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Use of Portable Technology in Patient Education of Shave/Punch Biopsies

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01110148
Recruitment Status : Completed
First Posted : April 26, 2010
Last Update Posted : April 26, 2010
Information provided by:
University of California, Davis

Brief Summary:
The investigators investigated the use of portable MP3 technology in patient education and informed consent of shave and punch biopsies. Eighty patients were divided randomly into a control and experimental group. Control patients received the standard of care in patient education and informed consent. Experimental patients watched a short 80-second video on shave or punch biopsies. All patients were given pre- and post-education questionnaires to assess the efficacy of each method.

Condition or disease Intervention/treatment Phase
Biopsy Other: video-based informed consent for skin biopsies Other: traditional informed consent Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 84 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Health Services Research
Official Title: Use of MP3 Portable Technology in Patient Education and Informed Consent of Shave and Punch Biopsies
Study Start Date : July 2009
Actual Primary Completion Date : April 2010
Actual Study Completion Date : April 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Biopsy

Arm Intervention/treatment
Experimental: Video-based informed consent
patients receiving informed consent through video format
Other: video-based informed consent for skin biopsies
video-based informed consent for punch and shave biopsies

Active Comparator: traditional informed consent
patients receiving traditional informed consent from the physicians.
Other: traditional informed consent
traditional informed consent (standard of care) from physicians for shave and punch biopsies

Primary Outcome Measures :
  1. Measure the post-education knowledge of each intervention arm [ Time Frame: at the end of the study visit ]
    Compare the post-education knowledge between the two intervention arms: one conventional informed consent process, the other video-based informed consent process. Knowledge will be measured through a questionnaire administered before and after patient education is given.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • English speaker
  • Receiving shave or punch biopsy

Exclusion Criteria:

  • Under 18 years of age

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01110148

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United States, California
University of California Davis Medical Center
Sacramento, California, United States, 95816
Sponsors and Collaborators
University of California, Davis
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Principal Investigator: April W Armstrong, M.D. UC Davis Health System

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Responsible Party: April Armstrong, M.D., University of California, Davis Identifier: NCT01110148     History of Changes
Other Study ID Numbers: 200917169-1
First Posted: April 26, 2010    Key Record Dates
Last Update Posted: April 26, 2010
Last Verified: April 2010
Keywords provided by University of California, Davis:
skin biopsy
informed consent
patient education
video education
patients requiring skin biopsies