KIOS Mobile App Evaluation
Purpose
Evaluation of a mobile medical app (KIOS) vs. treatment as usual for the treatment of opioid use disorder (OUD).
Condition
- Opioid Use Disorder
Eligibility
- Eligible Ages
- Over 18 Years
- Eligible Genders
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- Male or female outpatients 18 years of age or older 2. Patients must be able to communicate meaningfully with the investigator and must be legally competent to provide written informed consent. 3. DSM-5 (Diagnostic and Statistical Manual of Mental Disorders fifth edition) criteria for opioid use disorder 4. ability to access KIOS via smartphone or tablet 5. Recently (less than 6 months) enrolled in and currently participating in MAT at a Be Well Texas (UT Health San Antonio) participating clinic
Exclusion Criteria
- Unwilling or unable to comply with study requirements 2. psychiatric or medical disorder interfering with ability to use the app 3. incarceration
Study Design
- Phase
- N/A
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- Intervention Model Description
- Randomized controlled 2 arm trial
- Primary Purpose
- Treatment
- Masking
- Single (Investigator)
- Masking Description
- Randomization will be stratified by three characteristics: (1) buprenorphine or methadone, (2) history of MAT, and (3) 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.
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental Active Treatment as Usual plus KIOS App |
Treatment as usual in clinics with the use of the KIOS App |
|
|
Sham Comparator Treatment as Usual plus KIOS education App |
Treatment as usual in clinics with the use of the KIOs education App (Sham) |
|
Recruiting Locations
San Antonio, Texas 78229
More Details
- Status
- Recruiting
- Sponsor
- The University of Texas Health Science Center at San Antonio
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.