Transition of Adolescents and Young Adults With Diabetes From Pediatric to Adult Care

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Kurt Midyett, MD, CDE, University of Kansas Medical Center Research Institute
ClinicalTrials.gov Identifier:
NCT01109797
First received: April 19, 2010
Last updated: June 4, 2012
Last verified: June 2012

April 19, 2010
June 4, 2012
April 2010
May 2012   (final data collection date for primary outcome 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. [ Time Frame: 6 months and 12 months ] [ Designated as safety issue: No ]
Measure and compare change in diabetes self-efficacy as measured by the Michigan Diabetes Empowerment Scale (DES)" [ Time Frame: 6 months ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01109797 on ClinicalTrials.gov Archive Site
  • 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 [ Time Frame: 6 months and 12 months ] [ Designated as safety issue: No ]
  • 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. [ Time Frame: 6 months and 12 months ] [ Designated as safety issue: No ]
  • 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). [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Make exploratory baseline comparisons between the two groups of HgbA1c [ Time Frame: 6 months and 12 months ] [ Designated as safety issue: No ]
Measure the change in diabetes knowledge, change in diabetes quality of life, change in family conflict related to diabetes, change in treatment satisfaction as measured by the Michigan Diabetes scales. [ Time Frame: 6 months ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Transition of Adolescents and Young Adults With Diabetes From Pediatric to Adult Care
A Comparison of Two Models for Transition of Adolescents and Young Adults With Diabetes From Pediatric to Adult Care

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.

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.

Interventional
Not Provided
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Type 1 Diabetes
  • Behavioral: Transition Social Behavioral Intervention
    If you are assigned to the first group, you will have two all-day Saturday sessions four weeks apart on the KU campus in Lawrence. The objectives of the Saturday programs are to promote positive behavior change with respect to "taking ownership" of diabetes and its demands by providing transition-specific information, enabling participants to practice the life skills needed to successfully manage diabetes as an adult, and fostering peer-to-peer social networking over the 6-month period of the intervention (and beyond). You will continue to see your current provider of diabetes care outside of the parameters of this study.
  • Behavioral: Diabetes Transition Clinic
    Patients who participate in the transition clinic arm of the study will be seen six times during a six-month time period, as well as receive psychological assessment and intervention, as necessary, prior to the first clinic visit (intake) and as part of visits 2 and 4. Three of the six visits will be standard of care medical visits with either a pediatric or adult provider or both. Three will be individual or group education sessions with diabetes educators focused on transition issues such as, managing the adult health care system, talking with your care provider,and dealing with adult issues (pregnancy, genetic concerns, etc).
  • Experimental: Transition Social Behavioral Intervention
    Intervention: Behavioral: Transition Social Behavioral Intervention
  • Experimental: Diabetes Transition Clinic
    Intervention: Behavioral: Diabetes Transition Clinic
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
28
May 2012
May 2012   (final data collection date for primary outcome measure)

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
Both
16 Years to 29 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01109797
12157
No
Kurt Midyett, MD, CDE, University of Kansas Medical Center Research Institute
Kurt Midyett, MD, CDE
Not Provided
Principal Investigator: Kurt Midyett, MD University of Kansas
University of Kansas
June 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP