Ignite Creation Date:
2025-12-25 @ 2:31 AM
Ignite Modification Date:
2026-04-14 @ 6:51 AM
Study NCT ID:
NCT05330234
Status:
COMPLETED
Last Update Posted:
2024-03-18
First Post:
2022-04-01
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Usability Study of OnTrack Tools
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020521', 'term': 'Stroke'}], 'ancestors': [{'id': 'D002561', 'term': 'Cerebrovascular Disorders'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'g.fusari@imperial.ac.uk', 'phone': '--', 'title': 'Mr Gianpaolo Fusari', 'organization': 'Imperial College London'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'timeFrame': 'No adverse event data was collected for this study', 'description': 'This was a simulation study involving staff members reviewing the interface of a software device', 'eventGroups': [{'id': 'EG000', 'title': 'Therapists', 'description': "Single arm study. Participants are members of the therapy team at Imperial College Healthcare NHS Trust's stroke wards.\n\nOnTrack Tools: The intervention is the OnTrack Tools system consisting of a graphical user interface (GUI) used to manage patients who are users of the OnTrack rehabilitation system. Participants will be asked to complete clinical and non-clinical tasks in simulation using OnTrack Tools. The themes for the scenarios of use presented in each of the three phases are summarised below:\n\nPhase 1 - Account creation, system onboarding and general system navigation. Phase 2 - Individual patient management. Phase 3 - Content and data management.", 'otherNumAtRisk': 0, 'deathsNumAtRisk': 0, 'otherNumAffected': 0, 'seriousNumAtRisk': 0, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'System Usability Scale (Phase 1)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Therapists (Phase 1)', 'description': "Single arm study. Participants are members of the therapy team at Imperial College Healthcare NHS Trust's stroke wards.\n\nOnTrack Tools: The intervention is the OnTrack Tools system consisting of a graphical user interface (GUI) used to manage patients who are users of the OnTrack rehabilitation system. Participants will be asked to complete clinical and non-clinical tasks in simulation using OnTrack Tools. The themes for the scenarios of use presented in each of the three phases are summarised below:\n\nPhase 1 - Account creation, system onboarding and general system navigation. Phase 2 - Individual patient management. Phase 3 - Content and data management."}], 'classes': [{'categories': [{'measurements': [{'value': '73.3', 'groupId': 'OG000', 'lowerLimit': '62.5', 'upperLimit': '90'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Up to 60 days.', 'description': 'In systems engineering, the system usability scale (SUS) is a simple, ten-item attitude Likert scale giving a global view of subjective assessments of usability. It was developed by John Brooke\\[1\\] at Digital Equipment Corporation in the UK in 1986 as a tool to be used in usability engineering of electronic office systems.\n\nThe measure is scored on a 0-100 scale, a higher score means a better outcome.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'System Usability Scale (Phase 2)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Therapists (Phase 2)', 'description': "Single arm study. Participants are members of the therapy team at Imperial College Healthcare NHS Trust's stroke wards.\n\nOnTrack Tools: The intervention is the OnTrack Tools system consisting of a graphical user interface (GUI) used to manage patients who are users of the OnTrack rehabilitation system. Participants will be asked to complete clinical and non-clinical tasks in simulation using OnTrack Tools. The themes for the scenarios of use presented in each of the three phases are summarised below:\n\nPhase 1 - Account creation, system onboarding and general system navigation. Phase 2 - Individual patient management. Phase 3 - Content and data management."}], 'classes': [{'categories': [{'measurements': [{'value': '78.3', 'groupId': 'OG000', 'lowerLimit': '72.5', 'upperLimit': '92.5'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Up to 60 days', 'description': 'In systems engineering, the system usability scale (SUS) is a simple, ten-item attitude Likert scale giving a global view of subjective assessments of usability. It was developed by John Brooke\\[1\\] at Digital Equipment Corporation in the UK in 1986 as a tool to be used in usability engineering of electronic office systems.\n\nThe measure is scored on a 0-100 scale, a higher score means a better outcome.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'System Usability Scale (Phase 3)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Therapists (Phase 3)', 'description': "Single arm study. Participants are members of the therapy team at Imperial College Healthcare NHS Trust's stroke wards.