University Student Intervention to Increase Organ Donation

January 31, 2019 updated by: John Daryl Thornton, MD, MPH, Case Western Reserve University

College and University Student Intervention to Increase Consent for Organ Donation

The purpose of this study is to determine the effect of brief organ donation video interventions on consent for organ donation among college and university students. Our hypothesis is that the organ donation video interventions will be superior to lay health websites for increasing organ donation consent.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This randomized controlled trial will involve 600 intervention and 600 control university students. Students will be randomized to 1 of 3 arms: a 5-minute video by the U.S. Department of Health and Human Services, a 5-minute video by the study principal investigator, or a health-related website by the Centers for Disease Control. After viewing the intervention, participants will be asked questions including whether they would like to consent to organ donation on their state electronic registry.

Study Type

Interventional

Enrollment (Actual)

2261

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Ohio
      • Berea, Ohio, United States, 44017
        • Baldwin Wallace University
      • Cleveland, Ohio, United States, 44106
        • Case Western Reserve University
      • Cleveland, Ohio, United States, 44115
        • Cleveland State University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Currently enrolled student
  • English speaking
  • No severe visual or auditory impairment
  • Citizen of the United States of America
  • Not a currently registered organ donor
  • Has a driver's license, state identification card, or learner's permit from one of the 50 states

Exclusion Criteria:

  • Not a currently enrolled student
  • Limited English proficiency
  • Severe visual or auditory impairment
  • Registered organ donor
  • Does not have an active driver's license, state identification card, or learner's permit from one of the 50 states

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: HRSA Video Intervention
5-minute video on organ donation from U.S. Department of Health and Human Services
Behavioral: HRSA Video Intervention
Experimental: PI Video Intervention
5-minute video on organ donation created in part by the principal investigator.
Behavioral: PI Video Intervention
Placebo Comparator: CDC Health Website Intervention
This control intervention will include text from the CDC website on health and wellness.
Behavioral: CDC Health Website Intervention

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Proportion of students who agreed to consent to donation on the state electronic donor registry
Time Frame: One day
Proportion of students who agreed to consent to donation on the state electronic donor registry
One day

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Proportion of students who were willing to donate within 6 months
Time Frame: One day
Proportion of students who were willing to donate within 6 months
One day
Intervention quality
Time Frame: One day
Student-reported quality of the intervention
One day

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Case Western Reserve University

Collaborators

National Institute on Minority Health and Health Disparities (NIMHD)

Investigators

  • Principal Investigator: John D Thornton, MD, MPH, Case Western Reserve University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 1, 2013

Primary Completion (Actual)

July 1, 2016

Study Completion (Actual)

December 1, 2016

Study Registration Dates

First Submitted

October 22, 2013

First Submitted That Met QC Criteria

October 22, 2013

First Posted (Estimate)

October 25, 2013

Study Record Updates

Last Update Posted (Actual)

February 1, 2019

Last Update Submitted That Met QC Criteria

January 31, 2019

Last Verified

January 1, 2019

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • P60MD00265DT3
  • 1P60MD002265-01 (U.S. NIH Grant/Contract)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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