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

• ClinicalTrials.gov Identifier: NCT00810901
• Recruitment Status: Completed
• First Posted: December 18, 2008
• Results First Posted: June 25, 2015
• Last Update Posted: June 25, 2015
• Sponsor: University of Hawaii
• Collaborator: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
• Information provided by (Responsible Party): University of Hawaii

Study Description

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 Design

• 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

Arms and Interventions

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

Outcome Measures

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

Eligibility Criteria

• Ages Eligible for Study: 14 Years to 19 Years (Child, Adult)
• Sexes Eligible for Study: All
• 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

Locations

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)

Investigators

• Principal Investigator: Cheryl Albright, PhD, MPH; University of Hawaii

More Information

• Responsible Party: University of Hawaii
• ClinicalTrials.gov Identifier: NCT00810901
• Other Study ID Numbers: DK079684; R01DK079684 ( U.S. NIH Grant/Contract ); R01DK079684-03S1 ( U.S. NIH Grant/Contract )
• First Posted: December 18, 2008
• 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