Accepted for/Published in: JMIR Research Protocols
Date Submitted: Oct 10, 2025
Date Accepted: Dec 18, 2025
Impact of the POPulation Medicine Multimorbidity Intervention in Xishui County (POPMIX) on people at high risk for COPD: Protocol of the POPMIX-COPD cluster-randomized controlled trial
ABSTRACT
Background:
Tobacco-related non-communicable diseases (NCDs) present a major public health challenge to China, requiring population-level management. Chronic obstructive pulmonary disease (COPD) is the most common and prevalent chronic respiratory disease linked with tobacco use. Additionally, COPD shares risk factors with other NCDs that frequently co-occur, leading to multimorbidity.
Objective:
This study focuses on the early detection and integrated management of COPD and related multimorbidity among high-risk populations. Population medicine, an emerging and evolving concept that aims to maximize population health and wellbeing, presents a promising framework for shifting the focus of intervention against COPD from the individual patient to the population level.
Methods:
We are conducting a two-arm population-based stratified cluster-randomized controlled trial (cRCT) to evaluate the effectiveness of a population medicine multimorbidity intervention package on individuals at high risk for COPD. The intervention integrates community screening, chronic disease management, patient education, digital follow-up, and team-based care. The trial is being implemented in Xishui County, Guizhou Province, a low-resource county in Southwestern China. We considered each of the 26 townships in Xishui County as a cluster and stratified them into large and small townships based on population size. We randomized the same number of residents in each township stratum (large and small) to undergo the COPD Screening Questionnaire (COPD-SQ). Individuals identified as high risk for COPD were considered study participants and subsequently enrolled in the intervention or control arm. The target sample size was approximately 2,850 individuals.
Results:
As of July 2025, 11,443 individuals at high risk for COPD had been recruited into the study, with 5,433 entering into the intervention arm and 6,010 entering into the control arm. All participants are being followed for one year, with one telephone follow-up occurring at month three and in-person follow-ups occurring at months six and 12. Primary outcomes for each participant include the number of chronic conditions controlled, whether the participant received lung function testing, and forced expiratory volume in 1 second (FEV1). In addition, we are also evaluating secondary outcomes including health-related quality of life, mental and behavioral health status, healthcare utilization, knowledge of COPD and asthma, and care cascade indicators for chronic conditions.
Conclusions:
This cRCT is the first multimorbidity intervention study designed under the population medicine framework that targets the high-COPD-risk population. It was featured as a case study in the report of the Lancet Commission on Investing in Health. The results of the trial will inform the next generation of multimorbidity management and population medicine practices among global health authorities and practitioners. Clinical Trial: ClinicalTrials.gov Identifier: NCT06456996. Registered on June 7, 2024.
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