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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
Results First Posted : October 26, 2021
Last Update Posted : October 26, 2021
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 : December 20, 2017
Actual Study Completion Date : September 28, 2018

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. Number of All Causes Deaths and (Unplanned) Hospitalizations [ Time Frame: 18 months ]
    Composite morbidity-mortality criterion combining the number of unplanned hospitalizations for any cause and deaths from any cause (adjudicated events)

  2. Number of All Causes Deaths and (Unplanned) Hospitalizations in NYHA Class III or IV Patients [ Time Frame: 18 months ]
    Composite morbidity-mortality criterion combining the number of unplanned hospitalizations for any cause and deaths from any cause (adjudicated events)

  3. Number of All Causes Deaths and (Unplanned) Hospitalizations in Socially Isolated Patients [ Time Frame: 18 months ]
    Composite morbidity-mortality criterion combining the number of unplanned hospitalizations for any cause and deaths from any cause (adjudicated events)


Secondary Outcome Measures :
  1. Time to First Unplanned Hospital Readmission or Death From Any Cause [ Time Frame: 18 months ]
    Time to first unplanned hospital readmission (adjudicated events) or death from any cause, whichever occurred first in the subgroup of patients concerned

  2. All Causes Deaths - Number of Patients Who Died From Any Cause [ Time Frame: 18 months ]
    Number of patients who died from any cause

  3. Time to Death From Any Cause [ Time Frame: 18 months ]
    Time to death from any cause in the subgroup of patients who died

  4. Number of Unplanned Hospitalizations for Any Cause [ Time Frame: 18 months ]
    Number of unplanned hospitalizations for any cause (adjudicated events)

  5. Number of Deaths and Unplanned Hospitalizations From Cardiovascular Cause [ Time Frame: 18 months ]
    Composite morbidity-mortality criterion combining the number of cardiovascular unplanned hospitalizations and deaths from cardiovascular cause (adjudicated events)

  6. Number of Unplanned Hospitalizations for Heart Failure [ Time Frame: 18 months ]
    Number of unplanned hospitalizations for heart failure (adjudicated events)

  7. Number of Unplanned Hospitalizations for Heart Failure in NYHA Class III or IV Patients [ Time Frame: 18 months ]
    Number of unplanned hospitalizations for heart failure (adjudicated events)

  8. Number of Unplanned Hospitalizations for Heart Failure in Socially Isolated Patients [ Time Frame: 18 months ]
    Number of unplanned hospitalizations for heart failure (adjudicated events)

  9. Time to First Unplanned Hospital Readmission for Heart Failure [ Time Frame: 18 months ]
    Time to first unplanned hospital readmission for heart failure (adjudicated events) in the subgroup of patients concerned

  10. Evolution of Quality of Life Assessed by Short Form-36 (SF-36) Questionnaire Scores [ Time Frame: Between baseline and 12 months and between baseline and 18 months ]
    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.

  11. Annualized Number of Unplanned Hospitalizations for Any Cause During the Extension Period [ Time Frame: 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 for any cause according to investigators in patients hospitalized at least once during the extension period

  12. Number of Patients Who Died From Any Cause During the Extension Period [ Time Frame: 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

  13. Annualized Number of Unplanned Hospitalizations From Cardiovascular Cause During the Extension Period [ Time Frame: 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 according to investigators in patients hospitalized at least once for cardiovascular cause during the extension period

  14. Number of Patients Who Died From Cardiovascular Cause During the Extension Period [ Time Frame: 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 according to investigators during the extension period



Information from the National Library of Medicine

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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
  Study Documents (Full-Text)

Documents provided by CDM e-Health:
Study Protocol  [PDF] September 6, 2018
Statistical Analysis Plan  [PDF] March 21, 2019

Publications of Results:
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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
Results First Posted: October 26, 2021
Last Update Posted: October 26, 2021
Last Verified: September 2021
Keywords provided by CDM e-Health:
E health
Telemonitoring
Prevention
Heart Failure
Cordiva
Telecardiology Program
Remote Patient Management
Education
Additional relevant MeSH terms:
Layout table for MeSH terms
Heart Failure
Heart Diseases
Cardiovascular Diseases