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

Chronic Heart Failure Clinical Trial

— OSICAT  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02068118
• Other study ID #: 2012-A01672-41
• Status: Completed
• Phase: N/A
• Start date: May 2013
• Est. completion date: September 28, 2018

Study information

• Verified date: September 2021
• Source: CDM e-Health
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 990
• Est. completion date: September 28, 2018
• Est. primary completion date: December 20, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Chronic Heart Failure
• Heart Failure

Intervention

Device:
• Telecardiology program
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.

Locations

Country	Name	City	State
France	Centre Hospitalier Universitaire d'Amiens de Picardie	Amiens
France	Centre Hospitalier Universitaire d'Angers	Angers
France	Centre Hospitalier Général d'Auch	Auch	Midi-Pyrénées
France	Centre Hospitalier d'Avignon - Hospital Henri Duffaut	Avignon
France	Centre Hospitalier de Bastia	Bastia
France	Centre de réadaptation cardiovasculaire Midi-Gascogne	Beaumont de Lomagne	Midi-Pyrénées
France	Centre Hospitalier de Béziers	Beziers	Languedoc-Roussillon
France	Cabinet de Cardiologie - Pôle médical spécialisé	Béziers	Languedoc-Rousillon
France	Centre Hospitalier Universitaire Bordeaux - Hôpital Saint André	Bordeaux
France	Centre Hospitalier Universitaire de Brest	Brest
France	Centre Hospitalier Universitaire de Lyon - Hôpital Louis Pradel	Bron
France	Centre Hospitalier de Cahors	Cahors	Midi-Pyrénées
France	Centre Hospitalier Intercommunal Castres-Mazamet	Castres	Midi-Pyrénées
France	Clinique des Cèdres	Cornebarrieu	Midi-Pyrénées
France	Centre Hospitalier Universitaire François Mitterrand - Cardiologie 2 : Rythmologie et Insuffisance Cardiaque	Dijon
France	Centre Hospitalier Universitaire François Mitterrand - Cardiologie Générale	Dijon
France	Hôpital Léon Bérard	Hyères
France	Clinique de l'Union et du Vaurais	L'Union	Midi-Pyrénées
France	Centre Hospitalier Universitaire de Grenoble - Hôpital Antoine Michallon	La Tronche
France	Centre Hospitalier Universitaire de Limoges - Hôpital Dupuytren	Limoges
France	Centre Hospitalier Universitaire de Marseille - Hôpital Nord	Marseille
France	Clinique du Pont de Chaume	Montauban	Midi-Pyrénées
France	Centre Hospitalier Régional Universitaire de Montpellier	Montpellier
France	Cabinet libéral de Cardiologie du Muret	Muret	Midi-pyrenées
France	Centre Hospitalier Universitaire de Nice - Hôpital Pasteur	Nice
France	Centre Hospitalier Universitaire Caremeau	Nîmes
France	Centre Hospitalier de Pau	Pau
France	Centre Hospitalier de Périgueux	Périgueux
France	Centre Hospitalier Universitaire Bordeaux - Hôpital Haut Lévêque	Pessac
France	Centre Hospitalier de Rodez	Rodez	Midi-Pyrénées
France	Centre Hospitalier Intercommunal du Val d'Ariège	Saint-Jean-de-Verges	Midi-Pyrénées
France	Cabinet libéral	St Yrieix la Perche	Limousin
France	Polyclinique de l'Ormeau	Tarbes	Midi-Pyrénées
France	Centre Hospitalier Intercommunal de Toulon - La Seyne-sur-Mer	Toulon
France	Centre Hospitalier Universitaire de Toulouse - Hôpital de Rangueil	Toulouse	Midi-Pyrénées
France	Clinique Pasteur	Toulouse	Midi-Pyrénées
France	Hôpital Joseph Ducuing	Toulouse	Midi-Pyrénées
Martinique	Centre Hospitalier Universitaire de Martinique	Fort-de-France

Sponsors (1)

Lead Sponsor	Collaborator
CDM e-Health

Countries where clinical trial is conducted

France,  Martinique, 

References & Publications (1)

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, Tartière L, Ruidavets JB, Bongard V, Delval C, Lancman G, Pasche H, Ramirez-Gil JF, Pathak A; OSICAT Investiga — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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	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
Secondary	All Causes Deaths - Number of Patients Who Died From Any Cause	Number of patients who died from any cause	18 months
Secondary	Time to Death From Any Cause	Time to death from any cause in the subgroup of patients who died	18 months
Secondary	Number of Unplanned Hospitalizations for Any Cause	Number of unplanned hospitalizations for any cause (adjudicated events)	18 months
Secondary	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
Secondary	Number of Unplanned Hospitalizations for Heart Failure	Number of unplanned hospitalizations for heart failure (adjudicated events)	18 months
Secondary	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
Secondary	Number of Unplanned Hospitalizations for Heart Failure in Socially Isolated Patients	Number of unplanned hospitalizations for heart failure (adjudicated events)	18 months
Secondary	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
Secondary	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
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)