Improving Health Behavior and Outcomes After Angioplasty | NCT00248976

Studies
Improving Health Behavior and Outcomes After Angioplasty

NCT00248976

Sponsor

Weill Medical College of Cornell University

Status

Completed

Last Update Posted

Oct 29, 2018Actual

Enrollment

660Actual

Phase

Not Applicable

Conditions

Angioplasty

Interventions

Net-present value of individual health behaviors in years

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2018

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 1999

Primary Completion Date

Mar 29, 2004Actual

Completion Date

Mar 29, 2004Actual

First Submitted Date

Nov 3, 2005

First Submission Date that Met QC Criteria

Nov 3, 2005

First Posted Date

Nov 4, 2005Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 25, 2018

Last Update Posted Date

Oct 29, 2018Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Mary E. Charlson, MD, The William T. Foley Distinguished Professor in Medicine, Weill Medical College of Cornell UniversityPrincipal Investigator

Lead Sponsor

Weill Medical College of Cornell UniversityOTHER

Collaborators

Name	Class
National Heart, Lung, and Blood Institute (NHLBI)	NIH

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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

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.
To determine whether the net-present value intervention will enable patients to sustain behavioral change over the long-term.
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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

660Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
Net-present value of individual health behaviors in years	Behavioral		2

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Mortality
Myocardial Infarction
Angina
Severe ischemia on non-invasive testing
Stroke

Secondary Outcomes

Measure	Description	Time Frame
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.

Other Outcomes

Not provided

Eligibility Module

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Mary E Charlson, MD	Weill Medical College of Cornell University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
New York Presbyterian College-Weill Medical Center		New York	New York	10021	United States