Clinical trial NCT06458205: Impact of Multi-Component Interventions on High-Risk COPD Smokers
Official title: Population Medicine Multimorbidity Interventions in Xishui on High-risk COPD Smokers: a Cluster Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Multimorbidity
Tobacco Use Cessation
Smoking Reduction
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: In our study, we focus on smokers who self-report a "current smoking" status or smoking cessation less than 6 months. This trial is a sub-trial of "Impact of Multi-Component Interventions on a High-Risk COPD population" (Protocol ID: CAMS\&PUMC-IEC-2024-040). All smokers in this trial are either from the high-risk COPD population (defined by COPD-SQ score≥16) .

Intervention: 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. For those whose score of COPD-SQ ≥ 16, we will provide a face-to-face survey, simple physical examination, pulmonary function tests, and provide a multi-component intervention at baseline. For smokers in the intervention arm, we provide a digital health intervention program, NicQuit, to whom could familiarly use intelligent mobile phones, and health education for all smokers. We also provide community-based spirometry pulmonary function test (PFT) and education to smokers. If smokers 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) another digital health intervention programs to smokers 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 self-reported average number of cigarettes consumed per day, smoking dependence index, and CO measurement.


Eligibility criteria: Inclusion Criteria:

* Aged 35 and above;
* High-risk COPD population defined by the score of COPD-SQ ≥ 16;
* Self-report currently smoking or smoking cessation less than 6 month;
* Local residents who stay within a township in the previous 3 months and plan to stay within the same township for the next 12 months.

Exclusion Criteria:

* Those who suffer from severe cognitive disorder or total loss of ability of daily living.

Primary outcomes:
measure: Amount of smoking
timeFrame: 1 year
measure: Smoking Dependence
timeFrame: 1 year
Secondary outcomes:
measure: Self-rate health status
timeFrame: 1 year
measure: Number of Chronic Conditions Controlled
timeFrame: 1 year
measure: Physical proof of cigarettes
timeFrame: 1 year
measure: FEV1 measurement
timeFrame: 1 year
measure: COPD Screening
timeFrame: 1 year
measure: Self-awareness of COPD
timeFrame: 1 year
measure: COPD-Knowledge
timeFrame: 1 year
measure: Treatment adherence
timeFrame: 1 year
measure: COPD 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
timeFrame: 1 year
measure: Productivity Loss
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: 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
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: