BiopsyNCT01110148
Use of Portable Technology in Patient Education of Shave/Punch Biopsies
A study testing video-based informed consent for skin biopsies and traditional informed consent in people with Biopsy, run by University of California, Davis at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Biopsy
- What is being tested?
- video-based informed consent for skin biopsies and traditional informed consent
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 84 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2009to Apr 2010
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- English speaker
- Receiving shave or punch biopsy
Who cannot join
- Under 18 years of age
Trial locations and contacts
1 site in 1 country.
United States1 site
University of California Davis Medical Center
Sacramento, California, 95816
About this study
Official title: 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.
- Conditions
- Biopsy
- Being tested
- video-based informed consent for skin biopsies, traditional informed consent
- Keywords
- skin biopsy, informed consent, patient education, video education, patients requiring skin biopsies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
video-based informed consent for skin biopsiesOther
video-based informed consent for punch and shave biopsies
traditional informed consentOther
traditional informed consent (standard of care) from physicians for shave and punch biopsies
| Study group | Role | What they receive |
|---|---|---|
| Video-based informed consent | Experimental | patients receiving informed consent through video format Receives: Other: video-based informed consent for skin biopsies |
| traditional informed consent | Active comparator | patients receiving traditional informed consent from the physicians. Receives: Other: traditional informed consent |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: at the end of the study visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Apr 2010 (estimated)
- Study startJul 2009
- Primary completionApr 2010
- Study completionApr 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for BiopsyStudies of the same condition, open and under way.
- More trials run by University of California, DavisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 84 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, Davis
- Sponsor type
- University, hospital or other
- Investigators
- April W Armstrong, M.D., Principal investigator, UC Davis Health System
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01110148
- Sponsor's protocol ID
- 200917169-1
- Status last verified
- Apr 2010
- First submitted
- 13 Apr 2010
- Last updated
- 26 Apr 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Apr 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of MP3 Portable Technology in Patient Education and Informed Consent of Shave and Punch Biopsies
- ClinicalTrials.gov ID
- NCT01110148
- Acronym / sponsor ID
- 200917169-1
- Conditions
- Biopsy
- Keywords
- skin biopsy, informed consent, patient education, video education, patients requiring skin biopsies
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 84 participants (actual)
- Lead sponsor
- University of California, DavisUniversity, hospital or other
- Study start
- Jul 2009
- Primary completion
- Apr 2010 (actual)
- Study completion
- Apr 2010 (actual)
- First posted
- 26 Apr 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Video-based informed consent | Experimental | Other: video-based informed consent for skin biopsiespatients receiving informed consent through video format |
| traditional informed consent | Active comparator | Other: traditional informed consentpatients receiving traditional informed consent from the physicians. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- English speaker
- Receiving shave or punch biopsy
Key exclusion criteria (1 listed)
- Under 18 years of age
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| video-based informed consent for skin biopsiesvideo-based informed consent for punch and shave biopsies | Other | Video-based informed consent |
| traditional informed consenttraditional informed consent (standard of care) from physicians for shave and punch biopsies | Other | traditional informed consent |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Apr 2010.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
April W Armstrong, M.D. principal investigator
UC Davis Health System
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing video-based informed consent for skin biopsies and traditional informed consent in people with Biopsy, run by University of California, Davis at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Apr 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Measure the post-education knowledge of each intervention arm (time frame: at the end of the study visit). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Apr 2010.