Sleep coach intervention for teens with type 1 diabetes: Randomized pilot study.
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ABSTRACT: Background
Teens with type 1 diabetes (T1D) experience increased sleep disturbances, which have been linked to problems with adherence and glycemic control. As such, sleep represents a novel target to improve outcomes in teens.Objective
To evaluate the feasibility, acceptability, and preliminary efficacy of a sleep-promoting intervention in teens with T1D.Research design and methods
Teens aged 13 to 17 with T1D (n = 39) completed measures of sleep quality and diabetes management and wore actigraphs to obtain an objective measure of sleep. Hemoglobin A1C (HbA1c) was collected from medical records. Teens were randomized to Usual Care (n = 19) or the Sleep Coach intervention (n = 20). Teens in the Sleep Coach group received educational materials on healthy sleep habits and completed three individual telephone sessions. Follow-up data were collected at 3 months, including exit interviews with teens and parents.Results
Feasibility of the study was excellent; 80% of teens in the Sleep Coach group completed all three sessions, and retention was high (90%). Based on actigraphy data, a significant improvement in sleep efficiency and sleep duration was observed (48-minute increase) among teens randomized to the Sleep Coach intervention, and teens in the control group were 7.5 times more likely to report poor sleep quality after 3 months than intervention participants. No change in HbA1c was observed.Conclusions
The Sleep Coach intervention for teens with T1D is a feasible and acceptable program that increased sleep duration and improved sleep quality for this high-risk population.
SUBMITTER: Jaser SS
PROVIDER: S-EPMC7670490 | biostudies-literature |
REPOSITORIES: biostudies-literature
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Project description:ObjectiveTo assess the feasibility and acceptability of an educational sleep-promoting intervention (Sleep Coach Jr.) for school-aged children (ages 5-9) with type 1 diabetes (T1D) and their parents.MethodsParents and children (N = 39 dyads, mean child age = 8 years, 64% girls,) were randomized to either the Sleep Coach Jr. intervention, consisting of educational materials and three individual phone calls (N = 20), or the Standard Care condition (N = 19). Data were collected at enrollment and 3 months later. Children and parents wore actigraphy devices to obtain an objective measure of sleep characteristics, and parents completed questionnaire measures of sleep quality and psychosocial outcomes. Clinical data (i.e., hemoglobin A1c, glucose data) were obtained from children's medical records.ResultsFeasibility and acceptability of the study were demonstrated to be high; all three sessions were completed by 80% of parents randomized to the Sleep Coach Jr. intervention, and 90% of parents completed follow-up data at 3 months. Parents reported high levels of satisfaction with the study and identified barriers to participation. No changes were observed in children's sleep or diabetes outcomes, but parental sleep quality and well-being improved.ConclusionsA brief, behavioral sleep-promoting intervention is feasible and acceptable for school-aged children with T1D and their parents. A larger trial is needed to evaluate efficacy of the intervention.
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Project description:Adolescents with type 1 diabetes (T1D) experience high rates of diabetes distress, which negatively influence self-management and glycemic control. Building on effective positive psychology interventions to improve adherence in adults, as well as our pilot work to adapt these interventions for adolescents, we developed a positive psychology intervention for adolescents with T1D. The goal of THR1VE! is to reduce diabetes distress in adolescents with T1D and improve their diabetes outcomes. This multi-site randomized controlled trial compares a Diabetes Education + text-message-based Positive Affect intervention, to a Diabetes Education control condition. In the ongoing trial, we are evaluating the effects of the intervention on adolescents' diabetes distress, self-management, and glycemic control. This paper describes the rationale, trial design, and methodology of the THR1VE! Study.
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Project description:BackgroundType 1 diabetes mellitus (T1DM) afflicts approximately 154,000 people under the age of 20 in the United States. Most people with T1DM are diagnosed at a young age, and parents have to take on the responsibility of T1DM management. Eventually, the child must begin to transition to self-management. Adolescents often struggle to take on responsibility for all the necessary tasks to successfully self-manage their T1DM. In fact, approximately three-quarters of adolescents are not achieving American Diabetes Association-recommended glycated hemoglobin (HbA1c) targets. This lack of adherence can lead to negative health outcomes.ObjectiveThe goals of this interdisciplinary proposal are as follows: (1) to develop a unique and theory-driven technology using a mobile phone app to promote self-management behaviors for adolescents aged 10-15 years with T1DM and their parents and (2) to explore the feasibility and impact of the self-management mobile app.MethodsThis study has two phases: app development and pilot testing. In the app development phase, the app will be conceptualized and a prototype will be tested. In Phase 2, the mobile app will undergo pilot testing to determine its feasibility and impact on diabetes self-management.ResultsThe pilot test was launched in September 2017. Data collection for the final pilot test is underway, and results are forthcoming.ConclusionsAdolescents with T1DM and their parents can have a difficult time managing the transition of diabetes care. It is hoped that this app can help. The focus groups and prototype testing have indicated promising outcomes of app use.Trial registrationClinicalTrials.gov NCT03436628; https://clinicaltrials.gov/ct2/show/NCT03436628 (Archived by WebCite at http://www.webcitation.org/72tHXTE2Z).International registered report identifier (irrid)RR1-10.2196/10803.
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Project description:BACKGROUND:Internet-based cognitive-behavioral therapy (iCBT) is more effective when it is guided by human support than when it is unguided. This may be attributable to higher adherence rates that result from a positive effect of the accompanying support on motivation and on engagement with the intervention. This protocol presents the design of a pilot randomized controlled trial that aims to start bridging the gap between guided and unguided interventions. It will test an intervention that includes automated support delivered by an embodied conversational agent (ECA) in the form of a virtual coach. METHODS/DESIGN:The study will employ a pilot two-armed randomized controlled trial design. The primary outcomes of the trial will be (1) the effectiveness of iCBT, as supported by a virtual coach, in terms of improved intervention adherence in comparison with unguided iCBT, and (2) the feasibility of a future, larger-scale trial in terms of recruitment, acceptability, and sample size calculation. Secondary aims will be to assess the virtual coach's effect on motivation, users' perceptions of the virtual coach, and general feasibility of the intervention as supported by a virtual coach. We will recruit N?=?70 participants from the general population who wish to learn how they can improve their mood by using Moodbuster Lite, a 4-week cognitive-behavioral therapy course. Candidates with symptoms of moderate to severe depression will be excluded from study participation. Included participants will be randomized in a 1:1 ratio to either (1) Moodbuster Lite with automated support delivered by a virtual coach or (2) Moodbuster Lite without automated support. Assessments will be taken at baseline and post-study 4 weeks later. DISCUSSION:The study will assess the preliminary effectiveness of a virtual coach in improving adherence and will determine the feasibility of a larger-scale RCT. It could represent a significant step in bridging the gap between guided and unguided iCBT interventions. TRIAL REGISTRATION:Netherlands Trial Register (NTR) NL8110 . Registered on 23 October 2019.
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