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| ID | Type | Description | Link |
|---|---|---|---|
| 4-SRA-2024-1580-M-B | Other Grant/Funding Number | Breakthrough T1D |
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| Name | Class |
|---|---|
| Breakthrough T1D | OTHER |
| Seattle Children's Hospital | OTHER |
| University of Washington | OTHER |
| Kaiser Permanente |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| AHEAD Program | Experimental | 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. |
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| Usual Care | No Intervention | Usual Care participants will receive diabetes care as currently being provided by their primary medical team. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Hemoglobin A1c (HbA1c) | HbA1c laboratory measurement. | From enrollment (baseline clinic visit: 0 months) to the end of intervention period (6th clinic visit: 15-24 months). |
| Measure | Description | Time Frame |
|---|---|---|
| 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). | From enrollment (baseline clinic visit: 0 months) to the end of intervention period (6th clinic visit: 15-24 months). |
| Diabetes Distress |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Beth Loots, MPH, MSW | Contact | 206-884-4488 | beth.loots@seattlechildrens.org | |
| Faisal S Malik, MD, MSc | Contact | 604-875-2117 | faisal.malik@bcchr.ca |
| Name | Affiliation | Role |
|---|---|---|
| Faisal S Malik, MD, MSc | University of British Columbia | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Seattle Children's | Recruiting | Seattle | Washington | 98101 | United States |
The datasets generated during and/or analysed during the current study will be stored in a publicly available repository (OpenScience Framework: https://osf.io/). To address privacy and confidentiality concerns, sharing of data generated will be limited to de-identified data at the aggregate level.
Data requests can be submitted at the end of the funding period and the data will be made accessible for up to 10 years.
Access, distribution, and reuse of the data will require approval from study investigators.
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| OTHER |
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Diabetes distress will be assessed with the Problem Areas in Diabetes Scale -- Teen Version. Higher scores indicate higher diabetes distress (score: 14-84). |
| From enrollment (baseline clinic visit: 0 months) to the end of intervention period (6th clinic visit: 15-24 months). |
| 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. | From enrollment (baseline clinic visit: 0 months) to the end of intervention period (6th clinic visit: 15-24 months). |
| 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. | From enrollment (baseline clinic visit: 0 months) to the end of intervention period (6th clinic visit: 15-24 months). |
| Diabetes Family Conflict | Diabetes family conflict will be assessed with the Diabetes Family Conflict Scale. Higher scores indicate higher diabetes family conflict (score: 19-57). | From enrollment (baseline clinic visit: 0 months) to the end of intervention period (6th clinic visit: 15-24 months). |
| Relatedness | Relatedness will be measured using the Health Care Climate Questionnaire. Higher scores indicate more supportive health care practitioner(s) (score: 15-105). | From enrollment (baseline clinic visit: 0 months) to the end of intervention period (6th clinic visit: 15-24 months). |
| Autonomy Treatment Self-Regulation Questionnaire | Autonomy will be measured using the Treatment Self-Regulation Questionnaire. Higher scores indicate higher autonomy (score: 15-105). | From enrollment (baseline clinic visit: 0 months) to the end of intervention period (6th clinic visit: 15-24 months). |
| Disordered eating | Disordered eating will be measured using the Disordered Eating Problem Survey - Revised. Higher scores indicate increase disordered eating behaviors (score: 0-80). | From enrollment (baseline clinic visit: 0 months) to the end of intervention period (6th clinic visit: 15-24 months). |
| Depression | Depression will be measured using the Patient Health Questionnaire-9. Higher scores indicate higher depression severity (score: 0-27). | From enrollment (baseline clinic visit: 0 months) to the end of intervention period (6th clinic visit: 15-24 months). |
| Generalized Anxiety | Anxiety will be measured using the Generalized Anxiety Disorder-7 questionnaire. Higher scores indicate higher severity of anxiety (score: 0-21). | From enrollment (baseline clinic visit: 0 months) to the end of intervention period (6th clinic visit: 15-24 months). |
| Social needs | Social needs will be measured using the social needs questionnaire. Endorsement of financial insecurity, food insecurity, transportation challenges, and housing insecurity, will indicate higher social need(s) (score: N/A). | From enrollment (baseline clinic visit: 0 months) to the end of intervention period (6th clinic visit: 15-24 months). |
| ID | Term |
|---|---|
| D003922 | Diabetes Mellitus, Type 1 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
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