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

NCT05234944 | Completed

• 1 other identifier: H-50359
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 3

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.

Conditions

Diabetes Mellitus, Type 1

Keywords

behavioral intervention

Outcome Measures

Primary Outcomes (2)

• Feasibility of participant accrual, data collection, intervention delivery

  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

  Post-intervention, up to 6 months

• Acceptability

  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.

  Post-intervention, up to 6 months

Secondary Outcomes (5)

• 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

Study Arms (1)

Intervention

EXPERIMENTAL

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.

Behavioral: Type 1 Diabetes and Life

Interventions

Type 1 Diabetes and Life 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.

Intervention

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Baylor College of Medicine: lead
• The Leona M. and Harry B. Helmsley Charitable Trust: collaborator

Study Sites (3)

Stanford University

Stanford, California, 94305, United States

Location

Joslin Diabetes Center at SUNY Upstate Medical University

Syracuse, New York, 13214, United States

Location

Baylor College of Medicine

Houston, Texas, 77030, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Marisa Hilliard, PhD

  Baylor College of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: Non-randomized
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: Non-randomized pilot study, all participants will receive intervention

Study Record Dates

• First Submitted: February 1, 2022
• First Posted: February 10, 2022
• Study Start: December 9, 2022
• Primary Completion: October 1, 2024
• Study Completion: October 1, 2024
• Last Updated: October 10, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: 6 months after publication
• Access Criteria: Upon request to PI

Locations

US (3)