Observational Study of Patient Comprehension, Perception, Fears and Appreciation Following Home-Monitoring Implementation

Tachycardia Clinical Trial

— Educ@t  

Official title:

Evaluation and Description of Mutual Influences Between Patient Training, Perception and Adoption of Home-Monitoring Technology

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01006746
• Other study ID #: HS050
• Status: Completed
• Phase: N/A
• First received: November 1, 2009
• Last updated: March 3, 2014
• Start date: February 2009
• Est. completion date: August 2011

Study information

• Verified date: March 2014
• Source: Biotronik France
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 571
• Est. completion date: August 2011
• Est. primary completion date: April 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Defibrillators
• Tachycardia

Intervention

Other:
• Remote monitoring by Home Monitoring system
Standard of care completed with remote monitoring for ICD patients follow-up

Locations

Country	Name	City	State
France	CHU Le Bocage, Dijon	Dijon

Sponsors (2)

Lead Sponsor	Collaborator
Biotronik France	Biotronik SE & Co. KG

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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		6 months	No