronic monitor (EM) attached to the medication canister. The EM contains a chip registering the amount of foam, day and time the patient use the foam dispenser. The information is displayed...

Probiotics: Prevention of Severe Pneumonia and Endotracheal Colonization Trial-PROSPECT: protocol for a feasibility randomized pilot trial.

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Johnstone, Jennie; Meade, Maureen; Marshall, John; Heyland, Daren K; Surette, Michael G; Bowdish, Dawn Me; Lauzier, Francois; Thebane, Lehana; Cook, Deborah J

2015-01-01

Probiotics are defined as live microorganisms that may confer health benefits when ingested. Meta-analysis of probiotic trials suggests a 25 % lower ventilator-associated pneumonia (VAP) and 18 % lower infection rates overall when administered to patients in the intensive care unit (ICU). However, prior trials are small, largely single center, and at high risk of bias. Before a large rigorous trial is launched, testing whether probiotics confer benefit, harm, or have no impact, a pilot trial is needed. The aim of the PROSPECT Pilot Trial is to determine the feasibility of performing a larger trial in mechanically ventilated critically ill patients investigating Lactobacillus rhamnosus GG. A priori, we determined that the feasibility of the larger trial would be based on timely recruitment, high protocol adherence, minimal contamination, and an acceptable VAP rate. Patients ≥18 years old in the ICU who are anticipated to receive mechanical ventilation for ≥72 hours will be included. Patients are excluded if they are at increased risk of probiotic-associated infection, have strict enteral medication contraindications, are pregnant, previously enrolled in a related trial, or are receiving palliative care. Following informed consent, patients are randomized in variable unspecified block sizes in a fixed 1:1 ratio, stratified by ICU, and medical, surgical, or trauma admitting diagnosis. Patients receive 1 × 10 10 colony forming units of L. rhamnosus GG (Culturelle, Locin Industries Ltd) or an identical placebo suspended in tap water administered twice daily via nasogastric tube in the ICU. Clinical and research staff, patients, and families are blinded. The primary outcomes for this pilot trial are the following: (1) recruitment success, (2) ≥90 % protocol adherence, (3) ≤5 % contamination, and (4) ~10 % VAP rate. Additional clinical outcomes are VAP, other infections, diarrhea (total, antibiotic associated, and Clostridium difficile), ICU and

Sub-optimal adherence to doxycycline and treatment outcomes among men with non-gonococcal urethritis: a prospective cohort study

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Khosropour, Christine M.; Manhart, Lisa E.; Colombara, Danny V.; Gillespie, Catherine W.; Lowens, M. Sylvan; Totten, Patricia A.; Golden, Matthew R.; Simoni, Jane

2014-01-01

Objective Doxycycline, one of two recommended therapies for non-gonococcal urethritis (NGU), consists of a seven-day course of therapy (100mg BID). Since suboptimal adherence may contribute to poor treatment outcomes, we examined the association between self-reported imperfect adherence to doxycycline and clinical and microbiologic failure among men with NGU. Methods Men aged ≥16 years with NGU attending a Seattle, WA sexually transmitted diseases clinic were enrolled in a double-blind, parallel-group superiority trial from January 2007 to July 2011. Men were randomized to active doxycycline/placebo azithromycin or placebo doxycycline/active azithromycin. Imperfect adherence was defined as missing ≥1 dose in 7 days. Urine was tested for Chlamydia trachomatis (CT), Mycoplasma genitalium (MG), and Ureaplasma urealyticum-biovar2 (UU-2) using nucleic acid amplification tests. Clinical failure (symptoms and ≥5 PMNs/HPF or discharge) and microbiologic failure (positive tests for CT, MG, and/or UU-2) were determined after 3-weeks. Results 184 men with NGU were randomized to active doxycycline and provided data on adherence. Baseline prevalence of CT, MG, and UU-2 was 26%, 13%, and 27%, respectively. 28% of men reported imperfect adherence and this was associated with microbiologic failure among men with CT (aRR=9.33; 95% CI=1.00–89.2) and UU-2 (aRR=3.08; 95% CI=1.31–7.26) but not MG. Imperfect adherence was not significantly associated with clinical failure overall or for any specific pathogens, but it was more common among imperfectly adherent men with CT (aRR=2.63; 0.93–7.41, p=0.07). Conclusions Adherence may be important for microbiologic cure of select pathogens. Factors other than adherence should be considered for CT-negative men with persistent NGU. PMID:24106340

Facilitators and barriers to medication adherence in an HIV prevention study among men who have sex with men in the iPrEx study in Chiang Mai, Thailand.

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Tangmunkongvorakul, Arunrat; Chariyalertsak, Suwat; Amico, K Rivet; Saokhieo, Pongpun; Wannalak, Vorawan; Sangangamsakun, Thirayut; Goicochea, Pedro; Grant, Robert

2013-08-01

In 2008, the Pre-exposure Prophylaxis Initiative (iPrEx) study expanded to include men who have sex with men (MSM) in Chiang Mai, Thailand. In full, 114 participants from Chiang Mai joined this international double-blinded trial of daily FTC-TDF (Truvada®) or placebo as a pre-exposure prophylaxis (PrEP) HIV prevention strategy. To better understand the characteristics of iPrEx participants specifically from this underserved population in Thailand, and gain insights into their experiences of trying to take a daily tablet as part of this blinded PrEP trial, we conducted a qualitative study. In 2010, 32 MSM iPrEx participants provided in-depth interviews and an additional 14 joined focus group discussions. Results of the qualitative analyzes suggested that participants held generally positive attitudes toward the iPrEx study and study medication and related this to high rates of adherence to the daily regimen. Participants also reflected on the provision of quality health care as part of participation in the trial, as well as support from clinical research staff, family and friends as helpful in supporting high rates of study medication adherence. Discourse concerning challenges to adherence included medication taking behavior, which was contextualized by lifestyle, living arrangement, social life, social stigma in terms of being mistakenly identified as HIV positive or unintentional disclosure of sexual identity to family and friends, and relationship conflicts with partners. The results provide broader perspectives of participant experiences of the study medication and daily adherence in the larger contexts of the MSM community, close relationships, and the study climate, and can be leveraged in constructing PrEP adherence support approaches within these communities.

Benefits of adherence to psychotropic medications on depressive symptoms and antiretroviral medication adherence among men and women living with HIV/AIDS.

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Cruess, Dean G; Kalichman, Seth C; Amaral, Christine; Swetzes, Connie; Cherry, Chauncey; Kalichman, Moira O

2012-04-01

Psychotropic medications are commonly used for depressive symptoms among people living with HIV/AIDS. We examined the relationships between adherence to psychotropic medications, depressive symptoms, and antiretroviral adherence. We assessed depressive symptoms among 324 people living with HIV/AIDS across a 3-month period (70% men; mean age 45 years; 90% African-American). Psychotropic and antiretroviral adherence was assessed using monthly, unannounced telephone pill counts. Multiple-regression and mediation analyses were utilized to examine associations under investigation. Greater depressive symptoms were associated with lower antiretroviral and psychotropic medication adherence. Greater adherence to psychotropic medications regardless of medication class was positively related to higher antiretroviral adherence. Greater adherence to psychotropic medications also significantly mediated the association between depressive symptoms and antiretroviral adherence. This study demonstrates the benefits of adherence to psychotropic medications on both depressive symptoms and antiretroviral adherence. Future work examining psychotropic medication adherence on disease outcomes in people living with HIV/AIDS is warranted.

Effect of Financial Incentives on Glucose Monitoring Adherence and Glycemic Control Among Adolescents and Young Adults With Type 1 Diabetes: A Randomized Clinical Trial.

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Wong, Charlene A; Miller, Victoria A; Murphy, Kathryn; Small, Dylan; Ford, Carol A; Willi, Steven M; Feingold, Jordyn; Morris, Alexander; Ha, Yoonhee P; Zhu, Jingsan; Wang, Wenli; Patel, Mitesh S

2017-12-01

Glycemic control often deteriorates during adolescence and the transition to young adulthood for patients with type 1 diabetes. The inability to manage type 1 diabetes effectively during these years is associated with poor glycemic control and complications from diabetes in adult life. To determine the effect of daily financial incentives on glucose monitoring adherence and glycemic control in adolescents and young adults with type 1 diabetes. The Behavioral Economic Incentives to Improve Glycemic Control Among Adolescents and Young Adults With Type 1 Diabetes (BE IN CONTROL) study was an investigator-blinded, 6-month, 2-arm randomized clinical trial conducted between January 22 and November 2, 2016, with 3-month intervention and follow-up periods. Ninety participants (aged 14-20) with suboptimally controlled type 1 diabetes (hemoglobin A1c [HbA1c] >8.0%) were recruited from the Diabetes Center for Children at the Children's Hospital of Philadelphia. All participants were given daily blood glucose monitoring goals of 4 or more checks per day with 1 or more level within the goal range (70-180 mg/dL) collected with a wireless glucometer. The 3-month intervention consisted of a $60 monthly incentive in a virtual account, from which $2 was subtracted for every day of nonadherence to the monitoring goals. During a 3-month follow-up period, the intervention was discontinued. The primary outcome was change in HbA1c levels at 3 months. Secondary outcomes included adherence to glucose monitoring and change in HbA1c levels at 6 months. All analyses were by intention to treat. Of the 181 participants screened, 90 (52 [57.8%] girls) were randomized to the intervention (n = 45) or control (n = 45) arms. The mean (SD) age was 16.3 (1.9) years. The intervention group had significantly greater adherence to glucose monitoring goals in the incentive period (50.0% vs 18.9%; adjusted difference, 27.2%; 95% CI, 9.5% to 45.0%; P = .003) but not in the follow-up period (15

Self-reported Medication Adherence and CKD Progression

Directory of Open Access Journals (Sweden)

Esteban A. Cedillo-Couvert

2018-05-01

Full Text Available Introduction: In the general population, medication nonadherence contributes to poorer outcomes. However, little is known about medication adherence among adults with chronic kidney disease (CKD. We evaluated the association of self-reported medication adherence with CKD progression and all-cause death in patients with CKD. Methods: In this prospective observational study of 3305 adults with mild-to-moderate CKD enrolled in the Chronic Renal Insufficiency Cohort (CRIC Study, the baseline self-reported medication adherence was assessed by responses to 3 questions and categorized as high, medium, and low. CKD progression (50% decline in eGFR or incident end-stage renal disease and all-cause death were measured using multivariable Cox proportional hazards. Results: Of the patients, 68% were categorized as high adherence, 17% medium adherence, and 15% low adherence. Over a median follow-up of 6 years, there were 969 CKD progression events and 675 deaths. Compared with the high-adherence group, the low-adherence group experienced increased risk for CKD progression (hazard ratio = 1.27, 95% confidence interval = 1.05, 1.54 after adjustment for sociodemographic and clinical factors, cardiovascular medications, number of medication types, and depressive symptoms. A similar association existed between low adherence and all-cause death, but did not reach standard statistical significance (hazard ratio = 1.14 95% confidence interval = 0.88, 1.47. Conclusion: Baseline self-reported low medication adherence was associated with an increased risk for CKD progression. Future work is needed to better understand the mechanisms underlying this association and to develop interventions to improve adherence. Keywords: CKD, death, medication adherence, progression

Short-Term Effectiveness of a Mobile Phone App for Increasing Physical Activity and Adherence to the Mediterranean Diet in Primary Care: A Randomized Controlled Trial (EVIDENT II Study).

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Recio-Rodriguez, Jose I; Agudo-Conde, Cristina; Martin-Cantera, Carlos; González-Viejo, Mª Natividad; Fernandez-Alonso, Mª Del Carmen; Arietaleanizbeaskoa, Maria Soledad; Schmolling-Guinovart, Yolanda; Maderuelo-Fernandez, Jose-Angel; Rodriguez-Sanchez, Emiliano; Gomez-Marcos, Manuel A; Garcia-Ortiz, Luis

2016-12-19

The use of mobile phone apps for improving lifestyles has become generalized in the population, although little is still known about their effectiveness in improving health. We evaluate the effect of adding an app to standard counseling on increased physical activity (PA) and adherence to the Mediterranean diet, 3 months after implementation. A randomized, multicenter clinical trial was carried out. A total of 833 participants were recruited in six primary care centers in Spain through random sampling: 415 in the app+counseling group and 418 in the counseling only group. Counseling on PA and the Mediterranean diet was given to both groups. The app+counseling participants additionally received training in the use of an app designed to promote PA and the Mediterranean diet over a 3-month period. PA was measured with the 7-day Physical Activity Recall (PAR) questionnaire and an accelerometer; adherence to the Mediterranean diet was assessed using the Mediterranean Diet Adherence Screener questionnaire. Participants were predominantly female in both the app+counseling (249/415, 60.0%) and counseling only (268/418, 64.1%) groups, with a mean age of 51.4 (SD 12.1) and 52.3 (SD 12.0) years, respectively. Leisure-time moderate-to-vigorous physical activity (MVPA) by 7-day PAR increased in the app+counseling (mean 29, 95% CI 5-53 min/week; P=.02) but not in the counseling only group (mean 17.4, 95% CI -18 to 53 min/week; P=.38). No differences in increase of activity were found between the two groups. The accelerometer recorded a decrease in PA after 3 months in both groups: MVPA mean -55.3 (95% CI -75.8 to -34.9) min/week in app+counseling group and mean -30.1 (95% CI -51.8 to -8.4) min/week in counseling only group. Adherence to the Mediterranean diet increased in both groups (8.4% in app+counseling and 10.4% in counseling only group), with an increase in score of 0.42 and 0.53 points, respectively (Pincreased more in the app+counseling than counseling only group

HABIT, a Randomized Feasibility Trial to Increase Hydroxyurea Adherence, Suggests Improved Health-Related Quality of Life in Youths with Sickle Cell Disease.

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Smaldone, Arlene; Findley, Sally; Manwani, Deepa; Jia, Haomiao; Green, Nancy S

2018-06-01

To examine the effect of a community health worker (CHW) intervention, augmented by tailored text messages, on adherence to hydroxyurea therapy in youths with sickle cell disease, as well as on generic and disease-specific health-related quality of life (HrQL) and youth-parent self-management responsibility concordance. We conducted a 2-site randomized controlled feasibility study (Hydroxyurea Adherence for Personal Best in Sickle Cell Treatment [HABIT]) with 2:1 intervention allocation. Youths and parents participated as dyads. Intervention dyads received CHW visits and text message reminders. Data were analyzed using descriptive statistics, the Wilcoxon signed-rank test, and growth models adjusting for group assignment, time, and multiple comparisons. Changes in outcomes from 0 to 6 months were compared with their respective minimal clinically important differences. A total of 28 dyads (mean age of youths, 14.3 ± 2.6 years; 50% Hispanic) participated (18 in the intervention group, 10 in the control group), with 10.7% attrition. Accounting for group assignment, time, and multiple comparisons, at 6 months intervention youths reported improved generic HrQL total score (9.8 points; 95% CI, 0.4-19.2) and Emotions subscale score (15.0 points; 95% CI, 1.6-28.4); improved disease-specific subscale scores for Worry I (30.0 points; 95% CI, 8.5-51.5), Emotions (37.0 points, 95% CI, 9.4-64.5), and Communication I (17.8 points; 95% CI, 0.5-35.1); and 3-month dyad self-management responsibility concordance (3.5 points; 95% CI, -0.2 to 7.1). There were no differences in parent proxy-reported HrQL measures at 6 months. These findings add to research examining effects of behavioral interventions on HrQL outcomes in youths with sickle cell disease. ClinicalTrials.gov: NCT02029742. Copyright © 2018 Elsevier Inc. All rights reserved.

A Systematic Review of CPAP Adherence Across Age Groups: Clinical and Empiric Insights for Developing CPAP Adherence Interventions

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Sawyer, A.M.; Gooneratne, N.; Marcus, C.L.; Ofer, D.; Richards, K.C.; Weaver, T.E.

2011-01-01

Continuous positive airway pressure (CPAP) is a highly efficacious treatment for obstructive sleep apnea (OSA) but adherence to the treatment limits its overall effectiveness across all age groups of patients. Factors that influence adherence to CPAP include disease and patient characteristics, treatment titration procedures, technological device factors and side effects, and psychological and social factors. These influential factors have guided the development of interventions to promote CPAP adherence. Various intervention strategies have been described and include educational, technological, psychosocial, pharmacological, and multi-dimensional approaches. Though evidence to date has led to innovative strategies that address adherence in CPAP-treated children, adults, and older adults, significant opportunities exist to develop and test interventions that are clinically applicable, specific to subgroups of patients likely to demonstrate poor adherence, and address the multifactorial nature of CPAP adherence. The translation of CPAP adherence promotion interventions to clinical practice is imperative to improve health and functional outcomes in all persons with CPAP-treated OSA. PMID:21652236

Rationale and design of the Atrial Fibrillation health Literacy Information Technology Trial: (AF-LITT).

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Guhl, Emily N; Schlusser, Courtney L; Henault, Lori E; Bickmore, Timothy W; Kimani, Everlyne; Paasche-Orlow, Michael K; Magnani, Jared W

2017-11-01

Atrial Fibrillation (AF) is a common cardiac arrhythmia that is challenging for patients and adversely impacts health-related quality of life (HRQoL). Long-term management of AF requires that patients adhere to complex therapies, understand difficult terminology, navigate subspecialty care, and have continued symptom monitoring with the goal of preventing adverse outcomes. Continued interventions to ameliorate the patient experience of AF are essential. The Atrial Fibrillation health Literacy Information Technology Trial (AF-LITT; NCT03093558) is an investigator-initiated, 2-arm randomized clinical trial (RCT). This RCT is a pilot in order to implement a novel, smartphone-based intervention to address the patient experience of AF. This pilot RCT will compare a combination of the Embodied Conversational Agent (ECA) and the Alive Cor Kardia Mobile heart rhythm monitor to the current standard of care. The study will enroll 180 adults with non-valvular AF who are receiving anticoagulation for stroke prevention and randomize them to receive a 30-day intervention (smartphone-based ECA/Kardia) or standard of care, which will include a symptom and adherence journal. The primary end-points are improvement in HRQoL and self-reported adherence to anticoagulation. The secondary end-points are the acceptability of the intervention to participants, its use by participants, and acceptability to referring physicians. The AF-LITT pilot aims to evaluate the efficacy of the ECA/Kardia to improve HRQoL and anticoagulant adherence, and to guide its implementation in a larger, multicenter clinical trial. The intervention has potential to improve HRQoL, adherence, and health care utilization in individuals with chronic AF. Copyright © 2017 Elsevier Inc. All rights reserved.

