REAL-Fam occupational therapy program to support rural families managing youth type 1 diabetes
Feasibility of REAL-Fam to Support Diabetes Self-Management, Family Participation, and Child Health
NA · University of North Carolina, Chapel Hill · NCT07212790
This study will test whether a 12-week REAL-Fam telehealth occupational therapy program helps rural caregivers and their children with type 1 diabetes improve daily diabetes routines and family quality of life.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 16 (estimated) |
| Ages | 2 Years to 99 Years |
| Sex | All |
| Sponsor | University of North Carolina, Chapel Hill (other) |
| Locations | 1 site (Chapel Hill, North Carolina) |
| Trial ID | NCT07212790 on ClinicalTrials.gov |
What this trial studies
This is a randomized feasibility trial comparing a 12-week REAL-Fam occupational therapy telehealth intervention to an attention control group for rural caregiver–child dyads living with type 1 diabetes. Sixteen dyads (approximately 8 per group) will be enrolled and followed with quantitative assessments and follow-up interviews to examine recruitment, acceptability, interventionist fidelity, and preliminary family and glycemic outcomes. Outcomes include caregiver diabetes-management self-efficacy, family quality of life and participation, and child blood glucose stability. The trial uses community-engaged methods to tailor the intervention for rural families and to refine procedures for a future larger randomized trial.
Who should consider this trial
Good fit: Ideal participants are caregivers aged 19 or older who are the parent or legal guardian of a child with type 1 diabetes, live in a rural area more than one hour from pediatric endocrinology care, and have reliable internet access.
Not a fit: Caregivers who are not involved in diabetes supervision, whose child is already receiving occupational therapy, who lack reliable internet, or whose child has a severe developmental or neurological disability are unlikely to benefit from this program.
Why it matters
Potential benefit: If successful, the REAL-Fam approach could increase access to family-centered diabetes support for rural households and improve caregiver confidence, family routines, and children’s blood glucose stability.
How similar studies have performed: Telehealth behavioral and diabetes-support interventions have shown promise in improving self-management, but occupational-therapy–focused telehealth for rural families with pediatric type 1 diabetes is relatively novel and has limited prior evidence.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Chapel Hill, North Carolina
- The University of North Carolina at Chapel Hill — Chapel Hill, North Carolina, United States (RECRUITING)
Study contacts
- Principal investigator: Vanessa Jewell, PhD — University of North Carolina, Chapel Hill
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Type 1 Diabetes, Rural Health, Occupational Therapy, Diabetes Management, Behavioral Health, Family-Centered Care, Psychosocial, Family Health