Trial Outcomes & Findings for Smartphone Intervention for Overdose and COVID-19 (NCT NCT05518461)
NCT ID: NCT05518461
Last Updated: 2024-12-05
Results Overview
Study feasibility will be in part based on intervention content completion rates. The study will be considered feasible if participants complete any intervention content on at least 50% (i.e., 6) of the 12 weeks. We will report the number of participants who completed at least 6 of the 12 weeks.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
60 participants
Primary outcome timeframe
up to 12 weeks
Results posted on
2024-12-05
Participant Flow
Participant milestones
| Measure |
iThrive WI Intervention
Participants will receive COVID-19 and overdose-related educational and motivational content over the course of 12 weeks through the Thrive4Life Connect, a mobile health application. They will be invited to set goals for lowering overdose and COVID-19 risk.
iThrive WI Intervention: Participants will receive COVID-19 and overdose-related educational and motivational content over the course of 12 weeks through the Thrive4Life Connect, a mobile health application. They will be invited to set goals for lowering overdose and COVID-19 risk.
|
|---|---|
|
Overall Study
STARTED
|
60
|
|
Overall Study
Completed at 3 Months
|
44
|
|
Overall Study
Completed at 6 Months
|
38
|
|
Overall Study
Completed All 3 Surveys
|
35
|
|
Overall Study
Completed Only Baseline and 3 Month
|
9
|
|
Overall Study
Completed Only Baseline and 6 Month
|
3
|
|
Overall Study
COMPLETED
|
35
|
|
Overall Study
NOT COMPLETED
|
25
|
Reasons for withdrawal
| Measure |
iThrive WI Intervention
Participants will receive COVID-19 and overdose-related educational and motivational content over the course of 12 weeks through the Thrive4Life Connect, a mobile health application. They will be invited to set goals for lowering overdose and COVID-19 risk.
iThrive WI Intervention: Participants will receive COVID-19 and overdose-related educational and motivational content over the course of 12 weeks through the Thrive4Life Connect, a mobile health application. They will be invited to set goals for lowering overdose and COVID-19 risk.
|
|---|---|
|
Overall Study
Lost to Follow-up
|
25
|
Baseline Characteristics
Smartphone Intervention for Overdose and COVID-19
Baseline characteristics by cohort
| Measure |
iThrive WI Intervention
n=60 Participants
Participants will receive COVID-19 and overdose-related educational and motivational content over the course of 12 weeks through the Thrive4Life Connect, a mobile health application. They will be invited to set goals for lowering overdose and COVID-19 risk.
iThrive WI Intervention: Participants will receive COVID-19 and overdose-related educational and motivational content over the course of 12 weeks through the Thrive4Life Connect, a mobile health application. They will be invited to set goals for lowering overdose and COVID-19 risk.
|
|---|---|
|
Age, Continuous
|
34 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
28 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
32 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
8 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
51 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
4 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
47 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
4 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
5 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
60 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: up to 12 weeksStudy feasibility will be in part based on intervention content completion rates. The study will be considered feasible if participants complete any intervention content on at least 50% (i.e., 6) of the 12 weeks. We will report the number of participants who completed at least 6 of the 12 weeks.
Outcome measures
| Measure |
iThrive WI Intervention
n=60 Participants
Participants will receive COVID-19 and overdose-related educational and motivational content over the course of 12 weeks through the Thrive4Life Connect, a mobile health application. They will be invited to set goals for lowering overdose and COVID-19 risk.
iThrive WI Intervention: Participants will receive COVID-19 and overdose-related educational and motivational content over the course of 12 weeks through the Thrive4Life Connect, a mobile health application. They will be invited to set goals for lowering overdose and COVID-19 risk.
|
Using Opioids or Stimulants While Alone
Average of the number of days opioids and stimulants were used while alone in the past 30 days.
|
Injection Drug Use and/or Speedballing
Average of the reported number of days of opioid injection, stimulant injection, opioid and stimulant use within a 6-hour time periods, and opioid and stimulant use at the same time within the past 30 days.
|
Opioid and Alcohol Use
Number of days that opioids and alcohol were used within a 6-hour time frame in the past 30 days.
|
Opioid and Benzodiazepine Use
Number of days that opioids and benzodiazepines were used within a 6-hour time frame in the past 30 days.
|
|---|---|---|---|---|---|
|
Content Completion Rate Assessed as Number of Participants Who Completed at Least 6 of the 12 Weeks of the Intervention
|
40 Participants
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: baseline, 3 months, 6 monthsPopulation: Losses to follow-up occurred across study measurement timepoints.
