Smartphone Intervention for Overdose and COVID-19

NCT05518461 | Completed Results

• 5 other identifiers: 2022-0956A545000Protocol Version 7/29/2022UG3DA044826-01NUR/FACULTY AFFAIRS/ADMIN
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

This study will examine if the use of a smartphone application called Thrive4Life Connect can help people who use drugs lower their risk of overdose and learn more about COVID-19 vaccines. 60 participants will be enrolled and can expect to be on study for up to 6 months.

Conditions

Substance Use Disorders; Overdose; COVID-19

Outcome Measures

Primary Outcomes (1)

• Content Completion Rate Assessed as Number of Participants Who Completed at Least 6 of the 12 Weeks of the Intervention

  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.

  up to 12 weeks

Secondary Outcomes (2)

• Number of Days in the Past Month Endorsing Overdose Risk Behaviors

  baseline, 3 months, 6 months

• Change in COVID-19 Vaccination Rates From Baseline

  baseline, 3 months, 6 months

Study Arms (1)

iThrive WI Intervention

EXPERIMENTAL

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.

Device: iThrive WI Intervention

Interventions

iThrive WI Intervention DEVICE

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• years old or older
• Willing to attend in person study encounters at any of the following Vivent Health locations: Milwaukee, Appleton, and Eau Claire
• Used opioids to get high in the past 30 days
• Injected drugs at least 2 times in the past 7 days
• Express interest in reducing their overdose risk

Sponsors & Collaborators

• University of Wisconsin, Madison: lead
• National Institute on Drug Abuse (NIDA): collaborator

Study Sites (1)

University of Wisconsin

Madison, Wisconsin, 53726, United States

Location

MeSH Terms

Conditions

Substance-Related Disorders; Drug Overdose; COVID-19

Condition Hierarchy (Ancestors)

Chemically-Induced Disorders; Mental Disorders; Prescription Drug Misuse; Drug Misuse; Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Results Point of Contact

• Title: Dr. Rachel Gicquelais
• Organization: University of Wisconsin - Madison

gicquelais@wisc.edu

(608) 890-1837

Study Officials

• Rachel E Gicquelais, PhD, MPH

  University of Wisconsin, Madison

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Preliminary outcomes will be measured from 60 participants at baseline (pre-test), followed by a 12-week intervention through the Thrive4Life Connect smartphone application, and re-assessment of outcomes at months 3 and 6.

Study Record Dates

• First Submitted: August 25, 2022
• First Posted: August 26, 2022
• Study Start: December 19, 2022
• Primary Completion: December 15, 2023
• Study Completion: December 15, 2023
• Last Updated: December 5, 2024
• Results First Posted: December 5, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)