I50
Conditions
Interventions
Group 1: The intervention is defined as 12 months of care under a structured and evidence-based care and case management (HI-PLUS) implemented with the help of a coordinating, structured trained medic
supplemental home visits are also possible, depending on need and severity of illness.
Depending on the patient's profile, the HI-MFA consults with the cardiologist about treatment goals. The HI-MFA
Sponsors
Deutsches Zentrum für Herzinsuffizienz (DZHI) Universitätsklinikum Würzburg
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
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
Exclusion criteria: Advanced cognitive impairment (assessment by study physician). Lack of telephone access (landline or mobile) Language barrier that prevents training or telephone consultation
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary endpoint is the change in KCCQ-OSS between baseline and time point 12 months after inclusion in the study. | — |
Secondary
| Measure | Time frame |
|---|---|
| Composite of unplanned HI-associated hospitalizations & death from any cause. Components of this composite considered individually Change in/of: KCCQ Clinical Summary Score KCCQ Total Symptom Score NYHA class Glomerular Filtration Rate NT-proBNP value PHQ-9 GAD-7 EQ-5D-5L MoCA test Quality indicators of the planned DMP HI (according to the currently valid specification for the planned DMP HI of the G-BA) Follow-up costs after 12 months resulting from HI-PLUS Quality-adjusted life years (health economic project evaluation) Acceptance of nVF by patients, cardiologists, general practitioners and HI-MFAS | — |
Countries
Germany
Contacts
Public ContactPeter Heuschmann
Institut für Klinische Epidemiologie und Biometrie (IKE-B) der Universität Würzburg
Outcome results
None listed