Clinical trial NCT03317951: Investigation of a Novel Integrated Care Concept (NICC) for Patients Suffering From Chronic Cardiovascular Disease
Official title: A Randomized Controlled Trial for Investigating a Novel Integrated Care Concept (NICC) for Patients Suffering From Chronic Cardiovascular Disease: CardioCare MV
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Heart Failure
Atrial Fibrillation
Treatment Resistant Hypertension
Lead sponsor: University of Rostock
Sponsor class: OTHER
Collaborators: name: AOK Nordwest
name: Techniker Krankenkasse
name: Philips GmbH Market DACH
name: AMEDON GmbH
name: Lohfert & Lohfert AG
name: Society for Network & Innovation Management of Industry (Germany)
name: Gemeinsamer Bundesausschuss
name: Universitätsmedizin Rostock Versorgungsstrukturen GmbH
First posted: 2017-10-23
Enrollment: 964
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Prospective, controlled, open-label, randomized, bicenter study parallel-group design
Primary purpose: TREATMENT

Brief summary: 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.

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Composite endpoint death and cardiovascular events
timeFrame: 1-year after randomization
measure: Hospitalization
timeFrame: 1-year after randomization
measure: Composite endpoint death and broader cardiovascular events
timeFrame: 1-year after randomization
Secondary outcomes:
measure: Adherence to novel integrated care concept
timeFrame: 1-year after randomization
measure: Quality of life
timeFrame: Baseline, 6 months, 1 year
measure: Cost
timeFrame: 1-year after randomization
measure: Safety as measured by cardiovascular events
timeFrame: 1-year after randomization
measure: Beliefs about medicine questionnaire
timeFrame: Baseline, 6 months, 1 year
measure: Time to event
timeFrame: 1-year after randomization
measure: Medication adherence report scale
timeFrame: Baseline, 6 months, 1 year
measure: Illness-specific Social Support Scale Short version-8
timeFrame: Baseline, 6 months, 1 year
measure: Patient activation measure
timeFrame: Baseline, 6 months, 1 year
measure: Heart specific quality of life
timeFrame: Baseline, 6 months, 1 year
measure: Patient Health Questionnaire depression module
timeFrame: Baseline, 6 months, 1 year
measure: Generalized Anxiety Disorder scale
timeFrame: Baseline, 6 months, 1 year
measure: World Health Organization Well-Being Index
timeFrame: Baseline, 6 months, 1 year
Other outcomes:
Locations:
city: Rostock
country: Germany
facility: Universitätsmedizin Rostock
Study officials:
affiliation: Universitätsmedizin Rostock
name: Christian Schmidt, Prof Dr
role: PRINCIPAL_INVESTIGATOR
References:
citation: Palmer MJ, Machiyama K, Woodd S, Gubijev A, Barnard S, Russell S, Perel P, Free C. Mobile phone-based interventions for improving adherence to medication prescribed for the primary prevention of cardiovascular disease in adults. Cochrane Database Syst Rev. 2021 Mar 26;3(3):CD012675. doi: 10.1002/14651858.CD012675.pub3.
citation: Ziegler A, Mann M, Brandewiede B, Dittrich H, Hintz S, Krockenberger K, Oner A, de Sousa MO, Schmidt C. Statistical analysis plan for the randomized controlled trial CardioCare MV investigating a novel integrated care concept (NICC) for patients suffering from chronic cardiovascular disease. Trials. 2020 Feb 3;21(1):131. doi: 10.1186/s13063-020-4052-6.
citation: Schmidt C, Oner A, Mann M, Krockenberger K, Abbondanzieri M, Brandewiede B, Bruge A, Hostenkamp G, Kaiser A, Neumeyer H, Ziegler A. A novel integrated care concept (NICC) versus standard care in the treatment of chronic cardiovascular diseases: protocol for the randomized controlled trial CardioCare MV. Trials. 2018 Feb 20;19(1):120. doi: 10.1186/s13063-018-2502-1.