Trial Outcomes & Findings for Reducing High School Athletes' Prescription Opioids Misuse and Diversion Through the Student Athlete Wellness Portal (NCT NCT05209191)
NCT ID: NCT05209191
Last Updated: 2023-09-15
Results Overview
10 items in agree-disagree format (sale 1-5) modified from the SUS scale to measure the useability of a website. Range 1-5, higher scores reflect better usability.
COMPLETED
NA
102 participants
Posttest
2023-09-15
Participant Flow
Recruitment for the trial began April 24, 2020. Four high schools were recruited to participate. Due to COVID-19, 3 dropped out. New high schools were recruited to replace them but new waves of COVID required delays in completing recruitment.
Participant milestones
| Measure |
Student Athlete Wellness Portal
Web-based intervention that illustrates opioid misuse and diversion resistance strategies.
Student Athlete Wellness Portal: A web-based design that illustrates various opioid misuse and diversion resistance strategies.
|
|---|---|
|
Overall Study
STARTED
|
102
|
|
Overall Study
COMPLETED
|
102
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Reducing High School Athletes' Prescription Opioids Misuse and Diversion Through the Student Athlete Wellness Portal
Baseline characteristics by cohort
| Measure |
Student Athlete Wellness Portal
n=102 Participants
Web-based intervention that illustrates opioid misuse and diversion resistance strategies.
Student Athlete Wellness Portal: A web-based design that illustrates various opioid misuse and diversion resistance strategies.
|
|---|---|
|
Age, Continuous
|
16.6 years
STANDARD_DEVIATION 1.50 • n=5 Participants
|
|
Sex: Female, Male
Female
|
49 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
53 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Hispanic
|
8 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White, not Hispanic
|
57 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
17 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian
|
5 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
American Indian/Alaskan Native
|
5 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
other
|
10 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
102 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Posttest10 items in agree-disagree format (sale 1-5) modified from the SUS scale to measure the useability of a website. Range 1-5, higher scores reflect better usability.
Outcome measures
| Measure |
Student Athlete Wellness Portal
n=102 Participants
Web-based intervention that illustrates opioid misuse and diversion resistance strategies.
Student Athlete Wellness Portal: A web-based design that illustrates various opioid misuse and diversion resistance strategies.
|
|---|---|
|
Usability
|
3.49 score on a scale
Standard Deviation 0.65
|
PRIMARY outcome
Timeframe: Posttest8 items in agree-disagree (scale 1-5) format to measure the degree to which a participant felt engaged with the website. Range 1-5, with higher scores reflecting more engagement. Subscales of interest, realism, and identification.
Outcome measures
| Measure |
Student Athlete Wellness Portal
n=102 Participants
Web-based intervention that illustrates opioid misuse and diversion resistance strategies.
Student Athlete Wellness Portal: A web-based design that illustrates various opioid misuse and diversion resistance strategies.
|
|---|---|
|
Engagement
|
3.50 score on a scale
Standard Deviation 0.72
|
PRIMARY outcome
Timeframe: Posttest.2 items measuring the degree (scale 1-5) to which participants felt confident resisting offers of prescription opioids. Range 1-5, with higher scores reflecting more efficacy.
Outcome measures
| Measure |
Student Athlete Wellness Portal
n=102 Participants
Web-based intervention that illustrates opioid misuse and diversion resistance strategies.
Student Athlete Wellness Portal: A web-based design that illustrates various opioid misuse and diversion resistance strategies.
|
|---|---|
|
Efficacy in Resisting Offers of Opioids
|
3.91 score on a scale
Standard Deviation 1.02
|
PRIMARY outcome
Timeframe: Posttest2 items measured participants' willing to misuse opioids. Each presented a scenario followed by a checklist, each with 6 options indicating possible responses to opioid offers. For analyses, items were dichotomized to indicate if participants were willing to misuse (1) or not willing (0). If they checked any of the choices indicating they were willing to misuse prescription opioids, they were scored 1, which is the worst outcome. Range 0-1.
Outcome measures
| Measure |
Student Athlete Wellness Portal
n=102 Participants
Web-based intervention that illustrates opioid misuse and diversion resistance strategies.
Student Athlete Wellness Portal: A web-based design that illustrates various opioid misuse and diversion resistance strategies.
|
|---|---|
|
Number of Participants Willing to Misuse Prescription Opioids
Pretest
|
44 Participants
|
|
Number of Participants Willing to Misuse Prescription Opioids
Posttest
|
37 Participants
|
Adverse Events
Student Athlete Wellness Portal
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place