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

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.

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.

Study Overview

• Status: Terminated
• Conditions: Stroke; Atrial Fibrillation; Deep Vein Thrombosis
• Intervention / Treatment: Device: Weekly monitoring using the capillary International Normalised Ratio strategy

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.

• Study Type: Interventional
• Enrollment (Actual): 45
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Laurens, France, 34480
    • EHPAD La Murelle
  • Montpellier, France, 34090
    • Centre Bellevue-CHU Montpellier
  • Nîmes, France, 30900
    • EHPAD "Korian Mas de Lauze"
  • Vergèze, France, 30310
    • EHPAD La Pinède
  • Vilallonga dels Monts, France, 66740
    • EHPAD Léon Bourgeois
  • GARD
    • Aigues-Mortes, GARD, France, 30220
      • EHPAD " Coté Canal "
    • Alès, GARD, France, 30100
      • EHPAD "Samdo Rochebelle"
    • Aramon, GARD, France, 30390
      • EHPAD "Docteur Henry Granet"
    • Bernis, GARD, France, 30620
      • EHPAD "Les Capitelles"
    • Cabrières, GARD, France, 30210
      • EHPAD Résidence "Les Caprésianes"
    • Euzet, GARD, France, 30360
      • EHPAD "Jean Lasserre"
    • Fons, GARD, France, 30730
      • EHPAD "Les Jasses"
    • Garons, GARD, France, 30128
      • EHPAD "Les 5 sens Garons"
    • Le Grau-du-Roi, GARD, France, 30240
      • EHPAD Saint-Vincent de Paul
    • Meynes, GARD, France, 30840
      • EHPAD "Sophia la Capitelle"
    • Montfrin, GARD, France, 30490
      • EHPAD "Les oliviers"
    • Moussac, GARD, France, 30190
      • EHPAD "Jacques Saurin"
    • Nîmes, GARD, France, 30000
      • EHPAD "Ma Maison"
    • Nîmes, GARD, France, 30000
      • EHPAD Serre-Cavalier Sites 1 and 2
    • Parignargues, GARD, France, 30730
      • EHPAD ORPEA "Château Notre Dame"
    • Redessan, GARD, France, 30129
      • EHPAD "Villa Rediciano"
    • Saint-Martin-de-Valgalgues, GARD, France, 30520
      • EHPAD "Résidence les Magnans"
    • Uzès, GARD, France, 30700
      • EHPAD "Les Jardins de l'Escalette"
    • Vauvert, GARD, France, 30600
      • EHPAD Résidence "l'Accueil"
  • Gard
    • Nîmes, Gard, France, 30029
      • Nîmes University Hospital, Place du Pr. Debré
  • HERAULT
    • Lunel, HERAULT, France, 34400
      • EHPAD Korian "Les Meunières"
    • Montpellier, HERAULT, France, 34090
      • EHPAD Malbosc
    • Saint-Bauzille-de-Putois, HERAULT, France, 34190
      • SCM Médicale St Bauzille de Putois
  • Hérault
    • Ganges, Hérault, France, 34190
      • EHPAD "Les Dominicaines"
    • Montpellier, Hérault, France, 34090
      • Maison de Retraite Protestante
    • Montpellier, Hérault, France, 34097
      • EHPAD "Les Monts d'Aurelle"
    • Saint-Gély-du-Fesc, Hérault, France, 34980
      • EHPAD "La BELLE Viste"
  • LOZERE
    • Langogne, LOZERE, France, 48300
      • EHPAD du centre hospitalier de Langogne

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 60 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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%

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: CONTROL 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.
Experimental: INTERVENTIONAL GROUP; 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.	Device: Weekly monitoring using the capillary International Normalised Ratio strategy; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Over 6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Venous Thromboembolic Events Occurring During the 6-month Monitoring Period.	Venous thromboembolic events (yes / no) occurring during the 6-month monitoring period will be recorded for each patient.	Day 0 to Month 6
Haemorrhagic Events Occurring During the 6-month Monitoring Period.	Haemorrhagic events (yes / no) occurring during the 6-months monitoring period will be recorded for each patient.	Day 0 to Month 6
Time in Therapeutic Range Using International Normalized Range Weekly Monitoring Strategy in Patients ≤90.	Percentage of Time in Therapeutic Range using International Normalized Range weekly monitoring strategy in patients ≤90.	Day 0 to 6 months
Time in Therapeutic Range Using the International Normalized Range Weekly Monitoring Strategy in Patients >90.	Time in Therapeutic Range using the International Normalized Range weekly monitoring strategy in patients >90.	Day 0 to 6 months
Cost-consequences Study on the Weekly INRc Monitoring Strategy	Cost in terms of hospitalisations (due to haemorrhagic, ischemic and thromboembolic events) 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.	Day 0 to 6 months
Agreement Between Capillary and Veinous Measures	Assess, over the 6-month observation period, the agreement between INRc and INRv	Over 6 months