Asthma and Adherence to Inhaled Corticosteroids

DEFF Research Database (Denmark)

Bårnes, Camilla Boslev; Ulrik, Charlotte Suppli

2015-01-01

Inhaled corticosteroids (ICS) are the cornerstone of maintenance asthma therapy. However, in spite of this, adherence to ICS remains low. The aim of this systematic literature review was to provide an overview of the current knowledge of adherence to ICS, effects of poor adherence, and means...... was found to be between 22 and 63%, with improvement up to and after an exacerbation. Poor adherence was associated with youth, being African-American, having mild asthma, ... prescribed fixed-combination therapy (ICS and long-acting β2 agonists). Good adherence was associated with higher FEV1, a lower percentage of eosinophils in sputum, reduction in hospitalizations, less use of oral corticosteroids, and lower mortality rate. Overall, 24% of exacerbations and 60% of asthma...

Reporting of clinical trials: a review of research funders' guidelines

Directory of Open Access Journals (Sweden)

Williamson Paula R

2008-11-01

Full Text Available Abstract Background Randomised controlled trials (RCTs represent the gold standard methodological design to evaluate the effectiveness of an intervention in humans but they are subject to bias, including study publication bias and outcome reporting bias. National and international organisations and charities give recommendations for good research practice in relation to RCTs but to date no review of these guidelines has been undertaken with respect to reporting bias. Methods National and international organisations and UK based charities listed on the Association for Medical Research Charities website were contacted in 2007; they were considered eligible for this review if they funded RCTs. Guidelines were obtained and assessed in relation to what was written about trial registration, protocol adherence and trial publication. It was also noted whether any monitoring against these guidelines was undertaken. This information was necessary to discover how much guidance researchers are given on the publication of results, in order to prevent study publication bias and outcome reporting bias. Results Seventeen organisations and 56 charities were eligible of 140 surveyed for this review, although there was no response from 12. Trial registration, protocol adherence, trial publication and monitoring against the guidelines were often explicitly discussed or implicitly referred too. However, only eleven of these organisations or charities mentioned the publication of negative as well as positive outcomes and just three of the organisations specifically stated that the statistical analysis plan should be strictly adhered to and all changes should be reported. Conclusion Our review indicates that there is a need to provide more detailed guidance for those conducting and reporting clinical trials to help prevent the selective reporting of results. Statements found in the guidelines generally refer to publication bias rather than outcome reporting bias

Mobile health for early retention in HIV care: a qualitative study in ...

African Journals Online (AJOL)

Mobile health for early retention in HIV care: a qualitative study in Kenya (WelTel Retain). Kirsten Smillie, Natasha Van Borek, Mia L van der Kop, Abigael Lukhwaro, Neville Li, Sarah Karanja, Anik R Patel, David Ojakaa, Richard T Lester ...

Predictors of Vitamin Adherence After Bariatric Surgery.

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Sunil, Supreet; Santiago, Vincent A; Gougeon, Lorraine; Warwick, Katie; Okrainec, Allan; Hawa, Raed; Sockalingam, Sanjeev

2017-02-01

Vitamin supplementation in bariatric aftercare is essential to prevent nutrient deficiencies; however, rates of vitamin adherence have been as low as 30 % 6 months post-surgery. Preliminary literature suggests non-adherence to prescribed treatments can be linked to demographic and psychological factors. We aimed to determine the relationship between these factors to vitamin adherence in post-bariatric surgery patients. A total of 92 bariatric patients were assessed 6 months post-surgery. Patients were administered a questionnaire collecting demographic information, psychological scores, and self-reported adherence. Nutrient deficiencies were analyzed through serum vitamin levels measured 3 and 6 months after surgery. Wilcoxon rank-sum and chi-square tests were used for analysis. Non-adherence was associated with male sex and full-time employment (p = 0.027, p = 0.015). There were no differences with respect to living situation, education level, or relationship type. Non-adherent patients did not have significantly higher scores for generalized anxiety, depressive symptoms, or avoidant behaviors. However, non-adherent patients displayed greater attachment anxiety than their adherent counterparts (p = 0.0186). Non-adherence was also associated with lower vitamin B12 levels 6 months post-surgery (p = 0.001). Male gender and full-time work have previously been shown to be associated with non-adherence. This is the first study to demonstrate that attachment anxiety is associated with poor multivitamin adherence in the post-surgical bariatric population. This result is concordant with recent literature that has demonstrated attachment anxiety is associated with poor adherence to dietary recommendations in bariatric patients 6 months postoperatively. Presurgical screening for attachment anxiety could facilitate early interventions to promote better bariatric aftercare in this group.

Current Situation of Medication Adherence in Hypertension.

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Vrijens, Bernard; Antoniou, Sotiris; Burnier, Michel; de la Sierra, Alejandro; Volpe, Massimo

2017-01-01

Despite increased awareness, poor adherence to treatments for chronic diseases remains a global problem. Adherence issues are common in patients taking antihypertensive therapy and associated with increased risks of coronary and cerebrovascular events. Whilst there has been a gradual trend toward improved control of hypertension, the number of patients with blood pressure values above goal has remained constant. This has both personal and economic consequences. Medication adherence is a multifaceted issue and consists of three components: initiation, implementation, and persistence. A combination of methods is recommended to measure adherence, with electronic monitoring and drug measurement being the most accurate. Pill burden, resulting from free combinations of blood pressure lowering treatments, makes the daily routine of medication taking complex, which can be a barrier to optimal adherence. Single-pill fixed-dose combinations simplify the habit of medication taking and improve medication adherence. Re-packing of medication is also being utilized as a method of improving adherence. This paper presents the outcomes of discussions by a European group of experts on the current situation of medication adherence in hypertension.

Acute migraine therapy: recent evidence from randomized comparative trials

DEFF Research Database (Denmark)

Mett, A.; Tfelt-Hansen, P.

2008-01-01

(1) A wide array of data regarding acute migraine treatment are available, but few trials strictly adhere to International Headache Society guidelines for patient inclusion criteria. (2) Triptans appear to have similar efficacy profiles, but among newer triptans, almotriptan offers improved...

Effectiveness of behavioural change techniques in physiotherapy interventions to promote physical activity adherence in patients with hip and knee osteoarthritis: a systematic review protocol

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Willett, Matthew; Duda, Joan; Gautrey, Charlotte; Fenton, Sally; Greig, Carolyn; Rushton, Alison

2017-01-01

Introduction Osteoarthritis (OA) is a common degenerative articular disease, the highest cause of individual level disability and a significant socioeconomic burden to healthcare services. Patient education and physical activity (PA) prescription are recommended components of interventions in several healthcare guidelines and are commonly provided by physiotherapists. However, these interventions lack long-term clinical effectiveness. Patient adherence to PA prescription requires patients to modify their PA behaviour and appears critical in maintaining symptomatic improvements. This systematic review aims to evaluate the effectiveness of behavioural change techniques (BCTs) used in physiotherapy interventions to improve PA adherence. Methods and analysis Medline, Cochrane and PEDro registers of Controlled Trials, EMBASE, CINAHL and PsycInfo databases, and key grey literature sources will be rigorously searched for randomised controlled trials that compared a physiotherapy intervention incorporating BCTs with other therapies, placebo interventions, usual care or no-treatment. Two independent researchers will conduct literature searches, assess trial eligibility, extract data, conduct risk of bias assessment (using Cochrane risk of bias tool), classify BCTs and evaluate the quality of the body of literature following Grading of Recommendations, Assessment, Development and Evaluation (GRADE) guidelines. Narrative synthesis of key outcomes will be presented and meta-analysis will be performed if included trials are clinically homogenous, based on their intervention and comparator groups and outcome measures. This review will be reported in line with the Preferred Reporting Items for Systematic review and Meta-Analysis guidelines. Ethics and dissemination Research ethics approval is not required. This review will help inform clinicians and researchers on the most effective behavioural change techniques used in physiotherapy interventions to enhance adherence to PA

Mental models of adherence: parallels in perceptions, values, and expectations in adherence to prescribed home exercise programs and other personal regimens.

