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.
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
- Type of treatment
- Lifestyle or therapy programme
- 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.
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.
- Conditions
- Tissue and Organ Procurement
- 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 group | Role | What they receive |
|---|---|---|
| First initiation site | Experimental | University 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 site | Experimental | University 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 site | Experimental | University 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.
Donor Status
number of subjects who are designated organ donor on license
Measured: 2 years
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.
- First posted17 Dec 2014 (estimated)
- Study start1 Nov 2014
- Primary completion31 Dec 2016
- Study completion31 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Tissue and Organ ProcurementStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- University of Hawaii
- Sponsor type
- University, hospital or other
- Collaborators
- Health Resources and Services Administration (HRSA)
- Responsible party
- Sponsor
- Investigators
- Cheryl L Albright, PhD, MPH, Principal investigator, University of Hawaii
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
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Social and Behavioral Interventions to Increase Solid Organ Donation
- ClinicalTrials.gov ID
- NCT02318849
- Acronym / sponsor ID
- iDecide / R39OT26993
- Conditions
- Tissue and Organ Procurement
- Keywords
- designated organ donor, college students
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 4,827 participants (actual)
- Lead sponsor
- University of HawaiiUniversity, hospital or other
- Collaborators
- Health Resources and Services Administration (HRSA)
- Study start
- 1 Nov 2014 (actual)
- Primary completion
- 31 Dec 2016 (actual)
- Study completion
- 31 Dec 2018 (actual)
- First posted
- 17 Dec 2014 (estimated)
- Results
- Posted 5 Feb 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Single blind (participant)
- Number of arms
- 3
- 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).
| Arm | Type | Receives |
|---|---|---|
| First initiation site | Experimental | Behavioral: Web interventionUniversity randomized to receive intervention after 1 baseline assessment. Duration of intervention was 3 semesters. This was University of Hawaii at Manoa (UHM). |
| Second initiation site | Experimental | Behavioral: Web interventionUniversity randomized to receive intervention after 3 baseline assessments. Duration of intervention was 2 semesters. This was University of Hawaii at Hilo (UHH). |
| Third initiation site | Experimental | Behavioral: Web interventionUniversity randomized to receive intervention after 5 baseline assessments. Duration of intervention was 2 semesters. This was Hawaii Pacific University (HPU). |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (1 listed)
- Not an undergraduate college student at one of the participating university sites
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Web interventionAlso: iDecide Hawaiiinteractive website using social media and gamification | Behavioural | First initiation site, Second initiation site, Third initiation site |
Primary outcome
Donor Status
Time frame: 2 years
number of subjects who are designated organ donor on license
Talk to Peers/Family
Time frame: 2 years
number of subjects who report talking to family or peers about choice be organ donor
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Feb 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
Related trials for Tissue and Organ Procurement
Not yet recruiting
Drone Transport of Deceased-Donor Kidney Grafts Between Two French Hospitals Before Transplantation: a Pilot Safety Study
Kidney Failure, Chronic, Kidney Transplantation
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Cheryl L Albright, PhD, MPH principal investigator
University of Hawaii
1 site in 1 country: see every site and its status.
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.