Ignite Creation Date:
2025-12-24 @ 12:20 PM
Ignite Modification Date:
2025-12-27 @ 10:15 PM
Study NCT ID:
NCT03857061
Status:
COMPLETED
Last Update Posted:
2025-01-24
First Post:
2018-07-23
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Wearable and a Self-management Application for Chronic Obstructive Pulmonary Disease (COPD) Patients at Home
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D029424', 'term': 'Pulmonary Disease, Chronic Obstructive'}], 'ancestors': [{'id': 'D008173', 'term': 'Lung Diseases, Obstructive'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D002908', 'term': 'Chronic Disease'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 30}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-06-29', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-01', 'completionDateStruct': {'date': '2023-12-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-01-22', 'studyFirstSubmitDate': '2018-07-23', 'studyFirstSubmitQcDate': '2019-02-25', 'lastUpdatePostDateStruct': {'date': '2025-01-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-02-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-06-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in self-management as measured by the Mastery sub-section of the Chronic Respiratory Disease Questionnaire', 'timeFrame': '6 months', 'description': 'Can an app designed for patients with COPD that includes biosensor feedback improve self-management of COPD?\n\nWe 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.'}], 'secondaryOutcomes': [{'measure': 'Change in self-efficacy as measured by the COPD Self-Efficacy Scale', 'timeFrame': '6 months', 'description': 'Can an app designed for patients with COPD that includes biosensor feedback improve self-efficacy of COPD?\n\nThis 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.\n\n1. Very confident\n2. Pretty confident\n3. Somewhat confident\n4. Not very confident\n5. Not at all confident\n\nA lower score indicates higher self-efficacy.'}, {'measure': "Change in Health related quality of life as measured by the St. George's respiratory questionnaire", 'timeFrame': '6 months', 'description': "Can an app designed for patients with COPD that includes biosensor feedback improve health related quality of life?\n\nScoring and Scales\n\nQuestions 1 - 7 Scale: Most days a week - Not At All\n\nWhere a patient has ticked a box, a value of 1 is entered for the appropriate question.\n\nQuestion 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.\n\nQuestions 9, 10 \\& 17 Where a patient has ticked a box, a value of 1 is entered for the appropriate question.\n\nQuestions 11 - 16 Where a patient has ticked 'True' a value of 1 is entered for the appropriate question.\n\nIn response to question 14, if a patient is not receiving medication, enter the responses as zero.\n\nScore = 100 x (Summed weights from positive items in the questionnaire divided by the Sum of weights for all items in the questionnaire)\n\nlower scores indicate higher health related quality of life"}, {'measure': 'Change in symptom scale as measured by the MRC dyspnea scale', 'timeFrame': '6 months', 'description': 'Can an app designed for patients with COPD that includes biosensor feedback improve COPD symptoms?\n\nThe MRC Dyspnea scale asks you to rate your breathlessness on a 5 point likert scale.'}, {'measure': 'Accuracy of our derived prediction algorithm to detect acute exacerbations as measured by the daily symptom score.', 'timeFrame': '6 months', 'description': 'We will correlate sensor data from the smartwatch to exacerbations defined by the daily symptom score.\n\nThe 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'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['wearables', 'self-monitoring'], 'conditions': ['Pulmonary Disease, Chronic Obstructive']}, 'referencesModule': {'references': [{'pmid': '38443858', 'type': 'DERIVED', 'citation': '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.'}]}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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.\n\nResearch questions:\n\nCan an app designed for patients with COPD that includes biosensor feedback improve self-management of COPD?\n\nWhat is the accuracy of our sensor data (heart rate, activity, respiratory rate, oxygen saturation, coughing, and other sounds of interest) in detecting early AECOPDs?'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '40 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': '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.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Able to speak English\n* Moderate to very severe COPD (GOLD C and D) as defined by the GOLD guidelines\n* Clinically relevant disease, as defined by a history of exacerbation in the previous 12 months\n* Previous spirometry or Pulmonary Function Test results of Forced Expiration Volume/Forced Vital Capacity (FEV1/FVC) \\<0.70 with an FEV1 below 80% predicted\n* Patient resides at home (not long term care residence or another hospital)\n\nExclusion Criteria:\n\n* Pulmonary condition other than COPD as the main respiratory disease such as bronchiectasis or asthma\n* Rapid lethal disease, e.g. lung cancer, advance heart failure, end-stage renal disease\n* Any medical conditions that would impair their ability to participate in the study'}, 'identificationModule': {'nctId': 'NCT03857061', 'acronym': 'COPDwear', 'briefTitle': 'A Wearable and a Self-management Application for Chronic Obstructive Pulmonary Disease (COPD) Patients at Home', 'organization': {'class': 'OTHER', 'fullName': 'University Health Network, Toronto'}, 'officialTitle': 'COPDwear V2 - A Wearable and a Self-management Application for COPD Patients at Home: a Pilot Prospective Cohort Study', 'orgStudyIdInfo': {'id': '18-5462'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'COPD Patients', 'description': '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.', 'interventionNames': ['Device: smartphone, smartwatch, WearCOPDv2 application']}], 'interventions': [{'name': 'smartphone, smartwatch, WearCOPDv2 application', 'type': 'DEVICE', 'description': 'WearCOPD2 consists of hardware and software components.\n\n6.1 Hardware The hardware for wearCOPDv2 consists of three main components; (1) a smartwatch, (2) a phone, and (3) a server.\n\n6.2 Software\n\nThe wearCOPDv2 system has two main software components:\n\n1. Data collection service\n2. Participant user interface', 'armGroupLabels': ['COPD Patients']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'M5G 2C4', 'city': 'Toronto', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Toronto General Hospital', 'geoPoint': {'lat': 43.70643, 'lon': -79.39864}}], 'overallOfficials': [{'name': 'Robert Wu', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Health Network, Toronto'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL'], 'timeFrame': 'Data will become available right away for up to 5 years.', 'ipdSharing': 'YES', 'description': 'UHN, research personnel will have direct access to the source documents with identifying information.\n\nUHN, University of Toronto (UofT) and Samsung Research America (SRA) will have access to the anonymized subject data for analysis purposes.', 'accessCriteria': 'Data will be stored and analyzed on the secure UHN server'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Health Network, Toronto', 'class': 'OTHER'}, 'collaborators': [{'name': 'University of Toronto', 'class': 'OTHER'}, {'name': 'Samsung Electronics', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'General Internal Medicine Site Director', 'investigatorFullName': 'Robert Wu', 'investigatorAffiliation': 'University Health Network, Toronto'}}}}