About this trial
Chronic obstructive pulmonary disease (COPD) is a major chronic respiratory condition with high prevalence of multimorbidity. COPD and comorbidities interact dynamically, contributing to symptom fluctuation, acute exacerbations, hospitalization, and long-term disease progression.
The IMPACT COPD Cohort (China) is a multicenter prospective observational cohort designed to establish a real-world evidence base for integrative Chinese-Western medicine management of COPD with comorbidities. The cohort integrates conventional clinical assessments (symptoms, questionnaires, spirometry, imaging, and biomarkers) with continuous multisensor digital monitoring (e.g., heart rate, blood pressure, activity, sleep patterns, and other physiological and behavioral measures) and digital Traditional Chinese Medicine (TCM) phenotyping (e.g., tongue, pulse, and facial diagnostics).
The study aims to characterize risk profiles of high-risk populations and patients with confirmed comorbidities, develop and validate prediction models for comorbidity risk and acute exacerbation events, and support evidence generation for long-term management strategies with early screening and risk warning capabilities across hospital, community, and home settings.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
None
Disqualifiers
None
Trial population
Participants will be recruited from multiple hospitals in China. Eligible participants are adults aged 40-80 years with COPD diagnosed according to the 2025 GOLD criteria, identified in outpatient clinics and/or inpatient settings and enrolled for prospective follow-up.
Trial design
Cohort
Prospective
Treatments tested in this trial
Real-World Integrative COPD Care and Continuous Multisensor Monitoring
Other interventionParticipants will receive routine clinical care according to GOLD guideline and local clinical practice. This observational cohort collects longitudinal data through conventional clinical assessments (questionnaires, spirometry, imaging, and biomarkers) and continuous multisensor digital monitoring (e.g., heart rate, blood pressure, activity, and sleep), along with digital Traditional Chinese Medicine (TCM) phenotyping (tongue, pulse, and facial features). No study-mandated therapeutic intervention is assigned.
Treatment groups
Trial outcomes
Primary outcomes
Annual rate of COPD exacerbation
Incidence of COPD-related comorbidities (hypertension, coronary artery disease, arrhythmia, heart failure, diabetes, etc.)
Sponsors and contacts
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