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Rizzo, Jon; Bell, Alexandra

2018-05-09

A mental model is the collection of an individual's perceptions, values, and expectations about a particular aspect of their life, which strongly influences behaviors. This study explored orthopedic outpatients mental models of adherence to prescribed home exercise programs and how they related to mental models of adherence to other types of personal regimens. The study followed an interpretive description qualitative design. Data were collected via two semi-structured interviews. Interview One focused on participants prior experiences adhering to personal regimens. Interview Two focused on experiences adhering to their current prescribed home exercise program. Data analysis followed a constant comparative method. Findings revealed similarity in perceptions, values, and expectations that informed individuals mental models of adherence to personal regimens and prescribed home exercise programs. Perceived realized results, expected results, perceived social supports, and value of convenience characterized mental models of adherence. Parallels between mental models of adherence for prescribed home exercise and other personal regimens suggest that patients adherence behavior to prescribed routines may be influenced by adherence experiences in other aspects of their lives. By gaining insight into patients adherence experiences, values, and expectations across life domains, clinicians may tailor supports that enhance home exercise adherence. Implications for Rehabilitation A mental model is the collection of an individual's perceptions, values, and expectations about a particular aspect of their life, which is based on prior experiences and strongly influences behaviors. This study demonstrated similarity in orthopedic outpatients mental models of adherence to prescribed home exercise programs and adherence to personal regimens in other aspects of their lives. Physical therapists should inquire about patients non-medical adherence experiences, as strategies patients

Effect of a Behavioral Self-Regulation Intervention on Patient Adherence to Fluid-Intake Restrictions in Hemodialysis: a Randomized Controlled Trial.

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Howren, M Bryant; Kellerman, Quinn D; Hillis, Stephen L; Cvengros, Jamie; Lawton, William; Christensen, Alan J

2016-04-01

The purpose of this study is to evaluate the efficacy of a behavioral self-regulation intervention vs. active control condition using a parallel-group randomized clinical trial with a sample of center hemodialysis patients with chronic kidney disease. Participants were recruited from 8 hemodialysis treatment centers in the Midwest. Eligible patients were (a) fluid nonadherent as defined by an interdialytic weight gain >2.5 kg over a 4-week period, (b) >18 years of age, (c) English-speaking without severe cognitive impairment, (d) treated with center-based hemodialysis for >3 months, and (e) not living in a care facility in which meals were managed. Medical records were used to identify eligible patients. Patients were randomly assigned to either a behavioral self-regulation intervention or active control condition in which groups of 3-8 patients met for hour-long, weekly sessions for 7 weeks at their usual hemodialysis clinic. Primary analyses were intention-to-treat. Sixty-one patients were randomized to the intervention while 58 were assigned to the attention-placebo support and discussion control. Covariate-adjusted between-subjects analyses demonstrated no unique intervention effect for the primary outcome, interdialytic weight gain (β = 0.13, p = 0.48). Significant within-subjects improvement over time was observed for the intervention group (β = -0.32, p = 0.014). The present study found that participation in a behavioral self-regulation intervention resulted in no unique intervention effect on a key indicator of adherence for those with severe chronic kidney disease. There was, however, modest within-subjects improvement in interdialytic weight gain for the intervention group which meshes with other evidence showing the utility of behavioral interventions in this patient population. ClinicalTrials.gov Identifier: NCT01066949.

Improving adherence to antiretroviral therapy

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Nischal K

2005-01-01

Full Text Available Antiretroviral therapy (ART has transformed HIV infection into a treatable, chronic condition. However, the need to continue treatment for decades rather than years, calls for a long-term perspective of ART. Adherence to the regimen is essential for successful treatment and sustained viral control. Studies have indicated that at least 95% adherence to ART regimens is optimal. It has been demonstrated that a 10% higher level of adherence results in a 21% reduction in disease progression. The various factors affecting success of ART are social aspects like motivation to begin therapy, ability to adhere to therapy, lifestyle pattern, financial support, family support, pros and cons of starting therapy and pharmacological aspects like tolerability of the regimen, availability of the drugs. Also, the regimen′s pill burden, dosing frequency, food requirements, convenience, toxicity and drug interaction profile compared with other regimens are to be considered before starting ART. The lack of trust between clinician and patient, active drug and alcohol use, active mental illness (e.g. depression, lack of patient education and inability of patients to identify their medications, lack of reliable access to primary medical care or medication are considered to be predictors of inadequate adherence. Interventions at various levels, viz. patient level, medication level, healthcare level and community level, boost adherence and overall outcome of ART.

[Transcultural adaptation of scales for treatment adherence in hemodialysis: Renal Adherence Behaviour Questionnaire(RABQ) and Renal Adherence Attitudes Questionnaire(RAAQ)].

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Machado, Inês Maria de Jesus; Bandeira, Marina Bittencourt; Pinheiro, Hélady Sanders; Dutra, Nathália Dos Santos

2015-10-01

Treatment adherence in hemodialysis is important for guaranteeing better results for patients, but Brazil still lacks validated assessment tools for this purpose. The current study aimed to perform a cross-cultural adaptation of the Renal Adherence Behaviour Questionnaire (RABQ) and the Renal Adherence Attitudes Questionnaire (RAAQ). The two questionnaires were submitted to the following cross-cultural adaptation procedures: translation, back-translation, expert panel review, and pilot study. Changes were made in the items' wording and application, which requires a face-to-face interview. It was not necessary to change the choices of answers. The Brazilian versions of the RABQ and RAAQ showed semantic and cultural equivalence to the original versions and are easy for the target population to understand. The two scales still require validity and reliability studies before use in the field.

Pregnancy and contraceptive use among women participating in the FEM-PrEP trial.

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Callahan, Rebecca; Nanda, Kavita; Kapiga, Saidi; Malahleha, Mookho; Mandala, Justin; Ogada, Teresa; Van Damme, Lut; Taylor, Douglas

2015-02-01

Pregnancy among study participants remains a challenge for trials of new HIV prevention agents despite promotion and provision of contraception. We evaluated contraceptive use, pregnancy incidence, and study drug adherence by contraceptive method among women enrolled in the FEM-PrEP trial of once-daily oral tenofovir disoproxil fumarate and emtricitabine (TDF-FTC) for HIV prevention. We required women to be using effective non-barrier contraception at enrollment. At each monthly follow-up visit, women were counseled on contraceptive use and tested for pregnancy. TDF-FTC adherence was determined by measuring plasma drug concentrations at 4-week intervals. We used Cox proportional hazards models to assess factors associated with incident pregnancy and multivariate logistic regression to examine the relationship between contraceptive method used at enrollment and TDF-FTC adherence. More than half of women were not using effective contraception before enrollment. Ninety-eight percent of these women adopted either injectable (55%) or oral (43%) contraceptives. The overall pregnancy rate was 9.6 per 100 woman-years. Among injectable users and new users of combined oral contraceptives (COCs), the rates were 1.6 and 35.1, respectively. New users of injectables had significantly greater odds of adhering to TDF-FTC than new COC users [odds ratio (95% confidence interval): 4.4 (1.7 to 11.6), P = 0.002], existing COC users [3.1 (1.3 to 7.3), P = 0.01], and existing injectable users [2.4 (1.1 to 5.6), P = 0.04]. Women using COCs during FEM-PrEP, particularly new adopters, were more likely to become pregnant and less likely to adhere to study product than injectable users. HIV prevention trials should consider requiring long-acting methods, including injectables, for study participation.

Understanding how adherence goals promote adherence behaviours: a repeated measure observational study with HIV seropositive patients

Directory of Open Access Journals (Sweden)

Jones Gareth

2012-08-01

Full Text Available Abstract Background The extent to which patients follow treatments as prescribed is pivotal to treatment success. An exceptionally high level (> 95% of HIV medication adherence is required to suppress viral replication and protect the immune system and a similarly high level (> 80% of adherence has also been suggested in order to benefit from prescribed exercise programmes. However, in clinical practice, adherence to both often falls below the desirable level. This project aims to investigate a wide range of psychological and personality factors that may lead to adherence/non-adherence to medical treatment and exercise programmes. Methods HIV positive patients who are referred to the physiotherapist-led 10-week exercise programme as part of the standard care are continuously recruited. Data on social cognitive variables (attitude, intention, subjective norms, self-efficacy, and outcome beliefs about the goal and specific behaviours, selected personality factors, perceived quality of life, physical activity, self-reported adherence and physical assessment are collected at baseline, at the end of the exercise programme and again 3 months later. The project incorporates objective measures of both exercise (attendance log and improvement in physical measures such as improved fitness level, weight loss, improved circumferential anthropometric measures and medication adherence (verified by non-invasive hair analysis. Discussion The novelty of this project comes from two key aspects, complemented with objective information on exercise and medication adherence. The project assesses beliefs about both the underlying goal such as following prescribed treatment; and about the specific behaviours such as undertaking the exercise or taking the medication, using both implicit and explicit assessments of patients’ beliefs and attitudes. We predict that i the way people think about the underlying goal of their treatments explains medication and exercise

Patient education combined in a music and habit-forming intervention for adherence to continuous positive airway (CPAP) prescribed for sleep apnea.

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Smith, Carol E; Dauz, Emily; Clements, Faye; Werkowitch, Marilyn; Whitman, Robert

2009-02-01

As many as 50% of patients diagnosed with obstructive sleep apnea stop adhering to the prescribed medical treatment of continuous positive airway pressure (CPAP) within 1-3 weeks of onset. Thus, a theory-based intervention using music to support habit formation was designed to improve CPAP adherence at onset. The intervention materials included directions for CPAP nightly use, a diary for recording nightly use and writing about CPAP benefits or problems. In addition, an audiotape with softly spoken instructions for placing the CPAP mask comfortably, using deep breathing and muscle relaxation along with the slowly decreasing music tempo was provided to listen to at bedtime each night. Effects of this music intervention were tested in a randomized, placebo-controlled trial of 97 patients with 53 males (55%) and 44 females (45%). Moderate to severe apnea/hyponea scores (per sleep laboratory data) and medical diagnosis of OSA were required for study inclusion. Compared to placebo controls, a greater proportion of experimental patients were adhering (chi(2)=14.67, peffect for improving adherence to CPAP at 1 month. Adherence at the onset of treatment is critical and the audio music intervention was easily administered. Other interventions that target problems interfering with longer-term CPAP adherence are needed.

