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
  Purpose

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.


Condition Intervention
Angioplasty Patients
Behavioral: Positive affect induction and /or self affirmation induction

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double-Blind
Official Title: A Pilot Study: Changing Multiple Behaviors in Post-Angioplasty Patients

Resource links provided by NLM:


Further study details as provided by Weill Medical College of Cornell University:

Primary Outcome Measures:
  • Within patient change on the Positive and Negative Affect Scale

Estimated Enrollment: 40
Study Start Date: February 2004
Estimated Study Completion Date: June 2004
Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00248950

Locations
United States, New York
The New York Presbyterian Hospital-Weill Medical Center
New York, New York, United States, 10021
Sponsors and Collaborators
Weill Medical College of Cornell University
Investigators
Principal Investigator: Mary E Charlson, MD Weill Medical College of Cornell University
  More Information

No publications provided

Responsible Party: Mary E. Charlson, MD, Weill Cornell Medical College
ClinicalTrials.gov Identifier: NCT00248950     History of Changes
Other Study ID Numbers: N01-HC-25196 (0103-660)
Study First Received: November 3, 2005
Last Updated: April 1, 2008
Health Authority: United States: Federal Government
United States: Institutional Review Board

Keywords provided by Weill Medical College of Cornell University:
Angioplasty
Behavior Change

ClinicalTrials.gov processed this record on August 20, 2014