Assessing Pain as a Mediator of Behavior Change in Post-coronary Angioplasty Patients

Completed

• Conditions: Pain; Depressive Symptoms; Quality of Life

• Registration Number: NCT01469780
• Lead Sponsor: Weill Medical College of Cornell University

Brief Summary

The focus of this secondary data analysis is to determine whether pain due to a combination of both cardiac and non cardiac sources operates as a mediator of behavior change, an area that has not been previously evaluated.

Detailed Description

This is a secondary data analysis of an existing dataset generated from The Healthy Behavior Trial, an NHLBI-funded randomized controlled trial that enrolled 660 post-coronary angioplasty patients between October 1999 and March 2001. This study employed a behavioral intervention to motivate PCI patients to adopt health behaviors in order to reduce major cardiac and neurologic morbidity and mortality. Patients in the experimental arm were told their estimated biologic age (calculated from the health risk assessment) and risk factors were presented in terms of "biologic age reduction" that could be achieved if a change was made in each health behavior area. Those in the control arm were provided with risk factors (also obtained from the health risk assessment) and told that changing each health behavior could "increase your lifespan."

Specific Aims:

Utilizing 12 month longitudinal data for patients with cardiovascular disease who have undergone coronary angioplasty we will:

Specific aim 1: Determine if pain is a mediator of health behavior change over 12 months.

Specific aim 2: Assess behavior change patterns over 12 months, stratifying for degree of pain, depression and/or stress.

Specific aim 3: Evaluate the effect of pain on quality of life (physical, social, role-physical, role-emotional, vitality, mental health, bodily pain and general health domains), combined major cardiac and neurologic morbidity/mortality and hospitalizations over 12 months.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 1999-04
• Primary Completion: 2003-08
• Study Completion: 2005-02
• Study First Submitted: 2011-11-08
• Study First Submitted QC: 2011-11-09
• Study First Posted: 2011-11-10
• Status Verified: 2012-03
• Last Update Submitted: 2012-03-07
• Last Update Posted: 2012-03-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 660

Inclusion Criteria

• all patients in the database who had participated in the Healthy Behavior Trial. The Healthy Behavior Trial was a randomized controlled trial of a psychoeducational intervention designed to motivate multi-behavior change (changing 2 or more cardiovascular risk factors) in post-coronary angioplasty patients over the course of 24 months.

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Exclusion Criteria

• Non-participants in the Healthy Behavior Trial

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
successful behavior change over 12 months	Baseline, 3, 6, 9 and 12 months	Health behavior will be examined in five areas: overall physical activity, strength training, aerobic activity, weight loss, and smoking cessation. Successful health behavior change will be defined as "action" (engaging in the behavior \< six months) or "maintenance" (engaging in the behavior ≥ six months to five years), according to the Transtheoretical Model. We will use self-reported data.

Secondary Outcome Measures

Name	Time	Method
Quality of life	Within-patient change from baseline to 12 months	The SF-36 health survey will be the primary measure of quality of life. Each of the eight individual domain scores will be evaluated (physical, social, role-physical, role-emotional, vitality, mental health, bodily pain and general health) and the within-patient change from baseline to 12 months will be calculated. The physical and mental component summary measures will also be calculated, as will the within-patient change from baseline to 12 months for the component scores. We will assess these measures as both continuous and dichotomous measures.

Trial Locations

Locations (1)

Weill Cornell Medical College; 🇺🇸 New York, New York, United States