Transition of Adolescents and Young Adults With Diabetes From Pediatric to Adult Care
| Tracking Information | |||||
|---|---|---|---|---|---|
| First Received Date ICMJE | April 19, 2010 | ||||
| Last Updated Date | June 4, 2012 | ||||
| Start Date ICMJE | April 2010 | ||||
| Primary Completion Date | May 2012 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
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 ] | ||||
| Original Primary Outcome Measures ICMJE |
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 ] | ||||
| Change History | Complete list of historical versions of study NCT01109797 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
|
||||
| Original Secondary Outcome Measures ICMJE |
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 ] | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Transition of Adolescents and Young Adults With Diabetes From Pediatric to Adult Care | ||||
| Official Title ICMJE | A Comparison of Two Models for Transition of Adolescents and Young Adults With Diabetes From Pediatric to Adult Care | ||||
| 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. |
||||
| Study Type ICMJE | Interventional | ||||
| Study Phase | Not Provided | ||||
| Study Design ICMJE | Allocation: Non-Randomized Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
||||
| Condition ICMJE | Type 1 Diabetes | ||||
| Intervention ICMJE |
|
||||
| Study Arm (s) |
|
||||
| Publications * | Not Provided | ||||
|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
|||||
| Recruitment Information | |||||
| Recruitment Status ICMJE | Completed | ||||
| Enrollment ICMJE | 28 | ||||
| Completion Date | May 2012 | ||||
| Primary Completion Date | May 2012 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
|
||||
| Gender | Both | ||||
| Ages | 16 Years to 29 Years | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | United States | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT01109797 | ||||
| Other Study ID Numbers ICMJE | 12157 | ||||
| Has Data Monitoring Committee | No | ||||
| Responsible Party | Kurt Midyett, MD, CDE, University of Kansas Medical Center Research Institute | ||||
| Study Sponsor ICMJE | Kurt Midyett, MD, CDE | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
|
||||
| Information Provided By | University of Kansas | ||||
| Verification Date | June 2012 | ||||
|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
|||||