Идёт набор NCT06776601

Digital Therapy in Self-management of COPD Patients

Без фазы С лечением Chronic Obstructive Pulmonary Disease

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: Full process digital therapy intervention package.
Кому может быть актуально: Состояния в реестре: Chronic Obstructive Pulmonary Disease. Базовые параметры: от 40 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: Китай
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

Digital Therapy in Self-management of Chronic Obstructive Pulmonary Disease Patients：A Prospective, Open-labled, Multicenter Randomized Controlled Clinical Study.

Обзор

This project adopts a whole-process digital therapy intervention package composed of an inhalation technique assessment device, an electronic inhalant medication monitoring device and digital software to guide patients use the inhaler correctly personalizedly, record and manage the behavior data of chronic obstructive pulmonary disease (COPD) patients during the use of inhalant medication, and provide personalized reminders and feedback to patients according to the data. The purpose is to analyze whether this digital intervention scheme can reduce the number of acute exacerbations of COPD, improve the management effect of COPD, and reduce the burden of disease by improving the medication compliance of COPD patients.

Вмешательства

Поведенческое Full process digital therapy intervention package
Patients will receive individualized inhalation skills guidance after being tested by inhalation capacity measuring device, and be equipped with electronic inhalation monitoring devices, which can record their medication using data, reminding patients to use the medication on time, and correct their inhalation mistake. They can also check their inhalation record on their mobile phones. Clinicians can check the record every month to assess their adherence.

Первичные конечные точки

severe exacerbation [Срок оценки: 12 month]

Вторичные конечные точки (8)

First Second Forced Expiratory Volume/ Forced Vital Capacity [Срок оценки: 12 month]
First Second Forced Expiratory Volume percentage of estimated [Срок оценки: 12 month]
peak expiratory flow [Срок оценки: 12 month]
COPD Assessment Test score [Срок оценки: 12 month]
modified Medical Research Council scale [Срок оценки: 12 month]
St. George's Respiratory Questionnairefor chronic obstructive pulmonary disease (SGRQ) score [Срок оценки: 12 month]
peak inspiratory flow rate [Срок оценки: 12 month]
mild and moderate exacerbation [Срок оценки: 12 month]

Критерии участия

Критерии включения

Patients diagnosed with COPD
Aged 40 and above
Had one or more severe acute exacerbations in the past year, and be in stable condition for the last 4 weeks
Can operate a smartphone proficiently
Take inhalation medication suits for the inhalation monitoring device as treatment
Fully understand and be willing to sign the informed consent form