Impact of Multi-Component Interventions on High-Risk COPD Smokers

NCT ID: NCT06458205

Last Updated: 2025-03-30

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 7400 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-06-17
• Study Completion Date: 2026-06-30

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.

Conditions

Multimorbidity; Tobacco Use Cessation; Smoking Reduction

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: NONE

Study Groups

Intervention arm

For all townships within the intervention arm, we have constructed a pay-for-population mechanism to incentivize all medical practitioners to care for population health within each township. For smokers, we will provide a multi-component intervention: (1) NicQuit, a CBT-based digital health intervention for those who use intelligent mobile phones; (2) community-based pulmonary function test; (3) health education and encouragement to seek medication in superior hospitals for those spirometry-defined COPD patients; (4) CBT-based health education to the abnormal BMI; (5) health education to smoking cessation; (6) Active recruitment of smokers with high blood pressure or high blood glucose measurement. Intensive follow-ups will be at month 3, 6, and 12.

Group Type: EXPERIMENTAL

Multi-component intervention for smokers

Intervention Type: COMBINATION_PRODUCT

1. Community-based spirometry pulmonary function tests and result interpretations and health education;

2. A digital health intervention program, NicQuit, for smokers(very familiar with intelligent mobile phone);

3. A digital health intervention program, EmoEase, for smokers 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 smokers with mental health issues;

6. Encouragement to seek professional medication treatment in superior hospitals for spirometry-defined COPD patients or asthma patients;

7. To actively include smokers whose blood pressure's higher than 140/90 mmHg or/and whose random blood glucose higher than11.1mmol/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.

Control Arm

We will notify smokers with high-risk COPD to seek further diagnoses in superior hospitals. We provide a face-to-face survey to smokers with high-risk COPD. No other specified interventions will be given, they will be always accessible to usual care within the study period.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Multi-component intervention for smokers

1. Community-based spirometry pulmonary function tests and result interpretations and health education;

2. A digital health intervention program, NicQuit, for smokers(very familiar with intelligent mobile phone);

3. A digital health intervention program, EmoEase, for smokers 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 smokers with mental health issues;

6. Encouragement to seek professional medication treatment in superior hospitals for spirometry-defined COPD patients or asthma patients;

7. To actively include smokers whose blood pressure's higher than 140/90 mmHg or/and whose random blood glucose higher than11.1mmol/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 Type: COMBINATION_PRODUCT

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.

• Minimum Eligible Age: 35 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

China-Japan Friendship Hospital

OTHER

Sponsor Role: collaborator

Peking Union Medical College

OTHER

Sponsor Role: lead

Responsible Party

Simiao Chen

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Simiao Chen, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Peking Union Medical College

Locations

Xishui County for Xishui Trial

Zunyi, Guizhou, China

Countries

China

Other Identifiers

CAMS&PUMC-IEC-2024-042

Identifier Type: -

Identifier Source: org_study_id