Clinical trial NCT00248976: Improving Health Behavior and Outcomes After Angioplasty
Official title: Improving Health Behavior and Outcomes After Angioplasty
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Angioplasty
Keywords: Angioplasty
Motivating behavior change
Reducing risk factors
Enhancing quality of life
Improving treatment outcomes
Lead sponsor: Weill Medical College of Cornell University
Sponsor class: OTHER
Collaborators: name: National Heart, Lung, and Blood Institute (NHLBI)
First posted: 2005-11-04
Enrollment: 660
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: The objective of this randomized trials is to evaluate, among coronary artery disease patients who have just had either angioplasty or stents, whether a novel intervention based on feedback of individualized risk profiles framed as the opportunity to reduce one's biological age is more effective after two years in reducing mortality and major cardiovascular morbidity (specifically, myocardial infarction, stroke, class II-IV angina, and severe ischemia) than the standard risk reduction approach, which is framed as one's opportunity to reduce future risk. The novel strategy is based on the theory of net-present value and is tested in coronary artery disease patients who have a high risk of adverse outcomes by two years.

Detailed description: 1. To determine whether patients who receive the net-present value intervention have more improvements in their risk factor profile than those in the control group at two years.
2. To determine whether the net-present value intervention will enable patients to sustain behavioral change over the long-term.
3. To determine whether the net-present value intervention will improve overall functional status and prevent further disability.

The long-term objective of this study is to determine whether a net-present value approach for motivation behavior change is effective in reducing risk factors, improving treatment outcomes, and enhancing quality of life among a high-risk group of patients.

Eligibility criteria: Inclusion criteria:

* All patients undergoing coronary artery catheterization who are found to have at least single vessel stenosis and who have had revascularization with angioplasty or coronary artery stenting will be eligible for enrollment. Patients must be able to provide informed consent within the one week after the procedures.

Exclusion criteria:

* Patients must be verbally fluent in English. To ascertain this, we ask the patient to rate their fluency on a scale of 1-10 (with 10 as best), and if the score is 7 or more, they are approached for consent. The patient must be able to provide their own consent without translation.
* Enrollment in other trials designed to modify post-procedure behaviors.
* Patients who refuse to participate will be excluded.
* If at any time prior to enrollment in the study, the patient's cardiologist determines that the patient should not participate in this study, the patient will not be enrolled in the trial.

Primary outcomes:
measure: Mortality
measure: Myocardial Infarction
measure: Angina
measure: Severe ischemia on non-invasive testing
measure: Stroke
Secondary outcomes:
measure: a. To determine whether patients who receive the net-present value intervention have more improvements in their risk factor profile than those in the control group at two years.
measure: b. To determine whether the net-present value intervention will enable patients to sustain behavioral change over the long-term.
measure: c. To determine whether the net-present value intervention will improve overall functional status and prevent further disability.
Other outcomes:
Locations:
city: New York
country: United States
facility: New York Presbyterian College-Weill Medical Center
state: New York
Study officials:
affiliation: Weill Medical College of Cornell University
name: Mary E Charlson, MD
role: PRINCIPAL_INVESTIGATOR
References: