Feasibility of REAL-Fam to Support Diabetes Self-Management, Family Participation, and Child Health
University of North Carolina, Chapel Hill
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
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, qu…
Eligibility
- Age range
- 2–99 years
- Sex
- All
- Healthy volunteers
- Yes
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
Interventions
- BehavioralREAL-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.
Location
- The University of North Carolina at Chapel HillChapel Hill, North Carolina