COPDNCT06331416
Multiparametric Home Telemonitoring of Patients With Chronic Obstructive Pulmonary Disease Exacerbation
A study testing Telemonitoring in people with COPD and COPD Exacerbation Acute, run by University of Trieste at 1 site in Italy.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- COPD, COPD Exacerbation Acute
- What is being tested?
- Telemonitoring
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteItaly
- Study dates
- 29 Mar 2024to 30 Sep 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
- Age <= 90 and >= 18 years old at randomization.
Who cannot join
- 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)
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- 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
Trial locations and contacts
1 site in 1 country.
Italy1 site, 1 recruiting
- Recruiting
SC Pneumologia, Azienda Sanitaria Universitaria Giuliano-Isontina
Trieste, 34126
Francesco Salton, MD, 00390403994667, francesco.salton@asugi.sanita.fvg.it
About this study
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.
Read the detailed description
Respiratory diseases such as asthma, chronic obstructive pulmonary disease (COPD), lung cancer, obstructive sleep apnea syndrome, pulmonary fibrosis and others are important causes of morbidity and mortality and have a substantial impact on healthcare costs. Furthermore, the Coronavirus-19 (COVID-19) pandemic has shown how respiratory complications are the most dangerous for infected subjects, as they can evolve into a severe pneumonia burdened by either subacute or chronic complications. Strict monitoring, early treatment initiation and timely hospitalization are fundamental to ameliorate short-term prognosis and reduce long-term sequelae of all acute respiratory conditions, including chronic obstructive pulmonary disease (COPD). Indeed, acute worsening of respiratory symptoms, called exacerbations, often occur during the course of the disease. COPD exacerbations are associated with an accelerated decline in respiratory function, and exacerbation frequency or intensity is a powerful predictor of future episodes and ultimate mortality which reaches as high as 50% at 5 years. Indeed, exacerbation frequency is the strongest single factor related to future exacerbations, and mortality rates increase 3-fold as exacerbation frequency increases from 0 to 3 or more per year. Recent data shown that 30-day readmission rate for COPD patients after discharge ranged from 22.6% to 24%, while 90-day readmission was 35.1% to 43% in different studies. Furthermore, severe COPD exacerbations resulting in hospitalization can be up to 60 times more expensive than mild or moderate exacerbations managed by primary care services. As a consequence, the medical community have launched numerous initiatives to reduce exacerbations, with a particular focus on reducing readmissions. These initiatives involve improving medication regimens and adherence, smoking cessation, pulmonary rehabilitation, assessments for oxygen supplementation and noninvasive ventilation, and close follow-up by clinicians following discharge. At the current state of things, patients discharged after an hospitalization for COPD exacerbation are followed-up through discrete, in-person, evaluation within one to three months. However, this timeframe is often not sufficient to identify clinical deterioration and the need for changes in the therapeutic strategy (e.g. switch of inhaler, counselling on the inhalation technique, need for oral add-on therapy) to avoid recurrence of symptoms and re-hospitalization. Nevertheless, there are no established programs to help medical doctors reduce COPD re-admissions. Since over two decades, telemedicine has been demonstrated effective in improving patients' health-related quality of life and in increasing the efficiency of care processes, but it has only recently been proposed as a strategy to reduce COPD readmission rate. Indeed, The COVID-19 pandemic has increased the awareness on the available systems for telemonitoring and favored the development of new ones. Telemonitoring is one major field of telemedicine which encompasses remote tracking of physiological parameters, either in real time or using store-and-forward technologies, allowing to screen for the patients who could benefit most of either home visits or hospitalization. Multiple devices have been made available for these purposes during the COVID-19 pandemic. We designed a randomized controlled trial to evaluate the ability of telemonitoring to avoid lung function decline, reduce symptoms and the risk of re-hospitalizations of patients discharged after a COPD exacerbation.
- Conditions
- COPD, COPD Exacerbation Acute
- Being tested
- Telemonitoring
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TelemonitoringDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Telemonitoring | Experimental | Not described Receives: Device: Telemonitoring |
| Standard of care | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Re-hospitalization at 90 days
Proportion of re-hospitalized patients by day 90 in both groups
Measured: 90 days
Secondary outcomes (6)
Re-hospitalization at 30 days
Proportion of re-hospitalized patients by day 30 in both groups
Measured: 30 days
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.
Measured: 90 days
Unplanned medical evaluations
Number of unplanned pneumological evaluation in both groups.
Measured: 90 days
Need for mechanical ventilation at 30 days
Proportion of patients who require mechanical ventilation (either noninvasive or invasive) by day 30 in both groups.
Measured: 30 days
Need for mechanical ventilation at 90 days
Proportion of patients who require mechanical ventilation (either noninvasive or invasive) by day 90 in both groups.
Measured: 90 days
Satisfaction score
Self-reported score for overall satisfaction ≥ 8/10 for ≥ 80% of patients in the intervention group.
