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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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17 October 2012 |
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Main ID: |
NCT01109797 |
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Date of registration:
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19/04/2010 |
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Primary sponsor: |
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Public title:
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Transition of Adolescents and Young Adults With Diabetes From Pediatric to Adult Care
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Scientific title:
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A Comparison of Two Models for Transition of Adolescents and Young Adults With Diabetes From Pediatric to Adult Care |
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Date of first enrolment:
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April 2010 |
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Target sample size:
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28 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT01109797 |
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Study type:
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Interventional |
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Study design:
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Allocation: Non-Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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Countries of recruitment
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United States
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Contacts
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Name:
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Kurt Midyett, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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University of Kansas |
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Key inclusion & exclusion criteria
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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
Age minimum:
16 Years
Age maximum:
29 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Type 1 Diabetes
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Intervention(s)
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Behavioral: Diabetes Transition Clinic
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Behavioral: Transition Social Behavioral Intervention
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Primary Outcome(s)
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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]
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Secondary Outcome(s)
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Make exploratory baseline comparisons between the two groups of HgbA1c
[Time Frame: 6 months and 12 months]
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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]
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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]
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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]
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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