Optimization of the Ambulatory Monitoring for Patients With Heart Failure by Tele-cardiology

Study Overview
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Brief Summary
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Targeted population: Patients with heart failure causing hospitalization during the last twelve months. Hypothesis: The number of all cause deaths and hospitalizations will be smaller for the Telecardiology group than for the reference group (standard follow-up care). An 18 months period of observation is required. Main goal: To compare the rate of all cause deaths and hospitalizations of patients with heart failure between the Telecardiology group and the reference group after 18 months of monitoring.

Detailed Description
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COMPARATIVE STUDY: Comparative study of patients with chronic heart failure, randomized ratio (1:1), with two study arms (telecardiology vs usual care). French multicenter study. The planned enrolment is 990 patients in a total period of 3.5 years. This study will involve an enrolment visit, managed by the recruiting investigator cardiologist, then four telephone contacts by Clinical Studies Technicians (CST). The purpose of the CST telephone contacts is to record the study data, and this will be occur for both study arms. Throughout the study, the patients in the telecardiology study arm will have regular contact with the Cordiva nurses for the management of their chronic heart failure, through telemonitoring and coaching. There is no planned hospitalization for the study. Patients in the control group will receive the usual care: After enrolment, they will return home and will subsequently have regular visits to their General Practitioner (GP) or referring cardiologist. Patients in the telecardiology group will receive the necessary monitoring equipment in their home in the week following their enrolment visit. This equipment includes a connected electronic scale and a questionnaire box. This questionnaire is designed to evaluate the evolution of patient symptoms. During the presentation of the study to the patient before study inclusion, the investigator will inform the patient about the use of the equipment. The material provided is self installable but if the patient asks for help, the equipment will be installed at the patient's home by a private nurse, who also will check that the patient knows how to use the equipment. Each patient will respond daily to 8 yes/no questions: Did you have more breathing issues last night than the previous night? Did you need an extra pillow for better breathing last night? Do you cough more than usual? Are your legs are more swollen than usual? Do you feel yourself more tired than usual? Have you had or do you have a fever above 38.5 °C? Have you felt or do you feel palpitations? Do you find that your physical activity is more limited today than the previous days? Patients should simply answer yes or no to all of these questions through the questionnaire box. The self-monitoring parameters (weight and questionnaire answers) will be remotely transmitted via standard phone lines (wired, 3G or GPRS) to the secured servers. These data will be analyzed automatically by an expert system that will generate an alert in case of abnormal values. The objective is to anticipate possible acute cardiac failure. The specialized nurses from the Cordiva center will manage those alerts during working hours and will contact the patient to validate with him the relevance of the alert. If the clinical reality of the alert is confirmed, the nurse will advise the patient to contact his GP or referring cardiologist. In parallel to the nurse advising the patient, the referring physician will receive an alert report including the weight values and the symptoms which triggered this alert. Then, he can then take any action he considers appropriate. A binder will be sent to the patients. This will contain various information related to the management of their heart failure: heart physiology, symptoms, treatments, diet, physical activity... The purpose of this binder is to support the discussion between the Cordiva nurses and the patient. Upon receipt and installation of the equipment in the patient's home, the nurses will arrange a first telephone interview, which will last