Remote Intervention Versus Routine Monitoring in COPD Patients With Chronic Hypercapnia Receiving Home Non-invasive Respiratory Support

A Randomized Controlled Trial of Remote Intervention Versus Routine Monitoring in COPD Patients With Chronic Hypercapnia Receiving Home Non-invasive Respiratory Support

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Hypercapnia; Acute Exacerbation of COPD; COPD (Chronic Obstructive Pulmonary Disease)
• Intervention / Treatment: Other: Remote Management; Other: Remote Monitoring Only

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.

• Study Type: Interventional
• Enrollment (Estimated): 236
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Huiqing Ge, MD, PhD; Phone Number: +86 13588706787; Email: gehq@zju.edu.cn

Study Locations

• China
  • Henan
    • Zhengzhou, Henan, China
      • Henan Provincial People's Hospital
      • Contact: Qiang Kui, MD; Phone Number: +86 13460317523; Email: syhxzzggyx@163.com
  • Hunan
    • Changsha, Hunan, China, 410006
      • The second Xiangya Hospital of Central South University
      • Contact: Liucun Li; Phone Number: +86 0731-852959999; Email: xyeyyibd@sina.com
  • Zhejiang
    • Hangzhou, Zhejiang, China, 310016
      • Sir Run Run Shaw Hospital, School of Medicine, Zhejiang University
      • Contact: Huiqing Ge; Phone Number: +86 13588706787; Email: gehq@zju.edu.cn
    • Wenling, Zhejiang, China, 317523
      • Taizhou Hospital of Integrated Traditional Chinese and Western Medicine
      • Contact: Ting Jiang; Phone Number: +86 13758692956; Email: 13758692956@139.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Remote Intervention Group; Participants will receive home non-invasive respiratory support combined with active remote management.	Other: Remote 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.; Other: Remote Monitoring Only; 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.
Active Comparator: Monitoring Control Group; Participants will receive home non-invasive respiratory support with remote monitoring only.	Other: Remote Monitoring Only; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Health-Related Quality of Life	Measured by the change from baseline in the total score of the St. George's Respiratory Questionnaire (SGRQ) questionnaire at 12 months.	Baseline to 12 months
Number of COPD Exacerbations	The number of acute exacerbations requiring antibiotics and/or systemic corticosteroids within 12 months.	12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in PaCO₂	The change from baseline in arterial partial pressure of carbon dioxide (PaCO₂) at 1, 3, 6, and 12 months.	Baseline, 1, 3, 6, 12 months
Changes in PaO₂	The change from baseline in arterial partial pressure of oxygen (PaO₂) at 1, 3, 6, and 12 months.	Baseline, 1, 3, 6, 12 months
Change in Dyspnea Severity (mMRC Score)	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.	Baseline, 1, 3, 6, 12 months
Change in CAT Score	The change from baseline in the total score of the COPD Assessment Test (CAT) at 1, 3, 6, and 12 months.	Baseline, 1, 3, 6, and 12 months
Change in SRI Score	The change from baseline in the total score of the Severe Respiratory Insufficiency (SRI) questionnaire at 1, 3, 6, and 12 months.	Time Frame: Baseline, 1, 3, 6, and 12 months
Average daily usage of Non-invasive Ventilation	Average daily usage of the non-invasive ventilation device (hours per day) recorded at 1, 3, 6, and 12 months.	Baseline, 1, 3, 6, and 12 months
Adherence-Percentage of days with usage greater than 4 hours	Percentage of days with usage greater than 4 hours, recorded at 1, 3, 6, and 12 months.	Baseline, 1, 3, 6, and 12 months
Adverse Events	The number and type of adverse events (AEs) and serious adverse events (SAEs) reported throughout the 12-month study duration.	Baseline, 1, 3, 6, and 12 months

Collaborators and Investigators

• Sponsor: Sir Run Run Shaw Hospital

Study record dates

Study Major Dates

• Study Start (Estimated): August 1, 2027
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2028

Study Registration Dates

• First Submitted: July 30, 2026
• First Submitted That Met QC Criteria: August 3, 2026
• First Posted (Actual): August 6, 2026

Study Record Updates

• Last Update Posted (Actual): August 6, 2026
• Last Update Submitted That Met QC Criteria: August 3, 2026
• Last Verified: July 1, 2026

More Information

Terms related to this study

• Keywords: Telehealth; Home management
• Additional Relevant MeSH Terms: Pathologic Processes; Chronic Disease; Disease Attributes; Respiratory Tract Diseases; Lung Diseases; Lung Diseases, Obstructive; Signs and Symptoms, Respiratory; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Pulmonary Disease, Chronic Obstructive; Hypercapnia
• Other Study ID Numbers: 20260597

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No