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire de Nīmes
• Investigators: Principal Investigator: Chloé SIKIRDJI, Dr., CHU de Nîmes (NUH) Place du Pr. Debré 30029 NIMES Cedex9; Principal Investigator: Karen ZERBIB, Dr., EHPAD "Korian Mas de Lauze", 17, Chemin du puits de Louiset 30900 NIMES; Principal Investigator: Patrick DUTILLEUL, Dr., EHPAD Résidence "l'Accueil", 75 Rue Louis Aragon, 30600 VAUVERT; Principal Investigator: Alain BROUSSE, Dr., EHPAD "Les Jardins de l'Escalette",1 Avenue Marechal Foch 30700 UZES; Principal Investigator: Elodie MILLION, Dr., EHPAD Malbosc, 345 Avenue de Fes 34090 MONTPELLIER; Principal Investigator: Philippe SERAYET, Dr., EHPAD "Sophia la Capitelle", 57 Rue Henri Pitot 30840 MEYNES; Principal Investigator: Thierry CORNILLE, Dr., EHPAD "Docteur Henry Granet", 23 Chemin de la grave 30390 ARAMON +EHPAD "Les oliviers", 420 Chem. de Ceserac 30490 MONTFRIN; Principal Investigator: Gilles SEYLER, Dr., EHPAD "les Caprésianes",111 r. Alphonse Daudet 30210 CABRIERES, "Villa Rediciano", 6 r. du 19 Mars 1962, 30129 REDESSAN; Principal Investigator: Gil MEYRAND, Dr., EHPAD "Les Jasses", 155 Rue des Clapas 30730 FONS; Principal Investigator: Philippe VERNEDE, Dr., EHPAD "Jacques Saurin", Avenue des Loisirs 30190 MOUSSAC; Principal Investigator: Katia BRUNEL, Dr., EHPAD "Jean Lasserre", Chem. des Camisards 30360 EUZET; Principal Investigator: Marie-Hélène GRAS-JAEN, Dr., EHPAD ORPEA "Château notre dame", Pl. du Château 30730 PARIGNARGUES; Principal Investigator: Marc BORGHERO, Dr., EHPAD Samdo Rochebelle, 17 Rue des Châtaigniers 30100 ALES; Principal Investigator: Abderrahmane ALOUI, Dr., EHPAD Korian "Les Meunières" Place Denfert Rochereau 34400 LUNEL; Principal Investigator: Pierre MERLE, Dr., EHPAD du Centre hospitalier de Langogne, Clos de la Tuilerie 48300 LANGOGNE; Principal Investigator: Marc DUPUIS, Dr., EHPAD Saint-Vincent de Paul,16 Rue de l'Égalité 30240 LE GRAU-DU-ROI; Principal Investigator: Julie LANO, Dr., EHPAD "Coté Canal", 116 Rue Jacques Cœur 30220 AIGUES-MORTES; Principal Investigator: Florence CHAPOUTOUT, Dr., EHPAD "La belle viste", 149 Rue du parc BP 2 34980 ST GELY DU FESC; Principal Investigator: Nicole GARCIA, Dr., EHPAD "Les monts d'Aurelle",Parc Euromedecine 1632 Rue St Priest 34097 MONTPELLIER CEDEX 5; Principal Investigator: Robert LE STUM, Dr., Maison de Retraite Protestante, 2252 Rte de Mende 34090 MONTPELLIER; Principal Investigator: Marie-Aude BONNEL, Dr., EHPAD "les Dominicaines",2 Rue du Thirondel 34190 GANGES; Principal Investigator: Mélanie BADIN, Dr., 68 rue du charron 30310 VERGEZE; Principal Investigator: Murielle GLONDU-LASSIS, Dr., SCM Médicale St Bauzille de Putois 1193 avenue du chemin neuf 34190 ST BAUZILLE DE PUTOIS; Principal Investigator: Georges ALVADO, Dr., EHPAD "Les Capitelles", Impasse de la Thebaide 30620 BERNIS; Principal Investigator: Christine DE TADDEO, Dr., EHPAD Serre-Cavalier - Sites 1 & 2, Rue Pitot Prolongée 30000 Nîmes; Principal Investigator: Anne-Laure VITEAU, Dr., EHPAD "Les 5 sens Garons", Carieire dis Amourous 30128 GARONS; Principal Investigator: Adrien ROMARY, Dr., EHPAD "Résidence les Magnans", 85 Rue du Dix Neuf Mars 1962, 30520 SAINT-MARTIN-DE-VALGALGUES; Principal Investigator: Hermine SAGUY, Dr., 2 rue Ibn Sinaï Dit Avicenne 66330 Cabestany; Principal Investigator: Anne-Sophie ODOUL, Dr., 392 Boulevard Pedro de Luna 34070 MONTPELLIER; Principal Investigator: Victor LIVIOT, Dr., EHPAD Léon Bourgeois 1 Place du Puig Tarrous 66740 VILLELONGUE DELS MONTS; Principal Investigator: Philippe Roure, Dr., EHPAD La Pinède 110 chemin des cades 30310 Vergeze; Principal Investigator: Franck Raschilas, Dr., Centre Bellevue-CHU Montpellier 1 Pl. Jean Baumel 34090 Montpellier; Principal Investigator: Chloé Loeffler, Dr., EHPAD La Murelle Avenue de la Gare 34480 - LAURENS

Study record dates

Study Major Dates

• Study Start (Actual): November 18, 2022
• Primary Completion (Actual): December 13, 2024
• Study Completion (Actual): December 13, 2024

Study Registration Dates

• First Submitted: September 27, 2022
• First Submitted That Met QC Criteria: September 27, 2022
• First Posted (Actual): September 30, 2022

Study Record Updates

• Last Update Posted (Actual): March 3, 2026
• Last Update Submitted That Met QC Criteria: February 11, 2026
• Last Verified: December 1, 2024

More Information

Terms related to this study

• Keywords: Elderly; Stroke; Atrial Fibrillation; Thrombosis
• Additional Relevant MeSH Terms: Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Pathologic Processes; Heart Diseases; Arrhythmias, Cardiac; Embolism and Thrombosis; Pathological Conditions, Signs and Symptoms; Stroke; Thrombosis; Venous Thrombosis; Atrial Fibrillation
• Other Study ID Numbers: 2022-A00516-37

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No