Community Trial to Enhance Organ Donation | NCT00870506

Studies
Community Trial to Enhance Organ Donation

NCT00870506

Sponsor

Case Western Reserve University

Status

Completed

Last Update Posted

Aug 5, 2025Actual

Enrollment

973Actual

Phase

Not Applicable

Conditions

Tissue and Organ Procurement
Health Behavior

Interventions

video

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
1P60MD002265-01	U.S. NIH Grant/Contract		View source

Status Module

Record Verification Date

Jul 2025

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 2009

Primary Completion Date

Dec 2009Actual

Completion Date

Dec 2009Actual

First Submitted Date

Mar 26, 2009

First Submission Date that Met QC Criteria

Mar 26, 2009

First Posted Date

Mar 27, 2009Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 31, 2025

Last Update Posted Date

Aug 5, 2025Actual

Name	Class
Robert Wood Johnson Foundation	OTHER
National Institute on Minority Health and Health Disparities (NIMHD)	NIH

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The purpose of this study is to determine the effect of a 5-minute video intervention regarding organ donation and transplantation on increasing the number of organ donor cards signed in Northeastern Ohio Bureau of Motor Vehicles (OBMV) branches and on willingness to donate organs while living. The investigators hypothesize that persons in the intervention group will sign more donor cards and be more willing to donate organs while living than persons in the control group.

Detailed Description

We propose a community-based randomized controlled trial involving 450 intervention and 450 control patrons visiting Ohio Bureau of Motor Vehicle branches (OBMV) to obtain a driver's license. Interventions patrons will watch a 5-minute video prior to entering the OBMV. Study personnel will interview intervention and control patrons after they leave the OBMV to determine whether they signed an organ donor card. We will also determine the effect of the video intervention on willingness to donate organs while living.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

973Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
2	No Intervention	No intervention (control)
1	Experimental	5-minute video on donation and transplantation	Behavioral: video

Interventions

Name	Type	Description	Arm Group Labels	Other Names
video	Behavioral	5-minute video compared (intervention) to no video and no other intervention (control)	1

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Proportion of signed donor cards		One day

Secondary Outcomes

Measure	Description	Time Frame
Proportion of participants willing to donate organs while living		One Day

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

English speaking
Applying for driver's license, driver's permit or state id

Exclusion Criteria:

Non-English speaking
Persons who have already signed donor card

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

15 Years

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
John D Thornton, MD, MPH	Case Western Reserve University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Ohio Bureau of Motor Vehicles		Cleveland	Ohio	44109	United States

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
22473435	Derived	Thornton JD, Alejandro-Rodriguez M, Leon JB, Albert JM, Baldeon EL, De Jesus LM, Gallardo A, Hossain S, Perez EA, Martin JY, Lasalvia S, Wong KA, Allen MD, Robinson M, Heald C, Bowen G, Sehgal AR. Effect of an iPod video intervention on consent to donate organs: a randomized trial. Ann Intern Med. 2012 Apr 3;156(7):483-90. doi: 10.7326/0003-4819-156-7-201204030-00004.

ID	Term
D013637	Tape Recording
D001296	Audiovisual Aids
D018961	Educational Technology
D013672	Technology