Social Media-based Bundle Care of AECOPD Patients.

COPD Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05209607
• Other study ID #: Z201100005520031
• Status: Not yet recruiting
• Phase: Phase 4
• Start date: February 1, 2022
• Est. completion date: December 31, 2024

Study information

• Verified date: January 2022
• Source: Beijing Chao Yang Hospital
• Contact: Lin Yingxiang, PhD
• Phone: 13611370119
• Email: bjlin666[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 648
• Est. completion date: December 31, 2024
• Est. primary completion date: October 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 45 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Acute Exacerbation of COPD
• COPD
• Lung Diseases
• Lung Diseases, Obstructive
• Pulmonary Disease, Chronic Obstructive
• Readmission Rate

Intervention

Other:
• Mobile Medical and bundle management
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.
• Mobile Medical and standard of care
Based on the mobile medical, participants will receive advice on standard medication only.

Locations

Country	Name	City	State
n/a

Sponsors (11)

Lead Sponsor	Collaborator
Beijing Chao Yang Hospital	Beijing Anzhen Hospital, Beijing Jingmei Group Hospital, Beijing Jishuitan Hospital, Beijing Luhe Hospital, Beijing Shijingshan Hospital, Beijing Tongren Hospital, Emergency General Hospital, Guang'anmen Hospital of China Academy of Chinese Medical Sciences, Peking University, Xuanwu Hospital, Beijing

References & Publications (2)

Rothnie KJ, Müllerová 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Readmission rate due to acute exacerbation of COPD within one year	Collected within one year after discharge	One year
Secondary	The time interval from discharge to the next acute exacerbation of COPD	Collected within one year after discharge	One year
Secondary	The times of acute exacerbation of COPD	Collected within one year after discharge	One year
Secondary	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
Secondary	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
Secondary	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
Secondary	The changes of percent of eosinophil count	Collected within one year after discharge	One year
Secondary	Average annual medical cost	Collected within one year after discharge	One year
Secondary	The types and proportions of adverse events occurred during using WeChat official account.	Collected within one year after discharge	One year
Secondary	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