Идёт набор NCT05741112

The Long COVID-19 Wearable Device Study

Без фазы С лечением Long COVID Postural Orthostatic Tachycardia Syndrome Dysautonomia Myalgic Encephalomyelitis

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: Wearable device.
Кому может быть актуально: Состояния в реестре: Long COVID, Postural Orthostatic Tachycardia Syndrome, Dysautonomia, Myalgic Encephalomyelitis. 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 →

Не всё понятно в терминах? Прочитайте наш гид для пациентов →

Обзор

To further characterize Long COVID-19 by collecting data from individuals who already own wearable devices or are provided with a wearable device along with basic and enhanced educational materials to determine if both can improve Long COVID-19 symptom management and post-exertional malaise.

Подробное описание

This study will have two components:

One study group will consist of up to 100,000 individuals who own wearable devices and are willing to share their data. These participants will be randomized and will receive educational materials. The investigators will study these dynamic wearable data along with participant survey responses that focus on diagnoses, symptoms, and quality of life to improve disease characterization and understanding of differences within and between individuals.

The other group in the randomized trial will participants who do not already own a wearable device. The study will distribute wearable devices and pacing educational materials to 500 individuals who do not already own them and experience post-exertional malaise, or the worsening of symptoms following exertion.

The investigators hypothesize that access to personalized information from a wearable device will enable participants to reduce post-exertional malaise. The investigators will include up to 25% individuals whose post-exertional malaise is caused by a condition other than Long COVID-19.

Вмешательства

Устройство Wearable device
The treatment group will receive their wearable device and the enhanced education at the start of the study. Their outcomes will be compared with the control group who will receive at 3 months.

Первичные конечные точки

Primary Objective 1:Assess the effect of study-provided devices and enhanced educational materials to manage Long COVID-19 symptom severity, compared to general educational materials alone using data from participants survey responses. [Срок оценки: 3 months]
Primary Objective 2: Collate a unique longitudinal dataset combining patients' demographics, symptoms, symptom severity, quality of life, and sensor data including sleep, activity, heart rate, heart rate variability, and Body Battery. [Срок оценки: 12 months]

Вторичные конечные точки (1)

Secondary Objective: Assess the longitudinal impact of sustained use of the study-provided devices and enhanced educational materials on symptom severity. [Срок оценки: 12 months]

Критерии участия

Критерии включения

Is at least 18 years old.
Has a self/and or physician diagnosis of:
Long COVID (based on the WHO working definition),
ME/CFS (myalgic encephalomyelitis / chronic fatigue syndrome, self-diagnosis based on IOM criteria), and/or
POTS (Postural Orthostatic Tachycardia Syndrome).
Is interested in tools to manage ME/CFS, POTS, and/or Long COVID symptoms.
Owns a wearable device they are willing to use for this study or does not own a device and agrees to utilize a study-provided one.
Agrees to wear the device throughout the study period, share the data with the study, and sync data at least weekly.
Has access to a smartphone or tablet to enable syncing wearable data and viewing device feedback.
Agrees to disclose involvement in other ME/CFS, POTS, and/or Long COVID interventions such as medical treatment, self-management, and other interventional studies.
Agrees to complete at least 75% of the study surveys.