Effectiveness and Efficiency of Home Telemonitoring and Non-invasive Ventilation in Patients With… (NCT07679646) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Effectiveness and Efficiency of Home Telemonitoring and Non-invasive Ventilation in Patients With COPD and Hypercapnia (EVALECO)
Spain92 participantsStarted 2026-07
Plain-language summary
The purpose of this study is to evaluate the effectiveness and clinical efficiency of combining home non-invasive ventilation (NIV) with a continuous remote telemonitoring (TM) system in patients with Chronic Obstructive Pulmonary Disease (COPD) and persistent hypercapnia. In standard practice, patients with severe COPD and high carbon dioxide levels in their blood are treated with home non-invasive ventilation to support their breathing. This study compares two different care strategies over a one-year follow-up period:
1. One group of patients will receive standard home non-invasive ventilation alone.
2. Another group will receive home non-invasive ventilation combined with an automated telemonitoring system that tracks device parameters daily (such as air leaks, device usage, and breathing rates) and sends automated alerts to the healthcare team if deviations occur. The main goal of the project is to determine if adding a telemonitoring follow-up system can prevent clinical worsenings and significantly reduce the total number of days patients spend hospitalized due to severe COPD flare-ups. Additionally, the study will analyze the impact of both strategies on patients' overall health-related quality of life and the economic costs within the healthcare system.
Who can participate
Age range
50 Years – 90 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Age between 50 and 90 years.
. Confirmed diagnosis of Chronic Obstructive Pulmonary Disease (COPD) according to current Global Initiative for Chronic Obstructive Lung Disease (GOLD) criteria, demonstrating non-fully reversible airflow limitation with a Forced Expiratory Volume in 1 second (FEV1) \< 50% of the predicted value confirmed by spirometry.
. Persistent hypercapnia, defined as PaCO2 \> 53 mmHg documented for at least two weeks following an acute COPD exacerbation.
. History of two or more acute COPD exacerbations within the preceding year.
. Signed written informed consent.
Exclusion criteria
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Number of prevented days of hospitalization due to COPD acute exacerbations
. Prior ongoing treatment with home non-invasive ventilation (NIV) or Continuous Positive Airway Pressure (CPAP).
. Severe obstructive sleep apnea (OSA), defined as an Apnea-Hypopnea Index (AHI) \>= 30.
. Inability of the patient or the primary caregiver to comprehend or operate the telemonitoring and NIV procedures.
. Estimated life expectancy of less than one year.
. Terminal heart failure (New York Heart Association \[NYHA\] Class III-IV) or unstable angina.
. Advanced renal insufficiency (creatinine clearance \< 30%) or inclusion in an active dialysis program.
. Hepatic cirrhosis or active inclusion in a liver transplant program.
. Severe psychiatric illness requiring antipsychotic medication, active ongoing treatment for substance or alcohol addiction, or lack of a fixed home address upon hospital discharge.