Preliminary effectiveness will in part be measured by examining the number of days in the previous month endorsing overdose risk behaviors at months 3 and 6 (relative to baseline/study enrollment). Overdose risk behavior frequency will be assessed by participant self-report.
Outcome measures
| Measure |
iThrive WI Intervention
n=59 Participants
Participants will receive COVID-19 and overdose-related educational and motivational content over the course of 12 weeks through the Thrive4Life Connect, a mobile health application. They will be invited to set goals for lowering overdose and COVID-19 risk.
iThrive WI Intervention: Participants will receive COVID-19 and overdose-related educational and motivational content over the course of 12 weeks through the Thrive4Life Connect, a mobile health application. They will be invited to set goals for lowering overdose and COVID-19 risk.
|
Using Opioids or Stimulants While Alone
n=57 Participants
Average of the number of days opioids and stimulants were used while alone in the past 30 days.
|
Injection Drug Use and/or Speedballing
n=59 Participants
Average of the reported number of days of opioid injection, stimulant injection, opioid and stimulant use within a 6-hour time periods, and opioid and stimulant use at the same time within the past 30 days.
|
Opioid and Alcohol Use
n=60 Participants
Number of days that opioids and alcohol were used within a 6-hour time frame in the past 30 days.
|
Opioid and Benzodiazepine Use
n=58 Participants
Number of days that opioids and benzodiazepines were used within a 6-hour time frame in the past 30 days.
|
|---|---|---|---|---|---|
|
Number of Days in the Past Month Endorsing Overdose Risk Behaviors
baseline
|
2 days
Interval 0.0 to 10.0
|
5 days
Interval 0.0 to 15.0
|
14 days
Interval 9.0 to 23.0
|
0 days
Interval 0.0 to 1.0
|
0 days
Interval 0.0 to 0.0
|
|
Number of Days in the Past Month Endorsing Overdose Risk Behaviors
3 months
|
0 days
Interval 0.0 to 3.0
|
3 days
Interval 0.0 to 10.0
|
9 days
Interval 4.0 to 16.0
|
0 days
Interval 0.0 to 0.0
|
0 days
Interval 0.0 to 0.0
|
|
Number of Days in the Past Month Endorsing Overdose Risk Behaviors
6 months
|
0 days
Interval 0.0 to 7.0
|
1 days
Interval 0.0 to 7.0
|
5 days
Interval 1.0 to 16.0
|
0 days
Interval 0.0 to 0.0
|
0 days
Interval 0.0 to 0.0
|
SECONDARY outcome
Timeframe: baseline, 3 months, 6 monthsPopulation: Losses to follow-up occurred at months 3 and 6, resulting in a different subgroup of participants included in each time point.
Preliminary effectiveness will in part be assessed by measuring the proportion of participants vaccinated against COVID-19 at baseline and at months 3 and 6.
Outcome measures
| Measure |
iThrive WI Intervention
n=60 Participants
Participants will receive COVID-19 and overdose-related educational and motivational content over the course of 12 weeks through the Thrive4Life Connect, a mobile health application. They will be invited to set goals for lowering overdose and COVID-19 risk.
iThrive WI Intervention: Participants will receive COVID-19 and overdose-related educational and motivational content over the course of 12 weeks through the Thrive4Life Connect, a mobile health application. They will be invited to set goals for lowering overdose and COVID-19 risk.
|
Using Opioids or Stimulants While Alone
Average of the number of days opioids and stimulants were used while alone in the past 30 days.
|
Injection Drug Use and/or Speedballing
Average of the reported number of days of opioid injection, stimulant injection, opioid and stimulant use within a 6-hour time periods, and opioid and stimulant use at the same time within the past 30 days.
|
Opioid and Alcohol Use
Number of days that opioids and alcohol were used within a 6-hour time frame in the past 30 days.
|
Opioid and Benzodiazepine Use
Number of days that opioids and benzodiazepines were used within a 6-hour time frame in the past 30 days.
|
|---|---|---|---|---|---|
|
Change in COVID-19 Vaccination Rates From Baseline
baseline
|
30 Participants
|
—
|
—
|
—
|
—
|
|
Change in COVID-19 Vaccination Rates From Baseline
3 months
|
16 Participants
|
—
|
—
|
—
|
—
|
|
Change in COVID-19 Vaccination Rates From Baseline
6 months
|
17 Participants
|
—
|
—
|
—
|
—
|
Adverse Events
iThrive WI Intervention
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Dr. Rachel Gicquelais
University of Wisconsin - Madison
Phone: (608) 890-1837
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place