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Adolescent Emotional Control Moderates Benefits of a Multicomponent Intervention to Improve Type 1 Diabetes Adherence: A Pilot Randomized Controlled Trial.

ABSTRACT: Objective:We previously tested via randomized controlled trial a novel intervention for adolescents with type 1 diabetes and above-target glycemic control that combined web-delivered incentives for self-monitoring of blood glucose (SMBG) and brief web counseling with working memory training and parental contingency contracting training. Results showed improved SMBG and decreased glycosylated hemoglobin (HbA1c) at 6- and 12-month follow-ups. However, it has not been elucidated if improvements in SMBG mediated the immediate benefits of this treatment on HbA1c nor if this intensive intervention uniquely benefited a subgroup of adolescents with higher problems in emotional control. Methods:Adolescents with type 1 diabetes and above-target glycemic control (n?=?61) were randomized to receive the 6-month intervention (n?=?30) or usual care (n?=?31). Adolescents completed the Behavior Rating Inventory of Executive Function-Self-Report, problems with emotional control subscale at baseline, and provided meter downloads to assess frequency of SMBG and completed an HbA1c blood draw at baseline and 6 months later. Results:At 6-month follow-up, improvements in SMBG mediated the effects of receiving the treatment on having lower average HbA1c. Further, problems in emotional control moderated the benefits of the intervention on improvements in SMBG and in turn HbA1c. Only adolescents with above average problems in emotional control evidenced improvements in SMBG in response to treatment, which then explained lower HbA1c levels at 6-month follow-up. Conclusions:This multicomponent, web-delivered intervention provided unique benefits for improving SMBG and lowering HbA1c in teens with higher problems in emotional control.

SUBMITTER: Lansing AH

PROVIDER: S-EPMC6319445 | biostudies-literature | 2019 Jan

REPOSITORIES: biostudies-literature

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Adolescent Emotional Control Moderates Benefits of a Multicomponent Intervention to Improve Type 1 Diabetes Adherence: A Pilot Randomized Controlled Trial.

Lansing Amy Hughes AH Stoianova Maria M Stanger Catherine C

Journal of pediatric psychology 20190101 1

<h4>Objective</h4>We previously tested via randomized controlled trial a novel intervention for adolescents with type 1 diabetes and above-target glycemic control that combined web-delivered incentives for self-monitoring of blood glucose (SMBG) and brief web counseling with working memory training and parental contingency contracting training. Results showed improved SMBG and decreased glycosylated hemoglobin (HbA1c) at 6- and 12-month follow-ups. However, it has not been elucidated if improvem ...[more]

PMID: 30247640

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Project description:Pre-exposure prophylaxis (PrEP) provides a strong preventative benefit to individuals at risk for HIV. While PrEP adherence is highly correlated with its efficacy, adherence rates are variable both across and within persons.The objective of this study was to develop and pilot-test a smartphone-based intervention, known as mSMART, that targets PrEP adherence. mSMART provides contingency management in the form of monetary incentives for daily PrEP adherence based on a real-time adherence assessment using a camera-based medication event-monitoring tool as well as medication reminders, PrEP education, individualized behavioral strategies to address PrEP adherence barriers, and medication adherence feedback.This was a 4-week open-label, phase I trial in a community sample of young men who have sex with men already on PrEP (N=10).Although adherence composite scores corresponding to PrEP biomarkers indicated that 90% (9/10) of the sample already had an acceptable baseline adherence in the protective range, by the end of the 4-week period, the scores improved for 30% (3/10) of the sample-adherence did not worsen for any participants. Participants reported mean PrEP adherence rates of 91% via daily entries in mSMART. At the end of the 4-week period, participants indicated acceptable ratings of satisfaction, usability, and willingness to recommend mSMART to others. There were no technical difficulties associated with smartphone compatibility, user misunderstandings about mSMART features that interfered with daily use, or study attrition.This study is the first to apply contingency management to PrEP adherence. Findings indicated that mSMART is feasible and acceptable. Such an adherence intervention administered via a user-friendly smartphone app can allow for widespread dissemination. Future efficacy trials are needed.ClinicalTrials.gov NCT02895893; https://clinicaltrials.gov/ct2/show/NCT02895893 (Accessed by Webcite at http://www.webcitation.org/72JskjDJq).

