Self Operating of the Personal WheezoMeter by Intended Users - A Usability Study
The NAEPP (National Asthma Education and Prevention Program) guidelines recommend that spirometry be performed on patients with asthma because they serve as an objective measure of airway obstruction. Unfortunately, most children under 5 years of age are unable to perform a forced expiratory maneuver making conventional spirometry unavailable in this age group in most venues. Furthermore, other population groups such as retarded people, elderly or physically handicapped share the same difficulty.
Karmel Sonix Ltd has developed the Personal WheezoMeter a hand-held pulmonary sounds analyzer that utilizes contact sensors to acquire, amplify, filter, record and quantify the presence of wheezing. This usability study was designed to test independent home use and device interface effectiveness of the Personal WheezoMeter in order to validate its safe and effective use by intended users.
|Study Design:||Observational Model: Case-Only
Time Perspective: Prospective
|Official Title:||Self Operating of the Personal WheezoMeter by Intended Users - A Usability Study|
- Safety will be evaluated by success rate of task performance. [ Time Frame: At the end of the study meeting ] [ Designated as safety issue: Yes ]
- Number of questions addressed to the investigator required by the participant in order to complete tasks. [ Time Frame: during the study ] [ Designated as safety issue: No ]
- User satisfaction will be evaluated by questionnaire that focuses on subjective impressions regarding usability and potential safety problems. [ Time Frame: At the end of the study meeting. ] [ Designated as safety issue: No ]
|Study Start Date:||January 2009|
|Study Completion Date:||April 2009|
|Primary Completion Date:||April 2009 (Final data collection date for primary outcome measure)|
Usability study of the Personal Wheezometer
Device: Personal WheezoMeter
pulmonary sounds analyzer