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

Pain Clinical Trial

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

Status Completed

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Observational Model: Cohort, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Depressive Symptoms
• Pain
• Quality of Life

• NCT number: NCT01469780
• Study type: Observational
• Source: Weill Medical College of Cornell University
• Status: Completed
• Phase: N/A
• Start date: April 1999
• Completion date: February 2005