Effectiveness and Efficiency of Home Telemonitoring and Non-invasive Ventilation in Patients With COPD and Hypercapnia
Trial Snapshot
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Sponsor
- Enrollment
- 92
- Locations
- 1
- Primary Endpoint
- Number of prevented days of hospitalization due to COPD acute exacerbations
Study Overview
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:
- One group of patients will receive standard home non-invasive ventilation alone.
- 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.
Detailed Description
Background and Rationale:
Chronic Obstructive Pulmonary Disease (COPD) with persistent hypercapnia is associated with increased mortality, functional decline, and high healthcare costs. While home non-invasive ventilation (NIV) is established as standard care to correct chronic respiratory failure, integrating remote telemonitoring (TM) presents an opportunity to implement early clinical interventions by allowing continuous oversight of ventilator parameters.
Study Design and Setting:
This is a prospective, multicenter, comparative cohort study with an integrated economic and utility evaluation. The study will be conducted across 5 public university hospitals within the Community of Madrid, Spain. A total of 92 patients (46 patients in the NIV+TM cohort and 46 in the conventional NIV cohort).
Study Hypotheses:
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 50 Years to 90 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
- •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) >=
- •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.
- •Receipt of home palliative care.
- •Institutionalization.
- •Classification by the attending physician as non-compliant with medical therapies, treatments, or study protocols
Outcomes
Primary Outcomes
Number of prevented days of hospitalization due to COPD acute exacerbations
Time Frame: 12 months
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.
Secondary Outcomes
- 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)
- Direct Healthcare Costs(12 months)