- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05209607
Social Media-based Bundle Care of AECOPD Patients.
January 22, 2022 updated by: Yingxiang Lin, Beijing Chao Yang Hospital
A Multicenter Open-label Randomized Controlled Trial of Social Media-based Bundle Care in Patients With Exacerbation of Chronic Obstructive Pulmonary Disease.
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.
Study Overview
Status
Not yet recruiting
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Anticipated)
648
Phase
- Phase 4
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Lin Yingxiang, PhD
- Phone Number: 13611370119
- Email: bjlin666@163.com
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
45 years to 70 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Interventional group
Participants will be given mobile medical and bundle care
|
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.
|
Based on the mobile medical, participants will receive advice on standard medication only.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Readmission rate due to acute exacerbation of COPD within one year
Time Frame: One year
|
Collected within one year after discharge
|
One year
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
The time interval from discharge to the next acute exacerbation of COPD
Time Frame: One year
|
Collected within one year after discharge
|
One year
|
The times of acute exacerbation of COPD
Time Frame: One year
|
Collected within one year after discharge
|
One year
|
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.
|
One year
|
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.
|
One year
|
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.
|
One year
|
The changes of percent of eosinophil count
Time Frame: One year
|
Collected within one year after discharge
|
One year
|
Average annual medical cost
Time Frame: One year
|
Collected within one year after discharge
|
One year
|
The types and proportions of adverse events occurred during using WeChat official account.
Time Frame: One year
|
Collected within one year after discharge
|
One year
|
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.
|
One year
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- 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.
- 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Anticipated)
February 1, 2022
Primary Completion (Anticipated)
October 31, 2024
Study Completion (Anticipated)
December 31, 2024
Study Registration Dates
First Submitted
December 29, 2021
First Submitted That Met QC Criteria
January 22, 2022
First Posted (Actual)
January 26, 2022
Study Record Updates
Last Update Posted (Actual)
January 26, 2022
Last Update Submitted That Met QC Criteria
January 22, 2022
Last Verified
January 1, 2022
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- Z201100005520031
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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