NCT07212790 REAL-Fam Feasibility Study for Youth Diabetes Management
| NCT ID | NCT07212790 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of North Carolina, Chapel Hill |
| Condition | Type 1 Diabetes |
| Study Type | INTERVENTIONAL |
| Enrollment | 16 participants |
| Start Date | 2025-12-15 |
| Primary Completion | 2026-06 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 16 participants in total. It began in 2025-12-15 with a primary completion date of 2026-06.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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
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
Contact & Investigator
Vanessa Jewell, PhD
PRINCIPAL INVESTIGATOR
University of North Carolina, Chapel Hill
Frequently Asked Questions
Who can join the NCT07212790 clinical trial?
This trial is open to participants of all sexes, aged 2 Years or older, up to 99 Years, studying Type 1 Diabetes. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07212790 currently recruiting?
Yes, NCT07212790 is actively recruiting participants. Visit ClinicalTrials.gov or contact University of North Carolina, Chapel Hill to inquire about joining.
Where is the NCT07212790 trial being conducted?
This trial is being conducted at Chapel Hill, United States.
Who is sponsoring the NCT07212790 clinical trial?
NCT07212790 is sponsored by University of North Carolina, Chapel Hill. The principal investigator is Vanessa Jewell, PhD at University of North Carolina, Chapel Hill. The trial plans to enroll 16 participants.
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