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A systematic review of the inclusion of mechanisms of action in NIH-funded intervention trials to improve medication adherence.

ABSTRACT: Medication nonadherence contributes to morbidity/mortality, but adherence interventions yield small and inconsistent effects. Understanding the mechanisms underlying initiation and maintenance of adherence could improve interventions. The National Institutes of Health (NIH) support adherence research, but it is unclear whether existing NIH-funded research incorporates mechanisms. We conducted a systematic review to determine the proportion of NIH-funded adherence trials that have tested hypothesized mechanisms of intervention effects. We included randomized and quasi-randomized NIH-funded trials with medication adherence in adults as the primary outcome. Studies were identified by searching electronic databases from inception to 6/2016, references, and clinicaltrials.gov. Two of 18 (11%) NIH-funded trials tested a hypothesized mechanism of an intervention's effect on medication adherence. Another 44 studies with medication adherence as a secondary outcome were described in protocol form, and are either ongoing or never published results, but none mentioned mechanism tests. Overall, 3% of NIH-funded trials with adherence as an outcome conducted, or plan to conduct, tests of behavior change mechanisms. These results mirror previous findings that very few studies of behavior change interventions actually test the mechanism by which the intervention is hypothesized to improve health behaviors. We must understand mechanisms if we are to improve the effectiveness of interventions.

SUBMITTER: Edmondson D

PROVIDER: S-EPMC5800992 | biostudies-literature | 2018 Feb

REPOSITORIES: biostudies-literature

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A systematic review of the inclusion of mechanisms of action in NIH-funded intervention trials to improve medication adherence.

Edmondson Donald D Falzon Louise L Sundquist Kevin J KJ Julian Jacob J Meli Laura L Sumner Jennifer A JA Kronish Ian M IM

Behaviour research and therapy 20171005

Medication nonadherence contributes to morbidity/mortality, but adherence interventions yield small and inconsistent effects. Understanding the mechanisms underlying initiation and maintenance of adherence could improve interventions. The National Institutes of Health (NIH) support adherence research, but it is unclear whether existing NIH-funded research incorporates mechanisms. We conducted a systematic review to determine the proportion of NIH-funded adherence trials that have tested hypothes ...[more]

PMID: 29033097

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Project description:High levels of adherence to medications for HIV infection are essential for optimal clinical outcomes and to reduce viral transmission, but many patients do not achieve required levels. Clinician-delivered interventions can improve patients' adherence, but usually require substantial effort by trained individuals and may not be widely available. Computer-delivered interventions can address this problem by reducing required staff time for delivery and by making the interventions widely available via the Internet. We previously developed a computer-delivered intervention designed to improve patients' level of health literacy as a strategy to improve their HIV medication adherence. The intervention was shown to increase patients' adherence, but it was not clear that the benefits resulting from the increase in adherence could justify the costs of developing and deploying the intervention. The purpose of this study was to evaluate the relation of development and deployment costs to the effectiveness of the intervention.Costs of intervention development were drawn from accounting reports for the grant under which its development was supported, adjusted for costs primarily resulting from the project's research purpose. Effectiveness of the intervention was drawn from results of the parent study. The relation of the intervention's effects to changes in health status, expressed as utilities, was also evaluated in order to assess the net cost of the intervention in terms of quality adjusted life years (QALYs). Sensitivity analyses evaluated ranges of possible intervention effectiveness and durations of its effects, and costs were evaluated over several deployment scenarios.The intervention's cost effectiveness depends largely on the number of persons using it and the duration of its effectiveness. Even with modest effects for a small number of patients the intervention was associated with net cost savings in some scenarios and for durations greater than three months and longer it was usually associated with a favorable cost per QALY. For intermediate and larger assumed effects and longer durations of intervention effectiveness, the intervention was associated with net cost savings.Computer-delivered adherence interventions may be a cost-effective strategy to improve adherence in persons treated for HIV.Clinicaltrials.gov identifier NCT01304186.

Project description:BackgroundThe widespread adoption of smartphones provides researchers with expanded opportunities for developing, testing and implementing interventions. National Institutes of Health (NIH) funds competitive, investigator-initiated grant applications. Funded grants represent the state of the science and therefore are expected to anticipate the progression of research in the near future.ObjectiveThe objective of this paper is to provide an analysis of the kinds of smartphone-based intervention apps funded in NIH research grants during the five-year period between 2014 and 2018.MethodsWe queried NIH Reporter to identify candidate funded grants that addressed mHealth and the use of smartphones. From 1524 potential grants, we identified 397 that met the requisites of including an intervention app. Each grant's abstract was analyzed to understand the focus of intervention. The year of funding, type of activity (eg, R01, R34, and so on) and funding were noted.ResultsWe identified 13 categories of strategies employed in funded smartphone intervention apps. Most grants included either one (35.0%) or two (39.0%) intervention approaches. These included artificial intelligence (57 apps), bionic adaptation (33 apps), cognitive and behavioral therapies (68 apps), contingency management (24 apps), education and information (85 apps), enhanced motivation (50 apps), facilitating, reminding and referring (60 apps), gaming and gamification (52 apps), mindfulness training (18 apps), monitoring and feedback (192 apps), norm setting (7 apps), skills training (85 apps) and social support and social networking (59 apps). The most frequently observed grant types included Small Business Innovation Research (SBIR) and Small Business Technology Transfer (STTR) grants (40.8%) and Research Project Grants (R01s) (26.2%). The number of grants funded increased through the five-year period from 60 in 2014 to 112 in 2018.ConclusionsSmartphone intervention apps are increasingly competitive for NIH funding. They reflect a wide diversity of approaches that have significant potential for use in applied settings.

