Effectiveness and Efficiency of Home Telemonitoring and Non-invasive Ventilation in Patients With COPD and Hypercapnia (EVALECO)

NCT07679646 | Not Yet Recruiting

• 1 other identifier: EVALECO-TM+VNID-EPOC
• Study Type: observational
• Target: 92
• Locations: 1 country
• Sites: 1

Brief 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. 1.One group of patients will receive standard home non-invasive ventilation alone.
2. 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.

Conditions

Pulmonary Disease, Chronic Obstructive (COPD); Hypercapnia

Keywords

Home Noninvasive Ventilation; Telemonitoring; Respiratory Insufficiency

Outcome Measures

Primary Outcomes (1)

• Number of prevented days of hospitalization due to COPD acute exacerbations

  The total number of days a patient spends hospitalized in a general hospital ward or Intensive Care Unit (ICU) due to acute exacerbations of Chronic Obstructive Pulmonary Disease (COPD). An acute exacerbation is defined according to GOLD criteria as an increase in dyspnea, cough, and/or sputum worsening in less than 14 days.

  12 months

Secondary Outcomes (6)

• Health-Related Quality of Life and Utility (QALYs)

  Baseline, 30 days, 90 days, 180 days, 270 days, and 365 days.

• Number of Acute COPD Exacerbations

  12 months

• Number of Hospital Admissions due to COPD Exacerbations

  12 months

• Number of Emergency Department Visit

  12 months

• Time to first acute COPD exacerbation

  Up to 12 months

Study Arms (2)

NIV+TM Cohort

Patients managed with a combined strategy consisting of advanced pressure-controlled nocturnal home non-invasive ventilation (NIV) and continuous remote telemonitoring (TM). Device compliance, residual Apnea-Hypopnea Index (AHI), air leaks, respiratory rate, and tidal volume are monitored daily. High-priority automated alerts trigger a standardized clinical decision algorithm, requiring immediate telephone triage or parameter modifications.

Device: Home Non-Invasive Ventilation and Telemonitoring

Conventional NIV Cohort

Patients managed with conventional home non-invasive ventilation (NIV) following standard follow-up guidelines based on clinical dependence, without remote telemonitoring or automatic alert systems. Compliance and leak data are verified manually during scheduled domiciliary visits (monthly or quarterly depending on daily ventilation hours).

Interventions

Home Non-Invasive Ventilation and Telemonitoring DEVICE

Use of nocturnal home non-invasive ventilation devices equipped with or without integrated digital modems for automated parameter monitoring (compliance, leaks, residual AHI, respiratory rate, and tidal volume) over a 12-month follow-up period.

NIV+TM Cohort

Eligibility Criteria

• Age: 50 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

The study population consists of adult patients diagnosed with severe, stable Chronic Obstructive Pulmonary Disease (COPD) and chronic persistent hypercapnia, who are managed and followed at public university hospitals within the Community of Madrid, Spain, and who have a recent history of frequent acute respiratory exacerbations.

You may qualify if:

• 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.

You may not qualify if:

• 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.
• Severe psychiatric illness requiring antipsychotic medication, active ongoing treatment for substance or alcohol addiction, or lack of a fixed home address upon hospital discharge.
• Receipt of home palliative care.
• Institutionalization.
• Classification by the attending physician as non-compliant with medical therapies, treatments, or study protocols

Sponsors & Collaborators

• Air Liquide Healthcare Spain: lead

Study Sites (1)

Hospital General Universitario Gregorio Marañón

Madrid, Madrid, 28007, Spain

Location

MeSH Terms

Conditions

Lung Diseases; Pulmonary Disease, Chronic Obstructive; Hypercapnia; Respiratory Insufficiency

Condition Hierarchy (Ancestors)

Respiratory Tract Diseases; Lung Diseases, Obstructive; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Signs and Symptoms, Respiratory; Signs and Symptoms; Respiration Disorders

Central Study Contacts

Daniel López Padilla, MD, PhD

CONTACT

91 586 83 28; danieleduardo.lopez@salud.madrid.org

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 23, 2026
• First Posted: July 1, 2026
• Study Start: July 1, 2026
• Primary Completion: July 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: July 1, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)