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Multiparametric Home Telemonitoring of Patients With Chronic Obstructive Pulmonary Disease Exacerbation

NCT06331416 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2024-05-02

No results posted yet for this study

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

Interventions

DEVICE

Telemonitoring

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.

Sponsors & Collaborators

  • University of Trieste

    lead OTHER

Principal Investigators

  • Marco Confalonieri, MD · University of Trieste

Study Design

Allocation
RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
90 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-03-29
Primary Completion
2026-04-01
Completion
2026-09-30

Countries

  • Italy

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06331416 on ClinicalTrials.gov