Clinical trial NCT02207166: Identify Possible Errors on Home Use Blood Pressure Monitors by Usability Reasoning
Official title: Identify Possible Errors on Home Use Blood Pressure Monitors by Usability Reasoning (IPEOHUBPMBUR)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hypertension
Keywords: hypertension
device
errors
human factor engineering
usability engineering
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
First posted: 2014-08-04
Enrollment: 22
Sex: ALL
Minimum age (years): 20
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adults who are able to operate general healthcare devices (eg thermometer, electronic blood pressure measures)

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.

Eligibility criteria: 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)

Primary outcomes:
measure: Total steps of incorrect operations
timeFrame: During the 40-60 mins osbervation period
Secondary outcomes:
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital
Study officials:
affiliation: National Taiwan University Hospital
name: Ding-Cheng Chan, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: