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

NCT05234944 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 120

Last updated 2024-10-10

No results posted yet for this study

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

Interventions

BEHAVIORAL

Type 1 Diabetes and Life

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.

Sponsors & Collaborators

  • Baylor College of Medicine

    lead OTHER
  • The Leona M. and Harry B. Helmsley Charitable Trust

    collaborator OTHER

Principal Investigators

  • Marisa Hilliard, PhD · Baylor College of Medicine

Study Design

Allocation
NA
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-12-09
Primary Completion
2024-10-01
Completion
2024-10-01

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05234944 on ClinicalTrials.gov