SHIFT2: Improving Transition Care for Adolescents and Young Adults With Type 1 Diabetes
Study Details
Study Description
Brief Summary
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Detailed Description
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).
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Group A: SHIFT2 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. |
Behavioral: Transition preparation program
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.
Other Names:
|
| Placebo Comparator: Group B: TAU+/Control Participants will engage in routine medical visits and will receive education materials monthly (1x/month) regarding healthcare transition and diabetes management. |
Other: Educational materials
AYA and caregivers will receive educational materials regarding healthcare transition and diabetes management monthly for 6 months
|
Outcome Measures
Primary Outcome Measures
- Hemoglobin A1C (HbA1C) [6 months]
HbA1C will be assessed using a standard assay from a routine blood draw or an at-home testing kit
- Change in transition readiness [Baseline to 6 months]
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.
- Change in diabetes adherence [Baseline to 6 months]
Diabetes adherence will be assessed using the Self-Care Inventory-Revised, which will be completed by both AYA and caregivers.
- Attendance at clinic visits [6 months]
Attendance at routine clinic visits will be determined from medical records and will be assessed by the number of regularly scheduled visits attended.
Secondary Outcome Measures
- HbA1C [12 months]
HbA1C will be assessed using a standard assay from a routine blood draw or an at-home testing kit.
- Diabetes-related events [12 months]
Number of diabetes-related events will be determined from medical records
- Change in transition readiness [Baseline to 12 months]
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.
- Change in diabetes adherence [Baseline to 12 months]
Diabetes adherence will be assessed using the Self-Care Inventory-Revised, which will be completed by both AYA and caregivers.
- Attendance at clinic visits [12 months]
Attendance at routine clinic visits will be determined from medical records.
- Change in diabetes support [Baseline to 12 months]
Diabetes support will be assessed using the Diabetes Social Support Questionnaire - Family Version (DDSQ-Family), which will be completed by AYAs.
- Change in Diabetes Distress [Baseline to 12 months]
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.
- Change in Self Efficacy [Baseline to 12 months]
Self-efficacy will be measured using the Self-efficacy for Diabetes Self-Management scale (SEDSM), which will be completed by AYAs.
- Change in Quality of Life [Baseline to 12 months]
Quality of life will be measured using the T1D and Life (T1DAL), which will be completed by AYA and caregiver.
Other Outcome Measures
- Transition Status [Baseline to 12 months]
AYAs that transition from pediatric to adult T1D care will be assessed.
Eligibility Criteria
Criteria
Inclusion Criteria:
AYA:
-
Type 1 Diabetes diagnosis for at least 1 year (as documented in medical record)
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16-22 years old
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English speaking
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Children's Hospital of Richmond patient (Division of Pediatric Endocrinology)
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must have a caregiver willing to participate
Caregiver:
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Age greater than 18 years
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Provides care to AYA and willing to participate
Exclusion Criteria:
AYA:
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Non-English speaking
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Significant psychiatric, cognitive, medical or developmental conditions that would impair their ability to complete assessments and/or engage in diabetes self-care behaviors (e.g., malignancies, psychosis, intellectual disability
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Hospitalization for depression, suicidal ideation or other psychiatric disorder within the past 12 months. Life time history of psychotic disorder
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Medically-induced diabetes or diagnosis of diabetes other than type 1 diabetes.
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Currently pregnant, pregnant within the past 6 months, currently breastfeeding or planning to become pregnant within the next 12 months.
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Another member of the household (other than the participating parent) is a participant or staff member on this study.
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Participation in another research study that may interfere with this study.
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Previous participation in the SHIFT pilot study
Caregiver:
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Non-English speaking
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Significant psychiatric, cognitive, developmental conditions that would impair their ability to complete assessments and/or engage in supporting the AYA with diabetes self-care behaviors (e.g., psychosis, intellectual disability)
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Another member of the home (not AYA) is a participant/staff member on current study
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Participation in another research study that may interfere with current study
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Previous participation in SHIFT pilot study
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Virginia Commonwealth University | Richmond | Virginia | United States | 23298 |
Sponsors and Collaborators
- Virginia Commonwealth University
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Investigators
- Principal Investigator: Laura Caccavale, Virginia Commonwealth University
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- HM20024552
- 1K23DK131368