Improved Adherence to Vision Self-monitoring with the Vision and Memory Stimulating (VMS) Journal for Non-neovascular Age-related Macular Degeneration during a Randomized Controlled Trial.

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Bittner, Ava K; Torr-Brown, Sheryl; Arnold, Ellen; Nwankwo, Antonia; Beaton, Patricia; Rampat, Radhika; Dagnelie, Gislin; Roser, Mark

2014-01-22

An educational, interactive journal [Vision and Memory Stimulating (VMS) journal] was developed to boost patient confidence and promote long-term adherence with weekly vision self-monitoring in age-related macular degeneration (AMD) patients at risk for vision loss from new-onset neovascularization. In a multicenter randomized controlled trial, 198 subjects with intermediate stage, non-neovascular AMD received the VMS journal or followed usual care (e.g. their doctor's instructions for vision monitoring; Amsler grid). At 6 and/or 12 months post-enrollment, 157 subjects completed a questionnaire on vision self-monitoring. At 6 and 12 months, respectively, 85% and 80% of the VMS journal subjects reported vision monitoring at least weekly, which represent statistically significant 7.1 and 4.2 times greater odds than the 50% of controls who monitored weekly at both follow-up times (pself-monitoring. At 6 and 12 months, respectively, only 15% and 13% of the VMS journal subjects vs. 53% and 44% of the controls reported that they did not feel confident that they were taking care of their sight by self-monitoring (pself-monitoring between the groups (p=0.68), with 81% of all subjects reporting no change in frequency between 6 and 12 months. These findings support the efficacy of the VMS journal for increasing vision self-monitoring adherence and confidence, in addition to promoting persistence in weekly monitoring over the course of a year in AMD subjects at risk for exudative retinal changes.

Sharia Adherence Mosque Survey: Correlations between Sharia Adherence and Violent Dogma in U.S. Mosques

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Mordechai Kedar

2011-12-01

Full Text Available A random survey of 100 representative mosques in the U.S. was conducted to measure the correlation between Sharia adherence and dogma calling for violence against non-believers.  Of the 100 mosques surveyed, 51% had texts on site rated as severely advocating violence; 30% had texts rated as moderately advocating violence; and 19% had no violent texts at all.  Mosques that presented as Sharia adherent were more likely to feature violence-positive texts on site than were their non-Sharia-adherent counterparts.  In 84.5% of the mosques, the imam recommended studying violence-positive texts.  The leadership at Sharia-adherent mosques was more likely to recommend that a worshipper study violence-positive texts than leadership at non-Sharia-adherent mosques.  Fifty-eight percent of the mosques invited guest imams known to promote violent jihad.  The leadership of mosques that featured violence-positive literature was more likely to invite guest imams who were known to promote violent jihad than was the leadership of mosques that did not feature violence-positive literature on mosque premises.  

Study of determinants of Adherence to Antiretroviral Treatment among HIV Patients covered by Ahwaz Jundishapur University of Medical Sciences

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Ahmad Moradi

2016-11-01

Full Text Available Adherence to antiretroviral therapy is essential for achieving durable clinical outcomes in patients with HIV. In addition, suboptimal adherence can accelerate development of drug-resistant HIV and mitigate HAART’s role in reducing HIV incidence and transmission. The present research has been conducted to study treatment adherence and determine its effective factors on HIV/AIDS patients with the support of Ahvaz JundiShapur University of Medical Sciences in 2015. This is a cross-sectional study in which 158 HIV/AIDS patients who had been registered in the counseling centers of behavioral diseases of Ahvaz and were receiving antiretroviral treatment. They had been selected by census method. Data were collected using the AACTG (Adult Aids Clinical Trials Group questionnaire. The collected data was analyzed and interpreted using descriptive statistical tests, χ2 and step by step regression by spss-16 software. The mean age of patients was 32.8±10.36. Among them 20.8% were female, 47.5% were single and 35.6% had a job. Also 33.7% of the respondents had CD4+ cell count less than 350 cells/μL. and average treatment duration was 9 months at study entry. According to the findings of this study, the degree of adherence was reported as % 63.9.The main reasons for non-adherence were forgetfulness (26% and side effects (19%. There were no significant differences between highly adherent and less adherent patients with regard to age, gender, education Employment status, Treatment duration, time of diagnosis. Adherence to HAART is a key factor in disease course in persons with HIV/AIDS. Low-level adherence in subjects of the study indicated that educational and intervention is quite necessary for patients in order to improve their medication self-management.

The Steroids in the Maintenance of Remission of Proliferative Lupus Nephritis (SIMPL Pilot Trial

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Lauren Galbraith

2014-11-01

Full Text Available Background: Patients with proliferative lupus nephritis are at risk of frequent relapses. Whether low- dose prednisone prevents relapses is uncertain. Objectives: We undertook a pilot RCT to determine the feasibility of a larger trial. Design: Pilot randomized controlled trial. Setting: Single center Canadian outpatient nephrology clinic. Patients: Participants with systemic lupus erythematosus (SLE and a history of class III or IV lupus nephritis that achieved at least partial remission and remained on prednisone were eligible. Measurements: Feasibility: proportion of eligible patients randomized and adherence to tapering regimen. Clinical: occurrence of renal or major non-renal flare of SLE. Methods: We conducted a blinded, two-parallel-group randomized controlled trial of prednisone 7.5 mg/day (continuation compared to a matching placebo (withdrawal. Results: Of nineteen eligible patients screened, 15 (79% were recruited and randomized; 8 to prednisone continuation and seven to withdrawal. All participants adhered to the tapering protocol to their assigned withdrawal or low-dose maintenance target. Over 36 months, the primary outcome occurred in four (50% patients in the continuation group (three renal and one major non-renal flare, compared with one patient (14% in the withdrawal group (one renal flare. Three participants (38% in the continuation group had minor flares, while no patients in the withdrawal group did. Limitations: This pilot RCT was small and not designed to assess the efficacy or safety of maintenance with low-dose prednisone. Conclusions: The high proportion of eligible patients recruited, and success of protocol adherence suggest a large trial of prednisone maintenance therapy compared to withdrawal is feasible. Trial registration: Current Controlled Trials ISRCTN31327267.

Mechanism of Change in Cognitive Behavioral Therapy for Body Image and Self-Care on ART Adherence Among Sexual Minority Men Living with HIV.

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Lamb, Kalina M; Nogg, Kelsey A; Safren, Steven A; Blashill, Aaron J

2018-05-11

Body image disturbance is a common problem reported among sexual minority men living with HIV, and is associated with poor antiretroviral therapy (ART) adherence. Recently, a novel integrated intervention (cognitive behavioral therapy for body image and self-care; CBT-BISC) was developed and pilot tested to simultaneously improve body image and ART adherence in this population. Although CBT-BISC has demonstrated preliminary efficacy in improving ART adherence, the mechanisms of change are unknown. Utilizing data from a two-armed randomized controlled trial (N = 44 sexual minority men living with HIV), comparing CBT-BISC to an enhanced treatment as usual (ETAU) condition, sequential process mediation via latent difference scores was assessed, with changes in body image disturbance entered as the mechanism between treatment condition and changes in ART adherence. Participants assigned to CBT-BISC reported statistically significant reductions in body image disturbance post-intervention, which subsequently predicted changes in ART adherence from post-intervention to long term follow-up (b = 20.01, SE = 9.11, t = 2.19, p = 0.028). One pathway in which CBT-BISC positively impacts ART adherence is through reductions in body image disturbance. Body image disturbance represents one, of likely several, mechanism that prospectively predicts ART adherence among sexual minority men living with HIV.

Study to Measure the impact of Pharmacists and Pharmacy Services (STOMPP on Medication Non-Adherence: Medication Adherence and Clinical Outcomes

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Sharrel Pinto, BS Pharm, DMM, MS, PhD

2018-02-01

Full Text Available Objective: To compare the impact of various pharmacy-based services on medication adherence and clinical outcomes. Design: Prospective, randomized control trial Setting: A local endocrinology group (clinic setting and community pharmacies belonging to a regional integrated delivery network (IDN in Toledo, OH Population: Subjects included within this study had type 2 diabetes, were prescribed a minimum of five medications, at least 18 years of age, having the ability to self-administer medications as prescribed, and be able to speak and understand English. Subjects were required to have Paramount health insurance, must be willing and able to provide informed consent, actively participate in the assigned MTM sessions, and have adequate transportation to attend the sessions at a participating pharmacy.  Methods: Patients were recruited through flyers at practice sites, referrals from physicians and pharmacists, and direct mailers. Members of the research team would screen patients to assess their eligibility to participate in the study. Patients who fit the inclusion criteria were randomized into one of the following four different groups: Pill Bottle (PB, Blister Pack (BP, Pill Bottle + Medication Therapy Management (PB+MTM, and Adherence Pharmacy (BP+MTM. Patients enrolled in the BP groups had their medications synchronized. Patients in the AP group were given the option to have their medications delivered, if needed. Practice innovation: We partnered with a regional integrated delivery network (IDN with multiple community pharmacy practice sites and a practice group of endocrinologists. A new practice model called Adherence Pharmacy was conceptualized and implemented within the community setting and was accessible to patients. Main Outcomes Measures: Medication adherence, measured using proportions of days covered (PDC and pill count scores at baseline, 3 months, 6 months, 9 months, and 12 months; Hemoglobin A1c (HbA1c, body mass index (BMI

Can human error theory explain non-adherence?

