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Multiparametric Home Telemonitoring of Patients With Chronic Obstructive Pulmonary Disease Exacerbation

ConditionsCOPDCOPD Exacerbation Acute
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-90
SponsorUniversity of Trieste

About this trial

Chronic obstructive pulmonary disease (COPD) exacerbations are risk factors for disease progression and short-term re- hospitalizations. We propose a randomized controlled trial to evaluate the efficacy of a one-device multiparameter telemonitoring in reducing functional decline, symptoms, and risk of re-hospitalization of patients discharged after hospitalization for exacerbated COPD.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Able to understand and sign the informed consent form.

Already established diagnosis of COPD according to Global Initiative for Obstructive Lung Disease (GOLD) guidelines.[13]

Diagnosis of COPD exacerbation at admission, according to GOLD guidelines.[13]

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.

Disqualifiers

Heart failure as the main cause of acute respiratory failure

Acute pulmonary embolism/chronic pulmonary thromboembolism

Interstitial lung disease as the main cause of acute respiratory failure

Pneumonia as the main cause of acute respiratory failure

Trial design

Design model

Parallel

Treatments tested in this trial

  • Telemonitoring

    Device

    Patients will be asked to carry out one measurement (arterial pressure, oxygen saturation, body temperature, heart rate, spirometry) every 24 hours for 90 days. The system will be supplied by the company Vivisol. The telemonitoring data will be read once a day and the principal investigator will be alerted in case of alteration of any parameter. If vital parameters remain stable, a phone call will be performed every 5 days. In case of compromise of any parameter, the patient will be offered a phone call within the same day. In case of new occurrence of any respiratory or non-respiratory symptoms, the patient must contact the principal investigator and he will be offered a phone call or a video-assisted call within the same day. If the alterations or symptoms persist for 24 hours, or in any case upon decision of the investigator in charge, the patient will be offered an in-person evaluation in the same day. If deemed necessary according to usual care, the patient will be hospitalized.

Treatment groups

60 Participants
are divided into 2 treatment groups
Group A: TelemonitoringExperimental treatment 1 intervention
Group B: Standard of careNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

Re-hospitalization at 90 days

Proportion of re-hospitalized patients by day 90 in both groups

Time frame
90 days

Secondary outcomes

1

Re-hospitalization at 30 days

Proportion of re-hospitalized patients by day 30 in both groups

Time frame
30 days
2

Functional decline

Proportion of patients with ≥ 30 mL deflection in the predicted value of forced expiratory volume in the first second (FEV1) at spirometry or increase in COPD assessment test (CAT) score for symptoms evaluation ≥ 2 points between the first visit (one month after discharge) and the second visit (three months after discharge) in both groups.

Time frame
90 days
3

Unplanned medical evaluations

Number of unplanned pneumological evaluation in both groups.

Time frame
90 days
4

Need for mechanical ventilation at 30 days

Proportion of patients who require mechanical ventilation (either noninvasive or invasive) by day 30 in both groups.

Time frame
30 days

Other outcomes

Sponsors and contacts

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University of Trieste

Lead sponsor

Source ClinicalTrials.gov
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