Social Media-based Bundle Care of AECOPD Patients.

NCT05209607 | Unknown Phase 4 DMC

• 1 other identifier: Z201100005520031
• Study Type: interventional
• Target: 648
• Locations: 0 countries
• Sites: N/A

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.

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

Outcome Measures

Primary Outcomes (1)

• Readmission rate due to acute exacerbation of COPD within one year

  Collected within one year after discharge

  One year

Secondary Outcomes (9)

• The time interval from discharge to the next acute exacerbation of COPD

  One year

• The times of acute exacerbation of COPD

  One year

• The score of subjective symptom

  One year

• The changes of spirometry

  One year

• The changes of arterial blood gas analysis

  One year

Study Arms (2)

Interventional group

EXPERIMENTAL

Participants will be given mobile medical and bundle care

Other: Mobile Medical and bundle management

Control group

OTHER

Participants will be given mobile medical and standard of care.

Other: Mobile Medical and standard of care

Interventions

Mobile Medical and bundle management OTHER

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.

Interventional group

Mobile Medical and standard of care OTHER

Based on the mobile medical, participants will receive advice on standard medication only.

Control group

Eligibility Criteria

• Age: 45 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Beijing Chao Yang Hospital: lead
• Peking University: collaborator
• Xuanwu Hospital, Beijing: collaborator
• Beijing Anzhen Hospital: collaborator
• Beijing Tongren Hospital: collaborator
• Guang'anmen Hospital of China Academy of Chinese Medical Sciences: collaborator
• Emergency General Hospital: collaborator
• Beijing Jishuitan Hospital: collaborator
• Beijing Luhe Hospital: collaborator
• Beijing Shijingshan Hospital: collaborator
• Beijing Jingmei Group Hospital: collaborator

Related Publications (2)

• 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.

  PMID: 29474094 BACKGROUND

• 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.

  PMID: 28219878 BACKGROUND

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive; Lung Diseases, Obstructive

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Central Study Contacts

Lin Yingxiang, PhD

CONTACT

13611370119; bjlin666@163.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief physician of Department of Respiratory and Critical Care Medicine, Beijing Institute of Respiratory Medicine, Beijing Chao-Yang Hospital, Capital Medical University,

Study Record Dates

• First Submitted: December 29, 2021
• First Posted: January 26, 2022
• Study Start: February 1, 2022
• Primary Completion: October 31, 2024
• Study Completion: December 31, 2024
• Last Updated: January 26, 2022

Record last verified: 2022-01

Data Sharing

• IPD Sharing: Will not share