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Weekly Monitoring Strategy of Capillary INR Versus Monthly Monitoring Strategy of Venous INR in Elderly Patients in a Nursing Home. (INR-CAP)

Primary Purpose

Atrial Fibrillation, Deep Vein Thrombosis, Stroke

Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Weekly monitoring using the capillary International Normalised Ratio strategy
Sponsored by
Centre Hospitalier Universitaire de Nīmes
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Atrial Fibrillation focused on measuring Atrial Fibrillation, Thrombosis, Stroke, Elderly

Eligibility Criteria

60 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Arm Type

No Intervention

Experimental

Arm Label

CONTROL GROUP

INTERVENTIONAL GROUP

Arm Description

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.

Outcomes

Primary Outcome Measures

Interventional group : Time in Therapeutic Range using the capillary International Normalized Range weekly monitoring strategy
The CoaguChek INRange® device will be used. This small, portable monitoring medical device has already been used in several studies and can be used in hospital beds. After washing the patient's hands, the nurse will insert the strip test into the device, massaging the fingers and hand to activate blood circulation, and perform a capillary puncture using the lancet. An 8 μL drop of blood is required and must be deposited on the test strip less than 180 seconds after inserting the strip into the device and within 15 seconds after the start of blood drop formation. The International Normalized Ratio is displayed within one minute. When the nurse has the result, he/she will complete the VKA dose software (i.e. puncture number, strip number, current VKA type, current VKA dose, INRc value). The software will give the next puncture day and the correct VKA dose. If the INR > 4, there will be an alert and the nurse will have to contact the general practitioner for the rest of the procedure.
Interventional group : Time in Therapeutic Range using the capillary International Normalized Range weekly monitoring strategy
The CoaguChek INRange® device will be used. This small, portable monitoring medical device has already been used in several studies and can be used in hospital beds. After washing the patient's hands, the nurse will insert the strip test into the device, massaging the fingers and hand to activate blood circulation, and perform a capillary puncture using the lancet. An 8 μL drop of blood is required and must be deposited on the test strip less than 180 seconds after inserting the strip into the device and within 15 seconds after the start of blood drop formation. The International Normalized Ratio is displayed within one minute. When the nurse has the result, he/she will complete the VKA dose software (i.e. puncture number, strip number, current VKA type, current VKA dose, INRc value). The software will give the next puncture day and the correct VKA dose. If the INR > 4, there will be an alert and the nurse will have to contact the general practitioner for the rest of the procedure.
Control group : Time in Therapeutic Range using the venous International Normalized Range monthly monitoring strategy
The Time in Therapeutic Range will be measured as a percentage
Control group : Time in Therapeutic Range using the venous International Normalized Range monthly monitoring strategy
The Time in Therapeutic Range will be measured as a percentage

Secondary Outcome Measures

Interventional group: venous thromboembolic events occurring during the 6-month monitoring period.
In the group being monitored weekly with the CoaguChek INRange® device, the number of venous thromboembolic events occurring during the 6-month monitoring period will be recorded.
Interventional group: haemorrhagic events occurring during the 6-month monitoring period.
In the group being monitored weekly with the CoaguChek INRange® device, the number of haemorrhagic events occurring during the 6-month monitoring period will be recorded.
Control group: venous thromboembolic events occurring with the monthly venous monitoring strategy.
The number of venous thromboembolic events occurring during the 6-month monitoring period will be recorded.
Control group: haemorrhagic events occurring with the monthly venous monitoring strategy.
The number of haemorrhagic events occurring during the 6-month monitoring period will be recorded.
Interventional group : Time in Therapeutic Range using the capillary International Normalized Range weekly monitoring strategy in patients ≤90.
Interventional group : Time in Therapeutic Range using the capillary International Normalized Range weekly monitoring strategy in patients ≤90.
Interventional group : Time in Therapeutic Range using the capillary International Normalized Range weekly monitoring strategy in patients >90.
Interventional group : Time in Therapeutic Range using the capillary International Normalized Range weekly monitoring strategy in patients >90.
Control group: Time in Therapeutic Range using the monthly venous monitoring strategy in patients ≤90.
Control group: Time in Therapeutic Range using the monthly venous monitoring strategy in patients ≤90.
Control group: Time in Therapeutic Range using the monthly venous monitoring strategy in patients >90.
Control group: Time in Therapeutic Range using the monthly venous monitoring strategy in patients >90.
Interventional group : Cost-consequences study on the weekly INRc monitoring strategy
Cost in terms of hospitalisations (due to haemorrhagic, ischemic and thromboembolic events) using the weekly INRc monitoring strategy will be studied including the cost of the device (equipment and consumables) from the public health insurance's perspective and the nursing time from the point of view of the health care institution.
Interventional group : Budget impact analysis on the weekly INRc monitoring strategy
Estimation of the financial consequences in terms of hospitalisations (due to haemorrhagic, ischemic and thromboembolic events) of adopting the new intervention in France
Control group : Cost-consequences study on the monthly venous monitoring strategy
Cost in terms of hospitalisations (due to haemorrhagic, ischemic and thromboembolic events) using the monthly venous monitoring strategy will be studied from the public health insurance's perspective and the nursing time from the point of view of the health care institution.
Control group : Budget impact analysis on the monthly venous monitoring strategy
An estimation will be made of the financial consequences in terms of hospitalisations (due to haemorrhagic, ischemic and thromboembolic events.

