Situational Problem Solving in Adolescents With Type 2 Diabetes: Enhancing a Randomized Controlled Trial (RCT)
Recruitment status was Recruiting
| Tracking Information | |||||
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| First Received Date ICMJE | April 28, 2009 | ||||
| Last Updated Date | April 22, 2010 | ||||
| Start Date ICMJE | June 2009 | ||||
| Estimated Primary Completion Date | August 2011 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
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| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | Complete list of historical versions of study NCT00889785 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
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| Original Secondary Outcome Measures ICMJE | Same as current | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Situational Problem Solving in Adolescents With Type 2 Diabetes: Enhancing a Randomized Controlled Trial (RCT) | ||||
| Official Title ICMJE | Situational Problem Solving in Adolescents With Type 2 Diabetes: Enhancing an RCT | ||||
| Brief Summary | The proposed research will test a new comprehensive disease management intervention with adolescents who have type 2 diabetes using a randomized controlled trial (RCT). Adolescents subjects with a history of Type 2 Diabetes and a parent caregiver will be consented, enrolled, and randomly assigned to either an 6-month intervention (N=44) or a "usual care" comparison (N=44). Recruitment will take place within the Vanderbilt Eskind Pediatric Diabetes Clinic. The intervention will include participation in a comprehensive disease management program that includes: (1) application of treatment algorithms, (2) phone assessment from a diabetes nurse practitioner and dietician to assess barriers and promote problem solving, treatment adherence and management, and (3) a behavioral Internet-administered self-management problem solving component. Outcomes include self-reported self-management behaviors (exercise, diet, medication adherence, etc.), blood pressure, weight/BMI, and glycated hemoglobin (A1C). |
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| Detailed Description | Not Provided | ||||
| Study Type ICMJE | Interventional | ||||
| Study Phase | Not Provided | ||||
| Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Health Services Research |
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| Condition ICMJE | Adolescents With Type 2 Diabetes | ||||
| Intervention ICMJE |
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| Study Arm (s) |
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| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Recruiting | ||||
| Estimated Enrollment ICMJE | 88 | ||||
| Completion Date | Not Provided | ||||
| Estimated Primary Completion Date | August 2011 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria: Patients with a diagnosis of T2DM will be included if they are:
Exclusion Criteria: Patients will be excluded if they meet any of the following:
Parent Inclusion criteria:
Parent Exclusion criteria: Patients will be excluded if they meet any of the following:
Joint Inclusion criteria: Both the primary caregiver (parent) and adolescent must agree to participate in the research. |
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| Gender | Both | ||||
| Ages | 12 Years to 19 Years | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE |
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| Location Countries ICMJE | United States | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT00889785 | ||||
| Other Study ID Numbers ICMJE | 090076, K23 DK065294, R03 DK081726 | ||||
| Has Data Monitoring Committee | No | ||||
| Responsible Party | Russell Rothman, Vanderbilt University | ||||
| Study Sponsor ICMJE | Vanderbilt University | ||||
| Collaborators ICMJE | National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) | ||||
| Investigators ICMJE |
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| Information Provided By | Vanderbilt University | ||||
| Verification Date | April 2010 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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