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Improving Health Behavior and Outcomes After Angioplasty

This study has been completed.
Sponsor:
Collaborator:
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by:
Weill Medical College of Cornell University
ClinicalTrials.gov Identifier:
NCT00248976
First received: November 3, 2005
Last updated: March 28, 2008
Last verified: March 2008
History of Changes
  Purpose

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.


Condition Intervention
Angioplasty
 Behavioral: Net-present value of individual health behaviors in years

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Official Title: Improving Health Behavior and Outcomes After Angioplasty

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Weill Medical College of Cornell University:

Primary Outcome Measures:
  • Mortality
  • Myocardial Infarction
  • Angina
  • Severe ischemia on non-invasive testing
  • Stroke

Secondary Outcome Measures:
  • 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.

Enrollment: 660
Study Start Date: April 1999
Estimated Study Completion Date: March 2004
Arms Assigned Interventions
No Intervention: 1
Control
 Behavioral: Net-present value of individual health behaviors in years
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.
 Behavioral: Net-present value of individual health behaviors in 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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00248976

Locations
United States, New York
New York Presbyterian College-Weill Medical Center
New York, New York, United States, 10021
Sponsors and Collaborators
Weill Medical College of Cornell University
National Heart, Lung, and Blood Institute (NHLBI)
Investigators
Principal Investigator: Mary E Charlson, MD Weill Medical College of Cornell University
  More Information

No publications provided

Responsible Party: Mary E. Charlson, MD, Weill Cornell Medical College
ClinicalTrials.gov Identifier: NCT00248976     History of Changes
Other Study ID Numbers: 0698-267
Study First Received: November 3, 2005
Last Updated: March 28, 2008
Health Authority: United States: Federal Government
United States: Institutional Review Board

Keywords provided by Weill Medical College of Cornell University:
Angioplasty
Motivating behavior change
Reducing risk factors
Enhancing quality of life
Improving treatment outcomes

ClinicalTrials.gov processed this record on May 23, 2013