REAL-Fam Feasibility Study for Youth Diabetes Management

NCT ID: NCT07212790

Last Updated: 2025-10-08

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 16 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-10-31
• Study Completion Date: 2026-06-30

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

Detailed Description

The prevalence of type 1 diabetes (T1D) is increasing among youth in the U.S., with higher incidence rates documented in rural communities compared to their urban peers. This rise is especially concerning for rural families, because they are at risk for healthcare disparities resulting from transportation challenges, lack of healthcare access, decreased financial stability, and other social determinants of health. The Resilient Empowered Active Living for Families (REAL-Fam) occupational therapy telehealth intervention provides a practical, immediate solution to increase access to low-cost, quality healthcare services for rural-dwelling caregivers and children living with T1D. Utilizing community-engaged research methods, this randomized clinical trial with follow-up interviews examines the feasibility of the 12-week REAL-Fam intervention group (n=8 dyads) compared to an attention group (n=8 dyads) for rural-dwelling caregiver/child dyads to improve the a) caregivers' diabetes management self-efficacy, b) caregivers' quality of life, and the c) children's glycemic levels. The REAL-Fam is innovative because it will extend diabetes care beyond glucose monitoring to include culturally sensitive healthcare experiences, family-centered behavioral interventions, healthy habit and routine training, and school and childcare participation strategies within the scope of occupational therapy. The successful evaluation of the REAL-Fam is critical to evaluate the protocol and support a full-scale clinical trial, which may inform other historically underrepresented socio-demographic groups that may not have access to ongoing diabetes healthcare services.

The findings from this study will inform healthcare practitioners, patients, and other stakeholders of the needs of rural families who are caring for a child with T1D and their urgent healthcare needs, such as improving quality of life and increasing access to specialized healthcare services. From the interdisciplinary team's past research focusing on T1D stakeholder needs in rural communities, it was apparent that many caregivers reported a need to access specialized diabetes care quicker after their child's diagnosis, which without this access they experienced poor health outcomes. Overall, successful evaluation of the REAL-Fam telehealth intervention is an important, necessary step to support future studies that may contribute to the advancement of T1D healthcare practices and improved child health outcomes for rural dwelling families.

Conditions

Type 1 Diabetes

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: SINGLE

Study Groups

REAL-Fam Intervention Group

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 Type: EXPERIMENTAL

REAL-Fam Occupational Therapy Family Coaching

Intervention Type: 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.

Attention Group

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

REAL-Fam Occupational Therapy Family Coaching

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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

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

• Minimum Eligible Age: 2 Years
• Maximum Eligible Age: 99 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

American Occupational Therapy Foundation

OTHER

Sponsor Role: collaborator

Creighton University

OTHER

Sponsor Role: collaborator

DexCom, Inc.

INDUSTRY

Sponsor Role: collaborator

University of Southern California

OTHER

Sponsor Role: collaborator

University of North Carolina, Chapel Hill

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Vanessa Jewell, PhD

Role: PRINCIPAL_INVESTIGATOR

University of North Carolina, Chapel Hill

Locations

The University of North Carolina at Chapel Hill

Chapel Hill, North Carolina, United States

Countries

United States

Facility Contacts

Vanessa Jewell, PhD

Role: primary

Vanessa_Jewell@med.unc.edu

919-843-4463

Shelley Newpher, MA

Role: backup

Shelley_Newpher@med.unc.edu

Other Identifiers

25-0708

Identifier Type: -

Identifier Source: org_study_id