Early Warning Value of Consumer Wearable Devices in AECOPD (EWVCWDC)

July 26, 2023 updated by: Peking University First Hospital

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Estimated)

150

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

Study Contact Backup

Study Locations

  • China
    • Beijing
      • Beijing, Beijing, China, 100034
        • Recruiting
        • Peking University First Hospital
        • Sub-Investigator:
          • Chunbo Zhang
        • Contact:
        • Contact:
        • Principal Investigator:
          • Jiping Liao, MD.
        • Sub-Investigator:
          • Guangfa Wang, MD.
        • Sub-Investigator:
          • Zhe Jin, MD.
        • Sub-Investigator:
          • Meng Zhang
        • Sub-Investigator:
          • Yan Hu, MD.
        • Sub-Investigator:
          • Xueying Li
        • Sub-Investigator:
          • Jian Chen
      • Beijing, Beijing, China
        • Not yet recruiting
        • Aerospace 731 Hospital
        • Contact:
      • Beijing, Beijing, China
      • Beijing, Beijing, China
        • Not yet recruiting
        • Civil Aviation General Hospital
        • Contact:
      • Beijing, Beijing, China
        • Not yet recruiting
        • People's Hospital of Beijing Daxing District
        • Contact:
      • Beijing, Beijing, China
        • Not yet recruiting
        • Shichahai community health service center
        • Contact:
      • Beijing, Beijing, China
        • Not yet recruiting
        • The Hospital of Shunyi District Beijing
        • Contact:

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

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Outpatients and inpatients from Peking University First Hospital

Description

Inclusion Criteria:

  • 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;

Exclusion Criteria:

  • 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;
  • 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.

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

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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.
Device: Consumer wearable device
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes in symptoms (assessed by COPD Assessment Test, CAT)
Time Frame: 6 months
The change in CAT score is calculated by the difference in CAT score during follow-up.
6 months
Changes in symptoms (assessed by the modified Medical Research Council (mMRC) dyspnea scores)
Time Frame: 6 months
The change in mMRC score is calculated by the difference in CAT score during follow-up.
6 months
Changes in post-bronchodilator FEV1
Time Frame: 6 months
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.
6 months
Changes in post-bronchodilator FEV1%
Time Frame: 6 months
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.
6 months
Changes in post-bronchodilator FVC
Time Frame: 6 months
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.
6 months
Changes in post-bronchodilator FVC%
Time Frame: 6 months
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.
6 months
Changes in post-bronchodilator FEV1/FVC
Time Frame: 6 months
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.
6 months
Herat rate parameters
Time Frame: 6 months
A wearable device worn by the subject continuously monitors heart rate parameters, from which parameters such as heart rate can be obtained.
6 months
Blood oxygen saturation
Time Frame: 6 months
A wearable device worn by the subject continuously monitors blood oxygen saturation.
6 months
Physical parameters from wearable device
Time Frame: 6 months
A wearable device worn by the subject continuously monitors physical parameters, from which parameters such as steps can be obtained.
6 months
Sleep parameters from wearable device
Time Frame: 6 months
A wearable device worn by the subject continuously monitors sleep parameters, from which parameters such as sleep duration can be obtained.
6 months
Wearing compliance
Time Frame: 6 months
Compliance is defined as the ratio of the time of wearing a device to the total study time.
6 months
Data loss rate
Time Frame: 6 months
Data loss rate
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Peking University First Hospital

Investigators

  • Study Chair: Guangfa Wang, MD., Peking University First Hospital

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 (Actual)

June 21, 2022

Primary Completion (Estimated)

September 30, 2023

Study Completion (Estimated)

September 30, 2023

Study Registration Dates

First Submitted

September 27, 2022

First Submitted That Met QC Criteria

July 26, 2023

First Posted (Actual)

August 3, 2023

Study Record Updates

Last Update Posted (Actual)

August 3, 2023

Last Update Submitted That Met QC Criteria

July 26, 2023

Last Verified

July 1, 2023

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 2021397-20220703

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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