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.

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

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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.

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 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

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

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.

Adherence therapy improves medication adherence and quality of life in people with Parkinson's disease: a randomised controlled trial.

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Daley, D J; Deane, K H O; Gray, R J; Clark, A B; Pfeil, M; Sabanathan, K; Worth, P F; Myint, P K

2014-08-01

Many factors are associated with medication non-adherence in Parkinson's disease (PD), including complex treatment regimens, mood disorders and impaired cognition. However, interventions to improve adherence which acknowledge such factors are lacking. A phase II randomised controlled trial was conducted investigating whether Adherence Therapy (AT) improves medication adherence and quality of life (QoL) compared with routine care (RC) in PD. Eligible PD patients and their spouse/carers were randomised to intervention (RC plus AT) or control (RC alone). Primary outcomes were change in adherence (Morisky Medication Adherence Scale) and QoL (Parkinson's Disease Questionnaire-39) from baseline to week-12 follow up. Secondary outcomes were MDS-UPDRS (part I, II, IV), Beliefs about Medication Questionnaire (BMQ), EuroQol (EQ-5D) and the Caregiving Distress Scale. Blinded data were analysed using logistic and linear regression models based on the intention-to-treat principle. Seventy-six patients and 46 spouse/carers completed the study (intervention: n = 38 patients, n = 24 spouse/carers). At week-12 AT significantly improved adherence compared with RC (OR 8.2; 95% CI: 2.8, 24.3). Numbers needed to treat (NNT) were 2.2 (CI: 1.6, 3.9). Compared with RC, AT significantly improved PDQ-39 (-9.0 CI: -12.2, -5.8), BMQ general harm (-1.0 CI: -1.9, -0.2) and MDS-UPDRS part II (-4.8 CI: -8.1, -1.4). No significant interaction was observed between the presence of a spouse/carer and the effect of AT. Adherence Therapy improved self-reported adherence and QoL in a PD sample. The small NNT suggests AT may be cost-effective. A larger pragmatic trial to test the efficacy and cost-effectiveness of AT by multiple therapists is required. © 2014 John Wiley & Sons Ltd.

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.

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

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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

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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...

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

Directory of Open Access Journals (Sweden)

Anne Pauly

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

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.

Microbicide clinical trial adherence: insights for introduction.

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Woodsong, Cynthia; MacQueen, Kathleen; Amico, K Rivet; Friedland, Barbara; Gafos, Mitzy; Mansoor, Leila; Tolley, Elizabether; McCormack, Sheena

2013-04-08

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

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.

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.

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.

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

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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

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

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.

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

Science.gov (United States)

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.

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.

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

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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

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

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

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

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

2017-11-01

Due to the negative outcomes of medication nonadherence, interventions to improve adherence have been the focus of countless studies. The congruence between adherence-related patient characteristics and interventions may partly explain the variability of effectiveness in medication adherence studies. In their latest update of a Cochrane review reporting inconsistent effects of adherence interventions, the authors offered access to their database for subanalysis. We aimed to use this database to assess congruence between adherence-related patient characteristics and interventions and its association with intervention effects. We developed a congruence score consisting of six features related to inclusion criteria, patient characteristics at baseline, and intervention design. Two independent raters extracted and scored items from the 190 studies available in the Cochrane database. We correlated overall congruence score and individual features with intervention effects regarding adherence and clinical outcomes using Kruskal-Wallis rank sum test and Fisher's exact test. Interrater reliability for newly extracted data was almost perfect with a Cohen's Kappa of 0.92 [95% confidence interval (CI) = 0.89-0.94; P congruence score nor any other individual feature (i.e., "determinants of nonadherence as inclusion criteria," "tailoring of interventions to the inclusion criteria," "reasons for nonadherence assessed at baseline," "adjustment of intervention to individual patient needs," and "theory-based interventions") was significantly associated with intervention effects. The presence of only six studies that included nonadherent patients and the interdependency of this feature with the remaining five might preclude a conclusive assessment of congruence between patient characteristics and adherence interventions. In order to obtain clinical benefits from effective adherence interventions, we encourage researchers to focus on the inclusion of nonadherent patients. Copyright

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.

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

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....

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.

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

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.

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

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

Reporting non-adherence in cluster randomised trials: A systematic review.

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Agbla, Schadrac C; DiazOrdaz, Karla

2018-06-01

Treatment non-adherence in randomised trials refers to situations where some participants do not receive their allocated treatment as intended. For cluster randomised trials, where the unit of randomisation is a group of participants, non-adherence may occur at the cluster or individual level. When non-adherence occurs, randomisation no longer guarantees that the relationship between treatment receipt and outcome is unconfounded, and the power to detect the treatment effects in intention-to-treat analysis may be reduced. Thus, recording adherence and estimating the causal treatment effect adequately are of interest for clinical trials. To assess the extent of reporting of non-adherence issues in published cluster trials and to establish which methods are currently being used for addressing non-adherence, if any, and whether clustering is accounted for in these. We systematically reviewed 132 cluster trials published in English in 2011 previously identified through a search in PubMed. One-hundred and twenty three cluster trials were included in this systematic review. Non-adherence was reported in 56 cluster trials. Among these, 19 reported a treatment efficacy estimate: per protocol in 15 and as treated in 4. No study discussed the assumptions made by these methods, their plausibility or the sensitivity of the results to deviations from these assumptions. The year of publication of the cluster trials included in this review (2011) could be considered a limitation of this study; however, no new guidelines regarding the reporting and the handling of non-adherence for cluster trials have been published since. In addition, a single reviewer undertook the data extraction. To mitigate this, a second reviewer conducted a validation of the extraction process on 15 randomly selected reports. Agreement was satisfactory (93%). Despite the recommendations of the Consolidated Standards of Reporting Trials statement extension to cluster randomised trials, treatment adherence is

Telephone interventions for adherence to colpocytological examination

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Thais Marques Lima

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

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

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

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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.

The OPTIMIZE trial: Rationale and design of a randomized controlled trial of motivational enhancement therapy to improve adherence to statin medication.

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Rash, Joshua A; Lavoie, Kim L; Sigal, Ronald J; Campbell, David J T; Manns, Braden J; Tonelli, Marcello; Campbell, Tavis S

2016-07-01

Statins are a class of medications that are particularly effective for lowering cholesterol and reducing cardiovascular morbidity and mortality. Despite a range of benefits, non-adherence to statin medication is prevalent with 50% to 75% of patients failing to adhere to treatment within the first 2-years. A previous review on interventions to improve adherence to cholesterol lowering medication concluded that rigorous trials were needed with emphasis on the patient's perspective and shared decision making. Motivational interviewing (MInt) is a promising patient-centered approach for improving adherence in patients with chronic diseases. This manuscript describes the rational and design of a randomized controlled trial (RCT) testing the efficacy of MInt in improving adherence to statin medication. Patients filling their first statin prescription will be recruited to complete a 6-month observation run-in period (phase-1) after which medication possession ratio (MPR) will be assessed. Patients meeting criteria for non-adherence (MPR≤60%) will be invited to participate in the trial. 336 non-adherent new statin users will undergo a fasting lipid panel, complete baseline questionnaires, and be randomly allocated to receive four sessions of adherence education delivered using MInt (EdMInt) or to an education control (EC) delivered at 3-month intervals. Final assessments will occur 12-months after the first EdMInt or EC session. The primary outcome is change in MPR adherence to statin medication from baseline to 12-months. Secondary outcomes include within-patient change in self-reported medication adherence, stage of change and self-efficacy for medication adherence, motivation to adhere to statin medication, and lipid profile. Copyright © 2016 Elsevier Inc. All rights reserved.

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

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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

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.

Evaluation of Adherence to Nutritional Intervention Through Trajectory Analysis.

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Sevilla-Villanueva, B; Gibert, K; Sanchez-Marre, M; Fito, M; Covas, M I

2017-05-01

Classical pre-post intervention studies are often analyzed using traditional statistics. Nevertheless, the nutritional interventions have small effects on the metabolism and traditional statistics are not enough to detect these subtle nutrient effects. Generally, this kind of studies assumes that the participants are adhered to the assigned dietary intervention and directly analyzes its effects over the target parameters. Thus, the evaluation of adherence is generally omitted. Although, sometimes, participants do not effectively adhere to the assigned dietary guidelines. For this reason, the trajectory map is proposed as a visual tool where dietary patterns of individuals can be followed during the intervention and can also be related with nutritional prescriptions. The trajectory analysis is also proposed allowing both analysis: 1) adherence to the intervention and 2) intervention effects. The analysis is made by projecting the differences of the target parameters over the resulting trajectories between states of different time-stamps which might be considered either individually or by groups. The proposal has been applied over a real nutritional study showing that some individuals adhere better than others and some individuals of the control group modify their habits during the intervention. In addition, the intervention effects are different depending on the type of individuals, even some subgroups have opposite response to the same intervention.

Optimizing adherence in HIV prevention product trials: Development and psychometric evaluation of simple tools for screening and adherence counseling.

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Tolley, Elizabeth E; Guthrie, Kate Morrow; Zissette, Seth; Fava, Joseph L; Gill, Katherine; Louw, Cheryl E; Kotze, Philip; Reddy, Krishnaveni; MacQueen, Kathleen

2018-01-01

Low adherence in recent HIV prevention clinical trials highlights the need to better understand, measure, and support product use within clinical trials. Conventional self-reported adherence instruments within HIV prevention trials, often relying on single-item questions, have proven ineffective. While objective adherence measures are desirable, none currently exist that apply to both active and placebo arms. Scales are composed of multiple items in the form of questions or statements that, when combined, measure a more complex construct that may not be directly observable. When psychometrically validated, such measures may better assess the multiple factors contributing to adherence/non-adherence. This study aimed to develop and psychometrically evaluate tools to screen and monitor trial participants' adherence to HIV prevention products within the context of clinical trial research. Based on an extensive literature review and conceptual framework, we identified and refined 86 items assessing potential predictors of adherence and 48 items assessing adherence experience. A structured survey, including adherence items and other variables, was administered to former ASPIRE and Ring Study participants and similar non-trial participants (n = 709). We conducted exploratory factor analyses (EFA) to identify a reduced set of constructs and items that could be used at screening to predict potential adherence, and at follow-up to monitor and intervene on adherence. We examined associations with other variables to assess content and construct validity. The EFA of screener items resulted in a 6-factor solution with acceptable to very good internal reliability (α: .62-.84). Similar to our conceptual framework, factors represent trial-related commitment (Distrust of Research and Commitment to Research); alignment with trial requirements (Visit Adherence and Trial Incompatibility); Belief in Trial Benefits and Partner Disclosure. The EFA on monitoring items resulted in 4

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.

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

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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

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.

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

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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

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

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Hagen, Anja

2007-01-01

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

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:…

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 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

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

Improving medication adherence: a framework for community pharmacy-based interventions

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Pringle J

2015-11-01

Full Text Available Janice Pringle,1 Kim C Coley2 1Program Evaluation and Research Unit, Department of Pharmacy and Therapeutics, School of Pharmacy, University of Pittsburgh, Pittsburgh, PA, USA; 2Department of Pharmacy and Therapeutics, School of Pharmacy, University of Pittsburgh, Pittsburgh, PA, USA Abstract: Evidence supports that patient medication adherence is suboptimal with patients typically taking less than half of their prescribed doses. Medication nonadherence is associated with poor health outcomes and higher downstream health care costs. Results of studies evaluating pharmacist-led models in a community pharmacy setting and their impact on medication adherence have been mixed. Community pharmacists are ideally situated to provide medication adherence interventions, and effective strategies for how they can consistently improve patient medication adherence are necessary. This article suggests a framework to use in the community pharmacy setting that will significantly improve patient adherence and provides a strategy for how to apply this framework to develop and test new medication adherence innovations. The proposed framework is composed of the following elements: 1 defining the program's pharmacy service vision, 2 using evidence-based, patient-centered communication and intervention strategies, 3 using specific implementation approaches that ensure fidelity, and 4 applying continuous evaluation strategies. Within this framework, pharmacist interventions should include those services that capitalize on their specific skill sets. It is also essential that the organization's leadership effectively communicates the pharmacy service vision. Medication adherence strategies that are evidence-based and individualized to each patient's adherence problems are most desirable. Ideally, interventions would be delivered repeatedly over time and adjusted when patient's adherence circumstances change. Motivational interviewing principles are particularly well

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

Behavior change theory, content and delivery of interventions to enhance adherence in chronic respiratory disease: A systematic review.

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McCullough, Amanda R; Ryan, Crístín; Macindoe, Christopher; Yii, Nathan; Bradley, Judy M; O'Neill, Brenda; Elborn, J Stuart; Hughes, Carmel M

2016-07-01

We sought to describe the theory used to design treatment adherence interventions, the content delivered, and the mode of delivery of these interventions in chronic respiratory disease. We included randomized controlled trials of adherence interventions (compared to another intervention or control) in adults with chronic respiratory disease (8 databases searched; inception until March 2015). Two reviewers screened and extracted data: post-intervention adherence (measured objectively); behavior change theory, content (grouped into psychological, education and self-management/supportive, telemonitoring, shared decision-making); and delivery. "Effective" studies were those with p theories. Use of theory (n = 11,41%) was more common amongst effective interventions. Interventions were mainly educational, self-management or supportive interventions (n = 27,47%). They were commonly delivered by a doctor (n = 20,23%), in face-to-face (n = 48,70%), one-to-one (n = 45,78%) outpatient settings (n = 46,79%) across 2-5 sessions (n = 26,45%) for 1-3 months (n = 26,45%). Doctors delivered a lower proportion (n = 7,18% vs n = 13,28%) and pharmacists (n = 6,15% vs n = 1,2%) a higher proportion of effective than ineffective interventions. Risk of bias was high in >1 domain (n = 43, 93%) in most studies. Behavior change theory was more commonly used to design effective interventions. Few adherence interventions have been developed using theory, representing a gap between intervention design recommendations and research practice. Copyright © 2016 Elsevier Ltd. All rights reserved.

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.

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

Recent mobile health interventions to support medication adherence among HIV-positive MSM.

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Muessig, Kathryn E; LeGrand, Sara; Horvath, Keith J; Bauermeister, José A; Hightow-Weidman, Lisa B

2017-09-01

We describe recent mobile health (mHealth) interventions supporting antiretroviral therapy (ART) medication adherence among HIV-positive MSM. Keyword searches (1 January 2016-13 May 2017) identified 721 citations. Seven publications reporting on six studies met inclusion criteria. Five studies focused on MSM. Interventions primarily employed text messaging (n = 4), whereas two focused on smartphone apps and one on social media. Three studies measured intervention impact on adherence and found increased ART use intentions (n = 1), self-reported adherence (n = 1), and viral suppression (n = 1, no control group). Other mHealth interventions for HIV-positive MSM focused on status disclosure and reducing sexual risk. mHealth interventions to support ART adherence among MSM show acceptability, feasibility, and preliminary efficacy. No recent mHealth interventions for MSM measured impact on viral suppression compared with a control condition despite earlier (pre-2015) evidence for efficacy. Studies are underway that include multiple features designed to improve adherence within complex smartphone or internet-based platforms. Areas for future growth include overcoming measurement and engagement challenges, developing tools for coordinating patient and provider adherence data, testing combination interventions, and adapting efficacious interventions for new languages and geographic settings.

Multifaceted medication adherence intervention for patients with hypertension in secondary care

DEFF Research Database (Denmark)

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

study was to describe the content and process outcomes of an adherence program developed for hypertensive patients in a hospital setting. Methods The intervention development was based on adherence and behavioral theories, and evidence of effective interventions. The intervention was pharmacist...... action (60%) and was exercised in 94% of the patients. All participants gave informed consent and the study was approved by The Regional Scientific Ethical Committee for Southern Denmark and the Danish Registry Board Conclusions A pharmacist-led multifaceted tailored adherence intervention has been...

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

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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 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

The NKF-NUS hemodialysis trial protocol - a randomized controlled trial to determine the effectiveness of a self management intervention for hemodialysis patients

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Krishnan Deby

2011-01-01

Full Text Available Abstract Background Poor adherence to treatment is common in patients on hemodialysis which may increase risk for poor clinical outcomes and mortality. Self management interventions have been shown to be effective in improving compliance in other chronic populations. The aim of this trial is to evaluate the effectiveness of a recently developed group based self management intervention for hemodialysis patients compared to standard care. Methods/Design This is a multicentre parallel arm block randomized controlled trial (RCT of a four session group self management intervention for hemodialysis patients delivered by health care professionals compared to standard care. A total of 176 consenting adults maintained on hemodialysis for a minimum of 6 months will be randomized to receive the self management intervention or standard care. Primary outcomes are biochemical markers of clinical status and adherence. Secondary outcomes include general health related quality of life, disease-specific quality of life, mood, self efficacy and self-reported adherence. Outcomes will be measured at baseline, immediately post-intervention and at 3 and 9 months post-intervention by an independent assessor and analysed on intention to treat principles with linear mixed-effects models across all time points. A qualitative component will examine which aspects of program participants found particularly useful and any barriers to change. Discussion The NKF-NUS intervention builds upon previous research emphasizing the importance of empowering patients in taking control of their treatment management. The trial design addresses weaknesses of previous research by use of an adequate sample size to detect clinically significant changes in biochemical markers, recruitment of a sufficiently large representative sample, a theory based intervention and careful assessment of both clinical and psychological endpoints at various follow up points. Inclusion of multiple dependent

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

The effects of an individual, multistep intervention on adherence to treatment in hemodialysis patients.

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Rafiee Vardanjani, Leila; Parvin, Neda; Mahmoodi Shan, Gholamreza

2015-07-01

The present study was conducted to investigate the effect of individual, multistep intervention on adherence to treatment in hemodialysis patients referred to a hemodialysis center in Shahrekord, Iran. In this interventional study, hemodialysis patients referring the center of the study were randomly assigned into two control and intervention groups (each 33). The control group received routine treatment, recommended dietary and fluid restrictions. The intervention group participated in eight individual interventional sessions accompanied routine treatment. At the beginning and the end of the study, routine laboratory tests and end-stage renal disease-adherence questionnaire were filled out for patients in both groups. The data were analyzed using Mann-Whitney and Wilcoxon tests. At the end of the study, the two groups showed a significant difference in all domains of adherence except adherence to diet and adherence was better in the intervention group (p adherence to dialysis program (p = 0.04, r = 0.254). After intervention, serum phosphorus decreased significantly in the intervention group (p Adherence to treatment is one of the major problems in hemodialysis patients; however, comprehensive interventions are required in view of individual condition. Implications for Rehabilitation Adherence to treatment means that all patients' behaviors (diet, fluids and drugs intake) should be in line with the recommendations given by healthcare professionals. There is evidence on the association between adherence to treatment and decreased risk of hospitalization in dialysis patients. Individual structured programs are most likely to be successful in encouraging adherence to treatment.

Behavioral economics strategies for promoting adherence to sleep interventions.

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Stevens, Jack

2015-10-01

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

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.

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

Directory of Open Access Journals (Sweden)

Alfredo D. Oliveira-Filho

2014-12-01

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

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

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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

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

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Vrijens, B; Urquhart, J

2014-06-01

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

Dissemination strategies and adherence predictors for web-based interventions-how efficient are patient education sessions and email reminders?

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

2016-06-01

The Internet offers the potential to efficaciously deliver health interventions at a low cost and with a low threshold across any distance. However, since many web-based interventions are confronted with low use and adherence, proactive dissemination strategies are needed. We, therefore, tested the efficacy of a 1-h patient education session as part of a rehabilitation program and an email reminder 4 weeks later on the publicity and use of a web-based intervention aimed at lifestyle changes in patients with either coronary heart disease or chronic back pain (CBP) and examined adherence predictors. The website www.lebensstil-aendern.de is a cost-free, German-language website providing more than 1000 patient narratives about successful lifestyle changes. To test the efficacy of the dissemination strategies and to examine adherence predictors, we conducted a sequential controlled trial with heart and CBP patients recruited from German inpatient rehabilitation centers. The dissemination strategies were found to be efficient. Use rates, however, remained low. The email reminder and internal health locus of control emerged as notable factors in motivating patients to participate in the web-based intervention. Other factors that have been suggested to be related to nonuse, e.g. sociodemographic characteristics and medical condition, did not predict use or adherence. © The Author 2016. Published by Oxford University Press. All rights reserved. For permissions, please email: journals.permissions@oup.com.

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

A clinical nurse specialist-led intervention to enhance medication adherence using the plan-do-check-act cycle for continuous self-improvement.

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Russell, Cynthia L

2010-01-01

A clinical nurse specialist-led intervention to improve medication adherence in chronically ill adults using renal transplant recipients as an exemplar population is proposed. Meta-analyses and systematic reviews of chronically ill and transplant patients indicate that patient-specific characteristics not only are poor and inconsistent predictors for medication nonadherence but also are not amenable to intervention. Adherence has not meaningfully improved, despite meta-analyses and systematic narrative reviews of randomized controlled trials (RCTs) dealing with medication nonadherence in acutely and chronically ill persons and RCTs dealing with transplant patients. Interventions with a superior potential to enhance medication adherence must be developed. Use of a clinical nurse specialist-led continuous self-improvement intervention with adult renal transplant recipients is proposed. Continuous self-improvement focuses on improving personal systems thinking and behavior using the plan-do-check-act process. Electronic medication monitoring reports, one of several objective measures of medication adherence, are used by the clinician to provide patient feedback during the check process on medication-taking patterns. Continuous self-improvement as an intervention holds promise in supporting patient self-management and diminishing the blame that clinicians place on patients for medication nonadherence. Using an objective measure of medication adherence such as an electronic monitoring report fosters collaborative patient-clinician discussions of daily medication-taking patterns. Through collaboration, ideas for improving medication taking can be explored. Changes can be followed and evaluated for effectiveness through the continuous self-improvement process. Future studies should include RCTs comparing educational and/or behavioral interventions to improve medication adherence.

Development of a Personalized Bidirectional Text Messaging Tool for HIV Adherence Assessment and Intervention among Substance Abusers

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Ingersoll, Karen; Dillingham, Rebecca; Reynolds, George; Hettema, Jennifer; Freeman, Jason; Hosseinbor, Sharzad; Winstead-Derlega, Chris

2013-01-01

We describe the development of a two-way text messaging intervention tool for substance users who are non-adherent with HIV medications, and examine message flow data for feasibility and acceptability. The assessment and intervention tool, TxText, is fully automated, sending participants mood, substance use, and medication adherence queries by text message. Participants respond, the tool recognizes the category of response, and sends the personalized intervention message that participants designed in return. In 10 months, the tool sent 16,547 messages (half initial, half follow-up) to 31 participants assigned to the TxText condition, who sent 6711 messages in response to the initial messages. Response rates to substance use (n=2370), medication (n=2918) and mood (n=4639) queries were 67%, 69%, and 64%, respectively. Responses indicating medication adherence, abstinence from substances, and good moods were more common than negative responses. The TxText tool can send messages daily over a 3 month period, receive responses, and decode them to deliver personalized affirming or intervention messages. While we await the outcomes of a pilot randomized trial, the process analysis shows that TxText is acceptable and feasible for substance abusers with HIV, and may serve as a complement to HIV medical care. PMID:24029625

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

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

2012-01-01

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

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

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

2017-05-04

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

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

Science.gov (United States)

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

2012-11-14

Although web-based interventions for promoting health and health-related behavior can be effective, poor adherence is a common issue that needs to be addressed. Technology as a means to communicate the content in web-based interventions has been neglected in research. Indeed, technology is often seen as a black-box, a mere tool that has no effect or value and serves only as a vehicle to deliver intervention content. In this paper we examine technology from a holistic perspective. We see it as a vital and inseparable aspect of web-based interventions to help explain and understand adherence. This study aims to review the literature on web-based health interventions to investigate whether intervention characteristics and persuasive design affect adherence to a web-based intervention. We conducted a systematic review of studies into web-based health interventions. Per intervention, intervention characteristics, persuasive technology elements and adherence were coded. We performed a multiple regression analysis to investigate whether these variables could predict adherence. We included 101 articles on 83 interventions. The typical web-based intervention is meant to be used once a week, is modular in set-up, is updated once a week, lasts for 10 weeks, includes interaction with the system and a counselor and peers on the web, includes some persuasive technology elements, and about 50% of the participants adhere to the intervention. Regarding persuasive technology, we see that primary task support elements are most commonly employed (mean 2.9 out of a possible 7.0). Dialogue support and social support are less commonly employed (mean 1.5 and 1.2 out of a possible 7.0, respectively). When comparing the interventions of the different health care areas, we find significant differences in intended usage (p=.004), setup (psystem (p=.003) and peers (p=.017), duration (F=6.068, p=.004), adherence (F=4.833, p=.010) and the number of primary task support elements (F=5.631, p=.005

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.