Full Information

First Posted
September 27, 2022
Last Updated
July 4, 2023
Sponsor
Centre Hospitalier Universitaire de Nīmes
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1. Study Identification

Unique Protocol Identification Number
NCT05561244
Brief Title
Weekly Monitoring Strategy of Capillary INR Versus Monthly Monitoring Strategy of Venous INR in Elderly Patients in a Nursing Home.
Acronym
INR-CAP
Official Title
Assessment of Weekly Monitoring Strategy of Capillary INR Versus Monthly Monitoring Strategy of Venous INR in Elderly Patients in a Nursing Home: Multicentre Randomised Cluster Trial.
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
November 18, 2022 (Actual)
Primary Completion Date
January 1, 2024 (Anticipated)
Study Completion Date
January 1, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Hospitalier Universitaire de Nīmes

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
This primary care study aims to compare the "time in therapeutic range" (TTR) of two strategies for monitoring the international normalized ratio (INR) over 6 months in nursing homes. The population consists of frail elderly patients for whom Anti-Vitamin K treatments are frequent, and who are consequently more prone to embolic and hemorrhagic complications.
Detailed Description
Biological monitoring is essential to avoid strokes, deep vein thrombosis and hemorrhage. Generally speaking, this consists of a venous sampling for the international normalized ratio (INR), for which the therapeutic target is approximately 2.5 (tolerance range between 2 and 3) for atrial fibrillation (AF) and deep vein thrombosis (DVT). INR values below 2 indicate high risks of a stroke or DVT, whereas INR values over 3 refer to high risks of hemorrhage. INR monitoring requires monthly follow-ups or even more frequently if the HAS BLED score is ≥ 3. One parameter used to evaluate the benefit/risk ratio is the "time in therapeutic range" (TTR), referring to the time spent within the INR therapeutic target (INR between 2 and 3 for patients with Atrial Fibrillation/ Deep Vein Thrombosis). It is calculated using the Rosendaal method. According to the "European Society of Cardiology" guidelines, the minimum threshold necessary for a good risk/benefit ratio is 70%. In other countries, it has been shown that the TTR is higher: 61% in Canada, 64.4% in Spain, 68.9% in Italy and 76.2% in Sweden. Moreover, TTR determines the benefit/risk ratio of the treatment, which means that patients with a TTR < 60% have more than 2% absolute total mortality per patient-year compared to patients with TTR > 60%. As for the pilot study (Manuscript accepted in August 2019 in the Journal of Internal Medicine ), we expect approximately half the patients to be aged over 90. Patients will be recruited in nursing homes where they are monitored by nurses and care quality managers who are responsible for ensuring compliance with good clinical practices. This limits the risk of non-compliance with preanalytical venous INR conditions. Eighteen percent of subjects over 85 are treated with vitamin-K antagonists (VKA). For elderly patients with atrial fibrillation (AF) or deep venous thrombosis (DVT), stroke prophylaxis is a real clinical challenge. VKA treatments are indicated for the prevention of strokes in patients with Atrial Fibrillation, DVT or those who have received heart valve implants. VKAs have a narrow therapeutic range: if they are under-dosed, the risk of embolism (AVC and DVT) is high, whereas in the event of an overdose, the risk of bleeding is high. Given the annual incidence of severe hemorrhage (3-5%), the risk of a hemorrhage is their main side effect. The incidence of brain hemorrhages is 0.6 per 100 patient-years, for gastrointestinal bleeding it is 1.0 per 100 patient-years, and the risk of other serious bleeding is 1.4 per 100 patient-years. This risk of bleeding is usually assessed using the HAS-BLED score. The risk of hemorrhage is 4.2% per year in patients over 75 versus 1.7% per year for those under 75. Following the results of a pilot study (manuscript accepted in the Journal of Internal Medecine), the hypothesis is that a weekly monitoring strategy for capillary INR should increase the TTR of nursing home patients by 12% compared to the usual monitoring by venous INR, resulting in a decrease of thrombotic or hemorrhagic events.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atrial Fibrillation, Deep Vein Thrombosis, Stroke
Keywords
Atrial Fibrillation, Thrombosis, Stroke, Elderly

