[Försök med enhet som inte är godkänd eller godkänd av amerikanska FDA]
21 juli 2026 uppdaterad av: Elise Marino, The University of Texas Health Science Center at San Antonio
[Prövning av enhet som inte är godkänd eller godkänd av den amerikanska FDA]
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.
Studieöversikt
Status
Har inte rekryterat ännu
Betingelser
Intervention / Behandling
Detaljerad beskrivning
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.
Studietyp
Interventionell
Inskrivning (Beräknad)
134
Fas
- Inte tillämpbar
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studiekontakt
- Namn: Elise Marino, PhD
- Telefonnummer: (210) 567-5399
- E-post: marinoe@uthscsa.edu
Studera Kontakt Backup
- Namn: McKenna Garcia
- Telefonnummer: (210) 450-7371
- E-post: garciam98@uthscsa.edu
Studieorter
-
-
Texas
-
San Antonio, Texas, Förenta staterna, 78229
- University of Texas Health Science Center - Department of Psychiatry
-
-
Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
- Vuxen
- Äldre vuxen
Tar emot friska volontärer
Nej
Beskrivning
Inclusion Criteria:
- Male or female outpatients 18 years of age or older
- DSM-5 criteria for opioid use disorder
- Ability to access KIOS via smartphone or tablet
- Initiated buprenorphine treatment in the past 6 months
Exclusion Criteria:
- Unwilling or unable to comply with study requirements
- A psychiatric or medical condition interfering with ability to use the app
- Incarceration
- Suicide risk as determined by the treating medical clinician at the site
Studieplan
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Hälsovårdsforskning
- Tilldelning: N/A
- Interventionsmodell: Enskild gruppuppgift
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Experimentell: Treatment as usual and KIOS app
Participants will be set up onto their preferred device(s) with assistance from a research assistant.
KIOS will be accessible on all mobile devices as well as tablets.
Treatment as usual (TAU) will be administered to all participants.
|
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.
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Retention in treatment
Tidsram: Baseline to 1 year
|
The number of days from the start of the one-year intervention until the participant either leaves the trial or completes the trial.
|
Baseline to 1 year
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Diagnostic Statistical Manual Version 5 (DSM-5)
Tidsram: Baseline to 12 months
|
DSM-5 criteria describe OUD as a pattern of opioid use leading to problems or distress
|
Baseline to 12 months
|
|
Opioid Craving Scale
Tidsram: Baseline to 12 months
|
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.
|
Baseline to 12 months
|
|
Patient Health Questionnaire-9 (PHQ-9)
Tidsram: Baseline to 12 months
|
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.
|
Baseline to 12 months
|
|
Generalized Anxiety Disorder-7 (GAD-7)
Tidsram: Baseline to 12 months
|
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.
|
Baseline to 12 months
|
|
Treatment Progress and Recovery (TEA)
Tidsram: 6 to 12 months
|
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
|
6 to 12 months
|
|
System Usability Scale (SUS)
Tidsram: 6 months
|
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.
|
6 months
|
|
KIOS User Satisfaction Survey
Tidsram: 6 months
|
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.
|
6 months
|
Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Utredare
- Huvudutredare: Elise Marino, PhD, The University of Texas Health Science Center at San Antonio
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart (Beräknad)
17 augusti 2026
Primärt slutförande (Beräknad)
31 maj 2028
Avslutad studie (Beräknad)
30 juni 2028
Studieregistreringsdatum
Först inskickad
15 januari 2026
Först inskickad som uppfyllde QC-kriterierna
15 januari 2026
Första postat (Faktisk)
16 januari 2026
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
23 juli 2026
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
21 juli 2026
Senast verifierad
1 juli 2026
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- STUDY00002308
- 4R44DA059017-02 (U.S.S. NIH-anslag/kontrakt)
Läkemedels- och apparatinformation, studiedokument
Studerar en amerikansk FDA-reglerad läkemedelsprodukt
Nej
Studerar en amerikansk FDA-reglerad produktprodukt
Ja
produkt tillverkad i och exporterad från U.S.A.
Nej
Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .