The researchers will study the KIOS app, a digital health tool made to help people recovering from opioid addiction take better care of themselves. They want to see how the app works in real life and learn who benefits most from using it. The study will also ask participants what they think about the app and how easy it is to use.
Participation in the study will last 12 months. Participants will be asked to complete assessments at 33 timepoints over the 12-month trial. This will include 1 screening assessment, 24 weekly assessments, 6 monthly assessments, and 2 follow-up assessments. All study assessments will be completed remotely. Staff at each site will identify potential participants being treated with buprenorphine for opioid use disorder at their respective site. Providers will introduce the study and if interested, the participant will complete a screening assessment conducted by trained study staff to determine eligibility for the study. Participants who are eligible will be enrolled into the study and given access to the KIOS app. The active phase will include the first 6 months during which time participants will use the app, complete monthly assessments, and complete a weekly craving assessment. The second 6 months in the study will include two follow-up assessments at 9 months and 12 months post study start. At the end of the 12 months, app access will be removed. The follow up assessments will include the monthly assessments that were completed during the active phase, as well as the craving assessment. All assessments will be sent to the participants' email address for them to complete on any device with internet access. At the conclusion of 12 months of study participation, focus groups will be conducted with 25 of the participants to gather information about their perspectives on the app and its usability and features.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Enrollment
134
A digital health therapeutic intended to help individuals in recovery from opioid use disorder better self-manage their condition. KIOS offers individualized, evidence-based behavioral intervention strategies responsive to the patients' current clinical status outside the setting of the doctor's office or treatment facility.
University of Texas Health Science Center - Department of Psychiatry
San Antonio, Texas, United States
Retention in treatment
The number of days from the start of the one-year intervention until the participant either leaves the trial or completes the trial.
Time frame: Baseline to 1 year
Diagnostic Statistical Manual Version 5 (DSM-5)
DSM-5 criteria describe OUD as a pattern of opioid use leading to problems or distress
Time frame: Baseline to 12 months
Opioid Craving Scale
A brief 3-item measure used to measure opioid craving. The scale consists of 3 items rated on a visual analog scale from 0-10. Items are as follows: 1) How much do you currently crave opiates?; 2) In the past week, please rate how strong your desire to use opiates has been when something in the environment has reminded you of opiates?; and 3) Please imagine yourself in the environment in which you previously used opiates. If you were in this environment today and if it were the time of day that you typically used opiates, what is the likelihood that you would use opiates today. The total scores range from 3-30 with a higher score indicating more opioid craving.
Time frame: Baseline to 12 months
Patient Health Questionnaire-9 (PHQ-9)
A self-administered 9-item depression module that scores each of the 9 DSM-V (Diagnostic and Statistical Manual of Mental Disorders, 5th edition). Items are score 0 to 3, providing a 0 to 27 severity score. Scores of 5, 10, 15, and 20 represent cutoff points for mild, moderate, moderately severe, and severe depression, respectively.
Time frame: Baseline to 12 months
Generalized Anxiety Disorder-7 (GAD-7)
The Generalized Anxiety Disorder-7 (GAD-7)13 measures anxiety with 7 items scored from 0 to 3, providing a 0 to 21 severity score. Scores of 5, 10, and 15 represent cutoff points for mild, moderate, and severe anxiety, espectively.
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Time frame: Baseline to 12 months
Treatment Progress and Recovery (TEA)
The TEA gauges progress in treatment and recovery within four domains established by prior research: substance use, health (physical or emotional), lifestyle (housing/living situation, family, employment, relationships), and community (obeying laws, responsible member of society). For each area, the patient is asked to think about how much better things have become on a 10-point scale (1 = not better at all and 10 = very much better). Scores range between 0-40, with a higher score indicating greater progress in treatment and recovery
Time frame: 6 to 12 months
System Usability Scale (SUS)
The System Usability Scale (SUS)15 is a 10-item measure for assessing a system's usability on a 5-point Likert scale from strongly agree to strongly disagree. Scores are converted to a 100-point scale. A score above a 68 would be considered above average usability.
Time frame: 6 months
KIOS User Satisfaction Survey
Participants complete a survey specific to KIOS regarding: (1) the content, appropriateness, and relevance of the advice; (2) enhancement of self-management skills; (3) selfawareness; and (4) overall satisfaction with health. Survey items will be answered with level of agreement with a given statement recorded on a Likert-type 0 (Disagree) - 7 (Agree) scale.
Time frame: 6 months