approximately 45 minutes. The nurses will first introduce the team and the overall clinical approach, and will have a discussion with the patient to better understand the patient (anamnesis, treatment, psycho-social profile, smoking, alcohol use, physical activity, and so on). After this call, patient and nurse will together determine together the date for the next phone call date. On a regular basis (for example every three weeks), a Cordiva nurse will call the patient to check the current status of his disease and its treatment, and to assist him in the management of his disease on a daily basis (compliance, physical activity, nutrition, illness experience... ) . This call will last approx. 15 minutes, however, the duration of the call is not limited, but is defined according to the needs of the patient. At the end of each call, the nurse will define with the patient educational goals (disease knowledge, treatments, recognizing acute episodes symptoms, learning better health habits, practise regular physical activity). Cordiva center is also available for patient's inbound calls. In this way, patients will be able to easily call the center during working hours, and discuss with a specialized Cordiva nurse. This line is not an emergency line and does not replace the 112, which remains the only accredited contact in case of emergencies. In case of temporary travel of the patient away from home (i.e. for holidays), the patient can take the box and scale with him. This material is provided with GPRS SIM card, so the connection will be maintained. The patient may also provide an alternative phone number for the calls with the nurses. The patient's GP will be involved in this outpatient care from the beginning of the study. Indeed, data collected through the connected boxes and scales will be displayed in dedicated reports sent to the GP. These reports will be transmitted every 2 months. These reports will also be sent to the referring cardiologist if requested. Moreover, in case of validated alerts, the referring physician will have access to a weight and symptoms report, allowing him to take any action he thinks appropriate. ABOUT CORDIVA CENTER: The center has a team of specialized and graduated nurses in heart failure management and in therapeutic education, due to the dedicated training they have received. Indeed, many studies in the multidisciplinary care of heart failure patients have demonstrated the key role of nurses, acting as bridge between patients and health professionals. The nurses take care of patient compliance based on the referring cardiologist or general practitioner instructions, and monitor patient clinical parameters (weight and symptoms). The nurses use a software based interviews guide. Patient objectives are defined based on information regarding certain factors (health status, clinical signs, drugs), and this information will be collected by the nurses into a computerized database. This information is requested in strict patient accompanying perspective and therefore do not appear in the study results. The two data sets (data collected by nurses for patient management on one hand, and data collected by CST for the study on another hand) will never be connected and only study data from CST will be used to assess study criteria. To evaluate patient knowledge and needs, the nurses use active listening (open questions, paraphrasing, empathy and positive reinforcement). These techniques help them to customize information and messages and reinforce personalized care. Cordiva center nurses benefit from specialized training in motivational interviewing. They have also received dedicated training in cardiology and heart failure, mental state of heart failure patients, communication and patient education. Coherence of this informative approach is guaranteed on one hand because of the tools available for the nurses (binder, interview guide), and on the other hand because of the center organization itself: monitoring of patients insured by team of nurses, weekly debrief of recorded calls… EXTENSION PERIOD: The extension period will be conducted on an open, non-comparative basis. The aim of the extension period is to allow patients who wish to do so to follow the telemonitoring program until its marketing, regardless of the randomization group on initial inclusion in the study.

