University Student Intervention to Increase Organ Donation

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2014 by Case Western Reserve University
Sponsor:
Collaborator:
Information provided by (Responsible Party):
John Daryl Thornton, MD, MPH, Case Western Reserve University
ClinicalTrials.gov Identifier:
NCT01969864
First received: October 22, 2013
Last updated: May 9, 2014
Last verified: May 2014
  Purpose

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.


Condition Intervention
Organ Donation
Health Behavior
Behavioral: HRSA Video Intervention
Behavioral: PI Video Intervention
Behavioral: CDC Health Website Intervention

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Official Title: College and University Student Intervention to Increase Consent for Organ Donation

Further study details as provided by Case Western Reserve University:

Primary Outcome Measures:
  • Proportion of students who agreed to consent to donation on the state electronic donor registry [ Time Frame: One day ] [ Designated as safety issue: No ]

Estimated Enrollment: 1200
Study Start Date: October 2013
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: July 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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 Ohio, Illinois, Indiana, Michigan, or Pennsylvania

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 Ohio, Illinois, Indiana, Michigan, or Pennsylvania
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01969864

Contacts
Contact: John D Thornton, MD, MPH 2167782362 john.thornton@cwru.edu

Locations
United States, Ohio
Baldwin Wallace University Recruiting
Berea, Ohio, United States, 44017
Contact: John D Thornton, MD, MPH         
Principal Investigator: John D Thornton, MD, MPH         
Case Western Reserve University Recruiting
Cleveland, Ohio, United States, 44106
Contact: John Thornton, MD, MPH    216-778-2362    john.thornton@case.edu   
Principal Investigator: John D Thornton, MD, MPH         
Cleveland State University Recruiting
Cleveland, Ohio, United States, 44115
Principal Investigator: John D Thornton, MD, MPH         
Sponsors and Collaborators
Case Western Reserve University
Investigators
Principal Investigator: John D Thornton, MD, MPH Case Western Reserve University
  More Information

No publications provided

Responsible Party: John Daryl Thornton, MD, MPH, Associate Professor, Case Western Reserve University
ClinicalTrials.gov Identifier: NCT01969864     History of Changes
Other Study ID Numbers: P60MD00265DT3, 1P60MD002265-01
Study First Received: October 22, 2013
Last Updated: May 9, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Case Western Reserve University:
Randomized Controlled Trial
Healthcare Disparities

ClinicalTrials.gov processed this record on September 18, 2014