ACTIVE_NOT_RECRUITING

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

Conditions

Type 1 Diabetes Diabetes Management Transition

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2023-08-24

Study Completion:2026-12-31

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:ACTIVE_NOT_RECRUITING

Study ID

NCT05639088

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:16 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:CHILD, ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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 1. Age greater than 18 years 2. Provides care to AYA and willing to participate	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 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

Inclusion Criteria

Exclusion 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
1. Age greater than 18 years
2. Provides care to AYA and willing to participate

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
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

Contacts and Locations

Principal Investigator

Laura Caccavale

PRINCIPAL_INVESTIGATOR

Virginia Commonwealth University

Study Locations (Sites)

Virginia Commonwealth University

Richmond, Virginia, 23298

United States

Collaborators and Investigators

Sponsor: Virginia Commonwealth University

Laura Caccavale, PRINCIPAL_INVESTIGATOR, Virginia Commonwealth University

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-08-24

Study Completion Date2026-12-31

Study Record Updates

Study Start Date2023-08-24

Study Completion Date2026-12-31

Terms related to this study

Keywords Provided by Researchers

Diabetes Management
Transition

Additional Relevant MeSH Terms

Type 1 Diabetes