International Normalised Ratio Evaluation by Generalist Practitioners in Full-time Care Establishments for the Elderly (INR-Cap pilote)
International Normalised Ratio Evaluation by Generalist Practitioners in Full-time Care Establishments for the Elderly: a Pilot Study
Studienübersicht
Status
Bedingungen
Intervention / Behandlung
Detaillierte Beschreibung
The secondary objectives of this study are to:
A. Estimate the intra-patient variability of capillary INR measures.
B. Estimate the time spent in the target INR (TTR) window of dependent elderly patients in nursing homes, under AVK treatment, and with a capillary INR monitoring strategy.
C. Estimate the number of venous thromboembolic events and bleeding events over the 6-month observation period.
Studientyp
Einschreibung (Tatsächlich)
Phase
- Unzutreffend
Kontakte und Standorte
Studienorte
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Pont St Esprit, Frankreich, 30130
- EHPAD de l'Hôpital de Pont Saint Esprit
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Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
- Kind
- Erwachsene
- Älterer Erwachsener
Akzeptiert gesunde Freiwillige
Studienberechtigte Geschlechter
Beschreibung
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
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Diagnose
- Zuteilung: N / A
- Interventionsmodell: Einzelgruppenzuweisung
- Maskierung: Keine (Offenes Etikett)
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
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Experimental: The study population
The clinical phases of this study will be held in the nursing home (EHPAD; principal building + 2 annexes) of Pont-Saint-Esprit, located in France.
Patients are elderly dependents treated by anti-vitamin K for more than 6 months.
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We will be using the CoagucheckXSR device for capillary INR measures performed by nurses every 7 days during the 6 months of the study, plus after related intercurrent events. If capillary INR is <2 or >3 (with a tolerance of 1.9 to 3.1 given the margin of measurement inaccuracy of the coagulometer), then a classic venous measure is performed. If both tests agree, adaptation of treatment as indicated. If slightly discordant results, then the INR values are considered discordant and the decision to adjust the treatment dose and the next monitoring date for venous INR is made based on the value of the venous INR, according to the predefined protocol. If clinically significant discordance (> 0.3), a venous INR is reperformed within 24 hours and if the discrepancy persists, dose adjustment is made according to the venous INR and the predefined protocol. If capillary INR is > 4, then verification by venous measure and refer to general practitioner.
Andere Namen:
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Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
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Is the capillary INR concordant with the venous INR ? yes/no
Zeitfenster: 6 months
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Primary Outcome Measure as stated in protocol: Clinical concordances and clinical discrepancies between the capillary INR and venous INR every time they are concomitant
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6 months
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Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Zeitfenster |
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The number of thromboembolic events per patient
Zeitfenster: 6 months
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6 months
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The number of bleeding events per patient
Zeitfenster: 6 months
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6 months
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The number of thromboembolic or bleeding events per patient
Zeitfenster: 6 months
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6 months
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Coefficient of variation for capillary INR measures per patient
Zeitfenster: 6 months
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6 months
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Time in therapeutique range (days)
Zeitfenster: 6 months
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6 months
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Mitarbeiter und Ermittler
Ermittler
- Studienleiter: Chloé Sikirdji, Interne, Centre Hospitalier Universitaire De Nimes
- Hauptermittler: Jean-François Clape, MD, Centre Hospitalier Universitaire De Nimes
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn
Primärer Abschluss (Tatsächlich)
Studienabschluss (Tatsächlich)
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Schätzen)
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Schätzen)
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
Andere Studien-ID-Nummern
- LOCAL/2015/CS-01
- 2015-A01056-43 (Andere Kennung: RCB number)
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