Project description:BackgroundMedication nonadherence is an important obstacle to cardiovascular disease management.ObjectiveTo improve adherence through real-time feedback based on theories of how social forces influence behavior.DesignTwo randomized controlled pilot trials called PROMOTE and SUPPORT. Participants stored statin medication in wireless-enabled pill bottles that transmitted adherence data to researchers.ParticipantsAdults with diabetes and a history of low statin adherence based on pharmacy refills (i.e., Medication Possession Ratio [MPR] <80% in the pre-randomization screening period).InterventionIn PROMOTE, each participant was randomized to 1) weekly messages in which that participant's statin adherence was compared to that of other participants (comparison), 2) weekly summaries of that participant's statin adherence (summary), or 3) control. In SUPPORT, each participant identified another person (the Medication Adherence Partner [MAP]) to receive reports about that participant's adherence, and was randomized to 1) daily reports to MAP, 2) weekly reports to MAP, 3) reports to MAP only if dose was missed, or 4) control.Main outcomes measureAdherence measured by pill bottle.Key resultsAmong 45,000 health plan members contacted by mail, <1% joined the trial. Participants had low baseline MPRs (median?=?60%, IQR 41-72%) but high pill-bottle adherence (90% in PROMOTE, 92% in SUPPORT) during the trial. In PROMOTE (n?=?201) and SUPPORT (n?=?200), no intervention demonstrated significantly better adherence vs.ControlIn a subgroup of PROMOTE participants with the lowest pre-study MPR, pill-bottle-measured adherence in the comparison arm (89%) was higher than the control (86%) and summary (76%) arms, but differences were non-significant (p?=?0.10).ConclusionsInterventions based on social forces did not improve medication adherence vs. control over a 3-month period. Given the low percentage of invited individuals who enrolled, the studies may have attracted participants who required little encouragement to improve adherence other than study participation.

Project description:BackgroundThe SMS text Adherence suppoRt for people with type 2 diabetes (StAR2D) intervention is a pragmatic randomised controlled trial, testing the effectiveness of brief text messaging for improving clinical outcomes and medication adherence. The intervention did not impact glycaemic control. We conducted a pre-and post-trial process evaluation alongside the StAR2D study in Malawi and South Africa, exploring the experiences and perceptions of patient participants, to better understand potential underlying reasons for the trial outcomes.MethodsWe employed a qualitative research design, including conducting semi structured in-depth interviews and focus groups at both trial sites. Purposive sampling was used to ensure representation of a wide range of patients with type 2 diabetes with regards to age, gender, ethnicity, language, and duration of diabetes. We interviewed the same participants at baseline and at the end of the trial. We used within-case and across-case thematic analysis to identify key themes.ResultsBrief messages delivered by text were acceptable and useful for addressing informational and support needs for participants. Some participants reported behaviour changes because of the text reminders and advice on a healthy lifestyle. Both participating in the trial and the messages were experienced as a source of support, caring, and motivation. Participants' ability to act on the messages was limited. A common theme was frustration over the lack of ability to effectively control one's blood glucose level. They reported a range of routinised, partial diabetes care adherence behaviours, shaped by complex and interacting individual, social, and health service factors. Participant responses and intervention impact were similar across sites, despite differences in health services.ConclusionThis process evaluation provided context and insight into the factors influencing participants' engagement with the text messaging intervention. The complex context in which patients take their diabetes medication, may explain in part, why brief text messaging may have been insufficient to bring about changes in health outcomes. The scale of need for self-management and health service support, suggests that health system strengthening, and other forms of self-management support should accompany digital communication interventions. (Current Controlled Trials ISRCTN70768808 , registered 03/08/2015.).

