Ignite Creation Date:
2025-12-24 @ 2:14 PM
Ignite Modification Date:
2026-01-02 @ 10:15 AM
Study NCT ID:
NCT04452695
Status:
COMPLETED
Last Update Posted:
2022-09-21
First Post:
2020-06-29
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Acceptability of Telehealth Triage Using Robotic Systems in COVID-19
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000086382', 'term': 'COVID-19'}, {'id': 'D004630', 'term': 'Emergencies'}, {'id': 'D021821', 'term': 'Communicable Diseases, Emerging'}], 'ancestors': [{'id': 'D011024', 'term': 'Pneumonia, Viral'}, {'id': 'D011014', 'term': 'Pneumonia'}, {'id': 'D012141', 'term': 'Respiratory Tract Infections'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D018352', 'term': 'Coronavirus Infections'}, {'id': 'D003333', 'term': 'Coronaviridae Infections'}, {'id': 'D030341', 'term': 'Nidovirales Infections'}, {'id': 'D012327', 'term': 'RNA Virus Infections'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D003141', 'term': 'Communicable Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 40}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-03-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-09', 'completionDateStruct': {'date': '2020-08-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-09-16', 'studyFirstSubmitDate': '2020-06-29', 'studyFirstSubmitQcDate': '2020-06-29', 'lastUpdatePostDateStruct': {'date': '2022-09-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-06-30', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-08-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Acceptance of robotic telehealth system', 'timeFrame': 'Immediately after completion of triage', 'description': 'Quantitative questionnaire on the acceptance of virtual robotic care graded on a likert scale (higher scores better)'}, {'measure': 'Willingness to interact with robotic telehealth system', 'timeFrame': 'Immediately after completion of triage', 'description': 'Quantitative questionnaire on the willingness to use this system again based on a likert scale (higher scores better)'}, {'measure': 'Satisfaction of interacting with a robotic telehealth system', 'timeFrame': 'Immediately after completion of triage', 'description': 'Quantitative questionnaire on the user satisfaction with their triage experience (How satisfied were you with your experience interacting with the robotic system today?)'}], 'secondaryOutcomes': [{'measure': 'Use of robotic system versus in-person triage', 'timeFrame': 'Immediately after completion of triage', 'description': 'Quantitative questionnaire comparing robotic triage process with in-person triage: Do you think your interaction with the robotic system was better, the same or no different than an in-person evaluation?)'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['COVID-19', 'Telemedicine', 'Robotics', 'Emergencies', 'Emerging Infectious Disease']}, 'referencesModule': {'references': [{'pmid': '33662134', 'type': 'RESULT', 'citation': 'Chai PR, Dadabhoy FZ, Huang HW, Chu JN, Feng A, Le HM, Collins J, da Silva M, Raibert M, Hur C, Boyer EW, Traverso G. Assessment of the Acceptability and Feasibility of Using Mobile Robotic Systems for Patient Evaluation. JAMA Netw Open. 2021 Mar 1;4(3):e210667. doi: 10.1001/jamanetworkopen.2021.0667.'}, {'pmid': '35571871', 'type': 'RESULT', 'citation': 'Huang HW, Chen J, Chai PR, Ehmke C, Rupp P, Dadabhoy FZ, Feng A, Li C, Thomas AJ, da Silva M, Boyer EW, Traverso G. Mobile Robotic Platform for Contactless Vital Sign Monitoring. Cyborg Bionic Syst. 2022;2022:9780497. doi: 10.34133/2022/9780497. Epub 2022 Apr 30.'}]}, 'descriptionModule': {'briefSummary': 'The overall objective of this investigation is to understand the patient response to a robotic platform used to facilitate telehealth triage in the emergency department during the COVID-19 pandemic. The COVID-19 pandemic has altered the manner in which emergency department triage is completed. Attempts at cohorting individuals with potential COVID-19 disease in order to prevent disease transmission to healthcare workers and minimize the use of personal protective equipment (PPE) have renewed interest in telemedical solutions as a method to triage and manage individuals with COVID-19. This investigation deploys a legged robotic platform to facilitate agile, highly mobile telemedicine to manage COVID-19 patients in the emergency department. The primary objective is to measure the patient response to interacting with these systems.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Emergency department patients', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Presenting to the emergency department for evaluation\n* \\> 18 years old\n\nExclusion Criteria:\n\n* Brought to emergency department via ambulance\n* \\<18 years old\n* non-english speaking\n* in extremis, or unable to participate due to underlying acute medical condition'}, 'identificationModule': {'nctId': 'NCT04452695', 'briefTitle': 'Acceptability of Telehealth Triage Using Robotic Systems in COVID-19', 'organization': {'class': 'OTHER', 'fullName': "Brigham and Women's Hospital"}, 'officialTitle': 'Acceptability of Telehealth Triage Using Robotic Systems in COVID-19', 'orgStudyIdInfo': {'id': '2020P000957'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Intervention arm', 'description': 'Patients presenting to the emergency department are triaged using a novel robotic telehealth triage system. Once triage is complete, patients complete a quantitative assessment to measure their acceptance and willingness to interact with the robotic telehealth system.', 'interventionNames': ['Device: Doctor Spot']}], 'interventions': [{'name': 'Doctor Spot', 'type': 'DEVICE', 'description': 'Robotic platform (Boston Dynamics) controlled by clinician with video interface to facilitate telemedicine triage', 'armGroupLabels': ['Intervention arm']}]}, 'contactsLocationsModule': {'locations': [{'zip': '02115', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': "Brigham and Women's Hospital", 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Brigham and Women's Hospital", 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor', 'investigatorFullName': 'Peter R Chai', 'investigatorAffiliation': "Brigham and Women's Hospital"}}}}