Observational Study of Patient Comprehension, Perception, Fears and Appreciation Following Home-Monitoring Implementation (Educ@t)

This study has been completed.
Sponsor:
Collaborator:
Biotronik SE & Co. KG
Information provided by (Responsible Party):
Biotronik France
ClinicalTrials.gov Identifier:
NCT01006746
First received: November 1, 2009
Last updated: March 3, 2014
Last verified: March 2014
  Purpose

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.


Condition Intervention
Defibrillators
Tachycardia
Other: Remote monitoring by Home Monitoring system

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Evaluation and Description of Mutual Influences Between Patient Training, Perception and Adoption of Home-Monitoring Technology

Further study details as provided by Biotronik France:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Enrollment: 571
Study Start Date: February 2009
Study Completion Date: August 2011
Primary Completion Date: April 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
ICD patient and Home Monitoring
Patients primo implanted with ICD
Other: Remote monitoring by Home Monitoring system
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

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Patients in 46 french investigational sites (hospitals and private clinics)

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01006746

Locations
France
CHU Le Bocage, Dijon
Dijon, France, 21079
Sponsors and Collaborators
Biotronik France
Biotronik SE & Co. KG
Investigators
Principal Investigator: Gabriel Laurent, Dr CHU Dijon
  More Information

No publications provided

Responsible Party: Biotronik France
ClinicalTrials.gov Identifier: NCT01006746     History of Changes
Other Study ID Numbers: HS050
Study First Received: November 1, 2009
Last Updated: March 3, 2014
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by Biotronik France:
Remote monitoring
Defibrillators
Survey
Indication for ICD (primary and secondary prevention)

Additional relevant MeSH terms:
Tachycardia
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on October 19, 2014