Actively Recruiting

Phase Not Applicable
Age: 2Years - 99Years
All Genders
Healthy Volunteers
NCT07212790

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

Age: 2Years - 99Years
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

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
Not Eligible

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

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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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