Program to help young adults with Type 1 diabetes transition to adult care
Improving Transition Care for Adolescents and Young Adults With Type 1 Diabetes: A Randomized Controlled Trial of SHIFT2
This study is testing a program to help young adults with Type 1 diabetes, aged 16-22, smoothly transition from pediatric care to adult care with extra coaching and support.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 115 (estimated) |
| Ages | 16 Years and up |
| Sex | All |
| Sponsor | Virginia Commonwealth University Academic / other |
| Locations | 1 site (Richmond, Virginia) |
| Trial ID | NCT05639088 on ClinicalTrials.gov |
What this trial studies
This research evaluates a transition preparation program for adolescents and young adults (AYAs) aged 16-22 with Type 1 diabetes. The program aims to support AYAs and their caregivers as they move from pediatric to adult endocrinology care. Participants will be divided into two groups: one receiving monthly coaching sessions focused on diabetes management and healthcare transition, and the other receiving standard care with educational materials. The outcomes will help shape best practices for managing diabetes during this critical transition period.
Who should consider this trial
Good fit: Ideal candidates are adolescents and young adults aged 16-22 with a diagnosis of Type 1 diabetes and a participating caregiver.
Not a fit: Patients who are non-English speaking or have significant psychiatric or medical conditions that impair their ability to engage in diabetes self-care may not benefit from this study.
Why it matters
Potential benefit: If successful, this program could significantly improve the self-management skills of young adults with Type 1 diabetes as they transition to adult healthcare.
How similar studies have performed: Other studies have shown success in transition programs for chronic conditions, indicating potential for positive outcomes in this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Richmond, Virginia
- Virginia Commonwealth University — Richmond, Virginia, United States (Recruiting)
Study contacts
- Principal investigator: Laura Caccavale — Virginia Commonwealth University
- Study coordinator: Sarah Farthing
- Email: sarah.malone@vcuhealth.org
- Phone: 804-527-4756
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.