NCT05234944Completed
Pilot Study of Brief Intervention to Support Diabetes Health-Related Quality of Life
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
Source: ClinicalTrials.gov · Last updated 10 Oct 2024
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 120 (actual)
- First submitted
- 1 Feb 2022
- Start date
- 9 Dec 2022
- Primary completion date
- 1 Oct 2024
- Lead sponsor
- Baylor College of Medicine
- Diseases
- Type 1 diabetes
- NCT number
- NCT05234944
What you commit to
- Study type: Interventional
- Participants enrolled: 120
- From 9 Dec 2022 to the primary completion date, 1 Oct 2024
- 3 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Any major comorbid medical (PWD only), cognitive, or psychiatric condition that would limit ability to participate
Other
- Plans to move to another clinical site during the study.
Who the study is looking for
- 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
Sex: All · Does not accept healthy volunteers
Sites (3)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Baylor College of Medicine Coordinator of this site? Confirm its status | Houston | United States | Unknown status |
| Stanford University Coordinator of this site? Confirm its status | Stanford | United States | Unknown status |
| Joslin Diabetes Center at SUNY Upstate Medical University Coordinator of this site? Confirm its status | Syracuse | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.