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

NCT ID: NCT00248950

Last Updated: 2008-04-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-02-29

Study Completion Date

2004-06-30

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Angioplasty Patients

Keywords

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Angioplasty Behavior Change

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Blinding Strategy

DOUBLE

Interventions

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Positive affect induction and /or self affirmation induction

Intervention Type BEHAVIORAL

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Heart, Lung, and Blood Institute (NHLBI)

NIH

Sponsor Role collaborator

Weill Medical College of Cornell University

OTHER

Sponsor Role lead

Responsible Party

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Weill Cornell Medical College

Principal Investigators

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Mary E Charlson, MD

Role: PRINCIPAL_INVESTIGATOR

Weill Medical College of Cornell University

Locations

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The New York Presbyterian Hospital-Weill Medical Center

New York, New York, United States

Site Status

Countries

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United States

Other Identifiers

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N01HC25196

Identifier Type: NIH

Identifier Source: secondary_id

View Link

N01-HC-25196 (0103-660)

Identifier Type: -

Identifier Source: org_study_id