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Social Media-based Bundle Care of AECOPD Patients.

Sponsor
Beijing Chao Yang Hospital (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05209607
Collaborator
Peking University (Other), Xuanwu Hospital, Beijing (Other), Beijing Anzhen Hospital (Other), Beijing Tongren Hospital (Other), Guang'anmen Hospital of China Academy of Chinese Medical Sciences (Other), Emergency General Hospital (Other), Beijing Jishuitan Hospital (Other), Beijing Luhe Hospital (Other), Beijing Shijingshan Hospital (Other), Beijing Jingmei Group Hospital (Other)
648
Enrollment
2
Arms
35
Anticipated Duration (Months)

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Mobile Medical and bundle management
  • Other: Mobile Medical and standard of care
 Phase 4

Study Design

Study Type:
Interventional
Anticipated Enrollment :
648 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Investigator, Outcomes Assessor)
Primary Purpose:
Supportive Care
Official Title:
A Multicenter Open-label Randomized Controlled Trial of Social Media-based Bundle Care in Patients With Exacerbation of Chronic Obstructive Pulmonary Disease.
Anticipated Study Start Date :
Feb 1, 2022
Anticipated Primary Completion Date :
Oct 31, 2024
Anticipated Study Completion Date :
Dec 31, 2024

Arms and Interventions

Arm Intervention/Treatment
Experimental: Interventional group

Participants will be given mobile medical and bundle care

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.
Other: Control group

Participants will be given mobile medical and standard of care.

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

Outcome Measures

Primary Outcome Measures

  1. Readmission rate due to acute exacerbation of COPD within one year [One year]

    Collected within one year after discharge

Secondary Outcome Measures

  1. The time interval from discharge to the next acute exacerbation of COPD [One year]

    Collected within one year after discharge

  2. The times of acute exacerbation of COPD [One year]

    Collected within one year after discharge

  3. The score of subjective symptom [One year]

    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.

  4. The changes of spirometry [One year]

    Collected within one year after discharge. FEV1/FEV, FEV1 %pre，FVC, DLCO and RV/TLC etc will be collected.

  5. The changes of arterial blood gas analysis [One year]

    Collected within one year after discharge. PaO2, PaCO2, BE, HCO3-, Lac, K+, Na+, Glu etc will be collected.

  6. The changes of percent of eosinophil count [One year]

    Collected within one year after discharge

  7. Average annual medical cost [One year]

    Collected within one year after discharge

  8. The types and proportions of adverse events occurred during using WeChat official account. [One year]

    Collected within one year after discharge

  9. Compliance index [One year]

    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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
45 Years to 70 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Beijing Chao Yang Hospital
  • 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

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Yingxiang Lin, Chief physician of Department of Respiratory and Critical Care Medicine, Beijing Institute of Respiratory Medicine, Beijing Chao-Yang Hospital, Capital Medical University,, Beijing Chao Yang Hospital
ClinicalTrials.gov Identifier:
NCT05209607
Other Study ID Numbers:
  • Z201100005520031
First Posted:
Jan 26, 2022
Last Update Posted:
Jan 26, 2022
Last Verified:
Jan 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Yingxiang Lin, Chief physician of Department of Respiratory and Critical Care Medicine, Beijing Institute of Respiratory Medicine, Beijing Chao-Yang Hospital, Capital Medical University,, Beijing Chao Yang Hospital
Readmission rate
Chronic Obstructive Pulmonary Disease
Randomized Controlled Trial
Bundle care
Mobile Telemedicine
Mobile medical
Acute Exacerbation of Chronic Obstructive Pulmonary Disease
Additional relevant MeSH terms:
Lung Diseases
Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive

Study Results

No Results Posted as of Jan 26, 2022