COPDEWVCWDCNCT05974670
Early Warning Value of Consumer Wearable Devices in AECOPD
An observational study of COPD, run by Peking University First Hospital at 7 sites in China.
Trial summary
This is a prospective, multi-center cohort study. 150 subjects with COPD and in stable stage will be included. Wearable device's physiological parameters will be continually collected, the investigators aim to explore whether consumer wearable devices are useful for early warning deterioration of COPD. Read more about this study
- Who is it for?
- Ages 35 to 80 years
- Conditions the study is for
- COPD
- What is being tested?
- Consumer wearable device
- Type of treatment
- Medical device
- How many people
- 150 participants
- Where
- 7 sitesChina
- Study dates
- 21 Jun 2022to 30 Sep 2023
- Phase
- Observational
- 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 35 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Outpatients and inpatients from Peking University First Hospital
Who may be able to join
- Patients diagnosed with stable COPD (refer to 2021 GOLD guidelines);
- Age between 35 and 80 years (both 35 and 80), either gender;
- A post-bronchodilator forced expiratory volume in 1 second percentage (FEV1%) predicted between 25%~80%;
- Having mobile phone which can install APP of wearable device;
- Able to engage in daily activities;
Who cannot join
- History of asthma, lung cancer, active pulmonary tuberculosis, bronchiectasis, diffuse lung disease (interstitial pneumonia, pulmonary sarcoidosis, occupational lung disease, sarcoidosis et al) and pleural disease;
- History of lobectomy and/or lung transplantation;
- Predicted life expectancy less than 3 years;
- History of serious underlying diseases (including severe psychiatric illnesses, mental disorders, neurological disorders, malignant tumors, chronic liver disease, heart failure, autoimmune diseases, chronic kidney disease);
- Alcoholism, drug or toxic solvents abuse;
- Moderate to severe anemia;
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- Smoking or quitting smoking for less than 6 weeks;
- Skin pigmentation, deformity, arterial stenosis or occlusion of both upper limbs;
- Skin allergy to metal/plastic;
- Those who are participating in other clinical trials, cannot be followed up for a long time or have poor compliance.
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
China7 sites, 7 recruiting
- Recruiting
Peking University First Hospital
Beijing, Beijing Municipality, 100034
Jiping Liao, MD., 13521714181, colorfulwing01@163.com
Chunbo Zhang, 13086645758, 2399637945@qq.com
- Not yet recruiting
Aerospace 731 Hospital
Beijing, Beijing Municipality
Fengzhen Zhang, zfz731hx@163.com
- Not yet recruiting
Beijing Miyun Hospital
Beijing, Beijing Municipality
Chunhong Wang, 13701387739@163.com
- Not yet recruiting
Civil Aviation General Hospital
Beijing, Beijing Municipality
Xiaosen Qian, qian186@sohu.com
- Not yet recruiting
People's Hospital of Beijing Daxing District
Beijing, Beijing Municipality
Yongxiang Zhang, zyx8669@163.com
- Not yet recruiting
Shichahai Community Health Service Center
Beijing, Beijing Municipality
Lina Zhang, 10027698@qq.com
- Not yet recruiting
The Hospital of Shunyi District Beijing
Beijing, Beijing Municipality
Xisheng Chen, syhx2011@163.com
About this study
Official title: Early Warning Value of Consumer Wearable Devices in Chronic Obstructive Pulmonary Disease Exacerbation: An Evaluation Study
This is a prospective, multi-center cohort study. 150 subjects with COPD and in stable stage will be included. Wearable device's physiological parameters will be continually collected, the investigators aim to explore whether consumer wearable devices are useful for early warning deterioration of COPD.
Read the detailed description
This is a prospective cohort study. 150 subjects aged 35～80y with stable COPD will be recruited. After enrollment, subjects wear consumer wearable devices and install APP on their mobile phones. The first 7 days of wearing are to evaluate the stability of data collection and the subject compliance, and to correct the wrong wearing. The subjects are required to fill in the COPD symptom diary every day, and conducted online or offline follow-up at the 4th, 8th, 12th, 16th, 20th, and 24th weeks after enrollment. The physiological parameters of wearable devices, including pulse rate, blood oxygen saturation, physical activity, electrocardiogram, and sleep, will be continuously collected during the study. The Department of Respiratory and Critical Care of Peking University First Hospital is responsible for this research. Primary outcome is the moderate or more severe COPD acute exacerbation events. The purpose of this study is to use consumer wearable devices to monitor the changes of COPD, and to establish a physiological parameters model of wearable device that can predict the acute exacerbation of COPD.
The study protocol has been approved by the Peking University First Hospital Institutional Review Board (IRB) (2021-397). Any protocol modifications will be submitted for the IRB review and approval.
