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Liu Y, Chen W, Zhang S, Wang Y, Zheng Z, Huang K, Tang X, Cao Z, Tong X, Tang L, Zhao J, He L, Jiao L, Zhao T, Luo Y, Lai Q, Lyu X, Chen Q, Bunker A, Vollmer S, Geldsetzer P, Jamison D, Bärnighausen T, Yang T, Chen S, Wang C, POPMIX Group
Impact of the Population Medicine Multimorbidity Intervention in Xishui County (POPMIX) on People at High Risk for Chronic Obstructive Pulmonary Disease Who Experience Mental Health Symptoms: Protocol for the POPMIX-MH Cluster Randomized Controlled Trial
Warning: This is an author submission that is not peer-reviewed or edited. Preprints - unless they show as "accepted" - should not be relied on to guide clinical practice or health-related behavior and should not be reported in news media as established information.
Impact of POPulation Medicine Multimorbidity Intervention in Xishui County (POPMIX) on people at high risk for COPD who suffer from mental health symptoms: Protocol of the POPMIX-MH cluster-randomized controlled trial
Yuhao Liu;
Wenjin Chen;
Shiyu Zhang;
Yingping Wang;
Zhoutao Zheng;
Ke Huang;
Xingyao Tang;
Zhong Cao;
Xunliang Tong;
Lei Tang;
Jinghan Zhao;
Liu He;
Lirui Jiao;
Tianying Zhao;
Yingchi Luo;
Qiande Lai;
Xiangqin Lyu;
Qiushi Chen;
Aditi Bunker;
Sebastian Vollmer;
Pascal Geldsetzer;
Dean Jamison;
Till Bärnighausen;
Ting Yang;
Simiao Chen;
Chen Wang;
POPMIX Group
ABSTRACT
Background
Chronic obstructive pulmonary disease (COPD) and mental health conditions represent intersecting public health challenges, especially in resource-limited rural China. Existing care models often neglect the psychosocial needs of high-COPD-risk populations, resulting in limited effectiveness of prevention and management strategies for the condition. This study evaluates an integrated intervention designed to improve both mental and physical health outcomes among high-COPD-risk individuals with mental health symptoms, using a population medicine framework.
Methods
We are conducting a 12-month, two-arm cluster randomized controlled trial (cRCT) across 26 townships in Xishui County. A total of 44,000 residents aged 35 years or older were screened using the COPD-SQ, resulting in identification of 10,000 individuals at high risk for COPD. Among them, 6,000 individuals with WEMWBS scores below 45 were enrolled as participants. Intervention components include digital CBT-based mental health support, community screening, chronic disease management, patient education, digital follow-up, and team-based care. The primary outcomes are depression symptoms (PHQ-9), anxiety symptoms (GAD-7), and mental wellbeing (WEMWBS). Secondary outcomes cover numbers of chronic diseases controlled, physiological and functional indicators such as lung function, health-related quality of life, mental and behavioral health, healthcare utilization, knowledge of COPD and asthma, productivity loss, and care cascade indicators for chronic conditions.
Discussion
This study is the first to integrate psychological support, chronic disease management, and community-based screening into a single scalable intervention package targeting multimorbidity in China. It tests the feasibility of applying population medicine principles—emphasizing integrated, preventive, and population-level care—within primary care systems in low-resource settings. By targeting both mental and physical health, it redefines chronic care beyond traditional organ-specific approaches.
Trial registration
ClinicalTrials.gov Identifier: NCT06458218. Registered on June 9, 2024.
Citation
Please cite as:
Liu Y, Chen W, Zhang S, Wang Y, Zheng Z, Huang K, Tang X, Cao Z, Tong X, Tang L, Zhao J, He L, Jiao L, Zhao T, Luo Y, Lai Q, Lyu X, Chen Q, Bunker A, Vollmer S, Geldsetzer P, Jamison D, Bärnighausen T, Yang T, Chen S, Wang C, POPMIX Group
Impact of the Population Medicine Multimorbidity Intervention in Xishui County (POPMIX) on People at High Risk for Chronic Obstructive Pulmonary Disease Who Experience Mental Health Symptoms: Protocol for the POPMIX-MH Cluster Randomized Controlled Trial