Observational Study of Patient Comprehension, Perception, Fears and Appreciation Following Home-Monitoring Implementation
NCT ID: NCT01006746
Last Updated: 2014-03-04
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
571 participants
OBSERVATIONAL
2009-02-28
2011-08-31
Brief Summary
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Detailed Description
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The first one will assess the knowledges regarding Home-Monitoring which certainly depend on the time devoted to patient information during the implantation. This period of training is important and has a direct impact on the CardioMessenger use by the patient. Although the study is multicenter, the aim is not to evaluate or compare practices of each center for the information provided to patients. The objective is to find ways to improve this phase.
A second questionnaire was designed to observe the perception of Home-monitoring by the patient and thus to understand how this new technology is apprehended. This part is important because we must take in consideration patient point of view and expectations to improve care and offer new products or services.
A focus on patients' perception and appreciation may give a support to the elaboration of training and prevention strategies, the anticipation of the needs, and the improvement of the technology. All these improvements may eventually take part in the success of ICD treatment.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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ICD patient and Home Monitoring
Patients primo implanted with ICD
Remote monitoring by Home Monitoring system
Standard of care completed with remote monitoring for ICD patients follow-up
Interventions
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Remote monitoring by Home Monitoring system
Standard of care completed with remote monitoring for ICD patients follow-up
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* Pregnant women or women who plan to become pregnant during the trial
* Patient whose medical situation is not stable
* Presence of psychiatric illness, depression, anxiety disorders
* Presence of any disease, other than patient's cardiac disease, associated with reduced likelihood of survival for the duration of the trial, e.g. cancer, uraemia (urea \> 70mg/dl or creatinine \>3mg/dl, liver failure, etc.
* Age \< 18 years
* Patient unable to handle the CardioMessenger correctly
* The patient is not willing and able to comply with the protocol (i.e. unable to answer to the questionnaires)
* Change of residence expected during the study
* Participation in another clinical study
* Patient unwilling to sign patient informed consent
18 Years
ALL
No
Sponsors
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Biotronik SE & Co. KG
INDUSTRY
Biotronik France
INDUSTRY
Responsible Party
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Principal Investigators
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Gabriel Laurent, Dr
Role: PRINCIPAL_INVESTIGATOR
CHU Dijon
Locations
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CHU Le Bocage, Dijon
Dijon, , France
Countries
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Other Identifiers
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HS050
Identifier Type: -
Identifier Source: org_study_id
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