Studies
| Study First Submitted Date | 2023-04-13 |
| Study First Posted Date | 2023-05-15 |
| Last Update Posted Date | 2023-07-12 |
| Start Month Year | June 29, 2023 |
| Primary Completion Month Year | August 18, 2023 |
| Verification Month Year | July 2023 |
| Verification Date | 2023-07-31 |
| Last Update Posted Date | 2023-07-12 |
Detailed Descriptions
| Sequence: | 20719810 |
| 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. |
Facilities
| Sequence: | 200087876 |
| Status | Recruiting |
| Name | UT Health San Antonio |
| City | San Antonio |
| State | Texas |
| Zip | 78229 |
| Country | United States |
Facility Contacts
| Sequence: | 28102285 |
| Facility Id | 200087876 |
| Contact Type | primary |
| Name | Jennifer Potter, Ph.D. |
Conditions
| Sequence: | 52165832 |
| Name | Opioid-Related Disorders |
| Downcase Name | opioid-related disorders |
Id Information
| Sequence: | 40154892 | Sequence: | 40154893 |
| Id Source | org_study_id | Id Source | secondary_id |
| Id Value | 23-0232H | Id Value | R42DA054881 |
| Id Type | U.S. NIH Grant/Contract | ||
| Id Link | https://reporter.nih.gov/quickSearch/R42DA054881 |
Countries
| Sequence: | 42564666 |
| Name | United States |
| Removed | False |
Design Groups
| Sequence: | 55587788 |
| Group Type | Experimental |
| Title | KIOS Informational App evaluation |
| Description | 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. |
Interventions
| Sequence: | 52480704 |
| Intervention Type | Device |
| Name | KIOS Informational App |
| Description | 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. |
Design Outcomes
| Sequence: | 177361771 | Sequence: | 177361772 |
| Outcome Type | primary | Outcome Type | secondary |
| Measure | Usability Score | Measure | User Satisfaction |
| 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. | 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. |
| Description | 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. | Description | 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. |
Browse Conditions
| Sequence: | 193467360 | Sequence: | 193467361 | Sequence: | 193467362 | Sequence: | 193467363 | Sequence: | 193467364 |
| Mesh Term | Opioid-Related Disorders | Mesh Term | Narcotic-Related Disorders | Mesh Term | Substance-Related Disorders | Mesh Term | Chemically-Induced Disorders | Mesh Term | Mental Disorders |
| Downcase Mesh Term | opioid-related disorders | Downcase Mesh Term | narcotic-related disorders | Downcase Mesh Term | substance-related disorders | Downcase Mesh Term | chemically-induced disorders | Downcase Mesh Term | mental disorders |
| Mesh Type | mesh-list | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor |
Sponsors
| Sequence: | 48314731 | Sequence: | 48314732 | Sequence: | 48314733 |
| Agency Class | INDUSTRY | Agency Class | OTHER | Agency Class | NIH |
| Lead Or Collaborator | lead | Lead Or Collaborator | collaborator | Lead Or Collaborator | collaborator |
| Name | Biomedical Development Corporation | Name | The University of Texas Health Science Center at San Antonio | Name | National Institute on Drug Abuse (NIDA) |
Overall Officials
| Sequence: | 29282679 |
| Role | Principal Investigator |
| Name | Jennifer Potter, Ph.D. |
| Affiliation | UT Health San Antonio |
Central Contacts
| Sequence: | 12007478 | Sequence: | 12007479 |
| Contact Type | primary | Contact Type | backup |
| Name | Jennifer Potter, Ph.D. | Name | Meenakshi Rani, Ph.D. |
| Phone | (210) 562-5418 | Phone | 210-358-0478 |
| [email protected] | [email protected] | ||
| Role | Contact | Role | Contact |
Design Group Interventions
| Sequence: | 68142676 |
| Design Group Id | 55587788 |
| Intervention Id | 52480704 |
Eligibilities
| Sequence: | 30762530 |
| Gender | All |
| Minimum Age | 18 Years |
| Maximum Age | N/A |
| Healthy Volunteers | No |
| Criteria | Inclusion Criteria: 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. Exclusion Criteria: Unwilling or unable to comply with study requirements Have a psychiatric or medical disorder interfering with ability to use the app Incarcerated Pregnant |
| Adult | True |
| Child | False |
| Older Adult | True |
Calculated Values
| Sequence: | 254308202 |
| Number Of Facilities | 1 |
| Registered In Calendar Year | 2023 |
| Were Results Reported | False |
| Has Us Facility | True |
| Has Single Facility | True |
| Minimum Age Num | 18 |
| Minimum Age Unit | Years |
| Number Of Primary Outcomes To Measure | 1 |
| Number Of Secondary Outcomes To Measure | 1 |
Designs
| Sequence: | 30508719 |
| Allocation | N/A |
| Intervention Model | Single Group Assignment |
| Observational Model | |
| Primary Purpose | Other |
| Time Perspective | |
| Masking | None (Open Label) |
Intervention Other Names
| Sequence: | 26671166 |
| Intervention Id | 52480704 |
| Name | KIOS-I |
Responsible Parties
| Sequence: | 28875007 |
| Responsible Party Type | Sponsor |