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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
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

Full criteria on ClinicalTrials.gov

Sites (3)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Baylor College of Medicine
Coordinator of this site? Confirm its status
HoustonUnited StatesUnknown status
Stanford University
Coordinator of this site? Confirm its status
StanfordUnited StatesUnknown status
Joslin Diabetes Center at SUNY Upstate Medical University
Coordinator of this site? Confirm its status
SyracuseUnited StatesUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.