IMPACT COPD Cohort — integrated Chinese–Western care and digital monitoring in China

Integrative Medicine Program for COPD With Comorbidity Management

This project will try continuous wearable and digital monitoring plus combined Chinese and Western medicine approaches for people aged 40–80 who have COPD and other chronic conditions to see if it improves care.

Quick facts

• Study type: Observational
• Enrollment: 10000 (estimated)
• Ages: 40 Years to 80 Years
• Sex: All
• Sponsor: Beijing Chao Yang Hospital (Academic / other)
• Drugs / interventions: chemotherapy
• Locations: 4 sites (Hebi, Henan and 3 other locations)
• Trial ID: NCT07382986 on ClinicalTrials.gov

What this trial studies

IMPACT COPD Cohort is a multicenter prospective observational cohort enrolling people with COPD and multimorbidity across several Chinese hospitals. The study combines standard clinical assessments (symptoms, questionnaires, spirometry, imaging, and biomarkers) with continuous multisensor digital monitoring of physiology and behavior and with digital Traditional Chinese Medicine phenotyping (for example, tongue, pulse, and facial diagnostics). Data will be used to characterize risk profiles, symptom fluctuation, and exacerbation patterns in real-world integrative care settings and to support development of predictive models and management pathways. No investigational drug is administered because the study is observational and focuses on data collection and care integration.

Who should consider this trial

Good fit: Ideal participants are adults aged 40–80 with a diagnosis of COPD according to the 2025 GOLD criteria, especially those with one or more chronic comorbidities and who can attend follow-up visits at the participating hospitals.

Not a fit: Patients with a recent COPD exacerbation (within 4 weeks), other major pulmonary diseases causing chronic respiratory failure, recent or ongoing chemotherapy/radiotherapy, organ transplants, or uncontrolled systemic autoimmune disease are unlikely to qualify or benefit from this observational protocol.

Why it matters

Potential benefit: If successful, the project could enable earlier detection of worsening COPD and help tailor integrative treatment plans for people with multiple chronic conditions.

How similar studies have performed: Wearable/multisensor monitoring and integrated care models have shown promise in improving COPD monitoring and reducing some hospitalizations, but combining those approaches with digital TCM phenotyping is relatively novel and less well proven.

Eligibility criteria

Inclusion Criteria:

Age 40-80 years; Diagnosis of chronic obstructive pulmonary disease (COPD) according to the 2025 GOLD criteria.

Exclusion Criteria:

Acute exacerbation of COPD within the past 4 weeks; Presence of other pulmonary diseases causing chronic respiratory failure in addition to COPD, such as severe bronchiectasis, pneumoconiosis, post-tuberculosis destroyed lung, chest wall deformity, or neuromuscular disease; Cystic fibrosis or interstitial lung disease; Severe respiratory failure requiring long-term mechanical ventilation via tracheostomy; History of lung or other organ transplantation; Severe pleural disease or chest wall abnormalities that interfere with imaging or pulmonary function assessment; Lung cancer or other malignancy with widespread metastatic disease; Previous or current chemotherapy and/or radiotherapy that may affect pulmonary function or structural assessment; Uncontrolled rheumatic/autoimmune diseases (e.g., rheumatoid arthritis, systemic lupus erythematosus); HIV infection; Long-term use of immunosuppressive agents or systemic corticosteroids; Severe organ dysfunction, such as severe cardiac, hepatic, or renal failure, or severe pulmonary arterial hypertension; Hospitalization due to myocardial infarction, heart failure, or other cardiovascular events within the past 3 months; Major surgery involving the chest, abdomen, or eyes within the past 3 months; Presence of intrathoracic metallic foreign bodies or implants that interfere with imaging assessment (e.g., pacemaker, implantable cardioverter-defibrillator, metallic prosthetic valves, other metallic devices, or shrapnel); Allergy to any component of the investigational Chinese herbal compound formula(s); Allergy to any component of ICS+LABA+LAMA therapy or to inhaler propellants/excipients; Unable to accept and wear wearable devices; Pregnant or breastfeeding women; Long-term bedridden status, loss of ability to perform activities of daily living, or life expectancy \<1 year; Dementia or other cognitive impairment preventing informed consent and follow-up; Living far from the study center, or planned relocation within the next 3 years, making follow-up infeasible; Current participation in another interventional clinical trial involving the respiratory system; Refusal to provide written informed consent.

Where this trial is running

Hebi, Henan and 3 other locations

• Hebi Coal Industry Group General Hospital — Hebi, Henan, China (Recruiting)
• Tongliao Second People's Hospital — Tongliao, Neimeng, China (Recruiting)
• Mianyang Third People's Hospital — Mianyang, Sichuan, China (Recruiting)
• The First Affiliated Hospital of Shihezi University — Shihezi, Xinjiang, China (Recruiting)

Study contacts

• Study coordinator: Zujin Luo, MD

Conditions Chronic Obstructive Pulmonary Disease; Multimorbidities