Weekly Monitoring Strategy of Capillary INR Versus Monthly Monitoring Strategy of Venous INR in Elderly Patients in a Nursing Home. (INR-CAP)
Atrial Fibrillation, Deep Vein Thrombosis, Stroke
About this trial
This is an interventional prevention trial for Atrial Fibrillation focused on measuring Atrial Fibrillation, Thrombosis, Stroke, Elderly
Eligibility Criteria
Inclusion Criteria: The population corresponds to nursing homes patients treated with Vitamin K Antagonists for more than six months, because INRc cannot be used while anticoagulation treatment is being introduced.
- The patient or his/her trusted-person/legal representative/tutor signed the consent form
- The patient is an adult and lives in a nursing home
- The patient has been on treatment with Vitamin K Antagonists for more than six months
- The patient is treated for Atrial Fibrillation or Deep Vein Thrombosis
- The patient is affiliated to a health insurance program
Exclusion Criteria:
- The patient is participating in a Type 1 interventional study involving human beings (Jardé law).
- The patient is in an exclusion period determined by another study
- The patient is under safeguard of justice.
- It is not possible to give the patient (or his/her trusted-person/legal representative/tutor) informed information.
- The patient has a short life expectancy (< 1 month)
- The Karnofky index is ≤ 20%
- The patient has a heart valve implant
Sites / Locations
- EHPAD " Coté Canal "Recruiting
- EHPAD "Samdo Rochebelle"
- EHPAD "Docteur Henry Granet"Recruiting
- EHPAD "Les Capitelles"Recruiting
- EHPAD Résidence "Les Caprésianes"Recruiting
- EHPAD "Jean Lasserre"Recruiting
- EHPAD "Les Jasses"Recruiting
- EHPAD "Les 5 sens Garons"
- EHPAD Saint-Vincent de PaulRecruiting
- EHPAD "Sophia la Capitelle"Recruiting
- EHPAD "Les oliviers"Recruiting
- EHPAD "Jacques Saurin"Recruiting
- Nîmes University Hospital, Place du Pr. DebréRecruiting
- EHPAD "Ma Maison"Recruiting
- EHPAD Serre-Cavalier Sites 1 and 2Recruiting
- EHPAD ORPEA "Château Notre Dame"Recruiting
- EHPAD "Villa Rediciano"Recruiting
- EHPAD "Résidence les Magnans"Recruiting
- EHPAD "Les Jardins de l'Escalette"Recruiting
- EHPAD Résidence "l'Accueil"Recruiting
- EHPAD Korian "Les Meunières"Recruiting
- EHPAD MalboscRecruiting
- SCM Médicale St Bauzille de PutoisRecruiting
- EHPAD "Les Dominicaines"Recruiting
- Maison de Retraite ProtestanteRecruiting
- EHPAD "Les Monts d'Aurelle"Recruiting
- EHPAD "La BELLE Viste"Recruiting
- EHPAD du centre hospitalier de LangogneRecruiting
- EHPAD La Murelle
- Centre Bellevue-CHU Montpellier
- EHPAD "Korian Mas de Lauze"Recruiting
- EHPAD La Pinède
- EHPAD Léon Bourgeois
Arms of the Study
Arm 1
Arm 2
No Intervention
Experimental
CONTROL GROUP
INTERVENTIONAL GROUP
Control group (n = 16 nursing homes, 64 patients): Patients will be monitored as usual using the Venous International Normalised Ratio strategy. Practices will not be changed (i.e. prospective observation of real-life practices; according to recommendations, at least 1 Venous International Normalised Ratio per month will usually be performed) and patients will not receive any supplementary intervention specific to the trial. A reminder of good International Normalised Ratio practices will be provided to nurses and prescribers.
Intervention group (n = 16 nursing homes, 64 patients): Patients in the interventional group will be monitored using the capillary International Normalised Ratio strategy every week, and more often if the International Normalised Ratio is not in the therapeutic target. Venous International Normalised Ratio punctures will also be performed as described for the control group in order to calculate the Time in Therapeutic Range equivalently in both groups. Specific training in handling the device and the dose adjustment protocol will be provided to nurses and prescribers.