Trial Outcomes & Findings for Intervention to Motivate Teens to be a Designated Organ Donor on Driver's License (NCT NCT00810901)

NCT ID: NCT00810901

Last Updated: 2015-06-25

Results Overview

Number of students who reported not being donor at baseline but were donor at 12 months follow-up

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 429 participants
• Primary outcome timeframe: 12 months
• Results posted on: 2015-06-25

Participant Flow

Participant milestones

Measure	Organ Donor 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.	Alcohol Prevention 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.
Overall Study STARTED	253	176
Overall Study 1-month Follow up	242	146
Overall Study 6-month Follow-up	181	122
Overall Study COMPLETED	165	118
Overall Study NOT COMPLETED	88	58

Reasons for withdrawal

Measure	Organ Donor 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.	Alcohol Prevention 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.
Overall Study Lost to Follow-up	88	58

Baseline Characteristics

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

Baseline characteristics by cohort

Measure	Organ Donor n=253 Participants 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.	Alcohol Prevention n=176 Participants 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 n=429 Participants Total of all reporting groups
Age, Continuous	15.8 years STANDARD_DEVIATION 1.2 • n=5 Participants	16.1 years STANDARD_DEVIATION 1.3 • n=7 Participants	15.9 years STANDARD_DEVIATION 1.25 • n=5 Participants
Sex: Female, Male Female	126 Participants n=5 Participants	87 Participants n=7 Participants	213 Participants n=5 Participants
Sex: Female, Male Male	127 Participants n=5 Participants	89 Participants n=7 Participants	216 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	33 Participants n=5 Participants	35 Participants n=7 Participants	68 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	209 Participants n=5 Participants	130 Participants n=7 Participants	339 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	11 Participants n=5 Participants	11 Participants n=7 Participants	22 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) Asian	147 Participants n=5 Participants	95 Participants n=7 Participants	242 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	50 Participants n=5 Participants	46 Participants n=7 Participants	96 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	3 Participants n=7 Participants	3 Participants n=5 Participants
Race (NIH/OMB) White	21 Participants n=5 Participants	15 Participants n=7 Participants	36 Participants n=5 Participants
Race (NIH/OMB) More than one race	35 Participants n=5 Participants	16 Participants n=7 Participants	51 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment United States	253 participants n=5 Participants	176 participants n=7 Participants	429 participants n=5 Participants
Designated organ donor on driver's license Organ donor on license at baseline	52 participants n=5 Participants	39 participants n=7 Participants	91 participants n=5 Participants
Designated organ donor on driver's license Not organ donor on license at baseline	201 participants n=5 Participants	137 participants n=7 Participants	338 participants n=5 Participants

PRIMARY outcome

Timeframe: 12 months

Population: t-test

Number of students who reported not being donor at baseline but were donor at 12 months follow-up

Outcome measures

Measure	Alcohol Prevention n=118 Participants 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.	Organ Donor n=165 Participants 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.
Designated Organ Donor Status on Driver's License	67 participants Interval 63.0 to 71.0	38 participants Interval 36.0 to 40.0

SECONDARY outcome

Timeframe: 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

Outcome measures

Measure	Alcohol Prevention n=118 Participants 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.	Organ Donor n=165 Participants 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.
Talked to Parents About Choice to be Organ Donor on License at 12 Months	80 participants Interval 73.0 to 87.0	74 participants Interval 63.0 to 85.0

Adverse Events

Alcohol Prevention

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

Organ Donor

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Alcohol Prevention n=253 participants at risk 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.	Organ Donor n=176 participants at risk 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.
Social circumstances Emotional reaction	1.2% 3/253 • Number of events 3 • 12 months	1.1% 2/176 • Number of events 2 • 12 months

Additional Information

Cheryl Albright

University of Hawaii, School of Nursing

Phone: 8089569716

Email: cherylal@hawaii.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place