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Barber, Nick; Safdar, A; Franklin, Bryoney D

2005-08-01

To apply human error theory to explain non-adherence and examine how well it fits. Patients who were taking chronic medication were telephoned and asked whether they had been adhering to their medicine, and if not the reasons were explored and analysed according to a human error theory. Of 105 patients, 87 were contacted by telephone and they took part in the study. Forty-two recalled being non-adherent, 17 of them in the last 7 days; 11 of the 42 were intentionally non-adherent. The errors could be described by human error theory, and it explained unintentional non-adherence well, however, the application of 'rules' was difficult when considering mistakes. The consideration of error producing conditions and latent failures also revealed useful contributing factors. Human error theory offers a new and valuable way of understanding non-adherence, and could inform interventions. However, the theory needs further development to explain intentional non-adherence.

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.

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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

2018-01-01

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.

Reporting quality of randomised controlled trial abstracts among high-impact general medical journals: a review and analysis.

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Hays, Meredith; Andrews, Mary; Wilson, Ramey; Callender, David; O'Malley, Patrick G; Douglas, Kevin

2016-07-28

The aim of this study was to assess adherence to the Consolidated Standards of Reporting Trials (CONSORT) for Abstracts by five high-impact general medical journals and to assess whether the quality of reporting was homogeneous across these journals. This is a descriptive, cross-sectional study. Randomised controlled trial (RCT) abstracts in five high-impact general medical journals. We used up to 100 RCT abstracts published between 2011 and 2014 from each of the following journals: The New England Journal of Medicine (NEJM), the Annals of Internal Medicine (Annals IM), The Lancet, the British Medical Journal (The BMJ) and the Journal of the American Medical Association (JAMA). The primary outcome was per cent overall adherence to the 19-item CONSORT for Abstracts checklist. Secondary outcomes included per cent adherence in checklist subcategories and assessing homogeneity of reporting quality across the individual journals. Search results yielded 466 abstracts, 3 of which were later excluded as they were not RCTs. Analysis was performed on 463 abstracts (97 from NEJM, 66 from Annals IM, 100 from The Lancet, 100 from The BMJ, 100 from JAMA). Analysis of all scored items showed an overall adherence of 67% (95% CI 66% to 68%) to the CONSORT for Abstracts checklist. The Lancet had the highest overall adherence rate (78%; 95% CI 76% to 80%), whereas NEJM had the lowest (55%; 95% CI 53% to 57%). Adherence rates to 8 of the checklist items differed by >25% between journals. Among the five highest impact general medical journals, there is variable and incomplete adherence to the CONSORT for Abstracts reporting checklist of randomised trials, with substantial differences between individual journals. Lack of adherence to the CONSORT for Abstracts reporting checklist by high-impact medical journals impedes critical appraisal of important studies. We recommend diligent assessment of adherence to reporting guidelines by authors, reviewers and editors to promote transparency

Does providing prescription information or services improve medication adherence among patients discharged from the emergency department? A randomized controlled trial.

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McCarthy, Melissa L; Ding, Ru; Roderer, Nancy K; Steinwachs, Donald M; Ortmann, Melinda J; Pham, Julius Cong; Bessman, Edward S; Kelen, Gabor D; Atha, Walter; Retezar, Rodica; Bessman, Sara C; Zeger, Scott L

2013-09-01

We determine whether prescription information or services improve the medication adherence of emergency department (ED) patients. Adult patients treated at one of 3 EDs between November 2010 and September 2011 and prescribed an antibiotic, central nervous system, gastrointestinal, cardiac, or respiratory drug at discharge were eligible. Subjects were randomly assigned to usual care or one of 3 prescription information or services intervention groups: (1) practical services to reduce barriers to prescription filling (practical prescription information or services); (2) consumer drug information from MedlinePlus (MedlinePlus prescription information or services); or (3) both services and information (combination prescription information or services). Self-reported medication adherence, measured by primary adherence (prescription filling) and persistence (receiving medicine as prescribed) rates, was determined during a telephone interview 1 week postdischarge. Of the 3,940 subjects enrolled and randomly allocated to treatment, 86% (N=3,386) completed the follow-up interview. Overall, primary adherence was 88% and persistence was 48%. Across the sites, primary adherence and persistence did not differ significantly between usual care and the prescription information or services groups. However, at site C, subjects who received the practical prescription information or services (odds ratio [OR]=2.4; 95% confidence interval [CI] 1.4 to 4.3) or combination prescription information or services (OR=1.8; 95% CI 1.1 to 3.1) were more likely to fill their prescription compared with usual care. Among subjects prescribed a drug that treats an underlying condition, subjects who received the practical prescription information or services were more likely to fill their prescription (OR=1.8; 95% CI 1.0 to 3.1) compared with subjects who received usual care. Prescription filling and receiving medications as prescribed was not meaningfully improved by offering patients patient

Psychosocial and demographic predictors of adherence and non-adherence to health advice accompanying air quality warning systems: a systematic review.

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D'Antoni, Donatella; Smith, Louise; Auyeung, Vivian; Weinman, John

2017-09-22

Although evidence shows that poor air quality can harm human health, we have a limited understanding about the behavioural impact of air quality forecasts. Our aim was to understand to what extent air quality warning systems influence protective behaviours in the general public, and to identify the demographic and psychosocial factors associated with adherence and non-adherence to the health advice accompanying these warnings. In August 2016 literature was systematically reviewed to find studies assessing intended or actual adherence to health advice accompanying air quality warning systems, and encouraging people to reduce exposure to air pollution. Predictors of adherence to the health advice and/or self-reported reasons for adherence or non-adherence were also systematically reviewed. Studies were included only if they involved participants who were using or were aware of these warning systems. Studies investigating only protective behaviours due to subjective perception of bad air quality alone were excluded. The results were narratively synthesised and discussed within the COM-B theoretical framework. Twenty-one studies were included in the review: seventeen investigated actual adherence; three investigated intended adherence; one assessed both. Actual adherence to the advice to reduce or reschedule outdoor activities during poor air quality episodes ranged from 9.7% to 57% (Median = 31%), whereas adherence to a wider range of protective behaviours (e.g. avoiding busy roads, taking preventative medication) ranged from 17.7% to 98.1% (Median = 46%). Demographic factors did not consistently predict adherence. However, several psychosocial facilitators of adherence were identified. These include knowledge on where to check air quality indices, beliefs that one's symptoms were due to air pollution, perceived severity of air pollution, and receiving advice from health care professionals. Barriers to adherence included: lack of understanding of the indices

Adherence issues in inherited metabolic disorders treated by low natural protein diets

DEFF Research Database (Denmark)

MaCdonald, A; van Rijn, M; Feillet, F

2012-01-01

Common inborn errors of metabolism treated by low natural protein diets [amino acid (AA) disorders, organic acidemias and urea cycle disorders] are responsible for a collection of diverse clinical symptoms, each condition presenting at different ages with variable severity. Precursor......-free or essential L-AAs are important in all these conditions. Optimal long-term outcome depends on early diagnosis and good metabolic control, but because of the rarity and severity of conditions, randomized controlled trials are scarce. In all of these disorders, it is commonly described that dietary adherence...... on their neuropsychological profile. There are little data about their ability to self-manage their own diet or the success of any formal educational programs that may have been implemented. Trials conducted in non-phenylketonuria (PKU) patients are rare, and the development of specialist L-AAs for non-PKU AA disorders has...

Web-based depression treatment: associations of clients' word use with adherence and outcome.

Science.gov (United States)

Van der Zanden, Rianne; Curie, Keshia; Van Londen, Monique; Kramer, Jeannet; Steen, Gerard; Cuijpers, Pim

2014-05-01

The growing number of web-based psychological treatments, based on textual communication, generates a wealth of data that can contribute to knowledge of online and face-to-face treatments. We investigated whether clients' language use predicted treatment outcomes and adherence in Master Your Mood (MYM), an online group course for young adults with depressive symptoms. Among 234 participants from a randomised controlled trial of MYM, we tested whether their word use on course application forms predicted baseline levels of depression, anxiety and mastery, or subsequent treatment adherence. We then analysed chat session transcripts of course completers (n=67) to investigate whether word use changes predicted changes in treatment outcomes. Depression improvement was predicted by increasing use of 'discrepancy words' during treatment (e.g. should). At baseline, more discrepancy words predicted higher mastery level. Adherence was predicted by more words used at application, more social words and fewer discrepancy words. Many variables were included, increasing the chance of coincidental results. This risk was constrained by examining only those word categories that have been investigated in relation to depression or adherence. This is the first study to link word use during treatment to outcomes of treatment that has proven to be effective in an RCT. The results suggest that paying attention to the length of problem articulation at application and to 'discrepancy words' may be wise, as these seem to be psychological markers. To expand knowledge of word use as psychological marker, research on web-based treatment should include text analysis. Copyright © 2014 The Authors. Published by Elsevier B.V. All rights reserved.

