The Home INR Study (THINRS)
18 mars 2014 mis à jour par: US Department of Veterans Affairs
CSP #481 - The Home INR Study (THINRS)
Since home monitors of prothrombin time (PT) may potentially improve the safety, quality, and convenience of chronic anticoagulation management, it is likely that there will be demands from providers, patients, and manufacturers to make home monitors available to VA patients.
The rationale for patient self-testing (PST) is that, compared to conventional high quality anticoagulation management (HQACM), it would permit more intense monitoring and increased patient participation in his/her own care, resulting in increased precision in anticoagulation control and thus fewer events of thromboembolism (strokes) and bleeding.
The secondary hypothesis is that PST and HQACM will be comparable in terms of health care utilization and cost.
Aperçu de l'étude
Statut
Complété
Les conditions
Description détaillée
Intervention: Weekly patient self-testing (PST) of prothrombin time by international normalized ratio (PT INR) versus conventional monthly high quality anticoagulation management (HQACM) from an anticoagulation clinic with a minimum two years follow-up.
Primary Hypothesis: Compared to conventional monitoring in the clinic, PST of anticoagulation intensity will decrease the number of events of thromboembolism (strokes), bleeding, and all cause deaths and improve the quality of anticoagulation.
Second Hypothesis: PST and conventional monitoring will be comparable in terms of health care utilization and cost.
Primary Outcomes: Event rates (thromboembolism or bleeding episodes), time to first event, time within therapeutic range for anticoagulation intensity, and total health care cost (including price of PST monitors) and utilization.
Study Abstract: Since home monitors of prothrombin time (PT) may potentially improve the safety, quality, and convenience of chronic anticoagulation management, it is likely that there will be demands from providers, patients, and manufacturers to make home monitors available to VA patients. The rationale for PST is that it would permit more intense monitoring and increased patient participation in his/her own care, resulting in increased precision in anticoagulation control and thus fewer events.
Original plan was for a study at 32 sites with a total sample size of about 3,200 patients and a length of three years (one for recruitment and two years of follow-up). Final status was 28 sites that randomized 2922 patients in 2.75 years of recruitment with a minimum of two years of follow-up.
Type d'étude
Interventionnel
Inscription (Réel)
2922
Phase
- Phase 4
Contacts et emplacements
Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.
Lieux d'étude
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San Juan, Porto Rico, 00921
- VA Medical Center, San Juan
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Alabama
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Birmingham, Alabama, États-Unis, 35233
- VA Medical Center, Birmingham
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California
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Fresno, California, États-Unis, 93703
- VA Central California Health Care System, Fresno
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Loma Linda, California, États-Unis, 92357
- VA Medical Center, Loma Linda
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Palo Alto, California, États-Unis, 94304-1290
- VA Palo Alto Health Care System
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West Los Angeles, California, États-Unis, 90073
- VA Greater Los Angeles Healthcare System, West LA
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Colorado
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Denver, Colorado, États-Unis, 80220
- VA Eastern Colorado Health Care System, Denver
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Connecticut
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West Haven, Connecticut, États-Unis, 06516
- VA Connecticut Health Care System (West Haven)
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Illinois
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Hines, Illinois, États-Unis, 60141-5000
- Edward Hines, Jr. VA Hospital
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North Chicago, Illinois, États-Unis, 60064
- VA Medical Center, North Chicago
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Iowa
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Iowa City, Iowa, États-Unis, 52246-2208
- VA Medical Center, Iowa City
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Maryland
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Baltimore, Maryland, États-Unis, 21201
- VA Maryland Health Care System, Baltimore
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Michigan
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Detroit, Michigan, États-Unis, 48201
- John D. Dingell VA Medical Center, Detroit
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Minnesota
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Minneapolis, Minnesota, États-Unis, 55417
- VA Medical Center, Minneapolis
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Missouri
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Kansas City, Missouri, États-Unis, 64128
- VA Medical Center, Kansas City MO
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Nevada
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North Las Vegas, Nevada, États-Unis, 89036
- Las Vegas
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Reno, Nevada, États-Unis, 89502
- VA Sierra Nevada Health Care System
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New York
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Bronx, New York, États-Unis, 10468
- VA Medical Center, Bronx
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Buffalo, New York, États-Unis, 14215
- VA Western New York Healthcare System at Buffalo
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Syracuse, New York, États-Unis, 13210
- VA Medical Center, Syracuse
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North Carolina
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Durham, North Carolina, États-Unis, 27705
- Durham VA Medical Center HSR&D COE
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Ohio
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Cleveland, Ohio, États-Unis, 44106
- VA Medical Center, Cleveland
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Oklahoma
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Oklahoma City, Oklahoma, États-Unis, 73104
- VA Medical Center, Oklahoma City
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Pennsylvania
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Pittsburgh, Pennsylvania, États-Unis, 15240
- VA Pittsburgh Health Care System
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Rhode Island
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Providence, Rhode Island, États-Unis, 02908
- VA Medical Center, Providence
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Texas
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Dallas, Texas, États-Unis, 75216
- VA North Texas Health Care System, Dallas
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San Antonio, Texas, États-Unis, 78229
- VA South Texas Health Care System, San Antonio
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Virginia
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Salem, Virginia, États-Unis, 24153
- VA Medical Center, Salem VA
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Wisconsin
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Madison, Wisconsin, États-Unis, 53705
- Wlliam S. Middleton Memorial Veterans Hospital, Madison
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Critères de participation
Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.
