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

Tissue and Organ Procurement Clinical Trial

— Idecide  

Official title:

Multimedia Intervention to Motivate Ethnic Teens to be Designated Donors

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00810901
• Other study ID #: DK079684
• Secondary ID: R01DK079684R01DK
• Status: Completed
• Phase: N/A
• First received: December 17, 2008
• Last updated: June 23, 2015
• Start date: April 2008
• Est. completion date: December 2014

Study information

• Verified date: January 2015
• Source: University of Hawaii
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 429
• Est. completion date: December 2014
• Est. primary completion date: December 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 14 Years to 19 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Alcohol Abstinence
• Tissue and Organ Procurement

Intervention

Behavioral:
• Organ Donor
Subjects receive information about becoming a designated organ donor -via DVD, email, text messaging, website, and US mail.
• Alcohol Prevention
Use DVD, website, text messaging, email and US mail to educate teenagers about the consequences associated with purchasing and using alcohol.

Locations

Country	Name	City	State
United States	University of Hawaii School of Nursing and Dental Hygiene	Honolulu	Hawaii

Sponsors (2)

Lead Sponsor	Collaborator
University of Hawaii	National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	12 months	No
Secondary	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	12 months	No