Tissue and Organ ProcurementNCT00870506
Community Trial to Enhance Organ Donation
A study testing video in people with Tissue and Organ Procurement and Health Behavior, run by Case Western Reserve University at 1 site in United States.
Trial summary
The purpose of this study is to determine the effect of a 5-minute video intervention regarding organ donation and transplantation on increasing the number of organ donor cards signed in Northeastern Ohio Bureau of Motor Vehicles (OBMV) branches and on willingness to donate organs while living. Read more about this study
- Who is it for?
- Ages 15 years and olderHealthy volunteers can take part
- Conditions the study is for
- Tissue and Organ Procurement, Health Behavior
- What is being tested?
- video
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 973 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2009to Dec 2009
- 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 15 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- English speaking
- Applying for driver's license, driver's permit or state id
Who cannot join
- Non-English speaking
- Persons who have already signed donor card
Trial locations and contacts
1 site in 1 country.
United States1 site
Ohio Bureau of Motor Vehicles
Cleveland, Ohio, 44109
About this study
Official title: Community-based Intervention to Enhance Signing of Organ Donor Cards
The purpose of this study is to determine the effect of a 5-minute video intervention regarding organ donation and transplantation on increasing the number of organ donor cards signed in Northeastern Ohio Bureau of Motor Vehicles (OBMV) branches and on willingness to donate organs while living. The investigators hypothesize that persons in the intervention group will sign more donor cards and be more willing to donate organs while living than persons in the control group.
Read the detailed description
We propose a community-based randomized controlled trial involving 450 intervention and 450 control patrons visiting Ohio Bureau of Motor Vehicle branches (OBMV) to obtain a driver's license. Interventions patrons will watch a 5-minute video prior to entering the OBMV. Study personnel will interview intervention and control patrons after they leave the OBMV to determine whether they signed an organ donor card. We will also determine the effect of the video intervention on willingness to donate organs while living.
- Conditions
- Tissue and Organ Procurement, Health Behavior
- Being tested
- video
- Keywords
- Randomized Controlled Trial, Healthcare Disparities
- Medical subject headings
- Health Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
videoBehavioural
5-minute video compared (intervention) to no video and no other intervention (control)
| Study group | Role | What they receive |
|---|---|---|
| 2 | No intervention | No intervention (control) |
| 1 | Experimental | 5-minute video on donation and transplantation Receives: Behavioral: video |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of signed donor cards
Measured: One day
Secondary outcomes (1)
Proportion of participants willing to donate organs while living
Measured: One Day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2009 (estimated)
- Study startMar 2009
- Primary completionDec 2009
- Study completionDec 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Tissue and Organ ProcurementStudies of the same condition, open and under way.
- 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 973 participants (actual)
Sponsor and investigators
- Lead sponsor
- Case Western Reserve University
- Sponsor type
- University, hospital or other
- Collaborators
- Robert Wood Johnson Foundation, National Institute on Minority Health and Health Disparities (NIMHD)
- Responsible party
- Sponsor
- Investigators
- John D Thornton, MD, MPH, Principal investigator, Case Western Reserve University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00870506
- Sponsor's protocol ID
- P60MD002265DT1
- Other IDs
- 1P60MD002265-01
- Status last verified
- Jul 2025
- First submitted
- 26 Mar 2009
- Last updated
- 5 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
Publications
Thornton JD, Alejandro-Rodriguez M, Leon JB, Albert JM, Baldeon EL, De Jesus LM, Gallardo A, Hossain S, Perez EA, Martin JY, Lasalvia S, Wong KA, Allen MD, Robinson M, Heald C, Bowen G, Sehgal AR. Effect of an iPod video intervention on consent to donate organs: a randomized trial. Ann Intern Med. 2012 Apr 3;156(7):483-90. doi: 10.7326/0003-4819-156-7-201204030-00004.
PubMed 22473435
Study at a glance
From the registry record, last updated by the sponsor on 5 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Community-based Intervention to Enhance Signing of Organ Donor Cards
- ClinicalTrials.gov ID
- NCT00870506
- Acronym / sponsor ID
- P60MD002265DT1
- Conditions
- Tissue and Organ Procurement, Health Behavior
- Keywords
- Randomized Controlled Trial, Healthcare Disparities
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 973 participants (actual)
- Lead sponsor
- Case Western Reserve UniversityUniversity, hospital or other
- Collaborators
- Robert Wood Johnson Foundation, National Institute on Minority Health and Health Disparities (NIMHD)
- Study start
- Mar 2009
- Primary completion
- Dec 2009 (actual)
- Study completion
- Dec 2009 (actual)
- First posted
- 27 Mar 2009 (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 purpose of this study is to determine the effect of a 5-minute video intervention regarding organ donation and transplantation on increasing the number of organ donor cards signed in Northeastern Ohio Bureau of Motor Vehicles (OBMV) branches and on willingness to donate organs while living. The investigators hypothesize that persons in the intervention group will sign more donor cards and be more willing to donate organs while living than persons in the control group.
Detailed description
We propose a community-based randomized controlled trial involving 450 intervention and 450 control patrons visiting Ohio Bureau of Motor Vehicle branches (OBMV) to obtain a driver's license. Interventions patrons will watch a 5-minute video prior to entering the OBMV. Study personnel will interview intervention and control patrons after they leave the OBMV to determine whether they signed an organ donor card. We will also determine the effect of the video intervention on willingness to donate organs while living.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 2 | No intervention | –No intervention (control) |
| 1 | Experimental | Behavioral: video5-minute video on donation and transplantation |
Who may qualify
- Ages
- 15 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- English speaking
- Applying for driver's license, driver's permit or state id
Key exclusion criteria (2 listed)
- Non-English speaking
- Persons who have already signed donor card
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 |
|---|---|---|
| video5-minute video compared (intervention) to no video and no other intervention (control) | Behavioural | 1 |
Primary outcome
Proportion of signed donor cards
Time frame: One day
1 secondary outcome
Proportion of participants willing to donate organs while living
Time frame: One Day
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 5 Aug 2025.
- Derived from this study: PubMed 22473435Thornton JD, Alejandro-Rodriguez M, Leon JB, Albert JM, Baldeon EL, De Jesus LM, Gallardo A, Hossain S, Perez EA, Martin JY, Lasalvia S, Wong KA, Allen MD, Robinson M, Heald C, Bowen G, Sehgal AR. Effect of an iPod video intervention on consent to donate organs: a randomized trial. Ann Intern Med. 2012 Apr 3;156(7):483-90. doi: 10.7326/0003-4819-156-7-201204030-00004.
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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.
John D Thornton, MD, MPH principal investigator
Case Western Reserve University
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 in people with Tissue and Organ Procurement and Health Behavior, run by Case Western Reserve University 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 2 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 5 Aug 2025. 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?
Proportion of signed donor cards (time frame: One day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00870506, which also lists 1 linked publication.
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 5 Aug 2025.