Multiparametric Home Telemonitoring of Patients With Chronic Obstructive Pulmonary Disease Exacerbation

NCT06331416 | Recruiting

• 1 other identifier: CEUR-2023-Em-145
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

COPD; COPD Exacerbation Acute

Outcome Measures

Primary Outcomes (1)

• Re-hospitalization at 90 days

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

  90 days

Secondary Outcomes (6)

• Re-hospitalization at 30 days

  30 days

• Functional decline

  90 days

• Unplanned medical evaluations

  90 days

• Need for mechanical ventilation at 30 days

  30 days

• Need for mechanical ventilation at 90 days

  90 days

Study Arms (2)

Telemonitoring

EXPERIMENTAL

Device: Telemonitoring

Standard of care

NO INTERVENTION

Interventions

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.

Telemonitoring

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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.

You may not qualify if:

• 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
• Chronic renal failure with dialysis dependence
• Immunosuppression (i.e. cancer on treatment, post-organ transplantation, HIV-positive, on immunosuppressant therapy)
• Progressive neuro-muscular disorders
• Cognitively impaired, dementia or decompensated psychiatric disorder
• Quadriplegia/Hemiplegia or quadriparesis/hemiparesis
• Do-not-resuscitate order
• Any other condition that in the opinion of the investigator may significantly impact with patient's capability to comply with the protocol

Sponsors & Collaborators

• University of Trieste: lead

Study Sites (1)

SC Pneumologia, Azienda Sanitaria Universitaria Giuliano-Isontina

Trieste, 34126, Italy

RECRUITING

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Marco Confalonieri, MD

  University of Trieste

  STUDY CHAIR

Central Study Contacts

Francesco Salton, MD

CONTACT

00390403994667; francesco.salton@gmail.com

Msrco Confalonieri, MD

CONTACT

00390403994667; mconfalonieri@units.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Model Details: Open-label randomized controlled trial, allocation ratio 1:1

Study Record Dates

• First Submitted: March 19, 2024
• First Posted: March 26, 2024
• Study Start: March 29, 2024
• Primary Completion: April 1, 2026
• Study Completion (Estimated): September 30, 2026
• Last Updated: May 2, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF, CSR
• Time Frame: From the end of the study for 2 years
• Access Criteria: email to the PI

Locations

IT (1)