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
This study is interventional, prospective, comparative, superiority, multicentric, randomised by cluster, in closed cohort.
Masking
Care Provider
Allocation
Randomized
Enrollment
128 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
CONTROL GROUP
Arm Type
No Intervention
Arm Description
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.
Arm Title
INTERVENTIONAL GROUP
Arm Type
Experimental
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Weekly monitoring using the capillary International Normalised Ratio strategy
Intervention Description
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.
Primary Outcome Measure Information:
Title
Interventional group : Time in Therapeutic Range using the capillary International Normalized Range weekly monitoring strategy
Description
The CoaguChek INRange® device will be used. This small, portable monitoring medical device has already been used in several studies and can be used in hospital beds. After washing the patient's hands, the nurse will insert the strip test into the device, massaging the fingers and hand to activate blood circulation, and perform a capillary puncture using the lancet. An 8 μL drop of blood is required and must be deposited on the test strip less than 180 seconds after inserting the strip into the device and within 15 seconds after the start of blood drop formation. The International Normalized Ratio is displayed within one minute. When the nurse has the result, he/she will complete the VKA dose software (i.e. puncture number, strip number, current VKA type, current VKA dose, INRc value). The software will give the next puncture day and the correct VKA dose. If the INR > 4, there will be an alert and the nurse will have to contact the general practitioner for the rest of the procedure.
Time Frame
Day 0
Title
Interventional group : Time in Therapeutic Range using the capillary International Normalized Range weekly monitoring strategy
Description
The CoaguChek INRange® device will be used. This small, portable monitoring medical device has already been used in several studies and can be used in hospital beds. After washing the patient's hands, the nurse will insert the strip test into the device, massaging the fingers and hand to activate blood circulation, and perform a capillary puncture using the lancet. An 8 μL drop of blood is required and must be deposited on the test strip less than 180 seconds after inserting the strip into the device and within 15 seconds after the start of blood drop formation. The International Normalized Ratio is displayed within one minute. When the nurse has the result, he/she will complete the VKA dose software (i.e. puncture number, strip number, current VKA type, current VKA dose, INRc value). The software will give the next puncture day and the correct VKA dose. If the INR > 4, there will be an alert and the nurse will have to contact the general practitioner for the rest of the procedure.
Time Frame
Month 6
Title
Control group : Time in Therapeutic Range using the venous International Normalized Range monthly monitoring strategy
Description
The Time in Therapeutic Range will be measured as a percentage
Time Frame
Day 0
Title
Control group : Time in Therapeutic Range using the venous International Normalized Range monthly monitoring strategy
Description
The Time in Therapeutic Range will be measured as a percentage
Time Frame
Month 6
Secondary Outcome Measure Information:
Title
Interventional group: venous thromboembolic events occurring during the 6-month monitoring period.
Description
In the group being monitored weekly with the CoaguChek INRange® device, the number of venous thromboembolic events occurring during the 6-month monitoring period will be recorded.
Time Frame
Day 0 to Month 6
Title
Interventional group: haemorrhagic events occurring during the 6-month monitoring period.
Description
In the group being monitored weekly with the CoaguChek INRange® device, the number of haemorrhagic events occurring during the 6-month monitoring period will be recorded.
Time Frame
Day 0 to Month 6
Title
Control group: venous thromboembolic events occurring with the monthly venous monitoring strategy.
Description
The number of venous thromboembolic events occurring during the 6-month monitoring period will be recorded.
Time Frame
Day 0 to Month 6
Title
Control group: haemorrhagic events occurring with the monthly venous monitoring strategy.
Description
The number of haemorrhagic events occurring during the 6-month monitoring period will be recorded.
Time Frame
Day 0 to Month 6
Title
Interventional group : Time in Therapeutic Range using the capillary International Normalized Range weekly monitoring strategy in patients ≤90.
Time Frame
Day 0
Title
Interventional group : Time in Therapeutic Range using the capillary International Normalized Range weekly monitoring strategy in patients ≤90.
Time Frame
Month 6
Title
Interventional group : Time in Therapeutic Range using the capillary International Normalized Range weekly monitoring strategy in patients >90.
Time Frame
Day 0
Title
Interventional group : Time in Therapeutic Range using the capillary International Normalized Range weekly monitoring strategy in patients >90.
Time Frame
Month 6
Title
Control group: Time in Therapeutic Range using the monthly venous monitoring strategy in patients ≤90.
Time Frame
Day 0
Title
Control group: Time in Therapeutic Range using the monthly venous monitoring strategy in patients ≤90.
Time Frame
Month 6
Title
Control group: Time in Therapeutic Range using the monthly venous monitoring strategy in patients >90.
Time Frame
Day 0
Title
Control group: Time in Therapeutic Range using the monthly venous monitoring strategy in patients >90.
Time Frame
Month 6
Title
Interventional group : Cost-consequences study on the weekly INRc monitoring strategy
Description
Cost in terms of hospitalisations (due to haemorrhagic, ischemic and thromboembolic events) using the weekly INRc monitoring strategy will be studied including the cost of the device (equipment and consumables) from the public health insurance's perspective and the nursing time from the point of view of the health care institution.
Time Frame
Month 6
Title
Interventional group : Budget impact analysis on the weekly INRc monitoring strategy
Description
Estimation of the financial consequences in terms of hospitalisations (due to haemorrhagic, ischemic and thromboembolic events) of adopting the new intervention in France
Time Frame
Year 3
Title
Control group : Cost-consequences study on the monthly venous monitoring strategy
Description
Cost in terms of hospitalisations (due to haemorrhagic, ischemic and thromboembolic events) using the monthly venous monitoring strategy will be studied from the public health insurance's perspective and the nursing time from the point of view of the health care institution.
Time Frame
Month 6
Title
Control group : Budget impact analysis on the monthly venous monitoring strategy
Description
An estimation will be made of the financial consequences in terms of hospitalisations (due to haemorrhagic, ischemic and thromboembolic events.
Time Frame
Year 3

