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

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

Interventions

COMBINATION_PRODUCT

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.

Sponsors & Collaborators

• China-Japan Friendship Hospital

  collaborator OTHER

• Peking Union Medical College

  lead OTHER

Principal Investigators

• Simiao Chen, Ph.D. · Peking Union Medical College

Study Design

Allocation

RANDOMIZED

Purpose

HEALTH_SERVICES_RESEARCH

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

35 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2024-06-17

Primary Completion

2026-03-31

Completion

2026-06-30

Countries

• China

Study Locations