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

NCT03857061 | Completed

• 1 other identifier: 18-5462
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Pulmonary Disease, Chronic Obstructive

Keywords

wearables; self-monitoring

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Change in self-efficacy as measured by the COPD Self-Efficacy Scale

  6 months

• Change in Health related quality of life as measured by the St. George's respiratory questionnaire

  6 months

• Change in symptom scale as measured by the MRC dyspnea scale

  6 months

• Accuracy of our derived prediction algorithm to detect acute exacerbations as measured by the daily symptom score.

  6 months

Study Arms (1)

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.

Device: smartphone, smartwatch, WearCOPDv2 application

Interventions

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: 1. Data collection service 2. Participant user interface

COPD Patients

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• University Health Network, Toronto: lead
• University of Toronto: collaborator
• Samsung Electronics: collaborator

Study Sites (1)

Toronto General Hospital

Toronto, Ontario, M5G 2C4, Canada

Location

Related Publications (1)

• Wu R, de Lara E, Liaqat D, Liaqat S, Chen JL, Son T, Gershon AS. Feasibility of a wearable self-management application for patients with COPD at home: a pilot study. BMC Med Inform Decis Mak. 2024 Mar 5;24(1):66. doi: 10.1186/s12911-024-02461-y.

  PMID: 38443858 DERIVED

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

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

Study Officials

• Robert Wu

  University Health Network, Toronto

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: General Internal Medicine Site Director

Study Record Dates

• First Submitted: July 23, 2018
• First Posted: February 27, 2019
• Study Start: June 29, 2019
• Primary Completion: June 1, 2021
• Study Completion: December 30, 2023
• Last Updated: January 24, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: Data will become available right away for up to 5 years.
• Access Criteria: Data will be stored and analyzed on the secure UHN server

Locations

CA (1)