Feasibility of Delivering a Complex Behavioral Intervention for Young Adults With Diabetes Via Telehealth

Study Overview
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Brief Summary
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Feasibility of a Complex Behavioral Intervention for Young Adults with Diabetes: The Resilient, Empowered, Active Living-Telehealth (REAL-T) Study will evaluate the feasibility of implementing a diabetes management intervention via telehealth in preparation for a large-scale randomized controlled trial (RCT) entitled Evaluation of a Complex Behavioral Intervention for Young Adults with Diabetes: The Resilient, Empowered, Active Living-Telehealth (REAL-T) Study.

Detailed Description
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Feasibility of a Complex Behavioral Intervention for Young Adults with Diabetes: The Resilient, Empowered, Active Living-Telehealth (REAL-T) feasibility study will evaluate the feasibility of implementing a diabetes management intervention via telehealth in preparation for a large-scale RCT. Young adulthood is a challenging life stage for many individuals with diabetes; only 17% of YAs age 18-25 and 30% age 26-30 attain recommended A1C targets, and fewer than 1/3 perform self-care in accordance with national guidelines. Yet, it is a crucial stage for establishing health habits that persist throughout adulthood. To address these issues, our research team developed REAL Diabetes (Resilient, Empowered, Active Living with Diabetes), a 6-month individually tailored occupational therapy intervention focused on incorporating diabetes self-care into participants' daily habits and routines, and evaluated its efficacy in a pilot randomized controlled trial (n=81). REAL was shown in intention-to-treat analysis to significantly improve A1C (0.9% reduction; p=0.01) and diabetes-related quality of life (p=0.04). While REAL was highly promising in terms of its positive impact on health and quality of life, the intervention was delivered through home visits, limiting its potential for broad dissemination. Given that our target population experiences significant logistical barriers to clinic attendance (the impetus for our in-home treatment model), we therefore will adapt REAL to be delivered via telehealth (REAL-T), a highly promising care delivery model, and evaluate REAL-T in a large-scale RCT. The current feasibility study will evaluate the feasibility of implementing the REAL-T intervention via telehealth by enrolling 10 participants who are 18-30 years of age, conducting the REAL-T intervention with all participants over a 3-month period, and assessing the process of implementing the study (feasibility and participant satisfaction).

Official Title
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Feasibility of a Complex Behavioral Intervention for Young Adults With Diabetes: The Resilient, Empowered, Active Living-Telehealth (REAL-T) Study

Conditions
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Diabetes Mellitus

Intervention / Treatment
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* Behavioral: REAL-T Intervention


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Diagnosed with either type 1 diabetes or type 2 diabetes for at least 12 months Hemoglobin A1C >7.5% Resident of Los Angeles County with no imminent plans to relocate Fluent in English Previous participant in REAL Diabetes Study Exclusion Criteria: Pregnant or planning to become pregnant within the next 4 months Diagnosed with a comorbid cognitive or intellectual disability

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 30 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: REAL-T Intervention<br>The current feasibility study will evaluate the feasibility of implementing the REAL-T RCT by enrolling 10 participants who are 18-30 years of age, conducting the REAL-T intervention with all participants over a 3-month period, evaluating pre-to-post changes in their health and quality of life, and assessing the process of implementing the study (feasibility and participant satisfaction). | Behavioral: REAL-T Intervention<br>* Individualized lifestyle intervention conducted via internet-based videoconferencing and incorporating the following topics: Diabetes knowledge; access to healthcare; communication with healthcare providers; incorporation of diabetes self-care tasks within daily habits and routines; social support; and emotional well-being. Participants will have approximately 6-10 sessions lasting about one hour each, over a 3-month period.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Feasibility | Both formative and summative data will be gathered throughout the study to assess feasibility, defined herein as the extent to which the intervention can be successfully delivered via telehealth. Feasibility will be assessed through surveys. | 3 months | 
| Acceptability | Both formative and summative data will be gathered throughout the study to assess acceptability, defined herein as the perception of the intervention as agreeable/satisfactory. Acceptability will be assessed through interviews. | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in Audit of Diabetes-Dependent Quality of Life (ADD-QoL) at post-intervention | 19-item survey measure assessing impact of diabetes on social, physical, and emotional functioning | Baseline, 3 months | 
| Change from baseline in The Diabetes Empowerment Scale-Short Form (DES-SF) at post-intervention | 8 item survey measure assessing the psychosocial self-efficacy of people with diabetes | Baseline, 3 months | 
| Change from baseline in Problem Areas in Diabetes (PAID) survey at post-intervention | 5 item survey measure assessing diabetes-related stress | Baseline, 3 months | 
| Change from baseline in Patient Health Questionnaire-8 (PHQ-8) survey at post-intervention | 8-item survey measure assessing severity of depressive symptoms | Baseline, 3 months | 
| Change from baseline in Summary of Diabetes Self-Care Activities (SDSCA) at post-intervention | 14 item survey assessing diet, physical activity, medication adherence and other self-care behaviors relevant to diabetes | Baseline, 3 months | 
| Change from baseline in Glycated hemoglobin (HbA1C) at post-intervention | Measure of average blood glucose concentration over approximately the previous 12 weeks | Baseline, 3 months |