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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02068118
Recruitment Status : Completed
First Posted : February 21, 2014
Last Update Posted : December 3, 2019
Sponsor:
Information provided by (Responsible Party):
CDM e-Health

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.


Condition or disease Intervention/treatment Phase
Chronic Heart Failure Device: Telecardiology program Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 990 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Optimisation de la Surveillance Ambulatoire Des Insuffisants CArdiaques Par Télécardiologie (OSICAT)
Actual Study Start Date : May 2013
Actual Primary Completion Date : March 21, 2019
Actual Study Completion Date : March 21, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Failure

Arm Intervention/treatment
No Intervention: Standard care
Standard follow-up, with conventional monitoring involving consultations and monitoring by their general practitioners or referring cardiologists
Experimental: Tele-cardiology group
Telecardiology Program
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.





Primary Outcome Measures :
  1. All causes deaths and hospitalizations [ Time Frame: 18 months ]
    Composite morbidity-mortality criterion combining the number of hospitalizations (unplanned) for any cause and death from any cause during the 18-month comparative study follow-up period


Secondary Outcome Measures :
  1. Deaths and hospitalizations from cardiovascular cause (including from heart failure origin) [ Time Frame: 18 months ]
    Comparison of the number of events (deaths and hospitalizations of cardiovascular origin) between the two groups after 18 months

  2. Quality of life (SF36) [ Time Frame: 18 months ]
    Comparison of the means on inclusion and at 18 months of the SF36 quality of life scale scores in the two groups

  3. Cost analysis [ Time Frame: 18 months ]
    Difference of medical and non-medical direct costs and indirect costs between the two groups

  4. Societal acceptability for patients and healthcare professionals in the tele-cardiology group [ Time Frame: 18 months ]
    Assessment of the societal acceptability of management by telemonitoring for patients and healthcare professionals (interviews)

  5. Deaths and hospitalizations for any cause (extension period) [ Time Frame: Through study completion for extension period, an average of 1 year and four months ]
    Annualized number of hospitalizations and deaths for any cause occurring during the extension period for the patients who wished to participate in the latter

  6. Deaths and hospitalizations from cardiovascular cause (extension period) [ Time Frame: Through study completion for extension period, an average of 1 year and four months ]
    Annualized number of hospitalizations and deaths from cardiovascular cause occurring during the extension period for the patients who wished to participate in the latter



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02068118


Locations
Show Show 38 study locations
Sponsors and Collaborators
CDM e-Health
Investigators
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Principal Investigator: Michel GALINIER, MD-PhD Rangueil University Hospital - Toulouse
Principal Investigator: Atul PATHAK, MD-PhD Clinique Pasteur
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Responsible Party: CDM e-Health
ClinicalTrials.gov Identifier: NCT02068118    
Other Study ID Numbers: 2012-A01672-41
First Posted: February 21, 2014    Key Record Dates
Last Update Posted: December 3, 2019
Last Verified: December 2019
Keywords provided by CDM e-Health:
E health
Telemonitoring
Prevention
Heart Failure
Cordiva
Telecardiology Program
Remote Patient Management
Education
Additional relevant MeSH terms:
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Heart Failure
Heart Diseases
Cardiovascular Diseases