\n\nOnTrack Tools: The intervention is the OnTrack Tools system consisting of a graphical user interface (GUI) used to manage patients who are users of the OnTrack rehabilitation system. Participants will be asked to complete clinical and non-clinical tasks in simulation using OnTrack Tools. The themes for the scenarios of use presented in each of the three phases are summarised below:\n\nPhase 1 - Account creation, system onboarding and general system navigation. Phase 2 - Individual patient management. Phase 3 - Content and data management."}], 'classes': [{'categories': [{'measurements': [{'value': '77.1', 'groupId': 'OG000', 'lowerLimit': '72.5', 'upperLimit': '82.5'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Up to 60 days.', 'description': 'In systems engineering, the system usability scale (SUS) is a simple, ten-item attitude Likert scale giving a global view of subjective assessments of usability. It was developed by John Brooke\\[1\\] at Digital Equipment Corporation in the UK in 1986 as a tool to be used in usability engineering of electronic office systems.\n\nThe measure is scored on a 0-100 scale, a higher score means a better outcome.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Post-Study System Usability Questionnaire (PSSUQ)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Therapists (Phase 3)', 'description': "Single arm study. Participants are members of the therapy team at Imperial College Healthcare NHS Trust's stroke wards.\n\nOnTrack Tools: The intervention is the OnTrack Tools system consisting of a graphical user interface (GUI) used to manage patients who are users of the OnTrack rehabilitation system. Participants will be asked to complete clinical and non-clinical tasks in simulation using OnTrack Tools. The themes for the scenarios of use presented in each of the three phases are summarised below:\n\nPhase 1 - Account creation, system onboarding and general system navigation. Phase 2 - Individual patient management. Phase 3 - Content and data management."}], 'classes': [{'title': 'Overall', 'categories': [{'measurements': [{'value': '2.6', 'groupId': 'OG000', 'lowerLimit': '1.7', 'upperLimit': '3.1'}]}]}, {'title': 'SYSUSE', 'categories': [{'measurements': [{'value': '2.5', 'groupId': 'OG000', 'lowerLimit': '1.3', 'upperLimit': '3.2'}]}]}, {'title': 'INFOQUAL', 'categories': [{'measurements': [{'value': '2.7', 'groupId': 'OG000', 'lowerLimit': '1.5', 'upperLimit': '3.2'}]}]}, {'title': 'INTERQUAL', 'categories': [{'measurements': [{'value': '2.6', 'groupId': 'OG000', 'lowerLimit': '2', 'upperLimit': '4'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Up to 60 days.', 'description': 'The PSSUQ (Post-Study System Usability Questionnaire is a 16-item standardized questionnaire. It is widely used to measure users\' perceived satisfaction of a website, software, system or product at the end of a study.\n\nPSSUQ follows a 7-point Likert Scale (+ NA option).\n\n1 is "strongly agree" and 7 is "strongly disagree"\n\nResults are calculated by averaging the scores from the 7 points of the scale.\n\nThe PSSUQ has one overall score and 3 sub-scales, namely system usefulness, information quality, and interface quality scored as follows:\n\nOverall: the average scores of questions 1 to 16 System Usefulness (SYSUSE): the average scores of questions 1 to 6 Information Quality (INFOQUAL): the average scores of questions 7 to 12 Interface Quality (INTERQUAL): the average scores of questions 13 to 15\n\nThe lower the scores, the better the performance and the higher the perceived satisfaction.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Therapists', 'description': "Single arm study. Participants are members of the therapy team at Imperial College Healthcare NHS Trust's stroke wards.\n\nOnTrack Tools: The intervention is the OnTrack Tools system consisting of a graphical user interface (GUI) used to manage patients who are users of the OnTrack rehabilitation system. Participants will be asked to complete clinical and non-clinical tasks in simulation using OnTrack Tools. The themes for the scenarios of use presented in each of the three phases are summarised below:\n\nPhase 1 - Account creation, system onboarding and general system navigation. Phase 2 - Individual patient management. Phase 3 - Content and data management."}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '10'}]}, {'type': 'Phase 1', 'achievements': [{'groupId': 'FG000', 'numSubjects': '10'}]}, {'type': 'Phase 2', 'achievements': [{'groupId': 'FG000', 'numSubjects': '9'}]}, {'type': 'Phase 3', 'achievements': [{'groupId': 'FG000', 'numSubjects': '6'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '6'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '4'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Therapists', 'description': "Single arm study. Participants are members of the therapy team at Imperial College Healthcare NHS Trust's stroke wards.