DefibrillatorsEduc@tNCT01006746
Observational Study of Patient Comprehension, Perception, Fears and Appreciation Following Home-Monitoring Implementation
An observational study of Defibrillators and Tachycardia, run by Biotronik France at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Defibrillators, Tachycardia
- What is being tested?
- Remote monitoring by Home Monitoring system
- How many people
- 571 participants
- Where
- 1 siteFrance
- Study dates
- Feb 2009to Aug 2011
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients in 46 french investigational sites (hospitals and private clinics)
Who may be able to join
- Primo ICD implantation with Home-Monitoring system
Who cannot join
- 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
Show all 11Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation and Description of Mutual Influences Between Patient Training, Perception and Adoption of Home-Monitoring Technology
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.
Read the 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
- Being tested
- Remote monitoring by Home Monitoring system
- Keywords
- Remote monitoring, Defibrillators, Survey, Indication for ICD (primary and secondary prevention)
- Medical subject headings
- Tachycardia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Remote monitoring by Home Monitoring systemOther
Also called ICD: Lumax family (single-chamber, dual-chamber and CRT ICDs), Transmitter: cardioMessenger II or CardioMessenger IIs
Standard of care completed with remote monitoring for ICD patients follow-up
| Study group | Role | What they receive |
|---|---|---|
| ICD patient and Home Monitoring | Patients primo implanted with ICD Receives: Other: Remote monitoring by Home Monitoring system |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Nov 2009 (estimated)
- Study startFeb 2009
- Primary completionApr 2011
- Study completionAug 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DefibrillatorsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 571 participants (actual)
Sponsor and investigators
- Lead sponsor
- Biotronik France
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Biotronik SE & Co. KG
- Responsible party
- Sponsor
- Investigators
- Gabriel Laurent, Dr, Principal investigator, CHU Dijon
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01006746
- Sponsor's protocol ID
- HS050
- Acronym
- Educ@t
- Status last verified
- Mar 2014
- First submitted
- 1 Nov 2009
- Last updated
- 4 Mar 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation and Description of Mutual Influences Between Patient Training, Perception and Adoption of Home-Monitoring Technology
- ClinicalTrials.gov ID
- NCT01006746
- Acronym / sponsor ID
- Educ@t / HS050
- Conditions
- Defibrillators, Tachycardia
- Keywords
- Remote monitoring, Defibrillators, Survey, Indication for ICD (primary and secondary prevention)
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 571 participants (actual)
- Lead sponsor
- Biotronik FranceIndustry (pharma, biotech, devices)
- Collaborators
- Biotronik SE & Co. KG
- Study start
- Feb 2009
- Primary completion
- Apr 2011 (actual)
- Study completion
- Aug 2011 (actual)
- First posted
- 3 Nov 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ICD patient and Home Monitoring | – | Other: Remote monitoring by Home Monitoring systemPatients primo implanted with ICD |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients in 46 french investigational sites (hospitals and private clinics)
Key inclusion criteria (1 listed)
- Primo ICD implantation with Home-Monitoring system
Key exclusion criteria (11 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Remote monitoring by Home Monitoring systemAlso: ICD: Lumax family (single-chamber, dual-chamber and CRT ICDs), Transmitter: cardioMessenger II or CardioMessenger IIsStandard of care completed with remote monitoring for ICD patients follow-up | Other | ICD patient and Home Monitoring |
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Mar 2014.
Related trials for Defibrillators
Active, not recruiting
Assessment of Combined CCM and ICD Device in HFrEF
Heart Failure, Heart Failure With Reduced Ejection Fraction
RecruitingObservational study
Product Performance Report: Evaluate Long-term Reliability & Performance of Medtronic Marketed Cardiac Therapy Products
Arrhythmia, Bradycardia
Not yet recruiting
Compression-Only Versus Standard Basic Life Support Training in Nursing Students
Cardiopulmonary Resuscitation, Out-of-Hospital Cardiac Arrest
Recruiting
Evaluating a Digital Aid to Improve ICD Decisions
Shared Decision-making
Recruiting
Heart@Home Safety and Efficacy of Hospital-at-Home Care Versus Standard Hospitalization in Cardiac Patients
Myocardial Infarction, Myocarditis Acute
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gabriel Laurent, Dr principal investigator
CHU Dijon
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Defibrillators and Tachycardia, run by Biotronik France at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Mar 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome 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 (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Mar 2014.