Clinical trial NCT05234944: Pilot Study of Brief Intervention to Support Diabetes Health-Related Quality of Life
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes Mellitus, Type 1
Keywords: behavioral intervention
Lead sponsor: Baylor College of Medicine
Sponsor class: OTHER
Collaborators: name: The Leona M. and Harry B. Helmsley Charitable Trust
First posted: 2022-02-10
Enrollment: 120
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Non-randomized pilot study, all participants will receive intervention
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility 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.

Primary outcomes:
measure: Feasibility of participant accrual, data collection, intervention delivery
timeFrame: Post-intervention, up to 6 months
measure: Acceptability
timeFrame: Post-intervention, up to 6 months
Secondary outcomes:
measure: Diabetes health-related quality of life
timeFrame: Baseline and Post-intervention, up to 6 months
measure: Diabetes distress
timeFrame: Baseline and Post-intervention, up 6 months
measure: Adherence/Diabetes Self-management
timeFrame: Baseline and Post-intervention, up to 6 months
measure: Glycemic Outcome - HbA1c
timeFrame: Baseline and Post-intervention, up to 6 months
measure: Glycemic Outcome - Time in Range
timeFrame: Baseline and Post-intervention, up to 6 months
Other outcomes:
Locations:
city: Stanford
country: United States
facility: Stanford University
state: California
city: Syracuse
country: United States
facility: Joslin Diabetes Center at SUNY Upstate Medical University
state: New York
city: Houston
country: United States
facility: Baylor College of Medicine
state: Texas
Study officials:
affiliation: Baylor College of Medicine
name: Marisa Hilliard, PhD
role: PRINCIPAL_INVESTIGATOR
References: