Clinical trial NCT05209607: Social Media-based Bundle Care of AECOPD Patients.
Official title: A Multicenter Open-label Randomized Controlled Trial of Social Media-based Bundle Care in Patients With Exacerbation of Chronic Obstructive Pulmonary Disease.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Acute Exacerbation of COPD
Pulmonary Disease, Chronic Obstructive
COPD
Lung Diseases, Obstructive
Readmission Rate
Mobile Medical
Bundle Care
Mobile Telemedicine
Keywords: Readmission rate
Chronic Obstructive Pulmonary Disease
Randomized Controlled Trial
Bundle care
Mobile Telemedicine
Mobile medical
Acute Exacerbation of Chronic Obstructive Pulmonary Disease
Lead sponsor: Beijing Chao Yang Hospital
Sponsor class: OTHER
Collaborators: name: Peking University
name: Xuanwu Hospital, Beijing
name: Beijing Anzhen Hospital
name: Beijing Tongren Hospital
name: Guang'anmen Hospital of China Academy of Chinese Medical Sciences
name: Emergency General Hospital
name: Beijing Jishuitan Hospital
name: Beijing Luhe Hospital
name: Beijing Shijingshan Hospital
name: Beijing Jingmei Group Hospital
First posted: 2022-01-26
Enrollment: 648
Sex: ALL
Minimum age (years): 45
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Readmission rate due to acute exacerbation of COPD within one year
timeFrame: One year
Secondary outcomes:
measure: The time interval from discharge to the next acute exacerbation of COPD
timeFrame: One year
measure: The times of acute exacerbation of COPD
timeFrame: One year
measure: The score of subjective symptom
timeFrame: One year
measure: The changes of spirometry
timeFrame: One year
measure: The changes of arterial blood gas analysis
timeFrame: One year
measure: The changes of percent of eosinophil count
timeFrame: One year
measure: Average annual medical cost
timeFrame: One year
measure: The types and proportions of adverse events occurred during using WeChat official account.
timeFrame: One year
measure: Compliance index
timeFrame: One year
Other outcomes:
Locations:
Study officials:
References:
citation: Rothnie KJ, Mullerova H, Smeeth L, Quint JK. Natural History of Chronic Obstructive Pulmonary Disease Exacerbations in a General Practice-based Population with Chronic Obstructive Pulmonary Disease. Am J Respir Crit Care Med. 2018 Aug 15;198(4):464-471. doi: 10.1164/rccm.201710-2029OC.
citation: Sobnath DD, Philip N, Kayyali R, Nabhani-Gebara S, Pierscionek B, Vaes AW, Spruit MA, Kaimakamis E. Features of a Mobile Support App for Patients With Chronic Obstructive Pulmonary Disease: Literature Review and Current Applications. JMIR Mhealth Uhealth. 2017 Feb 20;5(2):e17. doi: 10.2196/mhealth.4951.