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.
Panoramica dello studio
Stato
Condizioni
Intervento / Trattamento
Descrizione dettagliata
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.
Tipo di studio
Iscrizione (Effettivo)
Fase
- Non applicabile
Contatti e Sedi
Luoghi di studio
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Minnesota
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Rochester, Minnesota, Stati Uniti, 55906
- Saint Marys Hospital
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Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Descrizione
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.)
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Diagnostico
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Triplicare
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
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Comparatore attivo: 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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Comparatore attivo: 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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Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Lasso di tempo |
|---|---|
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Mean Percentage of Time in Therapeutic Range
Lasso di tempo: baseline to 3 months
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baseline to 3 months
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Misure di risultato secondarie
Misura del risultato |
Lasso di tempo |
|---|---|
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Mean Percentage of INR Tests Within the Therapeutic Range
Lasso di tempo: baseline to 3 months
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baseline to 3 months
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Mean Number of INR Tests Performed
Lasso di tempo: baseline to 3 months
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baseline to 3 months
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Collaboratori e investigatori
Sponsor
Collaboratori
Investigatori
- Investigatore principale: Hartzell V Schaff, M.D. CS, Mayo Clinic
Pubblicazioni e link utili
Studiare le date dei record
Studia le date principali
Inizio studio
Completamento primario (Effettivo)
Completamento dello studio (Effettivo)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Stima)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Stima)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Altri numeri di identificazione dello studio
- 07-001398
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