NCT05859035

Informational App Development for mHealth for Patient Self-Management of Opioid Use Disorder

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 25 (actual)
• Sponsor: Biomedical Development Corporation · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

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.

Conditions

• Opioid-Related Disorders

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2023-06-29
• Primary completion: 2024-01-10
• Completion: 2024-01-10
• First posted: 2023-05-15
• Last updated: 2023-12-18

Locations

1 site across 1 country: United States