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Completed

NCT Number: NCT03857061

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

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.

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Key information

Conditions

Pulmonary Disease, Chronic Obstructive Chronic Disease Disease Attributes Lung Diseases Lung Diseases, Obstructive Pathologic Processes Pathological Conditions, Signs and Symptoms Respiratory Tract Diseases

Age range

40 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Toronto General Hospital

Toronto, Ontario, M5G 2C4, Canada

About this study

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?

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

smartphone, smartwatch, WearCOPDv2 application

Device

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

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

    • Very confident
    • Pretty confident
    • Somewhat confident
    • Not very confident
    • Not at all confident

    A lower score indicates higher self-efficacy.

  2. 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

  3. 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.

  4. 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

Sponsors and collaborators

Lead sponsor

University Health Network, Toronto

Other

Collaborators

  • Samsung Electronics
  • University of Toronto

Registry information

Official study title

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

Acronym: COPDwear

Important dates

Study start
2019
Primary completion
2021
Study completion
2023
First posted
Feb 27, 2019
Registry last updated
Jan 24, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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