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

NCT03317951 | Unknown DMC

• 1 other identifier: A2017-0117
• Study Type: interventional
• Target: 964
• Locations: 1 country
• Sites: 1

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.

Conditions

Heart Failure; Atrial Fibrillation; Treatment Resistant Hypertension

Outcome Measures

Primary Outcomes (3)

• Composite endpoint death and cardiovascular events

  Composite endpoint consisting of mortality (occurrence: yes/no), stroke (yes/no) and myocardial infarction (yes/no) within the 1-year observation period. Endpointed rated as yes if at least one yes

  1-year after randomization

• Hospitalization

  Number of hospitalizations within the 1-year observation period

  1-year after randomization

• Composite endpoint death and broader cardiovascular events

  Composite endpoint consisting of mortality (occurrence: yes/no), stroke (yes/no), myocardial infarction (yes/no) and cardiovascular decompensation (yes/no) within the 1-year observation period. Endpointed rated as yes if at least one yes.

  1-year after randomization

Secondary Outcomes (13)

• Adherence to novel integrated care concept

  1-year after randomization

• Quality of life

  Baseline, 6 months, 1 year

• Cost

  1-year after randomization

• Safety as measured by cardiovascular events

  1-year after randomization

• Beliefs about medicine questionnaire

  Baseline, 6 months, 1 year

Study Arms (2)

Novel integrated care concept (NICC)

EXPERIMENTAL

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.

Other: Novel integrated care concept (NICC)

Standard care

ACTIVE COMPARATOR

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).

Other: Standard care

Interventions

Novel integrated care concept (NICC) OTHER

Integrated care concept including, e.g., call center, guideline therapy, tablet and medical devices

Novel integrated care concept (NICC)

Standard care OTHER

Guideline therapy according to the guidelines of the European Society of Cardiology (ESC).

Standard care

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Pregnancy, suspected pregnancy or breast-feeding period.
• 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.

Sponsors & Collaborators

• University Medical Center Rostock: lead
• AOK Nordwest: collaborator
• Techniker Krankenkasse: collaborator
• Philips GmbH Market DACH: collaborator
• AMEDON GmbH: collaborator
• Lohfert & Lohfert AG: collaborator
• Society for Network & Innovation Management of Industry (Germany): collaborator
• Gemeinsamer Bundesausschuss: collaborator
• Universitätsmedizin Rostock Versorgungsstrukturen GmbH: collaborator

Study Sites (1)

Universitätsmedizin Rostock

Rostock, Germany

Location

Related Publications (4)

• Oner A, Dittrich H, Arslan F, Hintz S, Ortak J, Brandewiede B, Mann M, Krockenberger K, Thiery A, Ziegler A, Schmidt C; CardioCare MV Study Group. Comparison of telemonitoring combined with intensive patient support with standard care in patients with chronic cardiovascular disease - a randomized clinical trial. Eur J Med Res. 2023 Jan 11;28(1):22. doi: 10.1186/s40001-023-00991-1.

  PMID: 36631889 DERIVED

• 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.

  PMID: 33769555 DERIVED

• 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.

  PMID: 32014033 DERIVED

• 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.

  PMID: 29458404 DERIVED

MeSH Terms

Conditions

Heart Failure; Atrial Fibrillation

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Arrhythmias, Cardiac; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• Christian Schmidt, Prof Dr

  Universitätsmedizin Rostock

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Ärztlicher Vorstand

Model Details: Prospective, controlled, open-label, randomized, bicenter study parallel-group design

Study Record Dates

• First Submitted: October 5, 2017
• First Posted: October 23, 2017
• Study Start: December 1, 2017
• Primary Completion: September 30, 2020
• Study Completion: September 30, 2020
• Last Updated: November 29, 2019

Record last verified: 2019-11

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)