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REAL-Fam Feasibility Study for Youth Diabetes Management

RECRUITINGN/ASponsored by University of North Carolina, Chapel Hill
Actively Recruiting
PhaseN/A
SponsorUniversity of North Carolina, Chapel Hill
Started2025-12-15
Est. completion2026-06
Eligibility
Age2 Years – 99 Years
Healthy vol.Accepted
Locations1 site

Summary

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

Eligibility

Age: 2 Years – 99 YearsHealthy volunteers accepted
Inclusion Criteria:

* 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

Exclusion Criteria:

* Caregiver who is not completing any supervision/support for their child's diabetes management;
* If the child is currently receiving occupational therapy services;
* Has a severe developmental, intellectual, or neurological disability

Conditions2

DiabetesType 1 Diabetes

Locations1 site

The University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, 27514
Vanessa Jewell, PhD919-843-4463Vanessa_Jewell@med.unc.edu

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