Social Media-based Bundle Care of AECOPD Patients.

NCT ID: NCT05209607

Last Updated: 2022-01-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

648 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-02-01

Study Completion Date

2024-12-31

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.

Detailed Description

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Conditions

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

DOUBLE

Investigators Outcome Assessors

Study Groups

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Interventional group

Participants will be given mobile medical and bundle care

Group Type EXPERIMENTAL

Mobile Medical and bundle management

Intervention Type 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.

Control group

Participants will be given mobile medical and standard of care.

Group Type OTHER

Mobile Medical and standard of care

Intervention Type OTHER

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

Interventions

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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.

Intervention Type OTHER

Mobile Medical and standard of care

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

Intervention Type OTHER

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.
Minimum Eligible Age

45 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Peking University

OTHER

Sponsor Role collaborator

Xuanwu Hospital, Beijing

OTHER

Sponsor Role collaborator

Beijing Anzhen Hospital

OTHER

Sponsor Role collaborator

Beijing Tongren Hospital

OTHER

Sponsor Role collaborator

Guang'anmen Hospital of China Academy of Chinese Medical Sciences

OTHER

Sponsor Role collaborator

Emergency General Hospital

OTHER

Sponsor Role collaborator

Beijing Jishuitan Hospital

OTHER

Sponsor Role collaborator

Beijing Luhe Hospital

OTHER

Sponsor Role collaborator

Beijing Shijingshan Hospital

UNKNOWN

Sponsor Role collaborator

Beijing Jingmei Group Hospital

UNKNOWN

Sponsor Role collaborator

Beijing Chao Yang Hospital

OTHER

Sponsor Role lead

Responsible Party

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Yingxiang Lin

Chief physician of Department of Respiratory and Critical Care Medicine, Beijing Institute of Respiratory Medicine, Beijing Chao-Yang Hospital, Capital Medical University,

Responsibility Role PRINCIPAL_INVESTIGATOR

Central Contacts

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Lin Yingxiang, PhD

Role: CONTACT

13611370119

References

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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.

Reference Type BACKGROUND
PMID: 29474094 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 28219878 (View on PubMed)

Other Identifiers

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Z201100005520031

Identifier Type: -

Identifier Source: org_study_id

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