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Modified Consent Form Utility

The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2008 by University of California, Davis.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborator:
National Center for Research Resources (NCRR)
Information provided by:
University of California, Davis
ClinicalTrials.gov Identifier:
NCT00715923
First received: July 11, 2008
Last updated: NA
Last verified: July 2008
History: No changes posted
  Purpose

Subjects enrolling into a nutrition study of the effects of tea on fat absorption will be randomized to receive either a standard informed consent document or a modified document that is shorter and more easily understood than the standard document. The hypothesis is that using a shorter form that is more easily understood and more visually simple will lead to greater subject satisfaction in the consent process and will not compromise subject comprehension of key study aspects. Consent for study inclusion has been waived by the IRB because informing subjects of the nature and process of the study would likely affect the findings, and both the standard and modified consent forms were approved for use in the nutrition study.


Condition Intervention
Healthy
 Other: Modified consent form
Other: Standard consent form

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Official Title: CTSA Utility of Modified Consent Forms in Clinical Research: Fraga Tea Study

Further study details as provided by University of California, Davis:

Primary Outcome Measures:
  • Subject satisfaction [ Time Frame: close of parent study ] [ Designated as safety issue: No ]

Estimated Enrollment: 30
Study Start Date: November 2007
Estimated Study Completion Date: December 2008
Estimated Primary Completion Date: September 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Modified consent form
 Other: Modified consent form
modified consent form used
Active Comparator: 2
Standard consent form
 Other: Standard consent form
standard consent form used

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • participation in parent study, English speaking

Exclusion Criteria:

  • none
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00715923

Locations
United States, California
University of California Davis
Sacramento, California, United States, 95817
Sponsors and Collaborators
University of California, Davis
National Center for Research Resources (NCRR)
Investigators
Principal Investigator: Alexander A Kon, MD University of California, Davis
  More Information

No publications provided

Responsible Party: Alexander A. Kon, MD, University of California, Davis
ClinicalTrials.gov Identifier: NCT00715923     History of Changes
Other Study ID Numbers: 200715802
Study First Received: July 11, 2008
Last Updated: July 11, 2008
Health Authority: United States: Institutional Review Board

Keywords provided by University of California, Davis:
informed consent document
ethics

ClinicalTrials.gov processed this record on May 19, 2013