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

University Health Network, Toronto30 enrolled

Overview

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?

Study Type

OBSERVATIONAL

Enrollment

Conditions

Pulmonary Disease, Chronic Obstructive

Interventions

smartphone, smartwatch, WearCOPDv2 applicationDEVICE

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

Eligibility

Sex: ALLMin age: 40 Years

Medical Language ↔ Plain English

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

Locations (1)

Toronto General Hospital

Toronto, Ontario, Canada

Outcomes

Primary Outcomes

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

Secondary Outcomes

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

Data from ClinicalTrials.gov

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