Implementation and Cost-evaluation of a Smartphone-based Telemonitoring and Digital Support Platform in Patients With Heart Failure: the Bedicare-HF Multicentre Trial
Phase: NA
Conditions: Heart Failure, Heart Failure NYHA Class II, Heart Failure NYHA Class III, Heart Failure NYHA Class IV
Sponsor: Comunicare Solutions SA

BEDICARE-HF protocol – V2 – 1     11/02/2022 
 
Implementation and cost-evaluation of a smartphone-
based telemonitoring and digital support platform in 
patients with heart failure: the Bedicare-HF multicentre 
trial 
 
 
Study protocol  
Version 2 – 11/02/2022 
 
Authors: Falter M1,2,3, Scherrenberg M1,2, Dendale P1,2, Pouleur A-C4, Tomas M5, Attipoe A5, 
Troisfontaines P6  
1 Heart Centre Hasselt, Jessa Hospital, Hasselt, Belgium 
2 Hasselt University, Faculty of Medicine and Life Sciences, Hasselt, Belgium 
3 KU Leuven, Faculty of Medicine, Leuven, Belgium 
4 Cliniques Universitaires Sain-Luc, Brussels 
5 Comunicare Solutions SA, Liège 
6 CHR Citadelle, Liège 
 
 Correspondence address for scientific questions :  
Maarten Falter 
Heart Centre Hasselt, Jessa Hospital, Hasselt, Belgium 
Stadsomvaart 11 
3500 Hasselt, BELGIUM 
maarten.falter@jessazh.be 
This is an investigator-initiated study sponsored by Comunicare Solutions SA and the Belgian 
Working Group of Heart Failure. 
 
Keywords: heart failure, digital support, smartphone, digital health, implementation, remote 
patient management, telemonitoring 

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Introduction 
Heart failure (HF) is a chronic condition and one of the most challenging issues is to reduce 
hospital admission and readmission rates for worsening HF. The prevalence of HF is estimated 
at 1-2% of the total population and ≥10% among people >70 years of age (1). Increasingly, 
telemonitoring is used as a solution to intervene at the start of an HF decompensation before 
the patient starts to be symptomatic and to avoid hospitalisation. In recent years, many trials 
have been published that investigate the utility of telemonitoring in HF in different modalities 
including invasive monitoring (2,3) and non-invasive monitoring (4). 
The most recent large randomised controlled trial (RCT) that demonstrated the efficacy of 
telemonitoring in HF is the TIM-HF2 trial in which a structured remote patient management 
intervention reduced the percentage of days lost to unplanned cardiovascular hospital 
admission and all-cause mortality in patients with New York Heart Association (NYHA) class 
II-III HF with a hospitalisation within the last 12 months (5).  
The utility of smartphone applications for patient care is increasingly being appreciated and 
in Europe, clear guidelines exist for developers who aim to develop software as a medical 
device (6). The advantage of using smartphone applications is that little specialised 
equipment is needed and, if a digital support programme is proven successful, 
implementation can be widely performed at low cost. 
In the current context of the Covid-19 pandemic, HF patients are particularly suffering from 
the difficulty to meet their cardiologist and HF nurse on a regular basis. Developing the 
possibility for remote monitoring is a key alternative to avoid re-hospitalization or severe 
clinical cardiovascular outcome. 
We present the design of the Bedicare-HF trial, which aims to take  digital support research a 
step further. It uses an implementation design approach in which a real-life setting will be 
approximated. The trial aims thus to not only demonstrate the effectiveness of a smartphone-
based HF digital support      approach but also the feasibility of implementation in a European 
healthcare context. Also, it aims to evaluate the cost-effectiveness of a smartphone-based  
digital support approach. 
Objectives 
The objectives of this study are to demonstrate feasibility, acceptability, adoption, 
sustainability, and safety of a smartphone-based digital support system in the healthcare 
system in Belgium and to demonstrate effectiveness, to evaluate the implementation cost of 
the system, and to demonstrate cost-effectiveness. 
Methods 
Study design 
The study design is a multicentre implementation trial. The conduct of the study is guided by 
good clinical practice (GCP) in accordance with the Declaration of Helsinki and the laws and 
regulations applicable in Belgium. Written approval from the Ethics Committees at all 
involved centres is required and informed consent must be provided by each patient. 
 
