Let's Empower and Prepare Young Adults With Type 1 Diabetes
Condition: Type 1 Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 1
Study type: Interventional

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.
    

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.
    

Intervention name(s): Transition Empowerment Program; Transition Empowerment Program (TEP) + Diabetes Wellness Council (DWC); Online Transition Empowement Program Access
Intervention type(s): Behavioral; Behavioral; Behavioral
Intervention description(s): 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.
Other intervention name(s): TEP; TEP + DWP
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Health Services Research
Keywords: Transitional Care; Young Adult; Guided Imagery