RCT- Comparing Testimonial Versus Documentary Organ Donation Video Education
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ClinicalTrials.gov Identifier: NCT02836301 |
Recruitment Status :
Completed
First Posted : July 19, 2016
Last Update Posted : November 22, 2019
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Condition or disease | Intervention/treatment | Phase |
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Organ Donation | Behavioral: Control ending - Uplifting Behavioral: Negative Consequences Ending Behavioral: Unresolved Ending | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 1440 participants |
Allocation: | Randomized |
Intervention Model: | Factorial Assignment |
Masking: | Single (Participant) |
Primary Purpose: | Supportive Care |
Official Title: | Optimizing Educational Video Designs to Improve Minority Organ Donor Registration - Aim 2 Randomized Trial Comparing Testimonials Versus Documentary Videos |
Actual Study Start Date : | May 21, 2015 |
Actual Primary Completion Date : | July 15, 2017 |
Actual Study Completion Date : | December 1, 2017 |
Arm | Intervention/treatment |
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Active Comparator: Testimonials-Uplifting
2x3 matrix for the RCT comparing the control genre of only testimonials (G0) versus the experimental genre (G1) of a documentary with live footage along with the testimonials. The story ending (E) will serve as the cofactor.
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Behavioral: Control ending - Uplifting
The control ending is emotionally uplifting. In this video, the decedent previously registered as an organ donor through online registration and discussed his decision with family. The scene cuts to the family affirming the deceased's wish. In the next scene, the donor family and recipient meet for the first time, ending with a plea from both parties for viewers to register for donation. |
Active Comparator: Testimonials-Negative
2x3 matrix for the RCT comparing the control genre of only testimonials (G0) versus the experimental genre (G1) of a documentary with live footage along with the testimonials. The story ending (E) will serve as the cofactor.
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Behavioral: Negative Consequences Ending
A sad ending where the decedent did not register or discuss their position with family; family is asked to consider donation as an option, but they do not agree. The patient with kidney failure misses the window of opportunity, and the final scene is of both families grieving at their respective family members' grave plots…a missed opportunity. |
Active Comparator: Testimonials-Unresolved
2x3 matrix for the RCT comparing the control genre of only testimonials (G0) versus the experimental genre (G1) of a documentary with live footage along with the testimonials. The story ending (E) will serve as the cofactor.
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Behavioral: Unresolved Ending
In this ending, the team checks for registration status, and while searching, the scene cuts to physicians discussing the death with family and whether they might consider preservation and organ donation. The video then cuts to the potential recipient and family hoping for a kidney transplant before it is too late. The story ends without resolution, leaving viewers to contemplate how they might respond in the same situation |
Experimental: Documentary-Uplifting
2x3 matrix for the RCT comparing the control genre of only testimonials (G0) versus the experimental genre (G1) of a documentary with live footage along with the testimonials. The story ending (E) will serve as the cofactor.
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Behavioral: Control ending - Uplifting
The control ending is emotionally uplifting. In this video, the decedent previously registered as an organ donor through online registration and discussed his decision with family. The scene cuts to the family affirming the deceased's wish. In the next scene, the donor family and recipient meet for the first time, ending with a plea from both parties for viewers to register for donation. |
Experimental: Documentary-Negative
2x3 matrix for the RCT comparing the control genre of only testimonials (G0) versus the experimental genre (G1) of a documentary with live footage along with the testimonials. The story ending (E) will serve as the cofactor.
|
Behavioral: Negative Consequences Ending
A sad ending where the decedent did not register or discuss their position with family; family is asked to consider donation as an option, but they do not agree. The patient with kidney failure misses the window of opportunity, and the final scene is of both families grieving at their respective family members' grave plots…a missed opportunity. |
Experimental: Documentary-Unresolved
2x3 matrix for the RCT comparing the control genre of only testimonials (G0) versus the experimental genre (G1) of a documentary with live footage along with the testimonials. The story ending (E) will serve as the cofactor.
|
Behavioral: Unresolved Ending
In this ending, the team checks for registration status, and while searching, the scene cuts to physicians discussing the death with family and whether they might consider preservation and organ donation. The video then cuts to the potential recipient and family hoping for a kidney transplant before it is too late. The story ends without resolution, leaving viewers to contemplate how they might respond in the same situation |
- RA Assisted and Observed Immediate Registration [ Time Frame: 1 Day ]
- Confirmed Registration NYS DOH aggregate data by video group [ Time Frame: 1 Day ]
- Number pf participants who viewed "How To Register" Video [ Time Frame: 1 Day ]RA assisted / observed
- Number of participants who accepted Information/ Registry Forms [ Time Frame: 1 Day ]
- Organ Donation Beliefs (ODBI) Questionnaire [ Time Frame: 1 Day ]
- Emotional State (PANAS-CAT) Questionnaire [ Time Frame: 1 Day ]

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
- Dominican and Puerto Rican Latinos.
- Participants who pefer to speak Spanish.
- Participants who reside locally in NYC, New Jersey, or Connecticut, (tri-state area) for at least four weeks (28 days) in a year.
- Participants able to understand the verbal consent process.
Exclusion Criteria:
- 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 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 self-report to be registered in the New York State Organ Donor Registry.
- Persons who previously are enrolled in this randomized controlled trial.
- Persons psychologically unfit or who refuse.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02836301
United States, New York | |
New York University School of Medicine | |
New York, New York, United States, 10016 |
Principal Investigator: | Stephen Wall, MD | New York University Medical School |
Responsible Party: | NYU Langone Health |
ClinicalTrials.gov Identifier: | NCT02836301 |
Other Study ID Numbers: |
16-00454 |
First Posted: | July 19, 2016 Key Record Dates |
Last Update Posted: | November 22, 2019 |
Last Verified: | November 2019 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | Undecided |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |