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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.

NCT07292558 · University of British Columbia
In plain English

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Official title
Achieving Health in Emerging Adults With Diabetes (AHEAD) Study
About this study
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.
Eligibility criteria
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
Study design
Enrollment target: 306 participants
Allocation: randomized
Masking: none
Age groups: child, adult
Timeline
Starts: 2025-12-15
Estimated completion: 2028-12
Last updated: 2025-12-30
Interventions
Behavioral: AHEAD Program
Primary outcomes
  • Hemoglobin A1c (HbA1c) (From enrollment (baseline clinic visit: 0 months) to the end of intervention period (6th clinic visit: 15-24 months).)
Sponsor
University of British Columbia · other
With: Breakthrough T1D, Seattle Children's Hospital, University of Washington, Kaiser Permanente
Contacts & investigators
ContactBeth Loots, MPH, MSW · contact · beth.loots@seattlechildrens.org · 206-884-4488
ContactFaisal S Malik, MD, MSc · contact · faisal.malik@bcchr.ca · 604-875-2117
InvestigatorFaisal S Malik, MD, MSc · principal_investigator, University of British Columbia
All locations (1)
Seattle Children'sRecruiting
Seattle, Washington, United States
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. · TrialPath