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Набор скоро начнётся NCT06627465

Validating Digital Biomarkers to Detect Disease Activity and Disease Progression in Multiple Sclerosis

— Наблюдательное Multiple Sclerosis

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: MS Sherpa, Neurokeys.
Кому может быть актуально
Состояния в реестре: Multiple Sclerosis. 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
Нидерланды
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Обзор

The Connect-MS is multicentre real-world observational cohort study wherin the outcomes of standard care digital monitoring of 700 patients with multiple sclerosis (including all subtypes) are recorded over a follow-up period of two years. Patients use the MS sherpa and NeuroKeys applications. Outcomes are related to the utilisation of digital biomarkers including the adherence to digital monitoring and the impact digital outcomes have on clinical decision making, the effect of digital monitoring on healthcare consumption, and the ability of these technological biomarkers to detect clinical outcomes on the short and long term. Most recorded variables are part of the standard care, however participants of this study are also subject to additional questionnaires regarding the consumption of healthcare and the influence of digital monitoring on decision making during clinical consultation.

Вмешательства

  • Устройство MS Sherpa
    The MS Sherpa application is a CE-certified smartphone application (installed on the mobile phone of the patient) that collects digital biomarkers using tests (\~six minutes/test: self-monitoring questionnaires, smartphone 2-MWT, and a smartphone SDMT) once per week in the home environment of the patient.
  • Устройство Neurokeys
    The NeuroKeys application is a CE-certified application (installed on the mobile phone of the patient) that passively and continuously monitors keystroke dynamics of everyday typing as a digital biomarker.

Первичные конечные точки

  • Impact of digital monitoring questionnaire: healthcare provider [Срок оценки: At each clinical consultation throughout the two year study follow-up]
  • Adherence to the MS Sherpa application. [Срок оценки: Throughout the two year follow-up period. Assessments scheduled weekly.]
  • Application outcomes of MS Sherpa [Срок оценки: Throughout the two year follow-up period. Assessments scheduled weekly.]
  • Impact of digital monitoring questionnaire: patient [Срок оценки: At each clinical consultation throughout the two year study follow-up. Standard care is yearly clinical consultation.]
  • Adherence to the Neurokeys application [Срок оценки: Daily passive monotring throughout the two year follow-up period.]
  • Medical consumption questionnaire (iMCQ) [Срок оценки: At each clinical consultation throughout the two year study follow-up. Standard care is yearly clinical consultation.]
  • Productivity costs questionnaire (iPCQ) [Срок оценки: At each clinical consultation throughout the two year study follow-up. Standard care is yearly clinical consultation.]
  • Application outcomes of Neurokeys [Срок оценки: Continously and daily throughout the two year follow-up period.]

Критерии участия

In order to be eligible to participate in this study, a subject must meet all of the following criteria:

  • Have signed non-WMO informed consent
  • Be able to comply with the study protocol, as judged by the investigator.
  • Have a minimum age of 18 years.
  • Have a definite diagnosis multiple sclerosis (either RRMS, SPMS or PPMS) according to the revised 2017 McDonald criteria. (Thompson et al., 2018)
  • Willing and able to install and use MS Sherpa and NeuroKeys on a privately-owned cell phone.

Since this is an observational cohort study, concomitant participation in any intervention trial is allowed.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения
Когортное

Центры проведения

Нидерланды · 3 центра
  • Rijnstate Arnhem — Arnhem
  • Zuyderland Medical Center — Geleen
  • Amsterdam UMC — Amsterdam

Идентификаторы

NCT: NCT06627465 · 2024.0188

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