Impact of Remote Vital Signs Monitoring in People Using Long-term Oxygen Therapy

Официальное название

Impact of Remote Vital Signs Monitoring in People Using Long-term Oxygen Therapy : a Randomized Clinical Trial

Обзор

Assess quality of life of patients using prolonged oxygen therapy

Подробное описание

Adult participants of both sexes with COPD and PID, prolonged oxygen use, will be evaluated after being informed about the study, agreeing and signing the informed consent form. Participants will be randomized to a control group and a group monitored for 90 days. The monitored group will receive a wearable device to monitor vital signs of heart rate and oxygen saturation and the control group will receive a pulse oximeter. Both groups will be monitored through the cell phone application.

Вмешательства

• Поведенческое Group Monitoring
  In the intervention group (IG), participants receive a HR and SPO2 monitor watch and a pulse oximeter and will be monitored every 15 days by a nurse to check for non-adherence and/or technical failure, and/or exacerbations, and monthly to apply questionnaires.
• Поведенческое Control Group
  In the control group (CG), participants receive only a pulse oximeter and will be monitored monthly by a nurse to administer the questionnaires.

Первичные конечные точки

• Health-related quality of life (HRQOL): assessed using the EQ-5D-5L Questionnaire [Срок оценки: Change from baseline in 30 days over 90 days]

Вторичные конечные точки (4)

• Clinical Management: The COPD Assessment Test™ (CAT) is a specific questionnaire for COPD that assesses the impact of disease symptoms on quality of life factors in chronic obstructive pulmonary disease. [Срок оценки: Change from baseline in 30 days over 90 days]
• Changes related to quality of life factors in interstitial lung disease - King's Brief Interstitial Lung Disease (K-BILD) [Срок оценки: Change from baseline in 30 days over 90 days]
• Change in psychosocial symptoms [Срок оценки: Change from baseline in 30 days over 90 days]
• Change in dyspnea [Срок оценки: Change from baseline in 30 days over 90 days]

Критерии участия

Критерии включения

• Patients with a clinical, radiological and/or anatomopathological diagnosis of COPD and ILD according to the 2020 ATS/JRS/ALAT guidelines;
• Age over 18 years;
• Clinical stability (absence of exacerbations or hospitalizations related to the underlying disease) for at least 6 weeks;
• Patients who are on optimized drug therapy, including long-term home oxygen therapy (LTOT)
• Have a smartphone compatible with the monitoring device;
• Signing of the ICF to participate in the study.

Критерии исключения

• Presence of other concomitant lung diseases;
• Myocardial infarction within four months prior to the start of the study, unstable angina or severe heart disease (NYHA functional class III-IV) and/or decompensated.
• Patients who received a lung transplant during the study
• Living outside the coverage area or moving out of state

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Двойное слепое

Основная цель

Поддерживающая терапия

Центры проведения

Бразилия · 1 центр

• Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo (HCFMUSP), — São Paulo

Идентификаторы

NCT: NCT06882265 · 68384723900000068

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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