Antihypertensive Medications Adherence Among Nigerian ...

African Journals Online (AJOL)

Hospital, Ogbomosho, 2Goshen Heart Clinic, Osogbo, 3Department of Economics, Osun State University, Osogbo, Nigeria ... significant impact of antihypertensive medication adherence.[13]. The level of information provided to patients may also impact ..... Muntner P. New medication adherence scale versus pharmacy.

Microbial adherence to cosmetic contact lenses.

Science.gov (United States)

Chan, Ka Yin; Cho, Pauline; Boost, Maureen

2014-08-01

To investigate whether cosmetic contact lenses (CCL) with surface pigments affect microbial adherence. Fifteen brands of CCL were purchased from optical, non-optical retail outlets, and via the Internet. A standardized rub-off test was performed on each CCL (five lenses per brand) to confirm the location of the pigments. The rub-off test comprised gentle rubbing on the surfaces of each CCL with wetted cotton buds for a maximum of 20 rubs per surface. A new set of CCL (five lenses per brand) were incubated in Pseudomonas aeruginosa overnight. Viable counts of adhered bacteria were determined by the number of colony-forming units (CFU) on agar media on each lens. The adherence of P. aeruginosa as well as Staphylococcus aureus and Serratia marcescens to three brands of CCL (A-C) (five lenses per brand) were also compared to their adherences on their clear counterparts. Only two of the 15 brands of CCL tested (brands B and C) had pigments that did not detach with the rub-off test. The remaining 13 brands of CCL all failed the rub-off test and these lenses showed higher P. aeruginosa adherence (8.7 × 10(5)-1.9 × 10(6) CFU/lens). Brands B and C lenses showed at least six times less bacterial adhesion than the other 13 brands. Compared to their clear counterparts, bacterial adherence to brands B and C lenses did not differ significantly, whereas brand A lenses showed significantly higher adherence. Surface pigments on CCL resulted in significantly higher bacterial adherence. Copyright © 2013 British Contact Lens Association. Published by Elsevier Ltd. All rights reserved.

Use of a Novel Artificial Intelligence Platform on Mobile Devices to Assess Dosing Compliance in a Phase 2 Clinical Trial in Subjects With Schizophrenia.

Science.gov (United States)

Bain, Earle E; Shafner, Laura; Walling, David P; Othman, Ahmed A; Chuang-Stein, Christy; Hinkle, John; Hanina, Adam

2017-02-21

Accurately monitoring and collecting drug adherence data can allow for better understanding and interpretation of the outcomes of clinical trials. Most clinical trials use a combination of pill counts and self-reported data to measure drug adherence, despite the drawbacks of relying on these types of indirect measures. It is assumed that doses are taken, but the exact timing of these events is often incomplete and imprecise. The objective of this pilot study was to evaluate the use of a novel artificial intelligence (AI) platform (AiCure) on mobile devices for measuring medication adherence, compared with modified directly observed therapy (mDOT) in a substudy of a Phase 2 trial of the α7 nicotinic receptor agonist (ABT-126) in subjects with schizophrenia. AI platform generated adherence measures were compared with adherence inferred from drug concentration measurements. The mean cumulative pharmacokinetic adherence over 24 weeks was 89.7% (standard deviation [SD] 24.92) for subjects receiving ABT-126 who were monitored using the AI platform, compared with 71.9% (SD 39.81) for subjects receiving ABT-126 who were monitored by mDOT. The difference was 17.9% (95% CI -2 to 37.7; P=.08). Using drug levels, this substudy demonstrates the potential of AI platforms to increase adherence, rapidly detect nonadherence, and predict future nonadherence. Subjects monitored using the AI platform demonstrated a percentage change in adherence of 25% over the mDOT group. Subjects were able to use the technology successfully for up to 6 months in an ambulatory setting with early termination rates that are comparable to subjects outside of the substudy. ClinicalTrials.gov NCT01655680 https://clinicaltrials.gov/ct2/show/NCT01655680?term=NCT01655680. ©Earle E Bain, Laura Shafner, David P Walling, Ahmed A Othman, Christy Chuang-Stein, John Hinkle, Adam Hanina. Originally published in JMIR Mhealth and Uhealth (http://mhealth.jmir.org), 21.02.2017.

Is Mandatory Prospective Trial Registration Working to Prevent Publication of Unregistered Trials and Selective Outcome Reporting? An Observational Study of Five Psychiatry Journals That Mandate Prospective Clinical Trial Registration.

Directory of Open Access Journals (Sweden)

Amelia Scott

Full Text Available To address the bias occurring in the medical literature associated with selective outcome reporting, in 2005, the International Committee of Medical Journal Editors (ICMJE introduced mandatory trial registration guidelines and member journals required prospective registration of trials prior to patient enrolment as a condition of publication. No research has examined whether these guidelines are impacting psychiatry publications. Our objectives were to determine the extent to which articles published in psychiatry journals adhering to ICMJE guidelines were correctly prospectively registered, whether there was evidence of selective outcome reporting and changes to participant numbers, and whether there was a relationship between registration status and source of funding.Any clinical trial (as defined by ICMJE published between 1 January 2009 and 31 July 2013 in the top five psychiatry journals adhering to ICMJE guidelines (The American Journal of Psychiatry, Archives of General Psychiatry/JAMA Psychiatry, Biological Psychiatry, Journal of the American Academy of Child and Adolescent Psychiatry, and The Journal of Clinical Psychiatry and conducted after July 2005 (or 2007 for two journals was included. For each identified trial, where possible we extracted trial registration information, changes to POMs between publication and registry to assess selective outcome reporting, changes to participant numbers, and funding type.Out of 3305 articles, 181 studies were identified as clinical trials requiring registration: 21 (11.6% were deemed unregistered, 61 (33.7% were retrospectively registered, 37 (20.4% had unclear POMs either in the article or the registry and 2 (1.1% were registered in an inaccessible trial registry. Only 60 (33.1% studies were prospectively registered with clearly defined POMs; 17 of these 60 (28.3% showed evidence of selective outcome reporting and 16 (26.7% demonstrated a change in participant numbers of 20% or more; only 26 (14

Training mental health professionals in suicide practice guideline adherence : Cost-effectiveness analysis alongside a randomized controlled trial

NARCIS (Netherlands)

de Beurs, Derek P.; Bosmans, Judith E.; de Groot, Marieke H.; de Keijser, Jos; van Duijn, Erik; de Winter, Remco F. P.; Kerkhof, Ad J. F. M.

2015-01-01

Background: There is a lack of information on the cost-effectiveness of suicide prevention interventions. The current study examines the cost-effectiveness of a multifaceted structured intervention aiming to improve adherence to the national suicide practice guideline in comparison with usual

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

NARCIS (Netherlands)

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

2014-01-01

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

Patient Medication Knowledge Governing Adherence to Asthma ...

African Journals Online (AJOL)

Samuel Olaleye

disturbing levels of patients adherence with management recommendations. Asthma education strategies need to be modified to engage ... and quick procedure. ... Participants' medication adherence and skills at using .... In this study 17 of the 67 patients studied .... adherence: changing behaviour to promote better self-.

Promoting adherence to nebulized therapy in cystic fibrosis: poster development and a qualitative exploration of adherence.

Science.gov (United States)

Jones, Stephen; Babiker, Nathan; Gardner, Emma; Royle, Jane; Curley, Rachael; Hoo, Zhe Hui; Wildman, Martin J

2015-01-01

Cystic fibrosis (CF) health care professionals recognize the need to motivate people with CF to adhere to nebulizer treatments, yet little is known about how best to achieve this. We aimed to produce motivational posters to support nebulizer adherence by using social marketing involving people with CF in the development of those posters. The Sheffield CF multidisciplinary team produced preliminary ideas that were elaborated upon with semi-structured interviews among people with CF to explore barriers and facilitators to the use of nebulized therapy. Initial themes and poster designs were refined using an online focus group to finalize the poster designs. People with CF preferred aspirational posters describing what could be achieved through adherence in contrast to posters that highlighted the adverse consequences of nonadherence. A total of 14 posters were produced through this process. People with CF can be engaged to develop promotional material to support adherence, providing a unique perspective differing from that of the CF multidisciplinary team. Further research is needed to evaluate the effectiveness of these posters to support nebulizer adherence.

