mHealth for Patient Self-Management of Opioid Use Disorder

Study Overview
=================
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.

Detailed Description
-----------------
Participants will be enrolled in a 4-week single group pre-post evaluation. All participants will attend a two hour orientation to complete baseline assessments, learn how to access and use the software, and participate in a training session. Study participants will be asked to complete assessments online at least three times per week, but no more than once daily. The software may still be accessed by participants as many times as desired to review advice and graphs. After the four week evaluation phase, participants will return for a two hour debriefing and completion of assessment surveys. This approach permits users to be adequately trained while also evaluating the software within their typical environment rather than in a lab setting.

Official Title
-----------------
mHealth for Patient Self-Management of Opioid Use Disorder

Conditions
-----------------
Opioid-use Disorder

Intervention / Treatment
-----------------
* Other: KIOS OUD


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 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. Exclusion Criteria: are unwilling or unable to comply with study requirements; have a major untreated psychiatric illness (e.g., schizophrenia, bipolar disorder) or suicidality.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| KIOS OUD<br> | Other: KIOS OUD<br>* Study Participants will evaluate software known as KIOS-OUD<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Opioid Use | The total number of times opioid use was reported through the application pooled across all participants, self-reported in app. | 4 weeks | 
| Mean Change in Depression Score From Baseline | The Patient Health Questionnaire will be used to measure depression. This instrument is a nine question survey regarding depression in which patients answer on a 4 point scale (Not at all, Several days, More than half the days, or Nearly every day). A 0-3 number is applied to each answer and multiplied by the number of answers (9), and then summed. Scores range from 0-27 with higher scores indicative of greater depression severity. | 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 | The World Health Organization Quality of Life Assessment - Brief version will be used to measure quality of life pre and post study. This instrument is an abbreviated generic Quality of Life Scale developed through the World Health Organization. This is a self-administered questionnaire comprising 26 questions on the individual's perceptions of their health and well-being over the previous two weeks. Responses to questions are on a 1-5 Likert scale where 1 represents disagree or not at all and 5 represents completely agree or extremely. The instrument covers four domains each with specific facets: Physical Health, Psychological, Social Relationships, and Environment. The domain scores are reported individually. The total range for each domain score is from 4 - 20. Higher values represent a better outcome. | This instrument was issued at baseline and at the end of study (4-weeks) | 
| Mean Change on Patient-entered Data From KIOS App | Patients self-reported in the KIOS app on their craving, depressed mood, anxiety, irritability, absenteeism, conflicts with others, difficulty completing usual activities, difficulty sleeping, restlessness/agitation, and pain. All assessments were made in app on 0-6 visual analog scale with higher scores representing a worse outcome. Results are reported as mean change from baseline to the averages of individual assessment values taken during the final week of the study. | baseline 4-weeks |