Improving Health Behavior and Outcomes After Angioplasty

NCT00248976 | Completed

• 1 other identifier: 0698-267
• Study Type: interventional
• Target: 660
• Locations: 1 country
• Sites: 1

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.

Conditions

Angioplasty

Keywords

Angioplasty; Motivating behavior change; Reducing risk factors; Enhancing quality of life; Improving treatment outcomes

Outcome Measures

Primary Outcomes (5)

• Mortality

• Myocardial Infarction

• Angina

• Severe ischemia on non-invasive testing

• Stroke

Secondary Outcomes (3)

• 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.

Study Arms (2)

1

NO INTERVENTION

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

2

EXPERIMENTAL

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

Interventions

Net-present value of individual health behaviors in years BEHAVIORAL

2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Weill Medical College of Cornell University: lead
• National Heart, Lung, and Blood Institute (NHLBI): collaborator

Study Sites (1)

New York Presbyterian College-Weill Medical Center

New York, New York, 10021, United States

Location

Study Officials

• Mary E Charlson, MD

  Weill Medical College of Cornell University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: The William T. Foley Distinguished Professor in Medicine

Study Record Dates

• First Submitted: November 3, 2005
• First Posted: November 4, 2005
• Study Start: April 1, 1999
• Primary Completion: March 29, 2004
• Study Completion: March 29, 2004
• Last Updated: October 29, 2018

Record last verified: 2018-10

Locations

US (1)