Informational App Development for mHealth for Patient Self-Management of Opioid Use Disorder (KIOS-I)

This study will evaluate the feasibility of an app that provides drug information to people in recovery from opioid use disorder. This study is designed to test the prototype app, not to determine health outcomes. The study will confirm the design and operating specifications prior to being evaluated in a larger clinical trial.

Study Overview

• Status: Active, not recruiting
• Conditions: Opioid-Related Disorders
• Intervention / Treatment: Device: KIOS Informational App

Detailed Description

The overall study is designed in two steps: 1) a one-week proof-of-concept study; and 2) a one-month pilot study.

Step 1: A one-week proof-of-concept study will be performed in a small population (n=5) of individuals in opioid use disorder recovery as an indicator of the app's suitability. Study participants will use the sham app for one week and will then complete a usability and user satisfaction survey. If the app is found to be exhibit acceptable usability and satisfaction, a one month study will be completed in a larger sample (see Step 2, below). If not, modifications to the app will be made and the one-week study will be repeated in a new group of participants.

Step 2: After completion of the proof-of-concept study, 20 new participants will be enrolled in a 4-week trial. Study participants will complete baseline assessments and then be asked to use the app at least three times per week, for four weeks. At the end of four weeks, participants will complete usability and user satisfaction surveys.

• Study Type: Interventional
• Enrollment (Actual): 25
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Texas
    • San Antonio, Texas, United States, 78229
      • UT Health San Antonio

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Male or female outpatients 18 years of age or older
• Currently enrolled in an opioid treatment program and receiving medication assisted treatment for opioid use disorder
• Currently stable in opioid use disorder outpatient treatment for 4 weeks or longer
• Ability to access the app via smart phone, or tablet.

Exclusion Criteria:

• Unwilling or unable to comply with study requirements
• Have a psychiatric or medical disorder interfering with ability to use the app
• Incarcerated
• Pregnant

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: KIOS Informational App evaluation; Study participants will use the app at least three times per week. The app will contain a user interface that includes a login page, true/false questions for the user to answer, verified public domain educational information about drug and alcohol use, Likert-type questions regarding the information presented, and a closing "Thank You" screen.	Device: KIOS Informational App; The KIOS informational app will contain a user interface that includes a login page, true/false questions for the user to answer, verified public domain educational information about drug and alcohol use, Likert-type questions regarding the information presented, and a closing "Thank You" screen.; Other Names: KIOS-I

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Usability Score	The Systems Usability Scale-Modified is a non-health outcome, single-factor, 10-item self-report scale commonly used to evaluate participants' subjective experience using 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.	The Systems Usability Scale will be administered at the end of one-week for participants enrolled in Step 1 of the study and at the end of four-weeks for participants enrolled in Step 2.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
User Satisfaction	A user satisfaction survey will be administered to evaluate the study participants' overall satisfaction with the app. This is a non-health outcome designed to better understand the user's perception of the app. The survey will consist of 20 statements that users will rate on a 1-7 Likert type scale (1=Disagree, 7= Agree). Satisfaction scores will be averaged and converted to percentages with higher percentages representing better user satisfaction with the app.	A user satisfaction survey will be administered at the end of one-week for participants enrolled in Step 1 of the study and at the end of four-weeks for participants enrolled in Step 2.

Collaborators and Investigators

• Sponsor: Biomedical Development Corporation
• Collaborators: National Institute on Drug Abuse (NIDA); The University of Texas Health Science Center at San Antonio
• Investigators: Principal Investigator: Jennifer Potter, Ph.D., UT Health San Antonio

Study record dates

Study Major Dates

• Study Start (Actual): June 29, 2023
• Primary Completion (Estimated): January 10, 2024
• Study Completion (Estimated): January 10, 2024

Study Registration Dates

• First Submitted: April 13, 2023
• First Submitted That Met QC Criteria: May 11, 2023
• First Posted (Actual): May 15, 2023

Study Record Updates

• Last Update Posted (Actual): December 18, 2023
• Last Update Submitted That Met QC Criteria: December 15, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Chemically-Induced Disorders; Substance-Related Disorders; Narcotic-Related Disorders; Opioid-Related Disorders
• Other Study ID Numbers: 23-0232H; R42DA054881 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No