10. Eligibility

Sex
All
Minimum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
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's target INR range is 2,5 [2-3] or 3 [2,5-3,5] 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%
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
David COSTA, Dr.
Phone
+336.61.43.39.30
Email
drcostadavid@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Anissa MEGZARI
Phone
+33466684236
Email
drc@chu-nimes.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Chloé SIKIRDJI, Dr.
Organizational Affiliation
CHU de Nîmes (NUH) Place du Pr. Debré 30029 NIMES Cedex9
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Karen ZERBIB, Dr.
Organizational Affiliation
EHPAD "Korian Mas de Lauze", 17, Chemin du puits de Louiset 30900 NIMES
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Patrick DUTILLEUL, Dr.
Organizational Affiliation
EHPAD Résidence "l'Accueil", 75 Rue Louis Aragon, 30600 VAUVERT
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Alain BROUSSE, Dr.
Organizational Affiliation
EHPAD "Les Jardins de l'Escalette",1 Avenue Marechal Foch 30700 UZES
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Elodie MILLION, Dr.
Organizational Affiliation
EHPAD Malbosc, 345 Avenue de Fes 34090 MONTPELLIER
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Philippe SERAYET, Dr.
Organizational Affiliation
EHPAD "Sophia la Capitelle", 57 Rue Henri Pitot 30840 MEYNES
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Thierry CORNILLE, Dr.
Organizational Affiliation
EHPAD "Docteur Henry Granet", 23 Chemin de la grave 30390 ARAMON +EHPAD "Les oliviers", 420 Chem. de Ceserac 30490 MONTFRIN
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Gilles SEYLER, Dr.
Organizational Affiliation
EHPAD "les Caprésianes",111 r. Alphonse Daudet 30210 CABRIERES, "Villa Rediciano", 6 r. du 19 Mars 1962, 30129 REDESSAN
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Gil MEYRAND, Dr.
Organizational Affiliation
EHPAD "Les Jasses", 155 Rue des Clapas 30730 FONS
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Philippe VERNEDE, Dr.
Organizational Affiliation
EHPAD "Jacques Saurin", Avenue des Loisirs 30190 MOUSSAC
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Katia BRUNEL, Dr.
Organizational Affiliation
EHPAD "Jean Lasserre", Chem. des Camisards 30360 EUZET
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Georges ALVADO, Dr.
Organizational Affiliation
EHPAD "Les Capitelles", Impasse de la Thebaide 30620 BERNIS
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Christine DE TADDEO, Dr.
Organizational Affiliation
EHPAD Serre-Cavalier - Sites 1 & 2, Rue Pitot Prolongée 30000 Nîmes
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Marie-Hélène GRAS-JAEN, Dr.
Organizational Affiliation
EHPAD ORPEA "Château notre dame", Pl. du Château 30730 PARIGNARGUES
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Marc BORGHERO, Dr.
Organizational Affiliation
EHPAD Samdo Rochebelle, 17 Rue des Châtaigniers 30100 ALES
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Anne-Laure VITEAU, Dr.
Organizational Affiliation
EHPAD "Les 5 sens Garons", Carieire dis Amourous 30128 GARONS
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Abderrahmane ALOUI, Dr.
Organizational Affiliation
EHPAD Korian "Les Meunières" Place Denfert Rochereau 34400 LUNEL
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Pierre MERLE, Dr.
Organizational Affiliation
EHPAD du Centre hospitalier de Langogne, Clos de la Tuilerie 48300 LANGOGNE
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Marc DUPUIS, Dr.
Organizational Affiliation
EHPAD Saint-Vincent de Paul,16 Rue de l'Égalité 30240 LE GRAU-DU-ROI
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Julie LANO, Dr.
Organizational Affiliation
EHPAD "Coté Canal", 116 Rue Jacques Cœur 30220 AIGUES-MORTES
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Florence CHAPOUTOUT, Dr.
Organizational Affiliation
EHPAD "La belle viste", 149 Rue du parc BP 2 34980 ST GELY DU FESC
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Nicole GARCIA, Dr.
Organizational Affiliation
EHPAD "Les monts d'Aurelle",Parc Euromedecine 1632 Rue St Priest 34097 MONTPELLIER CEDEX 5
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Robert LE STUM, Dr.
Organizational Affiliation
Maison de Retraite Protestante, 2252 Rte de Mende 34090 MONTPELLIER
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Marie-Aude BONNEL, Dr.
Organizational Affiliation
EHPAD "les Dominicaines",2 Rue du Thirondel 34190 GANGES
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Adrien ROMARY, Dr.
Organizational Affiliation
EHPAD "Résidence les Magnans", 85 Rue du Dix Neuf Mars 1962, 30520 SAINT-MARTIN-DE-VALGALGUES
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Mélanie BADIN, Dr.
Organizational Affiliation
68 rue du charron 30310 VERGEZE
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Murielle GLONDU-LASSIS, Dr.
Organizational Affiliation
SCM Médicale St Bauzille de Putois 1193 avenue du chemin neuf 34190 ST BAUZILLE DE PUTOIS
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Hermine SAGUY, Dr.
Organizational Affiliation
2 rue Ibn Sinaï Dit Avicenne 66330 Cabestany
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Anne-Sophie ODOUL, Dr.
Organizational Affiliation
392 Boulevard Pedro de Luna 34070 MONTPELLIER
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Victor LIVIOT, Dr.
Organizational Affiliation
EHPAD Léon Bourgeois 1 Place du Puig Tarrous 66740 VILLELONGUE DELS MONTS
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Philippe Roure, Dr.
Organizational Affiliation
EHPAD La Pinède 110 chemin des cades 30310 Vergeze
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Franck Raschilas, Dr.
Organizational Affiliation
Centre Bellevue-CHU Montpellier 1 Pl. Jean Baumel 34090 Montpellier
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Chloé Loeffler, Dr.
Organizational Affiliation
EHPAD La Murelle Avenue de la Gare 34480 - LAURENS
Official's Role
Principal Investigator
Facility Information:
Facility Name
EHPAD " Coté Canal "
City
Aigues-mortes
State/Province
Gard
ZIP/Postal Code
30220
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Julie LANO, Dr.
Phone
+334 66 80 06 06
Email
mco.cotecanal@mutuelle-mbv.fr
Facility Name
EHPAD "Samdo Rochebelle"
City
Alès
State/Province
Gard
ZIP/Postal Code
30100
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Marc BORGHERO, Dr.
Phone
04 66 34 76 76
Email
marc.borghero@samdo.fr
Facility Name
EHPAD "Docteur Henry Granet"
City
Aramon
State/Province
Gard
ZIP/Postal Code
30390
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Thierry CORNILLE, Dr.
Phone
+334 66 02 23 80
Email
t.cornille@chuzes.fr
Facility Name
EHPAD "Les Capitelles"
City
Bernis
State/Province
Gard
ZIP/Postal Code
30620
