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| ID | Type | Description | Link |
|---|---|---|---|
| R01DK079684 | U.S. NIH Grant/Contract | View source | |
| R01DK079684-03S1 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) | NIH |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Organ Donor | Experimental | 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. |
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| Alcohol Prevention | Active Comparator | Intervention used a DVD and text messages, to educate teens about the laws that prohibit underage minors purchasing and consuming alcohol |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Organ Donor | Behavioral | Subjects receive information about becoming a designated organ donor -via DVD, email, text messaging, website, and US mail. |
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| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Cheryl Albright, PhD, MPH | University of Hawaii | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Hawaii School of Nursing and Dental Hygiene | Honolulu | Hawaii | 96822 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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. |
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| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. Organ Donor: Subjects receive information about becoming a designated organ donor -via DVD, email, text messaging, website, and US mail. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | mean age by study condition |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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 | t-test | Posted | Number | 95% Confidence Interval | participants | 12 months |
|
12 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Alcohol Prevention | 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. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Emotional reaction | Social circumstances | Systematic Assessment | Student became upset about condition-specific issue (i.e,. underage drinking problem) or had argument with parent about condition-specific issue (i.e., becoming organ donor on driver's license) |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Cheryl Albright | University of Hawaii, School of Nursing | 8089569716 | cherylal@hawaii.edu |
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| ID | Term |
|---|---|
| D064829 | Alcohol Abstinence |
| ID | Term |
|---|---|
| D004327 | Drinking Behavior |
| D001519 | Behavior |
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| ID | Term |
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| D000431 | Ethanol |
| ID | Term |
|---|---|
| D000438 | Alcohols |
| D009930 | Organic Chemicals |
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| Alcohol Prevention | Behavioral | Use DVD, website, text messaging, email and US mail to educate teenagers about the consequences associated with purchasing and using alcohol. |
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| BG001 |
| Alcohol Prevention |
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. |
| BG002 | Total | Total of all reporting groups |
| Mean |
| Standard Deviation |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Designated organ donor on driver's license | Number | participants |
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| 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 | Posted | Number | 95% Confidence Interval | participants | 12 months |
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| 0 |
| 253 |
| 3 |
| 253 |
| EG001 | 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. Organ Donor: Subjects receive information about becoming a designated organ donor -via DVD, email, text messaging, website, and US mail. | 0 | 176 | 2 | 176 |
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