Improving Transition Care for Adolescents and Young Adults With Type 1 Diabetes
- Conditions
- Type 1 Diabetes
- Interventions
- Other: Educational materialsBehavioral: Transition preparation program
- Registration Number
- NCT05639088
- Lead Sponsor
- Virginia Commonwealth University
- 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).
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 115
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
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Group B: TAU+/Control Educational materials Participants will engage in routine medical visits and will receive education materials monthly (1x/month) regarding healthcare transition and diabetes management. Group A: SHIFT2 Transition preparation program 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.
- Primary Outcome Measures
Name Time Method 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.
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.
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.
- Secondary Outcome Measures
Name Time Method 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.
Attendance at clinic visits 12 months Attendance at routine clinic visits will be determined from medical records.
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.
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.
Trial Locations
- Locations (1)
Virginia Commonwealth University
🇺🇸Richmond, Virginia, United States