A Pilot Study: Changing Multiple Behaviors in Post-Angioplasty Patients
| Tracking Information | |||||
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| First Received Date ICMJE | November 3, 2005 | ||||
| Last Updated Date | April 1, 2008 | ||||
| Start Date ICMJE | February 2004 | ||||
| Primary Completion Date | Not Provided | ||||
| Current Primary Outcome Measures ICMJE |
Within patient change on the Positive and Negative Affect Scale | ||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | Complete list of historical versions of study NCT00248950 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE | Not Provided | ||||
| Original Secondary Outcome Measures ICMJE | Not Provided | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | A Pilot Study: Changing Multiple Behaviors in Post-Angioplasty Patients | ||||
| Official Title ICMJE | A Pilot Study: Changing Multiple Behaviors in Post-Angioplasty Patients | ||||
| Brief Summary | We are interested in achieving an empirical test of the two intervention approaches under study. Specifically, we seek to determine the potential differential impact of positive affect induction and self affirmation following the qualitative study phase. |
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| Detailed Description | We seek to determine the potential differential impact of positive affect induction and self affirmation following the qualitative study phase.
Follow-up: At two weeks after enrollment all patients will be called to ascertain impact of the pilot intervention. |
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| Study Type ICMJE | Interventional | ||||
| Study Phase | Not Provided | ||||
| Study Design ICMJE | Allocation: Non-Randomized Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Double-Blind |
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| Condition ICMJE | Angioplasty Patients | ||||
| Intervention ICMJE | Behavioral: Positive affect induction and /or self affirmation induction | ||||
| Study Arm (s) | Not Provided | ||||
| 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 | Completed | ||||
| Enrollment ICMJE | 40 | ||||
| Completion Date | June 2004 | ||||
| Primary Completion Date | Not Provided | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria: All patients undergoing coronary artery catheterization who are found to have at least single vessel stenosis and who have had revascularization with angioplasty or coronary artery stenting will be eligible for enrollment. Patients must be able to provide informed consent within the one week after the procedure. Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 18 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 | NCT00248950 | ||||
| Other Study ID Numbers ICMJE | N01-HC-25196 (0103-660) | ||||
| Has Data Monitoring Committee | No | ||||
| Responsible Party | Mary E. Charlson, MD, Weill Cornell Medical College | ||||
| Study Sponsor ICMJE | Weill Medical College of Cornell University | ||||
| Collaborators ICMJE | National Heart, Lung, and Blood Institute (NHLBI) | ||||
| Investigators ICMJE |
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| Information Provided By | Weill Medical College of Cornell University | ||||
| Verification Date | April 2008 | ||||
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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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