A Systematic Review of Predictors of, and Reasons for, Adherence to Online Psychological Interventions.

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Beatty, Lisa; Binnion, Claire

2016-12-01

A key issue regarding the provision of psychological therapy in a self-guided online format is low rates of adherence. The aim of this systematic review was to assess both quantitative and qualitative data on the predictors of adherence, as well as participant reported reasons for adhering or not adhering to online psychological interventions. Database searches of PsycINFO, Medline, and CINAHL identified 1721 potentially relevant articles published between 1 January 2000 and 25 November 2015. A further 34 potentially relevant articles were retrieved from reference lists. Articles that reported predictors of, or reasons for, adherence to an online psychological intervention were included. A total of 36 studies met the inclusion criteria. Predictors assessed included demographic, psychological, characteristics of presenting problem, and intervention/computer-related predictors. Evidence suggested that female gender, higher treatment expectancy, sufficient time, and personalized intervention content each predicted higher adherence. Age, baseline symptom severity, and control group allocation had mixed findings. The majority of assessed variables however, did not predict adherence. Few clear predictors of adherence emerged overall, and most results were either mixed or too preliminary to draw conclusions. More research of predictors associated with adherence to online interventions is warranted.

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

Social Media Interventions to Promote HIV Testing, Linkage, Adherence, and Retention: Systematic Review and Meta-Analysis

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Gupta, Somya; Wang, Jiangtao; Hightow-Weidman, Lisa B; Muessig, Kathryn E; Tang, Weiming; Pan, Stephen; Pendse, Razia; Tucker, Joseph D

2017-01-01

Background Social media is increasingly used to deliver HIV interventions for key populations worldwide. However, little is known about the specific uses and effects of social media on human immunodeficiency virus (HIV) interventions. Objective This systematic review examines the effectiveness of social media interventions to promote HIV testing, linkage, adherence, and retention among key populations. Methods We used the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) checklist and Cochrane guidelines for this review and registered it on the International Prospective Register of Systematic Reviews, PROSPERO. We systematically searched six databases and three conference websites using search terms related to HIV, social media, and key populations. We included studies where (1) the intervention was created or implemented on social media platforms, (2) study population included men who have sex with men (MSM), transgender individuals, people who inject drugs (PWID), and/or sex workers, and (3) outcomes included promoting HIV testing, linkage, adherence, and/or retention. Meta-analyses were conducted by Review Manager, version 5.3. Pooled relative risk (RR) and 95% confidence intervals were calculated by random-effects models. Results Among 981 manuscripts identified, 26 studies met the inclusion criteria. We found 18 studies from high-income countries, 8 in middle-income countries, and 0 in low-income countries. Eight were randomized controlled trials, and 18 were observational studies. All studies (n=26) included MSM; five studies also included transgender individuals. The focus of 21 studies was HIV testing, four on HIV testing and linkage to care, and one on antiretroviral therapy adherence. Social media interventions were used to do the following: build online interactive communities to encourage HIV testing/adherence (10 studies), provide HIV testing services (9 studies), disseminate HIV information (9 studies), and develop

Improving medication adherence among community-dwelling seniors with cognitive impairment: a systematic review of interventions.

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Kröger, Edeltraut; Tatar, Ovidiu; Vedel, Isabelle; Giguère, Anik M C; Voyer, Philippe; Guillaumie, Laurence; Grégoire, Jean-Pierre; Guénette, Line

2017-08-01

Background Medication non-adherence may lead to poor therapeutic outcomes. Cognitive functions deteriorate with age, contributing to decreased adherence. Interventions have been tested to improve adherence in seniors with cognitive impairment or Alzheimer disease (AD), but high-quality systematic reviews are lacking. It remains unclear which interventions are promising. Objectives We conducted a systematic review to identify, describe, and evaluate interventions aimed at improving medication adherence among seniors with any type of cognitive impairment. Methods Following NICE guidance, databases and websites were searched using combinations of controlled and free vocabulary. All adherence-enhancing interventions and study designs were considered. Studies had to include community dwelling seniors, aged 65 years or older, with cognitive impairment, receiving at least one medication for a chronic condition, and an adherence measure. Study characteristics and methodological quality were assessed. Results We identified 13 interventions, including six RCTs. Two studies were of poor, nine of low/medium and two of high quality. Seven studies had sample sizes below 50 and six interventions focused on adherence to AD medication. Six interventions tested a behavioral, four a medication oriented, two an educational and one a multi-faceted approach. Studies rarely assessed therapeutic outcomes. All but one intervention showed improved adherence. Conclusion Three medium quality studies showed better adherence with patches than with pills for AD treatment. Promising interventions used educational or reminding strategies, including one high quality RCT. Nine studies were of low/moderate quality. High quality RCTs using a theoretical framework for intervention selection are needed to identify strategies for improved adherence in these seniors.

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....

Economic evaluation of an exercise-counselling intervention to enhance smoking cessation outcomes: The Fit2Quit trial.

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Leung, William; Roberts, Vaughan; Gordon, Louisa G; Bullen, Christopher; McRobbie, Hayden; Prapavessis, Harry; Jiang, Yannan; Maddison, Ralph

2017-01-01

In the Fit2Quit randomised controlled trial, insufficiently-active adult cigarette smokers who contacted Quitline for support to quit smoking were randomised to usual Quitline support or to also receive ≤10 face-to-face and telephone exercise-support sessions delivered by trained exercise facilitators over the 24-week trial. This paper aims to determine the cost-effectiveness of an exercise-counselling intervention added to Quitline compared to Quitline alone in the Fit2Quit trial. Within-trial and lifetime cost-effectiveness were assessed. A published Markov model was adapted, with smokers facing increased risks of lung cancer and cardiovascular disease. Over 24 weeks, the incremental programme cost per participant in the intervention was NZ$428 (US$289 or €226; purchasing power parity-adjusted [PPP]). The incremental cost-effectiveness ratio (ICER) for seven-day point prevalence measured at 24-week follow-up was NZ$31,733 (US$21,432 or €16,737 PPP-adjusted) per smoker abstaining. However, for the 52% who adhered to the intervention (≥7 contacts), the ICER for point prevalence was NZ$3,991 (US$2,695 or €2,105 PPP-adjusted). In this adherent subgroup, the Markov model estimated 0.057 and 0.068 discounted quality-adjusted life-year gains over the lifetime of 40-year-old males (ICER: NZ$4,431; US$2,993 or €2,337 PPP-adjusted) and females (ICER: NZ$2,909; US$1,965 or €1,534 PPP-adjusted). The exercise-counselling intervention will only be cost-effective if adherence is a minimum of ≥7 intervention calls, which in turn leads to a sufficient number of quitters for health gains. Australasian Clinical Trials Registry Number ACTRN12609000637246.

What interventions are used to improve exercise adherence in older people and what behavioural techniques are they based on? A systematic review.

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Room, Jonathan; Hannink, Erin; Dawes, Helen; Barker, Karen

2017-12-14

To conduct a systematic review of interventions used to improve exercise adherence in older people, to assess the effectiveness of these interventions and to evaluate the behavioural change techniques underpinning them using the Behaviour Change Technique Taxonomy (BCTT). Systematic review. A search was conducted on AMED, BNI, CINAHL, EMBASE, MEDLINE and PsychINFO databases. Randomised controlled trials that used an intervention to aid exercise adherence and an exercise adherence outcome for older people were included. Data were extracted with the use of a preprepared standardised form. Risk of bias was assessed with the Cochrane Collaboration's tool for assessing risk of bias. Interventions were classified according to the BCTT. Eleven studies were included in the review. Risk of bias was moderate to high. Interventions were classified into the following categories: comparison of behaviour, feedback and monitoring, social support, natural consequences, identity and goals and planning. Four studies reported a positive adherence outcome following their intervention. Three of these interventions were categorised in the feedback and monitoring category. Four studies used behavioural approaches within their study. These were social learning theory, socioemotional selectivity theory, cognitive behavioural therapy and self-efficacy. Seven studies did not report a behavioural approach. Interventions in the feedback and monitoring category showed positive outcomes, although there is insufficient evidence to recommend their use currently. There is need for better reporting, use and the development of theoretically derived interventions in the field of exercise adherence for older people. Robust measures of adherence, in order to adequately test these interventions would also be of use. CRD42015020884. © 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

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

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Ferdinand C. Mukumbang

2017-05-01

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

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.

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

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...

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

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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.

Long-term dietary intervention trials: critical issues and challenges

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Crichton Georgina E

2012-07-01

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

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.

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

2017-06-30

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. 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. 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 prescription for patients with lower limb OA. The findings will

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

Science.gov (United States)

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

2016-03-05

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

Effect of an Empowerment Intervention on Antiretroviral Drug Adherence in Thai Youth.

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Kaihin, Ratchaneekorn; Kasatpibal, Nongyao; Chitreechuer, Jittaporn; Grimes, Richard M

2015-01-01

A pilot study was conducted to determine effects of an empowerment intervention on antiretroviral therapy (ART) adherence among Thai youth living with HIV/AIDS. It compared two groups of 23 young persons (15-24 years) who receive ART from AIDS clinics at two community hospitals. One hospital's patients served as the experimental group, and the other as a control group. The experimental groups attended five sessions that empowered them to take control of their own health. The control group received the standard of care. The data were analyzed using descriptive statistics and Chi-square statistics. Before the empowerment, no one from the experimental group or the control group had ART adherence ≥ 95%. After the intervention, the 82.6% of the experimental group had ≥ 95% adherence compared to the control group, which had 21.7% adherence (p < .0001). The empowerment intervention resulted in a significant increase in ART adherence among Thai youth.

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

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

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Maria Rubio-Valera

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

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

Science.gov (United States)

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.

Do Overweight Adolescents Adhere to Dietary Intervention Messages? Twelve-Month Detailed Dietary Outcomes from Curtin University’s Activity, Food and Attitudes Program

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Kyla L. Smith

2015-06-01

Full Text Available Dietary components of adolescent obesity interventions are rarely evaluated with comprehensive reporting of dietary change. The objective was to assess dietary change in overweight adolescents, including adherence to dietary intervention. The dietary intervention was part of a multi-component intervention (CAFAP targeting the physical activity, sedentary and healthy eating behaviors of overweight adolescents (n = 69. CAFAP was a staggered entry, within-subject, waitlist controlled clinical trial with 12 months of follow up. Diet was assessed using three-day food records and a brief eating behavior questionnaire. Changes in dietary outcomes were assessed using linear mixed models, adjusted for underreporting. Food record data suggested reduced adherence to dietary intervention messages over time following the intervention, despite conflicting information from the brief eating behavior questionnaire. During the intervention, energy intake was stable but favorable nutrient changes occurred. During the 12 month maintenance period; self-reported eating behaviors improved, energy intake remained stable but dietary fat and saturated fat intake gradually returned to baseline levels. Discrepancies between outcomes from brief dietary assessment methods and three-day food records show differences between perceived and actual intake, highlighting the need for detailed dietary reporting. Further, adherence to dietary intervention principles reduces over time, indicating a need for better maintenance support.

Predictors of adherence to exercise interventions during and after cancer treatment : A systematic review

NARCIS (Netherlands)

Ormel, H L; van der Schoot, G G F; Sluiter, W J; Jalving, M; Gietema, J A; Walenkamp, A M E

Objective: Exercise interventions benefit cancer patients. However, only low numbers of patients adhere to these interventions. This review aimed to identify predictors of exercise intervention adherence in patients with cancer, during and after multimodality cancer treatment. Methods: A literature

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

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

2017-08-18

recruitment goal is 60 cardiac rehabilitation patients. Data collection is anticipated to be complete by July 2018. This pilot study will be the first to examine the effect of a Facebook intervention on patient adherence and motivation for exercise in a cardiac rehabilitation setting. Engagement in the Facebook group and participation in the study will help to determine the feasibility of using Facebook to affect adherence and motivation in cardiac rehabilitation patients, potentially improving outcomes through the use of a unique intervention. ClinicalTrials.gov NCT02971813; https://clinicaltrials.gov/ct2/show/NCT02971813 (Archived by WebCite at http://www.webcitation.org/6sRsz8Zpa). ©Lee Anne Siegmund, Haitham M Ahmed, Michael Todd Crawford, James Frank Bena. Originally published in JMIR Research Protocols (http://www.researchprotocols.org), 18.08.2017.

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.

Patient decision making: strategies for diabetes diet adherence intervention.

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Kavookjian, Jan; Berger, Bruce A; Grimley, Diane M; Villaume, William A; Anderson, Heidi M; Barker, Kenneth N

2005-09-01

Patient self-care is critical in controlling diabetes and its complications. Lack of diet adherence is a particular challenge to effective diabetes intervention. The Transtheoretical Model (TTM) of Change, decision-making theory, and self-efficacy have contributed to successful tailoring of interventions in many target behaviors. The purpose of this study was to develop a diagnostic tool, including TTM measures for the stages of change, decisional balance, and self-efficacy, that pharmacists involved in diabetes intervention can use for patients resistant to a diet regimen. A questionnaire was developed through a literature review, interviews with diabetic patients, an expert panel input, and pretesting. Cross-sectional implementation of the questionnaire among a convenience sample of 193 type 1 and type 2 diabetic patients took place at 4 patient care sites throughout the southeastern United States. Validated measures were used to collect respondent self-report for the TTM variables and for demographic and diabetes history variables. Social desirability was also assessed. Relationships among TTM measures for diet adherence generally replicated those established for other target behaviors. Salient items were identified as potential facilitators (decisional balance pros) or barriers (decisional balance cons and self-efficacy tempting situations) to change. Social desirability exhibited a statistically significant relationship with patient report of diet adherence, with statistically significant differences in mean social desirability across race categories. The TTM measures for the stages of change, decisional balance, and self-efficacy are useful for making decisions on individually tailored interventions for diet adherence, with caution asserted about the potential of diabetes patients to self-report the target behavior in a socially desirable manner. Future research directions, implications, and limitations of the findings are also presented.

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

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Aleksandra E. Zgierska

2017-01-01

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

Factors associated with the implementation of the Familias Unidas intervention in a type 3 translational trial

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St. George, Sara M.; Huang, Shi; Vidot, Denise C.; Smith, Justin D.; Brown, C. Hendricks; Prado, Guillermo

2015-01-01

This study highlights how Familias Unidas, a Hispanic-specific, evidence-based, family centered preventive intervention, progressed from intervention development (type 1 translation; T1) through rigorous evaluation (T2) and examines the role of intervention fidelity—adherence and competence—in a T3 trial. Effects of participant, provider, and organizational variables on direct (observational) and indirect (self-reported) fidelity were examined as were effects of fidelity. Two structural equat...

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

Determinants of adherence to the online component of a blended intervention for patients with hip and/or knee osteoarthritis : A mixed methods study embedded in the e-exercise trial

NARCIS (Netherlands)

De Vries, H.J.; Kloek, C.J.J.; De Bakker, Dinny H.; Dekker, J.; Bossen, D.; Veenhof, C.

2017-01-01

Background: Embedding Web-based interventions within physiotherapy has potential, but knowledge on patient adherence to these interventions is limited. Iintroduction: This study explores which patient-, intervention-, and environment-related factors are determinants of adherence to the online

Adherence to placebo and mortality in the Beta Blocker Evaluation of Survival Trial (BEST).

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Pressman, Alice; Avins, Andrew L; Neuhaus, John; Ackerson, Lynn; Rudd, Peter

2012-05-01

Randomized controlled trials have reported lower mortality among patients who adhere to placebo compared with those who do not. We explored this phenomenon by reanalyzing data from the placebo arm of the Beta Blocker Evaluation of Survival Trial (BEST), a randomized, double-blind, placebo-controlled trial of bucindolol and mortality. Our primary aim was to measure and explain the association between adherence to placebo and total mortality among the placebo-allocated participants in the BEST trial. Secondary aims included assessment of the association between placebo adherence and cause-specific mortality. Participants with "higher placebo adherence" were defined as having taken at least 75% of their placebo study medication over the entire course of each individual's participation in the study, while those with "lower placebo adherence" took <75%. Primary outcome was in-study all-cause mortality. To account for confounding, we adjusted for all available modifiable, non-modifiable and psychosocial variables. Adherent participants had a significantly lower total mortality compared to less-adherent participants (HR=0.61, 95% Confidence Interval: 0.46-0.82). Adjusting for available confounders did not change the magnitude or significance of the estimates. When considering cause-specific mortality, CVD and pump failure showed similar associations. Analyses of the BEST trial data support a strong association between adherence to placebo study medication and total mortality. While probably not due to publication bias or simple confounding by healthy lifestyle factors, the underlying explanation for the association remains a mystery. Prospective examination of this association is necessary to better understand the underlying mechanism of this observation. Copyright © 2012 Elsevier Inc. All rights reserved.

‘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

Web-Based Intervention for Women With Type 1 Diabetes in Pregnancy and Early Motherhood: Critical Analysis of Adherence to Technological Elements and Study Design.

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Berg, Marie; Linden, Karolina; Adolfsson, Annsofie; Sparud Lundin, Carina; Ranerup, Agneta

2018-05-02

Numerous Web-based interventions have been implemented to promote health and health-related behaviors in persons with chronic conditions. Using randomized controlled trials to evaluate such interventions creates a range of challenges, which in turn can influence the study outcome. Applying a critical perspective when evaluating Web-based health interventions is important. The objective of this study was to critically analyze and discuss the challenges of conducting a Web-based health intervention as a randomized controlled trial. The MODIAB-Web study was critically examined using an exploratory case study methodology and the framework for analysis offered through the Persuasive Systems Design model. Focus was on technology, study design, and Web-based support usage, with special focus on the forum for peer support. Descriptive statistics and qualitative content analysis were used. The persuasive content and technological elements in the design of the randomized controlled trial included all four categories of the Persuasive Systems Design model, but not all design principles were implemented. The study duration was extended to a period of four and a half years. Of 81 active participants in the intervention group, a maximum of 36 women were simultaneously active. User adherence varied greatly with a median of 91 individual log-ins. The forum for peer support was used by 63 participants. Although only about one-third of the participants interacted in the forum, there was a fairly rich exchange of experiences and advice between them. Thus, adherence in terms of social interactions was negatively affected by limited active participation due to prolonged recruitment process and randomization effects. Lessons learned from this critical analysis are that technology and study design matter and might mutually influence each other. In Web-based interventions, the use of design theories enables utilization of the full potential of technology and promotes adherence. The

Culturally adaptive storytelling intervention versus didactic intervention to improve hypertension control in Vietnam: a cluster-randomized controlled feasibility trial.

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Nguyen, Hoa L; Allison, Jeroan J; Ha, Duc A; Chiriboga, Germán; Ly, Ha N; Tran, Hanh T; Nguyen, Cuong K; Dang, Diem M; Phan, Ngoc T; Vu, Nguyen C; Nguyen, Quang P; Goldberg, Robert J

2017-01-01

Vietnam is experiencing an epidemiologic transition with an increased prevalence of non-communicable diseases. Novel, large-scale, effective, and sustainable interventions to control hypertension in Vietnam are needed. We report the results of a cluster-randomized feasibility trial at 3 months follow-up conducted in Hung Yen province, Vietnam, designed to evaluate the feasibility and acceptability of two community-based interventions to improve hypertension control: a "storytelling" intervention, "We Talk about Our Hypertension," and a didactic intervention. The storytelling intervention included stories about strategies for coping with hypertension, with patients speaking in their own words, and didactic content about the importance of healthy lifestyle behaviors including salt reduction and exercise. The didactic intervention included only didactic content. The storytelling intervention was delivered by two DVDs at 3-month intervals; the didactic intervention included only one installment. The trial was conducted in four communes, equally randomized to the two interventions. The mean age of the 160 study patients was 66 years, and 54% were men. Most participants described both interventions as understandable, informative, and motivational. Between baseline and 3 months, mean systolic blood pressure declined by 8.2 mmHg (95% CI 4.1-12.2) in the storytelling group and by 5.5 mmHg (95% CI 1.4-9.5) in the didactic group. The storytelling group also reported a significant increase in hypertension medication adherence. Both interventions were well accepted in several rural communities and were shown to be potentially effective in lowering blood pressure. A large-scale randomized trial is needed to compare the effectiveness of the two interventions in controlling hypertension. ClinicalTrials.gov, NCT02483780.

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.

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

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

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

2014-07-01

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

Diet and exercise intervention adherence and health-related outcomes among older long-term breast, prostate, and colorectal cancer survivors.

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Winger, Joseph G; Mosher, Catherine E; Rand, Kevin L; Morey, Miriam C; Snyder, Denise C; Demark-Wahnefried, Wendy

2014-10-01

Diet and exercise interventions for cancer survivors result in health benefits; however, few studies have examined health outcomes in relation to adherence. We examined associations between adherence to components of a diet-exercise intervention and survivors' physical and mental health. A randomized controlled trial tested a telephone and mailed print intervention among 641 older, overweight, long-term survivors of breast, prostate, and colorectal cancer. Dietary and exercise behaviors were assessed at 14 time points throughout the year-long intervention; health outcomes were examined postintervention. Telephone session attendance had significant indirect relationships with health outcomes through intervention-period exercise and dietary behavior. Attendance showed positive indirect relationships with physical function (β = 0.11, p < 0.05), basic and advanced lower extremity function (β = 0.10, p < 0.05/β = 0.09, p < 0.05), and mental health (β = 0.05, p < 0.05), and a negative indirect relationship with body mass index (β = -0.06, p < 0.05). Session attendance is vital in facilitating improvement in health behaviors and attendant outcomes (Clinicaltrials.gov number NCT00303875).

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

Healthcare provider-led interventions to support medication adherence following ACS: a meta-analysis.

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Crawshaw, Jacob; Auyeung, Vivian; Ashworth, Lucy; Norton, Sam; Weinman, John

2017-01-01

We conducted a systematic review and meta-analysis to determine the effectiveness of healthcare provider-led (HCPs) interventions to support medication adherence in patients with acute coronary syndrome (ACS). A systematic search of Cochrane Library, Medline, EMBASE, PsycINFO, Web of Science, IPA, CINAHL, ASSIA, OpenGrey, EthOS, WorldCat and PQDT was undertaken. Interventions were deemed eligible if they included adult ACS patients, were HCP-led, measured medication adherence and randomised participants to parallel groups. Intervention content was coded using the Behaviour Change Technique (BCT) Taxonomy and data were pooled for analysis using random-effects models. Our search identified 8870 records, of which 27 were eligible (23 primary studies). A meta-analysis (n=9735) revealed HCP-led interventions increased the odds of medication adherence by 54% compared to control interventions (k=23, OR 1.54, 95% CI 1.26 to 1.88, I 2 =57.5%). After removing outliers, there was a 41% increase in the odds of medication adherence with moderate heterogeneity (k=21, OR 1.41, 95% CI 1.21 to 1.65, I 2 =35.3%). Interventions that included phone contact yielded (k=12, OR 1.63, 95% CI 1.25 to 2.12, I 2 =32.0%) a larger effect compared to those delivered exclusively in person. A total of 32/93 BCTs were identified across interventions (mean=4.7, SD=2.2) with 'information about health consequences' (BCT 5.1) (19/23) the most common. HCP-led interventions for ACS patients appear to have a small positive impact on medication adherence. While we were able to identify BCTs among interventions, data were insufficient to determine the impact of particular BCTs on study effectiveness. CRD42016037706.

Cost of intervention delivery in a lifestyle weight loss trial in type 2 diabetes: results from the Look AHEAD clinical trial.

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Rushing, J; Wing, R; Wadden, T A; Knowler, W C; Lawlor, M; Evans, M; Killean, T; Montez, M; Espeland, M A; Zhang, P

2017-03-01

The Action for Health in Diabetes (Look AHEAD) trial was a randomized controlled clinical trial to compare the effects of 10 years of intensive lifestyle intervention (ILI) with a control condition of diabetes support and education (DSE) on health outcomes in over 5,000 participants with type 2 diabetes. The ILI had significantly greater weight losses than DSE throughout the trial. The goal of this analysis is to describe the cost of delivering the intervention. The ILI was designed to promote weight loss and increase physical activity. It involved a combination of group plus individual intervention sessions, with decreasing frequency of contact over the 10 years. The intervention incorporated a variety of strategies, including meal replacement products, to improve weight loss outcomes. The costs of intervention delivery were derived from staff surveys of effort and from records of intervention materials from the 16 US academic clinical trial sites. Costs were calculated from the payer perspective and presented in 2012 dollars. During the first year, when intervention delivery was most intensive, the annual cost of intervention delivery, averaged (standard deviation) across clinical sites, was $2,864.6 ($513.3) per ILI participant compared with $202.4 ($76.6) per DSE participant. As intervention intensity declined, costs decreased, such that from years 5 to 9 of the trial, the annual cost of intervention was $1,119.8 ($227.7) per ILI participant and $102.9 ($33.0) per DSE participant. Staffing accounted for the majority of costs throughout the trial, with meal replacements and materials to promote adherence accounting for smaller shares. The sustained weight losses produced by the Look AHEAD intervention were supported by intervention costs that were within the range of other weight loss programmes. Future work will include an evaluation of the cost-effectiveness of the ILI and will contain additional follow-up data.

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.

Endovascular Interventions for the Morbidly Adherent Placenta

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Claire Kaufman

2018-05-01

Full Text Available Morbidly adherent placentas are a spectrum of abnormalities ranging from placental invasion of the myometrium to invasion past the myometrium and muscular layers into adjacent structures. This entity is becoming more prevalent recently with increased number of cesarean deliveries. Given the high risk of morbidity and mortality, this was traditionally treated with pre-term planned cesarean hysterectomy. However, recently, uterine preservation techniques have been implemented for those women wishing to preserve future fertility or their uterus. Early identification is crucial as studies have shown better outcomes for women treated at tertiary care facilities by a dedicated multidisciplinary team. Interventional radiologists are frequently included in the care of these patients as there are several different endovascular techniques which can be implemented to decrease morbidity in these patients both in conjunction with cesarean hysterectomy and in the setting of uterine preservation. This article will review the spectrum of morbidly adherent placentas, imaging, as well as the surgical and endovascular interventions implemented in the care of these complex patients.

A therapist-focused knowledge translation intervention for improving patient adherence in musculoskeletal physiotherapy practice.

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Babatunde, Folarin Omoniyi; MacDermid, Joy Christine; MacIntyre, Norma

2017-01-01

Nonadherence to treatment remains high among patients with musculoskeletal conditions with negative impact on the treatment outcomes, use of personal and cost of care. An active knowledge translation (KT) strategy may be an effective strategy to support practice change. The purpose of this study was to deliver a brief, interactive, multifaceted and targeted KT program to improve physiotherapist knowledge and confidence in performing adherence enhancing activities related to risk, barriers, assessment and interventions. We utilised a 2-phase approach in this KT project. Phase 1 involved the development of an adherence tool kit following a synthesis of the literature and an iterative process involving 47 end-users. Clinicians treating patients with musculoskeletal conditions were recruited from two Physiotherapy and Occupational therapy national conferences in Canada. The intervention, based on the acronym SIMPLE TIPS was tested on 51 physiotherapists in phase 2. A pre- and post-repeated measures design was used in Phase 2. Graham's knowledge-to-action cycle was used as the conceptual framework. Participants completed a pre-intervention assessment, took part in a 1-h educational session and completed a post-intervention assessment. A questionnaire was used to measure knowledge of evidence-based treatment adherence barriers, interventions and measures and confidence to perform evidence-based adherence practice activities. Data was analysed using descriptive statistics (frequency and percentage), Fisher's exact test and Wilcoxon Sign-Ranked tests. Barriers and facilitators of adherence were identified under three domains (therapist, patient, health system) in phase 1. Seventy percent of the participants completed the questionnaire. Results indicated that 46.8% of respondents explored barriers including the use of behaviour change strategies and 45.7% reported that they measured adherence but none reported the use of validated outcomes. A significant improvement in

Computer-based intervention in HIV clinical care setting improves antiretroviral adherence: the LifeWindows Project.

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Fisher, Jeffrey D; Amico, K Rivet; Fisher, William A; Cornman, Deborah H; Shuper, Paul A; Trayling, Cynthia; Redding, Caroline; Barta, William; Lemieux, Anthony F; Altice, Frederick L; Dieckhaus, Kevin; Friedland, Gerald

2011-11-01

We evaluated the efficacy of LifeWindows, a theory-based, computer-administered antiretroviral (ARV) therapy adherence support intervention, delivered to HIV + patients at routine clinical care visits. 594 HIV + adults receiving HIV care at five clinics were randomized to intervention or control arms. Intervention vs. control impact in the intent-to-treat sample (including participants whose ARVs had been entirely discontinued, who infrequently attended care, or infrequently used LifeWindows) did not reach significance. Intervention impact in the On Protocol sample (328 intervention and control arm participants whose ARVs were not discontinued, who attended care and were exposed to LifeWindows regularly) was significant. On Protocol intervention vs. control participants achieved significantly higher levels of perfect 3-day ACTG-assessed adherence over time, with sensitivity analyses maintaining this effect down to 70% adherence. This study supports the utility of LifeWindows and illustrates that patients on ARVs who persist in care at clinical care sites can benefit from adherence promotion software.

Individuals motivated to participate in adherence, care and treatment (imPACT): development of a multi-component intervention to help HIV-infected recently incarcerated individuals link and adhere to HIV care.

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Golin, Carol E; Knight, Kevin; Carda-Auten, Jessica; Gould, Michele; Groves, Jennifer; L White, Becky; Bradley-Bull, Steve; Amola, Kemi; Fray, Niasha; Rosen, David L; Mugavaro, Michael J; Pence, Brian W; Flynn, Patrick M; Wohl, David

2016-09-06

Policy-makers promote a seek, test, treat and retain (STTR) strategy to expand HIV testing, support linkage and engagement in care, and enhance the continuous use of antiretroviral therapy for those HIV-infected. This HIV prevention strategy is particularly appropriate in correctional settings where HIV screening and treatment are routinely available yet many HIV-infected individuals have difficulty sustaining sufficient linkage and engagement in care, disease management, and viral suppression after prison release. Our research team developed Project imPACT (individuals motivated to Participate in Adherence, Care and Treatment), a multi-component approach for HIV-Infected recently incarcerated individuals that specifically targets their care linkage, retention, and medication adherence by addressing multiple barriers to care engagement after release. The ultimate goals of this intervention are to improve the health of HIV-infected individuals recently released from prison and reduce HIV transmission to their communities by maintaining viral suppression. This paper describes the intervention and technology development processes, based on best practices for intervention development and process evaluation. These processes included: 1) identifying the target population; 2) clarifying the theoretical basis for intervention design; 3) describing features of its foundational interventions; 4) conducting formative qualitative research; 5) integrating and adapting foundational interventions to create and refine intervention content based on target audience feedback. These stages along with the final intervention product are described in detail. The intervention is currently being evaluation and a two arm randomized, controlled trial in two US state prison systems. Based on a literature review, qualitative research, integration of proven interventions and behavioral theory, the final imPACT intervention focused on the transition period two to three months before and three

Identifying configurations of behavior change techniques in effective medication adherence interventions: a qualitative comparative analysis.

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Kahwati, Leila; Viswanathan, Meera; Golin, Carol E; Kane, Heather; Lewis, Megan; Jacobs, Sara

2016-05-04

Interventions to improve medication adherence are diverse and complex. Consequently, synthesizing this evidence is challenging. We aimed to extend the results from an existing systematic review of interventions to improve medication adherence by using qualitative comparative analysis (QCA) to identify necessary or sufficient configurations of behavior change techniques among effective interventions. We used data from 60 studies in a completed systematic review to examine the combinations of nine behavior change techniques (increasing knowledge, increasing awareness, changing attitude, increasing self-efficacy, increasing intention formation, increasing action control, facilitation, increasing maintenance support, and motivational interviewing) among studies demonstrating improvements in adherence. Among the 60 studies, 34 demonstrated improved medication adherence. Among effective studies, increasing patient knowledge was a necessary but not sufficient technique. We identified seven configurations of behavior change techniques sufficient for improving adherence, which together accounted for 26 (76 %) of the effective studies. The intervention configuration that included increasing knowledge and self-efficacy was the most empirically relevant, accounting for 17 studies (50 %) and uniquely accounting for 15 (44 %). This analysis extends the completed review findings by identifying multiple combinations of behavior change techniques that improve adherence. Our findings offer direction for policy makers, practitioners, and future comparative effectiveness research on improving adherence.

Creating a synergy effect: A cluster randomized controlled trial testing the effect of a tailored multimedia intervention on patient outcomes.

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Linn, Annemiek J; van Dijk, Liset; van Weert, Julia C M; Gebeyehu, Beniam G; van Bodegraven, Ad A; Smit, Edith G

2018-03-17

Improving adherence is a challenge and multiple barriers are likely to explain non-adherence. These barriers differ per patient and over course of the regimen. Hence, personalized interventions tailored to the specific barriers are needed. In a theoretical and evidence-based Tailored Multimedia Intervention, technology (online preparatory assessment, text messaging) was used as an add-on to a tailored counseling session (learned during a communication skills training), with the expectation of synergistic effects. A cluster randomized controlled trial was conducted in six hospitals, eight nurses and 160 chronic patients. Patient satisfaction with communication, beliefs about medication, self-efficacy and medication adherence were assessed at initiation of the treatment and after six months. Intervention effects were found for patient satisfaction with nurses' affective communication and self-efficacy at the initiation of treatment. The effect on self-efficacy remained after six months. By combining tailored counseling with technology, this intervention resulted in positive changes in important prerequisites of medication adherence. Technology can contribute significantly to health care providers' ability to tailor information to the patients' needs. Copyright © 2018. Published by Elsevier B.V.

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

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.

Designing clinical trials for assessing the effects of cognitive training and physical activity interventions on cognitive outcomes: The Seniors Health and Activity Research Program Pilot (SHARP-P Study, a randomized controlled trial

Directory of Open Access Journals (Sweden)

Rejeski W Jack

2011-05-01

Full Text Available Abstract Background The efficacy of non-pharmacological intervention approaches such as physical activity, strength, and cognitive training for improving brain health has not been established. Before definitive trials are mounted, important design questions on participation/adherence, training and interventions effects must be answered to more fully inform a full-scale trial. Methods SHARP-P was a single-blinded randomized controlled pilot trial of a 4-month physical activity training intervention (PA and/or cognitive training intervention (CT in a 2 × 2 factorial design with a health education control condition in 73 community-dwelling persons, aged 70-85 years, who were at risk for cognitive decline but did not have mild cognitive impairment. Results Intervention attendance rates were higher in the CT and PACT groups: CT: 96%, PA: 76%, PACT: 90% (p=0.004, the interventions produced marked changes in cognitive and physical performance measures (p≤0.05, and retention rates exceeded 90%. There were no statistically significant differences in 4-month changes in composite scores of cognitive, executive, and episodic memory function among arms. Four-month improvements in the composite measure increased with age among participants assigned to physical activity training but decreased with age for other participants (intervention*age interaction p = 0.01. Depending on the choice of outcome, two-armed full-scale trials may require fewer than 1,000 participants (continuous outcome or 2,000 participants (categorical outcome. Conclusions Good levels of participation, adherence, and retention appear to be achievable for participants through age 85 years. Care should be taken to ensure that an attention control condition does not attenuate intervention effects. Depending on the choice of outcome measures, the necessary sample sizes to conduct four-year trials appear to be feasible. Trial Registration Clinicaltrials.gov Identifier: NCT00688155

Effect of adherence to self-monitoring of diet and physical activity on weight loss in a technology-supported behavioral intervention

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Wang J

2012-03-01

Full Text Available Jing Wang1, Susan M Sereika2,3, Eileen R Chasens2, Linda J Ewing4, Judith T Matthews2,5, Lora E Burke2,31School of Nursing, University of Texas Health Science Center at Houston, Houston, TX, 2School of Nursing, 3Graduate School of Public Health, 4School of Medicine, 5University Center for Social and Urban Research, University of Pittsburgh, Pittsburgh, PA, USABackground: Examination of mediating behavioral factors could explain how an intervention works and thus provide guidance to optimize behavioral weight-loss programs. This study examined the mediating role of adherence to self-monitoring of diet and physical activity on weight loss in a behavioral weight-loss trial testing the use of personal digital assistants (PDA for self-monitoring.Methods: Mediation analysis was conducted to examine the possible mediating role of adherence to self-monitoring of diet and physical activity between treatments using varying self-monitoring methods (paper record, PDA, and PDA with daily tailored feedback messages and weight loss.Findings: The sample (N = 210 was predominantly white (78% and female (85%. Compared to a paper record, using a PDA for self-monitoring diet (P = 0.027 and physical activity (P = 0.014 had significant direct effects on weight loss at 12 months, as well as a significant indirect effect on outcomes through improved adherence to self-monitoring (PS < 0.001. Receiving an automated daily feedback message via PDA only had a significant indirect effect on weight through self-monitoring adherence to diet (P = 0.004 and physical activity (P = 0.002.Conclusions: Adherence to self-monitoring of diet and physical activity is important as the underlying mechanism in this technology-supported behavioral weight-loss intervention.Keywords: behavioral intervention, self-monitoring, mobile technology, mediation analysis, weight loss, adherence 

The importance of cholesterol medication adherence: the need for behavioral change intervention programs

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Bosworth HB

2018-03-01

Full Text Available Hayden B Bosworth,1–5 Barbara Ngouyombo,6 Jan Liska,7 Leah L Zullig,1,2 Caroline Atlani,8 Anne C Beal7 1Center for Health Services Research in Primary Care, Durham Veterans Affairs Health Care System, Durham, NC, USA; 2Department of Population Health Sciences, Duke University, Durham, NC, USA; 3School of Nursing, Duke University, Durham, NC, USA; 4Department of Psychiatry, Duke University, Durham, NC, USA; 5Department of Behavioral Sciences, Duke University, Durham, NC, USA; 6Value & Access Team, Sanofi Pasteur, Lyon, France; 7Center of Excellence for Patient Centricity, Sanofi, Paris, France; 8Patient Strategy, Diabetes & Cardiovascular Unit, Sanofi, Paris, France Abstract: Lipid-lowering medications have been shown to be efficacious, but adherence is suboptimal. This is a narrative, perspective review of recently published literature in the field of medication adherence research for lipid-lowering medications. We provide an overview of the impact of suboptimal adherence and use a World Health Organization framework (patient, condition, therapy, socioeconomic, and health system-related systems to discuss factors that influence hyperlipidemia treatment adherence. Further, the review involves an evaluation of intervention strategies to increase hyperlipidemia treatment adherence with a special focus on mHealth interventions, patient reminders on packaging labels, nurse- and pharmacist-led interventions, and health teams. It also highlights opportunities for pharmaceutical companies to support and scale such behavioral interventions. Medication adherence remains a challenge for the long-term management of chronic conditions, especially those involving asymptomatic disease such as hyperlipidemia. To engage patients and enhance motivation over time, hyperlipidemia interventions must be targeted to individual patients’ needs, with sequencing and frequency of contact tailored to the various stages of behavioral change. Keywords: cardiovascular

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

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

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

DEFF Research Database (Denmark)

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

2016-01-01

BACKGROUND: Adherence to antihypertensive medications is suboptimal. Hospital pharmacist interventions including motivational interviewing (MI) might assist in improving adherence in patients with hypertension. For an intervention to be useful, it is important to have tools that can easily identify...... potential adherence problems. OBJECTIVES: To evaluate process outcomes and patient- and pharmacist-reported outcomes of a pharmacist adherence intervention for hypertensive patients treated in hospital outpatient clinics. Secondly, to determine the agreement between two different adherence metrics......-39% reported increased knowledge, confidence and skills in relation to their medication as well as better quality of life. The pharmacists found that the intervention elements were meaningful pharmacist tasks, and that the DRAW tool was easy to use and helped them focus on addressing reasons for non...

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

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

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Peter, Wilfred; van der Wees, Philip J; Verhoef, John; de Jong, Zusana; van Bodegom-Vos, Leti; Hilberdink, Wim K H A; Fiocco, Marta; Vliet Vlieland, Thea P M

2015-01-01

To determine the effectiveness of an interactive educational intervention on a physiotherapy guideline for hip and knee osteoarthritis. Physiotherapists were randomly allocated to a 3-h interactive educational course with the collaboration of three patient partners or no intervention. Assessments comprised questionnaires on adherence (score range 0-24), knowledge (score range 0-76), and barriers to use the guideline (score range 0-80). Assessments were conducted 1 week before the interactive course (T0) immediately after (T1), and 3 months thereafter (T2). Change scores were compared between the groups by means of Mann-Whitney U tests and linear mixed models. 284 of 4328 eligible PTs (7%) were included. The intervention (n = 133) was significantly more effective than no intervention (n = 151) concerning self-reported adherence and knowledge with mean differences in change scores (95% CI) at T1 and T2 being 1.4 (0.7-2.0) and 0.9 (0.2-1.7) for adherence and 6.8 (4.5-9.1) and 3.9 (1.7-6.2) for knowledge, (all p values knee osteoarthritis showed a small to moderate positive effect on self-reported guideline adherence and knowledge, whereas for perceived barriers an advantage was only seen on the longer term.

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

Improving diabetes medication adherence: successful, scalable interventions

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Zullig LL

2015-01-01

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

Automated Reminders and Physician Notification to Promote Immunosuppression Adherence Among Kidney Transplant Recipients: A Randomized Trial.

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Reese, Peter P; Bloom, Roy D; Trofe-Clark, Jennifer; Mussell, Adam; Leidy, Daniel; Levsky, Simona; Zhu, Jingsan; Yang, Lin; Wang, Wenli; Troxel, Andrea; Feldman, Harold I; Volpp, Kevin

2017-03-01

Immunosuppression nonadherence increases the risk for kidney transplant loss after transplantation. Wireless-enabled pill bottles have created the opportunity to monitor medication adherence in real time. Reminders may help patients with poor memory or organization. Provision of adherence data to providers may motivate patients to improve adherence and help providers identify adherence barriers. Randomized controlled trial. Kidney transplant recipients (n=120) at a single center. Participants were provided wireless pill bottles to store tacrolimus and record bottle openings. Participants were randomly assigned 1:1:1 to adherence monitoring with customized reminders (including alarms, texts, telephone calls, and/or e-mails), monitoring with customized reminders plus provider notification (every 2 weeks, providers received notification if adherence decreased to adherence during the last 90 days of the 180-day trial. A secondary outcome was tacrolimus whole-blood concentrations at routine clinical visits. Adherence for the primary outcome was assessed via wireless pill bottle openings. Mean participant age was 50 years; 60% were men, and 40% were black. Mean adherence was 78%, 88%, and 55% in the reminders, reminders-plus-notification, and control arms (Padherence, but these strategies require evaluation in trials powered to detect differences in clinical outcomes. Copyright © 2016 National Kidney Foundation, Inc. Published by Elsevier Inc. All rights reserved.

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.

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

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.

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

Science.gov (United States)

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

Participants, usage, and use patterns of a web-based intervention for the prevention of depression within a randomized controlled trial.

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Kelders, Saskia M; Bohlmeijer, Ernst T; Van Gemert-Pijnen, Julia Ewc

2013-08-20

nonadherers and adherers, and fewer sessions to complete the lesson than adherers. Furthermore, late nonadherers seemed to have a shorter total duration of sessions than adherers. By using log data combined with baseline characteristics of participants, we extracted valuable lessons for redesign of this intervention and the design of Web-based interventions in general. First, although characteristics of respondents can significantly predict adherence, their predictive value is small. Second, it is important to design Web-based interventions to foster adherence and usage of all features in an intervention. Dutch Trial Register Number: NTR3007; http://www.trialregister.nl/trialreg/admin/rctview.asp?TC=3007 (Archived by WebCite at http://www.webcitation.org/6ILhI3rd8).

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

Science.gov (United States)

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

Scaled-Up Mobile Phone Intervention for HIV Care and Treatment: Protocol for a Facility Randomized Controlled Trial.

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L'Engle, Kelly L; Green, Kimberly; Succop, Stacey M; Laar, Amos; Wambugu, Samuel

2015-01-23

Adherence to prevention, care, and treatment recommendations among people living with HIV (PLHIV) is a critical challenge. Yet good clinical outcomes depend on consistent, high adherence to antiretroviral therapy (ART) regimens. Mobile phones offer a promising means to improve patient adherence and health outcomes. However, limited information exists on the impact that mobile phones for health (mHealth) programs have on ART adherence or the behavior change processes through which such interventions may improve patient health, particularly among ongoing clients enrolled in large public sector HIV service delivery programs and key populations such as men who have sex with men (MSM) and female sex workers (FSW). Our aim is to evaluate an mHealth intervention where text message reminders are used as supportive tools for health providers and as motivators and reminders for ART clients to adhere to treatment and remain linked to care in Ghana. Using an implementation science framework, we seek to: (1) evaluate mHealth intervention effects on patient adherence and health outcomes, (2) examine the delivery of the mHealth intervention for improving HIV care and treatment, and (3) assess the cost-effectiveness of the mHealth intervention. The 36-month study will use a facility cluster randomized controlled design (intervention vs standard of care) for evaluating the impact of mHealth on HIV care and treatment. Specifically, we will look at ART adherence, HIV viral load, retention in care, and condom use at 6 and 12-month follow-up. In addition, participant adoption and satisfaction with the program will be measured. This robust methodology will be complemented by qualitative interviews to obtain feedback on the motivational qualities of the program and benefits and challenges of delivery, especially for key populations. Cost-effectiveness will be assessed using incremental cost-effectiveness ratios, with health effects expressed in terms of viral load suppression and costs

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

Science.gov (United States)

Simco, Russell; McCusker, Jane; Sewitch, Maida

2014-01-01

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

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

Science.gov (United States)

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.

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

Science.gov (United States)

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

2017-04-20

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

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

Science.gov (United States)

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

2017-05-15

The number of adolescents with chronic health conditions (CHCs) continues to increase. Medication nonadherence is a global challenge among adolescents across chronic conditions and is associated with poor health outcomes. While there has been growing interest in the use of mHealth technology to improve medication adherence among adolescents with CHCs, particularly text messaging and mobile phone apps, there has been no prior systematic review of their efficacy. The purpose of this review was to systematically evaluate the most recent evidence for the efficacy of text messaging and mobile phone apps as interventions to promote medication adherence among adolescents with CHCs. PubMed, Embase, CENTRAL, PsycINFO, Web of Science, Google Scholar, and additional databases were searched from 1995 until November 2015. An additional hand search of related themes in the Journal of Medical Internet Research was also conducted. The Preferred Reporting Results of Systematic Reviews and Meta-Analyses guidelines were followed. Two reviewers independently screened titles/abstracts, assessed full-text articles, extracted data from included articles, and assessed their quality using Grades of Recommendation, Assessment, Development, and Evaluation criteria. Included studies were described in original research articles that targeted adherence in adolescents with CHCs (12-24 years-old). Of the 1423 records examined, 15 met predefined criteria: text messaging (n=12) and mobile phone apps (n=3). Most studies were performed in the United States (11/15, 73%), were randomized-controlled trials (8/15, 53%), had a sample size <50 (11/15, 73%), and included adherence self-report and/or biomarkers (9/15, 60%). Only four studies were designed based on a theoretical framework. Approaches for text messaging and mobile phone app interventions varied across studies. Seven articles (7/15, 47%) reported significant improvement in adherence with moderate to large standardized mean differences. Most of

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

Science.gov (United States)

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.

A systematic review of randomised control trials of sexual health interventions delivered by mobile technologies.

