A Randomized Controlled Trial for Investigating a Novel Integrated Care Concept (NICC) for Patients Suffering From Chronic Cardiovascular Disease: CardioCare MV
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Heart Failure
- Sponsor
- University Medical Center Rostock
- Enrollment
- 964
- Locations
- 1
- Primary Endpoint
- Composite endpoint death and cardiovascular events
- Last Updated
- 6 years ago
Overview
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.
Investigators
Christian Schmidt
Ärztlicher Vorstand
University of Rostock
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.
Outcomes
Primary Outcomes
Composite endpoint death and cardiovascular events
Time Frame: 1-year after randomization
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
Hospitalization
Time Frame: 1-year after randomization
Number of hospitalizations within the 1-year observation period
Composite endpoint death and broader cardiovascular events
Time Frame: 1-year after randomization
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.
Secondary Outcomes
- Time to event(1-year after randomization)
- Adherence to novel integrated care concept(1-year after randomization)
- Quality of life(Baseline, 6 months, 1 year)
- Safety as measured by cardiovascular events(1-year after randomization)
- Beliefs about medicine questionnaire(Baseline, 6 months, 1 year)
- Cost(1-year after randomization)
- Patient activation measure(Baseline, 6 months, 1 year)
- Generalized Anxiety Disorder scale(Baseline, 6 months, 1 year)
- Medication adherence report scale(Baseline, 6 months, 1 year)
- Illness-specific Social Support Scale Short version-8(Baseline, 6 months, 1 year)
- Heart specific quality of life(Baseline, 6 months, 1 year)
- Patient Health Questionnaire depression module(Baseline, 6 months, 1 year)
- World Health Organization Well-Being Index(Baseline, 6 months, 1 year)