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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| KIOS OUD |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| KIOS OUD | Other | Study Participants will evaluate software known as KIOS-OUD |
|
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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Twenty individuals diagnosed with opioid use disorder
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| Name | Affiliation | Role |
|---|---|---|
| Karla Ramirez, LCSW | Consultant | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Biomedical Development Corporation | San Antonio | Texas | 78212 | United States | ||
| Community Medical Services |
We will share data according to NIMH expectations
within 6 months of study completing
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Participants attended an online orientation on Zoom to learn how to access and use KIOS and participate in a training session.
Study participants were recruited from private opioid recovery clinics. Recruitment began July 1, 2020 through August 13, 2020
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| ID | Title | Description |
|---|---|---|
| FG000 | KIOS OUD | KIOS OUD: Study Participants will evaluate software known as KIOS-OUD |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Beta Test | All study participants used KIOS in a beta test to demonstrate feasibility of the software. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Posted | Mean | Standard Error | score on a scale | Usability was assessed at end of the study, at 4 weeks |
|
4 weeks
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | KIOS OUD | KIOS OUD: Study Participants will evaluate software known as KIOS-OUD |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Gregg Siegel | Biomedical Development Corporation | 2108638053 | gsiegel@biodevcorp.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | May 14, 2020 | Mar 16, 2021 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | May 14, 2020 | Mar 16, 2021 | SAP_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | May 14, 2020 | Jan 15, 2021 | ICF_002.pdf |
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| ID | Term |
|---|---|
| D009293 | Opioid-Related Disorders |
| ID | Term |
|---|---|
| D000079524 | Narcotic-Related Disorders |
| D019966 | Substance-Related Disorders |
| D064419 | Chemically-Induced Disorders |
| D001523 | Mental Disorders |
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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 |
| San Antonio |
| Texas |
| 78216 |
| United States |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Units |
|---|
| Counts |
|---|
| Participants |
|
|
| Secondary | Opioid Use | The total number of times opioid use was reported through the application pooled across all participants, self-reported in app. | Posted | Number | reported use of opioids | 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. | Posted | Mean | Standard Deviation | scores on a scale | 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. | Posted | Mean | Standard Deviation | scores on a scale | 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. | Posted | Mean | Standard Deviation | score on a scale | baseline 4-weeks |
|
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| 0 |
| 19 |
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| 19 |
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| 19 |
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| Title | Measurements |
|---|---|
|
| Environment Domain |
|
| Title | Measurements |
|---|---|
|
| Absenteeism |
|
| Difficulty with usual activities |
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| Conflicts with Others |
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| Irritability |
|
| Difficulty Sleeping |
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| Restlessness/Agitation |
|
| Pain |
|