Patient recruitment 
Eligible patients are consecutive patients that are hospitalised for HF decompensation. The 
patients will be included in the programme during their hospitalisation or up to one week 
after hospitalisation. All eligible patients will be offered to participate. At the time of inclusion, 

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patients must be in New York Heart Association (NYHA) class II, III, or IV with a left ventricular 
ejection fraction (LVEF) of ≤40%. The inclusion and exclusion criteria are shown in Table 1. A 
total of 165 patients will be included over 6 month. In total, 11 hospitals (local investigators) 
in Belgium with an HF clinic employing at least one certified HF nurse will be participating in 
patient recruitment. Patients are not randomised and will all be participating in the 
smartphone digital support intervention. 
A screening register will be kept including reasons why eligible patients that do not participate 
are disregarding inclusion. Patients refusing participation will also be asked to complete a 
quality of life (QOL)-questionnaire at 6 months and 12 months which will be answered online.  
A total of 165 patients (who do not want to participate) will be asked to answer this 
questionnaire. 
So the app will be made available to 165 patients for home monitoring and another group of 
165 patients without an application will be asked to answer quality of life questionnaires.  
Patients who agree to use the application can continue to use it after the study, if they wish. 
 
 
 
 
Inclusion criteria 
Exclusion criteria 
Diagnosed with HF – NYHA class II-IV 
Acute coronary syndrome 
LVEF ≤40%. 
High urgent listed for heart transplantation 
Hospitalisation due to decompensated HF at 
the moment of inclusion or up to 1 week 
prior to inclusion (i.e. discharged ≤1 week 
prior to inclusion). 
Planned revascularisation, TAVI, MitraClip 
and/or CRT implantation within 3 months 
after inclusion 
Owning a smartphone and able to use an 
application 
Known alcohol or drug abuse 
Written informed consent obtained 
Terminal 
renal 
insufficiency 
with 
haemodialysis or peritoneal dialysis 
 
Impairment or unwillingness to use the  
digital support equipment (e.g. dementia, 
impaired self-determination, lacking ability 
to communicate) 
 
Existence of any non-cardiac disease 
reducing life expectancy to less than 1 year  
 
Age <18 years 
 
Participation in other treatment studies or 
remote patient management programmes 
Table 1 – Inclusion and exclusion criteria. NYHA: New York Heart Association. LVEF: left 
ventricular ejection fraction. CRT: cardiac resynchronisation therapy. TAVI: transcatheter 
aortic valve implantation. 
 
 Digital support platform 
The digital support intervention uses the Comunicare patient support solution (Figure 1) 
specifically designed for digital support of HF. The solution consists of a smartphone-based 
mobile application designed to be used by patients and a web-based dashboard application 
to be used by the caregivers. The application is a class 1 certified medical device. It includes 

BEDICARE-HF protocol – V2 – 11/02/2022 
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different modules for patient education, medication adherence, tracking of vital signs and 
symptoms, electronic patient-reported outcome (ePRO), appointments, and video 
consultation.  
 
Patient Education module: a knowledge base has been configured into the application to 
provide patients with information about HF based on the latest ESC guidelines (1) and the 
local reimbursement context. The patient information that is provided includes descriptions 
of the function of the heart, the causes of HF, and advice about how to self-manage and 
understand HF. 
 
Medication adherence: the application enables patients to maintain a medication list and to 
configure a reminder system to receive notifications. If medication is not taken an explanation 
for non-intake can be provided. 
 
Tracking of vital signs and symptoms: the application enables patients to track and input vital 
signs and symptoms as recommended by the caregivers. A notification can be configured to 
remind the moment of measurement. Measured values can be inserted manually or captured 
directly from validated connected devices (blood pressure monitor, weight scale, activity 
tracker). Alarm limits can be set, and an alarm will then be triggered as soon as an input 
breaches the alarm limit. A Bluetooth-compatible blood pressure monitor and weighing scale 
will be provided at inclusion. If preferred by the patient manual input through their own 
devices can be performed. 
 
Electronic patient-reported outcome (ePRO): the application enables patients to complete 
questionnaires about their QOL. A notification can be configured to remind the moment to 
fill the questionnaires. When available, scoring of the questionnaires is generated in the 
dashboard for caregivers. 
 
Appointments and video consultation: the application includes an electronic agenda that can 
be input manually by the patients or automatically synchronized with the hospital system. It 
also includes a secure video consultation that can be triggered by the caregivers when 
deemed necessary after reviewing the patient-reported data. 
 
Caregiver dashboard application: this web-based application enables caregivers to 
administrate the care flow and review all patient-reported data and the alarm generated by 
the system.  
 
 

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Security and Privacy: the application complies with strict security and privacy-related 
regulations. All data storages are encrypted on the patients’ smartphone and a server located 
in an ISO-certified data centre located in Belgium, and all information exchanges are highly 
secured. A General Data Protection Regulation (GDPR)-compliant privacy notice defines how 
patient personal data is processed and how data protection principles are applied. 
 
According to the General Personal Data Regulation (GPDR), the data controller determines 
the purposes for which and the means by which personal data is processed and the data 
processor processes personal data only on behalf of the controller. The duties of the 
processor towards the controller are specified in a contract agreement and a Data Processing 
Agreement (DPA). 
 
In the context of a normal usage of the application, the hospital is data controller and 
Comunicare Solutions SA is the data processor.  
 
 
However, in the context of the clinical study, Comunicare Solutions SA is subject to the rights 
and obligations as “data controller” set forth under the GDPR in relation to the processing of 
personal data for the purpose of conducting the Study in accordance with the Protocol. In 
that respect Comunicare Solutions SA shall be considered as data controller of all Personal 
Data processed specifically for Study purposes. 
 
Each participating centre is subject to the rights and obligations as “data processor” set forth 
under the GDPR in relation to the processing of personal data for the purpose of conducting 
the Study in accordance with the Protocol.  
 
Each participating centre is also subject to the rights and obligations as a separate “data 
controller” set forth under the GDPR in relation to the processing of personal data of its 
patients for purposes other than conducting the Study. In particular, each participating centre 
remains data controller of the data contained in the patients’ medical records for the 
purposes of providing medical care to its patients and for academic research purposes. 
 

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Comunicare Solutions SA will provide patients with a GDPR policy, as required to inform the 
patient about his/her rights related to their personal data. The hospital will provide the 
patients with an informed consent document. 
 
 
 
Comunicare Solutions SA will provide each participating centre an appropriate number of 
patient access cards. Each patient access card displays an anonymous user ID and password 
as well as a scannable QR code. Once the written informed consent form (ICF) is obtained, 
the study personnel at each participating centre will add the patient to a ICF log (spreadsheet) 
and attribute a study number to each participant. The hospital study personnel will assign a 
specific patient access card to the participant and register its code on the ICF log. Data entered 
into the App and transferred to the sponsor’s database will thus be fully anonymized. 
The ICF log will allow the hospital study personnel to reconcile data with individual patient 
identity and should be kept by hospital study personnel in a secured location. Therefore, o     
nly the medical           staff under the responsibility of the      investigator      in each participating 
centre will be able to establish a link between the identity of the patient and the data 
collected throughout the study. The ICF log will not be communicated to the sponsor.      
For the statistical      analysis, the scientific staff of the Heart Centre Hasselt will only receive 
and process anonymized data     .  The      generation of anonymous patient code is done via 
a      Universally Unique Identifier (UUID), a 128-bit label generated according to standard 
methods (https://www.ietf.org/rfc/rfc4122.txt) that guarantee the uniqueness and the non-
reversibility. Therefore, the Heart Centre Hasselt will not process any personal data and is 
therefore not subject to GDPR requirements.  
 
Intervention design 
The assessments performed at each visit are displayed in Table 2. At inclusion, laboratory 
values and echocardiography results of ≤2 weeks prior to inclusion performed as part of 
routine care will be used.  
 
Smartphone intervention 
At inclusion, an account on the smartphone application will be created for the patient and the 
application will be installed on the patient’s smartphone. Instructions on how to use the 
application will be provided. Patients will be included for 6 months in which they will be asked 
to use the different modalities of the smartphone application. There will be low-threshold 
contact with a study nurse if the patient doesn’t use or doesn’t know how to use the 
application, as well as when predefined alarm limits are crossed. In case of patients that are 

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very motivated to participate in the intervention but do not own a smartphone, a smartphone 
can be provided by the study sponsor for the duration of the study. No costs will be charged 
to the patient, also in case of loss or damage 
 
Personalised alarm limits that can be predefined include: 
- 
Heart rate: an upper rate will be set to detect possible atrial fibrillation 
- 
Weight gain: ideal weight and alarm weight can be set by the case nurse. 
- 
Blood pressure: hypotension (under normal limits for the specific patient) and 
extreme hypertension. 
- 
Not using the application, no measurement input by the patient for a predefined time. 
 
After 6 months the inclusion will be ended. If the patient and the care providers deems it 
necessary for the continuity of care, they may continue using the application after the 6 
months period of the study. A new informed consent document should be signed and the 
application, inside or outside the study, will remain the same. Only the  data collected during 
the 6-month period of the study will be used for the initial data analysis. Further data analysis 
of the additional data after 6 months may take place in a second stage. 6 months after the 
end of the study, during a routine appointment (standard of care) of the patient with his 
cardiologist, he will be asked to answer questions about his well-being again. 
 
Data collection during the trial 
Data that will be collected by the smartphone application and the caregiver application for 
analysis purposes throughout the trial includes parameter measurement (blood pressure, 
heart rate, weight), medication adherence by using the medication module, and patient-
reported outcome questionnaires. In the caregiver dashboard application information on 
time spent on the caregiver dashboard application and all input (time spent, change in 
therapy, contacts) by caregivers (nurses, cardiologists, others) will be collected. 
 
Interventions because of the trial 
Personalised alarm cut-offs can be programmed by the caregiver team. There is no scheduled 
study contact on top of the usual care contacts. In case of application alarms being triggered, 
the patient will be called and the situation will be assessed. If needed, the problem will be 
discussed with a cardiologist. In emergency situations, the patient will be asked to present to 
the emergency department. 
Monitoring of alarms will not be continuous and will only take place during working hours 
throughout the working week (Monday to Friday) and patients will be instructed to call their 
general practitioner, the hospital, or the emergency number in case of problems and not to 
wait until they are contacted.  
 
End-of-trial assessment 
At the end of the trial, the assessments listed in Table 2 will be performed. Cost-related data 
will be collected: healthcare resource use, hospitalisation time, tests, procedures, and health 
expenditure. Cost-effectiveness will be calculated using healthcare cost data and work 
productivity and impairment (WPAI) questionnaire to calculate incremental cost-
effectiveness ratio (ICER).  
 
Re-evaluation at 12 months 

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After the end of the inclusion at 6 months, a re-evaluation of outcome parameters will take 
place at month 12 to evaluate the continued effect of the intervention after cessation. 
      
 
 
Baseline 
Final visit 
month 6 
Informed consent and patient information 
X 
 
Medical history: past medical history, symptom control, 
NYHA classification, smoking behaviour, current 
medication 
X 
X 
Physical examination including weight, height, blood 
pressure, heart rate 
X 
X 
Length of initial hospital stay 
X 
 
Registration of medication 
X 
X 
Echocardiography 
X 
X 
12-lead ECG 
X 
X 
Laboratory tests: haemoglobin, haematocrit, 
leukocytes, thrombocytes, sodium, potassium, 
creatinine, NT-proBNP 
X 
X 
ePROs: KCCQ-12, EQ5D, HeartQoL, PHQ9, HLS-EU-Q16, 
EHFScB-9, SUTAQ, WPAI. 
X 
X 
Registration of events: hospitalisation (with the length 
of stay), emergency department visit, death 
 
X 
Cost-evaluation 
 
X 
Table 2 – intervention design. ECG: electrocardiogram. ePRO: electronic patient-reported 
outcome. NT-proBNP: N-terminal prohormone of brain natriuretic peptide. KCCQ-12: Kansas 
City Cardiomyopathy Questionnaire. EQ5D: EuroQol 5-dimension questionnaire. HeartQol: 
Health-related quality of life questionnaire. PHQ9: patient health questionnaire-9. HLS-EU-
Q16: European Health Literacy Survey Questionnaire. EHFScB-9: European Heart Failure Self-
care Behaviour scale revised into a nine-item scale. SUTAQ: Service User Technology 
Acceptability Questionnaire. WPAI : work productivity and impairment. 
 
 
 

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Health economic analysis 
The costs considered for the cost-effectiveness analysis are direct costs of the smartphone-
based digital support intervention and the care utilisation recorded during the inclusion of 
the trial. The costs for the digital support intervention consist of costs for data management 
using the application, costs for devices that are provided in selected patients (blood pressure 
monitor, weighing scale), and personnel costs for inclusion and time spent on follow-up of 
alarms.  
Information on care utilisation will be collected at the end of the trial. Former studies have 
demonstrated that hospitalisation costs are the key driver of HF-related costs (7,8). This study 
will thus focus on reduction in length of hospital stay and reduction in rehospitalisations after 
initial hospitalisation. The 30-day and 90-day rehospitalisation rates will be assessed. All 
hospital-related costs will be collected from the hospital billing and financial departments. A 
distinction will be made between scheduled and non-scheduled hospitalisations. Scheduled 
hospitalisations for elective procedures and scheduled visits with the cardiologist or general 
practitioner will not be included in the cost-evaluation. 
Implementation cost and cost-effectiveness will be assessed in this trial following a pre-post 
economic model. A historical cohort of all patients hospitalised for HF on a cardiology ward 
in 2019 in all participating centres will be assessed for comparison. Hospital bills and hospital 
administrative data based on the international classification of disease (ICD)-codes will be 
collected. Propensity matching will be applied.  
QOL and healthcare-related costs will be collected in selected patients refusing to participate 
in the smartphone intervention. 
 
Cost reduction between the intervention group, the historical cohort, and the participation 
refusers will be calculated.  Costs and outcomes (utilities) will be compared by calculation of 
the incremental cost-effectiveness ratio (ICER) (ICER = (costintervention group – costhistorical cohort)/ 
(effectivenessintervention group – effectivenesshistorical cohort)). The incremental cost represents 
the difference in total average cost per patient between the intervention group and the 
historical cohort or the participation refusers. Effectiveness will be calculated by comparing 
QOL in the intervention group versus the participation refusers. 
 
 

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Study endpoints 
The endpoints that will be assessed are summarized in Table 3. As specified before, the 
objectives of the study are to demonstrate positive implementation measures (e.g. feasibility) 
as well as to demonstrate cost-effectiveness. Secondary objectives include assessment of 
clinical impact, based on measurement of clinical endpoints as specified in Table 3. 
Implementation outcome variables will be assessed using a mixed-method design. Patient 
and caregiver parameters will be calculated (e.g. time spent using the application). 
Questionnaires will be used to assess patient variables. Semi-structured interviews in a 
selection of patients and caregivers will be performed to assess further outcome variables 
regarding implementation. 
 
Implementation outcome variables 
 
Feasibility and patient acceptability 
SUTAQ, semi-structured interviews. 
 
Caregiver acceptability and burden of 
care 
SUTAQ, semi-structured interviews, daily time spent by case 
nurses using the platform 
Adoption and sustainability 
Number and percentage of patients refusing inclusion, of 
patients continuing application usage after 6 months. Total 
time-percentage ratio of patients using the application 
throughout the trial.  
Implementation cost 
Cost-related data: healthcare resource use, hospital days, 
tests, procedures, health expenditure. Cost-effectiveness:  
healthcare cost data, WPAI questionnaire, ICER. Cost of 
hospital stay at inclusion. 
 
Quality of life, literacy and patient self-
care 
KCCQ-12, EQ5D, HeartQoL, PHQ9, HLS-EU-Q16, EHFScB-9, 
SUTAQ. 
Clinical outcome measurement 
 
Combined endpoint 
Unplanned CV readmission and all-cause mortality 
Individual endpoints 
Symptom control (NYHA, KCCQ-12), emergency department 
visits, length of hospital stay during the trial, unplanned CV 
readmission, all-cause mortality. 
Table 3 - Study endpoints.  CV: cardiovascular. SUTAQ: Service User Technology Acceptability 
Questionnaire. KCCQ-12: Kansas City Cardiomyopathy Questionnaire. EQ5D: EuroQol 5-
dimension questionnaire. HeartQol: Health-related quality of life questionnaire. PHQ9: 
patient health questionnaire-9. HLS-EU-Q16: European Health Literacy Survey Questionnaire. 
EHFScB-9: European Heart Failure Self-care Behaviour scale revised into a nine-item scale. 
SUTAQ: Service User Technology Acceptability Questionnaire. WPAI : work productivity and 
impairment. ICER: incremental cost-effectiveness ratio. 
 
 
 

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Statistical analysis 
Sample size 
A total of 165 patients will be included in the study. The sample size is based on comparable 
implementation trials (9,10). An additional patient group will be included that is not part of 
the study intervention but will complete questionnaires; this is a non-randomized control 
group. A minimum of 165 patients will take part in this control group for completion of the 
study. 
 
Statistical analysis 
The primary analyses will be paired Student t-tests and Wilcoxon signed-rank tests comparing 
baseline, 6-month and 12-month values for all patient-level outcomes. Secondary analyses 
aimed at determining the longitudinal impact of the smartphone digital support programme 
(i.e., using outcome data from the additional time points), and the correlation of independent 
variables (e.g., patient characteristics and adherence rates) with outcomes will be analysed 
using general linear mixed-model procedures. In addition, descriptive statistics will be 
produced for all variables collected, and subgroup analyses will be performed. All statistical 
analyses will be performed using the statistical software application SPSS (IBM Corporation, 
USA). 
Descriptive statistics will be produced for the indicators of the implementation outcome to 
provide an objective measure of implementation success.  
Discussion 
The Bedicare-HF study is the first study that will investigate implementation of a smartphone-
based HF digital support system in a real-life context on the background of European GDPR 
and medical device regulations. 
In recent years, many studies have investigated telemonitoring and digital support of HF in 
different modalities (2–5) in a RCT setting using strict inclusion and exclusion criteria. Many 
of these trials had successful results and could prove the superiority of the digital support 
intervention on their primary endpoints. However, due to the RCT nature, it remains unclear 
how easily these results will translate into a real-life healthcare context. One trial investigated 
implementation of a smartphone-based HF digital support intervention and could report a 
50% decrease in HF-related hospitalisations (10). However, this trial was conducted in Canada 
and is thus specific for the Canadian healthcare context. 
 
By its implementation design, the Bedicare-HF study aims to take digital support of HF to the 
next step towards implementation. A large advantage is that it is an all-comers study, in which 
all patients meeting the inclusion criteria will be asked to participate, and that information on 
those who refuse participation will be available for analysis. This information will be of direct 
use for later implementation in the healthcare setting. An intrinsic limitation is that it is 
specific to the European and even Belgian healthcare context and that the results about 
implementation cannot necessarily be generalised to other healthcare systems. Another 
limitation is that due to the nature of the trial setup, no distinct comparator group is available 
and a historical cohort will need to be used. However, we believe that the strength of this trial 
is in its pragmatic design and the value of information not only on trial participants but also 
on trial non-participants. 
 

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A particular challenge to the Bedicare-HF trial will be the European GDPR-context and medical 
device regulations. The collaboration between a commercial partner and multiple hospitals 
means that sensitive data will need to be securely exchanged. Overcoming this challenge can 
directly yield useful information on the implementability of this technology.  
In Belgium, there is currently no framework for reimbursement of telemonitoring and digital 
support of HF, neither non-invasively nor invasively. Recently, a reimbursement framework 
was approved for reimbursement of medical smartphone applications. If the Bedicare-HF 
intervention is shown successful, this will have direct implications for reimbursement of HF  
digital support and telemonitoring in Belgium. 
Another important strength of this trial is the emphasis on cost-evaluation and cost-
effectiveness analysis which will provide useful information for possible reimbursement. By 
using semi-structured interviews the study aims to also evaluate important barriers for 
implementation in patients and physicians. 
Conclusion 
The Bedicare-HF study will investigate the implementation of a smartphone-supported HF 
telemonitoring and digital support intervention in a European legislative setting. The design 
is a multicentre implementation trial. It is an all-comers study in which information on 
participants but also on non-participants of the study will be collected. This design will allow 
to take the evaluation of HF digital support a step further and allows to evaluate a low-cost 
smartphone solution for HF telemonitoring and digital support in a real-life setting. The study 
will yield important information about the feasibility of implementation in a European 
healthcare context on a background of European medical device regulation for software. The 
results of this study will demonstrate if, and how, a smartphone-based digital support system 
improves the self-care capacities, clinical management, and health outcomes of patients with 
HF and will yield important information about the implementation of digital support systems 
into a specific healthcare setting. The results of our study are expected in 2022.  
 
Ethical considerations and additional regulations  
The study will be conducted in accordance with the study plan, Good Clinical Practice (GCP) 
guidelines, and the ethical principles for medical research involving human subjects, set out 
in the Declaration of the World Medical Association of Helsinki (the Helsinki Declaration). The 
present study will be submitted to the respective Ethics Committees of participating hospitals 
for approval. The study may only be started after approval by the respective Ethics 
Committees. 
Any change in the study plan and/or in the study participant information and declaration of 
consent shall be submitted to the responsible Ethics Committees for approval. All such 
changes shall be approved by the Ethics Committees before implementation. 
 
Funding 
This is an investigator-initiated study sponsored by Comunicare Solutions SA and the Belgian 
Working Group of Heart Failure. 
 
 

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Figures and Tables 
 
 
Figure 1 – The Comunicare patient platform. The parameter module is displayed.