Optimization of the Ambulatory Monitoring for Patients With Heart Failure by Tele-cardiology (OSICAT)
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|ClinicalTrials.gov Identifier: NCT02068118|
Recruitment Status : Completed
First Posted : February 21, 2014
Last Update Posted : December 3, 2019
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|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||990 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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|
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
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.
- 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
- 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
- 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
- Cost analysis [ Time Frame: 18 months ]Difference of medical and non-medical direct costs and indirect costs between the two groups
- 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)
- 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
- 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
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
|Principal Investigator:||Michel GALINIER, MD-PhD||Rangueil University Hospital - Toulouse|
|Principal Investigator:||Atul PATHAK, MD-PhD||Clinique Pasteur|