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
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Diabetes Mellitus, Type 1
- Sponsor
- Baylor College of Medicine
- Enrollment
- 120
- Locations
- 3
- Primary Endpoint
- Feasibility of participant accrual, data collection, intervention delivery
- Status
- Completed
- Last Updated
- last year
Overview
Brief 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.
Investigators
Marisa Hilliard
Associate Professor
Baylor College of Medicine
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
Feasibility of participant accrual, data collection, intervention delivery
Time Frame: Post-intervention, up to 6 months
Feasibility of conducting a research study about this intervention will be measured by percentage of eligible participants who consent to the study, complete questionnaires, and receive the full intervention dose. These outcomes will be calculated based on recruitment and program delivery tracking conducted by study staff
Acceptability
Time Frame: Post-intervention, up to 6 months
Participants will complete brief surveys at study completion that assess their experiences with the intervention, including helpfulness of conversations, value of time spent, overall acceptability of program, and recommendations for improvement. Items will be rated using a Likert-scale, with higher scores indicating higher satisfaction with each item.
Secondary Outcomes
- Diabetes health-related quality of life(Baseline and Post-intervention, up to 6 months)
- Diabetes distress(Baseline and Post-intervention, up 6 months)
- Adherence/Diabetes Self-management(Baseline and Post-intervention, up to 6 months)
- Glycemic Outcome - HbA1c(Baseline and Post-intervention, up to 6 months)
- Glycemic Outcome - Time in Range(Baseline and Post-intervention, up to 6 months)