Improving Health Behavior and Outcomes After Angioplasty

October 25, 2018 updated by: Mary E. Charlson, MD, Weill Medical College of Cornell University
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

660

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • New York, New York, United States, 10021
        • New York Presbyterian College-Weill Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: OTHER
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
NO_INTERVENTION: 1
This is the control group, which will be monitor. No intervention will be delivered to this group.
EXPERIMENTAL: 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.
Behavioral: Net-present value of individual health behaviors in years

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Mortality
Stroke
Myocardial Infarction
Angina
Severe ischemia on non-invasive testing

Secondary Outcome Measures

Outcome 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.
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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Weill Medical College of Cornell University

Collaborators

National Heart, Lung, and Blood Institute (NHLBI)

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 1999

Primary Completion (ACTUAL)

March 29, 2004

Study Completion (ACTUAL)

March 29, 2004

Study Registration Dates

First Submitted

November 3, 2005

First Submitted That Met QC Criteria

November 3, 2005

First Posted (ESTIMATE)

November 4, 2005

Study Record Updates

Last Update Posted (ACTUAL)

October 29, 2018

Last Update Submitted That Met QC Criteria

October 25, 2018

Last Verified

October 1, 2018

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 0698-267

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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