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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

30 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-06-29

Study Completion Date

2023-12-30

Brief Summary

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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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Detailed Description

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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?

Conditions

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Pulmonary Disease, Chronic Obstructive

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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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.

smartphone, smartwatch, WearCOPDv2 application

Intervention Type 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:

1. Data collection service
2. Participant user interface

Interventions

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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

Intervention Type DEVICE

Eligibility Criteria

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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

Minimum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No