Project description:BackgroundMobile health technologies have the potential to improve the reach and delivery of interventions for promoting long-term secondary prevention of coronary heart disease.ObjectiveThis study aims to determine the effectiveness of an SMS text messaging intervention (Text4HeartII) for improving adherence to medication and lifestyle changes over and above usual care in people with coronary heart disease at 24 and 52 weeks.MethodsA two-arm, parallel, randomized controlled trial was conducted in New Zealand. Participants with a recent acute coronary syndrome were randomized to receive usual cardiac services alone (control, n=153) or a 24-week SMS text message program for supporting self-management plus usual cardiac services (n=153). The primary outcome was adherence to medication at 24 weeks, defined as a medication possession ratio of 80% or more for aspirin, statin, and antihypertensive therapy. Secondary outcomes included medication possession ratio at 52 weeks, self-reported medication adherence, adherence to healthy lifestyle behaviors, and health-related quality of life at 24 and 52 weeks.ResultsParticipants were predominantly male (113/306, 80.3%) and European New Zealanders (210/306, 68.6%), with a mean age of 61 years (SD 11 years). Groups were comparable at baseline. National hospitalization and pharmacy dispensing records were available for all participants; 92% (282/306, 92.1%) of participants completed a 24-week questionnaire and 95.1% (291/306) of participants completed a 52-week questionnaire. Adherence with 3 medication classes were lower in the intervention group than in the control group (87/153, 56.8% vs 105/153, 68.6%, odds ratio 0.60, 95% CI 0.38-0.96; P=.03) and 52 weeks (104/153, 67.9% vs 83/153, 54.2%; odds ratio 0.56, 95% CI 0.35-0.89; P=.01). Self-reported medication adherence scores showed the same trend at 52 weeks (mean difference 0.3; 95% CI 0.01-0.59; P=.04). Moreover, self-reported adherence to health-related behaviors was similar between groups.ConclusionsText4HeartII did not improve dispensed medication or adherence to a favorable lifestyle over and above usual care. This finding contrasts with previous studies and highlights that the benefits of text interventions may depend on the context in which they are used.Trial registrationAustralian New Zealand Clinical Trials Registry ACTRN12616000422426; http://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=370398.International registered report identifier (irrid)RR2-10.1186/s13063-018-2468-z.

Project description:BackgroundHypertension (HTN) is a major public health concern in the United States, with almost 78 million Americans age 20 years and over suffering from the condition. Moreover, HTN is a key risk factor for health disease and stroke. African Americans disproportionately shoulder the burdens of HTN, with greater prevalence, disease severity, earlier onset, and more HTN-related complications than age-matched whites. Medication adherence for the treatment of HTN is poor, with estimates indicating that only about half of hypertensive patients are adherent to prescribed medication regimens. Although no single intervention for improving medication adherence has emerged as superior to others, text message medication reminders have the potential to help improve medication adherence in African Americans with uncontrolled HTN as mobile phone adoption is very high in this population.ObjectiveThe purpose of this two-phased study was to develop (Phase I) and test in a randomized controlled trial (RCT) (Phase II) a text message system, BPMED, to improve the quality of medication management through increasing medication adherence in African Americans with uncontrolled HTN.MethodsIn Phase I, we recruited 16 target end-users from a primary care clinic, to assist in the development of BPMED through participating in one of three focus groups. Focus groups sought to gain patient perspectives on HTN, medication adherence, mobile phone use, and the use of text messaging to support medication adherence. Potential intervention designs were presented to participants, and feedback on the designs was solicited. In Phase II, we conducted two pilot RCTs to determine the feasibility, acceptability, and preliminary efficacy of BPMED in primary care and emergency department settings. Both pilot studies recruited approximately 60 participants, who were randomized equally between usual care and the BPMED intervention.ResultsAlthough data collection is now complete, data analysis from the two pilot RCTs is still ongoing and results are expected in 2015.ConclusionsThis study was designed to determine preliminary feasibility and acceptability of our approach among African Americans with uncontrolled HTN in primary care and emergency department settings. Results from these studies are of great interest as little work has been done to document the use of text message medication reminders to improve HTN-related outcomes, particularly within underserved urban minorities.Trial registrationClinicaltrials.gov NCT01465217; https://clinicaltrials.gov/ct2/show/NCT01465217 (Archived by WebCite at http://www.webcitation.org/6V0tto0lZ).

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A systematic review of the inclusion of mechanisms of action in NIH-funded intervention trials to improve medication adherence.

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A systematic review of the inclusion of mechanisms of action in NIH-funded intervention trials to improve medication adherence.

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