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Georges ALVADO
Phone
+334 66 71 70 50
Email
medecin-bernis@lesopalines.fr
Facility Name
EHPAD Résidence "Les Caprésianes"
City
Cabrières
State/Province
Gard
ZIP/Postal Code
30210
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Gilles SEYLER, Dr.
Phone
+334 66 37 53 00
Email
g.seyler@chuzes.fr
Facility Name
EHPAD "Jean Lasserre"
City
Euzet
State/Province
Gard
ZIP/Postal Code
30360
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Katia BRUNEL, Dr.
Phone
+336 25 14 02 83
Email
k.brunel@chuzes.fr
Facility Name
EHPAD "Les Jasses"
City
Fons
State/Province
Gard
ZIP/Postal Code
30730
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Gil MEYRAND, Dr.
Phone
+334 66 74 66 70
Email
g.meyrand@chuzes.fr
Facility Name
EHPAD "Les 5 sens Garons"
City
Garons
State/Province
Gard
ZIP/Postal Code
30128
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Anne-Laure VITEAU, Dr.
Email
dir-nimes-poulx@domusvi.com
Facility Name
EHPAD Saint-Vincent de Paul
City
Le Grau-du-Roi
State/Province
Gard
ZIP/Postal Code
30240
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Marc DUPUIS, Dr.
Email
ehpad.stvincent@ville-legrauduroi.fr
Facility Name
EHPAD "Sophia la Capitelle"
City
Meynes
State/Province
Gard
ZIP/Postal Code
30840
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Philippe SERAYET, Dr.
Phone
+334 66 01 04 40
Email
philippe.serayet07@gmail.com
Facility Name
EHPAD "Les oliviers"
City
Montfrin
State/Province
Gard
ZIP/Postal Code
30490
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Thierry CORNILLE, Dr.
Phone
+334 66 02 23 80
Email
t.cornille@chuzes.fr
Facility Name
EHPAD "Jacques Saurin"
City
Moussac
State/Province
Gard
ZIP/Postal Code
30190
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Philippe VERNEDE, Dr.
Phone
+334 66 20 82 75
Email
p.vernede@chuzes.fr
Facility Name
Nîmes University Hospital, Place du Pr. Debré
City
Nimes
State/Province
Gard
ZIP/Postal Code
30029
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
David COSTA, Dr.
Phone
+336.61.43.39.30
Email
drcostadavid@gmail.com
First Name & Middle Initial & Last Name & Degree
Annissa MEGZARI
Phone
+33466684236
Email
drc@chu-nimes.fr
Facility Name
EHPAD "Ma Maison"
City
Nîmes
State/Province
Gard
ZIP/Postal Code
30000
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
David COSTA, Dr.
Phone
+33609881745
Email
drcostadavid@gmail.com
Facility Name
EHPAD Serre-Cavalier Sites 1 and 2
City
Nîmes
State/Province
Gard
ZIP/Postal Code
30000
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Christine DE TADDEO, Dr.
Phone
+334 66 68 34 75
Email
sandra.duvnjak@chu-nimes.fr
Facility Name
EHPAD ORPEA "Château Notre Dame"
City
Parignargues
State/Province
Gard
ZIP/Postal Code
30730
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Marie-Hélène GRAS-JEAN, Dr.
Phone
+334 66 02 78 80
Email
m.jaen-gras@orpea.net
Facility Name
EHPAD "Villa Rediciano"
City
Redessan
State/Province
Gard
ZIP/Postal Code
30129
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Gilles SEYLER, Dr.
Phone
+334 66 37 53 00
Email
g.seyler@chuzes.fr
Facility Name
EHPAD "Résidence les Magnans"
City
Saint-martin-de-valgalgues
State/Province
Gard
ZIP/Postal Code
30520
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Adrien ROMARY, Dr.
Phone
+334 66 52 90 90
Facility Name
EHPAD "Les Jardins de l'Escalette"
City
Uzes
State/Province
Gard
ZIP/Postal Code
30700
