Identify Possible Errors on Home Use Blood Pressure Monit... | NCT02207166

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

NCT02207166

Sponsor

National Taiwan University Hospital

Status

Completed

Last Update Posted

Mar 19, 2015Estimated

Enrollment

22Actual

Phase

Not provided

Conditions

Hypertension

Interventions

Not provided

Countries

Taiwan

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2015

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 2014

Primary Completion Date

Feb 2015Actual

Completion Date

Feb 2015Actual

First Submitted Date

Jul 27, 2014

First Submission Date that Met QC Criteria

Aug 1, 2014

First Posted Date

Aug 4, 2014Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 17, 2015

Last Update Posted Date

Mar 19, 2015Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

22Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
user group		volunteers who are willing to receive 40 minutes video monitoring and questionnaires while operation a electronic blood pressure measuring machines.

Interventions

Not provided

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

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)

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

75 Years

Standard Ages

AdultOlder Adult

Study Population

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

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Ding-Cheng Chan, MD, PhD	National Taiwan University Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
National Taiwan University Hospital		Taipei	Taiwan	100	Taiwan

Condition Browse Module

MeSH Terms

ID	Term
D006973	Hypertension

Ancestor Terms

ID	Term
D014652	Vascular Diseases
D002318	Cardiovascular Diseases

Browse Leaves

Not provided

Browse Branches

Not provided