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

Primary Purpose

Tissue and Organ Procurement, Alcohol Abstinence

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Organ Donor
Alcohol Prevention
Sponsored by
University of Hawaii
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Tissue and Organ Procurement focused on measuring ethnic minority adolescents, designated organ donor

Eligibility Criteria

14 Years - 19 Years (Child, Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • University of Hawaii School of Nursing and Dental Hygiene

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Organ Donor

Alcohol Prevention

Arm 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.

Intervention used a DVD and text messages, to educate teens about the laws that prohibit underage minors purchasing and consuming alcohol

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
December 17, 2008
Last Updated
June 23, 2015
Sponsor
University of Hawaii
Collaborators
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
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1. Study Identification

Unique Protocol Identification Number
NCT00810901
Brief Title
Intervention to Motivate Teens to be a Designated Organ Donor on Driver's License
Acronym
Idecide
Official Title
Multimedia Intervention to Motivate Ethnic Teens to be Designated Donors
Study Type
Interventional

2. Study Status

Record Verification Date
January 2015
Overall Recruitment Status
Completed
Study Start Date
April 2008 (undefined)
Primary Completion Date
December 2014 (Actual)
Study Completion Date
December 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Hawaii
Collaborators
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

4. Oversight

Data Monitoring Committee
Yes

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tissue and Organ Procurement, Alcohol Abstinence
Keywords
ethnic minority adolescents, designated organ donor

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
429 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Organ Donor
Arm Type
Experimental
Arm 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.
Arm Title
Alcohol Prevention
Arm Type
Active Comparator
Arm Description
Intervention used a DVD and text messages, to educate teens about the laws that prohibit underage minors purchasing and consuming alcohol
Intervention Type
Behavioral
Intervention Name(s)
Organ Donor
Other Intervention Name(s)
Idecide Project
Intervention Description
Subjects receive information about becoming a designated organ donor -via DVD, email, text messaging, website, and US mail.
Intervention Type
Behavioral
Intervention Name(s)
Alcohol Prevention
Other Intervention Name(s)
Roll of the Dice
Intervention Description
Use DVD, website, text messaging, email and US mail to educate teenagers about the consequences associated with purchasing and using alcohol.
Primary Outcome Measure Information:
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
Secondary Outcome Measure Information:
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
14 Years
Maximum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Cheryl Albright, PhD, MPH
Organizational Affiliation
University of Hawaii
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Hawaii School of Nursing and Dental Hygiene
City
Honolulu
State/Province
Hawaii
ZIP/Postal Code
96822
Country
United States

12. IPD Sharing Statement

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

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