NCT00248950

Brief Summary

We are interested in achieving an empirical test of the two intervention approaches under study. Specifically, we seek to determine the potential differential impact of positive affect induction and self affirmation following the qualitative study phase.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Feb 2004

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2004

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2004

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

November 3, 2005

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 4, 2005

Completed
Last Updated

April 3, 2008

Status Verified

April 1, 2008

First QC Date

November 3, 2005

Last Update Submit

April 1, 2008

Conditions

Angioplasty Patients

Keywords

AngioplastyBehavior Change

Outcome Measures

Primary Outcomes (1)

  • Within patient change on the Positive and Negative Affect Scale

Interventions

Positive affect induction and /or self affirmation inductionBEHAVIORAL

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (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 procedure.

You may not qualify if:

  • Patients who are unable to walk several blocks regardless of the reason will be excluded from all the trials (e.g., arthritis, stroke, claudication).
  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The New York Presbyterian Hospital-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
NON RANDOMIZED
Masking
DOUBLE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

November 3, 2005

First Posted

November 4, 2005

Study Start

February 1, 2004

Study Completion

June 1, 2004

Last Updated

April 3, 2008

Record last verified: 2008-04

Locations

US(1)