Improving Health Behavior and Outcomes After Angioplasty

NCT ID: NCT00248976

Last Updated: 2018-10-29

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 660 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 1999-04-30
• Study Completion Date: 2004-03-29

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.

Conditions

Angioplasty

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

1

This is the control group, which will be monitor. No intervention will be delivered to this group.

Group Type: NO_INTERVENTION

No interventions assigned to this group

2

This group received the experimental intervention. This is an intervention based on feedback of individualized risk profiles framed as the opportunity to reduce one's biologic age. Net-present value of individual health behaviors in years.

Group Type: EXPERIMENTAL

Net-present value of individual health behaviors in years

Intervention Type: BEHAVIORAL

Interventions

Net-present value of individual health behaviors in years

Intervention Type: BEHAVIORAL

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Heart, Lung, and Blood Institute (NHLBI)

NIH

Sponsor Role: collaborator

Weill Medical College of Cornell University

OTHER

Sponsor Role: lead

Responsible Party

Mary E. Charlson, MD

The William T. Foley Distinguished Professor in Medicine

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Mary E Charlson, MD

Role: PRINCIPAL_INVESTIGATOR

Weill Medical College of Cornell University

Locations

New York Presbyterian College-Weill Medical Center

New York, New York, United States

Countries

United States

Other Identifiers

0698-267

Identifier Type: -

Identifier Source: org_study_id