Measured: 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Mar 2024
- Study start29 Mar 2024
- Primary completion1 Apr 2026 (estimated)
- Study completion30 Sep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COPDStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Open-label randomized controlled trial, allocation ratio 1:1
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Trieste
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Confalonieri Marco, MD, University of Trieste
- Investigators
- Marco Confalonieri, MD, Study chair, University of Trieste
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06331416
- Sponsor's protocol ID
- CEUR-2023-Em-145
- Status last verified
- Apr 2024
- First submitted
- 19 Mar 2024
- Last updated
- 2 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Deidentified data will be shared upon motivated request to the PI
Study at a glance
From the registry record, last updated by the sponsor on 2 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multiparametric Home Telemonitoring of Patients With Chronic Obstructive Pulmonary Disease Exacerbation
- ClinicalTrials.gov ID
- NCT06331416
- Acronym / sponsor ID
- CEUR-2023-Em-145
- Conditions
- COPD, COPD Exacerbation Acute
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- University of TriesteUniversity, hospital or other
- Study start
- 29 Mar 2024 (actual)
- Primary completion
- 1 Apr 2026 (estimated)
- Study completion
- 30 Sep 2026 (estimated)
- First posted
- 26 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Respiratory diseases such as asthma, chronic obstructive pulmonary disease (COPD), lung cancer, obstructive sleep apnea syndrome, pulmonary fibrosis and others are important causes of morbidity and mortality and have a substantial impact on healthcare costs. Furthermore, the Coronavirus-19 (COVID-19) pandemic has shown how respiratory complications are the most dangerous for infected subjects, as they can evolve into a severe pneumonia burdened by either subacute or chronic complications. Strict monitoring, early treatment initiation and timely hospitalization are fundamental to ameliorate short-term prognosis and reduce long-term sequelae of all acute respiratory conditions, including chronic obstructive pulmonary disease (COPD). Indeed, acute worsening of respiratory symptoms, called exacerbations, often occur during the course of the disease. COPD exacerbations are associated with an accelerated decline in respiratory function, and exacerbation frequency or intensity is a powerful predictor of future episodes and ultimate mortality which reaches as high as 50% at 5 years. Indeed, exacerbation frequency is the strongest single factor related to future exacerbations, and mortality rates increase 3-fold as exacerbation frequency increases from 0 to 3 or more per year. Recent data shown that 30-day readmission rate for COPD patients after discharge ranged from 22.6% to 24%, while 90-day readmission was 35.1% to 43% in different studies. Furthermore, severe COPD exacerbations resulting in hospitalization can be up to 60 times more expensive than mild or moderate exacerbations managed by primary care services. As a consequence, the medical community have launched numerous initiatives to reduce exacerbations, with a particular focus on reducing readmissions. These initiatives involve improving medication regimens and adherence, smoking cessation, pulmonary rehabilitation, assessments for oxygen supplementation and noninvasive ventilation, and close follow-up by clinicians following discharge. At the current state of things, patients discharged after an hospitalization for COPD exacerbation are followed-up through discrete, in-person, evaluation within one to three months. However, this timeframe is often not sufficient to identify clinical deterioration and the need for changes in the therapeutic strategy (e.g. switch of inhaler, counselling on the inhalation technique, need for oral add-on therapy) to avoid recurrence of symptoms and re-hospitalization. Nevertheless, there are no established programs to help medical doctors reduce COPD re-admissions. Since over two decades, telemedicine has been demonstrated effective in improving patients' health-related quality of life and in increasing the efficiency of care processes, but it has only recently been proposed as a strategy to reduce COPD readmission rate. Indeed, The COVID-19 pandemic has increased the awareness on the available systems for telemonitoring and favored the development of new ones. Telemonitoring is one major field of telemedicine which encompasses remote tracking of physiological parameters, either in real time or using store-and-forward technologies, allowing to screen for the patients who could benefit most of either home visits or hospitalization. Multiple devices have been made available for these purposes during the COVID-19 pandemic. We designed a randomized controlled trial to evaluate the ability of telemonitoring to avoid lung function decline, reduce symptoms and the risk of re-hospitalizations of patients discharged after a COPD exacerbation.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Open-label randomized controlled trial, allocation ratio 1:1
| Arm | Type | Receives |
|---|---|---|
| Telemonitoring | Experimental | Device: Telemonitoring |
| Standard of care | No intervention | – |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TelemonitoringPatients 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. | Device | Telemonitoring |
Primary outcome
Re-hospitalization at 90 days
Time frame: 90 days
Proportion of re-hospitalized patients by day 90 in both groups
6 secondary outcomes
Re-hospitalization at 30 days
Time frame: 30 days
Functional decline
Time frame: 90 days
Unplanned medical evaluations
Time frame: 90 days
Need for mechanical ventilation at 30 days
Time frame: 30 days
Need for mechanical ventilation at 90 days
Time frame: 90 days
Satisfaction score
Time frame: 90 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 May 2024.
- Individual participant dataSharing planned: Yes. Deidentified data will be shared upon motivated request to the PI
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marco Confalonieri, MD study chair
University of Trieste
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Telemonitoring in people with COPD and COPD Exacerbation Acute, run by University of Trieste at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 2 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Francesco Salton, MD (00390403994667, francesco.salton@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Re-hospitalization at 90 days (time frame: 90 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 May 2024.