REAL-Fam Feasibility Study for Youth Diabetes Management

NCT07212790 | Recruiting

• 1 other identifier: 25-0708
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Type 1 Diabetes

Keywords

Type 1 Diabetes; Rural Health; Occupational Therapy; Diabetes Management; Behavioral Health; Family-Centered Care; Psychosocial; Family Health; Diabetes; Behavioral Intervention; Child Health; Family Participation; Diabetes Quality of Life

Outcome Measures

Primary Outcomes (9)

• Percentage of Families Consented Versus Approached

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

  12-week post treatment initiation

• Number and Percentage of Standard of Care Condition Participants Retained vs Enrolled

  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.

  12-week post treatment initiation

• Number and Percentage of Intervention Group Condition Participants Retained vs Enrolled

  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.

  12-week post treatment initiation

• Number and Percentage of Surveys Completed by Participants Who Completed the Study

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

  12-week post treatment initiation

• Number and Percentage of attendance at telehealth sessions

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

  12-week post treatment initiation

• Number and percentage of dyads enrolled for the different recruitment strategies

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

  12-week post treatment initiation

• Telehealth Satisfaction Survey

  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.

  12-week post treatment initiation

• Training Satisfaction Rating Scale

  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.

  12-week post treatment initiation

• Study Specific Interview Guide

  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.

  12-week post treatment initiation

Secondary Outcomes (5)

• WHO Quality of Life, Brief (WHOQOL-BREF)

  Baseline and 12-week post treatment initiation

• Diabetes Health Management Performance Scale - Parents of Children

  Baseline and 12-week post treatment initiation

• Problem Areas in Diabetes - Parents of Children

  Baseline and 12-week post treatment initiation

• Diabetes Family Conflict Scale - Revised

  Baseline and 12-week post treatment initiation

• Self-Efficacy for Diabetes Scale (MSED)

  Baseline and 12-week post treatment initiation

Study Arms (2)

REAL-Fam Intervention Group

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.

Behavioral: REAL-Fam Occupational Therapy Family Coaching

Attention Group

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.

Interventions

REAL-Fam Occupational Therapy Family Coaching BEHAVIORAL

The REAL-Fam draws on the expertise of occupational therapy in evaluating the fit between the demands of everyday activities and the skills and abilities of the parent-child dyads. The dyad and the occupational therapist will be equipped to co-develop personalized strategies to enable participation in these meaningful occupations. It facilitates the family's consistent, habitual, and effective performance of their child's diabetes management tasks into their personalized daily routines. Emphasis is on the creation or modification of family-centered diabetes management and routines and catered to the child's developmental needs. Due to the complexity of diabetes management cares and the child's age, the caregiver will be present for all sessions. When working towards a caregiver-centered outcome, the caregiver will participate with little child involvement. When working toward a child-centered outcome, the child will be the focus of that session.

REAL-Fam Intervention Group

Eligibility Criteria

• Age: 2 Years - 99 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 may not qualify if:

• 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

Sponsors & Collaborators

• University of North Carolina, Chapel Hill: lead
• American Occupational Therapy Foundation: collaborator
• Creighton University: collaborator
• DexCom, Inc.: collaborator
• University of Southern California: collaborator

Study Sites (1)

The University of North Carolina at Chapel Hill

Chapel Hill, North Carolina, 27514, United States

RECRUITING

MeSH Terms

Conditions

Diabetes Mellitus, Type 1; Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Vanessa Jewell, PhD

  University of North Carolina, Chapel Hill

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The statistician who is performing randomization and statistical analysis of data will be blinded to which arm of the study to which a participant was selected.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: There will be an intervention group and an attention group participating over the same 14 week study period.

Study Record Dates

• First Submitted: September 22, 2025
• First Posted: October 8, 2025
• Study Start: December 15, 2025
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): June 1, 2026
• Last Updated: January 23, 2026

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: beginning 9 and continuing for 36 months following publication
• Access Criteria: Investigator has approved IRB, IEC, or REB and an executed data use/sharing agreement with the University of North Carolina at Chapel Hill

Locations

US (1)