Ignite Creation Date:
2025-12-25 @ 5:19 AM
Ignite Modification Date:
2025-12-26 @ 4:27 AM
Study NCT ID:
NCT04059627
Status:
COMPLETED
Last Update Posted:
2019-08-19
First Post:
2019-08-14
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Feasibility of the "Heart-track" Rehabilitative Device Prototype
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009203', 'term': 'Myocardial Infarction'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}], 'ancestors': [{'id': 'D017202', 'term': 'Myocardial Ischemia'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D007238', 'term': 'Infarction'}, {'id': 'D007511', 'term': 'Ischemia'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D009336', 'term': 'Necrosis'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'Twelve community-dwelling adults who are also active member of cardiac rehab support group, aged above 50, and undergone coronary revascularisation for acute myocardial infarction at least 1 year before were recruited.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 12}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-07-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-08', 'completionDateStruct': {'date': '2018-09-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-08-15', 'studyFirstSubmitDate': '2019-08-14', 'studyFirstSubmitQcDate': '2019-08-14', 'lastUpdatePostDateStruct': {'date': '2019-08-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-08-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-09-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Survey', 'timeFrame': 'through study completion, an average of 3 months', 'description': 'Participants rated their experience with the hardware and software components of "Heart Track", and their acceptance of it as a cardiac rehabilitation tool. The survey form is a likert-scale ( Strongly agree to strongly disagree) survey that asking subjects about their feedback and satisfaction about the Heart Track hardware and software, and overall experience using Heart Track.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Cardiac Rehab'], 'conditions': ['Cardiac Infarct', 'Cardiac Event']}, 'descriptionModule': {'briefSummary': 'Abstract Title: "Heart-track" cardiac rehabilitation device prototype designed for exercise training post coronary revascularisation: A usability study Background: Percutaneous Coronary Intervention (PCI) is a common surgical procedure for heart attack patients. International guidelines recommend that all patients complete phase two (outpatient) cardiac rehabilitation (CR) after PCI, as it plays a critical role in reducing five-year cardiovascular mortality and the risk of cardiovascular-related hospital admission. Patients in our institution have suboptimal exercise compliance and effectiveness during cardiac rehabilitation. Root cause analysis identified \'lack of commitment\', \'lack of care monitoring and continuity\' and \'lack of motivation and engagement\' to be key contributing factors. Yet, healthcare resource limitations necessitate innovation for care continuity and patient engagement. "Heart-track", a novel, app-based innovation was created. By \'game-ifying\' cardiac rehabilitative exercise training program, "Heart-track" guides and tracks cardiac rehabilitation at home at patient\'s comfort.\n\nPurpose: To explore experiences of app usability in terms of content, functionality and design of the prototype "Heart-track" app to improve user experience.\n\nMethods: Twelve community-dwelling adults who are also active member of cardiac rehab support group, aged above 50, and undergone coronary revascularisation for acute myocardial infarction at least 1 year before were recruited. Participants were introduced to "Heart-Track" mobile app system and its navigational characteristics with standardised instructions. Each participant then performed a self-directed Cardiac rehabilitation session using the app. Participants rated their experience with the hardware and software components of "Heart Track", and their acceptance of it as a cardiac rehabilitation tool. Descriptive analysis of quantitative responses were analysed using IBM SPSS software version 19.0 (Armonk, NY: IBM Corp).', 'detailedDescription': 'Abstract Title: "Heart-track" cardiac rehabilitation device prototype designed for exercise training post coronary revascularisation: A usability study Background: Percutaneous Coronary Intervention (PCI) is a common surgical procedure for heart attack patients. International guidelines recommend that all patients complete phase two (outpatient) cardiac rehabilitation (CR) after PCI, as it plays a critical role in reducing five-year cardiovascular mortality and the risk of cardiovascular-related hospital admission. Patients in our institution have suboptimal exercise compliance and effectiveness during cardiac rehabilitation. Root cause analysis identified \'lack of commitment\', \'lack of care monitoring and continuity\' and \'lack of motivation and engagement\' to be key contributing factors. Yet, healthcare resource limitations necessitate innovation for care continuity and patient engagement. "Heart-track", a novel, app-based innovation was created. By \'game-ifying\' cardiac rehabilitative exercise training program, "Heart-track" guides and tracks cardiac rehabilitation at home at patient\'s comfort.\n\nPurpose: To explore experiences of app usability in terms of content, functionality and design of the prototype "Heart-track" app to improve user experience.\n\nMethods: Twelve community-dwelling adults who are also active member of cardiac rehab support group, aged above 50, and undergone coronary revascularisation for acute myocardial infarction at least 1 year before were recruited. Participants were introduced to "Heart-Track" mobile app system and its navigational characteristics with standardised instructions. Each participant then performed a self-directed Cardiac rehabilitation session using the app. Participants rated their experience with the hardware and software components of "Heart Track", and their acceptance of it as a cardiac rehabilitation tool. Descriptive analysis of quantitative responses were analysed using IBM SPSS software version 19.0 (Armonk, NY: IBM Corp).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '21 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Minimum 21 to 65 years of age\n* conversational fluency in English\n* undergone coronary revascularisation for acute myocardial infarction within last 5 years\n* last documented ejection fraction of at least 40%\n* completed a minimum of eight supervised CR sessions\n* exercises at least once a week for a minimum duration of thirty minutes\n* at least 6 months' experience using a smartphone\n* recent experience(at least one months' experience) with any mobile app\n* displaying capacity for self-monitoring and entering data.\n\nExclusion Criteria:\n\n-Abnormal physiological response during exercise"}, 'identificationModule': {'nctId': 'NCT04059627', 'briefTitle': 'Feasibility of the "Heart-track" Rehabilitative Device Prototype', 'organization': {'class': 'OTHER', 'fullName': 'Tan Tock Seng Hospital'}, 'officialTitle': 'Feasibility of the "Heart-track" Rehabilitative Device Prototype Designed for Exercise Training Post Coronary Revascularisation', 'orgStudyIdInfo': {'id': '2018/00307'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Experimental arm', 'description': 'Participants were introduced to "Heart-Track" mobile app system and its navigational characteristics with standardised instructions. Each participant then performed a self-directed Cardiac rehabilitation session using the app.', 'interventionNames': ['Device: Heart Track']}], 'interventions': [{'name': 'Heart Track', 'type': 'DEVICE', 'description': 'Description of the device: Wearable heart rate sensors are used in Heart-track, and a receiver on a smartphone app. Real-time wireless heart rate data is sent to paired mobile device with a wireless distance of up to 10m. The sensor is able to monitor a heart rate range of 30 to 240 beats per minute.\n\nAnother component of Heart-track is a "Heart-track" mobile app which captures and reflect real-time heart rate from the heart rate sensor. The mobile app also includes warm-up and cool down exercises that are gamified and supported on a smart-phone running on Android or iOS platforms.\n\nThe HR sensor will be purchased by our collaborator, Immersive Play Pte Ltd.', 'armGroupLabels': ['Experimental arm']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Singapore', 'country': 'Singapore', 'facility': 'Tan Tock Seng Hospital', 'geoPoint': {'lat': 1.28967, 'lon': 103.85007}}], 'overallOfficials': [{'name': 'Eng Chuan Neoh, masters', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Senior Physiotherapist'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Tan Tock Seng Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Senior Physiotherapist', 'investigatorFullName': 'Eng Chan Neoh', 'investigatorAffiliation': 'Tan Tock Seng Hospital'}}}}