Type 1 Diabetes
Conditions
Keywords
Diabetes Management, Transition
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).
Interventions
OTHEREducational materials
AYA and caregivers will receive educational materials regarding healthcare transition and diabetes management monthly for 6 months
BEHAVIORALTransition 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.
Sponsors
Virginia Commonwealth University
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
16 Years to No maximum
Healthy volunteers
No
Inclusion criteria
AYA: 1. Type 1 Diabetes diagnosis for at least 1 year (as documented in medical record) 2. 16-22 years old 3. English speaking 4. Children's Hospital of Richmond patient (Division of Pediatric Endocrinology) 5. must have a caregiver willing to participate Caregiver: 1. Age greater than 18 years 2. Provides care to AYA and willing to participate
Exclusion criteria
AYA: 1. Non-English speaking 2. 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 3. Hospitalization for depression, suicidal ideation or other psychiatric disorder within the past 12 months. Life time history of psychotic disorder 4. Medically-induced diabetes or diagnosis of diabetes other than type 1 diabetes. 5. Currently pregnant, pregnant within the past 6 months, currently breastfeeding or planning to become pregnant within the next 12 months. 6. Another member of the household (other than the participating parent) is a participant or staff member on this study. 7. Participation in another research study that may interfere with this study. 8. Previous participation in the SHIFT pilot study Caregiver: 1. Non-English speaking 2. 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) 3. Another member of the home (not AYA) is a participant/staff member on current study 4. Participation in another research study that may interfere with current study 5. Previous participation in SHIFT pilot study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORLaura Caccavale
Virginia Commonwealth University
Outcome results
None listed