Trial document



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  DRKS00013124

Trial Description

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Title

A randomized controlled trial for investigating a novel integrated care concept (NICC) for patients suffering from chronic cardiovascular disease: CardioCare MV

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Trial Acronym

CardioCare MV

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URL of the Trial

http://www.cardiocare-mv.de

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Brief Summary in Lay Language

Cardiovascular diseases are the number 1 cause of death globally and represent a major economic burden on health care systems. We 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.

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Brief Summary in Scientific Language

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, we 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 only be included who will be accompanied by their general practitioner and/or specialist during the clinical trial (cooperating care provider in the sense of a IV-contract according to §140 SGB V).
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.

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Do you plan to share individual participant data with other researchers?

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Description IPD sharing plan:

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Organizational Data

  •   DRKS00013124
  •   2017/10/05
  •   2017/10/05
  •   yes
  •   Approved
  •   A 2017-0117, Ethik-Kommission an der Medizinischen Fakultät der Universität Rostock
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Secondary IDs

  •   NCT03317951  (ClinicalTrials.gov)
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Health Condition or Problem studied

  •   I50 -  Heart failure
  •   I10 -  Essential (primary) hypertension
  •   I48 -  Atrial fibrillation and flutter
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Interventions/Observational Groups

  •   Novel integrated care concept (NICC):
    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.
    Every patient is treated for 1 year with NICC.
  •   Standard care: guideline therapy according to the European Society of Cardiology
    Guideline AF: Kirchhof et al. (2016 Eur Heart J).
    Guideline HF: Ponikowski et al. (2016 Eur Heart J)
    Guideline for TRH follows guideline for arterial hypertension Mancia et al. (2013 Eur Heart J).
    Follow-up per patient: 1 year.
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Characteristics

  •   Interventional
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  •   Randomized controlled trial
  •   Open (masking not used)
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  •   Active control (effective treament of control group)
  •   Treatment
  •   Parallel
  •   N/A
  •   N/A
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Primary Outcome

First primary endpoint: composite endpoint consisting of mortality, stroke and myocardial infarction within the 1-year observation period.
Second primary endpoint: number of hospitalizations within the 1-year observation period.
Third primary endpoint: composite endpoint consisting of mortality, stroke, myocardial infarction and cardiovascular decompensation within the 1-year observation period.

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Secondary Outcome

Quality of life: measured at baseline, after 6 months and 1 year; measured with EQ-5D-5L.
NYHA stadium, EHRA stadium, number of antihypertensives, blood pressure at the end of the 1-year observation period.
Treatment cost within the 1-year observation period, measured with data provided by health insurance company.
Safety: measure after 1 year; measured as mortality, stroke, TIA, myocardial infarction, hospitalization, cardiovascular decompensation.
Standard inventories: measured at baseline, after 6 months and 1 year, such as well-being (WHO-5).
Adherence to NICC; measured continuously (daily), e.g., frequency of transfer of measurements.
Association between adherence to NICC and outcome.

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • University Medical Center 
  • Medical Center 
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Recruitment

  •   Actual
  •   2017/12/04
  •   964
  •   Multicenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   no maximum age
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Additional 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.

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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.

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Addresses

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    • Universitätsmedizin Rostock
    • Mr.  Prof. Dr.  Christian  Schmidt 
    • Ernst-Heydemann-Str. 8
    • 18055  Rostock
    • Germany
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    • AMEDON GmbH
    • Ms.  Dr.  Katja  Krockenberger 
    • Willy-Brandt-Allee 31C
    • 23554  Lübeck
    • Germany
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    • Universitätsmedizin Rostock Versorgungsstrukturen GmbH
    • Ms.  Dr  Miriam  Mann 
    • Ernst-Heydemann-Str. 8
    • 18057  Rostock
    • Germany
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Sources of Monetary or Material Support

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    • Gemeinsamer Bundesausschuss
    • Postfach 120606
    • 10596  Berlin
    • Germany
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    • AOK Nordost - Die Gesundheitskasse
    • Behlertstraße 33 A
    • 14467  Potsdam
    • Germany
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    • Techniker Krankenkasse
    • Postfach 110 565
    • 19005  Schwerin
    • Germany
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Status

  •   Recruiting complete, follow-up continuing
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Trial Publications, Results and other Documents

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