University Student Intervention to Increase Organ Donation

• Sponsor: Case Western Reserve University (Other)
• Overall Status: Completed
• CT.gov ID: NCT01969864
• Collaborator: National Institute on Minority Health and Health Disparities (NIMHD) (NIH)
• Enrollment: 2,261
• Locations: 3
• Arms: 3
• Actual Duration (Months): 38
• Patients Per Site: 753.7
• Patients Per Site Per Month: 19.8

Study Details

Study Description

Brief Summary

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 or Disease	Intervention/Treatment	Phase
Organ Donation; Health Behavior	Behavioral: HRSA Video Intervention; Behavioral: PI Video Intervention; Behavioral: CDC Health Website Intervention	N/A

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 Design

• Study Type: Interventional
• Actual Enrollment: 2261 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Investigator)
• Primary Purpose: Other
• Official Title: College and University Student Intervention to Increase Consent for Organ Donation
• Actual Study Start Date: Oct 1, 2013
• Actual Primary Completion Date: Jul 1, 2016
• Actual Study Completion Date: Dec 1, 2016

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Proportion of students who agreed to consent to donation on the state electronic donor registry [One day]

   Proportion of students who agreed to consent to donation on the state electronic donor registry

Secondary Outcome Measures

1. Proportion of students who were willing to donate within 6 months [One day]

   Proportion of students who were willing to donate within 6 months

2. Intervention quality [One day]

   Student-reported quality of the intervention

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 65 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Baldwin Wallace University	Berea	Ohio	United States	44017
2	Case Western Reserve University	Cleveland	Ohio	United States	44106
3	Cleveland State University	Cleveland	Ohio	United States	44115

Sponsors and Collaborators

• Case Western Reserve University
• National Institute on Minority Health and Health Disparities (NIMHD)

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: John Daryl Thornton, MD, MPH, Associate Professor, Case Western Reserve University
• ClinicalTrials.gov Identifier: NCT01969864
• Other Study ID Numbers: P60MD00265DT3; 1P60MD002265-01
• First Posted: Oct 25, 2013
• Last Update Posted: Feb 1, 2019
• Last Verified: Jan 1, 2019

• Keywords provided by John Daryl Thornton, MD, MPH, Associate Professor, Case Western Reserve University: Randomized Controlled Trial; Healthcare Disparities

Study Results

No Results Posted as of Feb 1, 2019