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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.

ConditionDiabetes Mellitus, Type 1 Diabetes
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age16-19
SponsorUniversity of British Columbia

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

16-19 years of age

Have had type 1 diabetes ≥ 12 months

Had a recent HbA1c ≥7.0%

Currently receive outpatient diabetes care at a Seattle Children's Hospital Diabetes Clinic located in Bellevue, Everett, Federal Way, or Seattle

Disqualifiers

Have had a pilot program AHEAD clinic visit

Most recent Usual Care diabetes visit was with a current AHEAD provider

Trial design

Design model

Parallel

Treatments tested in this trial

  • AHEAD Program

    Behavioral

    Participants 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.

Treatment groups

306 Participants
are divided into 2 treatment groups
Group A: AHEAD ProgramExperimental treatment 1 intervention
Group B: Usual CareNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

Hemoglobin A1c (HbA1c)

HbA1c laboratory measurement.

Time frame
From enrollment (baseline clinic visit: 0 months) to the end of intervention period (6th clinic visit: 15-24 months).

Secondary outcomes

1

Time In Ranges

Continuous glucose monitor sensor glucose measurements that are in range (70-180 mg/dL), above range (\>180 mg/dL), and below range (\<70 mg/dL).

Time frame
From enrollment (baseline clinic visit: 0 months) to the end of intervention period (6th clinic visit: 15-24 months).
2

Diabetes Distress

Diabetes distress will be assessed with the Problem Areas in Diabetes Scale -- Teen Version. Higher scores indicate higher diabetes distress (score: 14-84).

Time frame
From enrollment (baseline clinic visit: 0 months) to the end of intervention period (6th clinic visit: 15-24 months).
3

Diabetes-Specific Health Care Transition Readiness

Diabetes-specific health care transition readiness will be assessed with the Readiness Assessment of Emerging Adults with Type 1 Diabetes tool. Higher scores (mean topic area score: 1-5) indicate higher diabetes-specific transition readiness.

Time frame
From enrollment (baseline clinic visit: 0 months) to the end of intervention period (6th clinic visit: 15-24 months).
4

General Health Care Transition Readiness

General health care transition readiness will be assessed with the Transition Readiness Assessment Questionnaire. Higher scores (mean topic area score: 1-5) indicate higher transition readiness.

Time frame
From enrollment (baseline clinic visit: 0 months) to the end of intervention period (6th clinic visit: 15-24 months).

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of British Columbia

Lead sponsor

Breakthrough T1D

Collaborator

Seattle Children's Hospital

Collaborator

University of Washington

Collaborator

Kaiser Permanente

Collaborator

Source ClinicalTrials.gov
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