REAL-Fam Feasibility Study for Youth Diabetes Management

Official title

Feasibility of REAL-Fam to Support Diabetes Self-Management, Family Participation, and Child Health

Overview

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.

Interventions

• Behavioral 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

Primary outcome measures

• Percentage of Families Consented Versus Approached [Time frame: 12-week post treatment initiation]
• Number and Percentage of Standard of Care Condition Participants Retained vs Enrolled [Time frame: 12-week post treatment initiation]
• Number and Percentage of Intervention Group Condition Participants Retained vs Enrolled [Time frame: 12-week post treatment initiation]
• Number and Percentage of Surveys Completed by Participants Who Completed the Study [Time frame: 12-week post treatment initiation]
• Number and Percentage of attendance at telehealth sessions [Time frame: 12-week post treatment initiation]
• Number and percentage of dyads enrolled for the different recruitment strategies [Time frame: 12-week post treatment initiation]
• Telehealth Satisfaction Survey [Time frame: 12-week post treatment initiation]
• Training Satisfaction Rating Scale [Time frame: 12-week post treatment initiation]
• Study Specific Interview Guide [Time frame: 12-week post treatment initiation]

Secondary outcome measures (5)

• WHO Quality of Life, Brief (WHOQOL-BREF) [Time frame: Baseline and 12-week post treatment initiation]
• Diabetes Health Management Performance Scale - Parents of Children [Time frame: Baseline and 12-week post treatment initiation]
• Problem Areas in Diabetes - Parents of Children [Time frame: Baseline and 12-week post treatment initiation]
• Diabetes Family Conflict Scale - Revised [Time frame: Baseline and 12-week post treatment initiation]
• Self-Efficacy for Diabetes Scale (MSED) [Time frame: Baseline and 12-week post treatment initiation]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Single blind

Primary purpose

Supportive care

Study locations

United States · 1 center

• The University of North Carolina at Chapel Hill — Chapel Hill

Identifiers

NCT: NCT07212790 · 25-0708

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