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

April 23, 2010 updated by: University of California, Davis

Use of MP3 Portable Technology in Patient Education and Informed Consent of Shave and Punch Biopsies

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

84

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Sacramento, California, United States, 95816
        • University of California Davis Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • English speaker
  • Receiving shave or punch biopsy

Exclusion Criteria:

  • Under 18 years of age

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
at the end of the study visit

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of California, Davis

Investigators

  • Principal Investigator: April W Armstrong, M.D., UC Davis Health System

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2009

Primary Completion (Actual)

April 1, 2010

Study Completion (Actual)

April 1, 2010

Study Registration Dates

First Submitted

April 13, 2010

First Submitted That Met QC Criteria

April 23, 2010

First Posted (Estimate)

April 26, 2010

Study Record Updates

Last Update Posted (Estimate)

April 26, 2010

Last Update Submitted That Met QC Criteria

April 23, 2010

Last Verified

April 1, 2010

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 200917169-1

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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