Clinical trial NCT02807155: Let's Empower and Prepare Young Adults With Type 1 Diabetes
Official title: Helmsley Type 1 Diabetes Youth Transitional Program
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Type 1 Diabetes Mellitus
Keywords: Transitional Care
Young Adult
Guided Imagery
Lead sponsor: University of Southern California
Sponsor class: OTHER
Collaborators: name: The Leona M. and Harry B. Helmsley Charitable Trust
First posted: 2016-06-21
Enrollment: 104
Sex: ALL
Minimum age (years): 19
Maximum age (years): 25
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Number of Routine Diabetes Clinic Visits
timeFrame: 12 Months
Secondary outcomes:
measure: Hemoglobin A1C
timeFrame: 12 Months
measure: Incidence of Hypoglycemia
timeFrame: 12 Months
measure: Health Care Utilization
timeFrame: 12 Months
measure: Diabetes Empowerment Scale- Short Form
timeFrame: 12 Months
measure: Diabetes Knowledge Test- Adapted
timeFrame: 12 Months
measure: Perceived Stress Scale- Adapted
timeFrame: 12 Months
measure: Patient Health Questionnaire-9
timeFrame: 12 Months
measure: Satisfaction with Life Scale
timeFrame: 12 Months
measure: Arizona Integrative Outcomes Scale
timeFrame: 12 Months
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: University of Southern California
state: California
Study officials:
affiliation: University of Southern California
name: Anne L Peters, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Weigensberg MJ, Vigen C, Sequeira P, Spruijt-Metz D, Juarez M, Florindez D, Provisor J, Peters A, Pyatak EA. Diabetes Empowerment Council: Integrative Pilot Intervention for Transitioning Young Adults With Type 1 Diabetes. Glob Adv Health Med. 2018 Mar 8;7:2164956118761808. doi: 10.1177/2164956118761808. eCollection 2018.