Actively Recruiting
REAL-Fam Feasibility Study for Youth Diabetes Management
Led by University of North Carolina, Chapel Hill · Updated on 2026-01-23
16
Participants Needed
1
Research Sites
24 weeks
Total Duration
On this page
Sponsors
U
University of North Carolina, Chapel Hill
Lead Sponsor
A
American Occupational Therapy Foundation
Collaborating Sponsor
AI-Summary
What this Trial Is About
The goal of this clinical trial is to learn if the REAL-Fam occupational therapy intervention is feasible to study in a larger-scale randomized controlled trial. It will also seek to understand how the intervention influences how a rural family participates in and manages their child's type 1 diabetes, their family quality of life, and the child's health outcomes. The main questions it aims to answer are: * Primary Aim 1: Evaluate the recruitment capability, participant inclusion criteria, assessment selection and process, and data. * Primary Aim 2: Evaluate the participant acceptability of and interventionist fidelity to the intervention. * Secondary Aim: Evaluate families' preliminary outcomes to the REAL-Fam on family quality of life and participation, diabetes management self-efficacy, and child blood glucose stability. Researchers will compare the REAL-Fam intervention to the Attention Group to see if there are changes in family diabetes-related health routines and psychosocial aspects of managing a child's type 1 diabetes. Participants will: * Children will wear continuous glucose monitors for study period * Caregiver participants will complete baseline and post-intervention surveys * Intervention Group: engage in 12 audio/video telehealth sessions with REAL-Fam intervention * Attention Group: engage in 3 audio/video Zoom meetings without specialized services * Complete a post-study interview
CONDITIONS
Official Title
REAL-Fam Feasibility Study for Youth Diabetes Management
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Caregiver over 19 years old and designated guardian or parent to a child living with Type 1 Diabetes
- Live in a rural area over 1 hour from pediatric endocrinology care team
- Access to reliable internet
You will not qualify if you...
- Caregiver who is not completing any supervision/support for their child's diabetes management
- Child is currently receiving occupational therapy services
- Child has a severe developmental, intellectual, or neurological disability
AI-Screening
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Trial Site Locations
Total: 1 location
1
The University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, United States, 27514
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
SUPPORTIVE_CARE
Number of Arms
2
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