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

Not Applicable

• Conditions: I50; I10; I48; Heart failure; Essential (primary) hypertension; Atrial fibrillation and flutter

• Registration Number: DRKS00013124
• Lead Sponsor: niversitätsmedizin Rostock

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2017-10-05
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 964

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.

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

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

Secondary Outcome Measures

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