Clinical trial NCT02068118: Optimization of the Ambulatory Monitoring for Patients With Heart Failure by Tele-cardiology
Official title: Optimisation de la Surveillance Ambulatoire Des Insuffisants CArdiaques Par Télécardiologie (OSICAT)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Heart Failure
Keywords: E health
Telemonitoring
Prevention
Heart Failure
Cordiva
Telecardiology Program
Remote Patient Management
Education
Lead sponsor: CDM e-Health
Sponsor class: INDUSTRY
First posted: 2014-02-21
Enrollment: 990
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: 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: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Number of All Causes Deaths and (Unplanned) Hospitalizations
timeFrame: 18 months
measure: Number of All Causes Deaths and (Unplanned) Hospitalizations in NYHA Class III or IV Patients
timeFrame: 18 months
measure: Number of All Causes Deaths and (Unplanned) Hospitalizations in Socially Isolated Patients
timeFrame: 18 months
Secondary outcomes:
measure: Time to First Unplanned Hospital Readmission or Death From Any Cause
timeFrame: 18 months
measure: All Causes Deaths - Number of Patients Who Died From Any Cause
timeFrame: 18 months
measure: Time to Death From Any Cause
timeFrame: 18 months
measure: Number of Unplanned Hospitalizations for Any Cause
timeFrame: 18 months
measure: Number of Deaths and Unplanned Hospitalizations From Cardiovascular Cause
timeFrame: 18 months
measure: Number of Unplanned Hospitalizations for Heart Failure
timeFrame: 18 months
measure: Number of Unplanned Hospitalizations for Heart Failure in NYHA Class III or IV Patients
timeFrame: 18 months
measure: Number of Unplanned Hospitalizations for Heart Failure in Socially Isolated Patients
timeFrame: 18 months
measure: Time to First Unplanned Hospital Readmission for Heart Failure
timeFrame: 18 months
measure: Evolution of Quality of Life Assessed by Short Form-36 (SF-36) Questionnaire Scores
timeFrame: Between baseline and 12 months and between baseline and 18 months
measure: Annualized Number of Unplanned Hospitalizations for Any Cause During the Extension Period
timeFrame: Extension period until the marketing of the telemonitoring program (from 2 to 16 months, with an average of 9.5 months)
measure: Number of Patients Who Died From Any Cause During the Extension Period
timeFrame: Extension period until the marketing of the telemonitoring program (from 2 to 16 months, with an average of 9.5 months)
measure: Annualized Number of Unplanned Hospitalizations From Cardiovascular Cause During the Extension Period
timeFrame: Extension period until the marketing of the telemonitoring program (from 2 to 16 months, with an average of 9.5 months)
measure: Number of Patients Who Died From Cardiovascular Cause During the Extension Period
timeFrame: Extension period until the marketing of the telemonitoring program (from 2 to 16 months, with an average of 9.5 months)
Other outcomes:
Locations:
city: Béziers
country: France
facility: Cabinet de Cardiologie - Pôle médical spécialisé
state: Languedoc-Rousillon
city: Beziers
country: France
facility: Centre Hospitalier de Béziers
state: Languedoc-Roussillon
city: St Yrieix la Perche
country: France
facility: Cabinet libéral
state: Limousin
city: Muret
country: France
facility: Cabinet libéral de Cardiologie du Muret
state: Midi-pyrenées
city: Auch
country: France
facility: Centre Hospitalier Général d'Auch
state: Midi-Pyrénées
city: Beaumont de Lomagne
country: France
facility: Centre de réadaptation cardiovasculaire Midi-Gascogne
state: Midi-Pyrénées
city: Cahors
country: France
facility: Centre Hospitalier de Cahors
