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

• Sponsor: University of Hawaii (Other)
• Overall Status: Completed
• CT.gov ID: NCT00810901
• Collaborator: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) (NIH)
• Enrollment: 429
• Location: 1
• Arms: 2
• Duration (Months): 80
• Patients Per Site Per Month: 5.4

Study Details

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	N/A

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
• 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: Apr 1, 2008
• Actual Primary Completion Date: Dec 1, 2014
• Actual Study Completion Date: Dec 1, 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 Names: 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 Names: Roll of the Dice

Outcome Measures

Primary Outcome Measures

1. Designated Organ Donor Status on Driver's License [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 [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

Criteria

• Ages Eligible for Study: 14 Years to 19 Years
• 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: University of Hawaii
• ClinicalTrials.gov Identifier: NCT00810901
• Other Study ID Numbers: DK079684; R01DK079684; R01DK079684-03S1
• First Posted: Dec 18, 2008
• Last Update Posted: Jun 25, 2015
• Last Verified: Jan 1, 2015

• Keywords provided by University of Hawaii: ethnic minority adolescents; designated organ donor
• Additional relevant MeSH terms: Alcohol Abstinence

Study Results

Participant Flow

Arm/Group Title	Organ Donor	Alcohol Prevention
Arm/Group Description	Intervention used a digital video disk (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. Organ Donor: Subjects receive information about becoming a designated organ donor -via DVD, email, text messaging, website, and US mail.	Intervention used a digital video disk (DVD) and text messages, to educate teens about the laws that prohibit underage minors purchasing and consuming alcohol Alcohol Prevention: Use DVD, website, text messaging, email and US mail to educate teenagers about the consequences associated with purchasing and using alcohol.
Period Title: Overall Study
STARTED	253	176
1-month Follow up	242	146
6-month Follow-up	181	122
COMPLETED	165	118
NOT COMPLETED	88	58

Baseline Characteristics

Arm/Group Title	Organ Donor	Alcohol Prevention	Total
Arm/Group Description	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. Organ Donor: Subjects receive information about becoming a designated organ donor -via DVD, email, text messaging, website, and US mail.	Intervention used a DVD and text messages, to educate teens about the laws that prohibit underage minors purchasing and consuming alcohol Alcohol Prevention: Use DVD, website, text messaging, email and US mail to educate teenagers about the consequences associated with purchasing and using alcohol.	Total of all reporting groups
Overall Participants	253	176	429
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	15.8 (1.2)	16.1 (1.3)	15.9 (1.25)
Sex: Female, Male (Count of Participants)
Female	126 49.8%	87 49.4%	213 49.7%
Male	127 50.2%	89 50.6%	216 50.3%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	33 13%	35 19.9%	68 15.9%
Not Hispanic or Latino	209 82.6%	130 73.9%	339 79%
Unknown or Not Reported	11 4.3%	11 6.3%	22 5.1%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%	1 0.6%	1 0.2%
Asian	147 58.1%	95 54%	242 56.4%
Native Hawaiian or Other Pacific Islander	50 19.8%	46 26.1%	96 22.4%
Black or African American	0 0%	3 1.7%	3 0.7%
White	21 8.3%	15 8.5%	36 8.4%
More than one race	35 13.8%	16 9.1%	51 11.9%
Unknown or Not Reported	0 0%	0 0%	0 0%
Region of Enrollment (participants) [Number]
United States	253 100%	176 100%	429 100%
Designated organ donor on driver's license (participants) [Number]
Organ donor on license at baseline	52 20.6%	39 22.2%	91 21.2%
Not organ donor on license at baseline	201 79.4%	137 77.8%	338 78.8%

Outcome Measures

1. Primary Outcome

Title	Designated Organ Donor Status on Driver's License
Description	Number of students who reported not being donor at baseline but were donor at 12 months follow-up
Time Frame	12 months

Outcome Measure Data

Analysis Population Description

t-test

Arm/Group Title	Alcohol Prevention	Organ Donor
Arm/Group Description	Intervention used a DVD and text messages, to educate teens about the laws that prohibit underage minors purchasing and consuming alcohol Alcohol Prevention: Use DVD, website, text messaging, email and US mail to educate teenagers about the consequences associated with purchasing and using alcohol.	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. Organ Donor: Subjects receive information about becoming a designated organ donor -via DVD, email, text messaging, website, and US mail.
Measure Participants	118	165
Number (95% Confidence Interval) [participants]	67 26.5%	38 21.6%

2. Secondary Outcome

Title	Talked to Parents About Choice to be Organ Donor on License at 12 Months
Description	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
Time Frame	12 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Alcohol Prevention	Organ Donor
Arm/Group Description	Intervention used a DVD and text messages, to educate teens about the laws that prohibit underage minors purchasing and consuming alcohol Alcohol Prevention: Use DVD, website, text messaging, email and US mail to educate teenagers about the consequences associated with purchasing and using alcohol.	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. Organ Donor: Subjects receive information about becoming a designated organ donor -via DVD, email, text messaging, website, and US mail.
Measure Participants	118	165
Number (95% Confidence Interval) [participants]	80 31.6%	74 42%

Adverse Events

Time Frame	12 months
Arm/Group Title	Alcohol Prevention		Organ Donor
Arm/Group Description	Intervention used a DVD and text messages, to educate teens about the laws that prohibit underage minors purchasing and consuming alcohol Alcohol Prevention: Use DVD, website, text messaging, email and US mail to educate teenagers about the consequences associated with purchasing and using alcohol.		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. Organ Donor: Subjects receive information about becoming a designated organ donor -via DVD, email, text messaging, website, and US mail.
All Cause Mortality
	Alcohol Prevention		Organ Donor
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Alcohol Prevention		Organ Donor
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/253 (0%)		0/176 (0%)
Other (Not Including Serious) Adverse Events
	Alcohol Prevention		Organ Donor
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	3/253 (1.2%)		2/176 (1.1%)
Social circumstances
Emotional reaction	3/253 (1.2%)	3	2/176 (1.1%)	2

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.