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

NCT06458205 | Active Not Recruiting

• 1 other identifier: CAMS&PUMC-IEC-2024-042
• Study Type: interventional
• Target: 7,400
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (2)

• Amount of smoking

  Definition: Average number of cigarettes smoked per day; Variable type: Continuous; Measurement: Respondent's answer to the question.

  1 year

• Smoking Dependence

  Definition: A scale that measures the degree of smoking dependence; Variable type: Continuous; Measurement: Respondent's answer to the question. Introduction to Smoking Dependence Scale: Chinese version of Fagerström test for nicotine dependence (FTND), ranging from 0 to 10, the higher the score, the severer nicotine dependence will be. Also Heaviness of Smoking Index (HSI) will also be measured, ranging from 0 to 6, the higher the score, the worsen the nicotine dependence will be

  1 year

Secondary Outcomes (34)

• Self-rate health status

  1 year

• Number of Chronic Conditions Controlled

  1 year

• Physical proof of cigarettes

  1 year

• FEV1 measurement

  1 year

• COPD Screening

  1 year

Study Arms (2)

Intervention arm

EXPERIMENTAL

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.

Combination Product: Multi-component intervention for smokers

Control Arm

NO INTERVENTION

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.

Interventions

Multi-component intervention for smokers 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.

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;
• 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.

You may not qualify if:

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

Sponsors & Collaborators

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

Study Sites (1)

Xishui County for Xishui Trial

Zunyi, Guizhou, China

Location

MeSH Terms

Conditions

Tobacco Use Cessation; Smoking Reduction

Condition Hierarchy (Ancestors)

Health Behavior; Behavior; Smoking

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 9, 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)