state: Midi-Pyrénées
city: Castres
country: France
facility: Centre Hospitalier Intercommunal Castres-Mazamet
state: Midi-Pyrénées
city: Cornebarrieu
country: France
facility: Clinique des Cèdres
state: Midi-Pyrénées
city: L'Union
country: France
facility: Clinique de l'Union et du Vaurais
state: Midi-Pyrénées
city: Montauban
country: France
facility: Clinique du Pont de Chaume
state: Midi-Pyrénées
city: Rodez
country: France
facility: Centre Hospitalier de Rodez
state: Midi-Pyrénées
city: Saint-Jean-de-Verges
country: France
facility: Centre Hospitalier Intercommunal du Val d'Ariège
state: Midi-Pyrénées
city: Tarbes
country: France
facility: Polyclinique de l'Ormeau
state: Midi-Pyrénées
city: Toulouse
country: France
facility: Centre Hospitalier Universitaire de Toulouse - Hôpital de Rangueil
state: Midi-Pyrénées
city: Toulouse
country: France
facility: Clinique Pasteur
state: Midi-Pyrénées
city: Toulouse
country: France
facility: Hôpital Joseph Ducuing
state: Midi-Pyrénées
city: Amiens
country: France
facility: Centre Hospitalier Universitaire d'Amiens de Picardie
city: Angers
country: France
facility: Centre Hospitalier Universitaire d'Angers
city: Avignon
country: France
facility: Centre Hospitalier d'Avignon - Hospital Henri Duffaut
city: Bastia
country: France
facility: Centre Hospitalier de Bastia
city: Bordeaux
country: France
facility: Centre Hospitalier Universitaire Bordeaux - Hôpital Saint André
city: Brest
country: France
facility: Centre Hospitalier Universitaire de Brest
city: Bron
country: France
facility: Centre Hospitalier Universitaire de Lyon - Hôpital Louis Pradel
city: Dijon
country: France
facility: Centre Hospitalier Universitaire François Mitterrand - Cardiologie 2 : Rythmologie et Insuffisance Cardiaque
city: Dijon
country: France
facility: Centre Hospitalier Universitaire François Mitterrand - Cardiologie Générale
city: Hyères
country: France
facility: Hôpital Léon Bérard
city: La Tronche
country: France
facility: Centre Hospitalier Universitaire de Grenoble - Hôpital Antoine Michallon
city: Limoges
country: France
facility: Centre Hospitalier Universitaire de Limoges - Hôpital Dupuytren
city: Marseille
country: France
facility: Centre Hospitalier Universitaire de Marseille - Hôpital Nord
city: Montpellier
country: France
facility: Centre Hospitalier Régional Universitaire de Montpellier
city: Nice
country: France
facility: Centre Hospitalier Universitaire de Nice - Hôpital Pasteur
city: Nîmes
country: France
facility: Centre Hospitalier Universitaire Caremeau
city: Pau
country: France
facility: Centre Hospitalier de Pau
city: Pessac
country: France
facility: Centre Hospitalier Universitaire Bordeaux - Hôpital Haut Lévêque
city: Périgueux
country: France
facility: Centre Hospitalier de Périgueux
city: Toulon
country: France
facility: Centre Hospitalier Intercommunal de Toulon - La Seyne-sur-Mer
city: Fort-de-France
country: Martinique
facility: Centre Hospitalier Universitaire de Martinique
Study officials:
affiliation: Rangueil University Hospital - Toulouse
name: Michel GALINIER, MD-PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Clinique Pasteur
name: Atul PATHAK, MD-PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Galinier M, Roubille F, Berdague P, Brierre G, Cantie P, Dary P, Ferradou JM, Fondard O, Labarre JP, Mansourati J, Picard F, Ricci JE, Salvat M, Tartiere L, Ruidavets JB, Bongard V, Delval C, Lancman G, Pasche H, Ramirez-Gil JF, Pathak A; OSICAT Investigators. Telemonitoring versus standard care in heart failure: a randomised multicentre trial. Eur J Heart Fail. 2020 Jun;22(6):985-994. doi: 10.1002/ejhf.1906. Epub 2020 Jun 15.