Clinical trial NCT01109797: Transition of Adolescents and Young Adults With Diabetes From Pediatric to Adult Care
Official title: A Comparison of Two Models for Transition of Adolescents and Young Adults With Diabetes From Pediatric to Adult Care
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Type 1 Diabetes
Lead sponsor: University of Kansas Medical Center
Sponsor class: OTHER
First posted: 2010-04-23
Enrollment: 28
Sex: ALL
Minimum age (years): 16
Maximum age (years): 29
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of the study is to compare two interventions for preparing diabetic teens and young adults for transition from pediatric to adult diabetes care.

Detailed description: One will represent a short-term intensive social-behavioral intervention supported by peer-to-peer social networking in which subjects receive "usual care" from their current diabetes provider outside the parameters of the study. The second intervention will be a traditional transition clinic model, where subjects will receive the standard of diabetes care from a team of combined pediatric and adult practitioners and educators, with added educational modules and behavioral evaluation and support designed to facilitate the transition to adult care (i.e., that foster "developmentally tailored care"). The first is a much less intensive intervention from the standpoint of the providers and gives special prominence to peer support; the second is provider-intensive. The goal of both interventions is to improve self-efficacy (confidence in taking ownership of and managing one's diabetes); i.e., to prepare the patient to move from primary support by family and providers to a reliance on self-ownership and self-management as a responsible, independent adult.

Optional sub-study available for parents, spouses, and significant others.

Eligibility criteria: Inclusion Criteria:

* Age 16-29
* Diagnosis of type 1 diabetes, or type 2 diabetes managed with insulin, at least one year prior to study initiation
* English-speaking
* Some form of private or public (e.g., Medicaid) health insurance

Exclusion Criteria:

* Cystic fibrosis-related or pancreatitis-related diabetes
* Diabetes related to a known specific genetic defect such as Down's Syndrome, Lipoatrophic Diabetes, Leprechaunism or Rabson-Mendenhall Syndrome, etc.
* Chronic liver disease
* History of chronic renal failure
* Serious psychiatric illness that in the judgment of the investigators would preclude the individual's ability to complete the study
* Pregnant or planning to become pregnant within 6 months

Primary outcomes:
measure: Measure and compare change in self-efficacy and change in diabetes knowledge, diabetes quality of life, family conflict, and treatment satisfaction for and between the two groups.
timeFrame: 6 months and 12 months
Secondary outcomes:
measure: Make exploratory baseline comparisons between the two groups regarding locus of diabetes care (kind of provider), comparing numbers of subjects in each group who made a successful transition to adult care
timeFrame: 6 months and 12 months
measure: Make exploratory baseline comparisons between the two groups of using some form of social networking by the two groups as an adjunt of diabetes care.
timeFrame: 6 months and 12 months
measure: Make exploratory baseline comparisons between the two groups regarding provider and educator time devoted in each arm of the intervention (in order to prepare for a robust comparative effectiveness analysis in a subsequent study).
timeFrame: 6 months
measure: Make exploratory baseline comparisons between the two groups of HgbA1c
timeFrame: 6 months and 12 months
Other outcomes:
Locations:
city: Kansas City
country: United States
facility: University of Kansas Medical Center
state: Kansas
Study officials:
affiliation: University of Kansas Medical Center
name: Kurt Midyett, MD
role: PRINCIPAL_INVESTIGATOR
References: