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

Heart Failure Clinical Trial

— CardioCare MV  

Official title:

A Randomized Controlled Trial for Investigating a Novel Integrated Care Concept (NICC) for Patients Suffering From Chronic Cardiovascular Disease: CardioCare MV

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03317951
• Other study ID #: A2017-0117
• Status: Active, not recruiting
• Phase: N/A
• Start date: December 1, 2017
• Est. completion date: September 30, 2020

Study information

• Verified date: November 2019
• Source: University of Rostock
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 964
• Est. completion date: September 30, 2020
• Est. primary completion date: September 30, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Atrial Fibrillation
• Cardiovascular Diseases
• Heart Failure
• Treatment Resistant Hypertension

Intervention

Other:
• Novel integrated care concept (NICC)
Integrated care concept including, e.g., call center, guideline therapy, tablet and medical devices
• Standard care
Guideline therapy according to the guidelines of the European Society of Cardiology (ESC).

Locations

Country	Name	City	State
Germany	Universitätsmedizin Rostock	Rostock

Sponsors (9)

Lead Sponsor	Collaborator
University Medical Center Rostock	Allgemeine Ortskrankenkasse Nordost, AMEDON GmbH, Gemeinsamer Bundesausschuss, Lohfert & Lohfert AG, Philips GmbH Market DACH, Society for Network & Innovation Management of Industry (Germany), Techniker Krankenkasse, Universitätsmedizin Rostock Versorgungsstrukturen GmbH

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Hospitalization	Number of hospitalizations within the 1-year observation period	1-year after randomization
Primary	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	Adherence to novel integrated care concept	Adherence to novel integrated care concept as measured, e.g., as percent of completed blood pressure measurements in patients with blood pressure device.	1-year after randomization
Secondary	Quality of life	Change in EuroQol (EQ-5D-5L). EQ-5D-5L health states, defined by the EQ-5D-5L descriptive system, will be converted into a single index value. The EQ-5D-5L index value will be calculated using the Crosswalk Index Value Calculator based on data from the German population. EQ-5D-5L analyses will be done separately for each level and each category.	Baseline, 6 months, 1 year
Secondary	Cost	Treatment cost within the 1-year observation period	1-year after randomization
Secondary	Safety as measured by cardiovascular events	Mortality, stroke, TIA, myocardial infarction, hospitalization, cardiovascular decompensation. All measured as yes/no within the 1-year observation period.	1-year after randomization
Secondary	Beliefs about medicine questionnaire	The BMQ consists of two sections, general and specific. The specific section assesses patients' beliefs about medications prescribed for a particular illness. Each statement has a 5-point Likert scale answers with 1 = strongly disagree, 2 = disagree, 3 = uncertain, 4 = agree and 5 = strongly agree. Points of each scale are summed to give a scale score. Higher scores indicate stronger beliefs in the concepts of the scale.	Baseline, 6 months, 1 year
Secondary	Time to event	Primary composite endpoints as time to event	1-year after randomization
Secondary	Medication adherence report scale	Self-reported adherence will be assessed using the MARS-5. Respondents score on 5-point Likert scales. The first statement of the MARS asks patients about unintentional non-adherence, whereas the other 4 statements question intentional non-adherence. The total score ranges from 5 to 25, with higher scores indicating higher self-reported adherence.	Baseline, 6 months, 1 year
Secondary	Illness-specific Social Support Scale Short version-8	The 8-item version of the ISSS measures positive support and detrimental interaction with four items each. Items are scored on a 5-point Likert scale ranging from 0 ('never') to 4 ('always'), and total scores may therefore range from 0 to 16.	Baseline, 6 months, 1 year
Secondary	Patient activation measure	The PAM13-D is an interval level, unidimensional Guttman-like scale with items sequenced by difficulty of activation. Patient activation is measured on a 0-100 scale, and activation scores can be converted to a four-level category score as described by Insignia Health.	Baseline, 6 months, 1 year
Secondary	Heart specific quality of life	The HeartQoLis a health-related quality of life questionnaire with 14 items.The 14-items in the HeartQoL scale cluster as a 10-item physical and a 4-item emotional subscale. Items score from 0 to 3 on a Likert scale, and means are calculated for each of the two domains and the total score. Higher scores indicate better quality of life.	Baseline, 6 months, 1 year
Secondary	Patient Health Questionnaire depression module	The PHQ-9 is the WHO depression module, which scores each of the 9 diagnostic criteria for major depression in Diagnostic and Statistical Manual Fourth Edition using a 4-point Likert scale which are 0 "not at all," 1 "several days," 2 "more than half the days" and 3 "nearly every day". Total scores may therefore range from 0 to 27.	Baseline, 6 months, 1 year
Secondary	Generalized Anxiety Disorder scale	The GAD-7 assesses the most prominent diagnostic features (diagnostic criteria A, B, and C from the Diagnostic and Statistical Manual of Mental Disorders, fourth edition [DSM-IV]) for GAD. Items are scored on a 4-point Likert scale, and they are 0 "not at all," 1 "several days," 2 "more than half the days" and 3 "nearly every day". The total score therefore ranges from 0 to 21. Low values represent no or mild anxiety.	Baseline, 6 months, 1 year
Secondary	World Health Organization Well-Being Index	The 5-item WHO Well-Being Index (WHO-5) assesses subjective psychological well-being.The respondent is asked to rate how well each of 5 statements applies to him or her when considering the last 14 days. Items are scored on a 6-point Likert scale from 5 "all of the time" to 0 "none of the time". The raw sum score ranges from 0, absence of well-being, to 25, maximal well-being. The scores are multiplied by 4 for a transformation to a percentage scale with values from 0 "absent" to 100 "maximal".	Baseline, 6 months, 1 year

External Links

•   Website for study