ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 1 of 1 for:    NCT03013816
Previous Study | Return to List | Next Study

Increasing Donor Designation Rates in Teenagers: Effectiveness of a Driver's Education Intervention

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03013816
Recruitment Status : Recruiting
First Posted : January 9, 2017
Last Update Posted : March 20, 2018
Sponsor:
Information provided by (Responsible Party):
James Rodrigue, Beth Israel Deaconess Medical Center

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:
The objective of this study is to evaluate the effectiveness of targeted video interventions designed to increase organ donation knowledge, intentions, and designations among adolescents enrolled in driver's education classes, as well as to increase the commitment of parents/legal guardians to authorize organ donation in the event of their adolescent's death. The central hypothesis is that integrating donation education into the driver's education curriculum will increase knowledge and attitudes that facilitate the behavioral action of donor designation at the time of getting a new driver's license.

Condition or disease Intervention/treatment Phase
Organ Donor Registration Organ Donation Education Behavioral: Organ Donation Education: Testimonial Messaging Behavioral: Organ Donation Education: Informational Messaging Behavioral: Organ Donation Education: Blended Messaging Not Applicable

Study Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 600 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: Increasing Donor Designation Rates in Teenagers: Effectiveness of a Driver's Education Intervention
Study Start Date : October 2014
Estimated Primary Completion Date : January 2019
Estimated Study Completion Date : January 2019
Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm Intervention/treatment
Experimental: Testimonial Messaging
There are no explicit statistics or facts about transplantation or donation in this video intervention. It is designed to appeal to those with lower motivation to process factual arguments, focusing instead on emotional appeal and peers modeling the targeted behavior, thus allowing for peripheral processing of the donation message.
 Behavioral: Organ Donation Education: Testimonial Messaging
The testimonial messaging video intervention will be shown
Experimental: Informational Messaging
This video intervention will mirror common educational campaigns and focus exclusively on factual arguments for organ donation, including the current supply-demand problem in transplantation, common reasons for/against donor designation, myths about donation, religious views of donation, the importance of communicating the donation decision to parents, and information about donor registries and how to register as a donor. This video will appeal to those with greater motivation to process factual arguments for donor designation. The video will be narrated by male and female adolescent peers. No personal testimonials will be displayed in this video.
 Behavioral: Organ Donation Education: Informational Messaging
The informational messaging video intervention will be shown
Experimental: Blended Messaging
This video intervention will comprise edited segments from the Informational Messaging and Testimonial Messaging videos.
 Behavioral: Organ Donation Education: Blended Messaging
The blended messaging video intervention will be shown


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. Organ Donation Registration [ Time Frame: 6 months ]
    The primary outcome is the adolescent's donor designation (yes-no) at the time of obtaining their first driver's license at the Registry of Motor Vehicles (RMV) office. For most study participants, this decision will occur within 3-6 months of the intervention. We have an established relationship with the Information Technology group in the Massachusetts Department of Transportation. They are able to provide us with de-identified individual-level data on donor designation, age, sex, and census tract identification. Additionally, adolescents will be asked to self-report age, sex, race/ethnicity, and school achievement level ("Mostly…As, Bs, Cs, Ds/Fs").


Secondary Outcome Measures :
  1. Organ Donation Knowledge and Attitudes [ Time Frame: 1 week ]
    Twenty one item questionnaires will be completed by adolescents in the driver's education classroom at pre-intervention, post-intervention and at 1 week follow-up.

  2. Parental Commitment [ Time Frame: 6 months ]
    To assess the commitment of parent/legal guardian to authorize donation consent for study participant, parents of enrolled students will be asked to complete a short questionnaire.


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Enrolled in driving school class
  • English speaking
  • Adolescent assent
  • Parental permission to participate

Exclusion Criteria:

  • Prior participation in a driver's education class in which organ donation education was provided
  • Parent permission form not signed
Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03013816


Contacts
Contact: Aaron Fleishman 617-632-7023 afleishm@bidmc.harvard.edu

Locations
United States, Massachusetts
Beth Israel Deaconess Medical Center Recruiting
Boston, Massachusetts, United States, 02215
Principal Investigator: James R Rodrigue, PhD         
Sponsors and Collaborators
Beth Israel Deaconess Medical Center
Investigators
Principal Investigator: James Rodrigue, PhD Beth Israel Deaconess Medical Center
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party: James Rodrigue, Professor, Beth Israel Deaconess Medical Center
ClinicalTrials.gov Identifier: NCT03013816     History of Changes
Other Study ID Numbers: 2015P000063
First Posted: January 9, 2017    Key Record Dates
Last Update Posted: March 20, 2018
Last Verified: March 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No