Opioid-use Disorder
Conditions
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.
Interventions
OTHERKIOS OUD
Study Participants will evaluate software known as KIOS-OUD
Sponsors
Biomedical Development Corporation
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Usability Score | Usability was assessed at end of the study, at 4 weeks | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Opioid Use | 4 weeks | The total number of times opioid use was reported through the application pooled across all participants, self-reported in app. |
| Mean Change in Depression Score From Baseline | 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. |
| Change in World Health Organization Quality of Life Assessment From Baseline | 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. |
| Mean Change on Patient-entered Data From KIOS App | 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. |
Countries
United States
Participant flow
Recruitment details
Study participants were recruited from private opioid recovery clinics. Recruitment began July 1, 2020 through August 13, 2020
Pre-assignment details
Participants attended an online orientation on Zoom to learn how to access and use KIOS and participate in a training session.
Participants by arm
| Arm | Count |
|---|---|
| Beta Test All study participants used KIOS in a beta test to demonstrate feasibility of the software. | 19 |
| Total | 19 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Did not login to software. Did not participate | 3 |
| Overall Study | Lost to Follow-up | 1 |
Baseline characteristics
| Characteristic | Beta Test |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 19 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 8 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 11 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 2 Participants |
| Race (NIH/OMB) Asian | 1 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants |
| Race (NIH/OMB) More than one race | 2 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 13 Participants |
| Region of Enrollment United States | 19 participants |
| Sex: Female, Male Female | 12 Participants |
| Sex: Female, Male Male | 7 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 19 |
| other Total, other adverse events | 0 / 19 |
| serious Total, serious adverse events | 0 / 19 |
Outcome results
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.
Time frame: Usability was assessed at end of the study, at 4 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| KIOS OUD | Usability Score | 89.5 score on a scale | Standard Error 9.2 |
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.
Time frame: This instrument was issued at baseline and at the end of study (4-weeks)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| 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 |
| KIOS OUD | Change in World Health Organization Quality of Life Assessment From Baseline | Psychological Domain | 1.29 scores on a scale | Standard Deviation 2.86 |
| KIOS OUD | Change in World Health Organization Quality of Life Assessment From Baseline | Social Domain | 0.36 scores on a scale | Standard Deviation 3.11 |
| KIOS OUD | Change in World Health Organization Quality of Life Assessment From Baseline | Environment Domain | 0.67 scores on a scale | Standard Deviation 2.87 |
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.
Time frame: This instrument was administered at baseline and at the end of the study (4 weeks)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| KIOS OUD | Mean Change in Depression Score From Baseline | -1.00 scores on a scale | Standard Deviation 5.06 |
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.
Time frame: baseline 4-weeks
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| KIOS OUD | Mean Change on Patient-entered Data From KIOS App | Craving | -1.01 score on a scale | Standard Deviation 1.55 |
| KIOS OUD | Mean Change on Patient-entered Data From KIOS App | Depressed Mood | -1.20 score on a scale | Standard Deviation 1.76 |
| KIOS OUD | Mean Change on Patient-entered Data From KIOS App | Anxiety | -1.48 score on a scale | Standard Deviation 1.63 |
| KIOS OUD | Mean Change on Patient-entered Data From KIOS App | Absenteeism | -1.05 score on a scale | Standard Deviation 1.72 |
| KIOS OUD | Mean Change on Patient-entered Data From KIOS App | Difficulty with usual activities | -1.08 score on a scale | Standard Deviation 1.25 |
| KIOS OUD | Mean Change on Patient-entered Data From KIOS App | Conflicts with Others | -1.30 score on a scale | Standard Deviation 1.83 |
| KIOS OUD | Mean Change on Patient-entered Data From KIOS App | Irritability | -1.57 score on a scale | Standard Deviation 1.69 |
| KIOS OUD | Mean Change on Patient-entered Data From KIOS App | Difficulty Sleeping | -1.33 score on a scale | Standard Deviation 1.91 |
| KIOS OUD | Mean Change on Patient-entered Data From KIOS App | Restlessness/Agitation | -1.47 score on a scale | Standard Deviation 1.72 |
| KIOS OUD | Mean Change on Patient-entered Data From KIOS App | Pain | -0.47 score on a scale | Standard Deviation 1.6 |
Secondary
Opioid Use
The total number of times opioid use was reported through the application pooled across all participants, self-reported in app.
Time frame: 4 weeks
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| KIOS OUD | Opioid Use | 1 reported use of opioids |