Monitoring vital signs in patients using long-term oxygen therapy
Impact of Remote Vital Signs Monitoring in People Using Long-term Oxygen Therapy : a Randomized Clinical Trial
This study tests if using a wearable device to monitor vital signs can improve the quality of life for adults with COPD and interstitial lung disease who are on long-term oxygen therapy.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 18 Years to 85 Years |
| Sex | All |
| Sponsor | University of Sao Paulo General Hospital Academic / other |
| Locations | 1 site (São Paulo, São Paulo) |
| Trial ID | NCT06882265 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates include adults over 18 with stable COPD or ILD who are on optimized drug therapy and long-term oxygen therapy.
Not a fit: Patients with other significant lung diseases or severe heart conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance the quality of life for patients on long-term oxygen therapy by providing better monitoring and management of their condition.
How similar studies have performed: Other studies have shown promise in using remote monitoring for chronic respiratory conditions, indicating potential success for this approach.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
São Paulo, São Paulo
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.