NCT06882265

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

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: University of Sao Paulo General Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Not accepted

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.

Conditions

• ILD
• COPD

Interventions

Type	Name	Description
BEHAVIORAL	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.
BEHAVIORAL	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.

Timeline

• Start date: 2024-11-10
• Primary completion: 2025-07-30
• Completion: 2025-12-15
• First posted: 2025-03-18
• Last updated: 2025-03-18

Locations

1 site across 1 country: Brazil