- Conditions
- COPD
- Being tested
- Consumer wearable device
- Keywords
- COPD, AECOPD, Consumer wearable device
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Consumer wearable deviceDevice
The subjects are required to wear the consumer wearable devices continuously during the whole study period. The device can provided several physiological parameters, including pulse rate, blood oxygen saturation, physical activity, electrocardiogram, and sleep.
| Study group | Role | What they receive |
|---|---|---|
| Wearing device | The subjects are required to fill in the COPD symptom diary every day, and conducted online or offline follow-up at the 4th, 8th, 12th, 16th, 20th, and 24th weeks after enrollment. The physiological parameters of wearable devices, including pulse rate, blood oxygen saturation, physical activity, electrocardiogram, and sleep, will be continuously collected during the study. Receives: Device: Consumer wearable device |
What is being measured
The primary outcome is the main question the study is designed to answer.
Moderate or more severe COPD exacerbation
Mild exacerbation: exacerbation requiring short-acting bronchodilator (SABD) therapy alone Moderate exacerbation: exacerbation requiring SABD and antimicrobials with or without oral corticosteroids Severe exacerbation: exacerbation requiring hospitalization or emergency, intensive care unit (ICU) treatment.
Measured: 6 months
Secondary outcomes (13)
Changes in symptoms (assessed by COPD Assessment Test, CAT)
The change in CAT score is calculated by the difference in CAT score during follow-up.
Measured: 6 months
Changes in symptoms (assessed by the modified Medical Research Council (mMRC) dyspnea scores)
The change in mMRC score is calculated by the difference in CAT score during follow-up.
Measured: 6 months
Changes in post-bronchodilator FEV1
Post-bronchodilator FEV1 is measured by trained staff. The change in post-bronchodilator FEV1 is defined as the difference in FEV1 between week 24 follow-up and enrollment.
Measured: 6 months
Changes in post-bronchodilator FEV1%
Post-bronchodilator FEV1% is measured by trained staff. The change in post-bronchodilator FEV1% is defined as the difference in FEV1 between week 24 follow-up and enrollment.
Measured: 6 months
Changes in post-bronchodilator FVC
Post-bronchodilator FVC is measured by trained staff. The change in post-bronchodilator FVC is defined as the difference in FEV1 between week 24 follow-up and enrollment.
Measured: 6 months
Changes in post-bronchodilator FVC%
Post-bronchodilator FVC% is measured by trained staff. The change in post-bronchodilator FVC% is defined as the difference in FEV1 between week 24 follow-up and enrollment.
Measured: 6 months
Changes in post-bronchodilator FEV1/FVC
Post-bronchodilator FEV1/FVC is measured by trained staff. The change in post-bronchodilator FEV1/FVC is defined as the difference in FEV1 between week 24 follow-up and enrollment.
Measured: 6 months
Herat rate parameters
A wearable device worn by the subject continuously monitors heart rate parameters, from which parameters such as heart rate can be obtained.
Measured: 6 months
Blood oxygen saturation
A wearable device worn by the subject continuously monitors blood oxygen saturation.
Measured: 6 months
Physical parameters from wearable device
A wearable device worn by the subject continuously monitors physical parameters, from which parameters such as steps can be obtained.
Measured: 6 months
Sleep parameters from wearable device
A wearable device worn by the subject continuously monitors sleep parameters, from which parameters such as sleep duration can be obtained.
Measured: 6 months
Wearing compliance
Compliance is defined as the ratio of the time of wearing a device to the total study time.
Measured: 6 months
Data loss rate
Data loss rate
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Aug 2023
- Study start21 Jun 2022
- Primary completion30 Sep 2023 (estimated)
- Study completion30 Sep 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COPDStudies of the same condition, open and under way.
- More trials run by Peking University First 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking University First Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Guangfa Wang, MD., Study chair, Peking University First Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05974670
- Sponsor's protocol ID
- 2021397-20220703
- Acronym
- EWVCWDC
- Status last verified
- Jul 2023
- First submitted
- 27 Sep 2022
- Last updated
- 3 Aug 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early Warning Value of Consumer Wearable Devices in Chronic Obstructive Pulmonary Disease Exacerbation: An Evaluation Study
- ClinicalTrials.gov ID
- NCT05974670
- Acronym / sponsor ID
- EWVCWDC / 2021397-20220703
- Conditions
- COPD
- Keywords
- COPD, AECOPD, Consumer wearable device
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Peking University First HospitalUniversity, hospital or other
- Study start
- 21 Jun 2022 (actual)
- Primary completion
- 30 Sep 2023 (estimated)
- Study completion
- 30 Sep 2023 (estimated)
- First posted
- 3 Aug 2023 (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.
