Brief 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.

Trial Health

At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date

Enrollment

150

participants targeted

Target at P50-P75 for all trials

Timeline

Completed

Started Jun 2022

Geographic Reach

1 country

7 active sites

Status

unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

1.3 years study duration

Study Start

First participant enrolled

June 21, 2022

Completed

3 months until next milestone

First Submitted

Initial submission to the registry

September 27, 2022

Completed

10 months until next milestone

First Posted

Study publicly available on registry

August 3, 2023

Completed

2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2023

Completed

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2023

Completed

Last Updated

August 3, 2023

Status Verified

July 1, 2023

Enrollment Period

1.3 years

First QC Date

September 27, 2022

Last Update Submit

July 26, 2023

Conditions

COPD

Keywords

COPDAECOPDConsumer wearable device

Outcome Measures

Primary Outcomes (1)

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.
6 months

Secondary Outcomes (13)

Changes in symptoms (assessed by COPD Assessment Test, CAT)
6 months
Changes in symptoms (assessed by the modified Medical Research Council (mMRC) dyspnea scores)
6 months
Changes in post-bronchodilator FEV1
6 months
Changes in post-bronchodilator FEV1%
6 months
Changes in post-bronchodilator FVC
6 months
+8 more secondary outcomes

Study Arms (1)

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

Interventions

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.

Wearing device

Eligibility Criteria

Age35 Years - 80 Years

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

Sampling MethodNon-Probability Sample

Study Population

Outpatients and inpatients from Peking University First Hospital

You may qualify if:

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;

You may not qualify if:

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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Peking University First Hospitallead

Study Sites (7)

Peking University First Hospital

Beijing, Beijing Municipality, 100034, China

RECRUITING

Aerospace 731 Hospital