Heart FailureCardioCare MVNCT03317951
Investigation of a Novel Integrated Care Concept (NICC) for Patients Suffering From Chronic Cardiovascular Disease
A study testing Novel integrated care concept (NICC) in people with Heart Failure and Atrial Fibrillation, run by University Medical Center Rostock at 1 site in Germany.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Failure, Atrial Fibrillation, Treatment Resistant Hypertension
- What is being tested?
- Novel integrated care concept (NICC)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 964 participants
- Where
- 1 siteGermany
- Study dates
- 1 Dec 2017to 30 Sep 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized Controlled Trial for Investigating a Novel Integrated Care Concept (NICC) for Patients Suffering From Chronic Cardiovascular Disease: CardioCare MV
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.
Read the 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.
- Being tested
- Novel integrated care concept (NICC), Standard care
- Medical subject headings
- Heart Failure, Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Novel integrated care concept (NICC)Other
Integrated care concept including, e.g., call center, guideline therapy, tablet and medical devices
Standard careOther
Guideline therapy according to the guidelines of the European Society of Cardiology (ESC).
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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). Receives: Other: Standard care |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 1-year after randomization
Hospitalization
Number of hospitalizations within the 1-year observation period
Measured: 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.
Measured: 1-year after randomization
Secondary outcomes (13)
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.
Measured: 1-year after randomization
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.
Measured: Baseline, 6 months, 1 year
Cost
Treatment cost within the 1-year observation period
Measured: 1-year after randomization
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.
Measured: 1-year after randomization
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.
Measured: Baseline, 6 months, 1 year
Time to event
Primary composite endpoints as time to event
Measured: 1-year after randomization
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.
Measured: Baseline, 6 months, 1 year
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.
Measured: Baseline, 6 months, 1 year
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.
Measured: Baseline, 6 months, 1 year
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.
Measured: Baseline, 6 months, 1 year
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.
Measured: Baseline, 6 months, 1 year
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.
Measured: Baseline, 6 months, 1 year
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".
Measured: Baseline, 6 months, 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Oct 2017
- Study start1 Dec 2017
- Primary completion30 Sep 2020 (estimated)
- Study completion30 Sep 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Heart FailureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Prospective, controlled, open-label, randomized, bicenter study parallel-group design
- Masking
- None (open label)
- Enrolment
- 964 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Medical Center Rostock
- Sponsor type
- University, hospital or other
- Collaborators
- AOK Nordwest, Techniker Krankenkasse, Philips GmbH Market DACH, AMEDON GmbH, Lohfert & Lohfert AG, Society for Network & Innovation Management of Industry (Germany), Gemeinsamer Bundesaussschuss, Universitätsmedizin Rostock Versorgungsstrukturen GmbH
- Responsible party
- Principal investigator, Christian Schmidt, University of Rostock
- Investigators
- Christian Schmidt, Prof Dr, Principal investigator, Universitätsmedizin Rostock
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03317951
- Sponsor's protocol ID
- A2017-0117
- Acronym
- CardioCare MV
- Status last verified
- Nov 2019
- First submitted
- 5 Oct 2017
- Last updated
- 29 Nov 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 36631889Palmer 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.
PubMed 33769555Ziegler 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.
PubMed 32014033Schmidt 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.
PubMed 29458404
Study at a glance
From the registry record, last updated by the sponsor on 29 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Trial for Investigating a Novel Integrated Care Concept (NICC) for Patients Suffering From Chronic Cardiovascular Disease: CardioCare MV
- ClinicalTrials.gov ID
- NCT03317951
- Acronym / sponsor ID
- CardioCare MV / A2017-0117
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 964 participants (actual)
- Lead sponsor
- University Medical Center RostockUniversity, hospital or other
- Collaborators
- AOK Nordwest, Techniker Krankenkasse, Philips GmbH Market DACH, AMEDON GmbH, Lohfert & Lohfert AG, Society for Network & Innovation Management of Industry (Germany), Gemeinsamer Bundesaussschuss, Universitätsmedizin Rostock Versorgungsstrukturen GmbH
- Study start
- 1 Dec 2017 (actual)
- Primary completion
- 30 Sep 2020 (estimated)
- Study completion
- 30 Sep 2020 (estimated)
- First posted
- 23 Oct 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Prospective, controlled, open-label, randomized, bicenter study parallel-group design
| Arm | Type | Receives |
|---|---|---|
| Novel integrated care concept (NICC) | Experimental | Other: Novel integrated care concept (NICC)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. |
| Standard care | Active comparator | Other: Standard carePatients 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). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Novel integrated care concept (NICC)Integrated care concept including, e.g., call center, guideline therapy, tablet and medical devices | Other | Novel integrated care concept (NICC) |
| Standard careGuideline therapy according to the guidelines of the European Society of Cardiology (ESC). | Other | Standard care |
Primary outcome
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.
13 secondary outcomes
Adherence to novel integrated care concept
Time frame: 1-year after randomization
Quality of life
Time frame: Baseline, 6 months, 1 year
Cost
Time frame: 1-year after randomization
Safety as measured by cardiovascular events
Time frame: 1-year after randomization
Beliefs about medicine questionnaire
Time frame: Baseline, 6 months, 1 year
Time to event
Time frame: 1-year after randomization
Medication adherence report scale
Time frame: Baseline, 6 months, 1 year
Illness-specific Social Support Scale Short version-8
Time frame: Baseline, 6 months, 1 year
Patient activation measure
Time frame: Baseline, 6 months, 1 year
Heart specific quality of life
Time frame: Baseline, 6 months, 1 year
Patient Health Questionnaire depression module
Time frame: Baseline, 6 months, 1 year
Generalized Anxiety Disorder scale
Time frame: Baseline, 6 months, 1 year
World Health Organization Well-Being Index
Time frame: Baseline, 6 months, 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Nov 2019.
- Derived from this study: PubMed 36631889Oner 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.
- Derived from this study: PubMed 33769555Palmer 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.
- Derived from this study: PubMed 32014033Ziegler 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.
- Derived from this study: PubMed 29458404Schmidt 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Christian Schmidt, Prof Dr principal investigator
Universitätsmedizin Rostock
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Novel integrated care concept (NICC) in people with Heart Failure and Atrial Fibrillation, run by University Medical Center Rostock at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 29 Nov 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Composite endpoint death and cardiovascular events (time frame: 1-year after randomization). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03317951, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Nov 2019.