- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT00703963
Improved Time in Therapeutic Range With Patient Self-Testing of Their INR Compared to Usual Care
Improved Time in Therapeutic Range With Patient Self-Testing of Their INR Compared to Usual Care: A Randomized Controlled Trial
Patients who receive a mechanical heart valve to replace a diseased heart valve must take an anticoagulation medicine the rest of their lives, and monitor their level of anticoagulation. Until recently, the testing of the level of anticoagulation was performed at medical laboratories or hospitals.
The purpose of this study is to see if patients who test their level of anticoagulation by themselves at home and then call their doctor with the result have better control of their anticoagulation as compared to patients whose anticoagulation is checked only by their physician.
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
Prosthetic replacement of diseased heart valves is a routine procedure, and mechanical heart valves have excellent hemodynamic performance and durability. However, mechanical valves are thrombogenic, necessitating lifelong anticoagulation. Hazards of anticoagulation include bleeding when it is excessive or thromboembolism when the intensity of anticoagulation is below the recommended level. Monitoring the level of anticoagulation is accomplished by analyzing the International Normalized Ratio. Until recently, this was performed at medical laboratories or hospitals, but recent literature suggests that patient self-testing of oral anticoagulation improves patient compliance, medical outcomes, and quality of life.
The objective of this study is to evaluate the time in therapeutic range of patients who self-test their INR compared to patients receiving the usual care. Additionally, we will evaluate the educational components and corollaries of self-testing.
Two hundred consecutively enrolled adults, having undergone implantation of a mechanical heart valve, will be randomized to either self-testing or usual care. Those randomized to the self-testing group will undergo self-testing instruction prior to hospital dismissal. For three months after hospital discharge, subject will record their INR results obtained by self-testing or as prescribed by their primary physician. They will then submit the record of the INR results and complete a survey.
Type d'étude
Inscription (Réel)
Phase
- N'est pas applicable
Contacts et emplacements
Lieux d'étude
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Minnesota
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Rochester, Minnesota, États-Unis, 55906
- Saint Marys Hospital
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Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
Inclusion Criteria:
- Patients that received a mechanical valve while in our hospital
- Age > 18 years
Exclusion Criteria:
- Pregnant or lactating women
- Patients that have genetic clotting disorders such as Factor 5
- Physical disabilities (for example, poor eyesight, tremor, or other neurological disability) that would prevent the patient from being able to perform finger stick blood sampling. (Patients may not be excluded for physical disabilities if a care giver is willing to learn and assist with performing patient self-testing.)
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Diagnostique
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Tripler
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
---|---|
Comparateur actif: Usual Care
Subjects will be having their INR tested by their Primary Care Provider as often as their Care Provider dictates.
This study phase is twelve weeks long beginning at the day of discharge from our hospital.
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Usual care is defined as that care currently received by patients into whom mechanical heart valves are placed.
Typically, these patients undergo frequent checks of their INR level until the therapeutic range is achieved.
Then periodic INR levels are drawn at the discretion of the managing physician.
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Comparateur actif: Patient Self Testing
Subjects will be testing their INR at home using an FDA approved device (INRatio monitor by Hemosense) reporting their results to Quality Assured Services (QAS) via an 800 phone number; their Primary Care Provider will receive a fax with the INR result.
We ask this group of patients to test at minimum one time a week, additional testing as requested by their Primary Care Provider.
This phase lasts twelve weeks, beginning on the day of discharge from our hospital.
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Home testing monitor to test patients INR by placing a capillary drop of blood from the finger onto a test strip.
The test strip is then inserted into the INRatio point-of-care self-testing coagulometer.
After approximately 2 minutes of analysis, the INR value will be presented on the meter's display.
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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Délai |
---|---|
Mean Percentage of Time in Therapeutic Range
Délai: baseline to 3 months
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baseline to 3 months
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Mesures de résultats secondaires
Mesure des résultats |
Délai |
---|---|
Mean Percentage of INR Tests Within the Therapeutic Range
Délai: baseline to 3 months
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baseline to 3 months
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Mean Number of INR Tests Performed
Délai: baseline to 3 months
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baseline to 3 months
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Collaborateurs et enquêteurs
Parrainer
Collaborateurs
Les enquêteurs
- Chercheur principal: Hartzell V Schaff, M.D. CS, Mayo Clinic
Publications et liens utiles
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude
Achèvement primaire (Réel)
Achèvement de l'étude (Réel)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Estimation)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Estimation)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Mots clés
Autres numéros d'identification d'étude
- 07-001398
Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .
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