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

NCT02207166 | Completed

• 1 other identifier: 201406066RINB
• Study Type: observational
• Target: 22
• Locations: 1 country
• Sites: 1

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.

Conditions

Hypertension

Keywords

hypertension; device; errors; human factor engineering; usability engineering

Outcome Measures

Primary Outcomes (1)

• Total steps of incorrect operations

  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.

  During the 40-60 mins osbervation period

Study Arms (1)

user group

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

Eligibility Criteria

• Age: 20 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adults who are able to operate general healthcare devices (eg thermometer, electronic blood pressure measures)

You may qualify if:

• 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

You may not qualify if:

• vulnerable population (including pregnant woman, disabled, etc)

Sponsors & Collaborators

• National Taiwan University Hospital: lead

Study Sites (1)

National Taiwan University Hospital

Taipei, Taiwan, 100, Taiwan

Location

MeSH Terms

Conditions

Hypertension

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Study Officials

• Ding-Cheng Chan, MD, PhD

  National Taiwan University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 27, 2014
• First Posted: August 4, 2014
• Study Start: August 1, 2014
• Primary Completion: February 1, 2015
• Study Completion: February 1, 2015
• Last Updated: March 19, 2015

Record last verified: 2015-03

Locations

TW (1)