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

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.

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Key information

Conditions

Defibrillators Arrhythmias, Cardiac Cardiac Conduction System Disease Cardiovascular Diseases Heart Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Tachycardia

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

CHU Le Bocage, Dijon

Dijon, 21079, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Remote monitoring by Home Monitoring system

Other

Standard of care completed with remote monitoring for ICD patients follow-up

Other names: ICD: Lumax family (single-chamber, dual-chamber and CRT ICDs), Transmitter: cardioMessenger II or CardioMessenger IIs

Primary outcomes

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

Time frame: 6 months

Sponsors and collaborators

Lead sponsor

Biotronik France

Industry

Collaborators

Biotronik SE & Co. KG

Registry information

Official study title

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

Acronym: Educ@t

Important dates

Study start: 2009
Primary completion: 2011
Study completion: 2011
First posted: Nov 3, 2009
Registry last updated: Mar 4, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed