Organ TransplantsNCT02676102
RCT Comparing Tailored Versus Targeted Organ Donation Video Education
A study testing Targeted Intervention and Tailored Intervention in people with Organ Transplants, run by NYU Langone Health at 1 site in United States.
Trial summary
The primary purpose of this 3-phase mixed methods design study is to investigate how presenting content at varying levels of audience specificity (generic, targeted, and tailored) influences organ donor registration behavior among black men using video-based educational programming produced and distributed in… Read more about this study
- Who is it for?
- Ages 18 years and older, men onlyHealthy volunteers can take part
- Conditions the study is for
- Organ Transplants
- What is being tested?
- Targeted Intervention and Tailored Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,440 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2015to Mar 2018
- 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
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Black men who visit BOBs
- Participants whose primary language is English
- Participants who reside locally in NYC for at least four weeks (28 days) in a year
Who cannot join
- Women are excluded from this study, as it is focused on black men who visit BOBs, who are among the most in need for transplants, and least likely to register as organ donors.
- Women are excluded from this study, as it is focused on black men who visit BOBs, who are among the most in need for transplants, and least likely to register as organ donors.
- Persons not self-reporting being a black male are excluded. Including other minority groups would preclude conducting this research given its budget and time constraints.
- Children under 18 years old are excluded from this research.
- Persons who are visually impaired and are unable to watch the videos.
- Persons who are hearing impaired and are unable to hear the audio on the videos.
Show all 22Show fewer
- Persons who self report to be registered in the New York State Organ Donor Registry.
- Persons who are cognitively impaired and thus are unable to provide consent to register for organ donation by signing the New York State Organ Donor Registry application.
- Persons who previously are enrolled in this randomized controlled trial. Women are excluded from this study, as it is focused on black men who visit BOBs, who are among the most in need for transplants, and least likely to register as organ donors.
- Persons not self-reporting being a black male are excluded. Including other minority groups would preclude conducting this research given its budget and time constraints.
- Children under 18 years old are excluded from this research.
- Persons who are visually impaired and are unable to watch the videos.
- Persons who are hearing impaired and are unable to hear the audio on the videos.
- Persons who self report to be registered in the New York State Organ Donor Registry.
- Persons who are cognitively impaired and thus are unable to provide consent to register for organ donation by signing the New York State Organ Donor Registry application.
- Persons who previously are enrolled in this randomized controlled trial. Persons not self-reporting being a black male are excluded. Including other minority groups would preclude conducting this research given its budget and time constraints.
- Children under 18 years old are excluded from this research.
- Persons who are visually impaired and are unable to watch the videos.
- Persons who are hearing impaired and are unable to hear the audio on the videos.
- Persons who self report to be registered in the New York State Organ Donor Registry.
- Persons who are cognitively impaired and thus are unable to provide consent to register for organ donation by signing the New York State Organ Donor Registry application.
- Persons who previously are enrolled in this randomized controlled trial.
Trial locations and contacts
1 site in 1 country.
United States1 site
New York University School of Medicine
New York, New York, 10016
About this study
Official title: Community Based Research to Improve Organ Donor Registration Among Black Men - Aim 2 Randomized Trial Comparing Tailored Versus Targeted Videos.
The primary purpose of this 3-phase mixed methods design study is to investigate how presenting content at varying levels of audience specificity (generic, targeted, and tailored) influences organ donor registration behavior among black men using video-based educational programming produced and distributed in partnership with our network of Black Owned Barbershops (BOBs). Investigators have completed a development phase using digital video interviewing to both derive and provide culturally specific content for the videos. This phase of this investigation is a 3 arm randomized control trial (RCT) phase, in which customers will be randomized to receive the generic, targeted, or tailored video programming delivered with iPads, after which an immediate organ donation opportunity will be offered through registration online or with a mailed in application. The final phase of this investigation will be a failure analysis whereby we will interview a subset of participants who registered or failed to register one month after their educational session to ascertain how the programming impacted their decision (Aim 3 - the subject of a future IRB application).
- Conditions
- Organ Transplants
- Being tested
- Control Group, Targeted Intervention, Tailored Intervention
- Keywords
- barber shops, organ transplant, transplants, organ donor registration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Control GroupBehavioural
Generic Video about organ donation
Targeted InterventionBehavioural
an educational video produced in partnership with the community of black men including customers, employees, and owners of BOBs. Video production was informed by entertainment education models and produced with experts including an Academy Award winning filmmaker.
Tailored InterventionBehavioural
Videos with content individualized to participant's pre-intervention Organ Donation Belief Index (ODBI).
| Study group | Role | What they receive |
|---|---|---|
| Control Group | Active comparator | Participant will watch an educational video produced in partnership with the community of black men including customers, employers and owners of BOBs. Receives: Behavioral: Control Group |
| Targeted Intervention | Active comparator | Participants will watch an educational video produced in partnership with the community of black men including customers, employees, and owners of BOBs. Video production was informed by entertainment education models and produced with experts including an Academy Award winning filmmaker. Receives: Behavioral: Targeted Intervention |
| Tailored Intervention | Active comparator | Participants will watch videos with content individualized to participant's pre-intervention ODBI scores representing their organ donation beliefs Receives: Behavioral: Tailored Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Immediate Registrations
Enrollment number in the the NY State Organ Donor Registry
Measured: 1 Day
Secondary outcomes (4)
Number of Confirmed Registrations
Post Intervention NY State Department of Health aggregate data by video group
Measured: 1 Day
Number of participants that viewed "How To Register" Video
Post Intervention research assistant assisted / observed
Measured: 1 Day
Accepted Information Score
Post Intervention RA assisted / observed
Measured: 1 Day
Organ Donation Beliefs (ODBI) Survey Score
Pre-Intervention iPad Survey
Measured: 1 Day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Feb 2016 (estimated)
- Study startFeb 2015
- Primary completionMar 2018
- Study completionMar 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Organ TransplantsStudies of the same condition, open and under way.
