Clinical trial NCT06458218: Impact of Multi-component Interventions on Populations with Mental Health Symptoms and High-risk COPD
Official title: Population Medicine Multimorbidity Interventions in Xishui on a High-Risk COPD Population with Mental Health Symptoms: a Cluster Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Multimorbidity
Mental Health Issue
Multi-component Interventions
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: 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.


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.

Primary outcomes:
measure: Depression Symptoms
timeFrame: 1 year
measure: Anxiety Symptoms
timeFrame: 1 year
measure: Warwick-Edinburgh Mental Well-being Scale, WEM -WBS
timeFrame: 1 year
Secondary outcomes:
measure: Number of chronic diseases controlled
timeFrame: 1 year
measure: Self-rated health status
timeFrame: 1 year
measure: FEV1 measurement
timeFrame: 1 year
measure: mMRC score
timeFrame: 1 year
measure: CAT score
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: Outpatient
timeFrame: 1 year
measure: Inpatient
timeFrame: 1 year
measure: Medical expenditure within a family over the past year
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: Smoking Amount
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
measure: Smoking Dependence
timeFrame: 1 year
Other outcomes:
Locations:
city: Zunyi
country: China
facility: Xishui County
state: Guizhou
Study officials:
affiliation: Peking Union Medical College
name: Simiao Chen, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: