NCT00032552

Brief Summary

Patients in 'parent' cooperative studies projects are interviewed about their experiences in the informed consent process.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
632

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Apr 1999

Longer than P75 for all trials

Geographic Reach
1 country

18 active sites

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 1999

Completed
3 years until next milestone

First Submitted

Initial submission to the registry

March 27, 2002

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 28, 2002

Completed
3.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2006

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2006

Completed
Last Updated

March 25, 2010

Status Verified

March 1, 2010

Enrollment Period

6.8 years

First QC Date

March 27, 2002

Last Update Submit

March 23, 2010

Conditions

Outcome Measures

Primary Outcomes (1)

  • measuring the process and outcome if informed consent

    immediately during patient interview

Study Arms (1)

1

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Veterans

You may qualify if:

  • Depends on 'parent' study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (18)

VA Medical Center, Birmingham

Birmingham, Alabama, 35233, United States

Location

VA Palo Alto Health Care System

Palo Alto, California, 94304-1207, United States

Location

MIMA Century Research Assoc. (CSP #424) (DP)

Melbourne, Florida, 32901, United States

Location

West Palm Beach VA Medical Center

West Palm Beach, Florida, 33410, United States

Location

Edward Hines, Jr. VA Hospital

Hines, Illinois, 60141-5000, United States

Location

Richard Roudebush VA Medical Center, Indianapolis

Indianapolis, Indiana, 46202-2884, United States

Location

VA Ann Arbor Healthcare System

Ann Arbor, Michigan, 48113, United States

Location

VA Medical Center, Minneapolis

Minneapolis, Minnesota, 55417, United States

Location

Mayo Clinic Rochester (CSP #424) (DP)

Rochester, Minnesota, 55905, United States

Location

VA Medical Center, St Louis

St Louis, Missouri, 63106, United States

Location

VA Sierra Nevada Health Care System

Reno, Nevada, 89502, United States

Location

VA Western New York Healthcare System at Buffalo

Buffalo, New York, 14215, United States

Location

New York Harbor HCS

New York, New York, 10010, United States

Location

VA Medical Center, Northport

Northport, New York, 11768, United States

Location

VA Medical Center, Durham

Durham, North Carolina, 27705, United States

Location

VA Medical Center, Philadelphia

Philadelphia, Pennsylvania, 19104, United States

Location

Michael E. DeBakey VA Medical Center (152)

Houston, Texas, 77030, United States

Location

VA Puget Sound Health Care System, Seattle

Seattle, Washington, 98108, United States

Location

Study Officials

  • Philip Lavori, PhD

    VA Palo Alto Health Care System

    STUDY CHAIR

Study Design

Study Type
observational
Sponsor Type
FED

Study Record Dates

First Submitted

March 27, 2002

First Posted

March 28, 2002

Study Start

April 1, 1999

Primary Completion

February 1, 2006

Study Completion

February 1, 2006

Last Updated

March 25, 2010

Record last verified: 2010-03

Locations