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| ID | Type | Description | Link |
|---|---|---|---|
| 1K23DK131368 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) | NIH |
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The purpose of this research study is to evaluate a transition preparation program designed for adolescents and young adults (AYAs) with type 1 diabetes (T1D). This transition program will support AYAs as they prepare to transition from pediatric to adult endocrinology medical care and will also include a caregiver. Results from this study will inform clinical recommendations regarding self-management best practices for AYAs with T1D prior to transitioning to adult medical care.
Investigators will recruit adolescents and young adults ages 16-22 years with T1D and a parent/guardian. Families will participate in one of two 6-month treatments: 1) SHIFT2, engaging in monthly sessions with transition coaches providing education on diabetes management and healthcare transition, or 2) Enhanced treatment (TAU+), engaging in routine medical care and receiving monthly education (no coaches).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group A: SHIFT2 | Experimental | Adolescents and young adults will engage in routine medical visits and attend 6 sessions (1x/month) focused on transition preparation and diabetes management with a transition coach and will receive bi-weekly messages during these 6-months that encourage self-management behaviors. Parents will attend 2 sessions (month 1 and 6) with a transition coach and will receive materials, complementing their child's lesson, 1x/month for months 2-5 that focus on transition their role and supporting their child's diabetes management. |
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| Group B: TAU+/Control | Placebo Comparator | Participants will engage in routine medical visits and will receive education materials monthly (1x/month) regarding healthcare transition and diabetes management. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Transition preparation program | Behavioral | AYA will participate in virtual or in-person sessions with a transition coach and receive bi-weekly messages that encourage self-management. Caregivers will attend a virtual or in-person session with a transition coach. |
| Measure | Description | Time Frame |
|---|---|---|
| Hemoglobin A1C (HbA1C) | HbA1C will be assessed using a standard assay from a routine blood draw or an at-home testing kit | 6 months |
| Change in transition readiness | Transition readiness will be measured using the Readiness Assessment of Emerging Adults with Type 1 Diabetes Diagnosed in Youth (READDY) scale, which will be completed by AYAs. | Baseline to 6 months |
| Change in diabetes adherence | Diabetes adherence will be assessed using the Self-Care Inventory-Revised, which will be completed by both AYA and caregivers. | Baseline to 6 months |
| Attendance at clinic visits | Attendance at routine clinic visits will be determined from medical records and will be assessed by the number of regularly scheduled visits attended. | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| HbA1C | HbA1C will be assessed using a standard assay from a routine blood draw or an at-home testing kit. | 12 months |
| Diabetes-related events | Number of diabetes-related events will be determined from medical records |
| Measure | Description | Time Frame |
|---|---|---|
| Transition Status | AYAs that transition from pediatric to adult T1D care will be assessed. | Baseline to 12 months |
Inclusion Criteria:
AYA:
Caregiver:
Exclusion Criteria:
AYA:
Caregiver:
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| Name | Affiliation | Role |
|---|---|---|
| Laura Caccavale | Virginia Commonwealth University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Virginia Commonwealth University | Richmond | Virginia | 23298 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40529395 | Derived | Caccavale LJ, Streisand R, LaRose JG, Wickham EP 3rd, Hilliard ME, Thornton LM, Bean MK. A clinic-based healthcare transition preparation program for adolescents and young adults with type 1 diabetes: Study protocol for the SHIFT randomized clinical trial. Contemp Clin Trials Commun. 2025 May 27;46:101500. doi: 10.1016/j.conctc.2025.101500. eCollection 2025 Aug. | |
| 39382077 | Derived | Lalji R, Koh L, Francis A, Khalid R, Guha C, Johnson DW, Wong G. Patient navigator programmes for children and adolescents with chronic diseases. Cochrane Database Syst Rev. 2024 Oct 9;10(10):CD014688. doi: 10.1002/14651858.CD014688.pub2. |
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| ID | Term |
|---|---|
| D003922 | Diabetes Mellitus, Type 1 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| Educational materials | Other | AYA and caregivers will receive educational materials regarding healthcare transition and diabetes management monthly for 6 months |
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| 12 months |
| Change in transition readiness | Transition readiness will be measured using the Readiness Assessment of Emerging Adults with Type 1 Diabetes Diagnosed in Youth (READDY) scale, which will be completed by AYAs. | Baseline to 12 months |
| Change in diabetes adherence | Diabetes adherence will be assessed using the Self-Care Inventory-Revised, which will be completed by both AYA and caregivers. | Baseline to 12 months |
| Attendance at clinic visits | Attendance at routine clinic visits will be determined from medical records. | 12 months |
| Change in diabetes support | Diabetes support will be assessed using the Diabetes Social Support Questionnaire - Family Version (DDSQ-Family), which will be completed by AYAs. | Baseline to 12 months |
| Change in Diabetes Distress | Diabetes distress will be assessed using the Diabetes Distress Scale (DDS) for Type 1 Diabetes (DDS), which will be completed by both AYA and caregivers. AYA will complete specific versions corresponding to age (>18 or <18) and caregivers complete their own version of the measure. | Baseline to 12 months |
| Change in Self Efficacy | Self-efficacy will be measured using the Self-efficacy for Diabetes Self-Management scale (SEDSM), which will be completed by AYAs. | Baseline to 12 months |
| Change in Quality of Life | Quality of life will be measured using the T1D and Life (T1DAL), which will be completed by AYA and caregiver. | Baseline to 12 months |
| D004700 | Endocrine System Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |