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

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.

Study Overview

• Status: Completed
• Conditions: Quality of Life; Pain; Depressive Symptoms

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 Type: Observational
• Enrollment (Actual): 660

Contacts and Locations

Study Locations

• United States
  • New York
    • New York, New York, United States, 10065
      • Weill Cornell Medical College

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

The is a database study of a cohort of 660 patients with cardiovascular disease who had recently undergone coronary angioplasty.

Description

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.

Exclusion Criteria:

• Non-participants in the Healthy Behavior Trial

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
successful behavior change over 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.	Baseline, 3, 6, 9 and 12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Quality of life	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.	Within-patient change from baseline to 12 months

Collaborators and Investigators

• Sponsor: Weill Medical College of Cornell University
• Collaborators: National Institute on Aging (NIA)
• Investigators: Principal Investigator: Janey C Peterson, EdD, MS, RN, Weill Medical College of Cornell University

Publications and helpful links

General Publications

• Charlson ME, Peterson JC, Boutin-Foster C, Briggs WM, Ogedegbe GG, McCulloch CE, Hollenberg J, Wong C, Allegrante JP. Changing health behaviors to improve health outcomes after angioplasty: a randomized trial of net present value versus future value risk communication. Health Educ Res. 2008 Oct;23(5):826-39. doi: 10.1093/her/cym068. Epub 2007 Nov 19.

Helpful Links

• Related Info

Study record dates

Study Major Dates

• Study Start: April 1, 1999
• Primary Completion (Actual): August 1, 2003
• Study Completion (Actual): February 1, 2005

Study Registration Dates

• First Submitted: November 8, 2011
• First Submitted That Met QC Criteria: November 9, 2011
• First Posted (Estimate): November 10, 2011

Study Record Updates

• Last Update Posted (Estimate): March 8, 2012
• Last Update Submitted That Met QC Criteria: March 7, 2012
• Last Verified: March 1, 2012

More Information

Terms related to this study

• Keywords: Cardiovascular disease; Pain; Morbidity; Outcomes; Mortality; Coronary angioplasty; Health behavior change
• Additional Relevant MeSH Terms: Behavioral Symptoms; Depression
• Other Study ID Numbers: 9806003392; 3P30AG022845-07S1 (U.S. NIH Grant/Contract)