Organ DonationNCT01969864
University Student Intervention to Increase Organ Donation
A study testing HRSA Video Intervention, PI Video Intervention and CDC Health Website Intervention in people with Organ Donation and Health Behavior, run by Case Western Reserve University at 3 sites in United States.
Trial summary
The purpose of this study is to determine the effect of brief organ donation video interventions on consent for organ donation among college and university students. Our hypothesis is that the organ donation video interventions will be superior to lay health websites for increasing organ donation consent. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Organ Donation, Health Behavior
- What is being tested?
- HRSA Video Intervention, PI Video Intervention and CDC Health Website Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 2,261 participants
- Where
- 3 sitesUnited States
- Study dates
- Oct 2013to Dec 2016
- 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 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Currently enrolled student
- English speaking
- No severe visual or auditory impairment
- Citizen of the United States of America
- Not a currently registered organ donor
- Has a driver's license, state identification card, or learner's permit from one of the 50 states
Who cannot join
- Not a currently enrolled student
- Limited English proficiency
- Severe visual or auditory impairment
- Registered organ donor
- Does not have an active driver's license, state identification card, or learner's permit from one of the 50 states
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Baldwin Wallace University
Berea, Ohio, 44017
Case Western Reserve University
Cleveland, Ohio, 44106
Cleveland State University
Cleveland, Ohio, 44115
About this study
Official title: College and University Student Intervention to Increase Consent for Organ Donation
The purpose of this study is to determine the effect of brief organ donation video interventions on consent for organ donation among college and university students. Our hypothesis is that the organ donation video interventions will be superior to lay health websites for increasing organ donation consent.
Read the detailed description
This randomized controlled trial will involve 600 intervention and 600 control university students. Students will be randomized to 1 of 3 arms: a 5-minute video by the U.S. Department of Health and Human Services, a 5-minute video by the study principal investigator, or a health-related website by the Centers for Disease Control. After viewing the intervention, participants will be asked questions including whether they would like to consent to organ donation on their state electronic registry.
- Conditions
- Organ Donation, Health Behavior
- Being tested
- HRSA Video Intervention, PI Video Intervention, CDC Health Website Intervention
- 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.
HRSA Video InterventionBehavioural
PI Video InterventionBehavioural
CDC Health Website InterventionBehavioural
| Study group | Role | What they receive |
|---|---|---|
| HRSA Video Intervention | Experimental | 5-minute video on organ donation from U.S. Department of Health and Human Services Receives: Behavioral: HRSA Video Intervention |
| PI Video Intervention | Experimental | 5-minute video on organ donation created in part by the principal investigator. Receives: Behavioral: PI Video Intervention |
| CDC Health Website Intervention | Placebo comparator | This control intervention will include text from the CDC website on health and wellness. Receives: Behavioral: CDC Health Website Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of students who agreed to consent to donation on the state electronic donor registry
Proportion of students who agreed to consent to donation on the state electronic donor registry
Measured: One day
Secondary outcomes (2)
Proportion of students who were willing to donate within 6 months
Proportion of students who were willing to donate within 6 months
Measured: One day
Intervention quality
Student-reported quality of the intervention
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 posted25 Oct 2013 (estimated)
- Study startOct 2013
- Primary completionJul 2016
- Study completionDec 2016
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 Organ DonationStudies 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
- Single blind
- Who is masked
- Investigator
- Enrolment
- 2,261 participants (actual)
Sponsor and investigators
- Lead sponsor
- Case Western Reserve University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Minority Health and Health Disparities (NIMHD)
- Responsible party
- Principal investigator, John Daryl Thornton, MD, MPH, Case Western Reserve University
- Investigators
- John D Thornton, MD, MPH, Principal investigator, Case Western Reserve University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01969864
- Sponsor's protocol ID
- P60MD00265DT3
- Other IDs
- 1P60MD002265-01
- Status last verified
- Jan 2019
- First submitted
- 22 Oct 2013
- Last updated
- 1 Feb 2019
- Results posted
- No
- Data monitoring committee
- No
Publications
Thornton JD, Patrick B, Sullivan C, Albert JM, Wong KA, Allen MD, Kimble L, Mekesa H, Bowen G, Sehgal AR. Comparing web-based video interventions to enhance university student willingness to donate organs: A randomized controlled trial. Clin Transplant. 2019 Apr;33(4):e13506. doi: 10.1111/ctr.13506. Epub 2019 Mar 13.
