Identify Possible Errors on Home Use Blood Pressure Monitors by Usability Reasoning

NCT ID: NCT02207166

Last Updated: 2015-03-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

22 participants

Study Classification

OBSERVATIONAL

Study Start Date

2014-08-31

Study Completion Date

2015-02-28

Brief Summary

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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.

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.

Detailed Description

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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.

Conditions

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Hypertension

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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user group

volunteers who are willing to receive 40 minutes video monitoring and questionnaires while operation a electronic blood pressure measuring machines.

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* age between 20-75 years
* capable of operating the blood pressure measure machine provided by the study
* willing to operate the provided device and accept video taping from shoulder and below
* willing to fill the study questionnaire and to provide feedback after use of the device

Exclusion Criteria

* vulnerable population (including pregnant woman, disabled, etc)
Minimum Eligible Age

20 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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National Taiwan University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Ding-Cheng Chan, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

National Taiwan University Hospital

Locations

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National Taiwan University Hospital

Taipei, Taiwan, Taiwan

Site Status

Countries

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Taiwan

Other Identifiers

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201406066RINB

Identifier Type: -

Identifier Source: org_study_id

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