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

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02207166

Acronym

IPEOHUBPMBUR

Enrollment

Registered

2014-08-04

Start date

2014-08-31

Completion date

2015-02-28

Last updated

2015-03-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hypertension

Keywords

hypertension, device, errors, human factor engineering, usability engineering

Brief summary

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

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.

Interventions

None listed

Study design

Observational model

CASE_ONLY

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

20 Years to 75 Years

Healthy volunteers

Yes

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)

Design outcomes

Primary

Measure	Time frame	Description
Total steps of incorrect operations	During the 40-60 mins osbervation period	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.

Countries

Taiwan

Outcome results