Improving Transition Care for Adolescents and Young Adults With Type 1 Diabetes

Study Overview
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Brief Summary
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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.

Detailed Description
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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).

Official Title
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Improving Transition Care for Adolescents and Young Adults With Type 1 Diabetes: A Randomized Controlled Trial of SHIFT2

Conditions
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Type 1 Diabetes

Intervention / Treatment
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* Behavioral: Transition preparation program
* Other: Educational materials


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: AYA: Type 1 Diabetes diagnosis for at least 1 year (as documented in medical record) 16-22 years old English speaking Children's Hospital of Richmond patient (Division of Pediatric Endocrinology) must have a caregiver willing to participate Caregiver: Age greater than 18 years Provides care to AYA and willing to participate Exclusion Criteria: AYA: Non-English speaking 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 Hospitalization for depression, suicidal ideation or other psychiatric disorder within the past 12 months. Life time history of psychotic disorder Medically-induced diabetes or diagnosis of diabetes other than type 1 diabetes. Currently pregnant, pregnant within the past 6 months, currently breastfeeding or planning to become pregnant within the next 12 months. Another member of the household (other than the participating parent) is a participant or staff member on this study. Participation in another research study that may interfere with this study. Previous participation in the SHIFT pilot study Caregiver: Non-English speaking 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) Another member of the home (not AYA) is a participant/staff member on current study Participation in another research study that may interfere with current study Previous participation in SHIFT pilot study

Ages Eligible for Study
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Minimum Age: 16 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group A: SHIFT2<br>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<br>* 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.<br>* Other names: SHIFT2;|
| Placebo Comparator: Group B: TAU+/Control<br>Participants will engage in routine medical visits and will receive education materials monthly (1x/month) regarding healthcare transition and diabetes management. | Other: Educational materials<br>* AYA and caregivers will receive educational materials regarding healthcare transition and diabetes management monthly for 6 months<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Diabetes Management, Transition