Feasibility of a Complex Behavioral Intervention for Young Adults With Diabetes: The Resilient, Empowered, Active Living-Telehealth (REAL-T) Study
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 8
- Locations
- 1
- Primary Endpoint
- Feasibility
Study Overview
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).
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Other
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 30 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
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).
Intervention: REAL-T Intervention (Behavioral)
Outcomes
Primary Outcomes
Feasibility
Time Frame: 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.
Acceptability
Time Frame: 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.
Secondary Outcomes
- Change from baseline in Patient Health Questionnaire-8 (PHQ-8) survey at post-intervention(Baseline, 3 months)
- Change from baseline in Audit of Diabetes-Dependent Quality of Life (ADD-QoL) at post-intervention(Baseline, 3 months)
- Change from baseline in The Diabetes Empowerment Scale-Short Form (DES-SF) at post-intervention(Baseline, 3 months)
- Change from baseline in Problem Areas in Diabetes (PAID) survey at post-intervention(Baseline, 3 months)
- Change from baseline in Summary of Diabetes Self-Care Activities (SDSCA) at post-intervention(Baseline, 3 months)
- Change from baseline in Glycated hemoglobin (HbA1C) at post-intervention(Baseline, 3 months)
Investigators
Elizabeth Pyatak
Assistant Professor
University of Southern California