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Social Media-based Bundle Care of AECOPD Patients.

Primary Purpose

Acute Exacerbation of COPD, Pulmonary Disease, Chronic Obstructive, COPD

Status
Not yet recruiting
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Mobile Medical and bundle management
Mobile Medical and standard of care
Sponsored by
Beijing Chao Yang Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Acute Exacerbation of COPD focused on measuring Readmission rate, Chronic Obstructive Pulmonary Disease, Randomized Controlled Trial, Bundle care, Mobile Telemedicine, Mobile medical, Acute Exacerbation of Chronic Obstructive Pulmonary Disease

Eligibility Criteria

45 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Other

    Arm Label

    Interventional group

    Control group

    Arm Description

    Participants will be given mobile medical and bundle care

    Participants will be given mobile medical and standard of care.

    Outcomes

    Primary Outcome Measures

    Readmission rate due to acute exacerbation of COPD within one year
    Collected within one year after discharge

    Secondary Outcome Measures

    The time interval from discharge to the next acute exacerbation of COPD
    Collected within one year after discharge
    The times of acute exacerbation of COPD
    Collected within one year after discharge
    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.
    The changes of spirometry
    Collected within one year after discharge. FEV1/FEV, FEV1 %pre,FVC, DLCO and RV/TLC etc will be collected.
    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.
    The changes of percent of eosinophil count
    Collected within one year after discharge
    Average annual medical cost
    Collected within one year after discharge
    The types and proportions of adverse events occurred during using WeChat official account.
    Collected within one year after discharge
    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.

    Full Information

    First Posted
    December 29, 2021
    Last Updated
    January 22, 2022
    Sponsor
    Beijing Chao Yang Hospital
    Collaborators
    Peking University, Xuanwu Hospital, Beijing, Beijing Anzhen Hospital, Beijing Tongren Hospital, Guang'anmen Hospital of China Academy of Chinese Medical Sciences, Emergency General Hospital, Beijing Jishuitan Hospital, Beijing Luhe Hospital, Beijing Shijingshan Hospital, Beijing Jingmei Group Hospital
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05209607
    Brief Title
    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

    2. Study Status

    Record Verification Date
    January 2022
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    February 1, 2022 (Anticipated)
    Primary Completion Date
    October 31, 2024 (Anticipated)
    Study Completion Date
    December 31, 2024 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Beijing Chao Yang Hospital
    Collaborators
    Peking University, Xuanwu Hospital, Beijing, Beijing Anzhen Hospital, Beijing Tongren Hospital, Guang'anmen Hospital of China Academy of Chinese Medical Sciences, Emergency General Hospital, Beijing Jishuitan Hospital, Beijing Luhe Hospital, Beijing Shijingshan Hospital, Beijing Jingmei Group Hospital

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    Yes

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    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

    7. Study Design

    Primary Purpose
    Supportive Care
    Study Phase
    Phase 4
    Interventional Study Model
    Parallel Assignment
    Masking
    InvestigatorOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    648 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Interventional group
    Arm Type
    Experimental
    Arm Description
    Participants will be given mobile medical and bundle care
    Arm Title
    Control group
    Arm Type
    Other
    Arm Description
    Participants will be given mobile medical and standard of care.
    Intervention Type
    Other
    Intervention Name(s)
    Mobile Medical and bundle management
    Intervention Description
    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
    Intervention Name(s)
    Mobile Medical and standard of care
    Intervention Description
    Based on the mobile medical, participants will receive advice on standard medication only.
    Primary Outcome Measure Information:
    Title
    Readmission rate due to acute exacerbation of COPD within one year
    Description
    Collected within one year after discharge
    Time Frame
    One year
    Secondary Outcome Measure Information:
    Title
    The time interval from discharge to the next acute exacerbation of COPD
    Description
    Collected within one year after discharge
    Time Frame
    One year
    Title
    The times of acute exacerbation of COPD
    Description
    Collected within one year after discharge
    Time Frame
    One year
    Title
    The score of subjective symptom
    Description
    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.
    Time Frame
    One year
    Title
    The changes of spirometry
    Description
    Collected within one year after discharge. FEV1/FEV, FEV1 %pre,FVC, DLCO and RV/TLC etc will be collected.
    Time Frame
    One year
    Title
    The changes of arterial blood gas analysis
    Description
    Collected within one year after discharge. PaO2, PaCO2, BE, HCO3-, Lac, K+, Na+, Glu etc will be collected.
    Time Frame
    One year
    Title
    The changes of percent of eosinophil count
    Description
    Collected within one year after discharge
    Time Frame
    One year
    Title
    Average annual medical cost
    Description
    Collected within one year after discharge
    Time Frame
    One year
    Title
    The types and proportions of adverse events occurred during using WeChat official account.
    Description
    Collected within one year after discharge
    Time Frame
    One year
    Title
    Compliance index
    Description
    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.
    Time Frame
    One year

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    45 Years
    Maximum Age & Unit of Time
    70 Years
    Accepts Healthy Volunteers
    No
    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.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Lin Yingxiang, PhD
    Phone
    13611370119
    Email
    bjlin666@163.com

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    Citations:
    PubMed Identifier
    29474094
    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.
    Results Reference
    background
    PubMed Identifier
    28219878
    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.
    Results Reference
    background

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    Social Media-based Bundle Care of AECOPD Patients.

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