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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
University of Kansas
ClinicalTrials.gov Identifier:
NCT01109797
First received: April 19, 2010
Last updated: May 23, 2014
Last verified: May 2014
  Purpose

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.


Condition Intervention
Type 1 Diabetes
Behavioral: Transition Social Behavioral Intervention
Behavioral: Diabetes Transition Clinic

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Comparison of Two Models for Transition of Adolescents and Young Adults With Diabetes From Pediatric to Adult Care

Resource links provided by NLM:


Further study details as provided by University of Kansas:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 28
Study Start Date: April 2010
Study Completion Date: May 2012
Primary Completion Date: May 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Transition Social Behavioral Intervention 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.
Experimental: Diabetes Transition Clinic 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).

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

Ages Eligible for Study:   16 Years to 29 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01109797

Locations
United States, Kansas
University of Kansas Medical Center
Kansas City, Kansas, United States, 66160
Sponsors and Collaborators
University of Kansas
Investigators
Principal Investigator: Kurt Midyett, MD University of Kansas
  More Information

No publications provided

Responsible Party: University of Kansas
ClinicalTrials.gov Identifier: NCT01109797     History of Changes
Other Study ID Numbers: 12157
Study First Received: April 19, 2010
Last Updated: May 23, 2014
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 1
Autoimmune Diseases
Endocrine System Diseases
Glucose Metabolism Disorders
Immune System Diseases
Metabolic Diseases

ClinicalTrials.gov processed this record on October 23, 2014