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

Biomedical Development Corporation

Status: Active, not recruiting

Conditions: Opioid-Related Disorders

Treatments: Device: KIOS Informational App

Study type: Interventional

Funder types: Other; Industry; NIH

Identifiers

NCT05859035

R42DA054881 (U.S. NIH Grant/Contract)

23-0232H

Details and patient eligibility

About

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.

Full 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.

Enrollment: 25 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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25 participants in 1 patient group

KIOS Informational App evaluation

Experimental group

Description:

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.

Treatment:

Device: KIOS Informational App