Determinants of Cardiac Risk Factor Modification in Latin... | NCT00248859

Studies
Determinants of Cardiac Risk Factor Modification in Latinos With Coronary Artery Disease

NCT00248859

Sponsor

Weill Medical College of Cornell University

Status

Completed

Last Update Posted

Feb 20, 2017Actual

Enrollment

198Actual

Phase

Not provided

Conditions

Coronary Artery Disease

Interventions

Not provided

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

ID	Type	Description	Link
5K01HL076567	U.S. NIH Grant/Contract		View source

Status Module

Record Verification Date

Feb 2017

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

Aug 2004

Primary Completion Date

Jun 2010Actual

Completion Date

Jun 2010Actual

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

Feb 17, 2017

Last Update Posted Date

Feb 20, 2017Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Carla Boutin-Foster, MD, Study Principal Investigator, 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

This is an observational study among Latino patients who have coronary artery disease. The goal of the study is to determine the association between having depressive symptoms and the ability to modify one's health behavior. Specifically, participate in physical activity.

Detailed Description

Specific aims: Among 213 Latino adult patients who have had coronary artery angioplasty within the past month, the specific aims of the proposed study are:

To determine whether patients who have more depressive symptoms at the time of angioplasty are less likely to be active in physical activity at two years. Physical activity will be measured by a survey that asks patients to describe their activities including leisure activities or housework.
To determine whether lower perceived social support, lower self-efficacy for engaging in physical activity, and greater perceived stress mediate the effects of depressive symptoms on participation in physical activity.

Long-term objectives: The long-term objective of this study is to use these data to develop a culturally tailored intervention to increase participation in physical activity and ultimately improve the overall health and well being of Latino adults with coronary artery disease.

Outcome: The outcome is being in the action or maintenance stage of physical activity two years after angioplasty The stage of physical activity participation will be based on the Stages of Change model. This model describes behavior change as a continuum from pre-contemplation to contemplation.

Design Module

Study Type

Observational

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 provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

198Actual

Eligibility Module

Eligibility Criteria

Inclusion Criteria

Patients must identify their ethnicity as Latino or Hispanic
Patients must be able to complete a questionnaire in either English or Spanish.
Patients must have angiographic evidence of coronary artery disease requiring angioplasty
Patients must also be clinically stable for an interview
Patient must be able to provide informed consent.

Exclusion criteria

Patients who are not clinically stable such as those who had cardiac arrest, who are intubated, who have active psychosis, or who are cognitively impaired.
Patients who are unable to provide consent.

Accepts Healthy Volunteers

Yes

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

Cardiovascular DiSease

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Carla Boutin-Foster, MD	Weill Medical College of Cornell University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Joan and Sanford I. Weill Medical College		New York	New York	10021	United States

IPD Sharing Statement Module

Plan to Share IPD

Description

No plan to share IPD

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D003324	Coronary Artery Disease
D003863	Depression

Ancestor Terms

ID	Term
D003327	Coronary Disease
D017202	Myocardial Ischemia
D006331	Heart Diseases
D002318	Cardiovascular Diseases

Browse Leaves

Not provided

Browse Branches

Not provided