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Alain BROUSSE, Dr.
Phone
+334 66 63 72 57
Email
a.brousse@chuzes.fr
Facility Name
EHPAD Résidence "l'Accueil"
City
Vauvert
State/Province
Gard
ZIP/Postal Code
30600
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Patrick DUTILLEUL, Dr.
Phone
+336 03 51 11 17
Email
dutilleul.p@wanadoo.fr
Facility Name
EHPAD Korian "Les Meunières"
City
Lunel
State/Province
Herault
ZIP/Postal Code
34400
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Abderrahmane ALOUI, Dr.
Phone
04 67 83 27 80
Email
abderrahmane.aloui@korian.fr
Facility Name
EHPAD Malbosc
City
Montpellier
State/Province
Herault
ZIP/Postal Code
34090
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Elodie MILLION, Dr.
Phone
+334 99 63 72 32
Email
elomega@free.fr
Facility Name
SCM Médicale St Bauzille de Putois
City
St Bauzille de Putois
State/Province
Herault
ZIP/Postal Code
34190
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Murielle GLONDU-LASSIS, Dr.
Email
mglondulassis@hotmail.fr
Facility Name
EHPAD "Les Dominicaines"
City
Ganges
State/Province
Hérault
ZIP/Postal Code
34190
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Marie-Aude BONNEL, dr.
Phone
+337 85 91 69 62
Email
dr.bonnel.marieaude@gmail.com
Facility Name
Maison de Retraite Protestante
City
Montpellier
State/Province
Hérault
ZIP/Postal Code
34090
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Robert LE STUM, Dr.
Phone
+334 67 63 64 30
Email
x.guido@mrp34.org
Facility Name
EHPAD "Les Monts d'Aurelle"
City
Montpellier
State/Province
Hérault
ZIP/Postal Code
34097
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nicole GARCIA, Dr.
Phone
+334 99 74 75 00
Email
n.garcia@orpea.net
Facility Name
EHPAD "La BELLE Viste"
City
St Gely Du Fesc
State/Province
Hérault
ZIP/Postal Code
34980
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Florence CHAPOUTOUT, Dr.
Phone
+334 67 60 17 00
Email
florence.chapoutot@belleviste-stgely.fr
Facility Name
EHPAD du centre hospitalier de Langogne
City
Langogne
State/Province
Lozere
ZIP/Postal Code
48300
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Pierre MERLE, Dr.
Phone
+334 66 69 78 00
Email
dr.pierre.merle@orange.fr
Facility Name
EHPAD La Murelle
City
Laurens
ZIP/Postal Code
34480
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Chloé Loeffler, Dr.
Phone
04 67 90 69 94
Email
loeffler.c@outlook.fr
Facility Name
Centre Bellevue-CHU Montpellier
City
Montpellier
ZIP/Postal Code
34090
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Franck Raschilas, Dr.
Phone
04 67 33 90 05
Facility Name
EHPAD "Korian Mas de Lauze"
City
Nîmes
ZIP/Postal Code
30900
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Karen ZERBIB, Dr.
Phone
+334 66 05 00 22
Email
karen.zerbib-popiolek@korian.fr
Facility Name
EHPAD La Pinède
City
Vergeze
ZIP/Postal Code
30310
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Philippe Roure, Dr.
Phone
04 66 35 76 00
Email
philippe.roure6@orange.fr
Facility Name
EHPAD Léon Bourgeois
City
Villelongue Dels Monts
ZIP/Postal Code
66740
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Victor LIVIOT, Dr.
Phone
04.68.68.71.32
Email
v.liviot@adpep66.org

12. IPD Sharing Statement

Learn more about this trial

Weekly Monitoring Strategy of Capillary INR Versus Monthly Monitoring Strategy of Venous INR in Elderly Patients in a Nursing Home.

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