Evaluation of a mobile medical app (KIOS) vs. treatment as usual for the treatment of opioid use disorder (OUD).
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
116
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
University of Texas Health Science Center - Department of Psychiatry
San Antonio, Texas, United States
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
Time frame: Baseline to 13 weeks
Measure of opioid use reduction
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
Time frame: 60 days to 13 weeks
Percentage of Opioid Abstinent Days
Total abstinence, measured by urinalysis confirmed self-report of opioid use during the 13-week intervention
Time frame: Baseline to 13 weeks
Completion of treatment
Number of subjects that completed their participation in the study
Time frame: Baseline to 13 weeks
Patient Health Questionnaire-9 (PHQ-9)
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.
Time frame: Baseline and 13 weeks
Treatment Effectiveness Assessment TEA)
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.
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Time frame: Baseline and 13 weeks