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Completed

NCT Number: NCT01109797

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.

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Key information

Age range

16 year–29 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Kansas Medical Center

Kansas City, Kansas, 66160, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Transition Social Behavioral Intervention

Behavioral

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.

Diabetes Transition Clinic

Behavioral

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).

Primary outcomes

  1. 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

Secondary outcomes

  1. 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

  2. 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

  3. 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

  4. Make exploratory baseline comparisons between the two groups of HgbA1c

    Time frame: 6 months and 12 months

Sponsors and collaborators

Lead sponsor

University of Kansas

Other

Registry information

Official study title

A Comparison of Two Models for Transition of Adolescents and Young Adults With Diabetes From Pediatric to Adult Care

Important dates

Study start
2010
Primary completion
2012
Study completion
2012
First posted
Apr 23, 2010
Registry last updated
May 26, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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