Usability Evaluation - Reassure Respiration Rate Device: Home User Study

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

48 participants

Study Classification

OBSERVATIONAL

Study Start Date

2014-10-31

Study Completion Date

2015-12-31

Brief Summary

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This is a usability evaluation of the Reassure device. The device is a non-contact device which passively monitors breathing.

The purpose of this usability evaluation is to understand any issues that the intended user population have while using the device unsupervised in the home and to determine if the device can collect data that is of sufficient quality to be successfully analysed for respiration rate.

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Detailed Description

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The aim of the set of Reassure Home User Trials is to understand any usability issues that users have while using the Reassure non contact monitor in their home environment.

Other objectives:

* To gather useful feedback on the user interface and suggestions for its improvement.
* To gather information on the device stability in the more variable conditions of the home user environment.
* To gather data in order to demonstrate compliance with IEC62366, and thus IEC60601-1

The users had the device for a minimum of 10 nights, to confirm if the device could be used for an extended period and the likely compliance rates of users

Conditions

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Ease of Use

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

RETROSPECTIVE

Study Groups

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HUT1

First phase of the home user trial. 19 users, 12 who were part of a couple and 7 who were single.

No interventions assigned to this group

HUT2

Second phase of home user trial, testing improvements to the device user interface as a result of the experience from HUT1. Total 11 users.

Main change to device was a simpler set of displays and button-sequence on a 24 hour period.

No interventions assigned to this group

HUT3

Third phase of home user trial, testing the final improvements to the device. A total of 18 users, 16 of which who were part of a couple and 2 who were single.

Main change was the introduction of a scheduled recording option, making the device totally automatic in routine use.

No interventions assigned to this group