REAL-Fam Feasibility Study for Youth Diabetes Management
This study is testing a program called REAL-Fam Occupational Therapy Family Coaching. This program uses occupational therapy to help families living in rural areas manage their child's Type 1 Diabetes. It focuses on finding personalized ways for parents and children to handle daily activities related to diabetes. The study wants to see if it's practical to study this program on a larger scale and how it affects families' quality of life and children's health. You might be able to join if you are a caregiver over 19 years old for a child with Type 1 Diabetes, live in a rural area more than an hour from a pediatric endocrinology (hormone specialist) team, and have reliable internet. The study is currently unclear on its recruitment status and plans to enroll 16 families.
- Study design
- This is an interventional study comparing two groups of participants, with 8 families in each group. It is a randomized clinical trial, meaning participants are assigned to groups by chance.
- What's involved
- The intervention group will participate in a 12-week REAL-Fam program. The study will measure how many families join and stay in the study for 12 weeks after treatment starts.
- Compensation
- Not stated in the trial record.
- Follow-up
- Participants will be followed for 12 weeks after treatment begins to assess retention.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
REAL-Fam Feasibility Study for Youth Diabetes Management
At a glance
Conditions
Where it's being run
1 sites across 1 statesStudy leadership
- Vanessa Jewell, PhD · PRINCIPAL_INVESTIGATOR · University of North Carolina, Chapel Hill
Who to contact
This trial hasn't published a contact. View it on ClinicalTrials.gov
Do you actually qualify for this trial?
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Inclusion
Exclusion
What this trial measures
- Percentage of Families Consented Versus Approached12-week post treatment initiation
One feasibility measure was to evaluate the number and percentage of families consented compared to those approached for participation in the study.
- Number and Percentage of Standard of Care Condition Participants Retained vs Enrolled12-week post treatment initiation
Number and Percentage of standard of care condition participants retained in the study compared to those enrolled. Retention is defined as participants who completed post-intervention assessments.
- Number and Percentage of Intervention Group Condition Participants Retained vs Enrolled12-week post treatment initiation
Number and Percentage of Intervention Group participants retained in the study compared to those enrolled. Retention is defined as participants who completed post-intervention assessments.
- Number and Percentage of Surveys Completed by Participants Who Completed the Study12-week post treatment initiation
Number and Percentage of surveys over time completed by participants who completed the study.
- Number and Percentage of attendance at telehealth sessions12-week post treatment initiation
The total number/amount of sessions attended out of the total number of sessions available, reported as both the total number and the percentage.
- Number and percentage of dyads enrolled for the different recruitment strategies12-week post treatment initiation
For each recruitment strategy, the researchers will document the total number and percentage of how many families were eligible, approached, and enrolled
- Telehealth Satisfaction Survey12-week post treatment initiation
A self-reported questionnaire for caregivers to rate how satisfied they were with the telehealth sessions (a measure of study acceptability). It includes 10 questions with 1-4 ratings, with higher scores indicating higher levels of satisfaction.
- Training Satisfaction Rating Scale12-week post treatment initiation
A self-reported questionnaire for caregivers to rate their satisfaction with the REAL-Fam intervention. It includes the following subdomains: Objectives and content (3 questions); Method of training context (6 questions); Usefulness and overall rating (3 questions). Items are rated on a 1-5 scale, with higher scores indicating higher levels of acceptability.
- Study Specific Interview Guide12-week post treatment initiation
A semi-structured interview guide to qualitatively assess feasibility and acceptability of the REAL-Fam intervention framework. It includes questions related to recruitment and enrollment (3 questions); scheduling and time commitment (3 questions); assessments and data collection (3 questions); technology use (2 questions); overall burden/ease (2 questions); perceived value of the intervention ( 2 questions); engagement and enjoyment (2 questions); format delivery (2 questions); relevance to family's life (2 questions); therapist interaction (2 questions); rural context (2 questions); modules and content (3 questions); habit \& routine focus of the intervention (3 questions); perceived changes/impact (2 questions); recommendations for improvement (2 questions); and overall reflections (2 questions). Qualitative results will be reported by each sub-domain.