Clinical trial NCT06882265: Impact of Remote Vital Signs Monitoring in People Using Long-term Oxygen Therapy
Official title: Impact of Remote Vital Signs Monitoring in People Using Long-term Oxygen Therapy : a Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: ILD
COPD
Keywords: Quality of life
Monitoring remote
ILD
COPD
Lead sponsor: University of Sao Paulo General Hospital
Sponsor class: OTHER
Collaborators: name: Air Liquide SA
First posted: 2025-03-18
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: Assess quality of life of patients using prolonged oxygen therapy

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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

Primary outcomes:
measure: Health-related quality of life (HRQOL): assessed using the EQ-5D-5L Questionnaire
timeFrame: Change from baseline in 30 days over 90 days
Secondary outcomes:
measure: 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.
timeFrame: Change from baseline in 30 days over 90 days
measure: Changes related to quality of life factors in interstitial lung disease - King's Brief Interstitial Lung Disease (K-BILD)
timeFrame: Change from baseline in 30 days over 90 days
measure: Change in psychosocial symptoms
timeFrame: Change from baseline in 30 days over 90 days
measure: Change in dyspnea
timeFrame: Change from baseline in 30 days over 90 days
Other outcomes:
measure: Adherence
timeFrame: Baseline
measure: Exarcebations
timeFrame: Baseline
measure: Função pulmonar
timeFrame: Baseline
Locations:
city: São Paulo
country: Brazil
facility: Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo (HCFMUSP),
state: SP
Study officials:
References: