Improving Diabetes Outcomes With Activity, Nutrition and Medication
Tracking Information | |||||||||
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First Received Date ICMJE | September 13, 2005 | ||||||||
Last Updated Date | April 27, 2009 | ||||||||
Start Date ICMJE | July 2003 | ||||||||
Primary Completion Date | July 2008 (final data collection date for primary outcome measure) | ||||||||
Current Primary Outcome Measures ICMJE |
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Original Primary Outcome Measures ICMJE |
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Change History | Complete list of historical versions of study NCT00179374 on ClinicalTrials.gov Archive Site | ||||||||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE |
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Current Other Outcome Measures ICMJE | |||||||||
Original Other Outcome Measures ICMJE | |||||||||
Descriptive Information | |||||||||
Brief Title ICMJE | Improving Diabetes Outcomes With Activity, Nutrition and Medication | ||||||||
Official Title ICMJE | Improving Diabetes Medication Adherence and Outcomes | ||||||||
Brief Summary | This study has the following specific aims:
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Detailed Description | Metabolic control of type 2 diabetes and prevention of its complications are related to management of blood glucose and other factors. Medication and lifestyle modifications are integral to most self-management plans; however, adherence remains a great challenge. Many patients have abnormal HbA1c, blood pressure and lipid values, and are at greater risk for complications. This study is to evaluate the effectiveness and costs of a tailored, telephone intervention to promote adherence in middle-aged and older adults with type-2 diabetes who are members of a union/employer-sponsored health benefit plan. The target population includes English- and Spanish-speaking individuals from the health plan database. This study has the following specific aims:
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Study Type ICMJE | Interventional | ||||||||
Study Phase | |||||||||
Study Design ICMJE | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Outcomes Assessor) |
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Condition ICMJE | Diabetes Mellitus, Type 2 | ||||||||
Intervention ICMJE |
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Study Arm (s) |
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Publications * | |||||||||
* 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 | Completed | ||||||||
Estimated Enrollment ICMJE | 556 | ||||||||
Completion Date | July 2008 | ||||||||
Primary Completion Date | July 2008 (final data collection date for primary outcome measure) | ||||||||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Gender | Both | ||||||||
Ages | 40 Years and older | ||||||||
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 | NCT00179374 | ||||||||
Other Study ID Numbers ICMJE | #2003-068, 1 R18 DK062038-01A1 | ||||||||
Has Data Monitoring Committee | No | ||||||||
Responsible Party | Elizabeth A. Walker, PhD, Principal Investigator, Albert Einstein College of Medicine | ||||||||
Study Sponsor ICMJE | Albert Einstein College of Medicine of Yeshiva University | ||||||||
Collaborators ICMJE | National Institutes of Health (NIH) | ||||||||
Investigators ICMJE |
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Information Provided By | Albert Einstein College of Medicine of Yeshiva University | ||||||||
Verification Date | April 2009 | ||||||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |