A Wearable and a Self-management Application for Chronic Obstructive Pulmonary Disease (COPD) Patients at Home (COPDwear)

COPDwear V2 - A Wearable and a Self-management Application for COPD Patients at Home: a Pilot Prospective Cohort Study

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Pulmonary Disease, Chronic Obstructive
• Intervention / Treatment: Device: smartphone, smartwatch, WearCOPDv2 application

Detailed Description

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?

• Study Type: Observational
• Enrollment (Actual): 30

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • Toronto, Ontario, Canada, M5G 2C4
      • Toronto General Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

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.

Description

Inclusion Criteria:

• Able to speak English
• Moderate to very severe COPD (GOLD C and D) as defined by the GOLD guidelines
• Clinically relevant disease, as defined by a history of exacerbation in the previous 12 months
• Previous spirometry or Pulmonary Function Test results of Forced Expiration Volume/Forced Vital Capacity (FEV1/FVC) <0.70 with an FEV1 below 80% predicted
• Patient resides at home (not long term care residence or another hospital)

Exclusion Criteria:

• Pulmonary condition other than COPD as the main respiratory disease such as bronchiectasis or asthma
• Rapid lethal disease, e.g. lung cancer, advance heart failure, end-stage renal disease
• Any medical conditions that would impair their ability to participate in the study

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
COPD Patients; 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: Data collection service; Participant user interface

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.; Very confident; Pretty confident; Somewhat confident; Not very confident; Not at all confident A lower score indicates higher self-efficacy.	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	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.	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	6 months

Collaborators and Investigators

• Sponsor: University Health Network, Toronto
• Collaborators: University of Toronto; Samsung Electronics
• Investigators: Principal Investigator: Robert Wu, University Health Network, Toronto

Study record dates

Study Major Dates

• Study Start (Actual): June 29, 2019
• Primary Completion (Actual): June 1, 2021
• Study Completion (Anticipated): December 30, 2023

Study Registration Dates

• First Submitted: July 23, 2018
• First Submitted That Met QC Criteria: February 25, 2019
• First Posted (Actual): February 27, 2019

Study Record Updates

• Last Update Posted (Actual): May 15, 2023
• Last Update Submitted That Met QC Criteria: May 12, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Keywords: self-monitoring; wearables
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Pulmonary Disease, Chronic Obstructive
• Other Study ID Numbers: 18-5462

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

IPD Plan Description

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.

• IPD Sharing Time Frame: Data will become available right away for up to 5 years.
• IPD Sharing Access Criteria: Data will be stored and analyzed on the secure UHN server
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No