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Clinical Trials/NCT02676102
NCT02676102CompletedNot Applicable

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

NYU Langone Health1 site in 1 country1,440 target enrollmentStarted: February 2015Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
1,440
Locations
1
Primary Endpoint
Number of Immediate Registrations

Study Overview

Brief 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 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

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Other
Masking
Single (Participant)

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
Male
Accepts Healthy Volunteers
Yes

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.

Outcomes

Primary Outcomes

Number of Immediate Registrations

Time Frame: 1 Day

Enrollment number in the the NY State Organ Donor Registry

Secondary Outcomes

  • Number of Confirmed Registrations(1 Day)
  • Number of participants that viewed "How To Register" Video(1 Day)
  • Accepted Information Score(1 Day)
  • Organ Donation Beliefs (ODBI) Survey Score(1 Day)

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (1)

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