RCT Comparing Tailored Versus Targeted Organ Donation Video Education

Organ Transplants Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02676102
• Other study ID #: 14-02109
• Status: Completed
• Phase: N/A
• Start date: February 2015
• Est. completion date: March 2018

Study information

• Verified date: May 2018
• Source: New York University School of Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1440
• Est. completion date: March 2018
• Est. primary completion date: March 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Organ Transplants

Intervention

Behavioral:
• Control Group
Generic Video about organ donation
• Targeted Intervention
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
Videos with content individualized to participant's pre-intervention Organ Donation Belief Index (ODBI).

Locations

Country	Name	City	State
United States	New York University School of Medicine	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
New York University School of Medicine

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Participant Demographics	Age, education, religion, sex, race	1 Day
Primary	Number of Immediate Registrations	Enrollment number in the the NY State Organ Donor Registry	1 Day
Secondary	Number of Confirmed Registrations	Post Intervention NY State Department of Health aggregate data by video group	1 Day
Secondary	Number of participants that viewed "How To Register" Video	Post Intervention research assistant assisted / observed	1 Day
Secondary	Accepted Information Score	Post Intervention RA assisted / observed	1 Day
Secondary	Organ Donation Beliefs (ODBI) Survey Score	Pre-Intervention iPad Survey	1 Day