An observational study in Pulmonary Disease, Chronic Obstructive, sponsored by University Health Network, Toronto. Completed at 1 site in Canada. Open to participants aged 40 Years and older. Per ClinicalTrials.gov, last updated 2025-01-24.
Sponsored by University Health Network, Toronto · Observational
Our overall research goal for this project is to create a wearable device and mobile application, appealing to patients with Chronic Obstructive Pulmonary Disease (COPD), which provides them with appropriate self-management tools and detects AECOPDs early to permit prompt treatment and prevent severe exacerbations requiring hospitalization.
Our overall research goal for this project is to create a wearable device and mobile application, appealing to patients with COPD, which provides them with appropriate self-management tools and detects Acute Exacerbations of COPD (AECOPDs) early to permit prompt treatment and prevent severe exacerbations requiring hospitalization. Currently, the investigators are developing a second version of this app, WearCOPDv2. This app will incorporate features identified as being desirable from our patient interviews: 1) new sensor that was requested by patients - oxygen saturation, and 2) the app will incorporate a patient-facing interface as patients requested a method to view their data as well as access to information to learn how to manage their condition better.
Research questions:
Can an app designed for patients with COPD that includes biosensor feedback improve self-management of COPD?
What is the accuracy of our sensor data (heart rate, activity, respiratory rate, oxygen saturation, coughing, and other sounds of interest) in detecting early AECOPDs?
3,303 studies on the registry are indexed under Lung Diseases; 355 are open to participants now.
This study's enrollment of 30 is below the median of 157 across 929 observational studies indexed under Lung Diseases.
Browse Lung Diseases studies →University Health Network, Toronto is the lead sponsor of 1,411 studies on the registry; 292 are open to participants now.
Of its 17 completed or terminated interventional studies of FDA-regulated products, 3 (18%) have results posted.
Counted across the registry records on this site, refreshed daily.
The investigators will recruit patients who have clinically relevant COPD who live at home. They will be identified in clinics and the wards by members of their care team. Posters informing people of the study will also be posted at University Health Network (UHN) with a contact number.
Exclusion Criteria:
This is a prospective cohort study enrolling patients with COPD to 1) wear a smartwatch that passively senses heart rate, motion, audio, 2) use a smartphone that can obtain oxygen saturation upon demand, 3) use a self-management app on the smartwatch, smartphone and a webapp.
Device: smartphone, smartwatch, WearCOPDv2 application
WearCOPD2 consists of hardware and software components. 6.1 Hardware The hardware for wearCOPDv2 consists of three main components; (1) a smartwatch, (2) a phone, and (3) a server. 6.2 Software The wearCOPDv2 system has two main software components: 1. Data collection service 2. Participant user interface
Change in self-management as measured by the Mastery sub-section of the Chronic Respiratory Disease Questionnaire
Can an app designed for patients with COPD that includes biosensor feedback improve self-management of COPD? We will use the Mastery sub-section of the Chronic Respiratory Disease Questionnaire to measure our research question. Mastery is measured with a 7-point likert scale where higher scores indicate better health-related mastery.
Time frame: 6 months
Change in self-efficacy as measured by the COPD Self-Efficacy Scale
Can an app designed for patients with COPD that includes biosensor feedback improve self-efficacy of COPD? This will be measured by the COPD self-efficacy scale. Participants will determine how confident they are that they could manage breathing difficulty or avoid breathing difficulty in certain situations. Usin the following scale. 1. Very confident 2. Pretty confident 3. Somewhat confident 4. Not very confident 5. Not at all confident A lower score indicates higher self-efficacy.
Time frame: 6 months
Change in Health related quality of life as measured by the St. George's respiratory questionnaire
Can an app designed for patients with COPD that includes biosensor feedback improve health related quality of life? Scoring and Scales Questions 1 - 7 Scale: Most days a week - Not At All Where a patient has ticked a box, a value of 1 is entered for the appropriate question. Question 8 Where a patient has ticked 'Yes' to having a worse wheeze in the morning, a value of 1 is entered for the appropriate question. Questions 9, 10 \& 17 Where a patient has ticked a box, a value of 1 is entered for the appropriate question. Questions 11 - 16 Where a patient has ticked 'True' a value of 1 is entered for the appropriate question. In response to question 14, if a patient is not receiving medication, enter the responses as zero. Score = 100 x (Summed weights from positive items in the questionnaire divided by the Sum of weights for all items in the questionnaire) lower scores indicate higher health related quality of life
Time frame: 6 months
Change in symptom scale as measured by the MRC dyspnea scale
Can an app designed for patients with COPD that includes biosensor feedback improve COPD symptoms? The MRC Dyspnea scale asks you to rate your breathlessness on a 5 point likert scale.
Time frame: 6 months
Accuracy of our derived prediction algorithm to detect acute exacerbations as measured by the daily symptom score.
We will correlate sensor data from the smartwatch to exacerbations defined by the daily symptom score. The daily symptom score asks about daily symptoms of COPD and patients are asked to answer yes or no to whether or not they have experienced a decline of any of the symptoms
Time frame: 6 months
Plan to share: Yes — UHN, research personnel will have direct access to the source documents with identifying information. UHN, University of Toronto (UofT) and Samsung Research America (SRA) will have access to the anonymized subject data for analysis purposes.
Supporting information: Study protocol
No publications or documents are linked to this record.
This study is completed, as verified in Jan 2025. You cannot join it, but the record below documents what was studied.
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University Health Network, Toronto