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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. Identifier: NCT02807155
Recruitment Status : Completed
First Posted : June 21, 2016
Last Update Posted : June 21, 2016
The Leona M. and Harry B. Helmsley Charitable Trust
Information provided by (Responsible Party):
Anne Peters, University of Southern California

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.

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

Detailed Description:
The Final LEAP Program is a one year curriculum designed to give young adults with type 1 diabetes the skills to effectively transfer from pediatric to adult care without lapse in medical treatment. The Final LEAP curriculum consists of four modules; 1) back-to-basics diabetes education, 2) handling daily life with diabetes, 3) navigating the healthcare system/transitioning, and 4) issues relating to sex, drugs and alcohol. Additionally, the program includes quarterly group classes covering topics such as enrolling into an L.A. County Health Care Plan, carbohydrate counting, and community connections. Each individual module will be introduced in packet form 3 months before the scheduled clinic appointments. At each clinic appointment throughout the year the modules will be taught and a post-test will be given to assess knowledge. Study participants will continue their standard diabetes clinic appointments, which occur every 3 months. At these visits, the study team will collect an additional HbA1C at baseline, 6mo, and 12mo of the correlating study/standard visit. An HbA1c test will be performed during their standard diabetes clinic appointment using the DCA 2000, which requires an additional patient-administered finger stick. Protected Health Information will be accessed through medical records for those participants consented into the Continuity Control and Intervention groups. Measures gathered at baseline, 6 months, and 12 months will be height, weight, BMI, lipid panel, and insulin regiment. Apart from the DCA 2000 HbA1c measurement, all three clinics assess HbA1c using a laboratory and these results are recorded in the patient's chart. HbA1c obtained through lab measurements will be abstracted from the patients chart at baseline, 3 months, 6 months, 9 months, and 12 months.Additionally, 25 participants will be selected to take part in an empowerment group as part of the intervention. The participants will be chosen at random. The empowerment group will meet monthly, either in the evening or on a weekend. 10 -12 participants will gather and will have the opportunity to talk about issues affecting their lives in regards to diabetes. . We are looking to see if participation in an empowerment group has positive results on a person's diabetes care.Rescue Group - Participants will be assigned to either the LAC+USC Diabetes Transition Clinic (Experimental Group) or to a clinic near their home, based on their choice.Continuity Group - The Continuity Intervention Group will be recruited from among current patients attending the pediatric diabetes clinics at the 2 study sites, LAC+USC and CHLA and assigned to the experimental group. Participants will receive the 1-year Final LEAP program. Half of the participants will be randomized to participate in the Diabetes Wellness Council and these results will be compared to those who did not participate. The Continuity control group will be individuals followed at CHOC receiving standard care. The control group participants will meet the same inclusion/exclusion criteria as those in the experimental group.STATISTICS: For the Rescue group, 100 participants in each group would be sufficient to detect an effect of .4, a moderate effect, which translates into a difference in change of A1C of .49%. For the Continuity group, at the proposed sample sizes of 50-50-100, it would be possible to detect a difference for an omnibus ANOVA of an effect size of .22, a small effect. This would translate into a difference across groups in change of A1C of .27%.PLANS FOR ANALYSIS: Both experimental and control group participants will assessed at 6 and 12 months for A1c and psychosocial outcomes.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 104 participants
Allocation: Non-Randomized
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Diabetes Type 1

Arm Intervention/treatment
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.

Primary Outcome Measures :
  1. Number of Routine Diabetes Clinic Visits [ Time Frame: 12 Months ]

Secondary Outcome Measures :
  1. Hemoglobin A1C [ Time Frame: 12 Months ]
  2. Incidence of Hypoglycemia [ Time Frame: 12 Months ]
  3. Health Care Utilization [ Time Frame: 12 Months ]
  4. Diabetes Empowerment Scale- Short Form [ Time Frame: 12 Months ]
  5. Diabetes Knowledge Test- Adapted [ Time Frame: 12 Months ]
  6. Perceived Stress Scale- Adapted [ Time Frame: 12 Months ]
  7. Patient Health Questionnaire-9 [ Time Frame: 12 Months ]
  8. Satisfaction with Life Scale [ Time Frame: 12 Months ]
  9. Arizona Integrative Outcomes Scale [ Time Frame: 12 Months ]

Information from the National Library of Medicine

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Ages Eligible for Study:   19 Years to 25 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • 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)

Exclusion Criteria:

  • Pregnant or planning to become pregnant within 12 months

Information from the National Library of Medicine

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 identifier (NCT number): NCT02807155

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United States, California
University of Southern California
Los Angeles, California, United States, 90033
Sponsors and Collaborators
University of Southern California
The Leona M. and Harry B. Helmsley Charitable Trust
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Principal Investigator: Anne L Peters, MD University of Southern California
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Anne Peters, Professor of Clinical Medicine, University of Southern California Identifier: NCT02807155    
Other Study ID Numbers: 2010PG-T1D011
First Posted: June 21, 2016    Key Record Dates
Last Update Posted: June 21, 2016
Last Verified: June 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Anne Peters, University of Southern California:
Transitional Care
Young Adult
Guided Imagery
Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 1
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases