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Tissue and Organ ProcurementiDecideNCT02318849

Online Intervention for ANHPI College Students

A study testing Web intervention in people with Tissue and Organ Procurement, run by University of Hawaii at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Taking advantage of college students' frequent use of online technology, including social networking sites (e.g., Instagram a social media site /Facebook a social networking site) and social media sites (e.g., YouTube), the investigators will create an online intervention that leverages this technology to engage and… Read more about this study

Who is it for?
Ages 18 to 60 yearsHealthy volunteers can take part
Conditions the study is for
Tissue and Organ Procurement
What is being tested?
Web intervention
Could I receive a placebo?
No, everyone receives an active treatment
How many people
4,827 participants
Where
1 siteUnited States
Study dates
1 Nov 2014to 31 Dec 2018
Phase
Interventional
Are there results?
Yes, posted in the registrySummary in the doctors' view

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 18 to 60 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • Must be registered undergraduate student at University of Hawaii at Manoa, University of Hawaii at Hilo, or Hawaii Pacific University
  • Must be over the age of 18yrs

Who cannot join

  • Not an undergraduate college student at one of the participating university sites

Trial locations and contacts

1 site in 1 country.

United States1 site
  • Cheryl Albright, PhD, MPH

    Honolulu, Hawaii, 96822

Other trials in United States

About this study

Official title: Social and Behavioral Interventions to Increase Solid Organ Donation

Taking advantage of college students' frequent use of online technology, including social networking sites (e.g., Instagram a social media site /Facebook a social networking site) and social media sites (e.g., YouTube), the investigators will create an online intervention that leverages this technology to engage and educate Asian, Native Hawaiian, Pacific Islanders (ANHPI)students about a range of topics related to organ donation following death.

Read the detailed description

Over 56% of the 120,000 critically ill Americans waiting on transplant waiting lists are ethnic minorities. The proportion of ethnic minorities, including Asian, Native Hawaiian, Pacific Islanders (ANHPI), on waiting lists exceeds their representation in the general population. However, few ANHPI adults are designated organ donors (DOD) on their driver's licenses or in a donor registry. ANHPI college students (aged 18-29) also have low DOD rates, particularly Filipinos. Individuals are typically asked about becoming a DOD when renewing a driver's license; but most never think about OD outside of the short-lived Department of Motor Vehicles (DMV) transaction. Knowing someone's status as a DOD on their license can be an influential factor in solidifying a family's feelings about donating a relative's organs after his/her death, if their consent is necessary. Of those who choose DOD status on a license, most will remain one for life. Intervening with drivers before the date of their license renewal can be difficult to arrange; however, opportunities arise when college students turn 21 and want to renew their license in order to remove formatting / colors signifying that the license belongs to an underage minor (< 21 years old).

Taking advantage of college students' frequent use of online technology, including social networking sites (e.g., Instagram a social media site /Facebook a social networking site) and social media sites (e.g., YouTube), the investigators created an online intervention that leveraged this technology to engage and educate ANHPI students about a range of topics related to organ donation (OD). It will also provide culturally sensitive messages tailored to their interest in or wariness of organ donation and reframe students' attitudes about OD and becoming a DOD. Previous internet interventions to encourage college students to become DODs have not included culturally sensitive approaches for ANHPI, who have unique barriers to OD. The cross-sectional design will test the impact of introducing, sequentially, an online intervention tailored to college students at three universities (UH-Manoa, UH-Hilo, and Hawaii Pacific University). The sequence of when the a university received the intervention was randomly determined; thus, the study's design was a cross-sectional design. The goal was to increase DOD rates in college students, particularly ANHPI and encouraging peer discussions/interactions/advocacy about OD.

Effectiveness will be measured by a change over time in the percentage of students who report being a DOD on their license/donor registry (250 students per university measured across 6 time points; thus, the total sample = 4,500). The investigators anticipate a 12% increase in DOD rate in students who are exposed to the intervention. Increases in DOD status will also be tracked via an increase (over normal rates) in the number of new donors aged 18-29 who register as a donor on Hawaii's online donor registry. To make the study website relevant to college students the investigators will include resources useful for assignments in courses (e.g., both in required "general education" courses- including one on "writing skills", and courses on ethics, religion, sociology, and culture/ ethnic studies, etc.) Students and student organizations will participate in contests to win prizes (e.g., for the best 1-minute DOD focused-YouTube video/ Instagram picture, creating a "caption" for a photo on Instagram, and student organizations who compete for group awards). A goal of the intervention will be to reframe OD by engaging altruistic attitudes based on college students' commitment to "green" sustainability efforts (e.g., "go green, recycle yourself"). Innovative culturally sensitive strategies that can engage, educate, and reframe DOD for college students, including those who find it unappealing (i.e., the "ick factor") are clearly needed. The online intervention will saturate online venues (i.e., YouTube, Instagram) visited frequently by college students, and the investigators will use the new concept of "gamification" to turn college students' learning and advocacy ideas surrounding OD/DOD into a game or contest with their peers. This project builds upon Drs. Albright and Feeley's (consultant - Univ. of Buffalo, Dept. of Communications) previous work to encourage adolescents and young adults to become a DOD; thus, the investigators feel well-suited to design, implement, and evaluate the proposed project. The intervention will increase DOD rates in ANHPI students, and thus, increase the number of ethnic minorities who become deceased organ donors now and for years to come.

Being tested
Web intervention
Keywords
designated organ donor, college students

What participants receive

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

  • Web interventionBehavioural

    Also called iDecide Hawaii

    interactive website using social media and gamification

Study groups in NCT02318849
Study groupRoleWhat they receive
First initiation siteExperimentalUniversity randomized to receive intervention after 1 baseline assessment. Duration of intervention was 3 semesters. This was University of Hawaii at Manoa (UHM).
Receives: Behavioral: Web intervention
Second initiation siteExperimentalUniversity randomized to receive intervention after 3 baseline assessments. Duration of intervention was 2 semesters. This was University of Hawaii at Hilo (UHH).
Receives: Behavioral: Web intervention
Third initiation siteExperimentalUniversity randomized to receive intervention after 5 baseline assessments. Duration of intervention was 2 semesters. This was Hawaii Pacific University (HPU).
Receives: Behavioral: Web intervention

What is being measured

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

  1. Donor Status

    number of subjects who are designated organ donor on license

    Measured: 2 years

  2. Talk to Peers/Family

    number of subjects who report talking to family or peers about choice be organ donor

    Measured: 2 years

Timeline

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

  1. First posted17 Dec 2014 (estimated)
  2. Study start1 Nov 2014
  3. Primary completion31 Dec 2016
  4. Study completion31 Dec 2018

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
Treatment
Allocation
Randomised
Intervention model
Sequential
Model description
Online educational intervention of choice to be an organ donor was provided to undergraduate students at three universities. The intervention launch at the universities were sequentially initiated, in random order. The design included cross-sectional assessments (unique respondents at each site over time ) as well as longitudinal assessments (same students repeatedly assessed over time).
Masking
Single blind
Who is masked
Participant
Enrolment
4,827 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02318849
Sponsor's protocol ID
R39OT26993
Acronym
iDecide
Status last verified
May 2023
First submitted
12 Dec 2014
Last updated
5 Feb 2024
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Web intervention in people with Tissue and Organ Procurement, run by University of Hawaii 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 1 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: finished, as of the sponsor's last update on 5 Feb 2024. 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?

Yes. Results are posted in the registry (first posted 5 Feb 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Donor Status (time frame: 2 years). The study lists 2 primary outcomes in all. 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 5 Feb 2024.

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