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).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Enrollment
109
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.
AYA and caregivers will receive educational materials regarding healthcare transition and diabetes management monthly for 6 months
Virginia Commonwealth University
Richmond, Virginia, United States
Hemoglobin A1C (HbA1C)
HbA1C will be assessed using a standard assay from a routine blood draw or an at-home testing kit
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 6 months
HbA1C
HbA1C will be assessed using a standard assay from a routine blood draw or an at-home testing kit.
Time frame: 12 months
Diabetes-related events
Number of diabetes-related events will be determined from medical records
Time frame: 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.
Time frame: Baseline to 12 months
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Change in diabetes adherence
Diabetes adherence will be assessed using the Self-Care Inventory-Revised, which will be completed by both AYA and caregivers.
Time frame: Baseline to 12 months
Attendance at clinic visits
Attendance at routine clinic visits will be determined from medical records.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Baseline to 12 months