NCT01006746

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

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 571 (actual)
• Sponsor: Biotronik France · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Defibrillators
• Tachycardia

Interventions

Type	Name	Description
OTHER	Remote monitoring by Home Monitoring system	Standard of care completed with remote monitoring for ICD patients follow-up

Timeline

• Start date: 2009-02-01
• Primary completion: 2011-04-01
• Completion: 2011-08-01
• First posted: 2009-11-03
• Last updated: 2014-03-04

Locations

1 site across 1 country: France