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

NCT05561244 | Terminated Results

• 1 other identifier: 2022-A00516-37
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 33

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.

Conditions

Atrial Fibrillation; Deep Vein Thrombosis; Stroke

Keywords

Atrial Fibrillation; Thrombosis; Stroke; Elderly

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• Venous Thromboembolic Events Occurring During the 6-month Monitoring Period.

  Day 0 to Month 6

• Haemorrhagic Events Occurring During the 6-month Monitoring Period.

  Day 0 to Month 6

• 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.

  Day 0 to 6 months

• Cost-consequences Study on the Weekly INRc Monitoring Strategy

  Day 0 to 6 months

Study Arms (2)

CONTROL GROUP

NO INTERVENTION

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.

INTERVENTIONAL GROUP

EXPERIMENTAL

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

Interventions

Weekly monitoring using the capillary International Normalised Ratio strategy DEVICE

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.

INTERVENTIONAL GROUP

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• The patient is participating in a Type 1 interventional study involving human beings (Jardé law).
• 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%

Sponsors & Collaborators

• Centre Hospitalier Universitaire de Nīmes: lead

Study Sites (33)

EHPAD " Coté Canal "

Aigues-Mortes, GARD, 30220, France

Location

EHPAD "Samdo Rochebelle"

Alès, GARD, 30100, France

Location

EHPAD "Docteur Henry Granet"

Aramon, GARD, 30390, France

Location

EHPAD "Les Capitelles"

Bernis, GARD, 30620, France

Location

EHPAD Résidence "Les Caprésianes"

Cabrières, GARD, 30210, France

Location

EHPAD "Jean Lasserre"

Euzet, GARD, 30360, France

Location

EHPAD "Les Jasses"

Fons, GARD, 30730, France

Location

EHPAD "Les 5 sens Garons"

Garons, GARD, 30128, France

Location

EHPAD Saint-Vincent de Paul

Le Grau-du-Roi, GARD, 30240, France

Location

EHPAD "Sophia la Capitelle"

Meynes, GARD, 30840, France

Location

EHPAD "Les oliviers"

Montfrin, GARD, 30490, France

Location

EHPAD "Jacques Saurin"

Moussac, GARD, 30190, France

Location

EHPAD "Ma Maison"

Nîmes, GARD, 30000, France

Location

EHPAD Serre-Cavalier Sites 1 and 2

Nîmes, GARD, 30000, France

Location

Nîmes University Hospital, Place du Pr. Debré

Nîmes, Gard, 30029, France

Location

EHPAD ORPEA "Château Notre Dame"

Parignargues, GARD, 30730, France

Location

EHPAD "Villa Rediciano"

Redessan, GARD, 30129, France

Location

EHPAD "Résidence les Magnans"

Saint-Martin-de-Valgalgues, GARD, 30520, France

Location

EHPAD "Les Jardins de l'Escalette"

Uzès, GARD, 30700, France

Location

EHPAD Résidence "l'Accueil"

Vauvert, GARD, 30600, France

Location

EHPAD Korian "Les Meunières"

Lunel, HERAULT, 34400, France

Location

EHPAD Malbosc

Montpellier, HERAULT, 34090, France

Location

SCM Médicale St Bauzille de Putois

Saint-Bauzille-de-Putois, HERAULT, 34190, France

Location

EHPAD "Les Dominicaines"

Ganges, Hérault, 34190, France

Location

Maison de Retraite Protestante

Montpellier, Hérault, 34090, France

Location

EHPAD "Les Monts d'Aurelle"

Montpellier, Hérault, 34097, France

Location

EHPAD "La BELLE Viste"

Saint-Gély-du-Fesc, Hérault, 34980, France

Location

EHPAD du centre hospitalier de Langogne

Langogne, LOZERE, 48300, France

Location

EHPAD La Murelle

Laurens, 34480, France

Location

Centre Bellevue-CHU Montpellier

Montpellier, 34090, France

Location

EHPAD "Korian Mas de Lauze"

Nîmes, 30900, France

Location

EHPAD La Pinède

Vergèze, 30310, France

Location

EHPAD Léon Bourgeois

Vilallonga dels Monts, 66740, France

Location

MeSH Terms

Conditions

Atrial Fibrillation; Venous Thrombosis; Stroke; Thrombosis

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Embolism and Thrombosis; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Results Point of Contact

• Title: Dr Chris Serrand
• Organization: Nimes University Hospital

chris.serrand@chu-nimes.fr

0466683633

Study Officials

• 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

• 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

• 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

• Anne-Laure VITEAU, Dr.

  EHPAD "Les 5 sens Garons", Carieire dis Amourous 30128 GARONS

  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

• Adrien ROMARY, Dr.

  EHPAD "Résidence les Magnans", 85 Rue du Dix Neuf Mars 1962, 30520 SAINT-MARTIN-DE-VALGALGUES

  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

• 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

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: CARE PROVIDER
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This study is interventional, prospective, comparative, superiority, multicentric, randomised by cluster, in closed cohort.

Study Record Dates

• First Submitted: September 27, 2022
• First Posted: September 30, 2022
• Study Start: November 18, 2022
• Primary Completion: December 13, 2024
• Study Completion: December 13, 2024
• Last Updated: March 3, 2026
• Results First Posted: March 3, 2026

Record last verified: 2024-12

Locations

FR (33)