Improving Transition Care for Adolescents and Young Adults With Type 1 Diabetes (SHIFT2)

Virginia Commonwealth University (VCU)

Status: Enrolling

Conditions: Type 1 Diabetes

Treatments: Other: Educational materials; Behavioral: Transition preparation program

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT05639088

HM20024552

1K23DK131368 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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).

Enrollment: 115 estimated patients

Sex: All

Ages: 16+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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115 participants in 2 patient groups, including a placebo group

Group A: SHIFT2

Experimental group

Description:

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.

Treatment:

Behavioral: Transition preparation program

Group B: TAU+/Control

Placebo Comparator group

Description:

Participants will engage in routine medical visits and will receive education materials monthly (1x/month) regarding healthcare transition and diabetes management.

Treatment:

Other: Educational materials