Tissue and Organ ProcurementIdecideNCT00810901
Intervention to Motivate Teens to be a Designated Organ Donor on Driver's License
A study testing Organ Donor and Alcohol Prevention in people with Tissue and Organ Procurement and Alcohol Abstinence, run by University of Hawaii at 1 site in United States.
Trial summary
This study will test the effectiveness of a multimedia campaign to educate ethnic minority teens about the choice to become a designated organ donor on their first driver's license. Read more about this study
- Who is it for?
- Ages 14 to 19 yearsHealthy volunteers can take part
- Conditions the study is for
- Tissue and Organ Procurement, Alcohol Abstinence
- What is being tested?
- Organ Donor and Alcohol Prevention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 429 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2008to Dec 2014
- 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 14 to 19 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- adolescent aged 14-19
- member of a school club, youth program or teen group
- read and speak English
- parent provides consent
Who cannot join
- plans to permanently move out of state
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Hawaii School of Nursing and Dental Hygiene
Honolulu, Hawaii, 96822
About this study
Official title: Multimedia Intervention to Motivate Ethnic Teens to be Designated Donors
This study will test the effectiveness of a multimedia campaign to educate ethnic minority teens about the choice to become a designated organ donor on their first driver's license.
Read the detailed description
Less than a fourth of ethnic minority teens in the U.S. are a designated donor (DD) on their state-issued driver's license. Asian-American/Pacific Islander (AA/PI) adolescents in Hawaii are even less likely to be a DD or to have talked to their family about becoming an organ donor. Health education interventions for adolescents have demonstrated improvements in knowledge and intentions to be an organ donor; but, AA/PI teens are underrepresented in such studies. Nevertheless, whether changes in knowledge or intentions result in more organ donors is unclear, since previous studies have not included a concrete behavioral outcome such as the teen becoming a donor on their driver's license. This application will test, via a randomized clinical trial, the efficacy of an Interactive Multimedia Intervention (IMI) to increase the number of AA/PI adolescents who are a DD on their state issued driver's license, identification card, or organ donor card/donor registry. Teen groups will be recruited from the community (churches and high schools, n = 40 groups, 530 teens) and randomly assigned to either the intervention or a comparison condition on prevention of underage drinking of alcohol. The theoretically-derived intervention will include culturally sensitive messages and information about being a designated donor that will be delivered via a DVD, Email, text/instant messaging, and websites. The comparison condition includes materials (DVD) previously shown to increase awareness about laws restricting access to alcohol by teens. The primary outcome is objectively validated donor status on a teens' driver's license/state identification card (ID) or donor card after 12 months of intervention. A secondary outcome is the reported rate of family discussions about organ donation and knowledge/intentions about donation. We hypothesize the youth groups assigned to the intervention will have higher rates for family discussions and DD status, compared to groups in the comparison condition. We will also test whether psychosocial and cultural factors act as mediators of any change in teens' knowledge, attitudes \& stages of change to become a DD. After the randomized trial we will disseminate the intervention to Organ Procurement Organizations in Hawaii and other states, and track diffusion outcomes over a year. If IMI methods can increase the number of minority teens who become a DD on their driver's license by 10% this would translate to 500,000 more teenage designated donors in the U.S.
- Conditions
- Tissue and Organ Procurement, Alcohol Abstinence
- Being tested
- Organ Donor, Alcohol Prevention
- Keywords
- ethnic minority adolescents, designated organ donor
- Medical subject headings
- Alcohol Abstinence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Organ DonorBehavioural
Also called Idecide Project
Subjects receive information about becoming a designated organ donor -via DVD, email, text messaging, website, and US mail.
Alcohol PreventionBehavioural
Also called Roll of the Dice
Use DVD, website, text messaging, email and US mail to educate teenagers about the consequences associated with purchasing and using alcohol.
| Study group | Role | What they receive |
|---|---|---|
| Organ Donor | Experimental | Intervention used a DVD, text messaging, emails, a website, US Mail, and telephone calls to educate teens about their choice to become a designated organ donor on their first driver's license application. Receives: Behavioral: Organ Donor |
| Alcohol Prevention | Active comparator | Intervention used a DVD and text messages, to educate teens about the laws that prohibit underage minors purchasing and consuming alcohol Receives: Behavioral: Alcohol Prevention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Designated Organ Donor Status on Driver's License
Number of students who reported not being donor at baseline but were donor at 12 months follow-up
Measured: 12 months
Secondary outcomes (1)
Talked to Parents About Choice to be Organ Donor on License at 12 Months
Number of teens who talk had not talked to parents at baseline but reported they had talked to their parents about the choice to become an organ donor on their driver's license at 12 months
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Dec 2008 (estimated)
- Study startApr 2008
- Primary completionDec 2014
- Study completionDec 2014
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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 429 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Hawaii
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Cheryl Albright, PhD, MPH, Principal investigator, University of Hawaii
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00810901
- Sponsor's protocol ID
- DK079684
- Other IDs
- R01DK079684, R01DK079684-03S1
- Acronym
- Idecide
- Status last verified
- Jan 2015
- First submitted
- 17 Dec 2008
- Last updated
- 25 Jun 2015
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 25 Jun 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multimedia Intervention to Motivate Ethnic Teens to be Designated Donors
- ClinicalTrials.gov ID
- NCT00810901
- Acronym / sponsor ID
- Idecide / DK079684
- Conditions
- Tissue and Organ Procurement, Alcohol Abstinence
- Keywords
- ethnic minority adolescents, designated organ donor
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 429 participants (actual)
- Lead sponsor
- University of HawaiiUniversity, hospital or other
- Collaborators
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Study start
- Apr 2008
- Primary completion
- Dec 2014 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 18 Dec 2008 (estimated)
- Results
- Posted 25 Jun 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will test the effectiveness of a multimedia campaign to educate ethnic minority teens about the choice to become a designated organ donor on their first driver's license.
Detailed description
Less than a fourth of ethnic minority teens in the U.S. are a designated donor (DD) on their state-issued driver's license. Asian-American/Pacific Islander (AA/PI) adolescents in Hawaii are even less likely to be a DD or to have talked to their family about becoming an organ donor. Health education interventions for adolescents have demonstrated improvements in knowledge and intentions to be an organ donor; but, AA/PI teens are underrepresented in such studies. Nevertheless, whether changes in knowledge or intentions result in more organ donors is unclear, since previous studies have not included a concrete behavioral outcome such as the teen becoming a donor on their driver's license. This application will test, via a randomized clinical trial, the efficacy of an Interactive Multimedia Intervention (IMI) to increase the number of AA/PI adolescents who are a DD on their state issued driver's license, identification card, or organ donor card/donor registry. Teen groups will be recruited from the community (churches and high schools, n = 40 groups, 530 teens) and randomly assigned to either the intervention or a comparison condition on prevention of underage drinking of alcohol. The theoretically-derived intervention will include culturally sensitive messages and information about being a designated donor that will be delivered via a DVD, Email, text/instant messaging, and websites. The comparison condition includes materials (DVD) previously shown to increase awareness about laws restricting access to alcohol by teens. The primary outcome is objectively validated donor status on a teens' driver's license/state identification card (ID) or donor card after 12 months of intervention. A secondary outcome is the reported rate of family discussions about organ donation and knowledge/intentions about donation. We hypothesize the youth groups assigned to the intervention will have higher rates for family discussions and DD status, compared to groups in the comparison condition. We will also test whether psychosocial and cultural factors act as mediators of any change in teens' knowledge, attitudes \& stages of change to become a DD. After the randomized trial we will disseminate the intervention to Organ Procurement Organizations in Hawaii and other states, and track diffusion outcomes over a year. If IMI methods can increase the number of minority teens who become a DD on their driver's license by 10% this would translate to 500,000 more teenage designated donors in the U.S.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Organ Donor | Experimental | Behavioral: Organ DonorIntervention used a DVD, text messaging, emails, a website, US Mail, and telephone calls to educate teens about their choice to become a designated organ donor on their first driver's license application. |
| Alcohol Prevention | Active comparator | Behavioral: Alcohol PreventionIntervention used a DVD and text messages, to educate teens about the laws that prohibit underage minors purchasing and consuming alcohol |
Who may qualify
- Ages
- 14 to 19 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- adolescent aged 14-19
- member of a school club, youth program or teen group
- read and speak English
- parent provides consent
Key exclusion criteria (1 listed)
- plans to permanently move out of state
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 |
|---|---|---|
| Organ DonorAlso: Idecide ProjectSubjects receive information about becoming a designated organ donor -via DVD, email, text messaging, website, and US mail. | Behavioural | Organ Donor |
| Alcohol PreventionAlso: Roll of the DiceUse DVD, website, text messaging, email and US mail to educate teenagers about the consequences associated with purchasing and using alcohol. | Behavioural | Alcohol Prevention |
Primary outcome
Designated Organ Donor Status on Driver's License
Time frame: 12 months
Number of students who reported not being donor at baseline but were donor at 12 months follow-up
1 secondary outcome
Talked to Parents About Choice to be Organ Donor on License at 12 Months
Time frame: 12 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jun 2015.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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 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 Organ Donor and Alcohol Prevention in people with Tissue and Organ Procurement and Alcohol Abstinence, 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 4 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 25 Jun 2015. 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 25 Jun 2015). 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?
Designated Organ Donor Status on Driver's License (time frame: 12 months). 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 25 Jun 2015.