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

January 22, 2025 updated by: Robert Wu, University Health Network, Toronto

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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
30

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

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

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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:

  1. Data collection service
  2. Participant user interface

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change in self-management as measured by the Mastery sub-section of the Chronic Respiratory Disease Questionnaire
Time Frame: 6 months

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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change in self-efficacy as measured by the COPD Self-Efficacy Scale
Time Frame: 6 months

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.
6 months
Change in Health related quality of life as measured by the St. George's respiratory questionnaire
Time Frame: 6 months

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
Time Frame: 6 months

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.
Time Frame: 6 months

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

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University Health Network, Toronto

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
University of Toronto
Samsung Electronics

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Robert Wu, University Health Network, Toronto

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 29, 2019

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 1, 2021

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 30, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 23, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 25, 2019

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 27, 2019

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 25, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 22, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

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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