Project description:BackgroundBrief messaging interventions, including Short Message Service (SMS) text-messages, delivered via mobile device platforms, show promise to support and improve treatment adherence. To understand how these interventions work, and to facilitate transparency, we need clear descriptions of the intervention development process.MethodWe describe and reflect on the process of designing and pretesting an evidence- and theory-informed brief messaging intervention, to improve diabetes treatment adherence in sub-Saharan Africa. We followed the stepwise approach recommended by the Medical Research Council, United Kingdom (MRC UK) Framework for Development and Evaluation of Complex Health Interventions and guidance for mobile health intervention development.ResultsWe used a four-phase, iterative approach that first generated primary and secondary evidence on the lived experience of diabetes, diabetes treatment services and mobile-phone use. Second, we designed a type 2 diabetes-specific, brief text-message library, building on our previous hypertension text-message library, as well as drawing on the primary and secondary data from phase one, and on expert opinion. We then mapped the brief text-messages onto behaviour change (COM-B) theoretical constructs. Third, we refined and finalised the newly developed brief text-message library through stakeholder consultation and translated it into three local languages. Finally, we piloted the intervention by pre-testing the automated delivery of the brief text-messages in the trial sites in Malawi and South Africa. The final SMS text Adherence suppoRt for people with type 2 diabetes (StAR2D) intervention was tested in a randomised controlled trial in Malawi and South Africa (trial registration: ISRCTN70768808 ).ConclusionThe complexity of public health interventions requires that we give more attention to intervention development work. Our documentation and reflection on the StAR2D intervention development process promotes transparency, replicability, assessment of intervention quality, and comparison with other studies.

Project description:BACKGROUND:Research has underscored the need to develop socioculturally tailored interventions to improve adherence behaviors in minority patients with hypertension (HTN) and type 2 diabetes (T2D). Novel mobile health (mHealth) approaches are potential methods for delivering tailored interventions to minority patients with increased cardiovascular risk. OBJECTIVE:This study aims to develop and evaluate the acceptability and preliminary efficacy of a tailored mHealth adherence intervention versus attention control (AC) on medication adherence, systolic blood pressure (SBP), diastolic blood pressure (DBP), and hemoglobin A1c (HbA1c) at 3 months in 42 Black patients with uncontrolled HTN and/or T2D who were initially nonadherent to their medications. METHODS:This was a two-phase pilot study consisting of a formative phase and a clinical efficacy phase. The formative phase consisted of qualitative interviews with 10 members of the target patient population (7/10, 70% female; mean age 65.8 years, SD 5.6) to tailor the intervention based on the Information-Motivation-Behavioral skills model of adherence. The clinical efficacy phase consisted of a 3-month pilot randomized controlled trial to evaluate the tailored mHealth intervention versus an AC. The tablet-delivered intervention included a tailoring survey, an individualized adherence profile, and a personalized list of interactive adherence-promoting modules, whereas AC included the tailoring survey and health education videos delivered on the tablet. Acceptability was assessed through semistructured exit interviews. Medication adherence was assessed using the 8-item Morisky Medication Adherence Scale, whereas blood pressure and HbA1c were assessed using automated devices. RESULTS:In phase 1, thematic analysis of the semistructured interviews revealed the following 5 major barriers to adherence: disruptions in daily routine, forgetfulness, concerns about adverse effects, preference for natural remedies, and burdens of medication taking. Patients recommended the inclusion of modules that address improving patient-provider communication, peer vignettes, and stress reduction strategies to facilitate adherence. A total of 42 Black patients (23/42, 55% male; mean age 57.6 years, SD 11.1) participated in the clinical efficacy pilot trial. At 3 months, both groups showed significant improvements in adherence (mean 1.35, SD 1.60; P<.001) and SBP (-4.76 mm Hg; P=.04) with no between-group differences (P=.50 and P=.10). The decreases in DBP and HbA1c over time were nonsignificant (-1.97 mm Hg; P=.20; and -0.2%; P=.45, respectively). Patients reported high acceptability of the intervention for improving their adherence. CONCLUSIONS:This pilot study demonstrated preliminary evidence on the acceptability of a tailored mHealth adherence intervention among a sample of Black patients with uncontrolled HTN and T2D who were initially nonadherent to their medications. Future research should explore whether repeated opportunities to use the mHealth intervention would result in improvements in behavioral and clinical outcomes over time. Modifications to the intervention as a result of the pilot study should guide future efforts. TRIAL REGISTRATION:ClinicalTrials.gov NCT01643473; http://clinicaltrials.gov/ct2/show/ NCT01643473.

Dataset Information

Adolescent Emotional Control Moderates Benefits of a Multicomponent Intervention to Improve Type 1 Diabetes Adherence: A Pilot Randomized Controlled Trial.

Publications

Adolescent Emotional Control Moderates Benefits of a Multicomponent Intervention to Improve Type 1 Diabetes Adherence: A Pilot Randomized Controlled Trial.

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