Investigation of a Novel Integrated Care Concept (NICC) for Patients Suffering From Chronic Cardiovascular Disease (CardioCare MV)

University Medical Center Rostock

Status: Unknown

Conditions: Treatment Resistant Hypertension; Atrial Fibrillation; Heart Failure

Treatments: Other: Novel integrated care concept (NICC); Other: Standard care

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT03317951

A2017-0117

Details and patient eligibility

About

Cardiovascular diseases are the number 1 cause of death globally and represent a major economic burden on health care systems. The investigators have developed a novel integrated care concept (NICC) which combines telemedicine with intensive support by a call center, an integrated care network including in- and outpatient care providers and guideline therapy for patients with heart failure (HF), atrial fibrillation (AF) or therapy resistant hypertension (TRH). The aim of the study is to show that NICC is preferable over guideline therapy alone. We aim at including approximately 890 patients. Patients could be enrolled either directly at the Care-Center (location: University Hospital of Rostock) or at one of the advanced treatments rooms of the Care-Center (outpatient cardiological specialist practices).

The ethics commission's statement of the University of Rostock is available for amendment 2 since 20.08.2019 at the number A2017-0117.

Full description

Background: Cardiovascular diseases are the number 1 cause of death globally and represent a major economic burden on health care systems. Positive effects of disease management programs have been shown for patients with heart failure (HF). Remote monitoring and telemonitoring with active intervention are beneficial in atrial fibrillation (AF) and therapy resistant hypertension (TRH), respectively. For these patients, the investigators have developed a novel integrated care concept (NICC) which combines telemedicine with intensive support by a call center, an integrated care network including in- and outpatient care providers and guideline therapy for patients.

Methods: The aim of the study is to demonstrate the superiority of NICC over guideline therapy alone. The trial is designed as open-label bi-center parallel-group design with two groups. Patients will be included if they are either inpatients or if they are referred to the outpatient clinic of the hospitals by their treating physician. Randomization will be done individually with stratification by cardiovascular disease (AF, HF, TRH), center and admission type. Primary endpoints are based on the 1-year observation period after randomization. The first primary endpoint is the composite endpoint consisting of mortality, stroke and myocardial infarction. The number of hospitalizations form the second primary endpoint. The third primary endpoint is identical to the first primary endpoint plus cardiac decompensation. Adjustments for multiple testing are done using a fall back strategy. Secondary endpoints include patient adherence, health care costs, quality of life and safety. The power for the second primary endpoint is 80% at the two-sided 2.5% test-level with a sample size of 890 patients.

Discussion: This study will inform care providers whether quality of care can be improved by an integrated care concept providing telemedicine through a 24/7 care center approach. We expect that cost of the NICC will be lower than standard care because of reduced hospitalizations. If the study has a positive result, NICC is planned to be immediately rolled out in the state of Mecklenburg-West Pomerania. The trial will also guide additional research to disentangle the effects of this complex intervention.

Enrollment: 964 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. 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).
2. Member of health insurance company AOK Nordost or Techniker Krankenkasse (TK).
3. Inscription to integrated care contract with the health insurance company.
4. Residence in Mecklenburg-Vorpommern.
5. Age ≥ 18 years.
6. Written informed consent.

Exclusion criteria

1. Pregnancy, suspected pregnancy or breast-feeding period.
2. Participation in another clinical trial up to 30 days before inclusion in this trial.
3. Cognitive deficits: patients need to be able to read and understand German language as presented on a tablet.
4. Chronic kidney disease requiring dialysis or creatinine clearance < 15 ml/min.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

964 participants in 2 patient groups

Novel integrated care concept (NICC)

Experimental group

Description:

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.

Treatment:

Other: Novel integrated care concept (NICC)

Standard care

Active Comparator group

Description:

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).

Treatment:

Other: Standard care