KIOS Mobile App Evaluation
- Conditions
- Opioid Use Disorder
- Interventions
- Behavioral: KIOS App educationDevice: KIOS AppBehavioral: Treatment as usual
- Registration Number
- NCT06212557
- Brief Summary
Evaluation of a mobile medical app (KIOS) vs. treatment as usual for the treatment of opioid use disorder (OUD).
- Detailed Description
The study is a parallel intervention examining the KIOS app, a digital health therapeutic intended to help individuals in recovery from opioid use disorder better self-manage their condition. KIOS will offer individualized, evidence-based behavioral intervention strategies responsive to the patients' current clinical status outside the setting of the doctor's office or treatment facility. KIOS makes it possible to process patient-entered data and provide responsive behavioral advice to patients specific to their condition in real time. KIOS gives patients 24/7 access to behavioral intervention strategies that can augment and improve response to routine clinic-based counseling interventions.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 210
- 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
- Unwilling or unable to comply with study requirements
- Psychiatric or medical disorder interfering with ability to use the app
- Incarceration
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Treatment as Usual plus KIOS education App KIOS App education Treatment as usual in clinics with the use of the KIOs education App (Sham) Active Treatment as Usual plus KIOS App KIOS App Treatment as usual in clinics with the use of the KIOS App Treatment as Usual plus KIOS education App Treatment as usual Treatment as usual in clinics with the use of the KIOs education App (Sham) Active Treatment as Usual plus KIOS App Treatment as usual Treatment as usual in clinics with the use of the KIOS App
- Primary Outcome Measures
Name Time Method Retention in treatment Baseline to 13 weeks 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
- Secondary Outcome Measures
Name Time Method Measure of opioid use reduction 60 days to 13 weeks Defined as abstaining from opioids during the last week and for at least 2 of the previous 3 weeks of the third month of MOUD treatment
Percentage of Opioid Abstinent Days Baseline to 13 weeks Total abstinence, measured by urinalysis confirmed self-report of opioid use during the 13-week intervention
Completion of treatment Baseline to 13 weeks Number of subjects that completed their participation in the study
Patient Health Questionnaire-9 (PHQ-9) Baseline and 13 weeks A 9 item questionnaire scored from 0 (Not at all) to 4 (Nearly every day) with a potential score of 0-36 with a lower score indicating better health and emotional well-being.
Treatment Effectiveness Assessment TEA) Baseline and 13 weeks The TEA asks the participant to express the extent of changes for the better from your involvement in the program to this point (or how things are if it's your first TEA or baseline) in four areas: substance use, health, lifestyle, and community. For each area, think about how things have become better and circle the results on the scale below: the more you have improved, the higher the number -from 1 (not better at all) to 10 (very much better). Possible scores are between 1 and 40 with a lower score indicating a worse outcome.
Trial Locations
- Locations (1)
University of Texas Health Science Center - Department of Psychiatry
🇺🇸San Antonio, Texas, United States