Angioplasty
Conditions
Keywords
Angioplasty, Motivating behavior change, Reducing risk factors, Enhancing quality of life, Improving treatment outcomes
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.
Interventions
BEHAVIORALNet-present value of individual health behaviors in years
Sponsors
National Heart, Lung, and Blood Institute (NHLBI)
Weill Medical College of Cornell University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Stroke | — |
| Myocardial Infarction | — |
| Angina | — |
| Severe ischemia on non-invasive testing | — |
| Mortality | — |
Secondary
| Measure | Time frame |
|---|---|
| b. To determine whether the net-present value intervention will enable patients to sustain behavioral change over the long-term. | — |
| c. To determine whether the net-present value intervention will improve overall functional status and prevent further disability. | — |
| 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. | — |
Countries
United States
Outcome results
None listed