Telemonitoring for patients with COPD exacerbations

Multiparametric Home Telemonitoring of Patients With Chronic Obstructive Pulmonary Disease Exacerbation

This study tests if a special monitoring device can help people recently hospitalized for COPD feel better and avoid going back to the hospital.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 60 (estimated)
• Ages: 18 Years to 90 Years
• Sex: All
• Sponsor: University of Trieste (other)
• Locations: 1 site (Trieste)
• Trial ID: NCT06331416 on ClinicalTrials.gov

What this trial studies

This clinical trial evaluates the effectiveness of a multiparameter telemonitoring device for patients who have been hospitalized due to exacerbations of chronic obstructive pulmonary disease (COPD). The study aims to reduce functional decline, alleviate symptoms, and lower the risk of re-hospitalization after discharge. Participants will be monitored closely to ensure timely interventions and improve their overall health outcomes. The trial is randomized and controlled, focusing on patients who meet specific criteria related to their COPD condition.

Who should consider this trial

Good fit: Ideal candidates for this study are adults aged 18 to 90 with a confirmed diagnosis of COPD who have experienced an exacerbation requiring hospitalization.

Not a fit: Patients with heart failure as the primary cause of respiratory failure or those with interstitial lung disease may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could significantly reduce hospital readmissions and improve the quality of life for patients with COPD.

How similar studies have performed: Previous studies have shown promising results with telemonitoring approaches for managing COPD, indicating potential for success in this trial.

Eligibility criteria

Inclusion Criteria:

1. Able to understand and sign the informed consent form.
2. Already established diagnosis of COPD according to Global Initiative for Obstructive Lung Disease (GOLD) guidelines.\[13\]
3. Diagnosis of COPD exacerbation at admission, according to GOLD guidelines.\[13\]
4. Arterial partial pressure of oxygen (PaO2) \< 60 mmHg in ambient air at rest at admission and arterial partial pressure of oxygen (PaO2) \> 60 mmHg in ambient air at rest at discharge, if not on long-term oxygen therapy on ventilation.
5. Arterial partial pressure of oxygen (PaO2) \< 55 mmHg on usual oxygen supplement (L/min) and arterial partial pressure of oxygen (PaO2) \> 60 mmHg on oxygen supplement at discharge, if already on long-term oxygen therapy on ventilation.

g) Age \<= 90 and \>= 18 years old at randomization.

Exclusion Criteria:

1. Heart failure as the main cause of acute respiratory failure
2. Acute pulmonary embolism/chronic pulmonary thromboembolism
3. Interstitial lung disease as the main cause of acute respiratory failure
4. Pneumonia as the main cause of acute respiratory failure
5. Chronic renal failure with dialysis dependence
6. Immunosuppression (i.e. cancer on treatment, post-organ transplantation, HIV-positive, on immunosuppressant therapy)
7. Progressive neuro-muscular disorders
8. Cognitively impaired, dementia or decompensated psychiatric disorder
9. Quadriplegia/Hemiplegia or quadriparesis/hemiparesis
10. Do-not-resuscitate order
11. Any other condition that in the opinion of the investigator may significantly impact with patient's capability to comply with the protocol

Where this trial is running

Trieste

• SC Pneumologia, Azienda Sanitaria Universitaria Giuliano-Isontina — Trieste, Italy (RECRUITING)

Study contacts

• Study coordinator: Francesco Salton, MD

Conditions: COPD, COPD Exacerbation Acute