Skip to main content

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