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Burns, Kara; Keating, Patrick; Free, Caroline

2016-08-12

Sexually transmitted infections (STIs) pose a serious public health problem globally. The rapid spread of mobile technology creates an opportunity to use innovative methods to reduce the burden of STIs. This systematic review identified recent randomised controlled trials that employed mobile technology to improve sexual health outcomes. The following databases were searched for randomised controlled trials of mobile technology based sexual health interventions with any outcome measures and all patient populations: MEDLINE, EMBASE, PsycINFO, Global Health, The Cochrane Library (Cochrane Database of Systematic Reviews, Cochrane Central Register of Controlled Trials, Cochrane Methodology Register, NHS Health Technology Assessment Database, and Web of Science (science and social science citation index) (Jan 1999-July 2014). Interventions designed to increase adherence to HIV medication were not included. Two authors independently extracted data on the following elements: interventions, allocation concealment, allocation sequence, blinding, completeness of follow-up, and measures of effect. Trials were assessed for methodological quality using the Cochrane risk of bias tool. We calculated effect estimates using intention to treat analysis. A total of ten randomised trials were identified with nine separate study groups. No trials had a low risk of bias. The trials targeted: 1) promotion of uptake of sexual health services, 2) reduction of risky sexual behaviours and 3) reduction of recall bias in reporting sexual activity. Interventions employed up to five behaviour change techniques. Meta-analysis was not possible due to heterogeneity in trial assessment and reporting. Two trials reported statistically significant improvements in the uptake of sexual health services using SMS reminders compared to controls. One trial increased knowledge. One trial reported promising results in increasing condom use but no trial reported statistically significant increases in condom

Uptake and adherence of a self-directed internet-based mental health intervention with tailored e-mail reminders in senior high schools in Norway.

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Lillevoll, Kjersti R; Vangberg, Hans Christian B; Griffiths, Kathleen M; Waterloo, Knut; Eisemann, Martin R

2014-01-21

Internet-based cognitive behavioural therapy (ICBT) is a promising approach to the prevention and reduction of depressive symptoms among adolescents. This study aimed to evaluate the feasibility and efficacy of disseminating a self-directed internet-based mental health intervention (MoodGYM) in senior high schools. It also sought to investigate possible effects of tailored and weekly e-mail reminders on initial uptake and adherence to the intervention. A baseline survey was conducted in four senior high schools in two Norwegian municipalities (n = 1337). 52.8% (707/1337) of the students consented to further participation in the trial and were randomly allocated to one of three MoodGYM intervention groups (tailored weekly e-mail reminder (n = 175), standardized weekly e-mail reminder (n = 176 ) or no e-mail reminder (n = 175)) or a waitlist control group (n = 180). We tested for effects of the intervention on depression and self-esteem using multivariate analysis of variance, effects of tailored e-mail and self-reported current need of help on initial uptake of the intervention using logistic regression and the effect of weekly e-mails on adherence using ordinal regression. There was substantial non-participation from the intervention, with only 8.5% (45/527) participants logging on to MoodGYM, and few proceeding beyond the first part of the programme. No significant effect on depression or self-esteem was found among the sample as a whole or among participants with elevated depression scores at baseline. Having a higher average grade in senior high school predicted initial uptake of the intervention, but tailored e-mail and self-reported current need of help did not. Weekly e-mail prompts did not predict adherence. The main reasons for non-use reported were lack of time/forgetting about it and doubt about the usefulness of the program. Overall, disseminating a self-directed internet-based intervention to a school population proved difficult despite steps taken to

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.

Social Media Interventions to Promote HIV Testing, Linkage, Adherence, and Retention: Systematic Review and Meta-Analysis.

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Cao, Bolin; Gupta, Somya; Wang, Jiangtao; Hightow-Weidman, Lisa B; Muessig, Kathryn E; Tang, Weiming; Pan, Stephen; Pendse, Razia; Tucker, Joseph D

2017-11-24

Social media is increasingly used to deliver HIV interventions for key populations worldwide. However, little is known about the specific uses and effects of social media on human immunodeficiency virus (HIV) interventions. This systematic review examines the effectiveness of social media interventions to promote HIV testing, linkage, adherence, and retention among key populations. We used the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) checklist and Cochrane guidelines for this review and registered it on the International Prospective Register of Systematic Reviews, PROSPERO. We systematically searched six databases and three conference websites using search terms related to HIV, social media, and key populations. We included studies where (1) the intervention was created or implemented on social media platforms, (2) study population included men who have sex with men (MSM), transgender individuals, people who inject drugs (PWID), and/or sex workers, and (3) outcomes included promoting HIV testing, linkage, adherence, and/or retention. Meta-analyses were conducted by Review Manager, version 5.3. Pooled relative risk (RR) and 95% confidence intervals were calculated by random-effects models. Among 981 manuscripts identified, 26 studies met the inclusion criteria. We found 18 studies from high-income countries, 8 in middle-income countries, and 0 in low-income countries. Eight were randomized controlled trials, and 18 were observational studies. All studies (n=26) included MSM; five studies also included transgender individuals. The focus of 21 studies was HIV testing, four on HIV testing and linkage to care, and one on antiretroviral therapy adherence. Social media interventions were used to do the following: build online interactive communities to encourage HIV testing/adherence (10 studies), provide HIV testing services (9 studies), disseminate HIV information (9 studies), and develop intervention materials (1 study). Of the

Effects of Charitable Versus Monetary Incentives on the Acceptance of and Adherence to a Pedometer-Based Health Intervention: Study Protocol and Baseline Characteristics of a Cluster-Randomized Controlled Trial.

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Kowatsch, Tobias; Kramer, Jan-Niklas; Kehr, Flavius; Wahle, Fabian; Elser, Niklas; Fleisch, Elgar

2016-09-13

Research has so far benefited from the use of pedometers in physical activity interventions. However, when public health institutions (eg, insurance companies) implement pedometer-based interventions in practice, people may refrain from participating due to privacy concerns. This might greatly limit the applicability of such interventions. Financial incentives have been successfully used to influence both health behavior and privacy concerns, and may thus have a beneficial effect on the acceptance of pedometer-based interventions. This paper presents the design and baseline characteristics of a cluster-randomized controlled trial that seeks to examine the effect of financial incentives on the acceptance of and adherence to a pedometer-based physical activity intervention offered by a health insurance company. More than 18,000 customers of a large Swiss health insurance company were allocated to a financial incentive, a charitable incentive, or a control group and invited to participate in a health prevention program. Participants used a pedometer to track their daily physical activity over the course of 6 months. A Web-based questionnaire was administered at the beginning and at the end of the intervention and additional data was provided by the insurance company. The primary outcome of the study will be the participation rate, secondary outcomes will be adherence to the prevention program, physical activity, and health status of the participants among others. Baseline characteristics indicate that residence of participants, baseline physical activity, and subjective health should be used as covariates in the statistical analysis of the secondary outcomes of the study. This is the first study in western cultures testing the effectiveness of financial incentives with regard to a pedometer-based health intervention offered by a large health insurer to their customers. Given that the incentives prove to be effective, this study provides the basis for powerful health

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.

A randomized controlled trial of a multilevel intervention to increase colorectal cancer screening among Latino immigrants in a primary care facility.

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Aragones, Abraham; Schwartz, Mark D; Shah, Nirav R; Gany, Francesca M

2010-06-01

Latino immigrants face a higher burden of colorectal cancer (CRC) and screening rates are low. To assess the effectiveness of a multilevel intervention in increasing the rate of CRC screening among Latino immigrants. A randomized controlled trial, with randomization at the physician level. Pairs of 65 primary care physicians and 65 Latino immigrant patients participated, 31 in the intervention and 34 in the control group. CRC educational video in Spanish on a portable personal digital video display device accompanied by a brochure with key information for the patient, and a patient-delivered paper-based reminder for their physician. Completed CRC screening, physician recommendation for CRC screening, and patient adherence to physician recommended CRC screening. The overall rate of completed screening for CRC was 55% for the intervention and 18% for the control group (p = 0.002). Physicians recommended CRC screening for 61% of patients in the intervention group versus 41% in the control group (p = 0.08). Of those that received a recommendation, 90% in the intervention group adhered to it versus 26% in the control group (p = 0.007). The intervention was successful in increasing rates of completed CRC screening primarily through increasing adherence after screening was recommended. Additional efforts should focus on developing new strategies to increase physician recommendation for CRC screening, while employing effective patient adherence interventions.

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 phone reminder is important, but will others get to know about my illness?’ Patient perceptions of an mHealth antiretroviral treatment support intervention in the HIVIND trial in South India

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Rodrigues, Rashmi; Poongulali, S; Balaji, Kavitha; Atkins, Salla; Ashorn, Per; De Costa, Ayesha

2015-01-01

Objectives The recent explosion of mHealth applications in the area of HIV care has led to the development of mHealth interventions to support antiretroviral treatment adherence. Several of these interventions have been tested for effectiveness, but few studies have explored patient perspectives of such interventions. Exploring patient perspectives enhances the understanding of how an intervention works or why it does not. We therefore studied perceptions regarding an mHealth adherence intervention within the HIVIND trial in South India. Methods The study was conducted at three clinics in South India. The intervention comprised an automated interactive voice response (IVR) call and a pictorial short messaging service (SMS), each delivered weekly. Sixteen purposively selected participants from the intervention arm in the HIVIND trial were interviewed. All participants had completed at least 84 weeks since enrollment in the trial. Perceptions on the usefulness and perceived benefits and risks of receiving the intervention were sought. The interviews were transcribed and analysed using the framework approach to qualitative data analysis. Results Despite varying perceptions of the intervention, most participants found it useful. The intervention was perceived as a sign of ‘care’ from the clinic. The IVR call was preferred to the SMS reminder. Two-way communication was preferred to automated calls. Participants also perceived a risk of unintentional disclosure of their HIV status and stigma thereof via the intervention and took initiatives to mitigate this risk. Targeting reminders at those with poor adherence and those in need of social support was suggested. Conclusions mHealth adherence interventions go beyond their intended role to provide a sense of care and support to the recipient. Although automated interventions are impersonal, they could be a solution for scale up. Interventions that engage both the recipient and the healthcare provider have greater

Interventional study to improve diabetic guidelines adherence using mobile health (m-Health) technology in Lahore, Pakistan.

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Hashmi, Noreen Rahat; Khan, Shazad Ali

2018-05-31

To check if mobile health (m-Health) short message service (SMS) can improve the knowledge and practice of the American Diabetic Association preventive care guidelines (ADA guidelines) recommendations among physicians. Quasi-experimental pre-post study design with a control group. The participants of the study were 62 medical officers/medical postgraduate trainees from two hospitals in Lahore, Pakistan. Pretested questionnaire was used to collect baseline information about physicians' knowledge and adherence according to the ADA guidelines. All the respondents attended 1-day workshop about the guidelines. The intervention group received regular reminders by SMS about the ADA guidelines for the next 5 months. Postintervention knowledge and practice scores of 13 variables were checked again using the same questionnaire. Statistical analysis included χ 2 and McNemar's tests for categorical variables and t-test for continuous variables. Pearson's correlation analysis was done to check correlation between knowledge and practice scores in the intervention group. P values of improvement in knowledge (pimprovement in knowledge (p=0.002) and practice (p=0.001) between non-intervention and intervention groups. Adherence to individual 13 ADA preventive care guidelines level was noted to be suboptimal at baseline. Statistically significant improvement in the intervention group was seen in the following individual variables: review of symptoms of hypoglycaemia and hyperglycaemia, eye examination, neurological examination, lipid examination, referral to ophthalmologist, and counselling about non-smoking. m-Health technology can be a useful educational tool to help with improving knowledge and practice of diabetic guidelines. Future multicentre trials will help to scale this intervention for wider use in resource-limited countries. © Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2018. All rights reserved. No commercial use is

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

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Ma, Qingyan; Tso, Lai Sze; Rich, Zachary C; Hall, Brian J; Beanland, Rachel; Li, Haochu; Lackey, Mellanye; Hu, Fengyu; Cai, Weiping; Doherty, Meg; Tucker, Joseph D

2016-01-01

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

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

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.

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.

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

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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.

Improving pneumonia case-management in Benin: a randomized trial of a multi-faceted intervention to support health worker adherence to Integrated Management of Childhood Illness guidelines

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Lama Marcel

2009-08-01

Full Text Available Abstract Background Pneumonia is a leading cause of death among children under five years of age. The Integrated Management of Childhood Illness strategy can improve the quality of care for pneumonia and other common illnesses in developing countries, but adherence to these guidelines could be improved. We evaluated an intervention in Benin to support health worker adherence to the guidelines after training, focusing on pneumonia case management. Methods We conducted a randomized trial. After a health facility survey in 1999 to assess health care quality before Integrated Management of Childhood Illness training, health workers received training plus either study supports (job aids, non-financial incentives and supervision of workers and supervisors or "usual" supports. Follow-up surveys were conducted in 2001, 2002 and 2004. Outcomes were indicators of health care quality for Integrated Management-defined pneumonia. Further analyses included a graphical pathway analysis and multivariable logistic regression modelling to identify factors influencing case-management quality. Results We observed 301 consultations of children with non-severe pneumonia that were performed by 128 health workers in 88 public and private health facilities. Although outcomes improved in both intervention and control groups, we found no statistically significant difference between groups. However, training proceeded slowly, and low-quality care from untrained health workers diluted intervention effects. Per-protocol analyses suggested that health workers with training plus study supports performed better than those with training plus usual supports (20.4 and 19.2 percentage-point improvements for recommended treatment [p = 0.08] and "recommended or adequate" treatment [p = 0.01], respectively. Both groups tended to perform better than untrained health workers. Analyses of treatment errors revealed that incomplete assessment and difficulties processing clinical findings

A quantitative systematic review of the efficacy of mobile phone interventions to improve medication adherence.

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Park, Linda G; Howie-Esquivel, Jill; Dracup, Kathleen

2014-09-01

To evaluate the characteristics and efficacy of mobile phone interventions to improve medication adherence. Secondary aims are to explore participants' acceptability and satisfaction with mobile phone interventions and to evaluate the selected studies in terms of study rigour, impact, cost and resource feasibility, generalizability and implications for nursing practice and research. Medication non-adherence is a major global challenge. Mobile phones are the most commonly used form of technology worldwide and have the potential to promote medication adherence. Guidelines from the Centre for Reviews and Dissemination were followed for this systematic review. A comprehensive search of databases (PubMed, Web of Science, CINAHL, PsycInfo, Google Chrome and Cochrane) and bibliographies from related articles was performed from January 2002-January 2013 to identify the included studies. A quantitative systematic review without meta-analysis was conducted and the selected studies were critically evaluated to extract and summarize pertinent characteristics and outcomes. The literature search produced 29 quantitative research studies related to mobile phones and medication adherence. The studies were conducted for prevention purposes as well as management of acute and chronic illnesses. All of the studies used text messaging. Eighteen studies found significant improvement in medication adherence. While the majority of investigators found improvement in medication adherence, long-term studies characterized by rigorous research methodologies, appropriate statistical and economic analyses and the test of theory-based interventions are needed to determine the efficacy of mobile phones to influence medication adherence. © 2014 John Wiley & Sons Ltd.

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

Cultural adaptation of an evidence-based nursing intervention to improve medication adherence among people living with HIV/AIDS (PLWHA) in China.

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Williams, Ann B; Wang, Honghong; Burgess, Jane; Li, Xianhong; Danvers, Karina

2013-04-01

Adapting nursing interventions to suit the needs and culture of a new population (cultural adaptation) is an important early step in the process of implementation and dissemination. While the need for cultural adaptation is widely accepted, research-based strategies for doing so are not well articulated. Non-adherence to medications for chronic disease is a global problem and cultural adaptation of existing evidence-based interventions could be useful. This paper aims to describe the cultural adaptation of an evidence-based nursing intervention to improve medication adherence among people living with HIV/AIDS and to offer recommendations for adaptation of interventions across cultures and borders. SITE: The intervention, which demonstrated efficacy in a randomized controlled trial in North America, was adapted for the cultural and social context of Hunan Province, in south central China. The adaptation process was undertaken by intervention stakeholders including the original intervention study team, the proposed adaptation team, and members of a Community Advisory Board, including people living with HIV/AIDS, family members, and health care workers at the target clinical sites. The adaptation process was driven by quantitative and qualitative data describing the new population and context and was guided by principles for cultural adaptation drawn from prevention science research. The primary adaptation to the intervention was the inclusion of family members in intervention activities, in response to the cultural and social importance of the family in rural China. In a pilot test of the adapted intervention, self-reported medication adherence improved significantly in the group receiving the intervention compared to the control group (p=0.01). Recommendations for cultural adaptation of nursing interventions include (1) involve stakeholders from the beginning; (2) assess the population, need, and context; (3) evaluate the intervention to be adapted with attention to

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

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

2013-01-01

Anxiety is common among adolescents with autism spectrum disorders (ASD) and may amplify the core social disability, thus necessitating combined treatment approaches. This pilot, randomized controlled trial (RCT) evaluated the feasibility and preliminary outcomes of the Multimodal Anxiety and Social Skills Intervention (MASSI) program in a sample of 30 adolescents with ASD and anxiety symptoms of moderate or greater severity. The treatment was acceptable to families, subject adherence was hig...

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

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

'The phone reminder is important, but will others get to know about my illness?' Patient perceptions of an mHealth antiretroviral treatment support intervention in the HIVIND trial in South India.

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Rodrigues, Rashmi; Poongulali, S; Balaji, Kavitha; Atkins, Salla; Ashorn, Per; De Costa, Ayesha

2015-11-02

The recent explosion of mHealth applications in the area of HIV care has led to the development of mHealth interventions to support antiretroviral treatment adherence. Several of these interventions have been tested for effectiveness, but few studies have explored patient perspectives of such interventions. Exploring patient perspectives enhances the understanding of how an intervention works or why it does not. We therefore studied perceptions regarding an mHealth adherence intervention within the HIVIND trial in South India. The study was conducted at three clinics in South India. The intervention comprised an automated interactive voice response (IVR) call and a pictorial short messaging service (SMS), each delivered weekly. Sixteen purposively selected participants from the intervention arm in the HIVIND trial were interviewed. All participants had completed at least 84 weeks since enrollment in the trial. Perceptions on the usefulness and perceived benefits and risks of receiving the intervention were sought. The interviews were transcribed and analysed using the framework approach to qualitative data analysis. Despite varying perceptions of the intervention, most participants found it useful. The intervention was perceived as a sign of 'care' from the clinic. The IVR call was preferred to the SMS reminder. Two-way communication was preferred to automated calls. Participants also perceived a risk of unintentional disclosure of their HIV status and stigma thereof via the intervention and took initiatives to mitigate this risk. Targeting reminders at those with poor adherence and those in need of social support was suggested. mHealth adherence interventions go beyond their intended role to provide a sense of care and support to the recipient. Although automated interventions are impersonal, they could be a solution for scale up. Interventions that engage both the recipient and the healthcare provider have greater potential for success. Personalising m

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

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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.

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

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Yvonne Mühlig

2017-08-01

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

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

Community pharmacist intervention in depressed primary care patients (PRODEFAR study: randomized controlled trial protocol

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Travé Pere

2009-08-01

Full Text Available Abstract Background Treatment of depression, the most prevalent and costly mental disorder, needs to be improved. Non-concordance with clinical guidelines and non-adherence can limit the efficacy of pharmacological treatment of depression. Through pharmaceutical care, pharmacists can improve patients' compliance and wellbeing. The aim of this study is to evaluate the effectiveness and cost-effectiveness of a community pharmacist intervention developed to improve adherence and outcomes of primary care patients with depression. Methods/design A randomized controlled trial, with 6-month follow-up, comparing patients receiving a pharmaceutical care support programme in primary care with patients receiving usual care. The total sample comprises 194 patients (aged between 18 and 75 diagnosed with depressive disorder in a primary care health centre in the province of Barcelona (Spain. Subjects will be asked for written informed consent in order to participate in the study. Diagnosis will be confirmed using the SCID-I. The intervention consists of an educational programme focused on improving knowledge about medication, making patients aware of the importance of compliance, reducing stigma, reassuring patients about side-effects and stressing the importance of carrying out general practitioners' advice. Measurements will take place at baseline, and after 3 and 6 months. Main outcome measure is compliance with antidepressants. Secondary outcomes include; clinical severity of depression (PHQ-9, anxiety (STAI-S, health-related quality of life (EuroQol-5D, satisfaction with the treatment received, side-effects, chronic physical conditions and socio-demographics. The use of healthcare and social care services will be assessed with an adapted version of the Client Service Receipt Inventory (CSRI. Discussion This trial will provide valuable information for health professionals and policy makers on the effectiveness and cost-effectiveness of a pharmaceutical

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.

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

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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.

Facilitating return to work through early specialist health-based interventions (FRESH): protocol for a feasibility randomised controlled trial.

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Radford, Kathryn A; Phillips, Julie; Jones, Trevor; Gibson, Ali; Sutton, Chris; Watkins, Caroline; Sach, Tracey; Duley, Lelia; Walker, Marion; Drummond, Avril; Hoffman, Karen; O'Connor, Rory; Forshaw, Denise; Shakespeare, David

2015-01-01

Over one million people sustain traumatic brain injury each year in the UK and more than 10 % of these are moderate or severe injuries, resulting in cognitive and psychological problems that affect the ability to work. Returning to work is a primary rehabilitation goal but fewer than half of traumatic brain injury survivors achieve this. Work is a recognised health service outcome, yet UK service provision varies widely and there is little robust evidence to inform rehabilitation practice. A single-centre cohort comparison suggested better work outcomes may be achieved through early occupational therapy targeted at job retention. This study aims to determine whether this intervention can be delivered in three new trauma centres and to conduct a feasibility, randomised controlled trial to determine whether its effects and cost effectiveness can be measured to inform a definitive trial. Mixed methods study, including feasibility randomised controlled trial, embedded qualitative studies and feasibility economic evaluation will recruit 102 people with traumatic brain injury and their nominated carers from three English UK National Health Service (NHS) trauma centres. Participants will be randomised to receive either usual NHS rehabilitation or usual rehabilitation plus early specialist traumatic brain injury vocational rehabilitation delivered by an occupational therapist. The primary objective is to assess the feasibility of conducting a definitive trial; secondary objectives include measurement of protocol integrity (inclusion/exclusion criteria, intervention adherence, reasons for non-adherence) recruitment rate, the proportion of eligible patients recruited, reasons for non-recruitment, spectrum of TBI severity, proportion of and reasons for loss to follow-up, completeness of data collection, gains in face-to-face V s postal data collection and the most appropriate methods of measuring primary outcomes (return to work, retention) to determine the sample size for a

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

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

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

2016-03-01

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

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

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

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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.

Effect of a group intervention in the primary healthcare setting on continuing adherence to physical exercise routines in obese women.

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del Rey-Moya, Luz Maria; Castilla-Álvarez, Carmen; Pichiule-Castañeda, Myrian; Rico-Blázquez, Milagros; Escortell-Mayor, Esperanza; Gómez-Quevedo, Rosa

2013-08-01

To determine the effect of a seven-week-long, group-delivered, nurse-monitored, exercise training programme on the adherence of obese women to physical exercise routines at 12 months. The worldwide obesity epidemic is posing huge public health challenges. The main cause of obesity in Europe is very possibly a sedentary lifestyle. Uncertainty exists regarding whether people will continue to exercise once a structured intervention programme of physical activity ends. No-control-group (before-after) intervention study. One Hundred Seventy-Four women from the Madrid region (Spain) aged ≥ 45 years with a body mass index of ≥30 undertook a maximum of 21 × 1 hour exercise training programme sessions (three per week) over seven weeks starting in February 2009. The number of women making use of exercise training programme before the intervention, and at 6 and 12 months postintervention, was recorded using the Nursing Outcome Classification. Information was collected by interviewing the study subjects. Bivariate (McNemar and Student's t-tests) and multivariate (binary logistic regression) analyses were then performed. The Nursing Outcome Classification Indicator 'Does the subject follow an exercise training programme?' showed that at the end of one year, the percentage of women who remained adhered to exercise training programme increased in those who completed the study (from 11-41%). As the number of programmed exercise training programme sessions completed increased beyond 14, so too did the likelihood of adhering to an exercise training programme regime at one year. The results show that an exercise training programme intervention can encourage obese women to continue exercising after exercise interventions end. This type of intervention could provide a valuable means of helping women lose weight and improve their health. It may also have important economic benefits for health systems. Clinical trials with longer follow-up times and in other populations are needed

Interventions to improve medication adherence among Chinese patients with hypertension: a systematic review and meta-analysis of randomized controlled trails.

