Real World Evaluation of the Effectiveness and Implementation of a Digital Health Therapeutic for OUD
Ориентир для пациента и семьи
Простыми словами
Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.
- Что изучают
- В протоколе указаны: KIOS App.
- Кому может быть актуально
- Состояния в реестре: Opioid Use Disorder. Базовые параметры: от 18 лет · Все.
- Что важно проверить
- Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
- Где проводится
- США
- Следующий шаг
- Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
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Официальное название
Real World Evaluation of the Effectiveness and Implementation of a Digital Health Therapeutic for Opioid Use Disorder (OUD)
Обзор
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.
Подробное описание
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.
Вмешательства
- Устройство KIOS App
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.
Первичные конечные точки
- Retention in treatment [Срок оценки: Baseline to 1 year]
Вторичные конечные точки (7)
- Diagnostic Statistical Manual Version 5 (DSM-5) [Срок оценки: Baseline to 12 months]
- Opioid Craving Scale [Срок оценки: Baseline to 12 months]
- Patient Health Questionnaire-9 (PHQ-9) [Срок оценки: Baseline to 12 months]
- Generalized Anxiety Disorder-7 (GAD-7) [Срок оценки: Baseline to 12 months]
- Treatment Progress and Recovery (TEA) [Срок оценки: 6 to 12 months]
- System Usability Scale (SUS) [Срок оценки: 6 months]
- KIOS User Satisfaction Survey [Срок оценки: 6 months]
Критерии участия
Критерии включения
- 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
Критерии исключения
- 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
Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.
Здоровые добровольцы: Нет
Дизайн исследования
- Распределение
- Не применимо
- Модель
- Одна группа
- Маскирование
- Открытое
- Основная цель
- Организация здравоохранения
Центры проведения
США · 1 центр
- University of Texas Health Science Center - Department of Psychiatry — San Antonio
Идентификаторы
NCT: NCT07348796 · STUDY00002308 · 4R44DA059017-02