NCT05859035

Brief Summary

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
25

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jun 2023

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 13, 2023

Completed
1 month until next milestone

First Posted

Study publicly available on registry

May 15, 2023

Completed
2 months until next milestone

Study Start

First participant enrolled

June 29, 2023

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 10, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 10, 2024

Completed
Last Updated

December 18, 2023

Status Verified

December 1, 2023

Enrollment Period

7 months

First QC Date

April 13, 2023

Last Update Submit

December 15, 2023

Conditions

Opioid-Related Disorders

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • User Satisfaction

    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.

Study Arms (1)

KIOS Informational App evaluation

EXPERIMENTAL

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

Interventions

KIOS Informational AppDEVICE

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.

Also known as: KIOS-I
KIOS Informational App evaluation

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UT Health San Antonio

San Antonio, Texas, 78229, United States

Location

MeSH Terms

Conditions

Opioid-Related Disorders

Condition Hierarchy (Ancestors)

Narcotic-Related DisordersSubstance-Related DisordersChemically-Induced DisordersMental Disorders

Study Officials

  • Jennifer Potter, Ph.D.

    UT Health San Antonio

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

April 13, 2023

First Posted

May 15, 2023

Study Start

June 29, 2023

Primary Completion

January 10, 2024

Study Completion

January 10, 2024

Last Updated

December 18, 2023

Record last verified: 2023-12

Data Sharing

IPD Sharing
Will not share

Locations

US(1)