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Intervention to Motivate Teens to be a Designated Organ Donor on Driver's License (Idecide)
This study is currently recruiting participants.
Verified by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), December 2008
Sponsored by: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Information provided by: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
ClinicalTrials.gov Identifier: NCT00810901
  Purpose

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 Intervention Phase
Organ Donor
Behavioral: Multimedia educational campaign
Behavioral: Prevent use of alcohol
Phase III

Drug Information available for: Ethanol
U.S. FDA Resources
Study Type: Interventional
Study Design: Prevention, Randomized, Double Blind (Investigator, Outcomes Assessor), Dose Comparison, Parallel Assignment, Efficacy Study
Official Title: Multimedia Intervention to Motivate Ethnic Teens to be Designated Donors

Further study details as provided by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK):

Primary Outcome Measures:
  • Percent of students who are a designated organ donor on driver's license [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Percent of teens who talk to their parents about the choice to become an organ donor on their driver's license [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 540
Study Start Date: April 2008
Estimated Study Completion Date: April 2012
Estimated Primary Completion Date: April 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
1: Experimental
Use DVD, text messaging, emails, websites, US Mail, and telephone calls to educate teens about the choice to become an organ donor on their driver's license application.
Behavioral: Multimedia educational campaign
Subjects receive information about becoming a designated organ donor -via DVD, email, text messaging, website, and US mail.
2: Active Comparator
Education about the laws that prohibit underage minors purchasing and consuming alcohol
Behavioral: Prevent use of alcohol
Use DVD, website, text messaging, email and US mail to educate teenagers about the consequences associated with purchasing and using alcohol.

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 concete 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/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.

  Eligibility

Ages Eligible for Study:   14 Years to 19 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00810901

Contacts
Contact: Cheryl Albright, PhD, MPH 808 441 8189 calbright@crch.hawaii.edu
Contact: May Rose Dela Cruz, BA 8084413485 MRIsnec@crch.hawaii.edu

Locations
United States, Hawaii
Cancer Research Center of Hawaii Recruiting
Honolulu, Hawaii, United States, 96822
Contact: Sandy French     808-564-5978     sandy@crch.hawaii.edu    
Contact: May Rose Dela Cruz            
Sponsors and Collaborators
Investigators
Principal Investigator: Cheryl Albright, PhD, MPH University of Hawaii Cancer Research Center
  More Information

Responsible Party: Cancer Research Center of Hawaii; University of Hawaii ( Cheryl L Albright,PhD, MPH; Associate Professor )
Study ID Numbers: DK079684, 5R01Dk079684
Study First Received: December 17, 2008
Last Updated: December 17, 2008
ClinicalTrials.gov Identifier: NCT00810901  
Health Authority: United States: Federal Government

Keywords provided by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK):
ethnic minority adolescents
organ donor

Study placed in the following topic categories:
Ethanol

ClinicalTrials.gov processed this record on January 14, 2009