Clinical trial NCT06456996: Impact of Multi-Component Interventions on High Risk COPD Population
Official title: Population Medicine Multimorbidity Interventions in Xishui on a High-Risk COPD Population: a Cluster Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Multimorbidity
Population Medicine
Chronic Obstructive Pulmonary Disease
Keywords: Multi-component intervention for multimorbidity
Population Medicine
Clustered RCT
High-risk COPD population
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: High-risk COPD population, defined as individuals whose score of COPD-SQ is 16 and above and whose age is 35 and above. COPD-SQ questionnaire will be assigned to a representative sample of local residents in Xishui County, and they will finish the questionnaire online through mobile phone.

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 COPD-SQ questionnaire with notification of his or her COPD high risk status. Those whose score exceeds 16 will be invited to do a face-to-face survey, simple physical examination, pulmonary function tests, and provide a multi-component intervention at baseline. For High-risk COPD population in the intervention arm, we provide community-based spirometry pulmonary function test (PFT) and education; If individuals whose post-bronchodilator FEV1/FVC\<0.7, they will be spirometry-defined COPD patients 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 COPD-SQ online questionnaire with notification of his or her COPD high risk status and a face-to-face survey. No physical examinations, community-based pulmonary function tests will be given.

Outcomes: The primary outcomes are COPD knowledge, COPD screening, and FEV1 measurement at month 12.


Eligibility criteria: Inclusion Criteria:

* Aged 35 and above;
* COPD-SQ score is 16 and above;
* 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: FEV1 measurement
timeFrame: 1 year
Secondary outcomes:
measure: Self-rated health status
timeFrame: 1 year
measure: COPD knowledge
timeFrame: 1 year
measure: Self-awareness of COPD
timeFrame: 1 year
measure: COPD treatment adherence
timeFrame: 1 year
measure: COPD control
timeFrame: 1 year
measure: CAT score
timeFrame: 1 year
measure: mMRC score
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: Blood pressure
timeFrame: 1 year
measure: Blood Glucose
timeFrame: 1 year
measure: Waist circumference
timeFrame: 1 year
measure: BMI
timeFrame: 1 year
measure: Family level annual consumption expenditure
timeFrame: 1 year
measure: Employment status
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: Asthma knowledge
timeFrame: 1 year
measure: Saint George Respiratory Questionnaire score
timeFrame: 1 year
measure: ACT score
timeFrame: 1 year
measure: Asthma diagnosis
timeFrame: 1 year
measure: Smoking dependence
timeFrame: 1 year
measure: Productivity loss
timeFrame: 1 year
Other outcomes:
Locations:
city: Zunyi
country: China
facility: 26 township hospitals in Xishui County
state: Guizhou
Study officials:
affiliation: Peking Union Medical College
name: Simiao Chen, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: