Intervention to Motivate Teens to be a Designated Organ Donor on Driver's License (Idecide)

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. Read our disclaimer for details. Identifier: NCT00810901
Recruitment Status : Completed
First Posted : December 18, 2008
Results First Posted : June 25, 2015
Last Update Posted : June 25, 2015
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Information provided by (Responsible Party):
University of Hawaii

Brief 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.

Condition or disease Intervention/treatment Phase
Tissue and Organ Procurement Alcohol Abstinence Behavioral: Organ Donor Behavioral: Alcohol Prevention Not Applicable

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 Type : Interventional  (Clinical Trial)
Actual Enrollment : 429 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Prevention
Official Title: Multimedia Intervention to Motivate Ethnic Teens to be Designated Donors
Study Start Date : April 2008
Actual Primary Completion Date : December 2014
Actual Study Completion Date : December 2014

Arm Intervention/treatment
Experimental: Organ Donor
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.
Behavioral: Organ Donor
Subjects receive information about becoming a designated organ donor -via DVD, email, text messaging, website, and US mail.
Other Name: Idecide Project
Active Comparator: Alcohol Prevention
Intervention used a DVD and text messages, to educate teens about the laws that prohibit underage minors purchasing and consuming alcohol
Behavioral: Alcohol Prevention
Use DVD, website, text messaging, email and US mail to educate teenagers about the consequences associated with purchasing and using alcohol.
Other Name: Roll of the Dice

Primary Outcome Measures :
  1. 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

Secondary Outcome Measures :
  1. Talked to Parents About Choice to be Organ Donor on License at 12 Months [ Time Frame: 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

Information from the National Library of Medicine

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Ages Eligible for Study:   14 Years to 19 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • adolescent aged 14-19
  • member of a school club, youth program or teen group
  • read and speak English
  • parent provides consent

Exclusion Criteria:

  • plans to permanently move out of state

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 identifier (NCT number): NCT00810901

United States, Hawaii
University of Hawaii School of Nursing and Dental Hygiene
Honolulu, Hawaii, United States, 96822
Sponsors and Collaborators
University of Hawaii
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Principal Investigator: Cheryl Albright, PhD, MPH University of Hawaii

Responsible Party: University of Hawaii Identifier: NCT00810901     History of Changes
Other Study ID Numbers: DK079684
R01DK079684 ( U.S. NIH Grant/Contract )
R01DK079684-03S1 ( U.S. NIH Grant/Contract )
First Posted: December 18, 2008    Key Record Dates
Results First Posted: June 25, 2015
Last Update Posted: June 25, 2015
Last Verified: January 2015

Keywords provided by University of Hawaii:
ethnic minority adolescents
designated organ donor

Additional relevant MeSH terms:
Alcohol Abstinence
Drinking Behavior
Anti-Infective Agents, Local
Anti-Infective Agents
Central Nervous System Depressants
Physiological Effects of Drugs