Observational Study of Patient Comprehension, Perception, Fears and Appreciation Following Home-M… (NCT01006746) | Clinical Trial Compass
CompletedNot Applicable
Observational Study of Patient Comprehension, Perception, Fears and Appreciation Following Home-Monitoring Implementation
France571 participantsStarted 2009-02
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
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