Social Media-based Bundle Care of AECOPD Patients.

Study Overview
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Brief Summary
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Chronic obstructive pulmonary disease(COPD) is an incompletely reversible and progressive pulmonary disease characterized by airflow restriction, which is the third leading cause of death worldwide, accounting for 6% of all deaths worldwide. Acute exacerbation (AE) of COPD can accelerate the decline of lung function, worsening pulmonary symptoms, and increase the risk of death in patients. Health education, inhaled technical guidance training, individual self-management, psychological counseling, home oxygen therapy, nutritional support, and other comprehensive interventions can help improve the lung function of COPD patients, alleviate clinical symptoms, improve the quality of life. While a number of COPD applications have been developed, few provide comprehensive assessment and guidance for these kinds of patients. Therefore, the investigators aim to establish a bundle care mode based on the mode of hospital-home-community-patient, clarify the impact of the management on prognosis, and evaluate the effect of mobile medical-assisted bundle management mode. In this randomized controlled trial(RCT), AECOPD patients will be divided into interventional or control groups randomly. Patients in the interventional group will receive mobile medication and standard of care at the same time (bundle care mode). While patients in the control group will receive standard of care only (traditional management mode). This study will be conducted to compare the effects of traditional and bundle care modes, and to formulate the implementation path and specifications of bundle care for AECOPD patients after discharge in China.

Official Title
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A Multicenter Open-label Randomized Controlled Trial of Social Media-based Bundle Care in Patients With Exacerbation of Chronic Obstructive Pulmonary Disease.

Conditions
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COPD, Acute Exacerbation of COPD, Pulmonary Disease, Chronic Obstructive, Lung Diseases, Obstructive, Readmission Rate, Mobile Medical, Bundle Care, Mobile Telemedicine

Intervention / Treatment
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* Other: Mobile Medical and bundle management
* Other: Mobile Medical and standard of care


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: AECOPD Patients with pulmonary function grade GOLD2-4; Aged between 45 and 70 years old; Have a smartphone, and can skillfully use mobile Wechat official account; Willing to use Wechat official accounts to manage COPD; Willing to accept outpatient follow-up; Signed informed consent. Exclusion Criteria: Patients with asthma, bronchiectasis, tuberculosis, or other diseases; Patients with malignant tumors, liver and kidney failure, limb dyskinesia, and other diseases; Unstable angina pectoris in recent one month, myocardial infarction within a half year, severe arrhythmia, uncontrollable congestive heart failure, or poor blood pressure control (systolic blood pressure > 140mmHg and/or diastolic blood pressure > 90mmHg); Cognitive impairment; Combined with respiratory failure; With a life expectancy of less than one year; Plan to or participating in a COPD management project or mobile Wechat official account project; Completed another trial within 30 days.

Ages Eligible for Study
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Minimum Age: 45 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Interventional group<br>Participants will be given mobile medical and bundle care | Other: Mobile Medical and bundle management<br>* Based on the current follow-up management platform of respiratory disease, the WeChat official account will be designed and used to provide health education for patients, such as smoking cessation, reasonable diet, appropriate exercise, etc., and monitor some physiological indicators (such as body temperature, weight, the score of mMRC, etc.) and guide patients to standardize medication and pulmonary rehabilitation.<br>|
| Other: Control group<br>Participants will be given mobile medical and standard of care. | Other: Mobile Medical and standard of care<br>* Based on the mobile medical, participants will receive advice on standard medication only.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Readmission rate due to acute exacerbation of COPD within one year | Collected within one year after discharge | One year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The time interval from discharge to the next acute exacerbation of COPD | Collected within one year after discharge | One year | 
| The times of acute exacerbation of COPD | Collected within one year after discharge | One year | 
| The score of subjective symptom | Collected within one year after discharge. We will use modified Medical Research Council (mMRC) Dyspnoea Scale, COPD Assessment Test (CAT), St. George's Respiratory Questionnaire (SGRQ),Hospital Anxiety and Depression Scale (HADS) and Borg scale to assecc. | One year | 
| The changes of spirometry | Collected within one year after discharge. FEV1/FEV, FEV1 %pre，FVC, DLCO and RV/TLC etc will be collected. | One year | 
| The changes of arterial blood gas analysis | Collected within one year after discharge. PaO2, PaCO2, BE, HCO3-, Lac, K+, Na+, Glu etc will be collected. | One year | 
| The changes of percent of eosinophil count | Collected within one year after discharge | One year | 
| Average annual medical cost | Collected within one year after discharge | One year | 
| The types and proportions of adverse events occurred during using WeChat official account. | Collected within one year after discharge | One year | 
| Compliance index | It includes drug treatment compliance, mastery of drug inhalation skills, smoking cessation, improvement of nutritional status, changes of mental health status, compliance and mastery of lung rehabilitation exercise, and patients' cognitive level of chronic obstructive pulmonary disease. | One year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Readmission rate, Chronic Obstructive Pulmonary Disease, Randomized Controlled Trial, Bundle care, Mobile Telemedicine, Mobile medical, Acute Exacerbation of Chronic Obstructive Pulmonary Disease