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.
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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
964
Integrated care concept including, e.g., call center, guideline therapy, tablet and medical devices
Guideline therapy according to the guidelines of the European Society of Cardiology (ESC).
Universitätsmedizin Rostock
Rostock, Germany
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
Time frame: 1-year after randomization
Hospitalization
Number of hospitalizations within the 1-year observation period
Time frame: 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.
Time frame: 1-year after randomization
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.
Time frame: 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.
Time frame: Baseline, 6 months, 1 year
Cost
Treatment cost within the 1-year observation period
Time frame: 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.
Time frame: 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.
Time frame: Baseline, 6 months, 1 year
Time to event
Primary composite endpoints as time to event
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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".
Time frame: Baseline, 6 months, 1 year
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