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Xu, Rixiang; Xie, Xuefeng; Li, Shuting; Chen, Xiaoyu; Wang, Sheng; Hu, Chengyang; Lv, Xiongwen

2018-04-25

A systematic review and meta-analysis of randomized controlled trials (RCTs) were performed to understand the effectiveness of medication adherence (MA) interventions among Chinese patients with hypertension. A literature search was conducted with three English databases (PubMed, Web of Science and Embase) and three Chinese databases (China National Knowledge Infrastructure, Wanfang and VIP Database for Chinese Technical Periodicals) for the period from 1970 to October 2017. Only both RCTs with a minimum of 10 participants in each intervention group and Chinese patients with hypertension as participants were included. A random-effects model was applied to calculate pooled effect sizes with 95% CI. Subgroup analysis was conducted to identify potential sources of heterogeneity from duration of intervention, type of intervener, methods of intervention and sites of intervention. Funnel plots and Egger's test were used to evaluate for publication bias. A total of 48 studies met criteria for the meta-analysis, including 14 568 participants, testing 57 independent comparisons. Overall, the effect size revealed that interventions significantly improved MA (pooled relative risk = 1.59, 95% CI: 1.43 to 1.78; pooled Cohen's d = 1.42, 95% CI: 0.976 to 1.876). Interventions were found to significantly reduce blood pressure (BP) (systolic BP: Cohen's d = -0.85, 95% CI: -1.11 to -0.60 and diastolic BP: Cohen's d = -0.73, 95% CI: -1.00 to -0.46). Longer duration of intervention gave better effectiveness. Physician as interventionist, regular follow-up visits and interventions conducted at a hospital were associated with better effectiveness. Adherence interventions improve MA and reduce uncontrolled BP among Chinese patients with hypertension. In the future, investigators should adopt a skill set to address the problem of poor MA. © 2018 Royal Pharmaceutical Society.

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

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Maria Loreto Tarraga Marcos

2017-03-01

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

Educational intervention to improve adherence to the Mediterranean diet among parents and their children aged 1-2 years. EniM clinical trial.

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Roset-Salla, Margarita; Ramon-Cabot, Joana; Salabarnada-Torras, Jordi; Pera, Guillem; Dalmau, Albert

2016-04-01

The objective of the present study was to evaluate the effectiveness of an educational programme on healthy alimentation, carried out in day-care centres and aimed at the parents of children from 1 to 2 years of age, regarding the acquisition of healthy eating habits among themselves and their children. We performed a multicentre, multidisciplinary, randomized controlled study in a community setting. The EniM study (nutritional intervention study among children from Mataró) was performed in twelve day-care centres in Mataró (Spain). Centres were randomized into a control group (CG) and an intervention group (IG). IG received four or five educational workshops on diet, CG did not have workshops. Children, not exclusively breast-fed, from 1 to 2 years of age, in the participating day-care centres and the persons responsible for their alimentation (mother or father). Thirty-five per cent of the IG did not attend the minimum of three workshops and were excluded. The CG included seventy-four children and seventy-two parents and the IG seventy-five children and sixty-seven parents. Both groups were comparable at baseline. Basal adherence to the Mediterranean diet was 56·4 % in parents (Gerber index) and 7·7 points in children (Kidmed test). At 8 months, Mediterranean diet adherence had improved in the IG by 5·8 points in the Gerber index (P=0·01) and 0·6 points in the Kidmed test (P=0·02) compared with the CG. This educational intervention performed in parents at the key period of incorporation of a 1-2-year-old child to the family table showed significant increases in adherence of the parents to the Mediterranean diet, suggesting future improvement in different indicators of health and an expected influence on the diet of their children.

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.

Evaluation of the fidelity of an interactive face-to-face educational intervention to improve general practitioner management of back pain

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French, Simon D; Green, Sally E; Francis, Jill J; Buchbinder, Rachelle; O'Connor, Denise A; Grimshaw, Jeremy M; Michie, Susan

2015-01-01

Objectives Implementation intervention effects can only be fully realised and understood if they are faithfully delivered. However the evaluation of implementation intervention fidelity is not commonly undertaken. The IMPLEMENT intervention was designed to improve the management of low back pain by general medical practitioners. It consisted of a two-session interactive workshop, including didactic presentations and small group discussions by trained facilitators. This study aimed to evaluate the fidelity of the IMPLEMENT intervention by assessing: (1) observed facilitator adherence to planned behaviour change techniques (BCTs); (2) comparison of observed and self-reported adherence to planned BCTs and (3) variation across different facilitators and different BCTs. Design The study compared planned and actual, and observed versus self-assessed delivery of BCTs during the IMPLEMENT workshops. Method Workshop sessions were audiorecorded and transcribed verbatim. Observed adherence of facilitators to the planned intervention was assessed by analysing the workshop transcripts in terms of BCTs delivered. Self-reported adherence was measured using a checklist completed at the end of each workshop session and was compared with the ‘gold standard’ of observed adherence using sensitivity and specificity analyses. Results The overall observed adherence to planned BCTs was 79%, representing moderate-to-high intervention fidelity. There was no significant difference in adherence to BCTs between the facilitators. Sensitivity of self-reported adherence was 95% (95% CI 88 to 98) and specificity was 30% (95% CI 11 to 60). Conclusions The findings suggest that the IMPLEMENT intervention was delivered with high levels of adherence to the planned intervention protocol. Trial registration number The IMPLEMENT trial was registered in the Australian New Zealand Clinical Trials Registry, ACTRN012606000098538 (http://www.anzctr.org.au/trial_view.aspx?ID=1162). PMID:26155819

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.

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.

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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 .

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

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.

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.

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

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Badawy, Sherif M; Kuhns, Lisa M

2017-04-19

, sun protection, human papillomavirus (HPV) vaccination, smoking cessation, and sexual health. Most studies were performed in the United States (47%, 9/19), included younger adolescents (63%, 12/19), and had sample size <100 (63%, 12/19). Although most studies were randomized controlled trials (RCTs; 58%, 11/19), only 5 followed an intent-to-treat analysis. Only 6 of 19 studies (32%) incorporated a theoretical framework in their design. Most studies reported good feasibility with high acceptability and satisfaction. About half of the included studies (42%, 8/19) demonstrated significant improvement in preventive behavior with moderate standardized mean differences. As early efforts in this field to establish feasibility and initial efficacy, most studies were low to moderate in quality. Studies varied in sample size and methods of preventive behavior adherence or outcome assessment, which prohibited performing a meta-analysis. Despite the promising feasibility and acceptability of text messaging and mobile phone apps in improving preventive behavior among adolescents, overall findings were modest in terms of efficacy. Further research evaluating the efficacy, effectiveness, and cost-effectiveness of these intervention approaches in promoting preventive behavior among adolescents is needed. ©Sherif M Badawy, Lisa M Kuhns. Originally published in JMIR Mhealth and Uhealth (http://mhealth.jmir.org), 19.04.2017.

Interactive Two-Way mHealth Interventions for Improving Medication Adherence: An Evaluation Using The Behaviour Change Wheel Framework

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Amico, K Rivet; Atkins, Lou; Lester, Richard T

2018-01-01

Background Medication adherence is an important but highly complex set of behaviors, which for life-threatening and infectious diseases such as HIV carry critical consequences for individual and public health. There is growing evidence that mobile phone text messaging interventions (mHealth) connecting providers with patients positively impact medication adherence, particularly two-way engagement platforms that require bidirectional communication versus one-way in which responses are not mandatory. However, mechanisms of action have not been well defined. The Behavior Change Wheel is a comprehensive framework for behavior change that includes an all-encompassing model of behavior known as Capability Opportunity Motivation-Behavior and is complemented by a taxonomy of behavior change techniques. Evaluating mHealth interventions for medication adherence using these tools could provide useful insights that may contribute to optimizing their integration into the healthcare system and successful scaling-up. Objective This study aimed to help address the current knowledge gap regarding how two-way mHealth interventions for medication adherence may work by applying the Behavior Change Wheel to characterize WelTel: an interactive digital health outreach platform with robust evidence for improving adherence to antiretroviral therapy. Methods To characterize how WelTel may promote medication adherence, we applied the Behavior Change Wheel to systematically (1) generate a behavioral diagnosis through mapping known antiretroviral therapy adherence barriers onto the Capability Opportunity Motivation-Behavior model of behavior, (2) specify the behavior change techniques that WelTel delivers, (3) link identified behavior change techniques to corresponding intervention functions of the Behavior Change Wheel, and (4) connect these behavior change techniques and intervention functions to respective Capability Opportunity Motivation-Behavior influences on behavior to determine

Motivation is a crucial factor for adherence to a healthy lifestyle among people with coronary heart disease after percutaneous coronary intervention.

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Kähkönen, Outi; Kankkunen, Päivi; Saaranen, Terhi; Miettinen, Heikki; Kyngäs, Helvi; Lamidi, Marja-Leena

2015-10-01

To test the Theory of Adherence of People with Chronic Disease with regard to adherence to treatment among patients with coronary heart disease after a percutaneous coronary intervention. Increased knowledge of the concept of adherence is needed for the development of nursing interventions and nursing guidelines for patients with coronary heart disease. A cross-sectional, multi-centre study. This study was conducted from February-December 2013 with 416 patients with coronary heart disease 4 months after undergoing a percutaneous coronary intervention. A self-reported questionnaire was used to assess their adherence to treatment. Data were analysed using structural equation modelling. The theory explained 45% of the adherence to a healthy lifestyle and 7% of the adherence to medication. Structural equation modelling confirmed that motivation and results of care had the highest association with adherence to a healthy lifestyle. Responsibility was associated with adherence to medication. Support from next of kin, support from nurses and physicians, and motivation, co-operation, fear of complications and a sense of normality were associated with adherence. Patients who are motivated to perform self-care and consider the results of care to be important were more likely to adhere to a healthy lifestyle. Responsible patients were more likely to adhere to their medication. It is important to account for these elements as a part of secondary prevention strategies among patients with coronary heart disease after a percutaneous coronary intervention. © 2015 John Wiley & Sons Ltd.

Podiatry intervention versus usual care to prevent falls in care homes: pilot randomised controlled trial (the PIRFECT study).

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Wylie, Gavin; Menz, Hylton B; McFarlane, Sarah; Ogston, Simon; Sullivan, Frank; Williams, Brian; Young, Zoe; Morris, Jacqui

2017-07-12

Common foot problems are independent risk factors for falls in older people. There is evidence that podiatry can prevent falls in community-dwelling populations. The feasibility of implementing a podiatry intervention and trial in the care home population is unknown. To inform a potential future definitive trial, we performed a pilot randomised controlled trial to assess: (i) the feasibility of a trial of a podiatry intervention to reduce care home falls, and (ii) the potential direction and magnitude of the effect of the intervention in terms of number of falls in care home residents. Informed by Medical Research Council guidance on developing and evaluating complex interventions, we conducted a single blind, pilot randomised controlled trial in six care homes in the East of Scotland. Participants were randomised to either: (i) a three month podiatry intervention comprising core podiatry care, foot and ankle exercises, orthoses and footwear provision or (ii) usual care. Falls-related outcomes (number of falls, time to first fall) and feasibility-related outcomes (recruitment, retention, adherence, data collection rates) were collected. Secondary outcomes included: generic health status, balance, mobility, falls efficacy, and ankle joint strength. 474 care home residents were screened. 43 (9.1%) participants were recruited: 23 to the intervention, 20 to control. Nine (21%) participants were lost to follow-up due to declining health or death. It was feasible to deliver the trial elements in the care home setting. 35% of participants completed the exercise programme. 48% reported using the orthoses 'all or most of the time'. Completion rates of the outcome measures were between 93% and 100%. No adverse events were reported. At the nine month follow-up period, the intervention group per-person fall rate was 0.77 falls vs. 0.83 falls in the control group. A podiatry intervention to reduce falls can be delivered to care home residents within a pilot randomised

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.

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

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Martin, C Andrew; Upvall, Michele J

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

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.

Implementing trials of complex interventions in community settings: the USC-Rancho Los Amigos pressure ulcer prevention study (PUPS).

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Clark, Florence; Pyatak, Elizabeth A; Carlson, Mike; Blanche, Erna Imperatore; Vigen, Cheryl; Hay, Joel; Mallinson, Trudy; Blanchard, Jeanine; Unger, Jennifer B; Garber, Susan L; Diaz, Jesus; Florindez, Lucia I; Atkins, Michal; Rubayi, Salah; Azen, Stanley Paul

2014-04-01

Randomized trials of complex, non-pharmacologic interventions implemented in home and community settings, such as the University of Southern California (USC)-Rancho Los Amigos National Rehabilitation Center (RLANRC) Pressure Ulcer Prevention Study (PUPS), present unique challenges with respect to (1) participant recruitment and retention, (2) intervention delivery and fidelity, (3) randomization and assessment, and (4) potential inadvertent treatment effects. We describe the methods employed to address the challenges confronted in implementing PUPS. In this randomized controlled trial, we are assessing the efficacy of a complex, preventive intervention in reducing the incidence of, and costs associated with, the development of medically serious pressure ulcers in people with spinal cord injury. Individuals with spinal cord injury recruited from RLANRC were assigned to either a 12-month preventive intervention group or a standard care control group. The primary outcome is the incidence of serious pressure ulcers with secondary endpoints including ulcer-related surgeries, medical treatment costs, and quality of life. These outcomes are assessed at 12 and 24 months after randomization. Additionally, we are studying the mediating mechanisms that account for intervention outcomes. PUPS has been successfully implemented, including recruitment of the target sample size of 170 participants, assurance of the integrity of intervention protocol delivery with an average 90% treatment adherence rate, and enactment of the assessment plan. However, implementation has been replete with challenges. To meet recruitment goals, we instituted a five-pronged approach customized for an underserved, ethnically diverse population. In intervention delivery, we increased staff time to overcome economic and cultural barriers to retention and adherence. To ensure treatment fidelity and replicability, we monitored intervention protocol delivery in accordance with a rigorous plan. Finally, we

Adherence to a pedometer-based physical activity intervention following kidney transplant and impact on metabolic parameters.

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Lorenz, Elizabeth C; Amer, Hatem; Dean, Patrick G; Stegall, Mark D; Cosio, Fernando G; Cheville, Andrea L

2015-06-01

The majority of kidney transplant recipients die from cardiovascular events. Physical activity may be a modifiable risk factor for cardiovascular disease following transplant. The goal of our study was to examine adherence to a physical activity intervention following kidney transplant and its impact on metabolic parameters. All patients who received a kidney transplant at our center between 12/2010 and 12/2011 received usual care (n = 162), while patients transplanted between 12/2011 and 1/2013 received a 90-day pedometer-based physical activity intervention (n = 145). Metabolic parameters were assessed at four and 12 months post-transplant. Baseline demographics and clinical management were similar between cohorts. Adherence to the prescription was 36.5%. Patients in the physical activity cohort had lower systolic and diastolic blood pressure four months post-transplant compared to the usual care cohort (122 ± 18 vs. 126 ± 16 mmHg, p = 0.049 and 73 ± 10 vs. 77 ± 9, p = 0.004) and less impaired fasting glucose (20.7% vs. 30.9%, p = 0.04). Twelve-month outcomes were not different between cohorts. Over one-third of our cohort adhered to a pedometer-based physical activity intervention following kidney transplant, and the intervention was associated with improved metabolic parameters. Further study of post-transplant exercise interventions and methods to optimize long-term adherence are needed. © 2015 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd.

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

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

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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

Are randomised controlled trials positivist? Reviewing the social science and philosophy literature to assess positivist tendencies of trials of social interventions in public health and health services.

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Bonell, Chris; Moore, Graham; Warren, Emily; Moore, Laurence

2018-04-19

We have previously proposed that trials of social interventions can be done within a "realist" research paradigm. Critics have countered that such trials are irredeemably positivist and asked us to explain our philosophical position. We set out to explore what is meant by positivism and whether trials adhere to its tenets (of necessity or in practice) via a narrative literature review of social science and philosophical discussions of positivism, and of the trials literature and three case studies of trials. The philosophical literature described positivism as asserting: (1) the epistemic primacy of sensory information; (2) the requirement that theoretical terms equate with empirical terms; (3) the aim of developing universal laws; and (4) the unity of method between natural and social sciences. Regarding (1), it seems that rather than embodying the epistemic primacy of sensory data, randomised controlled trials (RCTs) of social interventions in health embrace an anti-positivist approach aiming to test hypotheses derived deductively from prior theory. Considering (2), while some RCTs of social interventions appear to limit theorisation to concepts with empirical analogues, others examine interventions underpinned by theories engaging with mechanisms and contextual contingencies not all of which can be measured. Regarding (3), while some trialists and reviewers in the health field do limit their role to estimating statistical trends as a mechanistic form of generalisation, this is not an inevitable feature of RCT-based research. Trials of social interventions can instead aim to generalise at the level of theory which specifies how mechanisms are contingent on context. In terms of (4), while RCTs are used to examine biomedical as well as social interventions in health, RCTs of social interventions are often distinctive in using qualitative analyses of data on participant accounts to examine questions of meaning and agency not pursued in the natural sciences. We

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).

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.

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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.

Evidence of improved fluid management in patients receiving haemodialysis following a self-affirmation theory-based intervention: A randomised controlled trial.

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Wileman, Vari; Chilcot, Joseph; Armitage, Christopher J; Farrington, Ken; Wellsted, David M; Norton, Sam; Davenport, Andrew; Franklin, Gail; Da Silva Gane, Maria; Horne, Robert; Almond, Mike

2016-01-01

Haemodialysis patients are at risk of serious health complications; yet, treatment non-adherence remains high. Warnings about health risks associated with non-adherence may trigger defensive reactions. We studied whether an intervention based on self-affirmation theory reduced resistance to health-risk information and improved fluid treatment adherence. In a cluster randomised controlled trial, 91 patients either self-affirmed or completed a matched control task before reading about the health-risks associated with inadequate fluid control. Patients' perceptions of the health-risk information, intention and self-efficacy to control fluid were assessed immediately after presentation of health-risk information. Interdialytic weight gain (IDWG), excess fluid removed during haemodialysis, is a clinical measure of fluid treatment adherence. IDWG data were collected up to 12 months post-intervention. Self-affirmed patients had significantly reduced IDWG levels over 12 months. However, contrary to predictions derived from self-affirmation theory, self-affirmed participants and controls did not differ in their evaluation of the health-risk information, intention to control fluid or self-efficacy. A low-cost, high-reach health intervention based on self-affirmation theory was shown to reduce IDWG over a 12-month period, but the mechanism by which this apparent behaviour change occurred is uncertain. Further work is still required to identify mediators of the observed effects.

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.

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

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

2012-01-01

Background: Although web-based interventions for promoting health and health-related behavior can be effective, poor adherence is a common issue that needs to be addressed. Technology as a means to communicate the content in web-based interventions has been neglected in research. Indeed, technology

Recruitment strategies and challenges in a large intervention trial: Systolic Blood Pressure Intervention Trial.

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Ramsey, Thomas M; Snyder, Joni K; Lovato, Laura C; Roumie, Christianne L; Glasser, Steven P; Cosgrove, Nora M; Olney, Christine M; Tang, Rocky H; Johnson, Karen C; Still, Carolyn H; Gren, Lisa H; Childs, Jeffery C; Crago, Osa L; Summerson, John H; Walsh, Sandy M; Perdue, Letitia H; Bankowski, Denise M; Goff, David C

2016-06-01

The Systolic Blood Pressure Intervention Trial is a multicenter, randomized clinical trial of 9361 participants with hypertension who are ≥50 years old. The trial is designed to evaluate the effect of intensive systolic blood pressure control (systolic blood pressure goal recruitment strategies and lessons learned during recruitment of the Systolic Blood Pressure Intervention Trial cohort and five targeted participant subgroups: pre-existing cardiovascular disease, pre-existing chronic kidney disease, age ≥75 years, women, and minorities. In collaboration with the National Institutes of Health Project Office and Systolic Blood Pressure Intervention Trial Coordinating Center, five Clinical Center Networks oversaw clinical site selection, recruitment, and trial activities. Recruitment began on 8 November 2010 and ended on 15 March 2013 (about 28 months). Various recruitment strategies were used, including mass mailing, brochures, referrals from healthcare providers or friends, posters, newspaper ads, radio ads, and electronic medical record searches. Recruitment was scheduled to last 24 months to enroll a target of 9250 participants; in just over 28 months, the trial enrolled 9361 participants. The trial screened 14,692 volunteers, with 33% of initial screens originating from the use of mass mailing lists. Screening results show that participants also responded to recruitment efforts through referral by Systolic Blood Pressure Intervention Trial staff, healthcare providers, or friends (45%); brochures or posters placed in clinic waiting areas (15%); and television, radio, newspaper, Internet ads, or toll-free numbers (8%). The overall recruitment yield (number randomized/number screened) was 64% (9361 randomized/14,692 screened), 77% for those with cardiovascular disease, 79% for those with chronic kidney disease, 70% for those aged ≥75 years, 55% for women, and 61% for minorities. As recruitment was observed to lag behind expectations, additional

Masivukeni: Development of a Multimedia Based Antiretroviral Therapy Adherence Intervention for Counselors and Patients in South Africa

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

2013-01-01

Effective medical treatment for HIV/AIDS requires patients’ optimal adherence to antiretroviral therapy (ART). In resource-constrained settings, lack of adequate standardized counseling for patients on ART remains a significant barrier to adherence. Masivukeni (“Lets Wake Up” in Xhosa) is an innovative multimedia-based intervention designed to help people living with HIV in resource-limited settings achieve and maintain high levels of ART adherence. Adapted from a couples-based intervention tested in the United States (US), Masivukeni was developed through community-based participatory research with US and South African partners and informed by Ewart’s Social Action Theory. Innovative computer-based multimedia strategies were used to translate a labor- and training-intensive intervention into one that could be readily and widely used by lay counselors with relatively little training with low-literacy patients. In this paper, we describe the foundations of this new intervention, the process of its development, and the evidence of its high acceptability and feasibility. PMID:23468079

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

Unearthing how, why, for whom and under what health system conditions the antiretroviral treatment adherence club intervention in South Africa works: A realist theory refining approach.

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

2018-05-09

Poor retention in care and suboptimal adherence to antiretroviral treatment (ART) undermine its successful rollout in South Africa. The adherence club intervention was designed as an adherence-enhancing intervention to enhance the retention in care of patients on ART and their adherence to medication. Although empirical evidence suggests the effective superiority of the adherence club intervention to standard clinic ART care schemes, it is poorly understood exactly how and why it works, and under what health system contexts. To this end, we aimed to develop a refined programme theory explicating how, why, for whom and under what health system contexts the adherence club intervention works (or not). We undertook a realist evaluation study to uncover the programme theory of the adherence club intervention. We elicited an initial programme theory of the adherence club intervention and tested the initial programme theory in three contrastive sites. Using a cross-case analysis approach, we delineated the conceptualisation of the intervention, context, actor and mechanism components of the three contrastive cases to explain the outcomes of the adherence club intervention, guided by retroductive inferencing. We found that an intervention that groups clinically stable patients on ART in a convenient space to receive a quick and uninterrupted supply of medication, health talks, counselling, and immediate access to a clinician when required works because patients' self-efficacy improves and they become motivated and nudged to remain in care and adhere to medication. The successful implementation and rollout of the adherence club intervention are contingent on the separation of the adherence club programme from other patients who are HIV-negative. In addition, there should be available convenient space for the adherence club meetings, continuous support of the adherence club facilitators by clinicians and buy-in from the health workers at the health-care facility and the

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.

Interactive Two-Way mHealth Interventions for Improving Medication Adherence: An Evaluation Using The Behaviour Change Wheel Framework.

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Chiang, Nicole; Guo, Michael; Amico, K Rivet; Atkins, Lou; Lester, Richard T

2018-04-12

Medication adherence is an important but highly complex set of behaviors, which for life-threatening and infectious diseases such as HIV carry critical consequences for individual and public health. There is growing evidence that mobile phone text messaging interventions (mHealth) connecting providers with patients positively impact medication adherence, particularly two-way engagement platforms that require bidirectional communication versus one-way in which responses are not mandatory. However, mechanisms of action have not been well defined. The Behavior Change Wheel is a comprehensive framework for behavior change that includes an all-encompassing model of behavior known as Capability Opportunity Motivation-Behavior and is complemented by a taxonomy of behavior change techniques. Evaluating mHealth interventions for medication adherence using these tools could provide useful insights that may contribute to optimizing their integration into the healthcare system and successful scaling-up. This study aimed to help address the current knowledge gap regarding how two-way mHealth interventions for medication adherence may work by applying the Behavior Change Wheel to characterize WelTel: an interactive digital health outreach platform with robust evidence for improving adherence to antiretroviral therapy. To characterize how WelTel may promote medication adherence, we applied the Behavior Change Wheel to systematically (1) generate a behavioral diagnosis through mapping known antiretroviral therapy adherence barriers onto the Capability Opportunity Motivation-Behavior model of behavior, (2) specify the behavior change techniques that WelTel delivers, (3) link identified behavior change techniques to corresponding intervention functions of the Behavior Change Wheel, and (4) connect these behavior change techniques and intervention functions to respective Capability Opportunity Motivation-Behavior influences on behavior to determine potential mechanisms of action. Our

A theory led narrative review of one-to-one health interventions: the influence of attachment style and client-provider relationship on client adherence.

