Opioid-Related DisordersKIOS-INCT05859035
Informational App Development for mHealth for Patient Self-Management of Opioid Use Disorder
A study testing KIOS Informational App in people with Opioid-Related Disorders, run by Biomedical Development Corporation at 1 site in United States.
Trial summary
This study will evaluate the feasibility of an app that provides drug information to people in recovery from opioid use disorder. This study is designed to test the prototype app, not to determine health outcomes. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Opioid-Related Disorders
- What is being tested?
- KIOS Informational App
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteUnited States
- Study dates
- 29 Jun 2023to 10 Jan 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
Who may be able to join
- Male or female outpatients 18 years of age or older
- Currently enrolled in an opioid treatment program and receiving medication assisted treatment for opioid use disorder
- Currently stable in opioid use disorder outpatient treatment for 4 weeks or longer
- Ability to access the app via smart phone, or tablet.
Who cannot join
- Unwilling or unable to comply with study requirements
- Have a psychiatric or medical disorder interfering with ability to use the app
- Incarcerated
- Pregnant
Trial locations and contacts
1 site in 1 country.
About this study
This study will evaluate the feasibility of an app that provides drug information to people in recovery from opioid use disorder. This study is designed to test the prototype app, not to determine health outcomes. The study will confirm the design and operating specifications prior to being evaluated in a larger clinical trial.
Read the detailed description
The overall study is designed in two steps: 1) a one-week proof-of-concept study; and 2) a one-month pilot study.
Step 1: A one-week proof-of-concept study will be performed in a small population (n=5) of individuals in opioid use disorder recovery as an indicator of the app's suitability. Study participants will use the sham app for one week and will then complete a usability and user satisfaction survey. If the app is found to be exhibit acceptable usability and satisfaction, a one month study will be completed in a larger sample (see Step 2, below). If not, modifications to the app will be made and the one-week study will be repeated in a new group of participants.
Step 2: After completion of the proof-of-concept study, 20 new participants will be enrolled in a 4-week trial. Study participants will complete baseline assessments and then be asked to use the app at least three times per week, for four weeks. At the end of four weeks, participants will complete usability and user satisfaction surveys.
- Conditions
- Opioid-Related Disorders
- Being tested
- KIOS Informational App
- 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 Informational AppDevice
Also called KIOS-I
The KIOS informational app will contain a user interface that includes a login page, true/false questions for the user to answer, verified public domain educational information about drug and alcohol use, Likert-type questions regarding the information presented, and a closing "Thank You" screen.
| Study group | Role | What they receive |
|---|---|---|
| KIOS Informational App evaluation | Experimental | Study participants will use the app at least three times per week. The app will contain a user interface that includes a login page, true/false questions for the user to answer, verified public domain educational information about drug and alcohol use, Likert-type questions regarding the information presented, and a closing "Thank You" screen. Receives: Device: KIOS Informational App |
What is being measured
The primary outcome is the main question the study is designed to answer.
Usability Score
The Systems Usability Scale-Modified is a non-health outcome, single-factor, 10-item self-report scale commonly used to evaluate participants' subjective experience using 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: The Systems Usability Scale will be administered at the end of one-week for participants enrolled in Step 1 of the study and at the end of four-weeks for participants enrolled in Step 2.
Secondary outcomes (1)
User Satisfaction
A user satisfaction survey will be administered to evaluate the study participants' overall satisfaction with the app. This is a non-health outcome designed to better understand the user's perception of the app. The survey will consist of 20 statements that users will rate on a 1-7 Likert type scale (1=Disagree, 7= Agree). Satisfaction scores will be averaged and converted to percentages with higher percentages representing better user satisfaction with the app.
