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

NCT ID: NCT05234944

Last Updated: 2024-10-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 120 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-12-09
• Study Completion Date: 2024-10-01

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.

Conditions

Diabetes Mellitus, Type 1

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Intervention

A CDCES trained by the research team will deliver the intervention via HIPAA compliant telehealth/videoconferencing platform. There will be 2 sessions within approximately 6 months. Prior to each session, participants will complete an assessment of T1D-specific health-related quality of life, which will generate a summary report for each person that lists aspects of quality of life that are going well and aspects that are potential areas for improvement. The CDCES will review the reports with the participants, focusing on building on areas of strength and teaching brief behavioral strategies or resources to address aspects of quality of life that could be improved. Strategies may include stress management, problem-solving techniques, goal-setting, strategies to seek social support, or other brief behavioral skills. The CDCES will also offer information about relevant resources and will provide referrals for mental health support as needed.

Group Type: EXPERIMENTAL

Type 1 Diabetes and Life

Intervention Type: BEHAVIORAL

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.

Interventions

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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• Type 1 diabetes diagnosis for at least 12 months
• Treated at the participating clinical site (for the pediatric and adult subspecialty sites)
• Fluent in English

• Age 18 years or older.
• Child/Partner with diabetes participating in study
• Fluent in English

Exclusion Criteria

• Any major comorbid medical (PWD only), cognitive, or psychiatric condition that would limit ability to participate
• Plans to move to another clinical site during the study.

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

The Leona M. and Harry B. Helmsley Charitable Trust

OTHER

Sponsor Role: collaborator

Baylor College of Medicine

OTHER

Sponsor Role: lead

Responsible Party

Marisa Hilliard

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Marisa Hilliard, PhD

Role: PRINCIPAL_INVESTIGATOR

Baylor College of Medicine

Locations

Stanford University

Stanford, California, United States

Joslin Diabetes Center at SUNY Upstate Medical University

Syracuse, New York, United States

Baylor College of Medicine

Houston, Texas, United States

Countries

United States

Other Identifiers

H-50359

Identifier Type: -

Identifier Source: org_study_id