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. (AHEAD Program)

University of British Columbia

Status: Enrolling

Conditions: Diabetes Mellitus, Type 1 Diabetes

Treatments: Behavioral: AHEAD Program

Study type: Interventional

Funder types: Other

Identifiers

NCT07292558

4-SRA-2024-1580-M-B (Other Grant/Funding Number)

H25-03574

Details and patient eligibility

About

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.

Full 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.

Enrollment: 306 estimated patients

Sex: All

Ages: 16 to 19 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. 16-19 years of age
2. Have had type 1 diabetes ≥ 12 months
3. Had a recent HbA1c ≥7.0%
4. Currently receive outpatient diabetes care at a Seattle Children's Hospital Diabetes Clinic located in Bellevue, Everett, Federal Way, or Seattle
5. Are able to complete written surveys
6. Will be able to receive clinical care in WA State for the next 2 years

Exclusion criteria

1. Have had a pilot program AHEAD clinic visit
2. Most recent Usual Care diabetes visit was with a current AHEAD provider

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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306 participants in 2 patient groups

AHEAD Program

Experimental group

Description:

AHEAD participants will receive support from a team of diabetes providers with expertise in supporting older adolescents and young adults who will work to build autonomy and competence needed to manage diabetes independently.

Treatment:

Behavioral: AHEAD Program

Usual Care

No Intervention group

Description:

Usual Care participants will receive diabetes care as currently being provided by their primary medical team.