Investigation of a Novel Integrated Care Concept (NICC) for Patients Suffering From Chronic Cardiovascular Disease (CardioCare MV)
Heart Failure, Atrial Fibrillation, Treatment Resistant Hypertension
About this trial
This is an interventional treatment trial for Heart Failure
Eligibility Criteria
Inclusion Criteria:
- Heart failure (I50, NYHA II-IV) or atrial fibrillation (I48, EHRA II-IV) or resistant hypertension (I10-15, ≥ 3 antihypertensive medicines from different drug classes, SBP > 140 /90mmHg or ≥ 4 antihypertensives irrespective of the blood pressure, with at least one drug being a diuretic).
- Member of health insurance company AOK Nordost or Techniker Krankenkasse (TK).
- Inscription to integrated care contract with the health insurance company.
- Residence in Mecklenburg-Vorpommern.
- Age ≥ 18 years.
- Written informed consent.
Exclusion Criteria:
- Pregnancy, suspected pregnancy or breast-feeding period.
- Participation in another clinical trial up to 30 days before inclusion in this trial.
- Cognitive deficits: patients need to be able to read and understand German language as presented on a tablet.
- Chronic kidney disease requiring dialysis or creatinine clearance < 15 ml/min.
Sites / Locations
- Universitätsmedizin Rostock
Arms of the Study
Arm 1
Arm 2
Experimental
Active Comparator
Novel integrated care concept (NICC)
Standard care
The care center is at the heart of the NICC structure. It will be available 24/7. It is the core platform to share information for all NICC patients in the care process and serves as integration point between the professional groups. The care center is utilizing the NICC platform for care coordination and patient monitoring. The NICC platform enables patient management from the distance and allows treating physicians to observe and follow the health status of patients daily. Using the NICC tablet, patients provide information from home about their health status. They will receive feedback about their therapy, measurements and reminders and motivation to follow care plans. The communication allows for a regular evaluation of the patient's situation, a review of the therapy and coordination of necessary adjustments with care providers. The general intervention rules are based on the current European Society of Cardiology (ESC) guidelines for treating AF, HF and TRH patients.
Patients will be treated according to current practice as described in the guidelines of the European Society of Cardiology (ESC). For AF, this has been provided by Kirchhof et al. (2016 Eur Heart J). HF treatment will follow the 2016 ESC guideline for HF (Ponikowski et al., 2016 Eur Heart J), and TRH will be treated according to the ESC treatment guideline for arterial hypertension (Mancia et al., 2013 Eur Heart J).