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Completed

NCT Number: NCT02676102

RCT Comparing Tailored Versus Targeted Organ Donation Video Education

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).

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Key information

Conditions

Organ Transplants

Age range

18 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

New York University School of Medicine

New York, 10016, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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.
  • 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.

Treatment and study plan

Control Group

Behavioral

Generic Video about organ donation

Targeted Intervention

Behavioral

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

Behavioral

Videos with content individualized to participant's pre-intervention Organ Donation Belief Index (ODBI).

Primary outcomes

  1. Number of Immediate Registrations

    Time frame: 1 Day

    Enrollment number in the the NY State Organ Donor Registry

Secondary outcomes

  1. Number of Confirmed Registrations

    Time frame: 1 Day

    Post Intervention NY State Department of Health aggregate data by video group

  2. Number of participants that viewed "How To Register" Video

    Time frame: 1 Day

    Post Intervention research assistant assisted / observed

  3. Accepted Information Score

    Time frame: 1 Day

    Post Intervention RA assisted / observed

  4. Organ Donation Beliefs (ODBI) Survey Score

    Time frame: 1 Day

    Pre-Intervention iPad Survey

Other outcomes

  1. Participant Demographics

    Time frame: 1 Day

    Age, education, religion, sex, race

Sponsors and collaborators

Lead sponsor

NYU Langone Health

Other

Registry information

Official study title

Community Based Research to Improve Organ Donor Registration Among Black Men - Aim 2 Randomized Trial Comparing Tailored Versus Targeted Videos.

Important dates

Study start
2015
Primary completion
2018
Study completion
2018
First posted
Feb 8, 2016
Registry last updated
May 15, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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