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
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
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
NCT ID
NCT05209607
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
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
Learn more about this trial
Social Media-based Bundle Care of AECOPD Patients.
We'll reach out to this number within 24 hrs