- More trials run by NYU Langone HealthThe 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 1,440 participants (actual)
Sponsor and investigators
- Lead sponsor
- NYU Langone Health
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Stephen Wall, MD, Principal investigator, New York University Medical School
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02676102
- Sponsor's protocol ID
- 14-02109
- Status last verified
- May 2018
- First submitted
- 3 Feb 2016
- Last updated
- 15 May 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Community Based Research to Improve Organ Donor Registration Among Black Men - Aim 2 Randomized Trial Comparing Tailored Versus Targeted Videos.
- ClinicalTrials.gov ID
- NCT02676102
- Acronym / sponsor ID
- 14-02109
- Conditions
- Organ Transplants
- Keywords
- barber shops, organ transplant, transplants, organ donor registration
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,440 participants (actual)
- Lead sponsor
- NYU Langone HealthUniversity, hospital or other
- Study start
- Feb 2015
- Primary completion
- Mar 2018 (actual)
- Study completion
- Mar 2018 (actual)
- First posted
- 8 Feb 2016 (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 primary purpose of this 3-phase mixed methods design study is to investigate how presenting content at varying levels of audience specificity (generic, targeted, and tailored) influences organ donor registration behavior among black men using video-based educational programming produced and distributed in partnership with our network of Black Owned Barbershops (BOBs). Investigators have completed a development phase using digital video interviewing to both derive and provide culturally specific content for the videos. This phase of this investigation is a 3 arm randomized control trial (RCT) phase, in which customers will be randomized to receive the generic, targeted, or tailored video programming delivered with iPads, after which an immediate organ donation opportunity will be offered through registration online or with a mailed in application. The final phase of this investigation will be a failure analysis whereby we will interview a subset of participants who registered or failed to register one month after their educational session to ascertain how the programming impacted their decision (Aim 3 - the subject of a future IRB application).
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Control Group | Active comparator | Behavioral: Control GroupParticipant will watch an educational video produced in partnership with the community of black men including customers, employers and owners of BOBs. |
| Targeted Intervention | Active comparator | Behavioral: Targeted InterventionParticipants will watch an educational video produced in partnership with the community of black men including customers, employees, and owners of BOBs. Video production was informed by entertainment education models and produced with experts including an Academy Award winning filmmaker. |
| Tailored Intervention | Active comparator | Behavioral: Tailored InterventionParticipants will watch videos with content individualized to participant's pre-intervention ODBI scores representing their organ donation beliefs |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Black men who visit BOBs
- Participants whose primary language is English
- Participants who reside locally in NYC for at least four weeks (28 days) in a year
Key exclusion criteria (22 listed)
- Women are excluded from this study, as it is focused on black men who visit BOBs, who are among the most in need for transplants, and least likely to register as organ donors.
- Women are excluded from this study, as it is focused on black men who visit BOBs, who are among the most in need for transplants, and least likely to register as organ donors.
- Persons not self-reporting being a black male are excluded. Including other minority groups would preclude conducting this research given its budget and time constraints.
- Children under 18 years old are excluded from this research.
- Persons who are visually impaired and are unable to watch the videos.
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 |
|---|---|---|
| Control GroupGeneric Video about organ donation | Behavioural | Control Group |
| Targeted Interventionan educational video produced in partnership with the community of black men including customers, employees, and owners of BOBs. Video production was informed by entertainment education models and produced with experts including an Academy Award winning filmmaker. | Behavioural | Targeted Intervention |
| Tailored InterventionVideos with content individualized to participant's pre-intervention Organ Donation Belief Index (ODBI). | Behavioural | Tailored Intervention |
Primary outcome
Number of Immediate Registrations
Time frame: 1 Day
Enrollment number in the the NY State Organ Donor Registry
4 secondary outcomes
Number of Confirmed Registrations
Time frame: 1 Day
Number of participants that viewed "How To Register" Video
Time frame: 1 Day
Accepted Information Score
Time frame: 1 Day
Organ Donation Beliefs (ODBI) Survey Score
Time frame: 1 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 15 May 2018.
Related trials for Organ Transplants
Recruiting
Multidisciplinary Non-Pharmacological Intervention to Improve Quality of Life in Solid Organ Transplant Recipients
Heart Transplant Patients, Kidney Transplant Patients
Not yet recruitingObservational study
Brain-based Prediction of the Dying Duration in Humans After Withdrawal of Life Sustaining Therapies to Inform Donation After Circulatory Death
Organ Donation After Circulatory Death
Not yet recruiting
Improving Deceased Organ Donation and Transplantation Using the Donation Advisor Clinical Decision Support Tool
Organ Donation After Circulatory Death, Organ Donation
RecruitingPhase 2
High vs.Standard Dose Influenza Vaccine in Pediatric Solid Organ Transplant (SOT) Recipients
Immunization; Infection, Transplantation Infection
RecruitingPhase 2
COVID-19 Booster and IIV Schedule in Immunocompromised Hosts
COVID 19, Influenza
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.
Stephen Wall, MD principal investigator
New York University Medical School
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Targeted Intervention and Tailored Intervention in people with Organ Transplants, run by NYU Langone Health 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 3 inclusion and 22 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 15 May 2018. 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?
Number of Immediate Registrations (time frame: 1 Day). 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 15 May 2018.