I50
Conditions
Interventions
Group 1: 50 - 100 patients with chronic heart failure, directly following a hospital stay for heart failure, will participate in the study. They will receive telemedical care for a minimum of 6 months
Sponsors
Charité- Campus Charité Mitte
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. patients with chronic heart failure in NYHA class II or III. 2. echocardiographically determined left ventricular ejection fraction (LVEF) =45% or LVEF >45% + at least 1 diuretic in long-term medical therapy. 3. have been hospitalised for cardiac decompensation<12 months prior to inclusion in the study (not related to a proven myocardial infarction without pre-existing moderately restricted LVEF) (doctor's letter available). 4. no moderate or severe depression 5. written informed consent of the patient
Exclusion criteria
Exclusion criteria: 1. hospitalisation within the last 7 days before study start (exept due to cardiac decompensation) 2. condition after implantation of a mechanical cardiac assist system 3. acute coronary syndrome within the last 7 days before study inclusion 4. high urgent HTX listing 5. planned revascularisation, TAVI, mitraclip and/or CRT implantation within 3 months of study inclusion 6. revascularisation and/or CRT implantation within 3 months prior to study inclusion 7. chronic drug or alcohol abuse as assessed by the physician 8. terminal renal failure with haemodialysis treatment 9. inability or unwillingness to perform telemonitoring (e.g. dementia, blindness, deafness, wheelchair use, insufficient knowledge of German, speech or voice disorders affecting voice analysis, limited informal self-determination) 10. illnesses with a life expectancy<12 months 11. age<18 years 12. pregnancy 13. participation in therapy studies (observational studies and registers are possible)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The sensitivity and specificity of the daily prediction of artificial intelligence (AI) scores regarding the occurrence of telemedicine interventions in heart failure patients sending daily vital signs from home to the telemedicine centre (TMC). For this purpose, patients identified by the scores as having a predicted need for telemedicine interventions will be compared with patients with interventions actually occurring that day in standard telemedicine care. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. in case of heart failure hospitalizations, the sensitivity of the score will be tested with respect to the identification and at least 1 presentation of the affected patient within the last 7 days before the event. 2. sensitivity and specificity of the daily prediction of the AI score with respect to TMC-initiated acute hospitalizations. (This will be done by comparing the risk patients identified by the score with the actual patients acutely hospitalized that day in standard telemedicine care). 3. sensitivity and specificity of the daily prediction of the AI score with respect to TMC-initiated acute presentations to the (primary) attending physician. (For this purpose, the patients at risk identified by the score are compared with the patients actually presented to the primary treating physician on this day by the TMC) 4. sensitivity and specificity of the daily prediction of the AI score regarding TMC-initiated medication changes as a form of telemedicine intervention. (This will be done by comparing risk patients identified by the score to patients who actually had a medication change initiated by the TMC on that day in standard telemedicine care). 5. sensitivity and specificity of the AI score's daily prediction of TMC staff calls to the patient for medical reasons. (This will be done by comparing risk patients identified by the score to patients who actually had a call of the TMC staff for medical reasons on that day in standard telemedicine care). 6. adherence to telemonitoring For each study patient, the measurements actually taken with at least one measuring device and with all measuring devices are measured in relation to the planned number of at least one daily measurement during the follow-up. (Scheduled logouts of patients (e.g. for vacations) and times during hospitalization are excluded from the adherence analysis). 7. change in quality of life during the course of the study due to telemedical management. | — |
Countries
Germany
Contacts
Public ContactFriedrich Köhler
Charité - Universitätsmedizin Berlin, Deutsches Herzzentrum der Charité, Arbeitsbereich Kardiovaskuläre Telemedizin
Outcome results
None listed