Official Title
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Optimisation de la Surveillance Ambulatoire Des Insuffisants CArdiaques Par Télécardiologie (OSICAT)

Conditions
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Chronic Heart Failure

Intervention / Treatment
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* Device: Telecardiology program


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Aged 18 years or older Men or women patient with heart failure having been hospitalized for cardiac decompensation during the last 12 months. Patient with access to a wireline telephone service or GPRS network. The patient is willing and able to sign an informed written consent Patient is insured under the social security system Exclusion Criteria: No available echocardiographic evaluation. BNP lower than 100pg/ml or NT-proBNP lower than 300pg/ml A prognosis of a life span of less than 12 months (apart from heart failure) Dialysis patients Heart transplant or cardiac assist devices Patients involved in inotropic treatment Patient doesn't have the necessary autonomy to use the equipment Patient enrolled in another clinical trial A pregnant or nursing woman, or patient of reproductive age who doesn't use contraceptives Patients under tutorship, curatorship or judicial protection Inclusion Criteria in the extension period: Participation in the open extension period is only offered to patients who participated in the comparative period of the study, did not withdraw prematurely from the latter and gave their free informed written consent to participate to the extension period.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Standard care<br>Standard follow-up, with conventional monitoring involving consultations and monitoring by their general practitioners or referring cardiologists | |
| Experimental: Tele-cardiology group<br>Telecardiology Program | Device: Telecardiology program<br>* The telecardiology program is a combination of a scale, a device asking the patients questions about the symptoms associated with their heart failure, and regular phone calls made by nurses. Automatic algorithms have been built-up in order to detect early the need for a hospitalization due to heart failure.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of All Causes Deaths and (Unplanned) Hospitalizations | Composite morbidity-mortality criterion combining the number of unplanned hospitalizations for any cause and deaths from any cause (adjudicated events) | 18 months | 
| Number of All Causes Deaths and (Unplanned) Hospitalizations in NYHA Class III or IV Patients | Composite morbidity-mortality criterion combining the number of unplanned hospitalizations for any cause and deaths from any cause (adjudicated events) | 18 months | 
| Number of All Causes Deaths and (Unplanned) Hospitalizations in Socially Isolated Patients | Composite morbidity-mortality criterion combining the number of unplanned hospitalizations for any cause and deaths from any cause (adjudicated events) | 18 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to First Unplanned Hospital Readmission or Death From Any Cause | Time to first unplanned hospital readmission (adjudicated events) or death from any cause, whichever occurred first in the subgroup of patients concerned | 18 months | 
| All Causes Deaths - Number of Patients Who Died From Any Cause | Number of patients who died from any cause | 18 months | 
| Time to Death From Any Cause | Time to death from any cause in the subgroup of patients who died | 18 months | 
| Number of Unplanned Hospitalizations for Any Cause | Number of unplanned hospitalizations for any cause (adjudicated events) | 18 months | 
| Number of Deaths and Unplanned Hospitalizations From Cardiovascular Cause | Composite morbidity-mortality criterion combining the number of cardiovascular unplanned hospitalizations and deaths from cardiovascular cause (adjudicated events) | 18 months | 
| Number of Unplanned Hospitalizations for Heart Failure | Number of unplanned hospitalizations for heart failure (adjudicated events) | 18 months | 
| Number of Unplanned Hospitalizations for Heart Failure in NYHA Class III or IV Patients | Number of unplanned hospitalizations for heart failure (adjudicated events) | 18 months | 
| Number of Unplanned Hospitalizations for Heart Failure in Socially Isolated Patients | Number of unplanned hospitalizations for heart failure (adjudicated events) | 18 months | 
| Time to First Unplanned Hospital Readmission for Heart Failure | Time to first unplanned hospital readmission for heart failure (adjudicated events) in the subgroup of patients concerned | 18 months | 
| Evolution of Quality of Life Assessed by Short Form-36 (SF-36) Questionnaire Scores | Evolution of Quality of Life assessed using absolute changes from baseline of each dimension and both component summary scores of SF-36 questionnaire. Indeed, SF-36 questionnaire include 8 general dimensions and 2 composite scores: the Physical Component Summary (PCS) and the Mental Component Summary (MCS). They are standardized to range between 0 and 100. Higher scores on all SF-36 scales indicate more favorable levels of functioning and less disability. Thus, higher Physical Functioning scores reflect higher physical functioning. Higher Role Physical scores reflect lower limitations due to physical problems. Higher Bodily Pain scores reflect less bodily pain. Higher General Health scores reflect higher general health perception. Higher Vitality scores reflect higher vitality. Higher Social Functioning scores reflect higher social functioning. Higher Role Emotional scores reflect lower limitations due to emotional problems. Higher Mental Health scores reflect better mental health. | Between baseline and 12 months and between baseline and 18 months | 
| Annualized Number of Unplanned Hospitalizations for Any Cause During the Extension Period | Annualized number of unplanned hospitalizations for any cause according to investigators in patients hospitalized at least once during the extension period | Extension period until the marketing of the telemonitoring program (from 2 to 16 months, with an average of 9.5 months) | 
| Number of Patients Who Died From Any Cause During the Extension Period | Number of patients who died from any cause during the extension period | Extension period until the marketing of the telemonitoring program (from 2 to 16 months, with an average of 9.5 months) | 
| Annualized Number of Unplanned Hospitalizations From Cardiovascular Cause During the Extension Period | Annualized number of unplanned hospitalizations from cardiovascular cause according to investigators in patients hospitalized at least once for cardiovascular cause during the extension period | Extension period until the marketing of the telemonitoring program (from 2 to 16 months, with an average of 9.5 months) | 
| Number of Patients Who Died From Cardiovascular Cause During the Extension Period | Number of patients who died from cardiovascular cause according to investigators during the extension period | Extension period until the marketing of the telemonitoring program (from 2 to 16 months, with an average of 9.5 months) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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E health, Telemonitoring, Prevention, Heart Failure, Cordiva, Telecardiology Program, Remote Patient Management, Education