Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Social Media-based Bundle Care of AECOPD Patients.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05209607
Recruitment Status : Not yet recruiting
First Posted : January 26, 2022
Last Update Posted : January 26, 2022
Sponsor:
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
Information provided by (Responsible Party):
Yingxiang Lin, Beijing Chao Yang Hospital

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
Acute Exacerbation of COPD Pulmonary Disease, Chronic Obstructive COPD Lung Diseases, Obstructive Readmission Rate Mobile Medical Bundle Care Mobile Telemedicine Other: Mobile Medical and bundle management Other: Mobile Medical and standard of care Phase 4

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated 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.
Estimated Study Start Date : February 1, 2022
Estimated Primary Completion Date : October 31, 2024
Estimated Study Completion Date : December 31, 2024

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.

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.




Primary Outcome Measures :
  1. Readmission rate due to acute exacerbation of COPD within one year [ Time Frame: One year ]
    Collected within one year after discharge


Secondary Outcome Measures :
  1. The time interval from discharge to the next acute exacerbation of COPD [ Time Frame: One year ]
    Collected within one year after discharge

  2. The times of acute exacerbation of COPD [ Time Frame: One year ]
    Collected within one year after discharge

  3. The score of subjective symptom [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: One year ]
    Collected within one year after discharge

  7. Average annual medical cost [ Time Frame: One year ]
    Collected within one year after discharge

  8. The types and proportions of adverse events occurred during using WeChat official account. [ Time Frame: One year ]
    Collected within one year after discharge

  9. Compliance index [ Time Frame: 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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   45 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05209607


Contacts
Layout table for location contacts
Contact: Lin Yingxiang, PhD 13611370119 bjlin666@163.com

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
Publications:
Layout table for additonal information
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: January 26, 2022    Key Record Dates
Last Update Posted: January 26, 2022
Last Verified: January 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Yingxiang Lin, 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:
Layout table for MeSH terms
Lung Diseases
Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Respiratory Tract Diseases