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Nanjappa, S; Chambers, S; Marcenes, W; Richards, D; Freeman, R

2014-10-01

A theory-led narrative approach was used to unpack the complexities of the factors that enable successful client adherence following one-to-one health interventions. Understanding this could prepare the provider to anticipate different adherence behaviours by clients, allowing them to tailor their interventions to increase the likelihood of adherence. The review was done in two stages. A theoretical formulation was proposed to explore factors which influence the effectiveness of one-to-one interventions to result in client adherence. The second stage tested this theory using a narrative synthesis approach. Eleven studies across the health care arena were included in the synthesis and explored the interplay between client attachment style, client-provider interaction and client adherence with health interventions. It emerged that adherence results substantially because of the relationship that the client has with the provider, which is amplified or diminished by the client's own attachment style. This occurs because the client's attachment style shapes how they perceive and behave in relationships with the health-care providers, who become the 'secure base' from which the client accepts, assimilates and adheres with the recommended health intervention. The pathway from one-to-one interventions to adherence is explained using moderated mediation and mediated moderation models. © The Author 2014. Published by Oxford University Press. All rights reserved. For permissions, please email: journals.permissions@oup.com.

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

Adherence to a Telephone-Supported Depression Self-Care Intervention for Adults With Chronic Physical Illnesses

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Russell Simco

2015-02-01

Full Text Available We assessed adherence to and predictors of two components of a telephone-supported self-care intervention for depression among primary care adults aged 40 and above with chronic physical illnesses and comorbid depressive symptoms. Participants received a “toolkit” containing six self-care tools. Trained lay self-care “coaches” negotiated a contact schedule of up to weekly contacts. Study outcomes were levels of completion of the self-care tool and the coach contacts at the 2-month follow-up. Coaches reported the number of completed contacts. In all, 57 of 63 participants completed the 2-month follow-up. Of these, 67% completed at least 1 tool; the mean number of coach contacts was 5.7 (SD = 2.4 of a possible 9 contacts (63% adherence. Higher disease comorbidity and lower initial depression severity independently predicted better tool adherence. Findings suggest that people with chronic physical illnesses can achieve acceptable levels of adherence to a depression self-care intervention similar to those reported for other populations.

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.

Implementing trials of complex interventions in community settings: The USC – Rancho Los Amigos Pressure Ulcer Prevention Study (PUPS)

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Clark, Florence; Pyatak, Elizabeth A.; Carlson, Mike; Blanche, Erna Imperatore; Vigen, Cheryl; Hay, Joel; Mallinson, Trudy; Blanchard, Jeanine; Unger, Jennifer B.; Garber, Susan L.; Diaz, Jesus; Florindez, Lucia I.; Atkins, Michal; Rubayi, Salah; Azen, Stanley Paul

2014-01-01

Background Randomized trials of complex, non-pharmacologic interventions implemented in home and community settings, such as the University of Southern California (USC)–Rancho Los Amigos National Rehabilitation Center (RLANRC) Pressure Ulcer Prevention Study (PUPS), present unique challenges with respect to: (a) participant recruitment and retention, (b) intervention delivery and fidelity, (c) randomization and assessment, and (d) potential inadvertent treatment effects. Purpose We describe the methods employed to address the challenges confronted in implementing PUPS. In this randomized controlled trial, we are assessing the efficacy of a complex, preventive intervention in reducing the incidence of, and costs associated with, the development of medically serious pressure ulcers in people with spinal cord injury. Method Individuals with spinal cord injury recruited from RLANRC were assigned to either a 12-month preventive intervention group or a standard care control group. The primary outcome is the incidence of serious pressure ulcers with secondary endpoints including ulcer-related surgeries, medical treatment costs, and quality of life. These outcomes are assessed at 12 and 24 months after randomization. Additionally, we are studying the mediating mechanisms that account for intervention outcomes. Results PUPS has been successfully implemented, including recruitment of the target sample size of 170 participants, assurance of the integrity of intervention protocol delivery with an average 90% treatment adherence rate, and enactment of the assessment plan. However, implementation has been replete with challenges. To meet recruitment goals, we instituted a five-pronged approach customized for an underserved, ethnically diverse population. In intervention delivery, we increased staff time to overcome economic and cultural barriers to retention and adherence. To ensure treatment fidelity and replicability, we monitored intervention protocol delivery in accord

In-depth analysis of patient-clinician cell phone communication during the WelTel Kenya1 antiretroviral adherence trial.

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Mia L van der Kop

Full Text Available The WelTel Kenya1 trial demonstrated that text message support improved adherence to antiretroviral therapy (ART and suppression of HIV-1 RNA load. The intervention involved sending weekly messages to patients inquiring how they were doing; participants were required to respond either that they were well or that there was a problem.1 Describe problems participants identified through mobile phone support and reasons why participants did not respond to the messages; 2 investigate factors associated with indicating a problem and not responding; and 3 examine participant perceptions of the intervention.Secondary analysis of WelTel Kenya1 trial data.Reasons participants indicated a problem or did not respond were extracted from the study log. Negative binomial regression was used to determine participant characteristics associated with indicating a problem and non-response. Data from follow-up questionnaires were used to describe participant perceptions of the intervention.Between 2007 and 2009, 271 participants generated 11,873 responses; 377 of which indicated a problem. Health issues were the primary reason for problem responses (72%. Rural residence (adjusted incidence rate ratio [IRR] 1.96; 95%CI 1.19-3.25; p=0.009 and age were associated with indicating a problem (adjusted IRR 0.63 per increase in age group category; 95%CI 0.50-0.80; p<0.001. Higher educational level was associated with a decreased rate of non-response (adjusted IRR 0.81; 95%CI 0.69-0.94; p=0.005. Of participants interviewed, 62% (n=129 stated there were no barriers to the intervention; cell phone issues were the most common barrier. Benefits included reminding patients to take medication and promoting a feeling that "someone cares".The WelTel intervention enabled frequent communication between clinicians and patients during the WelTel Kenya1 trial. Many patients valued the service for the support it provided, with health-related concerns comprising the majority of problems

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

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Brooke M Winzer

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

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

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

Partner randomized controlled trial: study protocol and coaching intervention

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Garbutt Jane M

2012-04-01

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

Reducing therapeutic misconception: A randomized intervention trial in hypothetical clinical trials.

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Paul P Christopher

Full Text Available Participants in clinical trials frequently fail to appreciate key differences between research and clinical care. This phenomenon, known as therapeutic misconception, undermines informed consent to clinical research, but to date there have been no effective interventions to reduce it and concerns have been expressed that to do so might impede recruitment. We determined whether a scientific reframing intervention reduces therapeutic misconception without significantly reducing willingness to participate in hypothetical clinical trials.This prospective randomized trial was conducted from 2015 to 2016 to test the efficacy of an informed consent intervention based on scientific reframing compared to a traditional informed consent procedure (control in reducing therapeutic misconception among patients considering enrollment in hypothetical clinical trials modeled on real-world studies for one of five disease categories. Patients with diabetes mellitus, hypertension, coronary artery disease, head/neck cancer, breast cancer, and major depression were recruited from medical clinics and a clinical research volunteer database. The primary outcomes were therapeutic misconception, as measured by a validated, ten-item Therapeutic Misconception Scale (range = 10-50, and willingness to participate in the clinical trial.154 participants completed the study (age range, 23-87 years; 92.3% white, 56.5% female; 74 (48.1% had been randomized to receive the experimental intervention. Therapeutic misconception was significantly lower (p = 0.004 in the scientific reframing group (26.4, 95% CI [23.7 to 29.1] compared to the control group (30.9, 95% CI [28.4 to 33.5], and remained so after controlling for education (p = 0.017. Willingness to participate in the hypothetical trial was not significantly different (p = 0.603 between intervention (52.1%, 95% CI [40.2% to 62.4%] and control (56.3%, 95% CI [45.3% to 66.6%] groups.An enhanced educational intervention augmenting

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

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Cugelman, Brian; Thelwall, Mike; Dawes, Phil

2011-02-14

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

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

NARCIS (Netherlands)

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

2014-01-01

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

Effects of a behavioral intervention that emphasizes spices and herbs on adherence to recommended sodium intake: results of the SPICE randomized clinical trial.

Science.gov (United States)

Anderson, Cheryl A M; Cobb, Laura K; Miller, Edgar R; Woodward, Mark; Hottenstein, Annette; Chang, Alex R; Mongraw-Chaffin, Morgana; White, Karen; Charleston, Jeanne; Tanaka, Toshiko; Thomas, Letitia; Appel, Lawrence J

2015-09-01

to improve adherence to recommendations. This trial was registered at clinicaltrials.gov as NCT01615159. © 2015 American Society for Nutrition.

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...

Effect of health information technology interventions on lipid management in clinical practice: a systematic review of randomized controlled trials.

Science.gov (United States)

Aspry, Karen E; Furman, Roy; Karalis, Dean G; Jacobson, Terry A; Zhang, Audrey M; Liptak, Gregory S; Cohen, Jerome D

2013-01-01

Large gaps in lipid treatment and medication adherence persist in high-risk outpatients in the United States. Health information technology (HIT) is being applied to close quality gaps in chronic illness care, but its utility for lipid management has not been widely studied. To perform a qualitative review of the impact of HIT interventions on lipid management processes of care (screening or testing; drug initiation, titration or adherence; or referrals) or clinical outcomes (percent at low density lipoprotein cholesterol goal; absolute lipid levels; absolute risk scores; or cardiac hospitalizations) in outpatients with coronary heart disease or at increased risk. PubMed and Google Scholar databases were searched using Medical Subject Headings related to clinical informatics and cholesterol or lipid management. English language articles that described a randomized controlled design, tested at least one HIT tool in high risk outpatients, and reported at least 1 lipid management process measure or clinical outcome, were included. Thirty-four studies that enrolled 87,874 persons were identified. Study ratings, outcomes, and magnitude of effects varied widely. Twenty-three trials reported a significant positive effect from a HIT tool on lipid management, but only 14 showed evidence that HIT interventions improve clinical outcomes. There was mixed evidence that provider-level computerized decision support improves outcomes. There was more evidence in support of patient-level tools that provide connectivity to the healthcare system, as well as system-level interventions that involve database monitoring and outreach by centralized care teams. Randomized controlled trials show wide variability in the effects of HIT on lipid management outcomes. Evidence suggests that multilevel HIT approaches that target not only providers but include patients and systems approaches will be needed to improve lipid treatment, adherence and quality. Copyright © 2013 National Lipid

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

The effectiveness of an educational intervention for sodium restriction in patients with hypertension: study protocol for a randomized controlled trial.

Science.gov (United States)

Rodrigues, Marcela Perdomo; Dos Santos, Luciana Kaercher John; Fuchs, Flavio Danni; Fuchs, Sandra Costa; Moreira, Leila Beltrami

2017-07-21

The effectiveness of nonpharmacological interventions in blood pressure reduction has been evidenced by several studies. Nevertheless, as adherence to a low-sodium diet is poor, interventions regarding habit changing should be of a motivational nature in order to develop the ability of overcoming obstacles regarding sodium-restriction behavior. The present study aims to describe the protocol and randomization of a clinical trial design in order to evaluate the effectiveness of an educational intervention based on Dietary Sodium Restriction Questionnaire (DSRQ) scores. The effectiveness measures are the DSRQ score variation and reduction in urinary sodium values from baseline to after 2 and 6 months. This parallel, randomized clinical trial will include 120 participants, recruited and randomized as follows: 60 of them to be allocated to a sodium-restriction educational intervention group whose results are based on the DSRQ application; and the other 60 allocated to a control group with usual care. Educational orientation and usual care sessions will be conducted once a month for a period of 6 months. Both spot urine collection - estimating sodium intake - and the DSRQ will be applied at the baseline, in the eighth week and at the end of the follow-up. There will also be blood collection and 24-h ambulatory blood pressure monitoring (ABPM) at the beginning and end of the follow-up. Anthropometric measurements, blood pressure measurement and 24-h food recall will be collected during follow-up. The study "The effectiveness of an educational intervention to sodium restriction in patients with hypertension" is based on the results of the DSRQ application, whose objective is to evaluate aspects related to nonadherence to the recommendation of a low-sodium diet, identifying adherence barriers and facilitators, contributing to the planning of interventions for improving the adoption of a low-sodium diet and, consequently, hypertension control. ClinicalTrials

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

Science.gov (United States)

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

2013-05-01

China is considered to be the new frontier of the global AIDS pandemic. Although effective treatment for HIV is becoming widely available in China, adherence to treatment remains a challenge. This study aimed to adapt an intervention promoting HIV-medication adherence-favorably evaluated in the West-for Chinese HIV-positive patients. The adaptation process was theory-driven and covered several key issues of cultural adaptation. We considered the importance of interpersonal relationships and family in China and cultural notions of health. Using an evidence-based treatment protocol originally designed for Western HIV-positive patients, we developed an 11-step Chinese Life-Steps program with an additional culture-specific intervention option. We describe in detail how the cultural elements were incorporated into the intervention and put into practice at each stage. Clinical considerations are also outlined and followed by two case examples that are provided to illustrate our application of the intervention. Finally, we discuss practical and research issues and limitations emerging from our field experiments in a HIV clinic in Beijing. The intervention was tailored to address both universal and culturally specific barriers to adherence and is readily applicable to generalized clinical settings. This evidence-based intervention provides a case example of the process of adapting behavioral interventions to culturally diverse communities with limited resources.

The design and development of a complex multifactorial falls assessment intervention for falls prevention: The Prevention of Falls Injury Trial (PreFIT).

Science.gov (United States)

Bruce, Julie; Ralhan, Shvaita; Sheridan, Ray; Westacott, Katharine; Withers, Emma; Finnegan, Susanne; Davison, John; Martin, Finbarr C; Lamb, Sarah E

2017-06-01

This paper describes the design and development of a complex multifactorial falls prevention (MFFP) intervention for implementation and testing within the framework of a large UK-based falls prevention randomised controlled trial (RCT). A complex intervention was developed for inclusion within the Prevention of Falls Injury Trial (PreFIT), a multicentre pragmatic RCT. PreFIT aims to compare the clinical and cost-effectiveness of three alternative primary care falls prevention interventions (advice, exercise and MFFP), on outcomes of fractures and falls. Community-dwelling adults, aged 70 years and older, were recruited from primary care in the National Health Service (NHS), England. Development of the PreFIT MFFP intervention was informed by the existing evidence base and clinical guidelines for the assessment and management of falls in older adults. After piloting and modification, the final MFFP intervention includes seven falls risk factors: a detailed falls history interview with consideration of 'red flags'; assessment of balance and gait; vision; medication screen; cardiac screen; feet and footwear screen and home environment assessment. This complex intervention has been fully manualised with clear, documented assessment and treatment pathways for each risk factor. Each risk factor is assessed in every trial participant referred for MFFP. Referral for assessment is based upon a screening survey to identify those with a history of falling or balance problems. Intervention delivery can be adapted to the local setting. This complex falls prevention intervention is currently being tested within the framework of a large clinical trial. This paper adheres to TIDieR and CONSORT recommendations for the comprehensive and explicit reporting of trial interventions. Results from the PreFIT study will be published in due course. The effectiveness and cost-effectiveness of the PreFIT MFFP intervention, compared to advice and exercise, on the prevention of falls and

Mobile phone-based interventions for improving contraception use.

Science.gov (United States)

Smith, Chris; Gold, Judy; Ngo, Thoai D; Sumpter, Colin; Free, Caroline

2015-06-26

Contraception provides significant benefits for women's and children's health, yet an estimated 225 million women had an unmet need for modern contraceptive methods in 2014. Interventions delivered by mobile phone have been demonstrated to be effective in other health areas, but their effects on use of contraception have not been established. To assess the effects of mobile phone-based interventions for improving contraception use. We searched for randomised controlled trials (RCTs) of client-provider interventions delivered by mobile phone to improve contraception use compared with standard care or another intervention. We searched the electronic databases Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, EMBASE, Global Health, PsycINFO, POPLINE, Africa-Wide Information and Latin American Caribbean Health Sciences Literature (LILACS) from January 1993 to October 2014, as well as clinical trials registries, online mHealth resources and abstracts from key conferences. Randomised controlled trials of mobile phone-based interventions to improve any form of contraception use amongst users or potential users of contraception. Outcome measures included uptake of contraception, measures of adherence, pregnancy and abortion. Two review authors independently screened titles and abstracts of studies retrieved using the search strategy and extracted data from the included studies. We calculated the Mantel-Haenszel risk ratio (RR) for dichotomous outcomes and the mean difference (MD) for continuous outcomes, together with 95% confidence intervals (CIs). Differences in interventions and outcome measures did not permit us to undertake meta-analysis. Five RCTs met our inclusion criteria. Three trials aimed to improve adherence to a specific method of contraception amongst existing or new contraception users by comparing automated text message interventions versus standard care. Two trials aimed to improve both uptake and adherence, not limited to one method, in

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

Science.gov (United States)

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.

Health Technology-Enabled Interventions for Adherence Support and Retention in Care Among US HIV-Infected Adolescents and Young Adults: An Integrative Review.

Science.gov (United States)

Navarra, Ann-Margaret Dunn; Gwadz, Marya Viorst; Whittemore, Robin; Bakken, Suzanne R; Cleland, Charles M; Burleson, Winslow; Jacobs, Susan Kaplan; Melkus, Gail D'Eramo

2017-11-01

The objective of this integrative review was to describe current US trends for health technology-enabled adherence interventions among behaviorally HIV-infected youth (ages 13-29 years), and present the feasibility and efficacy of identified interventions. A comprehensive search was executed across five electronic databases (January 2005-March 2016). Of the 1911 identified studies, nine met the inclusion criteria of quantitative or mixed methods design, technology-enabled adherence and or retention intervention for US HIV-infected youth. The majority were small pilots. Intervention dose varied between studies applying similar technology platforms with more than half not informed by a theoretical framework. Retention in care was not a reported outcome, and operationalization of adherence was heterogeneous across studies. Despite these limitations, synthesized findings from this review demonstrate feasibility of computer-based interventions, and initial efficacy of SMS texting for adherence support among HIV-infected youth. Moving forward, there is a pressing need for the expansion of this evidence base.

A problem-solving intervention for cardiovascular disease risk reduction in veterans: Protocol for a randomized controlled trial.

Science.gov (United States)

Nieuwsma, Jason A; Wray, Laura O; Voils, Corrine I; Gierisch, Jennifer M; Dundon, Margaret; Coffman, Cynthia J; Jackson, George L; Merwin, Rhonda; Vair, Christina; Juntilla, Karen; White-Clark, Courtney; Jeffreys, Amy S; Harris, Amy; Owings, Michael; Marr, Johnpatrick; Edelman, David

2017-09-01

Health behaviors related to diet, tobacco usage, physical activity, medication adherence, and alcohol use are highly determinative of risk for developing cardiovascular disease. This paper describes a study protocol to evaluate a problem-solving intervention that aims to help patients at risk for developing cardiovascular disease address barriers to adopting positive health behaviors in order to reduce cardiovascular risk. Eligible patients are adults enrolled in Veterans Affairs (VA) health care who have not experienced a cardiovascular event but are at elevated risk based on their Framingham Risk Score (FRS). Participants in this two-site study are randomized to either the intervention or care as usual, with a target of 400 participants. The study intervention, Healthy Living Problem-Solving (HELPS), consists of six group sessions conducted approximately monthly interspersed with individualized coaching calls to help participants apply problem-solving principles. The primary outcome is FRS, analyzed at the beginning and end of the study intervention (6months). Participants also complete measures of physical activity, caloric intake, self-efficacy, group cohesion, problem-solving capacities, and demographic characteristics. Results of this trial will inform behavioral interventions to change health behaviors in those at risk for cardiovascular disease and other health conditions. ClinicalTrials.gov identifier NCT01838226. Published by Elsevier Inc.

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

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

Science.gov (United States)

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

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

Science.gov (United States)

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

2017-09-01

Few evidence-based interventions to improve adherence to antiretroviral therapy have been adapted for use in Africa. We selected, culturally adapted and tested the feasibility of a cognitive-behavioural intervention for adherence and for delivery in a clinic setting in Harare, Zimbabwe. The feasibility of the intervention was evaluated using a mixed-methods assessment, including ratings of provider fidelity of intervention delivery, and qualitative assessments of feasibility using individual semi-structured interviews with counsellors (n=4) and patients (n=15). The intervention was feasible and acceptable when administered to 42 patients and resulted in improved self-reported adherence in a subset of 15 patients who were followed up after 6months.

Interventions to improve antiretroviral therapy adherence among adolescents in low- and middle-income countries: A systematic review of the literature

Science.gov (United States)

Dulli, Lisa S.; Murray, Kate R.; Silverstein, Hannah; Dal Santo, Leila; Olsen, Patrick; Darrow de Mora, Danielle; McCarraher, Donna R.

2018-01-01

Introduction Globally, an estimated 30% of new HIV infections occur among adolescents (15–24 years), most of whom reside in sub-Saharan Africa. Moreover, HIV-related mortality increased by 50% between 2005 and 2012 for adolescents 10–19 years while it decreased by 30% for all other age groups. Efforts to achieve and maintain optimal adherence to antiretroviral therapy are essential to ensuring viral suppression, good long-term health outcomes, and survival for young people. Evidence-based strategies to improve adherence among adolescents living with HIV are therefore a critical part of the response to the epidemic. Methods We conducted a systematic review of the peer-reviewed and grey literature published between 2010 and 2015 to identify interventions designed to improve antiretroviral adherence among adults and adolescents in low- and middle-income countries. We systematically searched PubMed, Web of Science, Popline, the AIDSFree Resource Library, and the USAID Development Experience Clearinghouse to identify relevant publications and used the NIH NHLBI Quality Assessment Tools to assess the quality and risk of bias of each study. Results and discussion We identified 52 peer-reviewed journal articles describing 51 distinct interventions out of a total of 13,429 potentially relevant publications. Forty-three interventions were conducted among adults, six included adults and adolescents, and two were conducted among adolescents only. All studies were conducted in low- and middle-income countries, most of these (n = 32) in sub-Saharan Africa. Individual or group adherence counseling (n = 12), mobile health (mHealth) interventions (n = 13), and community- and home-based care (n = 12) were the most common types of interventions reported. Methodological challenges plagued many studies, limiting the strength of the available evidence. However, task shifting, community-based adherence support, mHealth platforms, and group adherence counseling emerged as strategies

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

Science.gov (United States)

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.

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.

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

Science.gov (United States)

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

2015-07-10

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

Psychological interventions for people with cystic fibrosis and their families.

Science.gov (United States)

Glasscoe, Claire A; Quittner, Alexandra L

2008-07-16

With increasing survival estimates for cystic fibrosis (CF) long-term management has become an important focus. Psychological interventions are largely concerned with adherence to treatment, emotional and social adjustments and quality of life. We are unaware of any relevant systematic reviews. Assess whether psychological interventions for CF provide significant psychosocial and physical benefits in addition to standard care. Trials were identified from two Cochrane trial registers (CF and Genetic Disorders Group; Depression, Anxiety and Neurosis Group), Ovid MEDLINE and PsychINFO; unpublished trials were located through professional networks and Listserves. Most recent search: September 2007. Randomised controlled trials of a broad range of psychological interventions in children and adults with CF and their immediate family. Two authors independently selected relevant trials and assessed their methodological quality. The review includes 13 studies (five new at this update) representing data from 529 participants. Studies mainly assessed behavioural and educational interventions:1. gene pre-test education counselling for relatives of those with CF;2. biofeedback, massage and music therapy to assist physiotherapy;3. behavioural and educational interventions to improve dietary intake and airway clearance;4. self-administration of medication and education to promote independence, knowledge and quality of life; and5. systemic interventions promoting psychosocial functioning.A substantial proportion of outcomes were educational or behavioural relating to issues of adherence, change in physical status or other specific treatment concerns during the chronic phase of the disease. Some evidence was found for relative's acceptance of a genetic test for carrier status when using home-based rather than clinic-based information leaflets and testing. There is some evidence that behavioural interventions improve emotional outcomes in people with CF and their carers, and that

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

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

Science.gov (United States)

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.