This is a prospective, multi-center cohort study. 150 subjects with COPD and in stable stage will be included. Wearable device's physiological parameters will be continually collected, the investigators aim to explore whether consumer wearable devices are useful for early warning deterioration of COPD.
Detailed description
This is a prospective cohort study. 150 subjects aged 35～80y with stable COPD will be recruited. After enrollment, subjects wear consumer wearable devices and install APP on their mobile phones. The first 7 days of wearing are to evaluate the stability of data collection and the subject compliance, and to correct the wrong wearing. The subjects are required to fill in the COPD symptom diary every day, and conducted online or offline follow-up at the 4th, 8th, 12th, 16th, 20th, and 24th weeks after enrollment. The physiological parameters of wearable devices, including pulse rate, blood oxygen saturation, physical activity, electrocardiogram, and sleep, will be continuously collected during the study. The Department of Respiratory and Critical Care of Peking University First Hospital is responsible for this research. Primary outcome is the moderate or more severe COPD acute exacerbation events. The purpose of this study is to use consumer wearable devices to monitor the changes of COPD, and to establish a physiological parameters model of wearable device that can predict the acute exacerbation of COPD.
The study protocol has been approved by the Peking University First Hospital Institutional Review Board (IRB) (2021-397). Any protocol modifications will be submitted for the IRB review and approval.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Wearing device | – | Device: Consumer wearable deviceThe subjects are required to fill in the COPD symptom diary every day, and conducted online or offline follow-up at the 4th, 8th, 12th, 16th, 20th, and 24th weeks after enrollment. The physiological parameters of wearable devices, including pulse rate, blood oxygen saturation, physical activity, electrocardiogram, and sleep, will be continuously collected during the study. |
Who may qualify
- Ages
- 35 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Outpatients and inpatients from Peking University First Hospital
Key inclusion criteria (5 listed)
- Patients diagnosed with stable COPD (refer to 2021 GOLD guidelines);
- Age between 35 and 80 years (both 35 and 80), either gender;
- A post-bronchodilator forced expiratory volume in 1 second percentage (FEV1%) predicted between 25%~80%;
- Having mobile phone which can install APP of wearable device;
- Able to engage in daily activities;
Key exclusion criteria (10 listed)
- History of asthma, lung cancer, active pulmonary tuberculosis, bronchiectasis, diffuse lung disease (interstitial pneumonia, pulmonary sarcoidosis, occupational lung disease, sarcoidosis et al) and pleural disease;
- History of lobectomy and/or lung transplantation;
- Predicted life expectancy less than 3 years;
- History of serious underlying diseases (including severe psychiatric illnesses, mental disorders, neurological disorders, malignant tumors, chronic liver disease, heart failure, autoimmune diseases, chronic kidney disease);
- Alcoholism, drug or toxic solvents abuse;
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 |
|---|---|---|
| Consumer wearable deviceThe subjects are required to wear the consumer wearable devices continuously during the whole study period. The device can provided several physiological parameters, including pulse rate, blood oxygen saturation, physical activity, electrocardiogram, and sleep. | Device | Wearing device |
Primary outcome
Moderate or more severe COPD exacerbation
Time frame: 6 months
Mild exacerbation: exacerbation requiring short-acting bronchodilator (SABD) therapy alone Moderate exacerbation: exacerbation requiring SABD and antimicrobials with or without oral corticosteroids Severe exacerbation: exacerbation requiring hospitalization or emergency, intensive care unit (ICU) treatment.
13 secondary outcomes
Changes in symptoms (assessed by COPD Assessment Test, CAT)
Time frame: 6 months
Changes in symptoms (assessed by the modified Medical Research Council (mMRC) dyspnea scores)
Time frame: 6 months
Changes in post-bronchodilator FEV1
Time frame: 6 months
Changes in post-bronchodilator FEV1%
Time frame: 6 months
Changes in post-bronchodilator FVC
Time frame: 6 months
Changes in post-bronchodilator FVC%
Time frame: 6 months
Changes in post-bronchodilator FEV1/FVC
Time frame: 6 months
Herat rate parameters
Time frame: 6 months
Blood oxygen saturation
Time frame: 6 months
Physical parameters from wearable device
Time frame: 6 months
Sleep parameters from wearable device
Time frame: 6 months
Wearing compliance
Time frame: 6 months
Data loss rate
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Aug 2023.
- 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.
Guangfa Wang, MD. study chair
Peking University First Hospital
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of COPD, run by Peking University First Hospital at 7 sites in China.
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 5 inclusion and 10 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 3 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
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.
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 Jiping Liao, MD. (13521714181, colorfulwing01@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Moderate or more severe COPD exacerbation (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 3 Aug 2023.