Clinical trial NCT03857061: A Wearable and a Self-management Application for Chronic Obstructive Pulmonary Disease (COPD) Patients at Home
Official title: COPDwear V2 - A Wearable and a Self-management Application for COPD Patients at Home: a Pilot Prospective Cohort Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pulmonary Disease, Chronic Obstructive
Keywords: wearables
self-monitoring
Lead sponsor: University Health Network, Toronto
Sponsor class: OTHER
Collaborators: name: University of Toronto
name: Samsung Electronics
First posted: 2019-02-27
Enrollment: 30
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

Brief 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.

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?

Eligibility criteria: 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

Primary outcomes:
measure: Change in self-management as measured by the Mastery sub-section of the Chronic Respiratory Disease Questionnaire
timeFrame: 6 months
Secondary outcomes:
measure: Change in self-efficacy as measured by the COPD Self-Efficacy Scale
timeFrame: 6 months
measure: Change in Health related quality of life as measured by the St. George's respiratory questionnaire
timeFrame: 6 months
measure: Change in symptom scale as measured by the MRC dyspnea scale
timeFrame: 6 months
measure: Accuracy of our derived prediction algorithm to detect acute exacerbations as measured by the daily symptom score.
timeFrame: 6 months
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: Toronto General Hospital
state: Ontario
Study officials:
affiliation: University Health Network, Toronto
name: Robert Wu
role: PRINCIPAL_INVESTIGATOR
References: