Let's Empower and Prepare Young Adults With Type 1 Diabetes
LEAP
Helmsley Type 1 Diabetes Youth Transitional Program
1 other identifier
interventional
104
1 country
1
Brief Summary
In Los Angeles County, the most populous county in the United States, there are an estimated 8,000 children under the age of 21 with type 1 diabetes. Although provisions for pediatric care exist, once these children become young adults they age out of their health care services. There is no formal transitional care program to help these individuals through this process of changing health plans and many end up without adequate care. This project aims to develop and implement a transition care program for young adults with type 1 diabetes in order to ensure uninterrupted transition from pediatric to adult diabetes health care and improve health and psychological outcomes.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Oct 2009
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2009
CompletedFirst Submitted
Initial submission to the registry
June 15, 2016
CompletedFirst Posted
Study publicly available on registry
June 21, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2020
CompletedNovember 19, 2020
November 1, 2020
10.3 years
June 15, 2016
November 17, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Number of Routine Diabetes Clinic Visits
12 Months
Secondary Outcomes (9)
Hemoglobin A1C
12 Months
Incidence of Hypoglycemia
12 Months
Health Care Utilization
12 Months
Diabetes Empowerment Scale- Short Form
12 Months
Diabetes Knowledge Test- Adapted
12 Months
- +4 more secondary outcomes
Study Arms (3)
Non-Intervention Control
NO INTERVENTIONNo intervention will be delivered.
Continuity Group
EXPERIMENTALContinuity Group participants aged 20-21 (i.e. the last year of the LEAP Program) will be seen at one of the 2 study centers - 1) the newly established LAC+USC Diabetes Transition Clinic; or 2) Children's Hospital Los Angeles Pediatric Endocrinology Clinic, and will receive the full 1-year Transition Empowerment Program - Continuity Group"
Rescue Group
EXPERIMENTALRescue Group participants aged 21-25 will be connected to a diabetes healthcare "home" (medical clinic or doctor's office) in Los Angeles County based on geography and personal preference. Those individuals connected to the LAC+USC Diabetes Transition Clinic will receive the full 1-year Transition Empowerment Program - Rescue Group" (TEP-RG). Those assigned to other providers in LA County will have access to the web-based curriculum.
Interventions
Participants will receive the 1-year transition empowerment program/curriculum (TEP-CG) alone.
Participants will receive the identical 1-year Transition Empowerment Program, plus the innovative wellness-based group process (council).
Participants assigned to an outside medical home would be followed according to the clinical needs as assessed by their medical provider. They would be given access to the TEP website curriculum, but would not participate in other aspects of the 1-year TEP.
Eligibility Criteria
You may qualify if:
- Age 19 to 25 at time of enrollment
- Diagnosis of type 1 diabetes according to American Diabetes Association for at least two years
- Receiving routine diabetes care by an assigned provider
- in the last year of pediatric care (defined as anticipating transition to adult care within the next year)
You may not qualify if:
- Pregnant or planning to become pregnant within 12 months
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of Southern California
Los Angeles, California, 90033, United States
Related Publications (1)
Weigensberg MJ, Vigen C, Sequeira P, Spruijt-Metz D, Juarez M, Florindez D, Provisor J, Peters A, Pyatak EA. Diabetes Empowerment Council: Integrative Pilot Intervention for Transitioning Young Adults With Type 1 Diabetes. Glob Adv Health Med. 2018 Mar 8;7:2164956118761808. doi: 10.1177/2164956118761808. eCollection 2018.
PMID: 29552422DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Anne L Peters, MD
University of Southern California
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- HEALTH SERVICES RESEARCH
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor of Clinical Medicine
Study Record Dates
First Submitted
June 15, 2016
First Posted
June 21, 2016
Study Start
October 1, 2009
Primary Completion
January 1, 2020
Study Completion
July 1, 2020
Last Updated
November 19, 2020
Record last verified: 2020-11
Data Sharing
- IPD Sharing
- Will not share