RecruitingNot ApplicableNCT06331416

Multiparametric Home Telemonitoring of Patients With Chronic Obstructive Pulmonary Disease Exacerbation


Sponsor

University of Trieste

Enrollment

60 participants

Start Date

Mar 29, 2024

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 YearsMax Age: 90 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a home telemonitoring program for people with COPD (chronic obstructive pulmonary disease — a lung condition causing difficulty breathing) who have just been hospitalized for a flare-up (exacerbation) of their condition. Patients will use home monitoring devices after discharge so their healthcare team can keep track of their recovery remotely and intervene early if needed. Researchers want to know if this reduces re-hospitalization rates and improves quality of life. **You may be eligible if:** - You have an established diagnosis of COPD - You were admitted to hospital for a COPD flare-up - Your oxygen levels were low on admission but improved before discharge - You are between 18 and 90 years old **You may NOT be eligible if:** - Your breathing problems are mainly caused by heart failure, pulmonary embolism, interstitial lung disease, or pneumonia - You are on dialysis for chronic kidney failure - You have a compromised immune system (such as active cancer treatment, organ transplant, HIV, or immunosuppressive drugs) - You have progressive neuromuscular disease, significant cognitive impairment or dementia, paralysis, or a do-not-resuscitate order Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICETelemonitoring

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.


Locations(1)

SC Pneumologia, Azienda Sanitaria Universitaria Giuliano-Isontina

Trieste, Italy

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NCT06331416


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