NCT01969864

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
2,261

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Oct 2013

Typical duration for not_applicable

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2013

Completed
21 days until next milestone

First Submitted

Initial submission to the registry

October 22, 2013

Completed
3 days until next milestone

First Posted

Study publicly available on registry

October 25, 2013

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2016

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2016

Completed
Last Updated

February 1, 2019

Status Verified

January 1, 2019

Enrollment Period

2.8 years

First QC Date

October 22, 2013

Last Update Submit

January 31, 2019

Conditions

Keywords

Randomized Controlled TrialHealthcare Disparities

Outcome Measures

Primary Outcomes (1)

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

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

    One day

Secondary Outcomes (2)

  • Proportion of students who were willing to donate within 6 months

    One day

  • Intervention quality

    One day

Study Arms (3)

HRSA Video Intervention

EXPERIMENTAL

5-minute video on organ donation from U.S. Department of Health and Human Services

Behavioral: HRSA Video Intervention

PI Video Intervention

EXPERIMENTAL

5-minute video on organ donation created in part by the principal investigator.

Behavioral: PI Video Intervention

CDC Health Website Intervention

PLACEBO COMPARATOR

This control intervention will include text from the CDC website on health and wellness.

Behavioral: CDC Health Website Intervention

Interventions

HRSA Video Intervention
PI Video Intervention
CDC Health Website Intervention

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Baldwin Wallace University

Berea, Ohio, 44017, United States

Location

Case Western Reserve University

Cleveland, Ohio, 44106, United States

Location

Cleveland State University

Cleveland, Ohio, 44115, United States

Location

Related Publications (1)

  • Thornton JD, Patrick B, Sullivan C, Albert JM, Wong KA, Allen MD, Kimble L, Mekesa H, Bowen G, Sehgal AR. Comparing web-based video interventions to enhance university student willingness to donate organs: A randomized controlled trial. Clin Transplant. 2019 Apr;33(4):e13506. doi: 10.1111/ctr.13506. Epub 2019 Mar 13.

MeSH Terms

Conditions

Health Behavior

Condition Hierarchy (Ancestors)

Behavior

Study Officials

  • John D Thornton, MD, MPH

    Case Western Reserve University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

October 22, 2013

First Posted

October 25, 2013

Study Start

October 1, 2013

Primary Completion

July 1, 2016

Study Completion

December 1, 2016

Last Updated

February 1, 2019

Record last verified: 2019-01

Locations