Effects of a Group-Mediated Exercise and Dietary Intervention in the Treatment of Prostate Cancer Patients Undergoing Androgen Deprivation Therapy: Results From the IDEA-P Trial.

Science.gov (United States)

Focht, Brian C; Lucas, Alexander R; Grainger, Elizabeth; Simpson, Christina; Fairman, Ciaran M; Thomas-Ahner, Jennifer M; Buell, Jackie; Monk, J Paul; Mortazavi, Amir; Clinton, Steven K

2018-04-19

Although androgen-deprivation therapy (ADT) is the foundation of treatment for prostate cancer, the physiological impacts of ADT result in functional decline and enhanced risk of chronic disease and metabolic syndrome. The Individualized Diet and Exercise Adherence Pilot Trial (IDEA-P) is a single-blind, randomized, pilot trial comparing the effects of a group-mediated, cognitive-behavioral (GMCB) exercise and dietary intervention (EX+D) with those of a standard-of-care (SC) control during the treatment of prostate cancer patients undergoing ADT. A total of 32 prostate cancer patients (M age = 66.28, SD = 7.79) undergoing ADT were randomly assigned to the 12-week EX+D intervention (n = 16) or control (n = 16). The primary outcome in IDEA-P was change in mobility performance with secondary outcomes including body composition and muscular strength. Blinded assessment of outcomes were obtained at baseline and at 2- and 3-month follow-ups. Favorable adherence and retention rates were observed, and no serious intervention-related adverse events were documented. Intent-to-treat ANCOVA controlling for baseline value and ADT duration demonstrated that EX+D resulted in significantly greater improvements in mobility performance (p < .02), muscular strength (p < .01), body fat percentage (p < .05), and fat mass (p < .03) at 3-month follow-up, relative to control. Findings from the IDEA-P trial suggest that a GMCB-based EX+D intervention resulted in significant, clinically meaningful improvements in mobility performance, muscular strength, and body composition, relative to controls. Collectively, these results suggest that the EX+D was a safe and well-tolerated intervention for prostate cancer patients on ADT. The utility of implementing this approach in the treatment of prostate cancer patients on ADT should be evaluated in future large-scale efficacy trials. NCT02050906.

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

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

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Hare David L

2011-02-01

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

Electronic medication monitoring-informed counseling to improve adherence to combination anti-retroviral therapy and virologic treatment outcomes: a meta-analysis.

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Langebeek, Nienke; Nieuwkerk, Pythia

2015-01-01

Adherence to combination anti-retroviral therapy for HIV infection is a primary determinant of treatment success, but is often suboptimal. Previous studies have suggested that electronic medication monitoring-informed counseling is among the most effective adherence intervention components. Our objective was to review available evidence about the effectiveness of monitoring-informed counseling and to aggregate findings into quantitative estimates of the effect of such intervention on medication adherence and virologic treatment outcomes. We searched PubMed for papers reporting on randomized controlled trials comparing intervention groups receiving monitoring-informed counseling as one of the intervention components versus control groups not receiving such counseling 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 (CI). A total of 13 studies were included. Adherence was significantly higher in intervention groups than in control groups (SMD 0.51, 95% CI 0.31-0.71). Patients in intervention groups were significantly more likely to have undetectable HIV RNA concentrations than patients in control groups (OR 1.35, 95% CI 1.12-1.63). However, in studies in which monitoring-informed counseling was the only intervention component, the difference in adherence and virologic response between intervention and control groups was not statistically significant. Electronic monitoring-informed counseling improved adherence and virologic response compared with control groups not receiving such counseling in studies in which it was one out of multiple intervention components, but not in studies where it was the only intervention component.

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

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

2015-10-26

To investigate the feasibility of recruitment, adherence and likely effectiveness of an e-learning intervention for managers to improve employees' well-being and reduce sickness absence. The GEM Study (guided e-learning for managers) was a mixed methods pilot cluster randomised trial. Employees were recruited from four mental health services prior to randomising three services to the intervention and one to no-intervention control. Intervention managers received a facilitated e-learning programme on work-related stress. Main outcomes were Warwick Edinburgh Mental Wellbeing Scale (WEMWBS), 12-item GHQ and sickness absence employees, and additional observational data collected. 424 of 649 (65%) employees approached consented, of whom 350 provided WEMWBS at baseline and 284 at follow-up; 41 managers out of 49 were recruited from the three intervention clusters and 21 adhered to the intervention. WEMWBS scores fell from 50.4-49.0 in the control (n=59) and 51.0-49.9 in the intervention (n=225), giving an intervention effect of 0.5 (95% CI -3.2 to 4.2). 120/225 intervention employees had a manager who was adherent to the intervention. HR data on sickness absence (n=393) showed no evidence of effect. There were no effects on GHQ score or work characteristics. Online quiz knowledge scores increased across the study in adherent managers. Qualitative data provided a rich picture of the context within which the intervention took place and managers' and employees' experiences of it. A small benefit from the intervention on well-being was explained by the mixed methods approach, implicating a low intervention uptake by managers and suggesting that education alone may be insufficient. A full trial of the guided e-learning intervention and economic evaluation is feasible. Future research should include more active encouragement of manager motivation, reflection and behaviour change. ISRCTN58661009. Published by the BMJ Publishing Group Limited. For permission to use (where not

The Usability of Diabetes MAP: A Web-delivered Intervention for Improving Medication Adherence.

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Nelson, Lyndsay A; Bethune, Magaela C; Lagotte, Andrea E; Osborn, Chandra Y

2016-05-12

Web-delivered interventions are a feasible approach to health promotion. However, if a website is poorly designed, difficult to navigate, and has technical bugs, it will not be used as intended. Usability testing prior to evaluating a website's benefits can identify barriers to user engagement and maximize future use. We developed a Web-delivered intervention called Diabetes Medication Adherence Promotion (Diabetes MAP) and used a mixed-methods approach to test its usability prior to evaluating its efficacy on medication adherence and glycemic control in a randomized controlled trial. We recruited English-speaking adults with type 2 diabetes mellitus (T2DM) from an academic medical center who were prescribed diabetes medications. A trained research assistant administered a baseline survey, collected medical record information, and instructed participants on how to access Diabetes MAP. Participants were asked to use the site independently for 2 weeks and to provide survey and/or focus group feedback on their experience. We analyzed survey data descriptively and qualitative data thematically to identify participants' favorable and unfavorable experiences, characterize usability concerns, and solicit recommendations for improving Diabetes MAP. Enrolled participants (N=32) were an average of 51.7 ± 11.8 years old, 66% (21/32) female, 60% (19/32) non-Hispanic White, 88% (28/32) had more than 12 years of education, half had household incomes over $50,000, and 78% (25/32) were privately insured. Average duration of diagnosed diabetes was 7.8 ± 6.3 years, average A1c was 7.4 ± 2.0, and 38% (12/32) were prescribed insulin. Of enrolled participants, 91% (29/32) provided survey and/or focus group feedback about Diabetes MAP. On the survey, participants agreed website information was clear and easy to understand, but in focus groups they reported navigational challenges and difficulty overcoming user errors (eg, entering data in an unspecified format). Participants also

Patterns of Fitbit Use and Activity Levels Throughout a Physical Activity Intervention: Exploratory Analysis from a Randomized Controlled Trial.

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Hartman, Sheri J; Nelson, Sandahl H; Weiner, Lauren S

2018-02-05

There has been a rapid increase in the use of technology-based activity trackers to promote behavior change. However, little is known about how individuals use these trackers on a day-to-day basis or how tracker use relates to increasing physical activity. The aims were to use minute level data collected from a Fitbit tracker throughout a physical activity intervention to examine patterns of Fitbit use and activity and their relationships with success in the intervention based on ActiGraph-measured moderate to vigorous physical activity (MVPA). Participants included 42 female breast cancer survivors randomized to the physical activity intervention arm of a 12-week randomized controlled trial. The Fitbit One was worn daily throughout the 12-week intervention. ActiGraph GT3X+ accelerometer was worn for 7 days at baseline (prerandomization) and end of intervention (week 12). Self-reported frequency of looking at activity data on the Fitbit tracker and app or website was collected at week 12. Adherence to wearing the Fitbit was high and stable, with a mean of 88.13% of valid days over 12 weeks (SD 14.49%). Greater adherence to wearing the Fitbit was associated with greater increases in ActiGraph-measured MVPA (b interaction =0.35, PHartman, Sandahl H Nelson, Lauren S Weiner. Originally published in JMIR Mhealth and Uhealth (http://mhealth.jmir.org), 05.02.2018.

Design, Intervention Fidelity, and Behavioral Outcomes of a School-Based Water, Sanitation, and Hygiene Cluster-Randomized Trial in Laos

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Anna N. Chard

2018-03-01

Full Text Available Evidence of the impact of water, sanitation, and hygiene (WASH in schools (WinS interventions on pupil absence and health is mixed. Few WinS evaluations rigorously report on output and outcome measures that allow for comparisons of effectiveness between interventions to be made, or for an understanding of why programs succeed. The Water, Sanitation, and Hygiene for Health and Education in Laotian Primary Schools (WASH HELPS study was a randomized controlled trial designed to measure the impact of the United Nations Children’s Fund (UNICEF Laos WinS project on child health and education. We also measured the sustainability of intervention outputs and outcomes, and analyzed the effectiveness of group hygiene activities on behavior change and habit formation. Here, we present the design and intermediate results from this study. We found the WinS project improved the WASH environment in intervention schools; 87.8% of schools received the intervention per design. School-level adherence to outputs was lower; on average, schools met 61.4% of adherence-related criteria. The WinS project produced positive changes in pupils’ school WASH behaviors, specifically increasing toilet use and daily group handwashing. Daily group hygiene activities are effective strategies to improve school WASH behaviors, but a complementary strategy needs to be concurrently promoted for effective and sustained individual handwashing practice at critical times.

Empirical Validation of the Information–Motivation–Behavioral Skills Model of Diabetes Medication Adherence: A Framework for Intervention

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Mayberry, Lindsay S.; Osborn, Chandra Y.

2014-01-01

OBJECTIVE Suboptimal adherence to diabetes medications is prevalent and associated with unfavorable health outcomes, but it remains unclear what intervention content is necessary to effectively promote medication adherence in diabetes. In other disease contexts, the Information–Motivation–Behavioral skills (IMB) model has effectively explained and promoted medication adherence and thus may have utility in explaining and promoting adherence to diabetes medications. We tested the IMB model’s hypotheses in a sample of adults with type 2 diabetes. RESEARCH DESIGN AND METHODS Participants (N = 314) completed an interviewer-administered survey and A1C test. Structural equation models tested the effects of diabetes medication adherence-related information, motivation, and behavioral skills on medication adherence and the effect of medication adherence on A1C. RESULTS The IMB elements explained 41% of the variance in adherence, and adherence explained 9% of the variance in A1C. As predicted, behavioral skills had a direct effect on adherence (β = 0.59; P motivation (indirect effect 0.12 [0.05–0.20]) on adherence. Medication adherence significantly predicted glycemic control (β = −0.30; P motivation, and behavioral skills and assessing the degree to which change in these determinants leads to changes in medication adherence behavior. PMID:24598245

Empirical validation of the information-motivation-behavioral skills model of diabetes medication adherence: a framework for intervention.

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Mayberry, Lindsay S; Osborn, Chandra Y

2014-01-01

Suboptimal adherence to diabetes medications is prevalent and associated with unfavorable health outcomes, but it remains unclear what intervention content is necessary to effectively promote medication adherence in diabetes. In other disease contexts, the Information-Motivation-Behavioral skills (IMB) model has effectively explained and promoted medication adherence and thus may have utility in explaining and promoting adherence to diabetes medications. We tested the IMB model's hypotheses in a sample of adults with type 2 diabetes. Participants (N = 314) completed an interviewer-administered survey and A1C test. Structural equation models tested the effects of diabetes medication adherence-related information, motivation, and behavioral skills on medication adherence and the effect of medication adherence on A1C. The IMB elements explained 41% of the variance in adherence, and adherence explained 9% of the variance in A1C. As predicted, behavioral skills had a direct effect on adherence (β = 0.59; P information (indirect effect 0.08 [0.01-0.15]) and motivation (indirect effect 0.12 [0.05-0.20]) on adherence. Medication adherence significantly predicted glycemic control (β = -0.30; P information, motivation, and behavioral skills and assessing the degree to which change in these determinants leads to changes in medication adherence behavior.

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

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Snowden, Mark; Steinman, Lesley; Mochan, Kara; Grodstein, Francine; Prohaska, Thomas R; Thurman, David J; Brown, David R; Laditka, James N; Soares, Jesus; Zweiback, Damita J; Little, Deborah; Anderson, Lynda A

2011-04-01

There is evidence from observational studies that increasing physical activity may reduce the risk of cognitive decline in older adults. Exercise intervention trials have found conflicting results. A systematic review of physical activity and exercise intervention trials on cognition in older adults was conducted. Six scientific databases and reference lists of previous reviews were searched. Thirty studies were eligible for inclusion. Articles were grouped into intervention-outcome pairings. Interventions were grouped as cardiorespiratory, strength, and multicomponent exercises. Cognitive outcomes were general cognition, executive function, memory, reaction time, attention, cognitive processing, visuospatial, and language. An eight-member multidisciplinary panel rated the quality and effectiveness of each pairing. Although there were some positive studies, the panel did not find sufficient evidence that physical activity or exercise improved cognition in older adults. Future research should report exercise adherence, use longer study durations, and determine the clinical relevance of measures used. © 2011, Copyright the Authors. Journal compilation © 2011, The American Geriatrics Society.

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.

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

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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

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

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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.

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.

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.

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.

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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

Changing adherence-related beliefs about ICS maintenance treatment for asthma: feasibility study of an intervention delivered by asthma nurse specialists.

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Chapman, Sarah C E; Barnes, Neil; Barnes, Mari; Wilkinson, Andrea; Hartley, John; Piddock, Cher; Weinman, John; Horne, Rob

2015-06-05

The Necessity-Concerns Framework (NCF) posits that non-adherence to inhaled corticosteroids (ICS) in asthma is influenced by doubts about the necessity for ICS and concerns about their potential adverse effects. This feasibility study examined whether these beliefs could be changed by briefing asthma nurse specialists on ways of addressing necessity beliefs and concerns within consultations. Pre-post intervention study. Secondary care. Patients with a diagnosis of moderate to severe asthma who were prescribed daily ICS were recruited to either a hospital care group (n=79; 71.0% female) or intervention group (n=57; 66.7% female). Asthma nurse specialists attended a 1.5-day NCF briefing. Beliefs about ICS (primary outcome) and self-reported adherence were measured preconsultation and 1 month postconsultation. Participants also rated their satisfaction with their consultations immediately after the consultation. Consultation recordings were coded to assess intervention delivery. After the NCF briefing, nurse specialists elicited and addressed beliefs about medicine more frequently. The frequency of using the NCF remained low, for example, open questions eliciting adherence were used in 0/59 hospital care versus 14/49 (28.6%) intervention consultations. Doubts about personal necessity for, and concerns about, ICS were reduced at 1 month postbriefing (pchanged nurse consultations, but not sufficiently enough to fully address non-adherence or adherence-related ICS beliefs (necessity and concerns). More effective techniques are needed to support nurse specialists and other practitioners to apply the intervention in hospital asthma review consultations. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://group.bmj.com/group/rights-licensing/permissions.

A Motivational Interviewing Intervention by Pharmacy Students to Improve Medication Adherence.

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Abughosh, Susan; Wang, Xin; Serna, Omar; Esse, Tara; Mann, Amanda; Masilamani, Santhi; Holstad, Marcia McDonnell; Essien, Ekere James; Fleming, Marc

2017-05-01

Diabetes mellitus (DM) patients with comorbid hypertension (HTN) are at a higher risk of developing microvascular and macrovascular DM complications. Through guideline-driven recommendations, angiotensin-converting enzyme inhibitors (ACEIs) and angiotensin II receptor blockers (ARBs) are highly recommended for these patients. Unfortunately, medication adherence to these products, though crucial to achieving therapeutic benefit, is frequently suboptimal. Motivational interviewing (MI) is a patient-centered collaborative communication style that is used to strengthen internal motivation for change that may prove effective in enhancing adherence. To examine the effect of an MI telephone intervention conducted by pharmacy students in improving adherence to ACEIs/ARBs among Medicare Advantage Plan (MAP) patients with both DM and HTN. A prospective study was conducted among patients enrolled in a Texas MAP. Medical claims data were used to identify patients with DM and HTN, and pharmacy claims were observed to recognize those who filled either an ACEI or an ARB during June 2014. Patients with a 6-month proportion of days covered (PDC) sustainability of the intervention effect for longer time periods and its influence on associated clinical outcomes. This project was supported by the Pharmaceutical Research and Manufacturers of America Foundation (PhRMA). The content is solely the responsibility of the authors and does not necessarily represent the official views of PhRMA. The funding agency was not involved in research design, analysis, or reporting results. Funding was obtained by Abughosh. Holstad provided a consultation regarding the MI guide and provided the MI training. Study concept and design were contributed by Abughosh and Fleming, along with Serna, Esse, and Holstad. Serna, Esse, Mann, Holstad, and Masilamani collected the data, and data interpretation was performed by Abughosh, Wong, and Esse. The manuscript was written by Abughosh, Wong, and Esse and revised

The relationship between persuasive technology principles, adherence and effect of web-Based interventions for mental health: A meta-analysis.

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Wildeboer, Gina; Kelders, Saskia M; van Gemert-Pijnen, Julia E W C

2016-12-01

Research has shown that web-based interventions concerning mental health can be effective, although there is a broad range in effect sizes. Why some interventions are more effective than others is not clear. Persuasive technology is one of the aspects which has a positive influence on changing attitude and/or behavior, and can contribute to better outcomes. According to the Persuasive Systems Design Model there are various principles that can be deployed. It is unknown whether the number and combinations of principles used in a web-based intervention affect the effectiveness. Another issue in web-based interventions is adherence. Little is known about the relationship of adherence on the effectiveness of web-based interventions. This study examines whether there is a relationship between the number and combinations of persuasive technology principles used in web-based interventions and the effectiveness. Also the influence of adherence on effectiveness of web-based interventions is investigated. This study elaborates on the systematic review by [37] and therefore the articles were derived from that study. Only web-based interventions were included that were intended to be used on more than one occasion and studies were excluded when no information on adherence was provided. 48 interventions targeted at mental health were selected for the current study. A within-group (WG) and between-group (BG) meta-analysis were performed and subsequently subgroup analyses regarding the relationship between the number and combinations of persuasive technology principles and effectiveness. The influence of adherence on the effectiveness was examined through a meta-regression analysis. For the WG meta-analysis 40 treatment groups were included. The BG meta-analysis included 19 studies. The mean pooled effect size in the WG meta-analysis was large and significant (Hedges' g=0.94), while for the BG meta-analysis this was moderate to large and significant (Hedges' g=0.78) in favor of

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

NARCIS (Netherlands)

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

2015-01-01

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

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.

Inadequate description of educational interventions in ongoing randomized controlled trials

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Pino Cécile

2012-05-01

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

Frailty Intervention Trial (FIT

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Lockwood Keri

2008-10-01

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

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

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Thelwall, Mike; Dawes, Phil

2011-01-01

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

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.

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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

Training mental health professionals in suicide practice guideline adherence : Cost-effectiveness analysis alongside a randomized controlled trial

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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

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.

How completely are physiotherapy interventions described in reports of randomised trials?

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Yamato, Tiê P; Maher, Chris G; Saragiotto, Bruno T; Hoffmann, Tammy C; Moseley, Anne M

2016-06-01

Incomplete descriptions of interventions are a common problem in reports of randomised controlled trials. To date no study has evaluated the completeness of the descriptions of physiotherapy interventions. To evaluate the completeness of the descriptions of physiotherapy interventions in a random sample of reports of randomised controlled trials (RCTs). A random sample of 200 reports of RCTs from the PEDro database. We included full text papers, written in English, and reporting trials with two arms. We included trials evaluating any type of physiotherapy interventions and subdisciplines. The methodological quality was evaluated using the PEDro scale and completeness of intervention description using the Template for Intervention Description and Replication (TIDieR) checklist. The proportion and 95% confidence interval were calculated for intervention and control groups, and used to present the relationship between completeness and methodological quality, and subdisciplines. Completeness of intervention reporting in physiotherapy RCTs was poor. For intervention groups, 46 (23%) trials did not describe at least half of the items. Reporting was worse for control groups, 149 (75%) trials described less than half of the items. There was no clear difference in the completeness across subdisciplines or methodological quality. Our sample were restricted to trials published in English in 2013. Descriptions of interventions in physiotherapy RCTs are typically incomplete. Authors and journals should aim for more complete descriptions of interventions in physiotherapy trials. Copyright © 2016 Chartered Society of Physiotherapy. Published by Elsevier Ltd. All rights reserved.

Randomized Controlled Trial Comparing Exercise to Health Education for Stimulant Use Disorder: Results From the CTN-0037 STimulant Reduction Intervention Using Dosed Exercise (STRIDE) Study.

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Trivedi, Madhukar H; Greer, Tracy L; Rethorst, Chad D; Carmody, Thomas; Grannemann, Bruce D; Walker, Robrina; Warden, Diane; Shores-Wilson, Kathy; Stoutenberg, Mark; Oden, Neal; Silverstein, Meredith; Hodgkins, Candace; Love, Lee; Seamans, Cindy; Stotts, Angela; Causey, Trey; Szucs-Reed, Regina P; Rinaldi, Paul; Myrick, Hugh; Straus, Michele; Liu, David; Lindblad, Robert; Church, Timothy; Blair, Steven N; Nunes, Edward V

To evaluate exercise as a treatment for stimulant use disorders. The STimulant Reduction Intervention using Dosed Exercise (STRIDE) study was a randomized clinical trial conducted in 9 residential addiction treatment programs across the United States from July 2010 to February 2013. Of 497 adults referred to the study, 302 met all eligibility criteria, including DSM-IV criteria for stimulant abuse and/or dependence, and were randomized to either a dosed exercise intervention (Exercise) or a health education intervention (Health Education) control, both augmenting treatment as usual and conducted thrice weekly for 12 weeks. The primary outcome of percent stimulant abstinent days during study weeks 4 to 12 was estimated using a novel algorithm adjustment incorporating self-reported Timeline Followback (TLFB) stimulant use and urine drug screen (UDS) data. Mean percent of abstinent days based on TLFB was 90.8% (SD = 16.4%) for Exercise and 91.6% (SD = 14.7%) for Health Education participants. Percent of abstinent days using the eliminate contradiction (ELCON) algorithm was 75.6% (SD = 27.4%) for Exercise and 77.3% (SD = 25.1%) for Health Education. The primary intent-to-treat analysis, using a mixed model controlling for site and the ELCON algorithm, produced no treatment effect (P = .60). In post hoc analyses controlling for treatment adherence and baseline stimulant use, Exercise participants had a 4.8% higher abstinence rate (78.7%) compared to Health Education participants (73.9%) (P = .03, number needed to treat = 7.2). The primary analysis indicated no significant difference between exercise and health education. Adjustment for intervention adherence showed modestly but significantly higher percent of abstinent days in the exercise group, suggesting that exercise may improve outcomes for stimulant users who have better adherence to an exercise dose. ClinicalTrials.gov identifier: NCT01141608. © Copyright 2017 Physicians Postgraduate Press, Inc.

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

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Michelle T Hecker

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

The role of a behavioural medicine intervention in physiotherapy for the effects of rehabilitation outcomes in exercise-based cardiac rehabilitation (ECRA) - the study protocol of a randomised, controlled trial.

