Clinical trial NCT01469780: Assessing Pain as a Mediator of Behavior Change in Post-coronary Angioplasty Patients
Official title: Assessing Pain as a Mediator of Behavior Change in Post-coronary Angioplasty Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pain
Depressive Symptoms
Quality of Life
Keywords: Pain
Health behavior change
Coronary angioplasty
Cardiovascular disease
Outcomes
Morbidity
Mortality
Lead sponsor: Weill Medical College of Cornell University
Sponsor class: OTHER
Collaborators: name: National Institute on Aging (NIA)
First posted: 2011-11-10
Enrollment: 660
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: successful behavior change over 12 months
timeFrame: Baseline, 3, 6, 9 and 12 months
Secondary outcomes:
measure: Quality of life
timeFrame: Within-patient change from baseline to 12 months
Other outcomes:
Locations:
city: New York
country: United States
facility: Weill Cornell Medical College
state: New York
Study officials:
affiliation: Weill Medical College of Cornell University
name: Janey C Peterson, EdD, MS, RN
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.