\n\nOnTrack Tools: The intervention is the OnTrack Tools system consisting of a graphical user interface (GUI) used to manage patients who are users of the OnTrack rehabilitation system. Participants will be asked to complete clinical and non-clinical tasks in simulation using OnTrack Tools. The themes for the scenarios of use presented in each of the three phases are summarised below:\n\nPhase 1 - Account creation, system onboarding and general system navigation. Phase 2 - Individual patient management. Phase 3 - Content and data management."}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'BG000'}]}], 'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '10', 'groupId': 'BG000'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'BG000'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '5', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '5', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race and Ethnicity Not Collected', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Race and Ethnicity were not collected from any participant.'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United Kingdom', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '10', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2022-03-01', 'size': 220921, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2023-03-30T13:38', 'hasProtocol': True}, {'date': '2022-03-01', 'size': 242693, 'label': 'Informed Consent Form', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_001.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2023-03-30T13:40', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'This study aims to assess the usability of the OnTrack Tools GUI under simulation. The study follows up from a study of the OnTrack system that demonstrated the feasibility and acceptability of the patient-facing component of the system by stroke survivors and therapists. The design of this study was developed through a collaborative approach between the study researchers, patients, and front-line therapists. The OnTrack intervention is being developed by Imperial College, this usability study is part of the development process.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 10}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-05-12', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-03', 'completionDateStruct': {'date': '2022-06-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-03-15', 'studyFirstSubmitDate': '2022-04-01', 'resultsFirstSubmitDate': '2023-03-31', 'studyFirstSubmitQcDate': '2022-04-08', 'lastUpdatePostDateStruct': {'date': '2024-03-18', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2023-03-31', 'studyFirstPostDateStruct': {'date': '2022-04-15', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2024-01-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-06-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'System Usability Scale (Phase 1)', 'timeFrame': 'Up to 60 days.', 'description': 'In systems engineering, the system usability scale (SUS) is a simple, ten-item attitude Likert scale giving a global view of subjective assessments of usability. It was developed by John Brooke\\[1\\] at Digital Equipment Corporation in the UK in 1986 as a tool to be used in usability engineering of electronic office systems.\n\nThe measure is scored on a 0-100 scale, a higher score means a better outcome.'}, {'measure': 'System Usability Scale (Phase 2)', 'timeFrame': 'Up to 60 days', 'description': 'In systems engineering, the system usability scale (SUS) is a simple, ten-item attitude Likert scale giving a global view of subjective assessments of usability. It was developed by John Brooke\\[1\\] at Digital Equipment Corporation in the UK in 1986 as a tool to be used in usability engineering of electronic office systems.\n\nThe measure is scored on a 0-100 scale, a higher score means a better outcome.'}, {'measure': 'System Usability Scale (Phase 3)', 'timeFrame': 'Up to 60 days.', 'description': 'In systems engineering, the system usability scale (SUS) is a simple, ten-item attitude Likert scale giving a global view of subjective assessments of usability. It was developed by John Brooke\\[1\\] at Digital Equipment Corporation in the UK in 1986 as a tool to be used in usability engineering of electronic office systems.\n\nThe measure is scored on a 0-100 scale, a higher score means a better outcome.'}], 'secondaryOutcomes': [{'measure': 'Post-Study System Usability Questionnaire (PSSUQ)', 'timeFrame': 'Up to 60 days.', 'description': 'The PSSUQ (Post-Study System Usability Questionnaire is a 16-item standardized questionnaire. It is widely used to measure users\' perceived satisfaction of a website, software, system or product at the end of a study.\n\nPSSUQ follows a 7-point Likert Scale (+ NA option).\n\n1 is "strongly agree" and 7 is "strongly disagree"\n\nResults are calculated by averaging the scores from the 7 points of the scale.