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REAL-Fam Telehealth for Rural Families with Type 1 Diabetes

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Study AimThis 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

Type 1 Diabetes

From 2 to 99 Years
+6 Eligibility Criteria

See all eligibility criteria

How is the trial designed

Supportive Care Study

Interventional
Study Start: October 2025

See protocol details

Summary

Principal SponsorUniversity of North Carolina, Chapel Hill
Last updated: October 8, 2025
Sourced from a government-validated database.Claim as a partner
Study start date: October 1, 2025Actual 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: October 8, 2025
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 enrolledTotal 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.

How participants are assigned to different groups/arms
In this clinical study, participants are placed into groups randomly, like flipping a coin. This ensures that the study is fair and unbiased, making the results more reliable. By assigning participants by chance, researchers can better compare treatments without external influences.

Other Ways to Assign Participants
Non-randomized allocation: Participants are assigned based on specific factors, such as their medical condition or a doctor's decision.
None (Single-arm trial): If the study has only one group, all participants receive the same treatment, and no allocation is needed.

How treatments are given to participants
Participants are divided into different groups, each receiving a specific treatment at the same time. This helps researchers compare how well different treatments work against each other.

Other Ways to Assign Treatments
Single-group assignment: Everyone gets the same treatment.
Cross-over assignment: Participants switch between treatments during the study.
Factorial assignment: Participants receive different combinations of treatments.
Sequential assignment: Participants receive treatments one after another in a specific order, possibly based on individual responses.
Other assignment: Treatment assignment does not follow a standard or predefined design.

How the effectiveness of the treatment is controlled
In a non placebo-controlled study, no participants receive an inert substance (placebo) to compare outcomes. Instead, all participants receive either the experimental treatment or an alternative treatment (often the Standard of Care). This method allows researchers to compare the effects of the experimental treatment with those of a different active intervention, rather than a placebo.

Other Options
Placebo-Controlled: A placebo is used to compare the effects of the experimental treatment with those of an inert substance, isolating the true treatment effect.

How the interventions assigned to participants is kept confidential
Participants do not know which treatment they are receiving, but researchers do. This helps prevent bias from participants' expectations while still allowing researchers to monitor the study closely.

Other Ways to Mask Information
Open-label: Everyone knows which treatment is being given.
Double-blind: Neither participants nor researchers know which treatment is given.
Triple-blind: Participants, researchers, and outcome assessors do not know which treatment is given.
Quadruple-blind: Participants, researchers, outcome assessors, and care providers all do not know which treatment is given.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria
Any sexBiological sex of participants that are eligible to enroll.
From 2 to 99 YearsRange of ages for which participants are eligible to join.
Healthy volunteers allowedIf individuals who are healthy and do not have the condition being studied can participate.
Conditions
Pathology
Type 1 Diabetes
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
2 intervention groups 

are 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.
Group II
No Intervention
8 caregiver-child dyads will receive 3 attention group sessions with a research team member and engage in activities such as creating music play lists, playing games, and having conversation without specialized healthcare services.
Study Objectives
Primary Objectives

One feasibility measure was to evaluate the number and percentage of families consented compared to those approached for participation in the study.

Number and Percentage of standard of care condition participants retained in the study compared to those enrolled. Retention is defined as participants who completed post-intervention assessments.

Number and Percentage of Intervention Group participants retained in the study compared to those enrolled. Retention is defined as participants who completed post-intervention assessments.

Number and Percentage of surveys over time completed by participants who completed the study.

The total number/amount of sessions attended out of the total number of sessions available, reported as both the total number and the percentage.

For each recruitment strategy, the researchers will document the total number and percentage of how many families were eligible, approached, and enrolled

A self-reported questionnaire for caregivers to rate how satisfied they were with the telehealth sessions (a measure of study acceptability). It includes 10 questions with 1-4 ratings, with higher scores indicating higher levels of satisfaction.

A self-reported questionnaire for caregivers to rate their satisfaction with the REAL-Fam intervention. It includes the following subdomains: Objectives and content (3 questions); Method of training context (6 questions); Usefulness and overall rating (3 questions). Items are rated on a 1-5 scale, with higher scores indicating higher levels of acceptability.

A semi-structured interview guide to qualitatively assess feasibility and acceptability of the REAL-Fam intervention framework. It includes questions related to recruitment and enrollment (3 questions); scheduling and time commitment (3 questions); assessments and data collection (3 questions); technology use (2 questions); overall burden/ease (2 questions); perceived value of the intervention ( 2 questions); engagement and enjoyment (2 questions); format delivery (2 questions); relevance to family's life (2 questions); therapist interaction (2 questions); rural context (2 questions); modules and content (3 questions); habit \& routine focus of the intervention (3 questions); perceived changes/impact (2 questions); recommendations for improvement (2 questions); and overall reflections (2 questions). Qualitative results will be reported by each sub-domain.
Secondary Objectives

Self-reported quality of life; higher score = better quality of life. The World Health Organization Quality of Life - BREF (WHOQOL-BREF) is a self-report questionnaire which assesses 4 domains of quality of life (QOL): physical health, psychological health, social relationships, and environment. In addition, there are 2 items that measure overall QOL and general health. Subscales (domains): Physical Health (7 items) Psychological Health (6 items) Social Relationships (3 items) Environment (8 items) Scoring: Items scored 1-5. Raw domain score is the sum of respective item scores. All domain scores are then normalized to a range of 0-100. Results reported by each sub-domain and by total score.

Self-reported performance in various diabetes health management tasks; higher score = higher level of performance with diabetes self management. Includes two parts to the assessment. Part A has the caregiver rate their performance in each category from the past 3 months. There are 5 subdomains: Diabetes Self-Management, (6 questions); Nutrition (2 questions); Physical Activity \& Exercise (2 questions); School and Childcare (3 questions); and Lifestyle Management (12 questions). Part B has the caregiver rate their child's performance in the following subdomains: Diabetes Self-Management (5 questions); Nutrition (2 questions); Physical Activity and Exercise (2 questions); School and Childcare (1 question); and Lifestyle Management (3 questions). Results reported by each subdomain.

A self-reported questionnaire for caregivers to report any potential difficulties with managing their child's diabetes cares. It includes 16 questions, with a rating of 1-6, with higher scores indicating a more serious problem with managing their child's diabetes. Results reported as one total score.

A self-reported questionnaire for caregivers to report any potential family conflicts with managing their child's diabetes' cares. It includes 19 questions, with a 1-3 rating, and higher ratings indicating more family conflict.

A self-reported questionnaire for caregivers to report their confidence with managing their child's diabetes self-cares. Includes 17 questions, on a 1-5 rating, with higher scores indicating higher levels of confidence in completing diabetes self management.

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
Suspended
The University of North Carolina at Chapel HillChapel Hill, United StatesSee the location
Recruiting soonOne Study Center