Assessing Pain as a Mediator of Behavior Change in Post-coronary Angioplasty Patients
|ClinicalTrials.gov Identifier: NCT01469780|
Recruitment Status : Completed
First Posted : November 10, 2011
Last Update Posted : March 8, 2012
|Condition or disease|
|Pain Depressive Symptoms Quality of Life|
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."
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|
|Actual Enrollment :||660 participants|
|Official Title:||Assessing Pain as a Mediator of Behavior Change in Post-coronary Angioplasty Patients|
|Study Start Date :||April 1999|
|Actual Primary Completion Date :||August 2003|
|Actual Study Completion Date :||February 2005|
- successful behavior change over 12 months [ Time Frame: 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.
- Quality of life [ Time Frame: 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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01469780
|United States, New York|
|Weill Cornell Medical College|
|New York, New York, United States, 10065|
|Principal Investigator:||Janey C Peterson, EdD, MS, RN||Weill Medical College of Cornell University|