Impact of Multi-Component Intervention on Suspected Asthma Population

NCT06457009 | Active Not Recruiting

• 1 other identifier: CAMS&PUMC-IEC-2024-041
• Study Type: interventional
• Target: 7,400
• Locations: 1 country
• Sites: 1

Brief Summary

Study Participants: Suspected asthma population, defined as individuals whose score of asthma screening questionnaire used in ECRHS study exceeds 0 and whose age is 35 and above. Intervention: Within the intervention arm, we have constructed a population-based pay-for-performance mechanism to encourage medical practitioners to care for population health. For study participants in the intervention arm, we will ask them to finish an online ECRHS questionnaire with notification of his or her suspected asthma status. Individuals whose score of ECRHS asthma screening exceeds 0 will be given a face-to-face survey, simple physical examination, pulmonary function tests, and provide a multi-component intervention at baseline. For suspected asthma population in the intervention arm, we provide community-based spirometry pulmonary function test (PFT) and education; If individuals whose FEV1 improved by ≥12% and ≥200 mL following bronchodilator administration with 400 ug salbutamol, they will be spirometry-defined undiagnosed asthma patient and will be encouraged to seek treatment and medication to the superior hospitals. Additionally, we provide (1) two digital health intervention programs to smokers and individuals with mental health issues; (2) CBT-based health education for study participants with abnormal BMI; (3) active recruitment into National Essential Public Health Program in China for those with abnormal blood pressure and blood glucose. Intensive follow-ups will be conducted at month 3 (telephone interview), month 6 (face-to-face with full steps of physical examination), and month 12. Comparison: Those who are assigned in the control arm, we will ask them to finish the same ECRHS online questionnaire with notification of his or her suspected asthma status and a face-to-face survey. No physical examinations, community-based pulmonary function tests will be given. Outcomes: The primary outcomes are asthma knowledge, lung function testing, and ACT score at month 12.

Conditions

Chronic Asthma; Population Medicine; Multimorbidity

Keywords

Suspected Asthma; Multimorbidity Interventions and Management; Clustered RCT; Pay-for-population Mechanism

Outcome Measures

Primary Outcomes (3)

• Number of Chronic Diseases Controlled

  Among all objectively measured diseases (asthma, COPD, BMI, hypertensions, type 2 diabetes, depression symptoms, anxiety symptoms), the number of chronic diseases controlled defined by objective measurement at month 12.

  1 year

• Lung function testing

  Definition: Have you ever had a pulmonary function test?; Variable type: Binary; Measurement: Respondent's answer to the question;

  1 year

• ACT score

  Definition: Asthma Control Test score Variable type: Continuous; Measurement: Respondent's answer to the question; Introduction to ACT score: Asthma control test (ACT), ranging from 0 to 25, the lower the score, the better asthma controlled.

  1 year

Secondary Outcomes (39)

• Self-rated health status

  1 year

• Asthma Knowledge

  1 year

• Bronchial Asthma Screening

  1 year

• Bronchial Asthma Diagnosis

  1 year

• Bronchial Asthma Treatment

  1 year

Study Arms (2)

Intervention arm

EXPERIMENTAL

Within the intervention arm, all medical practitioners will be incentivized by a pay-for-population mechanism within their township. First, finish a ECRHS questionnaire with notification of suspected asthma risk status. Those noticed will be given a face-to-face survey, simple physical examination, pulmonary function tests, and provide a multi-component intervention at baseline. For suspected asthma population, we provide community-based spirometry PFT and education; If individuals whose FEV1 improved by ≥12% and ≥200 mL, they will be undiagnosed asthma patients and encouraged to seek treatment to the superior hospitals. We provide (1) two digital health intervention programs to smokers and individuals with mental health issues; (2) CBT-based health education for study participants with abnormal BMI; (3) active recruitment into National Essential Public Health Program for those with abnormal blood pressure and glucose. Intensive follow-ups will be conducted at month 3, 6, 12.

Combination Product: Multi-component Intervention Package

Control Arm

NO INTERVENTION

Those who are assigned in the control arm, we will ask them to finish the same ECRHS asthma screening online questionnaire with notification of his or her suspected asthma status and a face-to-face survey. No physical examinations, community-based pulmonary function tests will be given.

Interventions

Multi-component Intervention Package COMBINATION_PRODUCT

1. Community-based spirometry pulmonary function tests and result interpretations and health education for asthma; 2. A digital health intervention program, NicQuit, for smokers(very familiar with intelligent mobile phone); 3. A digital health intervention program, EmoEase, for individuals whose WEMWBS questionnaire score is lower than 45(very familiar with intelligent mobile phone); 4. Health education to smokers for smoking cessation; 5. Health education to individuals with mental health issues; 6. Encouragement to seek professional medication treatment in superior hospitals for undiagnosed asthma patients; 7. To actively include individuals whose blood pressure's higher than 140/90 mmHg or/and whose random blood glucose higher than 11.1 mmol/L into the National Essential Public Health Service in China; 8. A CBT-based health education to the BMI abnormal, i.e., BMI \> 24.0 or BMI \< 18.5; 9. Pay-for-population mechanism for medical practitioners.

Intervention arm

Eligibility Criteria

• Age: 35 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Aged 35 and above;
• Score of ECRHS asthma screening questionnaire exceeds 0;
• Residents who have lived in one township over the past 3 months and plan to reside in the same township in the upcoming year;
• Finished the informed consent

You may not qualify if:

• Pregnancy and other conditions that are not allowed to finish pulmonary function tests;
• Severe cognitive disorder or total loss of capability of daily living

Sponsors & Collaborators

• China-Japan Friendship Hospital: collaborator
• Peking Union Medical College: lead

Study Sites (1)

Xishui County for Xishui Trial

Zunyi, Guizhou, China

Location

Related Publications (1)

• Huang K, Tong X, Tang X, Lai Q, Liu Y, Zhang S, Zheng Z, Chen W, Cao Z, Tang L, Zhao J, He L, Jiao L, Wang Y, Zhao T, Luo YH, Lyu X, Chen Q, Vollmer S, Geldsetzer P, Jamison D, Barnighausen T, Chen S, Wang C, Yang T; POPMIX study investigators. Impact of the POPulation Medicine Multimorbidity Intervention in Xishui County (POPMIX) on suspected asthma patients: protocol for the POPMIX-Asthma cluster-randomized controlled trial. Trials. 2026 Apr 11. doi: 10.1186/s13063-026-09685-5. Online ahead of print.

  PMID: 41964072 DERIVED

Study Officials

• Simiao Chen, Ph.D.

  Peking Union Medical College

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: June 7, 2024
• First Posted: June 13, 2024
• Study Start: June 17, 2024
• Primary Completion: March 31, 2026
• Study Completion (Estimated): June 30, 2026
• Last Updated: April 13, 2026

Record last verified: 2026-04

Locations

CN (1)