The ABC Planning Study: Diabetes and Cardiovascular Risks in Primary Care
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ClinicalTrials.gov Identifier: NCT00223340 |
Recruitment Status :
Completed
First Posted : September 22, 2005
Last Update Posted : July 2, 2012
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Sponsor:
The University of Texas Health Science Center at San Antonio
Collaborator:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Information provided by (Responsible Party):
The University of Texas Health Science Center at San Antonio
Tracking Information | ||||
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First Submitted Date ICMJE | September 13, 2005 | |||
First Posted Date ICMJE | September 22, 2005 | |||
Last Update Posted Date | July 2, 2012 | |||
Study Start Date ICMJE | March 2005 | |||
Actual Primary Completion Date | June 2007 (Final data collection date for primary outcome measure) | |||
Current Primary Outcome Measures ICMJE |
Document changes made to study procedures to better implement this study's interventions that are designed to reduce risks of heart disease and stroke | |||
Original Primary Outcome Measures ICMJE |
Document changes made to study procedures to better implement this study's interventions that are designed to reduce risks of heart disease and stroke. | |||
Change History | ||||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE |
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Current Other Pre-specified Outcome Measures | Not Provided | |||
Original Other Pre-specified Outcome Measures | Not Provided | |||
Descriptive Information | ||||
Brief Title ICMJE | The ABC Planning Study: Diabetes and Cardiovascular Risks in Primary Care | |||
Official Title ICMJE | Diabetes and Cardiovascular Risks in Primary Care | |||
Brief Summary | The purpose of this pilot study is to collect preliminary information about the best way to implement an intervention to reduce the risks of heart disease and stroke. | |||
Detailed Description | This study has two types of interventions. The clinics and patients are randomly assigned to either a control or intervention group. All clinics have both control and intervention patients. In the clinic intervention, we help doctors monitor patient information about the risk factors of heart disease and stroke. In the patient intervention, we contact patients by phone to discuss these risk factors before their doctor visits. | |||
Study Type ICMJE | Interventional | |||
Study Phase ICMJE | Not Applicable | |||
Study Design ICMJE | Allocation: Randomized Intervention Model: Factorial Assignment Masking: Single |
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Condition ICMJE | Diabetes | |||
Intervention ICMJE | Behavioral: Patient Activation and Diabetes Registry | |||
Study Arms ICMJE | Not Provided | |||
Publications * | Not Provided | |||
* 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 | |||
Enrollment ICMJE |
400 | |||
Original Enrollment ICMJE | Same as current | |||
Study Completion Date ICMJE | June 2007 | |||
Actual Primary Completion Date | June 2007 (Final data collection date for primary outcome measure) | |||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years and older (Adult, Older Adult) | |||
Accepts Healthy Volunteers ICMJE | Yes | |||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
Listed Location Countries ICMJE | United States | |||
Removed Location Countries | ||||
Administrative Information | ||||
NCT Number ICMJE | NCT00223340 | |||
Other Study ID Numbers ICMJE | 1 R34 DK 067300-1A1 [NIDDK] 1 R34 DK 067300-1A1 [NIDDK] |
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Has Data Monitoring Committee | No | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement ICMJE | Not Provided | |||
Responsible Party | The University of Texas Health Science Center at San Antonio | |||
Study Sponsor ICMJE | The University of Texas Health Science Center at San Antonio | |||
Collaborators ICMJE | National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) | |||
Investigators ICMJE |
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PRS Account | The University of Texas Health Science Center at San Antonio | |||
Verification Date | June 2012 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |