- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03633929
mHealth for Patient Self-Management of Opioid Use Disorder
April 21, 2023 updated by: Biomedical Development Corporation
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.
Study Overview
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 Type
Observational
Enrollment (Actual)
19
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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Texas
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San Antonio, Texas, United States, 78212
- Biomedical Development Corporation
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San Antonio, Texas, United States, 78216
- Community Medical Services
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Sampling Method
Probability Sample
Study Population
Twenty individuals diagnosed with opioid use disorder
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- are unwilling or unable to comply with study requirements;
- have a major untreated psychiatric illness (e.g., schizophrenia, bipolar disorder) or suicidality.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
KIOS OUD
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Study Participants will evaluate software known as KIOS-OUD
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Usability Score
Time Frame: Usability was assessed at end of the study, at 4 weeks
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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.
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Usability was assessed at end of the study, at 4 weeks
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Opioid Use
Time Frame: 4 weeks
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The total number of times opioid use was reported through the application pooled across all participants, self-reported in app.
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4 weeks
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Mean Change on Patient-entered Data From KIOS App
Time Frame: baseline 4-weeks
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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.
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baseline 4-weeks
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Mean Change in Depression Score From Baseline
Time Frame: This instrument was administered at baseline and at the end of the study (4 weeks)
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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.
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This instrument was administered at baseline and at the end of the study (4 weeks)
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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)
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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.
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This instrument was issued at baseline and at the end of study (4-weeks)
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Karla Ramirez, LCSW, Consultant
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
July 8, 2020
Primary Completion (Actual)
September 30, 2020
Study Completion (Actual)
September 30, 2020
Study Registration Dates
First Submitted
August 13, 2018
First Submitted That Met QC Criteria
August 15, 2018
First Posted (Actual)
August 16, 2018
Study Record Updates
Last Update Posted (Actual)
April 25, 2023
Last Update Submitted That Met QC Criteria
April 21, 2023
Last Verified
April 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2018-1-100-OUD
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
YES
IPD Plan Description
We will share data according to NIMH expectations
IPD Sharing Time Frame
within 6 months of study completing
IPD Sharing Supporting Information Type
- ANALYTIC_CODE
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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