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

Primary Purpose

Type 1 Diabetes

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Transition Social Behavioral Intervention
Diabetes Transition Clinic
Sponsored by
University of Kansas
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Type 1 Diabetes

Eligibility Criteria

16 Years - 29 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of Kansas Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Transition Social Behavioral Intervention

Diabetes Transition Clinic

Arm Description

Outcomes

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.

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

Full Information

First Posted
April 19, 2010
Last Updated
May 23, 2014
Sponsor
University of Kansas
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1. Study Identification

Unique Protocol Identification Number
NCT01109797
Brief Title
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

2. Study Status

Record Verification Date
May 2014
Overall Recruitment Status
Completed
Study Start Date
April 2010 (undefined)
Primary Completion Date
May 2012 (Actual)
Study Completion Date
May 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Kansas

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 1 Diabetes

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
28 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Transition Social Behavioral Intervention
Arm Type
Experimental
Arm Title
Diabetes Transition Clinic
Arm Type
Experimental
Intervention Type
Behavioral
Intervention Name(s)
Transition Social Behavioral Intervention
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Diabetes Transition Clinic
Intervention Description
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 Outcome Measure Information:
Title
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 Outcome Measure Information:
Title
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
Title
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
Title
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
Title
Make exploratory baseline comparisons between the two groups of HgbA1c
Time Frame
6 months and 12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
16 Years
Maximum Age & Unit of Time
29 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kurt Midyett, MD
Organizational Affiliation
University of Kansas Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Kansas Medical Center
City
Kansas City
State/Province
Kansas
ZIP/Postal Code
66160
Country
United States

12. IPD Sharing Statement

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

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