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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
104

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Number of Routine Diabetes Clinic Visits
Time Frame: 12 Months
12 Months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Southern California

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
The Leona M. and Harry B. Helmsley Charitable Trust

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 1, 2009

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 1, 2020

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 1, 2020

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 15, 2016

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 15, 2016

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 21, 2016

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 19, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 17, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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.

Clinical Trials on Type 1 Diabetes Mellitus

Clinical Trials on Transition Empowerment Program

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings