Smart system for the management of Heart Failure in older adults

Completed

• Conditions: Heart Failure; 10019280

• Registration Number: NL-OMON45815
• Lead Sponsor: SGE

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 28 February 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 13

Inclusion Criteria

- patient should be 65 years of age or older;
- patient has chronic heart failure with NYHA Classification II or III;
- patient has an ejection fraction (EF) < 40%;
- patient has been clinically stable and has not been hospitalized for CHF in the past 2 months.

Exclusion Criteria

- Patient is not yet 65 years of age;
- Condition of the patient is not suitable;
- Patient had been hospitalized in the past 2 months.

Study & Design

• Study Type: Observational non invasive
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>This study:<br /><br><br /><br>1. Test of accuracy, reproducibility and user interface of the SmartBEAT system<br /><br>(method Jakob Nielsen heuristics):<br /><br>Outcome: accuracy, reproducibility and user-friendliness<br /><br><br /><br>2. Pilot test:<br /><br>Outcome measure: usability<br /><br>Reporting usability issues, and where necessary, changes to the<br /><br>SmartBEAT solution.<br /><br><br /><br>3. Field test:<br /><br>Outcome measure: perceptions<br /><br>Factors: user experiences user-friendliness, acceptance, usability,<br /><br>design and comfort, and the influence of the human factor<br /><br>On the reliability of the system<br /><br><br /><br>No part of this study:<br /><br><br /><br>- Medium-sized RCT<br /><br>Outcome measure: congestion<br /><br><br /><br>- Large scale RCT<br /><br>Outcome measure: hospitalizations</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>not applicable</p><br>