Clinical trial NCT06457009: Impact of Multi-Component Intervention on Suspected Asthma Population
Official title: Population Medicine Multimorbidity Intervention in Xishui on a Suspected Asthma Population: a Cluster Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Multimorbidity
Chronic Asthma
Population Medicine
Keywords: Suspected Asthma
Multimorbidity Interventions and Management
Clustered RCT
Pay-for-population Mechanism
Lead sponsor: Peking Union Medical College
Sponsor class: OTHER
Collaborators: name: China-Japan Friendship Hospital
First posted: 2024-06-13
Enrollment: 7400
Sex: ALL
Minimum age (years): 35
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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.


Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

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

Primary outcomes:
measure: Number of Chronic Diseases Controlled
timeFrame: 1 year
measure: Lung function testing
timeFrame: 1 year
measure: ACT score
timeFrame: 1 year
Secondary outcomes:
measure: Self-rated health status
timeFrame: 1 year
measure: Asthma Knowledge
timeFrame: 1 year
measure: Bronchial Asthma Screening
timeFrame: 1 year
measure: Bronchial Asthma Diagnosis
timeFrame: 1 year
measure: Bronchial Asthma Treatment
timeFrame: 1 year
measure: Bronchial Asthma Control
timeFrame: 1 year
measure: Blood pressure
timeFrame: 1 year
measure: Blood Glucose
timeFrame: 1 year
measure: Waist circumference
timeFrame: 1 year
measure: BMI
timeFrame: 1 year
measure: Number of Outpatient Visits
timeFrame: 1 year
measure: Number of Inpatient Visits
timeFrame: 1 year
measure: Medical expenditure within a family over the past year
timeFrame: 1 year
measure: Depression Symptoms
timeFrame: 1 year
measure: Anxiety Symptoms
timeFrame: 1 year
measure: Warwick-Edinburgh Mental Well-being Scale, WEM -WBS score
timeFrame: 1 year
measure: Family level annual consumption expenditure
timeFrame: 1 year
measure: Employment status
timeFrame: 1 year
measure: Productivity Loss
timeFrame: 1 year
measure: FEV1 measurement
timeFrame: 1 year
measure: HBP Screening
timeFrame: 1 year
measure: HBP Diagnosis
timeFrame: 1 year
measure: HBP Treatment
timeFrame: 1 year
measure: HBP Control
timeFrame: 1 year
measure: T2DM Screening
timeFrame: 1 year
measure: T2DM Diagnosis
timeFrame: 1 year
measure: T2DM Treatment
timeFrame: 1 year
measure: T2DM Control
timeFrame: 1 year
measure: Smoking Status
timeFrame: 1 year
measure: Smoking Amount
timeFrame: 1 year
measure: Drinking Status
timeFrame: 1 year
measure: Sugar Consumption
timeFrame: 1 year
measure: Salted Vegetables Consumption
timeFrame: 1 year
measure: Vegetable Consumption
timeFrame: 1 year
measure: Physical exercise
timeFrame: 1 year
measure: Self-awareness of COPD
timeFrame: 1 year
measure: COPD-Knowledge
timeFrame: 1 year
measure: mMRC score
timeFrame: 1 year
measure: Smoking Dependence
timeFrame: 1 year
Other outcomes:
Locations:
city: Zunyi
country: China
facility: Xishui County for Xishui Trial
state: Guizhou
Study officials:
affiliation: Peking Union Medical College
name: Simiao Chen, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: