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

Type 1 Diabetes Clinical Trial

— SHIFT2  

Official title:

Improving Transition Care for Adolescents and Young Adults With Type 1 Diabetes: A Randomized Controlled Trial of SHIFT2

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05639088
• Other study ID #: HM20024552
• Secondary ID: 1K23DK131368
• Status: Recruiting
• Phase: N/A
• Start date: August 24, 2023
• Est. completion date: January 1, 2026

Study information

• Verified date: April 2024
• Source: Virginia Commonwealth University
• Contact: Sarah Farthing
• Phone: 804-527-4756
• Email: sarah.malone[@]vcuhealth.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 110
• Est. completion date: January 1, 2026
• Est. primary completion date: June 30, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 16 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 1
• Type 1 Diabetes

Intervention

Behavioral:
• 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.

Other:
• Educational materials
AYA and caregivers will receive educational materials regarding healthcare transition and diabetes management monthly for 6 months

Locations

Country	Name	City	State
United States	Virginia Commonwealth University	Richmond	Virginia

Sponsors (2)

Lead Sponsor	Collaborator
Virginia Commonwealth University	National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Transition Status	AYAs that transition from pediatric to adult T1D care will be assessed.	Baseline to 12 months
Primary	Hemoglobin A1C (HbA1C)	HbA1C will be assessed using a standard assay from a routine blood draw or an at-home testing kit	6 months
Primary	Change in transition readiness	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.	Baseline to 6 months
Primary	Change in diabetes adherence	Diabetes adherence will be assessed using the Self-Care Inventory-Revised, which will be completed by both AYA and caregivers.	Baseline to 6 months
Primary	Attendance at clinic visits	Attendance at routine clinic visits will be determined from medical records and will be assessed by the number of regularly scheduled visits attended.	6 months
Secondary	HbA1C	HbA1C will be assessed using a standard assay from a routine blood draw or an at-home testing kit.	12 months
Secondary	Diabetes-related events	Number of diabetes-related events will be determined from medical records	12 months
Secondary	Change in transition readiness	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.	Baseline to 12 months
Secondary	Change in diabetes adherence	Diabetes adherence will be assessed using the Self-Care Inventory-Revised, which will be completed by both AYA and caregivers.	Baseline to 12 months
Secondary	Attendance at clinic visits	Attendance at routine clinic visits will be determined from medical records.	12 months
Secondary	Change in diabetes support	Diabetes support will be assessed using the Diabetes Social Support Questionnaire - Family Version (DDSQ-Family), which will be completed by AYAs.	Baseline to 12 months
Secondary	Change in Diabetes Distress	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.	Baseline to 12 months
Secondary	Change in Self Efficacy	Self-efficacy will be measured using the Self-efficacy for Diabetes Self-Management scale (SEDSM), which will be completed by AYAs.	Baseline to 12 months
Secondary	Change in Quality of Life	Quality of life will be measured using the T1D and Life (T1DAL), which will be completed by AYA and caregiver.	Baseline to 12 months