Opioid-use DisorderNCT03633929
mHealth for Patient Self-Management of Opioid Use Disorder
An observational study of Opioid-use Disorder, run by Biomedical Development Corporation at 2 sites in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Opioid-use Disorder
- What is being tested?
- KIOS OUD
- How many people
- 19 participants
- Where
- 2 sitesUnited States
- Study dates
- 8 Jul 2020to 30 Sep 2020
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Twenty individuals diagnosed with opioid use disorder
Who may be able to join
- 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.
Who cannot join
- are unwilling or unable to comply with study requirements;
- have a major untreated psychiatric illness (e.g., schizophrenia, bipolar disorder) or suicidality.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Biomedical Development Corporation
San Antonio, Texas, 78212
Community Medical Services
San Antonio, Texas, 78216
About this study
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.
Read the 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.
- Conditions
- Opioid-use Disorder
- Being tested
- KIOS OUD
- Medical subject headings
- Opioid-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
KIOS OUDOther
Study Participants will evaluate software known as KIOS-OUD
| Study group | Role | What they receive |
|---|---|---|
| KIOS OUD | Not described Receives: Other: KIOS OUD |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Usability was assessed at end of the study, at 4 weeks
Secondary outcomes (4)
Opioid Use
The total number of times opioid use was reported through the application pooled across all participants, self-reported in app.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: baseline 4-weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Aug 2018
- Study start8 Jul 2020
- Primary completion30 Sep 2020
- Study completion30 Sep 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Opioid-use DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- Biomedical Development Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Karla Ramirez, LCSW, Principal investigator, Consultant
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03633929
- Sponsor's protocol ID
- 2018-1-100-OUD
- Status last verified
- Apr 2023
- First submitted
- 13 Aug 2018
- Last updated
- 25 Apr 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: We will share data according to NIMH expectations
Study at a glance
From the registry record, last updated by the sponsor on 25 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- mHealth for Patient Self-Management of Opioid Use Disorder
- ClinicalTrials.gov ID
- NCT03633929
- Acronym / sponsor ID
- 2018-1-100-OUD
- Conditions
- Opioid-use Disorder
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 19 participants (actual)
- Lead sponsor
- Biomedical Development CorporationIndustry (pharma, biotech, devices)
- Study start
- 8 Jul 2020 (actual)
- Primary completion
- 30 Sep 2020 (actual)
- Study completion
- 30 Sep 2020 (actual)
- First posted
- 16 Aug 2018 (actual)
- Results
- Posted 25 May 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| KIOS OUD | – | Other: KIOS OUD |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Twenty individuals diagnosed with opioid use disorder
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (2 listed)
- are unwilling or unable to comply with study requirements;
- have a major untreated psychiatric illness (e.g., schizophrenia, bipolar disorder) or suicidality.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| KIOS OUDStudy Participants will evaluate software known as KIOS-OUD | Other | KIOS OUD |
Primary outcome
Usability Score
Time frame: 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.
4 secondary outcomes
Opioid Use
Time frame: 4 weeks
Mean Change in Depression Score From Baseline
Time frame: 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
Time frame: This instrument was issued at baseline and at the end of study (4-weeks)
Mean Change on Patient-entered Data From KIOS App
Time frame: baseline 4-weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Apr 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Yes. We will share data according to NIMH expectations
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Karla Ramirez, LCSW principal investigator
Consultant
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Opioid-use Disorder, run by Biomedical Development Corporation at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 25 May 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Usability Score (time frame: Usability was assessed at end of the study, at 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Apr 2023.