Occupational Therapy for Type 1 Diabetes
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests an occupational therapy program called REAL-Fam to determine if it helps families better manage their child's type 1 diabetes. The researchers aim to discover if this program can enhance family life and the child's health through telehealth sessions. Families with a child who has type 1 diabetes and live in a rural area far from a pediatric diabetes care team might be suitable candidates. Participants will either join the REAL-Fam sessions or a general activity group to compare outcomes. The goal is to assess whether the REAL-Fam program is effective and merits further study. As an unphased trial, this study offers families the opportunity to explore innovative support methods for managing type 1 diabetes.
Do I need to stop my current medications for this trial?
The trial information does not specify whether you need to stop taking your current medications. It seems focused on occupational therapy and family routines, so it's unlikely that medication changes are required.
What prior data suggests that the REAL-Fam occupational therapy intervention is safe for families managing type 1 diabetes?
Research shows that the REAL-Fam occupational therapy program is well-received. This program includes online sessions to help families better manage type 1 diabetes. Previous studies indicate that families using this method improved their diabetes management and engaged more in meaningful activities. No major reports of negative side effects have been linked to this type of therapy, suggesting it is safe for participants. Since this trial is in its early stages, it primarily aims to assess the program's feasibility for further study, rather than testing new drugs or invasive treatments.12345
Why are researchers excited about this trial?
Researchers are excited about the REAL-Fam Occupational Therapy Family Coaching intervention because it offers a fresh approach to managing Type 1 Diabetes by focusing on family dynamics and resilience. Unlike standard treatments that primarily target blood sugar levels through medication and diet, this program enhances family communication and problem-solving skills through 12 weekly telehealth sessions. By engaging both caregivers and children, it aims to empower families to manage diabetes more effectively and improve overall quality of life.
What evidence suggests that the REAL-Fam occupational therapy intervention could be effective for managing type 1 diabetes?
Research shows that the REAL-Fam occupational therapy coaching, available to participants in this trial, can help families manage type 1 diabetes in children more effectively. This program goes beyond tracking blood sugar; it provides healthcare experiences that respect different cultures and enhance family life. Studies indicate that similar programs can reduce stress for both parents and children and help control children's blood sugar levels. Telehealth extends this program's reach to families in rural areas. Early results suggest it might ease the challenges of living with type 1 diabetes for the entire family.23467
Who Is on the Research Team?
Vanessa Jewell, PhD
Principal Investigator
University of North Carolina, Chapel Hill
Are You a Good Fit for This Trial?
This trial is for families in rural areas managing a child's type 1 diabetes. Eligible participants include children with type 1 diabetes and their caregivers, who are willing to use continuous glucose monitors and complete surveys. Families must be able to attend telehealth sessions.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants engage in the REAL-Fam intervention or Attention Group activities over a 12-week period
Follow-up
Participants complete post-study interviews and surveys to assess outcomes and satisfaction
What Are the Treatments Tested in This Trial?
Interventions
- REAL-Fam Occupational Therapy Family Coaching
Trial Overview
The study tests the REAL-Fam occupational therapy family coaching intervention via telehealth against an Attention Group without specialized services. It aims to improve family participation in diabetes management, quality of life, self-efficacy, and the child's blood glucose stability.
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
Active Control
8 caregiver-child dyads will receive the Resilient, Empowered, Active Living for Families intervention. This is an occupational therapy family coaching intervention, which will be delivered via 12 weekly telehealth sessions.
8 caregiver-child dyads will receive 3 attention group sessions with a research team member and engage in activities such as creating music play lists, playing games, and having conversation without specialized healthcare services.
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of North Carolina, Chapel Hill
Lead Sponsor
American Occupational Therapy Foundation
Collaborator
Creighton University
Collaborator
University of Southern California
Collaborator
DexCom, Inc.
Industry Sponsor
Kevin Sayer
DexCom, Inc.
Chief Executive Officer since 2015
Bachelor’s and Master’s degrees in Accounting and Information Systems from Brigham Young University
Dr. Shelly Lane
DexCom, Inc.
Chief Medical Officer since 2023
MD from University of California, San Diego
Citations
REAL-Fam Feasibility Study for Youth Diabetes Management
The REAL-Fam is innovative because it will extend diabetes care beyond glucose monitoring to include culturally sensitive healthcare experiences ...
REAL-Fam Telehealth for Rural Families with Type 1 ...
This study focuses on helping families in rural areas manage type 1 diabetes in children more effectively. Type 1 diabetes is becoming more ...
Telehealth Family Coaching With Type 1 Diabetes
This study utilizes Occupation-Based-Coaching (OBC) via telehealth to improve quality of life of families and children diagnosed with type 1 diabetes living in ...
Occupational Therapy for Type 1 Diabetes
... REAL-Fam Occupational Therapy Family Coaching will have tolerable side effects & efficacy for patients with Type 1 Diabetes and Diabetes ...
A Systematic Review and Meta‐Analysis
Psychological interventions significantly reduced parent and child psychological distress post‐intervention and improved child blood glucose at short‐term ...
REAL-Fam Feasibility Study for Youth Diabetes Management
Researchers will compare the REAL-Fam intervention to the Attention Group to see if there are changes in family diabetes-related health routines ...
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researchgate.net
researchgate.net/publication/387363540_Telehealth_Occupation-Based_Coaching_for_Rural_Parents_of_Children_With_Type_1_Diabetes_A_Randomized_Controlled_Trial(PDF) Telehealth Occupation-Based Coaching for Rural ...
Families who received occupational therapy services were more likely to improve their family participation in meaningful activities and diabetes ...
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