\n\nThe PSSUQ has one overall score and 3 sub-scales, namely system usefulness, information quality, and interface quality scored as follows:\n\nOverall: the average scores of questions 1 to 16 System Usefulness (SYSUSE): the average scores of questions 1 to 6 Information Quality (INFOQUAL): the average scores of questions 7 to 12 Interface Quality (INTERQUAL): the average scores of questions 13 to 15\n\nThe lower the scores, the better the performance and the higher the perceived satisfaction.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['stroke, rehabilitation, neurology, digital health'], 'conditions': ['Research With Clinical Staff in Stroke Rehabilitation']}, 'descriptionModule': {'briefSummary': "Aims: Assess the usability of OnTrack Tools, a clinician facing interface to manage stroke survivors using the OnTrack rehabilitation system. Background: Arm disability is a common problem after stroke that can lead to loss of independence, it affects\n\n\\~450,000 people in the UK. Repetitive activity is critical for recovery but research shows people can struggle with intensity and keeping track of progress. The OnTrack system being developed at Imperial College London is a potential solution to this problem. Intervention: The OnTrack system consists of two software applications, OnTrack App - used by patients, and OnTrack Tools - used by clinicians. OnTrack Tools pulls data generated by the OnTrack App and enables the monitoring of clients' arm activity, and management of goals and educational content. The software is used to inform selfmanagement coaching by helping therapists understand more about how and when patients use their affected arm between treatment sessions. Design and methods: This study will assess the usability of the OnTrack Tools component of the system. The study will recruit stroke therapists from Imperial College Healthcare NHS Trust to provide feedback on the experience and usability of OnTrack Tools' graphical user interface (GUI). The study will be divided into three progressive cycles of testing, feedback and iteration. Each cycle will see participants individually completing specific tasks related to system navigation and the management of patients under simulation. Participants will complete outcome measures and take part in focus groups. Researchers will analyse and use the feedback to improve the GUI ready for the next testing cycle. Patient and public involvement: The project team includes a PPIE group of stroke survivors who oversee the project and help us with public facing documentation. They are members of the research team and are reimbursed for their time and travel, according to INVOLVE guidance. Dissemination: Results of the study will be written-up for technical reporting and publication. Participants will be provided with a summary of results at the end of the study. The study team will be providing general updates on the progress of the study via their social media channels (e.g. Twitter @OnTrackRehab @ImperialIGHI @HelixCentre)."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adult (18 years old or over) Occupational Therapists and Physiotherapists (Band 4 to Band 8) working in the stroke wards at ICHT.\n\nExclusion Criteria:\n\n* No exclusion criteria has been defined.'}, 'identificationModule': {'nctId': 'NCT05330234', 'briefTitle': 'Usability Study of OnTrack Tools', 'organization': {'class': 'OTHER', 'fullName': 'Imperial College London'}, 'officialTitle': 'Usability Study of OnTrack Tools: a Study to Assess the Usability of a Clinician-facing Software Application to Support Arm Rehabilitation After Stroke.', 'orgStudyIdInfo': {'id': '22CX7578'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Therapists', 'description': "Single arm study. Participants are members of the therapy team at Imperial College Healthcare NHS Trust's stroke wards.", 'interventionNames': ['Device: OnTrack Tools']}], 'interventions': [{'name': 'OnTrack Tools', 'type': 'DEVICE', 'description': 'The intervention is the OnTrack Tools system consisting of a graphical user interface (GUI) used to manage patients who are users of the OnTrack rehabilitation system. Participants will be asked to complete clinical and non-clinical tasks in simulation using OnTrack Tools. The themes for the scenarios of use presented in each of the three phases are summarised below:\n\nPhase 1 - Account creation, system onboarding and general system navigation. Phase 2 - Individual patient management. Phase 3 - Content and data management.', 'armGroupLabels': ['Therapists']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'W2 1NY', 'city': 'London', 'country': 'United Kingdom', 'facility': 'Imperial College Healthcare NHS Trust', 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}], 'overallOfficials': [{'name': 'Ara Darzi', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Imperial College London'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'No plan for individual participant data to be shared.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Imperial College London', 'class': 'OTHER'}, 'collaborators': [{'name': 'Imperial College Healthcare NHS Trust', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}