A Randomized Trial: Changing Behavior in Post-Angioplasty Patients

Not Applicable

Completed

• Conditions: Angioplasty Patients
• Interventions: Behavioral: Intervention Group

• Registration Number: NCT00248846
• Lead Sponsor: Weill Medical College of Cornell University

Brief Summary

The long-term objective of this study is to determine whether a positive affect and self-affirmation condition added to an empirically demonstrated approach for motivating behavior change is more effective than a standard approach in reducing risk factor behavior among a high-risk group of patients with coronary artery disease. Thus, the goal of the project is to refine and improve strategies for long-term maintenance of physical activity among patients post-angioplasty or stent.

Detailed Description

Among coronary artery disease patients who have just had either angioplasty or stents, the objective of this randomized trial is to evaluate whether a novel behavioral intervention that employs induced positive affect and self-affirmation is more effective than an intervention without positive affect in increasing the maintenance of newly initiated physical activity post-procedure.

Secondary objectives:

* To determine whether more patients who receive the positive affect and self-affirmation intervention initiate more multiple behavior changes (e.g., changes in more health behaviors directed to their risk-factor profile) than those in the control group at one year.

* To determine whether the positive affect and self-affirmation intervention increases physical activity among patients who have depressive symptoms.

* To determine whether patients who are successful in increasing physical activity are more successful at changing other health behaviors.

Study Timeline

• Study Start: 2004-10
• Study First Submitted: 2005-11-03
• Study First Submitted QC: 2005-11-03
• Study First Posted: 2005-11-04
• Primary Completion: 2008-01
• Study Completion: 2011-07
• Status Verified: 2017-02
• Last Update Submitted: 2017-02-17
• Last Update Posted: 2017-02-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 242

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention Group	Intervention Group	This group received follow-up every 2-months for one year. Follow-up included questions about their heart disease progression and how well they had been able to engage in their doctor approved physical activity goal, which was the same as the control arm. Additionally, subjects in this arm were encouraged to use positive affect and self-affirmation techniques to motivate an increased level of participation in their physical activity goal. These subjects also received small token gifts to remind them of their study participation.

Primary Outcome Measures

Name	Time	Method
Within patient change in the Paffenbarger Exercise and Physical Activity Index	basline, at 2-month intervals(2, 4, 6, 8, 10-months) and closeout

Trial Locations

Locations (1)

The New York Presbyterian Hospital-Weill Medical Center; 🇺🇸 New York, New York, United States