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

This study has been completed.
Sponsor:
Information provided by:
University of California, Davis
ClinicalTrials.gov Identifier:
NCT01110148
First received: April 13, 2010
Last updated: April 23, 2010
Last verified: April 2010
  Purpose

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 Intervention
Biopsy
Other: video-based informed consent for skin biopsies
Other: traditional informed consent

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (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

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

Primary Outcome Measures:
  • Measure the post-education knowledge of each intervention arm [ Time Frame: at the end of the study visit ] [ Designated as safety issue: No ]
    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.


Enrollment: 84
Study Start Date: July 2009
Study Completion Date: April 2010
Primary Completion Date: April 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • English speaker
  • Receiving shave or punch biopsy

Exclusion Criteria:

  • Under 18 years of age
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01110148

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

No publications provided

Responsible Party: April Armstrong, M.D., University of California, Davis
ClinicalTrials.gov Identifier: NCT01110148     History of Changes
Other Study ID Numbers: 200917169-1
Study First Received: April 13, 2010
Last Updated: April 23, 2010
Health Authority: United States: Institutional Review Board

Keywords provided by University of California, Davis:
skin biopsy
informed consent
patient education
video education
patients requiring skin biopsies

ClinicalTrials.gov processed this record on November 27, 2014