Let's Empower and Prepare Young Adults With Type 1 Diabetes (LEAP)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02807155|
Recruitment Status : Completed
First Posted : June 21, 2016
Last Update Posted : June 21, 2016
|Condition or disease||Intervention/treatment||Phase|
|Type 1 Diabetes Mellitus||Behavioral: Transition Empowerment Program Behavioral: Transition Empowerment Program + Diabetes Wellness Council Behavioral: Online Transition Empowement Program Access||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||104 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Health Services Research|
|Official Title:||Helmsley Type 1 Diabetes Youth Transitional Program|
|Study Start Date :||October 2009|
|Actual Primary Completion Date :||July 2013|
No Intervention: Non-Intervention Control
No intervention will be delivered.
Experimental: Continuity Group
Continuity 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"
Behavioral: Transition Empowerment Program
Participants will receive the 1-year transition empowerment program/curriculum (TEP-CG) alone.
Other Name: TEP
Behavioral: Transition Empowerment Program + Diabetes Wellness Council
Participants will receive the identical 1-year Transition Empowerment Program, plus the innovative wellness-based group process (council).
Other Name: TEP + DWP
Experimental: Rescue Group
Rescue 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.
Behavioral: Online Transition Empowement Program Access
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.
- Number of Routine Diabetes Clinic Visits [ Time Frame: 12 Months ]
- Hemoglobin A1C [ Time Frame: 12 Months ]
- Incidence of Hypoglycemia [ Time Frame: 12 Months ]
- Health Care Utilization [ Time Frame: 12 Months ]
- Diabetes Empowerment Scale- Short Form [ Time Frame: 12 Months ]
- Diabetes Knowledge Test- Adapted [ Time Frame: 12 Months ]
- Perceived Stress Scale- Adapted [ Time Frame: 12 Months ]
- Patient Health Questionnaire-9 [ Time Frame: 12 Months ]
- Satisfaction with Life Scale [ Time Frame: 12 Months ]
- Arizona Integrative Outcomes Scale [ Time Frame: 12 Months ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02807155
|United States, California|
|University of Southern California|
|Los Angeles, California, United States, 90033|
|Principal Investigator:||Anne L Peters, MD||University of Southern California|