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

Not Applicable

Completed

• Conditions: Diabetes Mellitus
• Interventions: Behavioral: REAL-T Intervention

• Registration Number: NCT03333772
• Lead Sponsor: University of Southern California

Brief Summary

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

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).

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2017-11-02
• Study First Submitted QC: 2017-11-03
• Study First Posted: 2017-11-07
• Study Start: 2017-11-15
• Primary Completion: 2018-02-10
• Study Completion: 2018-02-10
• Status Verified: 2018-05
• Last Update Submitted: 2018-05-02
• Last Update Posted: 2018-05-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 8

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

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Exclusion Criteria

• Pregnant or planning to become pregnant within the next 4 months
• Diagnosed with a comorbid cognitive or intellectual disability

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
REAL-T Intervention	REAL-T Intervention	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).

Primary Outcome Measures

Name	Time	Method
Acceptability	3 months	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.
Feasibility	3 months	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.

Secondary Outcome Measures

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

Trial Locations

Locations (1)

USC Center for Health Professionals; 🇺🇸 Los Angeles, California, United States