Improving Transition Care for Adolescents and Young Adults With Type 1 Diabetes: A Randomized Controlled Trial of SHIFT2
Overview
- Phase
- N/A
- Intervention
- Transition preparation program
- Conditions
- Type 1 Diabetes
- Sponsor
- Virginia Commonwealth University
- Enrollment
- 109
- Locations
- 1
- Primary Endpoint
- Hemoglobin A1C (HbA1C)
- Status
- Active, Not Recruiting
- Last Updated
- 16 days ago
Overview
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.
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).
Investigators
Eligibility Criteria
Inclusion Criteria
- •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
- •Age greater than 18 years
- •Provides care to AYA and willing to participate
Exclusion Criteria
- •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
- •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)
Arms & Interventions
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.
Intervention: Transition preparation program
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.
Intervention: Educational materials
Outcomes
Primary Outcomes
Hemoglobin A1C (HbA1C)
Time Frame: 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
Time Frame: 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.
Attendance at clinic visits
Time Frame: 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.
Change in diabetes adherence
Time Frame: Baseline to 6 months
Diabetes adherence will be assessed using the Self-Care Inventory-Revised, which will be completed by both AYA and caregivers.
Secondary Outcomes
- Change in diabetes support(Baseline to 12 months)
- Attendance at clinic visits(12 months)
- HbA1C(12 months)
- Diabetes-related events(12 months)
- Change in transition readiness(Baseline to 12 months)
- Change in diabetes adherence(Baseline to 12 months)
- Change in Diabetes Distress(Baseline to 12 months)
- Change in Self Efficacy(Baseline to 12 months)
- Change in Quality of Life(Baseline to 12 months)