Demand-optimized care by nonphysician professionals and heart failure eHealth platform.
Not Applicable
Recruiting
- Conditions
- I50Heart failure
- Registration Number
- DRKS00031997
- Lead Sponsor
- Deutsches Zentrum für Herzinsuffizienz (DZHI) Universitätsklinikum Würzburg
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 1332
Inclusion Criteria
Objectified heart failure with reduced left ventricular ejection fraction (LVEF =40%).
Informed consent
Consent for additional documentation or data sharing in the current project.
Exclusion Criteria
Advanced cognitive impairment (assessment by study physician).
Lack of telephone access (landline or mobile)
Language barrier that prevents training or telephone consultation
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Primary endpoint is the change in KCCQ-OSS between baseline and time point 12 months after inclusion in the study.
- Secondary Outcome Measures
Name Time Method Composite of unplanned HI-associated hospitalizations & death from any cause.<br>Components of this composite considered individually<br>Change in/of: <br>KCCQ Clinical Summary Score<br>KCCQ Total Symptom Score<br>NYHA class<br>Glomerular Filtration Rate<br>NT-proBNP value<br>PHQ-9<br>GAD-7<br>EQ-5D-5L<br>MoCA test<br>Quality indicators of the planned DMP HI (according to the currently valid specification for the planned DMP HI of the G-BA)<br>Follow-up costs after 12 months resulting from HI-PLUS<br>Quality-adjusted life years (health economic project evaluation)<br>Acceptance of nVF by patients, cardiologists, general practitioners and HI-MFAS