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

Pulmonary Disease, Chronic Obstructive Clinical Trial

— COPDwear  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03857061
• Other study ID #: 18-5462
• Status: Active, not recruiting
• Start date: June 29, 2019
• Est. completion date: December 30, 2023

Study information

• Verified date: May 2023
• Source: University Health Network, Toronto
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

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?

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 30
• Est. completion date: December 30, 2023
• Est. primary completion date: June 1, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Lung Diseases
• Pulmonary Disease, Chronic Obstructive

Intervention

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

Locations

Country	Name	City	State
Canada	Toronto General Hospital	Toronto	Ontario

Sponsors (3)

Lead Sponsor	Collaborator
University Health Network, Toronto	Samsung Electronics, University of Toronto

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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