IMPACT COPD Cohort (China)

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age40-80
SponsorBeijing Chao Yang Hospital

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 volunteers

Qualifiers

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

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Real-World Integrative COPD Care and Continuous Multisensor Monitoring

    Other intervention

    Participants 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

No treatment groups listed

Trial outcomes

Primary outcomes

1

Annual rate of COPD exacerbation

Time frame
up to 36 months
2

Incidence of COPD-related comorbidities (hypertension, coronary artery disease, arrhythmia, heart failure, diabetes, etc.)

Time frame
up to 36 months

Secondary outcomes

Other outcomes

Sponsors and contacts

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