Pilot Study of Brief Intervention to Support Diabetes Health-Related Quality of Life (T1DALPilot)

Baylor College of Medicine

Status: Completed

Conditions: Diabetes Mellitus, Type 1

Treatments: Behavioral: Type 1 Diabetes and Life

Study type: Interventional

Funder types: Other

Identifiers

NCT05234944

H-50359

Details and patient eligibility

About

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.

Full 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.

Enrollment: 120 patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria (People with Diabetes):

• 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

Inclusion Criteria (Parents/Partners):

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

Exclusion Criteria (all participants):

• 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.

Trial design

Primary purpose: Supportive Care

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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120 participants in 1 patient group

Intervention

Experimental group

Description:

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.

Treatment:

Behavioral: Type 1 Diabetes and Life