KIOS Mobile App Evaluation
Evaluation of KIOS in a 12-week Randomized Controlled Trial
2 other identifiers
interventional
210
1 country
1
Brief Summary
Evaluation of a mobile medical app (KIOS) vs. treatment as usual for the treatment of opioid use disorder (OUD).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started May 2024
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 8, 2024
CompletedFirst Posted
Study publicly available on registry
January 19, 2024
CompletedStudy Start
First participant enrolled
May 2, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
May 31, 2026
ExpectedApril 10, 2025
April 1, 2025
1.7 years
January 8, 2024
April 7, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Retention in treatment
Measured by the number of days from the start of the 13-week intervention until the participant either leaves the trial, or completes the trial
Baseline to 13 weeks
Secondary Outcomes (5)
Measure of opioid use reduction
60 days to 13 weeks
Percentage of Opioid Abstinent Days
Baseline to 13 weeks
Completion of treatment
Baseline to 13 weeks
Patient Health Questionnaire-9 (PHQ-9)
Baseline and 13 weeks
Treatment Effectiveness Assessment TEA)
Baseline and 13 weeks
Study Arms (2)
Active Treatment as Usual plus KIOS App
EXPERIMENTALTreatment as usual in clinics with the use of the KIOS App
Treatment as Usual plus KIOS education App
SHAM COMPARATORTreatment as usual in clinics with the use of the KIOs education App (Sham)
Interventions
KIOS provides patients on demand individualized advice and reinforcement of lifestyle interventions to improve self-management during Medication-Assisted Treatment (MAT)
Educational tools provided to participants with opioid use disorder
Behavioral counseling in clinic
Eligibility Criteria
You may qualify if:
- Male or female outpatients 18 years of age or older
- Patients must be able to communicate meaningfully with the investigator and must be legally competent to provide written informed consent.
- DSM-5 (Diagnostic and Statistical Manual of Mental Disorders fifth edition) criteria for opioid use disorder
- Ability to access KIOS via smartphone or tablet
- Recently (less than 6 months) enrolled in and currently participating in MOUD at a clinic in Texas
You may not qualify if:
- Unwilling or unable to comply with study requirements
- Psychiatric or medical disorder interfering with ability to use the app
- Incarceration
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of Texas Health Science Center - Department of Psychiatry
San Antonio, Texas, 78229, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jennifer Potter, PhD, MPH
The University of Texas Health Science Center at San Antonio
- PRINCIPAL INVESTIGATOR
Elise Marino, PhD
The University of Texas Health Science Center at San Antonio
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- INVESTIGATOR
- Masking Details
- Randomization will be stratified by two characteristics: (1) history of MOUD and (2) stimulant use in past one month. Allocation to treatment groups will be randomly assigned by 1:1 allotment to either KIOS + TAU (treatment as usual) or KIOS sham + TAU with strata. Study staff will be blind to the condition to which the participant is assigned.
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 8, 2024
First Posted
January 19, 2024
Study Start
May 2, 2024
Primary Completion
December 31, 2025
Study Completion (Estimated)
May 31, 2026
Last Updated
April 10, 2025
Record last verified: 2025-04
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF
- Time Frame
- After study completion and data analysis when summary results are posted on ClinicalTrials.gov and then after peer review and publication acceptance.
This study will be conducted in accordance with the following publication and data sharing policies and regulations: National Institutes of Health (NIH) Public Access Policy, which ensures that the public has access to the published results of NIH funded research. It requires scientists to submit final peer-reviewed journal manuscripts that arise from NIH funds to the digital archive PubMed Central upon acceptance for publication. This study will comply with the NIH Data Sharing Policy and Policy on the Dissemination of NIH-Funded Clinical Trial Information and the Clinical Trials Registration and Results Information Submission rule. As such, this trial will be registered at ClinicalTrials.gov, and results information from this trial will be submitted to ClinicalTrials.gov. In addition, every attempt will be made to publish results in peer-reviewed journals.