Modified Consent Form Utility

University of California (UC) Davis logo

University of California (UC) Davis

Status

Terminated

Conditions

Healthy

Treatments

Other: Modified consent form
Other: Standard consent form

Study type

Interventional

Funder types

Other
NIH

Identifiers

NCT00715923
200715802

Details and patient eligibility

About

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.

Enrollment

30 estimated patients

Sex

All

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

participation in parent study, English speaking

Exclusion criteria

none

Trial design

30 participants in 2 patient groups

1
Experimental group
Description:
Modified consent form
Treatment:
Other: Modified consent form
2
Active Comparator group
Description:
Standard consent form
Treatment:
Other: Standard consent form

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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