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RecruitingNCT07292558

Achieving Health in Emerging Adults With Diabetes (AHEAD) Program: A Clinical Trial Designed to Understand if Participation in a Clinical Program Developed Specifically to Support Emerging Adults With Type 1 Diabetes Leads to Improved Diabetes Outcomes.

Achieving Health in Emerging Adults With Diabetes (AHEAD) Study

Status
Recruiting
Phase
N/A
Study type
Interventional
Enrollment
306 (estimated)
Sponsor
University of British Columbia · Academic / Other
Sex
All
Age
16 Years – 19 Years
Healthy volunteers
Not accepted

Summary

The goal of this study is to determine whether the Achieving Health in Emerging Adults with Diabetes (AHEAD) Program helps emerging adults with type 1 diabetes improve their blood glucose management during the transition from pediatric to adult care. Participants will be randomized to receive Usual Care or the AHEAD Program, which provides tailored support to emerging adults to build autonomy and competence to facilitate independent diabetes management. Researchers will compare changes in glycemia and participant-reported outcomes between groups.

Detailed description

Many emerging adults with type 1 diabetes find it difficult to maintain their blood glucose levels within the recommended range most of the time. This can increase their risk for serious short- and long-term diabetes-related health problems. Managing diabetes becomes especially difficult during the transition from pediatric care to adult care when emerging adults are expected to manage their condition on their own. The Achieving Health in Emerging Adults with Diabetes (AHEAD) Program was developed to support emerging adults with their transition to independence. It focuses on helping them build autonomy and competence needed to manage their diabetes independently. The program is based on self-determination theory and best practices for supporting successful health care transition to adult care. In this study, 306 emerging adults will be randomly assigned to either the AHEAD Program or Usual Care arms. Participants will have 6 clinic visits and complete surveys prior to their clinic visits. AHEAD participants will receive support from a team of diabetes providers who have expertise in supporting emerging adults living with diabetes every three months. Usual Care participants will continue to receive the diabetes care as they do currently every three months. Researchers will evaluate changes in glycemia and participant-reported outcomes (e.g., diabetes distress, transition readiness). The study will also assess the cost and cost-effectiveness of AHEAD, as well as factors related to its implementation.

Conditions

Interventions

TypeNameDescription
BEHAVIORALAHEAD ProgramParticipants will complete self-assessments around health care transition readiness and mental health prior to an AHEAD clinic visit. Emerging adults will then received tailored clinical support based on their self-assessments and work to build their autonomy and competence to manage their diabetes and health care independently with the support of their AHEAD providers.

Timeline

Start date
2025-12-15
Primary completion
2028-12-01
Completion
2028-12-01
First posted
2025-12-18
Last updated
2025-12-30

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT07292558. Inclusion in this directory is not an endorsement.