Trial Outcomes & Findings for mHealth for Patient Self-Management of Opioid Use Disorder (NCT NCT03633929)

Last Updated: 2023-04-25

Results Overview

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.

Recruitment status

COMPLETED

Target enrollment

19 participants

Primary outcome timeframe

Usability was assessed at end of the study, at 4 weeks

Results posted on

2023-04-25

Participant Flow

Study participants were recruited from private opioid recovery clinics. Recruitment began July 1, 2020 through August 13, 2020

Participants attended an online orientation on Zoom to learn how to access and use KIOS and participate in a training session.

Participant milestones

Participant milestones
Measure	KIOS OUD KIOS OUD: Study Participants will evaluate software known as KIOS-OUD
Overall Study STARTED	19
Overall Study COMPLETED	15
Overall Study NOT COMPLETED	4

Reasons for withdrawal

Reasons for withdrawal
Measure	KIOS OUD KIOS OUD: Study Participants will evaluate software known as KIOS-OUD
Overall Study Lost to Follow-up	1
Overall Study Did not login to software. Did not participate	3

Baseline Characteristics

mHealth for Patient Self-Management of Opioid Use Disorder

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Beta Test n=19 Participants All study participants used KIOS in a beta test to demonstrate feasibility of the software.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	19 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Sex: Female, Male Female	12 Participants n=5 Participants
Sex: Female, Male Male	7 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	8 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	11 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	2 Participants n=5 Participants
Race (NIH/OMB) Asian	1 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	1 Participants n=5 Participants
Race (NIH/OMB) White	13 Participants n=5 Participants
Race (NIH/OMB) More than one race	2 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment United States	19 participants n=5 Participants

PRIMARY outcome

Timeframe: Usability was assessed at end of the study, at 4 weeks

Outcome measures

Outcome measures
Measure	KIOS OUD n=15 Participants KIOS OUD: Study Participants will evaluate software known as KIOS-OUD
Usability Score	89.5 score on a scale Standard Error 9.2

SECONDARY outcome

Timeframe: 4 weeks

The total number of times opioid use was reported through the application pooled across all participants, self-reported in app.

Outcome measures

Outcome measures
Measure	KIOS OUD n=15 Participants KIOS OUD: Study Participants will evaluate software known as KIOS-OUD
Opioid Use	1 reported use of opioids

SECONDARY outcome

Timeframe: This instrument was administered at baseline and at the end of the study (4 weeks)

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.

Outcome measures

Outcome measures
Measure	KIOS OUD n=15 Participants KIOS OUD: Study Participants will evaluate software known as KIOS-OUD
Mean Change in Depression Score From Baseline	-1.00 scores on a scale Standard Deviation 5.06

SECONDARY outcome

Timeframe: This instrument was issued at baseline and at the end of study (4-weeks)

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.

Outcome measures

Outcome measures
Measure	KIOS OUD n=15 Participants KIOS OUD: Study Participants will evaluate software known as KIOS-OUD
Change in World Health Organization Quality of Life Assessment From Baseline Physical Domain	0.11 scores on a scale Standard Deviation 2.45
Change in World Health Organization Quality of Life Assessment From Baseline Psychological Domain	1.29 scores on a scale Standard Deviation 2.86
Change in World Health Organization Quality of Life Assessment From Baseline Social Domain	0.36 scores on a scale Standard Deviation 3.11
Change in World Health Organization Quality of Life Assessment From Baseline Environment Domain	0.67 scores on a scale Standard Deviation 2.87

SECONDARY outcome

Timeframe: baseline 4-weeks

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.

Outcome measures

Outcome measures
Measure	KIOS OUD n=15 Participants KIOS OUD: Study Participants will evaluate software known as KIOS-OUD
Mean Change on Patient-entered Data From KIOS App Craving	-1.01 score on a scale Standard Deviation 1.55
Mean Change on Patient-entered Data From KIOS App Depressed Mood	-1.20 score on a scale Standard Deviation 1.76
Mean Change on Patient-entered Data From KIOS App Anxiety	-1.48 score on a scale Standard Deviation 1.63
Mean Change on Patient-entered Data From KIOS App Absenteeism	-1.05 score on a scale Standard Deviation 1.72
Mean Change on Patient-entered Data From KIOS App Difficulty with usual activities	-1.08 score on a scale Standard Deviation 1.25
Mean Change on Patient-entered Data From KIOS App Conflicts with Others	-1.30 score on a scale Standard Deviation 1.83
Mean Change on Patient-entered Data From KIOS App Irritability	-1.57 score on a scale Standard Deviation 1.69
Mean Change on Patient-entered Data From KIOS App Difficulty Sleeping	-1.33 score on a scale Standard Deviation 1.91
Mean Change on Patient-entered Data From KIOS App Restlessness/Agitation	-1.47 score on a scale Standard Deviation 1.72
Mean Change on Patient-entered Data From KIOS App Pain	-0.47 score on a scale Standard Deviation 1.60

Adverse Events

KIOS OUD

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Gregg Siegel

Biomedical Development Corporation

Phone: 2108638053

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place