Measured: A user satisfaction survey will be administered at the end of one-week for participants enrolled in Step 1 of the study and at the end of four-weeks for participants enrolled in Step 2.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 May 2023
- Study start29 Jun 2023
- Primary completion10 Jan 2024 (estimated)
- Study completion10 Jan 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Opioid-Related DisordersStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Biomedical Development Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- The University of Texas Health Science Center at San Antonio, National Institute on Drug Abuse (NIDA)
- Responsible party
- Sponsor
- Investigators
- Jennifer Potter, Ph.D., Principal investigator, The University of Texas Health Science Center at San Antonio
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05859035
- Sponsor's protocol ID
- 23-0232H
- Other IDs
- R42DA054881
- Acronym
- KIOS-I
- Status last verified
- Dec 2023
- First submitted
- 13 Apr 2023
- Last updated
- 18 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Informational App Development for mHealth for Patient Self-Management of Opioid Use Disorder
- ClinicalTrials.gov ID
- NCT05859035
- Acronym / sponsor ID
- KIOS-I / 23-0232H
- Conditions
- Opioid-Related Disorders
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Biomedical Development CorporationIndustry (pharma, biotech, devices)
- Collaborators
- The University of Texas Health Science Center at San Antonio, National Institute on Drug Abuse (NIDA)
- Study start
- 29 Jun 2023 (actual)
- Primary completion
- 10 Jan 2024 (estimated)
- Study completion
- 10 Jan 2024 (estimated)
- First posted
- 15 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will evaluate the feasibility of an app that provides drug information to people in recovery from opioid use disorder. This study is designed to test the prototype app, not to determine health outcomes. The study will confirm the design and operating specifications prior to being evaluated in a larger clinical trial.
Detailed description
The overall study is designed in two steps: 1) a one-week proof-of-concept study; and 2) a one-month pilot study.
Step 1: A one-week proof-of-concept study will be performed in a small population (n=5) of individuals in opioid use disorder recovery as an indicator of the app's suitability. Study participants will use the sham app for one week and will then complete a usability and user satisfaction survey. If the app is found to be exhibit acceptable usability and satisfaction, a one month study will be completed in a larger sample (see Step 2, below). If not, modifications to the app will be made and the one-week study will be repeated in a new group of participants.
Step 2: After completion of the proof-of-concept study, 20 new participants will be enrolled in a 4-week trial. Study participants will complete baseline assessments and then be asked to use the app at least three times per week, for four weeks. At the end of four weeks, participants will complete usability and user satisfaction surveys.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| KIOS Informational App evaluation | Experimental | Device: KIOS Informational AppStudy participants will use the app at least three times per week. The app will contain a user interface that includes a login page, true/false questions for the user to answer, verified public domain educational information about drug and alcohol use, Likert-type questions regarding the information presented, and a closing "Thank You" screen. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Male or female outpatients 18 years of age or older
- Currently enrolled in an opioid treatment program and receiving medication assisted treatment for opioid use disorder
- Currently stable in opioid use disorder outpatient treatment for 4 weeks or longer
- Ability to access the app via smart phone, or tablet.
Key exclusion criteria (4 listed)
- Unwilling or unable to comply with study requirements
- Have a psychiatric or medical disorder interfering with ability to use the app
- Incarcerated
- Pregnant
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 Informational AppAlso: KIOS-IThe KIOS informational app will contain a user interface that includes a login page, true/false questions for the user to answer, verified public domain educational information about drug and alcohol use, Likert-type questions regarding the information presented, and a closing "Thank You" screen. | Device | KIOS Informational App evaluation |
Primary outcome
Usability Score
Time frame: The Systems Usability Scale will be administered at the end of one-week for participants enrolled in Step 1 of the study and at the end of four-weeks for participants enrolled in Step 2.
The Systems Usability Scale-Modified is a non-health outcome, single-factor, 10-item self-report scale commonly used to evaluate participants' subjective experience using 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.
1 secondary outcome
User Satisfaction
Time frame: A user satisfaction survey will be administered at the end of one-week for participants enrolled in Step 1 of the study and at the end of four-weeks for participants enrolled in Step 2.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Dec 2023.
- Individual participant dataSharing planned: No
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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.
Jennifer Potter, Ph.D. principal investigator
The University of Texas Health Science Center at San Antonio
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing KIOS Informational App in people with Opioid-Related Disorders, run by Biomedical Development Corporation at 1 site 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 4 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: status not confirmed, as of the sponsor's last update on 18 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Results are not available in the source record.
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: The Systems Usability Scale will be administered at the end of one-week for participants enrolled in Step 1 of the study and at the end of four-weeks for participants enrolled in Step 2.). 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 18 Dec 2023.