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A Pilot Study: Changing Multiple Behaviors in Post-Angioplasty Patients

This study has been completed.
Sponsor:
Collaborator:
Information provided by:
Weill Medical College of Cornell University
ClinicalTrials.gov Identifier:
NCT00248950
First received: November 3, 2005
Last updated: April 1, 2008
Last verified: April 2008

November 3, 2005
April 1, 2008
February 2004
Not Provided
Within patient change on the Positive and Negative Affect Scale
Same as current
Complete list of historical versions of study NCT00248950 on ClinicalTrials.gov Archive Site
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A Pilot Study: Changing Multiple Behaviors in Post-Angioplasty Patients
A Pilot Study: Changing Multiple Behaviors in Post-Angioplasty Patients

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.

We seek to determine the potential differential impact of positive affect induction and self affirmation following the qualitative study phase.

  1. Positive affect induction: We will tests two types of positive affect induction. 1) sending patients a small gift, and 2) reminding patients of positive thoughts about themselves. Gift: Prior to a telephone call, patients in the positive affect condition will receive a small gift. The selection of gifts will be guided, in part, by data obtained from the qualitative study phase. Positive thoughts about themselves: Patients will be asked to describe a time when someone was helpful to them, and they felt good about it , and were nice to them in return.
  2. Self affirmation: consists of a series of items reminding people of their core values.
  3. Control: Control patients will have neither self affirmation nor gifts. After enrollment, patients will be randomized into four groups: control, the self affirmation, the positive affect gift group and the positive affect positive thought group. Thus, for the positive affect, we will test two different types of positive affect induction.

Follow-up: At two weeks after enrollment all patients will be called to ascertain impact of the pilot intervention.

Interventional
Not Provided
Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double-Blind
Angioplasty Patients
Behavioral: Positive affect induction and /or self affirmation induction
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
40
June 2004
Not Provided

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:

  1. Patients who are unable to walk several blocks regardless of the reason will be excluded from all the trials (e.g., arthritis, stroke, claudication).
  2. Enrollment in other trials designed to modify post-procedure behaviors.
  3. Patients who refuse to participate will be excluded.
  4. If at any time prior to enrollment in the study, the patient's cardiologist determines that the patient should not participate in this study, the patient will not be enrolled in the trial.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00248950
N01-HC-25196 (0103-660)
No
Mary E. Charlson, MD, Weill Cornell Medical College
Weill Medical College of Cornell University
National Heart, Lung, and Blood Institute (NHLBI)
Principal Investigator: Mary E Charlson, MD Weill Medical College of Cornell University
Weill Medical College of Cornell University
April 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP