R&D Study to Evaluate Cordio's Usability and to Collect Patient Speech Utterances
- Conditions
- Chronic Heart Failure
- Registration Number
- NCT05876533
- Lead Sponsor
- Cordio Medical
- Brief Summary
To determine the usability and technical aspects of Cordio HearO™
- Detailed Description
The system (including App and server) will be tested under simulated use conditions with representative users to identify potential changes required to the application user interface, to improve user performance and satisfaction, and to inform future design options.
The recordings data will also be used for algorithm improvement
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 216
Not provided
Not provided
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Patient Usability success defined as: 1.Total and individual usability score of ≥3 in the usability questionnaire in ≥80% of the users. 2 years The used scale is: Usability questionnaire for the Cordio HearO™ App. This Usability questionnaire is a subjective evaluation based on Likert score of device user satisfaction.
Maximum value for each item: 5 Minimum value for each item: 1 Higher scores means a better outcomePatient Usability success defined as: 2. Total Compliance 2 Years The total compliance will be determined by the total number of recording days. Success will be considered if total average compliance of 70 % of all days.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (6)
Kurker Family Medicine
🇺🇸South Windsor, Connecticut, United States
C&R Research Services
🇺🇸Miami, Florida, United States
Lake County Med Grp
🇺🇸Athens, Georgia, United States
Barzilai Medical Center- Cardiology
🇮🇱Ashkelon, Israel
Heart Failure Clinic - Clallit Be'er Sheva
🇮🇱Be'er Sheva, Israel
Rabin Medical Center - Cardiology- CHF
🇮🇱Petah tikva, Israel