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Enhanced Health Intervention for Chronic Obstructive Pulmonary Disease in Primary Care: A Cluster Randomized Controlled Trial

Enhanced Health Intervention for Chronic Obstructive Pulmonary Disease in Primary Care:A Cluster Randomized Controlled Trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2600125903
Enrollment
Unknown
Registered
2026-06-01
Start date
2026-07-10
Completion date
Unknown
Last updated
2026-07-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Obstructive Pulmonary Disease

Interventions

Intervention Group:Participants in the intervention group will receive a 12-month integrated primary care intervention delivered by a service team comprising respiratory specialists, primary care phys
Control Group:Usual care

Sponsors

Peking University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
35 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1.A previous diagnosis of chronic obstructive pulmonary disease (COPD), confirmed either by spirometry showing a post-bronchodilator FEV1/FVC < 0.70 or by a healthcare institution based on a comprehensive assessment of medical history, clinical presentation, pulmonary function testing, and imaging findings. 2.Aged 35–80 years, inclusive. 3.Having resided in the study area (the catchment area of the selected community health centers or township health centers) for at least 12 months. 4.Able to communicate effectively and understand study procedures, and capable of completing questionnaires, follow-up assessments, and other study-related data collection activities. 5.Willing to participate in the study, provide written informed consent, and comply with all study interventions and follow-up procedures.

Exclusion criteria

Exclusion criteria: 1.An expected life expectancy of less than 12 months, making participation in the study intervention and follow-up infeasible. 2.Inability to perform the required study interventions because of severe physical disability, cognitive impairment, or other conditions resulting in dependence in activities of daily living. 3.Unwillingness to participate in study-related interventions or data collection procedures. 4.Failure to meet the residency requirement, or plans to relocate outside the study area during the study period, thereby preventing completion of follow-up. 5.Participation in another COPD intervention study within the previous 3 months, which may affect the evaluation of the study outcomes.

Design outcomes

Primary

MeasureTime frame
Occurrence of acute exacerbations of COPD (AECOPD);

Secondary

MeasureTime frame
Rate of guideline-concordant inhaled pharmacotherapy;COPD Assessment Test (CAT) score;Health-related quality of life (EQ-5D);Depressive symptoms (Patient Health Questionnaire-9 [PHQ-9]);Adherence to inhaled medication;Healthcare utilization;Influenza and pneumococcal vaccination status;Modified Medical Research Council (mMRC) dyspnea score;

Countries

China

Contacts

Public ContactPing He

Peking University

2511110238@stu.pku.edu.cn+86 138 1201 6112

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Jul 23, 2026