NCT00032565

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
836

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Nov 2002

Longer than P75 for all trials

Geographic Reach
1 country

22 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

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
7 months until next milestone

Study Start

First participant enrolled

November 1, 2002

Completed
4.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2007

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2008

Completed
Last Updated

September 24, 2010

Status Verified

September 1, 2010

Enrollment Period

4.7 years

First QC Date

March 27, 2002

Last Update Submit

September 22, 2010

Conditions

Outcome Measures

Primary Outcomes (1)

  • Interview: Telephone based assessment of informed consent

    immediate

Study Arms (1)

1

No intervention. Telephone interview.

Eligibility Criteria

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

Patients in various VA clinics

You may qualify if:

  • Depends on 'parent' study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (22)

VA Medical Center, Birmingham

Birmingham, Alabama, 35233, United States

Location

Central Arkansas VHS Eugene J. Towbin Healthcare Ctr, Little Rock

No. Little Rock, Arkansas, 72114-1706, United States

Location

VA Medical Center, Loma Linda

Loma Linda, California, 92357, United States

Location

VA Palo Alto Health Care System

Palo Alto, California, 94304-1207, United States

Location

VA Connecticut Health Care System (West Haven)

West Haven, Connecticut, 06516, United States

Location

Atlanta VA Medical and Rehab Center, Decatur

Decatur, Georgia, 30033, United States

Location

Edward Hines, Jr. VA Hospital

Hines, Illinois, 60141-5000, United States

Location

VA Medical Center, Lexington

Lexington, Kentucky, 40502, United States

Location

Southeast Veterans Healthcare System, New Orleans

New Orleans, Louisiana, 70112, United States

Location

VA Maryland Health Care System, Baltimore

Baltimore, Maryland, 21201, United States

Location

VA Medical Center, Jamaica Plain Campus

Boston, Massachusetts, 02130, United States

Location

VA Boston Healthcare System, Brockton Campus

Brockton, Massachusetts, 02301, United States

Location

John D. Dingell VA Medical Center, Detroit

Detroit, Michigan, 48201, United States

Location

VA Medical Center, Minneapolis

Minneapolis, Minnesota, 55417, United States

Location

VA Western New York Healthcare System at Buffalo

Buffalo, New York, 14215, 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, Cincinnati

Cincinnati, Ohio, 45220, United States

Location

VA Medical Center, Philadelphia

Philadelphia, Pennsylvania, 19104, United States

Location

VA North Texas Health Care System, Dallas

Dallas, Texas, 75216, United States

Location

Michael E. DeBakey VA Medical Center (152)

Houston, Texas, 77030, United States

Location

Hunter Holmes McGuire VA Medical Center

Richmond, Virginia, 23249, United States

Location

Related Publications (1)

  • Lavori PW, Wilt TJ, Sugarman J. Quality assurance questionnaire for professionals fails to improve the quality of informed consent. Clin Trials. 2007;4(6):638-49. doi: 10.1177/1740774507085144.

Study Officials

  • Philip Lavori, PhD

    VA Palo Alto Health Care System

    STUDY CHAIR

Study Design

Study Type
observational
Time Perspective
CROSS SECTIONAL
Sponsor Type
FED

Study Record Dates

First Submitted

March 27, 2002

First Posted

March 28, 2002

Study Start

November 1, 2002

Primary Completion

July 1, 2007

Study Completion

March 1, 2008

Last Updated

September 24, 2010

Record last verified: 2010-09

Locations