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

Sponsors and Collaborators:	Weill Medical College of Cornell University National Heart, Lung, and Blood Institute (NHLBI)
Information provided by:	Weill Medical College of Cornell University
ClinicalTrials.gov Identifier:	NCT00248950

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:	Non-Randomized, Double-Blind, Uncontrolled, Single Group Assignment, Efficacy Study
Official Title:	A Pilot Study: Changing Multiple Behaviors in Post-Angioplasty Patients

Resource links provided by NLM:

MedlinePlus related topics: Angioplasty

U.S. FDA Resources

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.

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.
Self affirmation: consists of a series of items reminding people of their core values.
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:

Patients who are unable to walk several blocks regardless of the reason will be excluded from all the trials (e.g., arthritis, stroke, claudication).
Enrollment in other trials designed to modify post-procedure behaviors.
Patients who refuse to participate will be excluded.
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

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

National Heart, Lung, and Blood Institute (NHLBI)

Investigators

Principal Investigator:

Mary E Charlson, MD

Weill Medical College of Cornell University

More Information

No publications provided

Responsible Party:	Weill Cornell Medical College ( Mary E. Charlson, MD )
Study ID Numbers:	N01-HC-25196 (0103-660)
Study First Received:	November 3, 2005
Last Updated:	April 1, 2008
ClinicalTrials.gov Identifier:	NCT00248950 History of Changes
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 September 02, 2009