Clinical trial NCT01006746: Observational Study of Patient Comprehension, Perception, Fears and Appreciation Following Home-Monitoring Implementation
Official title: Evaluation and Description of Mutual Influences Between Patient Training, Perception and Adoption of Home-Monitoring Technology
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Defibrillators
Tachycardia
Keywords: Remote monitoring
Defibrillators
Survey
Indication for ICD (primary and secondary prevention)
Lead sponsor: Biotronik France
Sponsor class: INDUSTRY
Collaborators: name: Biotronik SE & Co. KG
First posted: 2009-11-03
Enrollment: 571
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients in 46 french investigational sites (hospitals and private clinics)

Brief summary: Describe the mutual influences between trainings realized in implantation centers, medico-technical knowledges, technical implementation, perception, fears and appreciation felt by the patients during Home Monitoring implementation.

Detailed description: 500 patients with an indication for ICD (primary and secondary prevention) will be included in the registry during a period of 12 months. For the survey, patients must answer two questionnaires.

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.

Eligibility criteria: Inclusion Criteria:

* Primo ICD implantation with Home-Monitoring system

Exclusion Criteria:

* NYHA Class IV
* 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

Primary outcomes:
measure: At 1 month: evaluation of centers training, knowledges and constraints of Home Monitoring implementation. At 6 months follow-up: observe and describe the behavior, the perception, the fears and the appreciation degree linked to this new technology
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Dijon
country: France
facility: CHU Le Bocage, Dijon
Study officials:
affiliation: CHU Dijon
name: Gabriel Laurent, Dr
role: PRINCIPAL_INVESTIGATOR
References: