Social Media-based Bundle Care of AECOPD Patients.

Phase 4

Not yet recruiting

• Conditions: Lung Diseases, Obstructive; COPD; Readmission Rate; Mobile Medical; Bundle Care; Mobile Telemedicine; Acute Exacerbation of COPD; Pulmonary Disease, Chronic Obstructive
• Interventions: Other: Mobile Medical and bundle management; Other: Mobile Medical and standard of care

• Registration Number: NCT05209607
• Lead Sponsor: Beijing Chao Yang Hospital

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-12-29
• Status Verified: 2022-01
• Study First Submitted QC: 2022-01-22
• Last Update Submitted: 2022-01-22
• Study First Posted: 2022-01-26
• Last Update Posted: 2022-01-26
• Study Start: 2022-02-01
• Primary Completion: 2024-10-31
• Study Completion: 2024-12-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 648

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Interventional group	Mobile Medical and bundle management	Participants will be given mobile medical and bundle care
Control group	Mobile Medical and standard of care	Participants will be given mobile medical and standard of care.

Primary Outcome Measures

Name	Time	Method
Readmission rate due to acute exacerbation of COPD within one year	One year	Collected within one year after discharge

Secondary Outcome Measures

Name	Time	Method
The time interval from discharge to the next acute exacerbation of COPD	One year	Collected within one year after discharge
The times of acute exacerbation of COPD	One year	Collected within one year after discharge
Average annual medical cost	One year	Collected within one year after discharge
The score of subjective symptom	One year	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.
Compliance index	One year	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.
The changes of spirometry	One year	Collected within one year after discharge. FEV1/FEV, FEV1 %pre，FVC, DLCO and RV/TLC etc will be collected.
The changes of percent of eosinophil count	One year	Collected within one year after discharge
The changes of arterial blood gas analysis	One year	Collected within one year after discharge. PaO2, PaCO2, BE, HCO3-, Lac, K+, Na+, Glu etc will be collected.
The types and proportions of adverse events occurred during using WeChat official account.	One year	Collected within one year after discharge