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Table 3 Trial-specific examinations

From: First outline and baseline data of a randomized, controlled multicenter trial to evaluate the health economic impact of home telemonitoring in chronic heart failure – CardioBBEAT

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  
  1. 6 MWD 6-minute walking distance, AE adverse event, AHA American Heart Association, staging of heart failure, ESC European Society of Cardiology, KCCQ Kansas City Cardiomyopathy Questionnaire with 23 items for measuring disease-specific domains in CHF, LVEF left ventricular ejection fraction, NYHA New York Heart Association, classification of heart failure, SAE serious adverse event, SF-36v2 short form health survey with 36 questions using norm-based scoring, WHO-5 World Health Organization Five, well-being index