Enrollment examination | |
1. Patient briefing | |
2. Written informed consent | |
3. Verification of inclusion and exclusion criteria | |
4. Demography | |
Sex | |
Date of birth | |
Marital status | |
Size and weight | |
5. Hemodynamic parameters | |
Heart rate | |
Blood pressure (systolic/diastolic) | |
6. Disease-related parameters | |
Medical history | |
CHF (date of diagnosis, aetiology, inpatient treatments, NYHA classification, AHA stadium) | |
Comorbidities | |
Medication | |
Care plan compilation | |
6 MWD | |
7. Health-related quality of life assessment | |
SF-36v2 (generic quality of life questionnaire) | |
WHO-5 (generic quality of life questionnaire) | |
KCCQ (disease-specific quality of life questionnaire) | |
Follow-up and final examination | |
1. Demography | |
Weight | |
2. Hemodynamic parameters | |
Heart rate | |
Blood pressure (systolic/diastolic) | |
3. Disease-related parameters | |
CHF (NYHA classification, AHA stadium) | |
Newly occurring comorbidities | |
Medication | |
Hospitalizations or admissions to a nursing home | |
Patient diary monitoring and validation of AE/SAE | |
6 MWD | |
4. Health-related quality of life assessment | |
SF-36v2 (generic quality of life questionnaire) | |
WHO-5 (generic quality of life questionnaire) | |
KCCQ (disease-specific quality of life questionnaire) | |
In case a patient dies during the trial | |
Date of death | |
Cause of death |