Clinical trial NCT05639088: Improving Transition Care for Adolescents and Young Adults With Type 1 Diabetes
Official title: Improving Transition Care for Adolescents and Young Adults With Type 1 Diabetes: A Randomized Controlled Trial of SHIFT2
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Type 1 Diabetes
Keywords: Diabetes Management
Transition
Lead sponsor: Virginia Commonwealth University
Sponsor class: OTHER
Collaborators: name: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
First posted: 2022-12-06
Enrollment: 115
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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).

Eligibility 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

Primary outcomes:
measure: Hemoglobin A1C (HbA1C)
timeFrame: 6 months
measure: Change in transition readiness
timeFrame: Baseline to 6 months
measure: Change in diabetes adherence
timeFrame: Baseline to 6 months
measure: Attendance at clinic visits
timeFrame: 6 months
Secondary outcomes:
measure: HbA1C
timeFrame: 12 months
measure: Diabetes-related events
timeFrame: 12 months
measure: Change in transition readiness
timeFrame: Baseline to 12 months
measure: Change in diabetes adherence
timeFrame: Baseline to 12 months
measure: Attendance at clinic visits
timeFrame: 12 months
measure: Change in diabetes support
timeFrame: Baseline to 12 months
measure: Change in Diabetes Distress
timeFrame: Baseline to 12 months
measure: Change in Self Efficacy
timeFrame: Baseline to 12 months
measure: Change in Quality of Life
timeFrame: Baseline to 12 months
Other outcomes:
measure: Transition Status
timeFrame: Baseline to 12 months
Locations:
city: Richmond
country: United States
facility: Virginia Commonwealth University
state: Virginia
Study officials:
affiliation: Virginia Commonwealth University
name: Laura Caccavale
role: PRINCIPAL_INVESTIGATOR
References: