Let's Empower and Prepare Young Adults With Type 1 Diabetes (LEAP)

November 17, 2020 updated by: Anne Peters, University of Southern California

Helmsley Type 1 Diabetes Youth Transitional Program

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 a Los Angeles 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 Los Angeles County + University of Southern California (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 Children's Hospital Los Angeles (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 Children's Hospital Orange County (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.

Study Type

Interventional

Enrollment (Actual)

104

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Los Angeles, California, United States, 90033
        • University of Southern California

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.

Eligibility Criteria

Ages Eligible for Study

19 years to 25 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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 Names:
  • TEP
Behavioral: Transition Empowerment Program (TEP) + Diabetes Wellness Council (DWC)
Participants will receive the identical 1-year Transition Empowerment Program, plus the innovative wellness-based group process (council).
Other Names:
  • 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Number of Routine Diabetes Clinic Visits
Time Frame: 12 Months
12 Months

Secondary Outcome Measures

Outcome Measure
Time Frame
Hemoglobin A1C
Time Frame: 12 Months
12 Months
Incidence of Hypoglycemia
Time Frame: 12 Months
12 Months
Health Care Utilization
Time Frame: 12 Months
12 Months
Diabetes Empowerment Scale- Short Form
Time Frame: 12 Months
12 Months
Diabetes Knowledge Test- Adapted
Time Frame: 12 Months
12 Months
Perceived Stress Scale- Adapted
Time Frame: 12 Months
12 Months
Patient Health Questionnaire-9
Time Frame: 12 Months
12 Months
Satisfaction with Life Scale
Time Frame: 12 Months
12 Months
Arizona Integrative Outcomes Scale
Time Frame: 12 Months
12 Months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Southern California

Collaborators

The Leona M. and Harry B. Helmsley Charitable Trust

Investigators

  • Principal Investigator: Anne L Peters, MD, University of Southern California

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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 Major Dates

Study Start (Actual)

October 1, 2009

Primary Completion (Actual)

January 1, 2020

Study Completion (Actual)

July 1, 2020

Study Registration Dates

First Submitted

June 15, 2016

First Submitted That Met QC Criteria

June 15, 2016

First Posted (Estimate)

June 21, 2016

Study Record Updates

Last Update Posted (Actual)

November 19, 2020

Last Update Submitted That Met QC Criteria

November 17, 2020

Last Verified

November 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2010PG-T1D011

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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