mHealth for Patient Self-Management of Opioid Use Disorder

Opioid-use Disorder Clinical Trial

Official title:

mHealth for Patient Self-Management of Opioid Use Disorder

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03633929
• Other study ID #: 2018-1-100-OUD
• Status: Completed
• Start date: July 8, 2020
• Est. completion date: September 30, 2020

Study information

• Verified date: April 2023
• Source: Biomedical Development Corporation
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 19
• Est. completion date: September 30, 2020
• Est. primary completion date: September 30, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. male or female outpatients 18 years of age or older;

2. opioid use disorder as assessed by MINI 6.0;

3. currently stable in OUD outpatient treatment for 4 weeks or longer; and

4. ability to access KIOS-OUD via computer, smartphone, or tablet.

Exclusion Criteria:

1. are unwilling or unable to comply with study requirements;

2. have a major untreated psychiatric illness (e.g., schizophrenia, bipolar disorder) or suicidality.

Related Conditions & MeSH terms

• Opioid-Related Disorders
• Opioid-use Disorder
• Substance-Related Disorders

Intervention

Other:
• KIOS OUD
Study Participants will evaluate software known as KIOS-OUD

Locations

Country	Name	City	State
United States	Biomedical Development Corporation	San Antonio	Texas
United States	Community Medical Services	San Antonio	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Biomedical Development Corporation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Opioid Use	The total number of times opioid use was reported through the application pooled across all participants, self-reported in app.	4 weeks
Secondary	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)
Secondary	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)
Secondary	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