Electronic medication monitoring-informed counselling to improve adherence to combination antiretroviral therapy and virologic treatment outcomes: a meta-analysis

Directory of Open Access Journals (Sweden)

Nienke eLangebeek

2015-05-01

Full Text Available Background: Adherence to combination antiretroviral therapy (cART for HIV infection is a primary determinant of treatment success, but is often suboptimal. Previous studies have suggested that electronic medication monitoring-informed counselling is among the most effective adherence intervention components. Our objective was to review available evidence about the effectiveness of monitoring-informed counselling and to aggregate findings into quantitative estimates of the effect of such intervention on medication adherence and virologic treatment outcomes.Methods: We searched PubMed for papers reporting on randomized controlled trials (RCTs comparing intervention groups receiving monitoring-informed counselling as one of the intervention components versus control groups not receiving such counselling for their effect on medication adherence and viral load concentrations. The standardized mean difference (SMD in adherence and the odds ratio (OR of undetectable HIV RNA in intervention versus control groups were the common effect sizes. Random-effect models with inverse variance weights were used to aggregate findings into pooled effect estimates with 95% confidence limits. Results: A total of 13 studies were included. Adherence was significantly higher in intervention groups than in control groups (SMD 0.51, 95% CI 0.31 to 0.71. Patients in intervention groups were significantly more likely to have undetectable HIV RNA concentrations than patients in control groups (OR 1.35, 95% CI 1.12 to 1.63. However, in studies in which monitoring-informed counselling was the only intervention component, the difference in adherence and virologic response between intervention and control groups was not statistically significant.Conclusion: Electronic monitoring-informed counselling improved adherence and virologic response compared with control groups not receiving such counselling in studies in which it was one out of multiple intervention components, but not

Adherence to and effectiveness of an individually tailored home-based exercise program for frail older adults, driven by mobility monitoring: design of a prospective cohort study.

Science.gov (United States)

Geraedts, Hilde A E; Zijlstra, Wiebren; Zhang, Wei; Bulstra, Sjoerd; Stevens, Martin

2014-06-07

With the number of older adults in society rising, frailty becomes an increasingly prevalent health condition. Regular physical activity can prevent functional decline and reduce frailty symptoms. In particular, home-based exercise programs can be beneficial in reducing frailty of older adults and fall risk, and in improving associated physiological parameters. However, adherence to home-based exercise programs is generally low among older adults. Current developments in technology can assist in enlarging adherence to home-based exercise programs. This paper presents the rationale and design of a study evaluating the adherence to and effectiveness of an individually tailored, home-based physical activity program for frail older adults driven by mobility monitoring through a necklace-worn physical activity sensor and remote feedback using a tablet PC. Fifty transitionally frail community-dwelling older adults will join a 6-month home-based physical activity program in which exercises are provided in the form of exercise videos on a tablet PC and daily activity is monitored by means of a necklace-worn motion sensor. Participants exercise 5 times a week. Exercises are built up in levels and are individually tailored in consultation with a coach through weekly telephone contact. The physical activity program driven by mobility monitoring through a necklace-worn sensor and remote feedback using a tablet PC is an innovative method for physical activity stimulation in frail older adults. We hypothesize that, if participants are sufficiently adherent, the program will result in higher daily physical activity and higher strength and balance assessed by physical tests compared to baseline. If adherence to and effectiveness of the program is considered sufficient, the next step would be to evaluate the effectiveness with a randomised controlled trial. The knowledge gained in this study can be used to develop and fine-tune the application of innovative technology in home

Determining how best to support overweight adults to adhere to lifestyle change: protocol for the SWIFT study.

Science.gov (United States)

Taylor, Rachael W; Roy, Melyssa; Jospe, Michelle R; Osborne, Hamish R; Meredith-Jones, Kim J; Williams, Sheila M; Brown, Rachel C

2015-09-04

Physical activity plays a critical role in health, including for effective weight maintenance, but adherence to guidelines is often poor. Similarly, although debate continues over whether a "best" diet exists for weight control, meta-analyses suggest little difference in outcomes between diets differing markedly in macronutrient composition, particularly over the longer-term. Thus a more important question is how best to encourage adherence to appropriate lifestyle change. While brief support is effective, it has on-going cost implications. While self-monitoring (weight, diet, physical activity) is a cornerstone of effective weight management, little formal evaluation of the role that self-monitoring technology can play in enhancing adherence to change has occurred to date. People who eat in response to hunger have improved weight control, yet how best to train individuals to recognise when true physical hunger occurs and to limit consumption to those times, requires further study. SWIFT (Support strategies for Whole-food diets, Intermittent Fasting, and Training) is a two-year randomised controlled trial in 250 overweight (body mass index of 27 or greater) adults that will examine different ways of supporting people to make appropriate changes to diet and exercise habits for long-term weight control. Participants will be randomised to one of five intervention groups: control, brief support (monthly weigh-ins and meeting), app (use of MyFitnessPal with limited support), daily self-weighing (with brief monthly feedback), or hunger training (four-week programme which trains individuals to only eat when physically hungry) for 24 months. Outcome assessments include weight, waist circumference, body composition (dual-energy x-ray absorptiometry), inflammatory markers, blood lipids, adiponectin and ghrelin, blood pressure, diet (3-day diet records), physical activity (accelerometry) and aerobic fitness, and eating behaviour. SWIFT is powered to detect clinically

Just showing up is not enough: Homework adherence and outcome in cognitive-behavioral therapy for cocaine dependence.

Science.gov (United States)

Decker, Suzanne E; Kiluk, Brian D; Frankforter, Tami; Babuscio, Theresa; Nich, Charla; Carroll, Kathleen M

2016-10-01

Homework in cognitive-behavioral therapy (CBT) provides opportunities to practice skills. In prior studies, homework adherence was associated with improved outcome across a variety of disorders. Few studies have examined whether the relationship between homework adherence and outcome is maintained after treatment end or is independent of treatment attendance. This study combined data from 4 randomized clinical trials of CBT for cocaine dependence to examine relationships among homework adherence, participant variables, and cocaine use outcomes during treatment and at follow-up. The data set included only participants who attended at least 2 CBT sessions to allow for assignment and return of homework (N = 158). Participants returned slightly less than half (41.1%) of assigned homework. Longitudinal random effects regression suggested a greater reduction in cocaine use during treatment and through 12-month follow-up for participants who completed half or more of assigned homework (3-way interaction), F(2, 910.69) = 4.28, p = .01. In multiple linear regression, the percentage of homework adherence was associated with greater number of cocaine-negative urine toxicology screens during treatment, even when accounting for baseline cocaine use frequency and treatment attendance; at 3 months follow-up, multiple logistic regression indicated homework adherence was associated with cocaine-negative urine toxicology screen, controlling for baseline cocaine use and treatment attendance. These results extend findings from prior studies regarding the importance of homework adherence by demonstrating associations among homework and cocaine use outcomes during treatment and up to 12 months after, independent of treatment attendance and baseline cocaine use severity. (PsycINFO Database Record (c) 2016 APA, all rights reserved).

Adherence to vitamin supplementation following adolescent bariatric surgery.

Science.gov (United States)

Modi, Avani C; Zeller, Meg H; Xanthakos, Stavra A; Jenkins, Todd M; Inge, Thomas H

2013-03-01

Adolescents with extreme obesity, who have undergone bariatric surgery, must adhere to many lifestyle and nutritional recommendations, including multivitamin therapy. Little is known about multivitamin adherence following adolescent bariatric surgery. The present study aims to document self-reported and electronically-monitored adherence to multivitamins, determine convergence between self-report and electronic monitoring adherence for multivitamins, and identify barriers to multivitamin adherence for adolescents who have undergone bariatric surgery. The study used a prospective, longitudinal observational design to assess subjective (self-reported) and objective (electronic monitors) multivitamin adherence in a cohort of 41 adolescents (Mean age = 17.1 ± 1.5; range = 13-19) who have undergone bariatric surgery at Cincinnati Children's Hospital Medical Center. Mean adherence as derived from electronic monitoring for the entire 6-month study period was 29.8% ± 23.9. Self-reported adherence was significantly higher than electronically monitored adherence across both the 1 and 6-month assessment points (z = 4.5, P bariatric surgery, high rates of nonadherence to multivitamin therapy were observed in adolescents who had undergone bariatric surgery with forgetting and difficulty swallowing pills as reported barriers to adherence. These high rates of nonadherence to multivitamin therapy should be considered when devising treatment and family education pathways for adolescents considering weight loss surgery. Copyright © 2012 The Obesity Society.

Associations between patients' adherence and GPs' attitudes towards risk, statin therapy and management of non-adherence

DEFF Research Database (Denmark)

Barfoed, Benedicte L; Paulsen, Maja S; Christensen, Palle M

2016-01-01

BACKGROUND: Previous studies suggest that doctors' personal lifestyle, risk taking personality and beliefs about risk reducing therapies may affect their clinical decision-making. Whether such factors are further associated with patients' adherence with medication is largely unknown. OBJECTIVE...... statin treatment as important, how they managed non-adherence and whether non-adherence annoyed them. The Jackson Personality Inventory-revised was used to measure risk attitude. The GPs' responses were linked to register data on their patients' redeemed statin prescriptions. Mixed effect logistic...

Self-replenishing low-adherence coatings

NARCIS (Netherlands)

Dikic, T.; Ming, W.; Benthem, van R.A.T.M.; With, de G.; Schmets, A.J.M.; Zwaag, van der S.

2007-01-01

Low-adherence coatings are widely used today since their water/oil repellency makes them easily cleanable (a well-known example is PTFE). The low surface tension is provided by fluorine- or silicon-containing species that are present at the film surface. Low adherence coatings have already been