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Tissue and Organ ProcurementNCT02585921

Organ Donation Interventions Among High Students

A study testing Video Interventions and Donation Discussion Education in people with Tissue and Organ Procurement and Adolescent Behavior, run by Case Western Reserve University at 1 site in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

The number of persons actively waiting on the national solid organ waiting list continues to rise while the number donating organs has failed to keep pace. This is a particular problem for some portions of northeastern Ohio where the donation rate is as low as 32%. Read more about this study

Who is it for?
Ages 15 to 26 yearsHealthy volunteers can take part
What is being tested?
Video Interventions and Donation Discussion Education
Could I receive a placebo?
No, everyone receives an active treatment
How many people
872 participants
Where
1 siteUnited States
Study dates
Oct 2015to Feb 2019
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 15 to 26 years
  • All sexes
  • Healthy volunteers accepted
  • Child, Adult

Who may be able to join

  • Not previously consented to organ donation
  • Attending high school or GED-granting school

Who cannot join

  • Non-English speaking
  • Visually impaired
  • Cognitively impaired

Trial locations and contacts

1 site in 1 country.

United States1 site
  • Case Western Reserve University

    Cleveland, Ohio, 44106

Other trials in United States

About this study

Official title: Combining, Expanding, and Evaluating Multiple Evidence-based Organ Donation Interventions

The number of persons actively waiting on the national solid organ waiting list continues to rise while the number donating organs has failed to keep pace. This is a particular problem for some portions of northeastern Ohio where the donation rate is as low as 32%. Adolescents are an important group for organ donation efforts as they have not yet applied for a driver's license and represent the majority of future donors. Yet many organ donation interventions have not targeted adolescents. The investigators propose to utilize existing high school teen summits developed by our Consortium partners to evaluate the effectiveness of existing donation interventions. Together, the investigators will conduct a randomized controlled 2x2 factorial trial to evaluate the independent and combined effects of two donor education interventions on consent for organ donation on the electronic Ohio Donor Registry. One thousand six hundred students over the age of 15.5 years from Cleveland-area high schools will be enrolled.

Read the detailed description

Over 74,000 people are actively waiting for a solid organ to improve and extend their lives yet each year the number of deceased donors remains less than 11,000.1 Substantial changes are needed to increase the number of donated organs or many persons in need of a transplant will die without receiving one. The major limiting factor to organ donation remains the low consent rate.2 Increasing consent for organ donation will likely increase both the availability of organs and, by extension, increase the duration and quality of life of those waiting.3,4 While most people who consent to organ donation do so while obtaining their driver's licenses at the bureau of motor vehicles,5,6 the bureau of motor vehicles' staff generally do not have the training to provide sufficient information to answer questions regarding donation. As a result, bureau of motor vehicle patrons may not be receiving the information necessary to allay their fears and concerns sufficiently enough to provide informed consent for donation. We have previously demonstrated that adolescents have concerns regarding organ donation that stem from lack of knowledge about the process and from a paucity of discussions regarding organ donation with their parents.7 We and others have also found that efforts to increase consent for organ donation among adolescents must address altruism regarding donation and the positive effects of donation.8,9. We incorporated these findings into the development of a video intervention tailored towards adolescents. In a community-based randomized trial, we found that the video was effective in increasing consent for organ donation.10 This project incorporated the successful aspects of these multiple organ donation interventions to facilitate consent for organ donation among adolescents.

Our consortium partners, the Cleveland branch of the Minority Organ and Tissue Transplant Education Program (Cleveland MOTTEP), Lifebanc (the Organ Procurement Organization for Northeast Ohio), the Cleveland Eye Bank, and the Kidney Foundation of Ohio, had been collaborating to conduct twice yearly organ donation summits for adolescents for almost 10 years. The summits were 1-day meetings of 100 - 150 students from 5 high schools in Cleveland and the surrounding neighborhoods. The goals of the summits were to increase knowledge and awareness of organ and tissue donation and transplantation, as well as to assist in chronic disease prevention. While the summits have become a mainstay in the community, they have been limited in scope, devoid of a uniform curriculum, variable in execution, and have lacked formal evaluation.

The purpose of this study was to expand on the existing high school education summits by creating and implementing a uniform, validated organ donation curriculum based on successful best practices with integration of successful organ donation video interventions and by rigorously evaluating the effect of the individual and combined components. We employed a 2x2 factorial randomized design to explore the independent and combined effects of the interventions.

Being tested
Video Interventions, Donation Discussion Education
Keywords
Urban Health
Medical subject headings
Adolescent Behavior, Communication

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Video InterventionsBehavioural

    Participants will watch 2 5-minute videos and then discuss them as a group.

  • Donation Discussion EducationBehavioural

    Participants will learn techniques for introducing and discussing organ donation with parents and guardians.

Study groups in NCT02585921
Study groupRoleWhat they receive
Health & WellnessNo interventionFollowing enrollment, participants will learn about health and wellness.
Organ Donation Video EducationExperimentalFollowing recruitment, participants will watch and discuss videos about organ donation.
Receives: Behavioral: Video Interventions
Organ Donation Discussion EducationExperimentalFollowing recruitment, participants will learn techniques to introduce and discuss the topic of organ donation with parents or guardians.
Receives: Behavioral: Donation Discussion Education
Both Video and Discussion EducationExperimentalFollowing recruitment, participants will watch and discuss videos about organ donation and then learn techniques to introduce and discuss the topic of organ donation with parents and guardians.
Receives: Behavioral: Video Interventions; Behavioral: Donation Discussion Education

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Proportion of participants who consent to donate organs

    Consent on the electronic donor registry

    Measured: 1 month

Secondary outcomes (2)
  1. Proportion of participants who reported having donation discussions with their parents

    Proportion of participants who reported having donation discussions with their parents

    Measured: 1 month

  2. Proportion of participants' parents who consent to donate organs

    Proportion of participants' parents who consent to donate organs

    Measured: 1 month

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 Oct 2015 (estimated)
  2. Study startOct 2015
  3. Primary completion31 May 2017
  4. Study completionFeb 2019

Why it stopped: Enrollment completed.

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Health services research
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Investigator, Outcomes assessor
Enrolment
872 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02585921
Sponsor's protocol ID
1 R39OT26989-01-00
Other IDs
R39OT26989-
Status last verified
Dec 2021
First submitted
22 Oct 2015
Last updated
14 Jan 2022
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A study testing Video Interventions and Donation Discussion Education in people with Tissue and Organ Procurement and Adolescent Behavior, run by Case Western Reserve University at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 14 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study was stopped early (reason given: Enrollment completed.). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Proportion of participants who consent to donate organs (time frame: 1 month). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jan 2022.

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