Use of Portable Technology in Patient Education of Shave/Punch Biopsies
Use of MP3 Portable Technology in Patient Education and Informed Consent of Shave and Punch Biopsies
1 other identifier
interventional
84
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Jul 2009
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2010
CompletedFirst Submitted
Initial submission to the registry
April 13, 2010
CompletedFirst Posted
Study publicly available on registry
April 26, 2010
CompletedApril 26, 2010
April 1, 2010
9 months
April 13, 2010
April 23, 2010
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Measure the post-education knowledge of each intervention arm
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.
at the end of the study visit
Study Arms (2)
Video-based informed consent
EXPERIMENTALpatients receiving informed consent through video format
traditional informed consent
ACTIVE COMPARATORpatients receiving traditional informed consent from the physicians.
Interventions
video-based informed consent for punch and shave biopsies
traditional informed consent (standard of care) from physicians for shave and punch biopsies
Eligibility Criteria
You may qualify if:
- English speaker
- Receiving shave or punch biopsy
You may not qualify if:
- Under 18 years of age
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of California Davis Medical Center
Sacramento, California, 95816, United States
Study Officials
- PRINCIPAL INVESTIGATOR
April W Armstrong, M.D.
UC Davis Health System
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- HEALTH SERVICES RESEARCH
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
April 13, 2010
First Posted
April 26, 2010
Study Start
July 1, 2009
Primary Completion
April 1, 2010
Study Completion
April 1, 2010
Last Updated
April 26, 2010
Record last verified: 2010-04