Impact of Multi-component Interventions on Populations with Mental Health Symptoms and High-risk COPD

NCT ID: NCT06458218

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: High-risk COPD population with mental health symptoms, defined as individuals whose score of COPD-SQ ≥ 16, whose age is 35 and above, and whose Warwick-Edinburgh Mental Well-being Scale <45 .

Intervention: We have constructed a pay-for-population mechanism for medical practitioners within the intervention townships to encourage them caring 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. For those with high-risk COPD population, we will provide face-to-face survey, simple physical examination, pulmonary function tests, and provide a multi-component intervention at baseline. For high-risk COPD population with mental health issues 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. A CBT-based digital health intervention program, EmoEase, will be provided to our study participants with an intelligent mobile phone. Also health education in terms of mental health issues will be given. Additionally, we provide (1) a digital health intervention programs to smokers; (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 PHQ-9 scores for depression symptoms, GAD-7 symptoms for anxiety symptoms, and WEM-WBS score at month 12.

Conditions

Multimorbidity; Mental Health Issue; Multi-component Interventions

Study Design

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

Study Groups

Intervention arm

We have constructed a pay-for-population mechanism to encourage medical workers caring for population health. We will ask study populations to finish online COPD-SQ questionnaire with notification of his or her COPD high risk status. For high-risk COPD population, we will provide a face-to-face survey and examination, and provide a multi-component intervention at baseline. We give community-based spirometry pulmonary function test and education; If individuals who are COPD patients, they will be encouraged to seek treatment to the superior hospitals. A CBT-based digital health program will be provided. Also health education will be given. Additionally, we provide (1) a digital health intervention programs to smokers; (2) CBT-based health education for the abnormal BMI; (3) active recruitment into National Essential Public Health Program for those with high blood pressure and blood glucose. Intensive follow-ups will be conducted at month 3, 6, 12.

Group Type: EXPERIMENTAL

Multi-component Interventions

Intervention Type: COMBINATION_PRODUCT

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

2. A digital health intervention program, EmoEase, for individuals with mental health issues among high-risk COPD population(very familiar with intelligent mobile phone);

3. NicQuit, digital health intervention to smokers;

4. Health education to smokers and individuals with mental health issues;

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

6. To actively include individuals whose blood pressure and glucose are higher than the normal value into the National Essential Public Health Service in China;

7. A CBT-based health education to the BMI abnormal;

8. Pay-for-performance incentives to medical workers.

Control Arm

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Multi-component Interventions

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

2. A digital health intervention program, EmoEase, for individuals with mental health issues among high-risk COPD population(very familiar with intelligent mobile phone);

3. NicQuit, digital health intervention to smokers;

4. Health education to smokers and individuals with mental health issues;

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

6. To actively include individuals whose blood pressure and glucose are higher than the normal value into the National Essential Public Health Service in China;

7. A CBT-based health education to the BMI abnormal;

8. Pay-for-performance incentives to medical workers.

Intervention Type: COMBINATION_PRODUCT

Eligibility Criteria

Inclusion Criteria

• Aged 35 and above;
• High-risk COPD population, defined by score of COPD-SQ ≥ 16;
• Mental health issues, defined by WEM-WBS scale < 45;
• 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

Zunyi, Guizhou, China

Countries

China

Other Identifiers

CAMS&PUMC-IEC-2024-043

Identifier Type: -

Identifier Source: org_study_id