Acute Exacerbation of COPDPhase 4NCT05209607
Social Media-based Bundle Care of AECOPD Patients.
A Phase 4 study testing Mobile Medical and bundle management in people with Acute Exacerbation of COPD and Pulmonary Disease, Chronic Obstructive, run by Beijing Chao Yang Hospital.
Trial 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. Read more about this study
- Who is it for?
- Ages 45 to 70 years
- Conditions the study is for
- Acute Exacerbation of COPD, Pulmonary Disease, Chronic Obstructive, COPD
- What is being tested?
- Mobile Medical and bundle management
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 648 participants
- Where
- No sites listed yet
- Study dates
- 1 Feb 2022to 31 Dec 2024
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: 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.
- Conditions
- Acute Exacerbation of COPD, Pulmonary Disease, Chronic Obstructive, COPD, Lung Diseases, Obstructive, Readmission Rate, Mobile Medical
- Being tested
- Mobile Medical and bundle management, Mobile Medical and standard of care
- Keywords
- Readmission rate, Chronic Obstructive Pulmonary Disease, Randomized Controlled Trial, Bundle care, Mobile Telemedicine, Mobile medical, Acute Exacerbation of Chronic Obstructive Pulmonary Disease
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive, Lung Diseases, Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mobile Medical and bundle managementOther
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.
Mobile Medical and standard of careOther
Based on the mobile medical, participants will receive advice on standard medication only.
| Study group | Role | What they receive |
|---|---|---|
| Interventional group | Experimental | Participants will be given mobile medical and bundle care Receives: Other: Mobile Medical and bundle management |
| Control group | Other | Participants will be given mobile medical and standard of care. Receives: Other: Mobile Medical and standard of care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Readmission rate due to acute exacerbation of COPD within one year
Collected within one year after discharge
Measured: One year
Secondary outcomes (9)
The time interval from discharge to the next acute exacerbation of COPD
Collected within one year after discharge
Measured: One year
The times of acute exacerbation of COPD
Collected within one year after discharge
Measured: One year
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.
Measured: One year
The changes of spirometry
Collected within one year after discharge. FEV1/FEV, FEV1 %pre，FVC, DLCO and RV/TLC etc will be collected.
Measured: One year
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.
Measured: One year
The changes of percent of eosinophil count
Collected within one year after discharge
Measured: One year
Average annual medical cost
Collected within one year after discharge
Measured: One year
The types and proportions of adverse events occurred during using WeChat official account.
Collected within one year after discharge
Measured: One year
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.
Measured: One year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2022
- Study start1 Feb 2022 (estimated)
- Primary completion31 Oct 2024 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Acute Exacerbation of COPDStudies of the same condition, open and under way.
- More trials run by Beijing Chao Yang HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 648 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beijing Chao Yang Hospital
- Sponsor type
- University, hospital or other
- 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
- Responsible party
- Principal investigator, Yingxiang Lin, Beijing Chao Yang Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05209607
- Sponsor's protocol ID
- Z201100005520031
- Status last verified
- Jan 2022
- First submitted
- 29 Dec 2021
- Last updated
- 26 Jan 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 29474094Sobnath 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.
PubMed 28219878
Study at a glance
From the registry record, last updated by the sponsor on 26 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter Open-label Randomized Controlled Trial of Social Media-based Bundle Care in Patients With Exacerbation of Chronic Obstructive Pulmonary Disease.
- ClinicalTrials.gov ID
- NCT05209607
- Acronym / sponsor ID
- Z201100005520031
- Conditions
- Acute Exacerbation of COPD, Pulmonary Disease, Chronic Obstructive, COPD, Lung Diseases, Obstructive, Readmission Rate, Mobile Medical
- Keywords
- Readmission rate, Chronic Obstructive Pulmonary Disease, Randomized Controlled Trial, Bundle care, Mobile Telemedicine, Mobile medical, Acute Exacerbation of Chronic Obstructive Pulmonary Disease
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 648 participants (estimated)
- Lead sponsor
- Beijing Chao Yang HospitalUniversity, hospital or other
- 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
- Study start
- 1 Feb 2022 (estimated)
- Primary completion
- 31 Oct 2024 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 26 Jan 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Interventional group | Experimental | Other: Mobile Medical and bundle managementParticipants will be given mobile medical and bundle care |
| Control group | Other | Other: Mobile Medical and standard of careParticipants will be given mobile medical and standard of care. |
Who may qualify
- Ages
- 45 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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;
Key exclusion criteria (8 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mobile Medical and bundle managementBased 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 | Interventional group |
| Mobile Medical and standard of careBased on the mobile medical, participants will receive advice on standard medication only. | Other | Control group |
Primary outcome
Readmission rate due to acute exacerbation of COPD within one year
Time frame: One year
Collected within one year after discharge
9 secondary outcomes
The time interval from discharge to the next acute exacerbation of COPD
Time frame: One year
The times of acute exacerbation of COPD
Time frame: One year
The score of subjective symptom
Time frame: One year
The changes of spirometry
Time frame: One year
The changes of arterial blood gas analysis
Time frame: One year
The changes of percent of eosinophil count
Time frame: One year
Average annual medical cost
Time frame: One year
The types and proportions of adverse events occurred during using WeChat official account.
Time frame: One year
Compliance index
Time frame: One year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jan 2022.
- Background: PubMed 29474094Rothnie 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.
- Background: PubMed 28219878Sobnath 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Mobile Medical and bundle management in people with Acute Exacerbation of COPD and Pulmonary Disease, Chronic Obstructive, run by Beijing Chao Yang Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 26 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Lin Yingxiang, PhD (13611370119, bjlin666@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Readmission rate due to acute exacerbation of COPD within one year (time frame: One year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05209607, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jan 2022.