PubMed 30793375
Study at a glance
From the registry record, last updated by the sponsor on 1 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- College and University Student Intervention to Increase Consent for Organ Donation
- ClinicalTrials.gov ID
- NCT01969864
- Acronym / sponsor ID
- P60MD00265DT3
- Conditions
- Organ Donation, Health Behavior
- Keywords
- Randomized Controlled Trial, Healthcare Disparities
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 2,261 participants (actual)
- Lead sponsor
- Case Western Reserve UniversityUniversity, hospital or other
- Collaborators
- National Institute on Minority Health and Health Disparities (NIMHD)
- Study start
- Oct 2013 (actual)
- Primary completion
- Jul 2016 (actual)
- Study completion
- Dec 2016 (actual)
- First posted
- 25 Oct 2013 (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 brief organ donation video interventions on consent for organ donation among college and university students. Our hypothesis is that the organ donation video interventions will be superior to lay health websites for increasing organ donation consent.
Detailed description
This randomized controlled trial will involve 600 intervention and 600 control university students. Students will be randomized to 1 of 3 arms: a 5-minute video by the U.S. Department of Health and Human Services, a 5-minute video by the study principal investigator, or a health-related website by the Centers for Disease Control. After viewing the intervention, participants will be asked questions including whether they would like to consent to organ donation on their state electronic registry.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| HRSA Video Intervention | Experimental | Behavioral: HRSA Video Intervention5-minute video on organ donation from U.S. Department of Health and Human Services |
| PI Video Intervention | Experimental | Behavioral: PI Video Intervention5-minute video on organ donation created in part by the principal investigator. |
| CDC Health Website Intervention | Placebo comparator | Behavioral: CDC Health Website InterventionThis control intervention will include text from the CDC website on health and wellness. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Currently enrolled student
- English speaking
- No severe visual or auditory impairment
- Citizen of the United States of America
- Not a currently registered organ donor
Key exclusion criteria (5 listed)
- Not a currently enrolled student
- Limited English proficiency
- Severe visual or auditory impairment
- Registered organ donor
- Does not have an active driver's license, state identification card, or learner's permit from one of the 50 states
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 |
|---|---|---|
| HRSA Video Intervention | Behavioural | HRSA Video Intervention |
| PI Video Intervention | Behavioural | PI Video Intervention |
| CDC Health Website Intervention | Behavioural | CDC Health Website Intervention |
Primary outcome
Proportion of students who agreed to consent to donation on the state electronic donor registry
Time frame: One day
Proportion of students who agreed to consent to donation on the state electronic donor registry
2 secondary outcomes
Proportion of students who were willing to donate within 6 months
Time frame: One day
Intervention quality
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 1 Feb 2019.
- Derived from this study: PubMed 30793375Thornton JD, Patrick B, Sullivan C, Albert JM, Wong KA, Allen MD, Kimble L, Mekesa H, Bowen G, Sehgal AR. Comparing web-based video interventions to enhance university student willingness to donate organs: A randomized controlled trial. Clin Transplant. 2019 Apr;33(4):e13506. doi: 10.1111/ctr.13506. Epub 2019 Mar 13.
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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
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing HRSA Video Intervention, PI Video Intervention and CDC Health Website Intervention in people with Organ Donation and Health Behavior, run by Case Western Reserve University at 3 sites 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 6 inclusion and 5 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 1 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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. Some participants in this study may receive a placebo. 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 students who agreed to consent to donation on the state electronic donor registry (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 NCT01969864, 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 1 Feb 2019.