Ignite Creation Date:
2025-12-24 @ 4:25 PM
Ignite Modification Date:
2026-02-26 @ 7:47 PM
Study NCT ID:
NCT02207166
Status:
COMPLETED
Last Update Posted:
2015-03-19
First Post:
2014-07-27
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Identify Possible Errors on Home Use Blood Pressure Monitors by Usability Reasoning
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006973', 'term': 'Hypertension'}], 'ancestors': [{'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 22}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-03', 'completionDateStruct': {'date': '2015-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-03-17', 'studyFirstSubmitDate': '2014-07-27', 'studyFirstSubmitQcDate': '2014-08-01', 'lastUpdatePostDateStruct': {'date': '2015-03-19', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-08-04', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Total steps of incorrect operations', 'timeFrame': 'During the 40-60 mins osbervation period', 'description': 'Possible errors may cause negative outcomes to a home-user when he/she uses the BPM. The principal concept of "usability" is that a good usability designed BPM is easy to operate it as the device designer expected a home-user to perform in real use.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['hypertension', 'device', 'errors', 'human factor engineering', 'usability engineering'], 'conditions': ['Hypertension']}, 'descriptionModule': {'briefSummary': "Medical devices are designed and manufactured by subjective design process that was only based on engineers' direct concepts to essential principles sets for the device. A home user may not easily use or operate the piece of medical device through the interfacing components as the designer's expected such as the meaning when pushing a button or switching a knob, even the required procedure needed when a certain display shown to fulfill some knowledge dependent judgment. In addition, the incompatible interfacing designed communication between a user and the device may cause possible errors that may trigger further negative consequences during the use of the device to a innocent home user.\n\nThe aim of this research is to closely understand the consequent results of human factor engineering or usability engineering practices of various types or models of marketed home-use blood pressure monitors (BPM) in real use.", 'detailedDescription': 'The aim of this research is to closely understand the consequent results of human factor engineering or usability engineering practices of various types or models of marketed home-use blood pressure monitors (BPM) in real use. Participants of the intended user population interact with marketed BPMs in research to assess ease of learning, ease of use, effectiveness and efficiency of use, memorability, safety, and/or user appeal among the many possible attributes of interest. With these understanding and analysis of human factors engineering / usability engineering (HFE/UE) practiced status, it can help manufacturers to capture the required and diversified HFE/UE essences with the minimum or limited professional technical resources in hand some more efficiently.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '20 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Adults who are able to operate general healthcare devices (eg thermometer, electronic blood pressure measures)', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* age between 20-75 years\n* capable of operating the blood pressure measure machine provided by the study\n* willing to operate the provided device and accept video taping from shoulder and below\n* willing to fill the study questionnaire and to provide feedback after use of the device\n\nExclusion Criteria:\n\n* vulnerable population (including pregnant woman, disabled, etc)'}, 'identificationModule': {'nctId': 'NCT02207166', 'acronym': 'IPEOHUBPMBUR', 'briefTitle': 'Identify Possible Errors on Home Use Blood Pressure Monitors by Usability Reasoning', 'organization': {'class': 'OTHER', 'fullName': 'National Taiwan University Hospital'}, 'officialTitle': 'Identify Possible Errors on Home Use Blood Pressure Monitors by Usability Reasoning (IPEOHUBPMBUR)', 'orgStudyIdInfo': {'id': '201406066RINB'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'user group', 'description': 'volunteers who are willing to receive 40 minutes video monitoring and questionnaires while operation a electronic blood pressure measuring machines.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '100', 'city': 'Taipei', 'state': 'Taiwan', 'country': 'Taiwan', 'facility': 'National Taiwan University Hospital', 'geoPoint': {'lat': 25.05306, 'lon': 121.52639}}], 'overallOfficials': [{'name': 'Ding-Cheng Chan, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'National Taiwan University Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'National Taiwan University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}