ClinicalTrials.gg
RecruitingNCT06331416Updated May 2, 2024

Multiparametric Home Telemonitoring of Patients With Chronic Obstructive Pulmonary Disease Exacerbation

An interventional study of Telemonitoring in COPD and COPD Exacerbation Acute, sponsored by University of Trieste. Recruiting at 1 site in Italy. Open to participants aged 18 Years to 90 Years. Per ClinicalTrials.gov, last updated 2024-05-02.

Sponsored by University of Trieste · Not applicable, Interventional, and Health services research

From the registry’s dates

  • Primary completion was expected by Apr 2026, 7 months ago, but the record still lists the study as recruiting.
  • Started Mar 2024; still recruiting 2 years 7 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
60
Allocation
Randomized
Ages
18 Years to 90 Years
Sex
All
01

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.

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.

02

Conditions studied

  • COPD
  • COPD Exacerbation Acute
03

In context

Pulmonary Disease, Chronic Obstructive

5,520 studies on the registry are indexed under Pulmonary Disease, Chronic Obstructive; 856 are open to participants now.

This study's planned enrollment of 60 is close to the median of 62 across 3,839 interventional studies indexed under Pulmonary Disease, Chronic Obstructive.

Browse Pulmonary Disease, Chronic Obstructive studies →

Lead sponsor

University of Trieste is the lead sponsor of 39 studies on the registry; 8 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 90 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. Able to understand and sign the form.
  2. Already established diagnosis of according to Global Initiative for Obstructive Lung Disease (GOLD) guidelines.[13]
  3. Diagnosis of COPD exacerbation at admission, according to GOLD guidelines.[13]
  4. 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.
  5. 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.

Exclusion criteria

Exclusion Criteria:

  1. Heart failure as the main cause of acute respiratory failure
  2. Acute pulmonary embolism/chronic pulmonary thromboembolism
  3. Interstitial lung disease as the main cause of acute respiratory failure
  4. Pneumonia as the main cause of acute respiratory failure
  5. Chronic renal failure with dialysis dependence
  6. (i.e. cancer on treatment, post-organ transplantation, -positive, on immunosuppressant therapy)
  7. Progressive neuro-muscular disorders
  8. Cognitively impaired, dementia or decompensated psychiatric disorder
  9. Quadriplegia/Hemiplegia or quadriparesis/hemiparesis
  10. Do-not-resuscitate order
  11. Any other condition that in the opinion of the investigator may significantly impact with patient's capability to comply with the protocol
Terms in these criteria, in plain language(4)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

COPD

Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.

Immunosuppression

A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.

Read whether the line is about a condition or about medicines, and which medicines and doses it means.

HIV

The human immunodeficiency virus, which weakens the immune system.

Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.

05

Study design

Phase
Not applicable
Primary purpose
Health services research
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
60 participants (estimated)

Study arms

  • Experimental
    Telemonitoring

    Device: Telemonitoring

  • No intervention
    Standard of care

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.

06

What researchers measure

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

  5. Need for mechanical ventilation at 90 days

    Proportion of patients who require mechanical ventilation (either noninvasive or invasive) by day 90 in both groups.

    Time frame: 90 days

  6. Satisfaction score

    Self-reported score for overall satisfaction ≥ 8/10 for ≥ 80% of patients in the intervention group.

    Time frame: 90 days

07

Study locations

1 of 1 sites recruiting
08

References and documents

Individual participant data

Plan to share: Yes — Deidentified data will be shared upon motivated request to the PI

Supporting information: Study protocol, Informed consent form, Clinical study report

Time frame: From the end of the study for 2 years

Access criteria: email to the PI

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Mar 2024 (actual). Primary completion is estimated for Apr 2026, 24 months after the start.

Of 1,094 non-industry interventional studies with no phase under Pulmonary Disease, Chronic Obstructive, half reached primary completion within 22 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 41. This study's planned 24 months is close to that.

Counting every sponsor, half of 1,181 studies reached it within 22 months; a quarter within 10 and three quarters within 39.

How these figures are worked out, and which studies are left out of them.

Registered
Mar 19, 2024
First posted
Mar 26, 2024
StartActual
Mar 29, 2024
Primary completionEst.
Apr 1, 2026
CompletionEst.
Sep 30, 2026
Last update
May 2, 2024
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on May 2, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06331416
Lead sponsor
University of Trieste
Responsible party
Confalonieri Marco, MD (MD, University of Trieste) — Principal investigator
First posted
Mar 26, 2024
Start date
Mar 29, 2024
Primary completion
Apr 1, 2026 (estimated)
Completion
Sep 30, 2026 (estimated)
Last update
May 2, 2024

Study contacts

Francesco Salton, MD
Contact
francesco.salton@gmail.com
00390403994667
Msrco Confalonieri, MD
Contact
mconfalonieri@units.it
00390403994667
Marco Confalonieri, MD
study chair · University of Trieste

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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