Monitoring vital signs in patients using long-term oxygen therapy

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study evaluates the quality of life in adults with chronic obstructive pulmonary disease (COPD) and interstitial lung disease (ILD) who are on long-term oxygen therapy. Participants will be randomized into two groups: one receiving continuous monitoring through a wearable device for 90 days, and the other receiving a standard pulse oximeter. Both groups will have their vital signs monitored via a mobile application to assess the impact of remote monitoring on their health outcomes.

Why it matters

Who can join: the full rules

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

Where it's running

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

Study contacts

• Study coordinator: Celso RF Carval, Diretor do Estudo
• Email: cscarval@usp.br
• Phone: 55 11 98415-3234

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.