Recruiting

REAL-Fam Telehealth for Rural Families with Type 1 Diabetes

0 criteria met from your profileSee at a glance how your profile meets each eligibility criteria.
Study Aim

This study aims to evaluate the effectiveness of telehealth support for rural families managing children with Type 1 Diabetes.

What is being tested

REAL-Fam Occupational Therapy Family Coaching

Behavioral
Who is being recruted

Autoimmune Diseases+5

+ Diabetes Mellitus

+ Diabetes Mellitus, Type 1

From 2 to 99 Years
+6 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Supportive Care Study

Interventional
Study Start: December 2025
See protocol details

Summary

Principal SponsorUniversity of North Carolina, Chapel Hill
Last updated: January 24, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: December 15, 2025

Actual date on which the first participant was enrolled.

This study focuses on helping families in rural areas manage type 1 diabetes in children more effectively. Type 1 diabetes is becoming more common among young people, especially those living in rural communities, who often face challenges like limited access to healthcare, transportation issues, and financial difficulties. The study tests a new program called REAL-Fam, designed to be delivered via telehealth, which aims to support families by teaching them how to manage diabetes better, improve their quality of life, and help children maintain healthy blood sugar levels. This program is important because it not only focuses on managing diabetes but also addresses cultural and social factors that can affect health, aiming to provide comprehensive care that fits into the daily lives of families. Participants in the study, which include caregiver and child pairs, will be randomly assigned to either a group receiving the REAL-Fam intervention or a control group for 12 weeks. The REAL-Fam group will receive training and support through online sessions, covering areas like healthy routines, family participation in care activities, and strategies for engaging with schools and childcare. The study will look at how well caregivers feel they can manage diabetes, their overall quality of life, and the children's blood sugar levels to evaluate the program's effectiveness. The results of this study could lead to more widespread use of the program, providing much-needed support to families in rural areas and potentially improving health outcomes for children with type 1 diabetes.

Official TitleFeasibility of REAL-Fam to Support Diabetes Self-Management, Family Participation, and Child Health 
Principal SponsorUniversity of North Carolina, Chapel Hill
Last updated: January 24, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

16 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Supportive Care Study

These studies explore ways to improve comfort and daily life for people living with a condition. They may focus on easing symptoms, reducing treatment side effects, or supporting overall well-being.



Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 2 to 99 Years

Range of ages for which participants are eligible to join.

Healthy volunteers allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Autoimmune DiseasesDiabetes MellitusDiabetes Mellitus, Type 1Endocrine System DiseasesImmune System DiseasesMetabolic DiseasesNutritional and Metabolic DiseasesGlucose Metabolism Disorders

Criteria

3 inclusion criteria required to participate
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

3 exclusion criteria prevent from participating
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

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

One single intervention group is designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Experimental
8 caregiver-child dyads will receive the Resilient, Empowered, Active Living for Families intervention. This is an occupational therapy family coaching intervention, which will be delivered via 12 weekly telehealth sessions.

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Recruiting

The University of North Carolina at Chapel Hill

Chapel Hill, United StatesSee the location
Recruiting
One Study Center