NCT01110148

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

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
84

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jul 2009

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2009

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2010

Completed
12 days until next milestone

First Submitted

Initial submission to the registry

April 13, 2010

Completed
13 days until next milestone

First Posted

Study publicly available on registry

April 26, 2010

Completed
Last Updated

April 26, 2010

Status Verified

April 1, 2010

Enrollment Period

9 months

First QC Date

April 13, 2010

Last Update Submit

April 23, 2010

Conditions

Keywords

skin biopsyinformed consentpatient educationvideo educationpatients requiring skin biopsies

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

EXPERIMENTAL

patients receiving informed consent through video format

Other: video-based informed consent for skin biopsies

traditional informed consent

ACTIVE COMPARATOR

patients receiving traditional informed consent from the physicians.

Other: traditional informed consent

Interventions

video-based informed consent for punch and shave biopsies

Video-based informed consent

traditional informed consent (standard of care) from physicians for shave and punch biopsies

traditional informed consent

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

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

Location

Study Officials

  • April W Armstrong, M.D.

    UC Davis Health System

    PRINCIPAL INVESTIGATOR

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

Locations