NCT05234944

Pilot Study of Brief Intervention to Support Diabetes Health-Related Quality of Life

A Brief Telehealth Intervention to Address Diabetes Health-related Quality of Life (HRQOL) in Families of Youth and Adults with Type 1 Diabetes Across Clinical Settings: a Pilot and Feasibility Study

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 120 (actual)
• Sponsor: Baylor College of Medicine · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

Summary

The aims of this pilot study are to evaluate the feasibility, acceptability, preliminary impact, and costs of a brief, behavioral intervention delivered remotely by diabetes educators to people with type 1 diabetes and their family members. The purpose of the intervention is to support health-related quality of life for people with type 1 diabetes of all ages and to support the diabetes health-related quality of life of their parents and partners. This pilot study will explore how this intervention works as a supplement to routine medical care in three clinical care settings: an adult specialty diabetes care setting, a pediatric subspecialty diabetes care setting, and for people who receive diabetes medical care from a primary care provider. To maximize data about feasibility and acceptability of the intervention, all participants in the pilot study will receive the intervention and there will not be randomization to a control condition.

Detailed description

The aims of this pilot study are to evaluate the feasibility, acceptability, preliminary impact, and costs of a brief behavioral intervention to support diabetes health-related quality of life, delivered remotely by diabetes educators to people with type 1 diabetes and their family members. The key components of the intervention include people with diabetes and their parents/partners completing a validated measure of diabetes-specific health-related quality of life around the time of two consecutive diabetes clinic appointments. A trained study certified diabetes care and education specialist (CDCES) will meet remotely (via secure, HIPAA-compliant cloud-based telehealth/videoconferencing platform) to guide the family in a brief discussion about each person's diabetes health-related quality of life. They will discuss the parts of quality of life that are going well and the parts that are more challenging, and the CDCES will teach brief behavioral strategies to address quality of life challenges. Using a non-randomized design, all participants will receive the intervention for the pilot study. Participants will complete surveys prior to receiving the intervention and again after the completion of the intervention, and clinical data will be collected from the person with diabetes and their medical records. To evaluate this pilot intervention, the specific aims are: (1) Evaluate the feasibility and acceptability of the intervention for participants in three clinical settings: pediatric subspecialty clinic, adult specialty clinic, and diabetes care from primary care providers. (2) Examine preliminary indicators of pre-post change in behavioral and clinical outcomes. (3) Explore costs associated with intervention delivery and receipt to inform the next phases of intervention development and testing.

Conditions

• Diabetes Mellitus, Type 1

Interventions

Type	Name	Description
BEHAVIORAL	Type 1 Diabetes and Life	Brief behavioral intervention, delivered remotely by certified diabetes care and education specialists, targeting diabetes-specific health-related quality of life for people with type 1 diabetes across the lifespan and for their parents and partners.

Timeline

• Start date: 2022-12-09
• Primary completion: 2024-10-01
• Completion: 2024-10-01
• First posted: 2022-02-10
• Last updated: 2024-10-10

Locations

3 sites across 1 country: United States