Improving Transition Care for Adolescents and Young Adults With Type 1 Diabetes
NCT ID: NCT05639088
Last Updated: 2025-12-15
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
NA
109 participants
INTERVENTIONAL
2023-08-24
2026-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
NONE
Study Groups
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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.
Transition 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.
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.
Educational materials
AYA and caregivers will receive educational materials regarding healthcare transition and diabetes management monthly for 6 months
Interventions
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Transition 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.
Educational materials
AYA and caregivers will receive educational materials regarding healthcare transition and diabetes management monthly for 6 months
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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
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
16 Years
ALL
No
Sponsors
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National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
NIH
Virginia Commonwealth University
OTHER
Responsible Party
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Principal Investigators
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Laura Caccavale
Role: PRINCIPAL_INVESTIGATOR
Virginia Commonwealth University
Locations
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Virginia Commonwealth University
Richmond, Virginia, United States
Countries
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References
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Caccavale LJ, Streisand R, LaRose JG, Wickham EP 3rd, Hilliard ME, Thornton LM, Bean MK. A clinic-based healthcare transition preparation program for adolescents and young adults with type 1 diabetes: Study protocol for the SHIFT randomized clinical trial. Contemp Clin Trials Commun. 2025 May 27;46:101500. doi: 10.1016/j.conctc.2025.101500. eCollection 2025 Aug.
Lalji R, Koh L, Francis A, Khalid R, Guha C, Johnson DW, Wong G. Patient navigator programmes for children and adolescents with chronic diseases. Cochrane Database Syst Rev. 2024 Oct 9;10(10):CD014688. doi: 10.1002/14651858.CD014688.pub2.
Other Identifiers
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HM20024552
Identifier Type: -
Identifier Source: org_study_id
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