Acute Exacerbation of COPD, COPD (Chronic Obstructive Pulmonary Disease), Hypercapnia
Conditions
Keywords
Home management, Telehealth
Brief summary
This study is a randomized controlled trial designed to compare the effectiveness of active remote intervention versus passive monitoring alone in patients with Chronic Obstructive Pulmonary Disease (COPD) and chronic hypercapnic respiratory failure who are receiving home non-invasive respiratory support. The primary goal is to evaluate the impact on health-related quality of life and the frequency of acute exacerbations over a 12-month period.
Detailed description
Chronic Obstructive Pulmonary Disease (COPD) is a major cause of morbidity and mortality worldwide. A subset of patients with severe COPD develops chronic hypercapnic respiratory failure, often requiring long-term home non-invasive ventilation (NIV). While NIV can improve gas exchange, optimal management strategies, particularly post-hospitalization, are still being investigated. This study aims to determine if a proactive, remote management strategy can improve patient outcomes compared to standard care with passive monitoring. Experimental Group (Remote Intervention): Participants will receive home NIV with remote monitoring. A respiratory therapist will actively review ventilation data, assess oxygenation, and perform remote parameter adjustments and individualized optimization based on pre-set conditions and risk predictions. Control Group (Monitoring Control): Participants will receive home NIV with remote monitoring. However, the study team will not perform active interventions based on the monitoring data. Patients will continue with their usual care and follow-up with their primary physician. The study team will only make contact in case of a severe safety risk. The study will enroll 236 participants who will be randomized 1:1 to one of the two groups. The primary outcomes are the change in health-related quality of life and the number of COPD exacerbations over 12 months.
Interventions
OTHERRemote Management
Participants will receive home non-invasive respiratory support combined with active remote management. This includes regular analysis of ventilation data, assessment of oxygenation status, risk prediction, and remote parameter adjustment by a respiratory therapist.
Participants will receive home non-invasive respiratory support with remote monitoring only. No active intervention will be performed by the study team based on the data. Patients will continue with standard care from their primary physician.
Sponsors
Sir Run Run Shaw Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
40 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* Meets the diagnostic criteria for Chronic Obstructive Pulmonary Disease (COPD) with confirmed persistent airflow limitation by spirometry. * Hospitalized due to an acute exacerbation of COPD. * Stable daytime arterial blood gas analysis showing PaCO₂ ≥ 50 mmHg, with hypoxemia. * Already receiving or planned to receive long-term home non-invasive respiratory support. * Capable of using a smartphone or tablet for video communication and has internet access. * Willing to participate and provides written informed consent.
Exclusion criteria
* Concurrent severe pulmonary diseases (e.g., active tuberculosis, diffuse pulmonary fibrosis, advanced lung cancer). * Chronic respiratory failure primarily caused by non-COPD conditions (e.g., neuromuscular disease, chest wall deformity, or severe obesity hypoventilation syndrome). * Severe cognitive impairment or psychiatric illness that would prevent cooperation with remote management. * Other severe systemic diseases with an expected survival of less than 1 year (e.g., advanced malignancy). * Pregnant or lactating women.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Health-Related Quality of Life | Baseline to 12 months | Measured by the change from baseline in the total score of the St. George's Respiratory Questionnaire (SGRQ) questionnaire at 12 months. |
| Number of COPD Exacerbations | 12 months | The number of acute exacerbations requiring antibiotics and/or systemic corticosteroids within 12 months. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in PaCO₂ | Baseline, 1, 3, 6, 12 months | The change from baseline in arterial partial pressure of carbon dioxide (PaCO₂) at 1, 3, 6, and 12 months. |
| Changes in PaO₂ | Baseline, 1, 3, 6, 12 months | The change from baseline in arterial partial pressure of oxygen (PaO₂) at 1, 3, 6, and 12 months. |
| Change in Dyspnea Severity (mMRC Score) | Baseline, 1, 3, 6, 12 months | The change from baseline in the modified Medical Research Council (mMRC) dyspnea scale score to each follow up. The scale ranges from 0 to 4, with higher scores indicating more severe dyspnea. |
| Change in CAT Score | Baseline, 1, 3, 6, and 12 months | The change from baseline in the total score of the COPD Assessment Test (CAT) at 1, 3, 6, and 12 months. |
| Change in SRI Score | Time Frame: Baseline, 1, 3, 6, and 12 months | The change from baseline in the total score of the Severe Respiratory Insufficiency (SRI) questionnaire at 1, 3, 6, and 12 months. |
| Average daily usage of Non-invasive Ventilation | Baseline, 1, 3, 6, and 12 months | Average daily usage of the non-invasive ventilation device (hours per day) recorded at 1, 3, 6, and 12 months. |
| Adherence-Percentage of days with usage greater than 4 hours | Baseline, 1, 3, 6, and 12 months | Percentage of days with usage greater than 4 hours, recorded at 1, 3, 6, and 12 months. |
| Adverse Events | Baseline, 1, 3, 6, and 12 months | The number and type of adverse events (AEs) and serious adverse events (SAEs) reported throughout the 12-month study duration. |
Countries
China
Contacts
CONTACTHuiqing Ge, MD, PhD
Outcome results
None listed