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

Primary Purpose

Type 1 Diabetes

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Transition preparation program
Educational materials
Sponsored by
Virginia Commonwealth University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Type 1 Diabetes focused on measuring Diabetes Management, Transition

Eligibility Criteria

16 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: AYA: Type 1 Diabetes diagnosis for at least 1 year (as documented in medical record) 16-22 years old English speaking Children's Hospital of Richmond patient (Division of Pediatric Endocrinology) must have a caregiver willing to participate Caregiver: Age greater than 18 years Provides care to AYA and willing to participate Exclusion Criteria: AYA: Non-English speaking 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 Hospitalization for depression, suicidal ideation or other psychiatric disorder within the past 12 months. Life time history of psychotic disorder Medically-induced diabetes or diagnosis of diabetes other than type 1 diabetes. Currently pregnant, pregnant within the past 6 months, currently breastfeeding or planning to become pregnant within the next 12 months. Another member of the household (other than the participating parent) is a participant or staff member on this study. Participation in another research study that may interfere with this study. Previous participation in the SHIFT pilot study Caregiver: Non-English speaking 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) Another member of the home (not AYA) is a participant/staff member on current study Participation in another research study that may interfere with current study Previous participation in SHIFT pilot study

Sites / Locations

  • Virginia Commonwealth UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Group A: SHIFT2

Group B: TAU+/Control

Arm 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.

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

Outcomes

Primary Outcome Measures

Hemoglobin A1C (HbA1C)
HbA1C will be assessed using a standard assay from a routine blood draw or an at-home testing kit
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.
Change in diabetes adherence
Diabetes adherence will be assessed using the Self-Care Inventory-Revised, which will be completed by both AYA and caregivers.
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.

Secondary Outcome Measures

HbA1C
HbA1C will be assessed using a standard assay from a routine blood draw or an at-home testing kit.
Diabetes-related events
Number of diabetes-related events will be determined from medical records
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.
Change in diabetes adherence
Diabetes adherence will be assessed using the Self-Care Inventory-Revised, which will be completed by both AYA and caregivers.
Attendance at clinic visits
Attendance at routine clinic visits will be determined from medical records.
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.
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.
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.
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.

Full Information

First Posted
November 28, 2022
Last Updated
August 25, 2023
Sponsor
Virginia Commonwealth University
Collaborators
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
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1. Study Identification

Unique Protocol Identification Number
NCT05639088
Brief Title
Improving Transition Care for Adolescents and Young Adults With Type 1 Diabetes
Acronym
SHIFT2
Official Title
Improving Transition Care for Adolescents and Young Adults With Type 1 Diabetes: A Randomized Controlled Trial of SHIFT2
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
August 24, 2023 (Actual)
Primary Completion Date
June 2025 (Anticipated)
Study Completion Date
January 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Virginia Commonwealth University
Collaborators
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 1 Diabetes
Keywords
Diabetes Management, Transition

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
110 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Group A: SHIFT2
Arm Type
Experimental
Arm 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.
Arm Title
Group B: TAU+/Control
Arm Type
Placebo Comparator
Arm Description
Participants will engage in routine medical visits and will receive education materials monthly (1x/month) regarding healthcare transition and diabetes management.
Intervention Type
Behavioral
Intervention Name(s)
Transition preparation program
Other Intervention Name(s)
SHIFT2
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Educational materials
Intervention Description
AYA and caregivers will receive educational materials regarding healthcare transition and diabetes management monthly for 6 months
Primary Outcome Measure Information:
Title
Hemoglobin A1C (HbA1C)
Description
HbA1C will be assessed using a standard assay from a routine blood draw or an at-home testing kit
Time Frame
6 months
Title
Change in transition readiness
Description
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.
Time Frame
Baseline to 6 months
Title
Change in diabetes adherence
Description
Diabetes adherence will be assessed using the Self-Care Inventory-Revised, which will be completed by both AYA and caregivers.
Time Frame
Baseline to 6 months
Title
Attendance at clinic visits
Description
Attendance at routine clinic visits will be determined from medical records and will be assessed by the number of regularly scheduled visits attended.
Time Frame
6 months
Secondary Outcome Measure Information:
Title
HbA1C
Description
HbA1C will be assessed using a standard assay from a routine blood draw or an at-home testing kit.
Time Frame
12 months
Title
Diabetes-related events
Description
Number of diabetes-related events will be determined from medical records
Time Frame
12 months
Title
Change in transition readiness
Description
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.
Time Frame
Baseline to 12 months
Title
Change in diabetes adherence
Description
Diabetes adherence will be assessed using the Self-Care Inventory-Revised, which will be completed by both AYA and caregivers.
Time Frame
Baseline to 12 months
Title
Attendance at clinic visits
Description
Attendance at routine clinic visits will be determined from medical records.
Time Frame
12 months
Title
Change in diabetes support
Description
Diabetes support will be assessed using the Diabetes Social Support Questionnaire - Family Version (DDSQ-Family), which will be completed by AYAs.
Time Frame
Baseline to 12 months
Title
Change in Diabetes Distress
Description
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.
Time Frame
Baseline to 12 months
Title
Change in Self Efficacy
Description
Self-efficacy will be measured using the Self-efficacy for Diabetes Self-Management scale (SEDSM), which will be completed by AYAs.
Time Frame
Baseline to 12 months
Title
Change in Quality of Life
Description
Quality of life will be measured using the T1D and Life (T1DAL), which will be completed by AYA and caregiver.
Time Frame
Baseline to 12 months
Other Pre-specified Outcome Measures:
Title
Transition Status
Description
AYAs that transition from pediatric to adult T1D care will be assessed.
Time Frame
Baseline to 12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: AYA: Type 1 Diabetes diagnosis for at least 1 year (as documented in medical record) 16-22 years old English speaking Children's Hospital of Richmond patient (Division of Pediatric Endocrinology) must have a caregiver willing to participate Caregiver: Age greater than 18 years Provides care to AYA and willing to participate Exclusion Criteria: AYA: Non-English speaking 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 Hospitalization for depression, suicidal ideation or other psychiatric disorder within the past 12 months. Life time history of psychotic disorder Medically-induced diabetes or diagnosis of diabetes other than type 1 diabetes. Currently pregnant, pregnant within the past 6 months, currently breastfeeding or planning to become pregnant within the next 12 months. Another member of the household (other than the participating parent) is a participant or staff member on this study. Participation in another research study that may interfere with this study. Previous participation in the SHIFT pilot study Caregiver: Non-English speaking 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) Another member of the home (not AYA) is a participant/staff member on current study Participation in another research study that may interfere with current study Previous participation in SHIFT pilot study
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Sarah Farthing
Phone
804-527-4756
Email
sarah.malone@vcuhealth.org
First Name & Middle Initial & Last Name or Official Title & Degree
Laura Caccavale
Phone
804-527-4756
Email
laura.caccavale@vcuhealth.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Laura Caccavale
Organizational Affiliation
Virginia Commonwealth University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Virginia Commonwealth University
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23298
Country
United States
Individual Site Status
Recruiting

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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