Impact of Remote Vital Signs Monitoring in People Using Long-term Oxygen Therapy (ILD; COPD)

University of Sao Paulo General Hospital

Status: Enrolling

Conditions: COPD; ILD

Treatments: Behavioral: Control Group; Behavioral: Group Monitoring

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT06882265

68384723900000068

Details and patient eligibility

About

Assess quality of life of patients using prolonged oxygen therapy

Full 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.

Enrollment: 60 estimated patients

Sex: All

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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60 participants in 2 patient groups

Group Monitoring

Experimental group

Description:

After randomization, participants in the GM group will receive the Venu® SQ monitor (Garmin). All participants will receive guidance on how to use the ODI in the educational class, and at the end they will receive specific instructions for use of the devices they will receive (wearable monitor or pulse oximeter). After the first visit, GM participants will be contacted biweekly by telephone to obtain information on their clinical progress, where they will be asked about the number of exacerbations, respiratory symptoms, medication adherence, time of O2 use, and dyspnea symptoms (mMRC). Likewise, monthly contact will be made to obtain information on health factors associated with quality of life (K-BILD), CAT and EQ-5D-5L, and symptoms of anxiety and depression (HADS).

Treatment:

Behavioral: Group Monitoring

Control Group

Active Comparator group

Description:

For the GC, contact will only be monthly to obtain all the information mentioned above in addition to the HR and SpO2 measurements taken on the day of the telephone application.

Treatment:

Behavioral: Control Group