mHealth for Patient Self-Management of Opioid Use Disorder

NCT03633929 | Completed Results

• 1 other identifier: 2018-1-100-OUD
• Study Type: observational
• Target: 19
• Locations: 1 country
• Sites: 2

Brief Summary

Twenty individuals diagnosed with opioid use disorder (OUD) will be recruited to participate in a beta test to demonstrate feasibility of using an online tool to help them better self-manage their recovery.

Conditions

Opioid-use Disorder

Outcome Measures

Primary Outcomes (1)

• Usability Score

  The Systems Usability Scale-Modified, a single-factor, 10-item self-report scale was used to evaluate participants' subjective experience using the software. Systems Usability Scale yields a single number representing a composite measure of the overall usability of the system being studied. Systems Usability Scale scores have a range of 0 to 100, with higher scores representing a better outcome. Systems in early development may expect to have a rating of 30, while more mature systems should rate between 60 - 80.

  Usability was assessed at end of the study, at 4 weeks

Secondary Outcomes (4)

• Opioid Use

  4 weeks

• Mean Change in Depression Score From Baseline

  This instrument was administered at baseline and at the end of the study (4 weeks)

• Change in World Health Organization Quality of Life Assessment From Baseline

  This instrument was issued at baseline and at the end of study (4-weeks)

• Mean Change on Patient-entered Data From KIOS App

  baseline 4-weeks

Study Arms (1)

KIOS OUD

Other: KIOS OUD

Interventions

KIOS OUD OTHER

Study Participants will evaluate software known as KIOS-OUD

KIOS OUD

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Twenty individuals diagnosed with opioid use disorder

You may qualify if:

• male or female outpatients 18 years of age or older;
• opioid use disorder as assessed by MINI 6.0;
• currently stable in OUD outpatient treatment for 4 weeks or longer; and
• ability to access KIOS-OUD via computer, smartphone, or tablet.

You may not qualify if:

• are unwilling or unable to comply with study requirements;
• have a major untreated psychiatric illness (e.g., schizophrenia, bipolar disorder) or suicidality.

Sponsors & Collaborators

• Biomedical Development Corporation: lead

Study Sites (2)

Biomedical Development Corporation

San Antonio, Texas, 78212, United States

Location

Community Medical Services

San Antonio, Texas, 78216, United States

Location

MeSH Terms

Conditions

Opioid-Related Disorders

Condition Hierarchy (Ancestors)

Narcotic-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Results Point of Contact

• Title: Gregg Siegel
• Organization: Biomedical Development Corporation

gsiegel@biodevcorp.com

2108638053

Study Officials

• Karla Ramirez, LCSW

  Consultant

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 13, 2018
• First Posted: August 16, 2018
• Study Start: July 8, 2020
• Primary Completion: September 30, 2020
• Study Completion: September 30, 2020
• Last Updated: April 25, 2023
• Results First Posted: May 25, 2021

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: ANALYTIC CODE
• Time Frame: within 6 months of study completing

Locations

US (2)