International Normalised Ratio Evaluation by Generalist Practitioners in Full-time Care Establish… (NCT02614573) | Clinical Trial Compass
CompletedNot Applicable
International Normalised Ratio Evaluation by Generalist Practitioners in Full-time Care Establishments for the Elderly
France31 participantsStarted 2016-02
Plain-language summary
The main objective of this study is to evaluate, for a 6-month observation period, the concordance in terms of clinical decision making concerning therapeutic adjustment as determined by a weekly capillary International Normalised Ratio (INR) monitoring strategy versus the usual strategy in a population of dependent elderly people in nursing homes, treated with anti-vitamin K (AVK).
Who can participate
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:
* The patient resides at the establishment for the dependent elderly (nursing home (EHPAD)) in Pont-Saint-Esprit, France
* The patient must be insured or beneficiary of a health insurance plan
* The patient treated with vitamin K antagonist for over six months
* The patient must have given his/her informed and signed consent
* For adults under guardianship, the legal guardian must have given free and informed consent and signed the consent
Exclusion Criteria:
* The patient is under judicial protection
* The general practitioner in charge of the patient at the EHPAD does not want to participate in the study
* It is impossible to correctly inform the patient, or his/her legal guardian
* The patient, or his/her legal guardian, refuses to sign the consent
* The patient is participating in another interventional study, or has participated in another interventional study within the past three months
* The patient is in an exclusion period determined by a previous study
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
Is the capillary INR concordant with the venous INR ? yes/no