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

Sponsor

Weill Medical College of Cornell University (Other)

Overall Status

Completed

CT.gov ID

NCT01469780

Collaborator

National Institute on Aging (NIA) (NIH)

660

Enrollment

Location

70.1

Duration (Months)

9.4

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Pain Depressive Symptoms Quality of Life

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.

Study Design

Study Type:

Observational

Actual Enrollment :

660 participants

Observational Model:

Cohort

Time Perspective:

Retrospective

Official Title:

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

Study Start Date :

Apr 1, 1999

Actual Primary Completion Date :

Aug 1, 2003

Actual Study Completion Date :

Feb 1, 2005

Outcome Measures

Primary Outcome Measures

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

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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.