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Borg, Sabina; Öberg, Birgitta; Nilsson, Lennart; Söderlund, Anne; Bäck, Maria

2017-05-25

To help patients with coronary artery disease (CAD) benefit from the positive health effects attained by exercise-based cardiac rehabilitation (CR), adherence to these programmes according to international guidelines is important. Strategies to increase adherence to exercise-based CR are mainly an unexplored area. The objective of this study is to investigate the effects of a behavioural medicine intervention in physiotherapy, containing goal-setting, self-monitoring and feedback, with the aim of improving rehabilitation outcomes for exercise-based CR, compared with usual care. This is a randomised, controlled trial. A total of 160 patients with CAD will be included consecutively at the Coronary Care Unit at a university hospital in Sweden. Patients are randomised 1:1 using sealed envelopes to usual care or a behavioural medicine intervention in physiotherapy, in addition to usual care for 4 months. Outcome assessment at baseline, 4 and 12 months includes submaximal aerobic capacity (primary outcome), exercise adherence, muscle endurance, level of physical activity, biomarkers, anxiety and depression, health-related quality of life, patient enablement and self-efficacy (secondary outcomes). This is the first study to evaluate the role of an integrated behavioural medicine intervention in exercise-based CR in the effects of rehabilitation outcomes. The results of this study will provide valuable information about the effect of these interventions in exercise-based CR and it has the potential to inform and assist in further treatment in secondary prevention for patients with CAD. The study include all items from the World Health Organization Trial Registration Data Set. NCT02895451, 2016-08-16, retrospectively registered.

Evaluating the PRASE patient safety intervention - a multi-centre, cluster trial with a qualitative process evaluation: study protocol for a randomised controlled trial.

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Sheard, Laura; O'Hara, Jane; Armitage, Gerry; Wright, John; Cocks, Kim; McEachan, Rosemary; Watt, Ian; Lawton, Rebecca

2014-10-29

of key data about intervention wards. Intervention fidelity will be assessed primarily by adherence to the intervention via scoring based on an adapted framework. This study will be one of the largest patient safety trials ever conducted, involving 32 hospital wards. The results will further understanding about how patient feedback on the safety of care can be used to improve safety at a ward level. Incorporating the 'patient voice' is critical if patient feedback is to be situated as an integral part of patient safety improvements. ISRCTN07689702, 16 Aug 2013.

Helping Older Adults Sustain Their Physical Therapy Gains: A Theory-Based Intervention to Promote Adherence to Home Exercise Following Rehabilitation.

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Gallagher, Kristel M

2016-01-01

The benefits of exercise gained by older adults during physical therapy are often not maintained once the program is over. This lack of sustained benefits is thought to be partially the result of poor adherence to the prescribed home exercise program to be continued once therapy is completed. Most of what is known about older adults' adherence to physical therapy and home exercise comes from research seeking to identify and understand predictors of adherence, rather than trying to enhance adherence explicitly. The purpose of this study was to test a theoretically grounded approach to promoting adherence to home exercise programs in older adults. Sixty older adults (M age = 69.3 (6.87) years) in a program of physical therapy received 1 of 2 print messages and magnets promoting adherence to home exercise. The content of the messages was informed by the goal-specific tenets of socioemotional selectivity theory-one message described the emotional and meaningful benefits of home exercise, such as time with loved ones and independence, and one message described facts and information about physiological benefits, such as balance and strength. Adherence to home exercise was measured 2 weeks after participants were discharged from physical therapy by calculating the percentage of the prescribed exercises participants reported completing at home. An analysis of covariance indicated that there was no statistically significant difference in adherence rates between participants receiving either message. However, a 2×2 analysis of covariance did reveal a significant interaction between the type of message participants received and the time at which they received that message. Post hoc analyses separately examined the rates of adherence in participants who received the intervention message with time remaining in their therapy program and participants who received the intervention message on the day of discharge. In the subset of participants who received their intervention

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.

Telephone interventions for adherence to colpocytological examination.

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

2017-02-06

to test the effects of behavioral and educational intervention by telephone on adherence of women with inappropriate periodicity to colpocytological examination. quasi-experimental study with a sample of 524 women, selected with the following inclusion criteria: be aged between 25 and 64 years, have initiated sexual activity, have inappropriate periodicity of examination and have mobile or landline phone. The women were divided into two groups for application of behavioral and educational intervention by telephone. It was used an intervention script according to the principles of Motivational Interviewing. on comparing the results before and after the behavioral and educational interventions, it was found that there was a statistically significant change (p = 0.0283) with increase of knowledge of women who participated in the educational intervention. There was no change in the attitude of women of any of the groups and there was an increase of adherence to colpocytological examination in both groups (p grupos para aplicação da intervenção comportamental e educativa por telefone. Utilizou-se um roteiro de intervenção segundo os preceitos da Entrevista Motivacional. ao comparar antes e depois das intervenções comportamental e educativa constatou-se que houve uma mudança estatisticamente significativa (p = 0,0283) no aumento do conhecimento das mulheres que participaram da intervenção educativa; não houve mudança comprovada na atitude das mulheres de nenhum dos grupos e houve um aumento da adesão ao exame colpocitológico nos dois grupos (p grupo comportamental (66,8%). as intervenções comportamentais e educativas por telefone foram eficazes na adesão das mulheres ao exame colpocitológico, representando estratégias importantes para educação permanente em saúde, promovendo a atenção para a prevenção do câncer cérvico-uterino. comprobar los efectos de intervención comportamental y educativa por teléfono en la adhesión de las mujeres, con

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.

Adherence challenges encountered in an intervention programme to combat chronic non-communicable diseases in an urban black community, Cape Town

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Nasheetah Solomons

2017-10-01

Full Text Available Background: Chronic non-communicable diseases (CNCD have become the greatest contributor to the mortality rate worldwide. Despite attempts by Governments and various non-governmental organisations to prevent and control the epidemic with various intervention strategies, the number of people suffering from CNCD is increasing at an alarming rate in South Africa and worldwide. Objectives: Study's objectives were to explore perceived challenges with implementation of, and adherence to health messages disseminated as part of a CNCD intervention programme; to gain an understanding of participants' expectations of CNCD intervention programmes;, and to explore the acceptability and preference of health message dissemination methods. In addition, participants' awareness of, and willingness to participate inCNCDs intervention programmes in their community was explored. Methods: Participants were recruited from the existing urban Prospective Urban Rural Epidemiology study site in Langa, Cape Town. Focus group discussions were conducted with 47participants using a question guide. Summative content analysis was used to analyse the data. Results: Four themes emerged from the data analysis: practical aspects of implementation and adherence to intervention programmes; participants' expectations of intervention programmes; aspects influencing participants' acceptance of interventions; and their preferences for health message dissemination. The results of this study will be used to inform CNCDs intervention programmes. Conclusions: Our findings revealed that although participants found current methods of health message dissemination in CNCDs intervention acceptable, they faced real challenges with implementing and adhering to CNCDs to these messages.

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 Mobile Gaming Intervention to Increase Adherence to Antiretroviral Treatment for Youth Living With HIV: Development Guided by the Information, Motivation, and Behavioral Skills Model.

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Whiteley, Laura; Brown, Larry; Lally, Michelle; Heck, Nicholas; van den Berg, Jacob J

2018-04-23

; and increasing personal relevance of HIV care. Behavioral skills themes centered on self-efficacy and strategies for medical adherence and self-care. On the client service questionnaire, 10 out of the 11 participants indicated they were "satisfied with the game activities," and 9 out of 11 "would recommend it to a friend." On the session evaluation form, 9 out of 11 agreed that they "learned a lot from the game." We utilized youth feedback, social learning theory (information-motivation-behavioral skills), and agile software development to create a multilevel, immersive, action-oriented iPhone gaming intervention to measure and improve treatment adherence for adolescents and young adults living with HIV. There is a dearth of gaming interventions for this population, and this study is a significant step in working toward the development and testing of an iPhone gaming app intervention to promote adherence to antiretroviral treatment. ClinicalTrials.gov NCT01887210; http://clinicaltrials.gov/ct2/show/NCT01887210 (Archived by WebCite at http://www.webcitation.org/6xHMW0NI1). ©Laura Whiteley, Larry Brown, Michelle Lally, Nicholas Heck, Jacob J van den Berg. Originally published in JMIR Mhealth and Uhealth (http://mhealth.jmir.org), 23.04.2018.

Effectiveness of a healthy lifestyle intervention for low back pain and osteoarthritis of the knee: protocol and statistical analysis plan for two randomised controlled trials

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Kate M. O’Brien

Full Text Available ABSTRACT Background These trials are the first randomised controlled trials of telephone-based weight management and healthy lifestyle interventions for low back pain and knee osteoarthritis. This article describes the protocol and statistical analysis plan. Method These trials are parallel randomised controlled trials that investigate and compare the effect of a telephone-based weight management and healthy lifestyle intervention for improving pain intensity in overweight or obese patients with low back pain or knee osteoarthritis. The analysis plan was finalised prior to initiation of analyses. All data collected as part of the trial were reviewed, without stratification by group, and classified by baseline characteristics, process of care and trial outcomes. Trial outcomes were classified as primary and secondary outcomes. Appropriate descriptive statistics and statistical testing of between-group differences, where relevant, have been planned and described. Conclusions A protocol for standard analyses was developed for the results of two randomised controlled trials. This protocol describes the data, and the pre-determined statistical tests of relevant outcome measures. The plan demonstrates transparent and verifiable use of the data collected. This a priori protocol will be followed to ensure rigorous standards of data analysis are strictly adhered to.

Effectiveness of a healthy lifestyle intervention for low back pain and osteoarthritis of the knee: protocol and statistical analysis plan for two randomised controlled trials

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O’Brien, Kate M.; Williams, Amanda; Wiggers, John; Wolfenden, Luke; Yoong, Serene; Campbell, Elizabeth; Kamper, Steven J.; McAuley, James; Attia, John; Oldmeadow, Chris; Williams, Christopher M.

2016-01-01

ABSTRACT Background These trials are the first randomised controlled trials of telephone-based weight management and healthy lifestyle interventions for low back pain and knee osteoarthritis. This article describes the protocol and statistical analysis plan. Method These trials are parallel randomised controlled trials that investigate and compare the effect of a telephone-based weight management and healthy lifestyle intervention for improving pain intensity in overweight or obese patients with low back pain or knee osteoarthritis. The analysis plan was finalised prior to initiation of analyses. All data collected as part of the trial were reviewed, without stratification by group, and classified by baseline characteristics, process of care and trial outcomes. Trial outcomes were classified as primary and secondary outcomes. Appropriate descriptive statistics and statistical testing of between-group differences, where relevant, have been planned and described. Conclusions A protocol for standard analyses was developed for the results of two randomised controlled trials. This protocol describes the data, and the pre-determined statistical tests of relevant outcome measures. The plan demonstrates transparent and verifiable use of the data collected. This a priori protocol will be followed to ensure rigorous standards of data analysis are strictly adhered to. PMID:27683839

Interventions for reducing self-stigma in people with mental illnesses: a systematic review of randomized controlled trials

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Büchter, Roland Brian

2017-04-01

Full Text Available Background: Self-stigma occurs when people with mental illnesses internalize negative stereotypes and prejudices about their condition. It can reduce help-seeking behaviour and treatment adherence. The effectiveness of interventions aimed at reducing self-stigma in people with mental illness is systematically reviewed. Results are discussed in the context of a logic model of the broader social context of mental illness stigma. Methods: Medline, Embase, PsycINFO, ERIC, and CENTRAL were searched for randomized controlled trials in November 2013. Studies were assessed with the Cochrane risk of bias tool.Results: Five trials were eligible for inclusion, four of which provided data for statistical analyses. Four studies had a high risk of bias. The quality of evidence was very low for each set of interventions and outcomes. The interventions studied included various group based anti-stigma interventions and an anti-stigma booklet. The intensity and fidelity of most interventions was high. Two studies were considered to be sufficiently homogeneous to be pooled for the outcome self-stigma. The meta-analysis did not find a statistically significant effect at 3 months: –0.26 [–0.64, 0.12], I=0%, n=108. None of the individual studies found sustainable effects on other outcomes, including recovery, help-seeking behaviour and self-stigma.Conclusions: The effectiveness of interventions against self-stigma is uncertain. Previous studies lacked statistical power, used questionable outcome measures and had a high risk of bias. Future studies should be based on robust methods and consider practical implications regarding intervention development (relevance, implementability, and placement in routine services.

Interventions for reducing self-stigma in people with mental illnesses: a systematic review of randomized controlled trials.

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Büchter, Roland Brian; Messer, Melanie

2017-01-01

Background: Self-stigma occurs when people with mental illnesses internalize negative stereotypes and prejudices about their condition. It can reduce help-seeking behaviour and treatment adherence. The effectiveness of interventions aimed at reducing self-stigma in people with mental illness is systematically reviewed. Results are discussed in the context of a logic model of the broader social context of mental illness stigma. Methods: Medline, Embase, PsycINFO, ERIC, and CENTRAL were searched for randomized controlled trials in November 2013. Studies were assessed with the Cochrane risk of bias tool. Results: Five trials were eligible for inclusion, four of which provided data for statistical analyses. Four studies had a high risk of bias. The quality of evidence was very low for each set of interventions and outcomes. The interventions studied included various group based anti-stigma interventions and an anti-stigma booklet. The intensity and fidelity of most interventions was high. Two studies were considered to be sufficiently homogeneous to be pooled for the outcome self-stigma. The meta-analysis did not find a statistically significant effect (SMD [95% CI] at 3 months: -0.26 [-0.64, 0.12], I 2 =0%, n=108). None of the individual studies found sustainable effects on other outcomes, including recovery, help-seeking behaviour and self-stigma. Conclusions: The effectiveness of interventions against self-stigma is uncertain. Previous studies lacked statistical power, used questionable outcome measures and had a high risk of bias. Future studies should be based on robust methods and consider practical implications regarding intervention development (relevance, implementability, and placement in routine services).

Prediabetes in pregnancy, can early intervention improve outcomes? A feasibility study for a parallel randomised clinical trial.

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Hughes, Ruth C E; Rowan, Janet; Williman, Jonathan

2018-03-03

Measurement of glycated haemoglobin (HbA1c) in early pregnancy is routine in New Zealand to identify women with diabetes and prediabetes. However, the benefit of early intervention in women with prediabetes is inconclusive. Our aim was to test the feasibility of a two-arm parallel randomised controlled trial of standard care versus early intervention in pregnancies complicated by prediabetes. Two tertiary referral centres in New Zealand. Women measured at booking, without pre-existing diabetes. Randomisation was done by remote web-based allocation into one of two groups. Women in the early intervention group attended an antenatal diabetes clinic, commenced daily home blood glucose monitoring, and medication was prescribed if lifestyle measures failed to maintain target blood glucose levels. Controls received lifestyle education, continued standard care with their midwife and/or obstetrician, and were asked to perform a 75 g oral glucose tolerance test at 24 weeks' gestation with a referral to clinic if this test was positive. Both groups received lifestyle questionnaires at recruitment and in late pregnancy. Recruitment rate, adherence to protocol and validation of potential primary outcomes. Recruitment rates were lower than expected, especially in Māori and Pacific women. Non-adherence to allocated treatment protocol was significant, 42% (95% CI 24% to 61%) in the early intervention group and 30% (95% CI 16% to 51%) in controls. Caesarean section and pre-eclampsia were signalled as potential primary outcomes, due to both the high observed incidence in the control group and ease of measurement. For a future definitive trial, extending the gestation of eligibility and stepped-wedge cluster randomisation may overcome the identified feasibility issues. Consistent with published observational data, pre-eclampsia and emergency caesarean section could be included as primary outcome measures, both of which have a significant impact on maternal and neonatal morbidity and

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.

Medicine non-adherence in kidney transplantation.

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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.

Community-led trials: Intervention co-design in a cluster randomised controlled trial.

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Andersson, Neil

2017-05-30

In conventional randomised controlled trials (RCTs), researchers design the interventions. In the Camino Verde trial, each intervention community designed its own programmes to prevent dengue. Instead of fixed actions or menus of activities to choose from, the trial randomised clusters to a participatory research protocol that began with sharing and discussing evidence from a local survey, going on to local authorship of the action plan for vector control.Adding equitable stakeholder engagement to RCT infrastructure anchors the research culturally, making it more meaningful to stakeholders. Replicability in other conditions is straightforward, since all intervention clusters used the same engagement protocol to discuss and to mobilize for dengue prevention. The ethical codes associated with RCTs play out differently in community-led pragmatic trials, where communities essentially choose what they want to do. Several discussion groups in each intervention community produced multiple plans for prevention, recognising different time lines. Some chose fast turnarounds, like elimination of breeding sites, and some chose longer term actions like garbage disposal and improving water supplies.A big part of the skill set for community-led trials is being able to stand back and simply support communities in what they want to do and how they want to do it, something that does not come naturally to many vector control programs or to RCT researchers. Unexpected negative outcomes can come from the turbulence implicit in participatory research. One example was the gender dynamic in the Mexican arm of the Camino Verde trial. Strong involvement of women in dengue control activities seems to have discouraged men in settings where activity in public spaces or outside of the home would ordinarily be considered a "male competence".Community-led trials address the tension between one-size-fits-all programme interventions and local needs. Whatever the conventional wisdom about how

Community-led trials: Intervention co-design in a cluster randomised controlled trial

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Neil Andersson

2017-05-01

Full Text Available Abstract In conventional randomised controlled trials (RCTs, researchers design the interventions. In the Camino Verde trial, each intervention community designed its own programmes to prevent dengue. Instead of fixed actions or menus of activities to choose from, the trial randomised clusters to a participatory research protocol that began with sharing and discussing evidence from a local survey, going on to local authorship of the action plan for vector control. Adding equitable stakeholder engagement to RCT infrastructure anchors the research culturally, making it more meaningful to stakeholders. Replicability in other conditions is straightforward, since all intervention clusters used the same engagement protocol to discuss and to mobilize for dengue prevention. The ethical codes associated with RCTs play out differently in community-led pragmatic trials, where communities essentially choose what they want to do. Several discussion groups in each intervention community produced multiple plans for prevention, recognising different time lines. Some chose fast turnarounds, like elimination of breeding sites, and some chose longer term actions like garbage disposal and improving water supplies. A big part of the skill set for community-led trials is being able to stand back and simply support communities in what they want to do and how they want to do it, something that does not come naturally to many vector control programs or to RCT researchers. Unexpected negative outcomes can come from the turbulence implicit in participatory research. One example was the gender dynamic in the Mexican arm of the Camino Verde trial. Strong involvement of women in dengue control activities seems to have discouraged men in settings where activity in public spaces or outside of the home would ordinarily be considered a “male competence”. Community-led trials address the tension between one-size-fits-all programme interventions and local needs. Whatever the

A holistic conceptual framework model to describe medication adherence in and guide interventions in diabetes mellitus.

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Jaam, Myriam; Awaisu, Ahmed; Mohamed Ibrahim, Mohamed Izham; Kheir, Nadir

2018-04-01

Nonadherence to medications in patients with diabetes, which results in poor treatment outcomes and increased healthcare costs, is commonly reported globally. Factors associated with medication adherence have also been widely studied. However, a clear and comprehensive, disease-specific conceptual framework model that captures all possible factors has not been established. This study aimed to develop a conceptual framework that addresses the complex network of barriers to medication adherence in patients with diabetes. Fourteen databases and grey literature sources were systematically searched for systematic reviews reporting barriers to medication adherence in patients with diabetes. A thematic approach was used to categorize all identified barriers from the reviews and to create a matrix representing the complex network and relations of the different barriers. Eighteen systematic reviews were identified and used for the development of the conceptual framework. Overall, six major themes emerged: patient-, medication-, disease-, provider-, system-, and societal-related factors. Each of these themes was further classified into different sub-categories. It was noted that most interactions were identified to be within the patient-related factors, which not only interact with other themes but also within the same theme. Patient's demographics as well as cultural beliefs were the most notable factors in terms of interactions with other categories and themes. The intricate network and interaction of factors identified between different themes and within individual themes indicate the complexity of the problem of adherence. This framework will potentially enhance the understanding of the complex relation between different barriers for medication adherence in diabetes and will facilitate design of more effective interventions. Future interventions for enhancing medication adherence should look at the overall factors and target multiple themes of barriers to improve patient

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

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

Integrating technology into complex intervention trial processes: a case study.

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Drew, Cheney J G; Poile, Vincent; Trubey, Rob; Watson, Gareth; Kelson, Mark; Townson, Julia; Rosser, Anne; Hood, Kerenza; Quinn, Lori; Busse, Monica

2016-11-17

Trials of complex interventions are associated with high costs and burdens in terms of paperwork, management, data collection, validation, and intervention fidelity assessment occurring across multiple sites. Traditional data collection methods rely on paper-based forms, where processing can be time-consuming and error rates high. Electronic source data collection can potentially address many of these inefficiencies, but has not routinely been used in complex intervention trials. Here we present the use of an on-line system for managing all aspects of data handling and for the monitoring of trial processes in a multicentre trial of a complex intervention. We custom built a web-accessible software application for the delivery of ENGAGE-HD, a multicentre trial of a complex physical therapy intervention. The software incorporated functionality for participant randomisation, data collection and assessment of intervention fidelity. It was accessible to multiple users with differing levels of access depending on required usage or to maintain blinding. Each site was supplied with a 4G-enabled iPad for accessing the system. The impact of this system was quantified through review of data quality and collation of feedback from site coordinators and assessors through structured process interviews. The custom-built system was an efficient tool for collecting data and managing trial processes. Although the set-up time required was significant, using the system resulted in an overall data completion rate of 98.5% with a data query rate of 0.1%, the majority of which were resolved in under a week. Feedback from research staff indicated that the system was highly acceptable for use in a research environment. This was a reflection of the portability and accessibility of the system when using the iPad and its usefulness in aiding accurate data collection, intervention fidelity and general administration. A combination of commercially available hardware and a bespoke online database

Supportive Accountability: A Model for Providing Human Support to Enhance Adherence to eHealth Interventions

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2011-01-01

The effectiveness of and adherence to eHealth interventions is enhanced by human support. However, human support has largely not been manualized and has usually not been guided by clear models. The objective of this paper is to develop a clear theoretical model, based on relevant empirical literature, that can guide research into human support components of eHealth interventions. A review of the literature revealed little relevant information from clinical sciences. Applicable literature was drawn primarily from organizational psychology, motivation theory, and computer-mediated communication (CMC) research. We have developed a model, referred to as “Supportive Accountability.” We argue that human support increases adherence through accountability to a coach who is seen as trustworthy, benevolent, and having expertise. Accountability should involve clear, process-oriented expectations that the patient is involved in determining. Reciprocity in the relationship, through which the patient derives clear benefits, should be explicit. The effect of accountability may be moderated by patient motivation. The more intrinsically motivated patients are, the less support they likely require. The process of support is also mediated by the communications medium (eg, telephone, instant messaging, email). Different communications media each have their own potential benefits and disadvantages. We discuss the specific components of accountability, motivation, and CMC medium in detail. The proposed model is a first step toward understanding how human support enhances adherence to eHealth interventions. Each component of the proposed model is a testable hypothesis. As we develop viable human support models, these should be manualized to facilitate dissemination. PMID:21393123

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. �

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

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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.

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

Usage of a generic web-based self-management intervention for breast cancer survivors: substudy analysis of the BREATH trial.

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van den Berg, Sanne W; Peters, Esmee J; Kraaijeveld, J Frank; Gielissen, Marieke F M; Prins, Judith B

2013-08-19

Generic fully automated Web-based self-management interventions are upcoming, for example, for the growing number of breast cancer survivors. It is hypothesized that the use of these interventions is more individualized and that users apply a large amount of self-tailoring. However, technical usage evaluations of these types of interventions are scarce and practical guidelines are lacking. To gain insight into meaningful usage parameters to evaluate the use of generic fully automated Web-based interventions by assessing how breast cancer survivors use a generic self-management website. Final aim is to propose practical recommendations for researchers and information and communication technology (ICT) professionals who aim to design and evaluate the use of similar Web-based interventions. The BREAst cancer ehealTH (BREATH) intervention is a generic unguided fully automated website with stepwise weekly access and a fixed 4-month structure containing 104 intervention ingredients (ie, texts, tasks, tests, videos). By monitoring https-server requests, technical usage statistics were recorded for the intervention group of the randomized controlled trial. Observed usage was analyzed by measures of frequency, duration, and activity. Intervention adherence was defined as continuous usage, or the proportion of participants who started using the intervention and continued to log in during all four phases. By comparing observed to minimal intended usage (frequency and activity), different user groups were defined. Usage statistics for 4 months were collected from 70 breast cancer survivors (mean age 50.9 years). Frequency of logins/person ranged from 0 to 45, total duration/person from 0 to 2324 minutes (38.7 hours), and activity from opening none to all intervention ingredients. 31 participants continued logging in to all four phases resulting in an intervention adherence rate of 44.3% (95% CI 33.2-55.9). Nine nonusers (13%), 30 low users (43%), and 31 high users (44%) were