Critère d'éligibilité
Âges éligibles pour étudier
18 ans et plus (Adulte, Adulte plus âgé)
Accepte les volontaires sains
Non
Sexes éligibles pour l'étude
Tout
La description
Inclusion Criteria:
To be enrolled in this study, patients must:
- have AF and/or a MHV;
- be scheduled to receive warfarin indefinitely (operationally defined as 2 years);
- be using warfarin according to the criteria described in the Coumadin package insert (no off-label uses);
- be expected to survive for the duration of the study;
- not be suffering from intracranial bleeding (intracranial hemorrhage, subarachnoid hemorrhage, hemorrhagic stroke) or any other contraindication described in the Coumadin package insert;
- be willing to perform PST;
- be willing to be randomized;
- possess adequate cognitive and language skills to follow the protocol and all related instructions;
- be willing to participate for the full duration of the study;
- sign the informed consent form; and
- not be enrolled in another randomized clinical trial that involves a drug or device intervention.
Exclusion Criteria:
Patients are excluded in this study if:
- subject has had intracranial hemorrhage, subarachnoid hemorrhage, hemorrhagic stroke, or any other absolute/major contraindication described in the warfarin package insert within the last month
- subject enrolled in another randomized clinical trial that involves a drug or device intervention
- subject is not able to follow the protocol and all related instructions, and does not have a caregiver with these skills
Plan d'étude
Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
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Comparateur actif: Arm 1
Patient Self-Testing (PST) of prothrombin time by international normalized ratio (PT-INR or INR) with weekly testing
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Autre: Arm 2
High quality anticoagulation management (HQACM) with conventional monthly testing
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HQACM with testing every 4 weeks and as indicated for out of range values, medication/clinical changes.
Autres noms:
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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
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Time to First Event (Death, Stroke, Major Bleed)
Délai: Time to event
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Time to first event (death, stroke, major bleed) The primary outcome was time to first event, and we used the Kaplan-Meier method to compare survival curves and the results using the log-rank test. The number of patients with a primary outcome is what was reported in the NEJM paper. Below is the unpublished cumulative incidence information. |
Time to event
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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Time in Therapeutic Range Over Full Length of Follow-up (0 to 100 Percent)
Délai: Full length of follow-up; average of 3 years
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Time in target range (TTR) based on Prothrombin Time standardized to the International Normalized Ratio
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Full length of follow-up; average of 3 years
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DASS at 2 Years of Follow-up
Délai: At two years of follow-up
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Satisfaction with care was quantified using the Duke Anticoagulation Satisfaction Scale (DASS).
Scores range from 25 to 225, with lower scores indicating higher satisfaction.
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At two years of follow-up
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Cumulative Gain in Health Utilities at 2 Year
Délai: After 2 years of follow-up for each subject
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Scores range from -0.36 to 1.00 per year, with a negative score indicating a state worse than being dead and a score of 1.00 indicating perfect health.
Since the time frame is 2 years, the range is -0.72 to 2.00.
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After 2 years of follow-up for each subject
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Health Care Costs at 2 Year
Délai: After 2 years of follow-up for each subject
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After 2 years of follow-up for each subject
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Collaborateurs et enquêteurs
C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.
Parrainer
Les enquêteurs
- Chaise d'étude: David B. Matchar, MD, Durham VA Medical Center HSR&D COE
Publications et liens utiles
La personne responsable de la saisie des informations sur l'étude fournit volontairement ces publications. Il peut s'agir de tout ce qui concerne l'étude.
Publications générales
- Dolor RJ, Ruybalid RL, Uyeda L, Edson RG, Phibbs C, Vertrees JE, Shih MC, Jacobson AK, Matchar DB; THINRS Site Investigators. An evaluation of patient self-testing competency of prothrombin time for managing anticoagulation: pre-randomization results of VA Cooperative Study #481--The Home INR Study (THINRS). J Thromb Thrombolysis. 2010 Oct;30(3):263-75. doi: 10.1007/s11239-010-0499-8.
- Matchar DB, Jacobson A, Dolor R, Edson R, Uyeda L, Phibbs CS, Vertrees JE, Shih MC, Holodniy M, Lavori P; THINRS Executive Committee and Site Investigators. Effect of home testing of international normalized ratio on clinical events. N Engl J Med. 2010 Oct 21;363(17):1608-20. doi: 10.1056/NEJMoa1002617. Erratum In: N Engl J Med. 2011 Jan 6;364(1):93.
- Matchar DB, Jacobson AK, Edson RG, Lavori PW, Ansell JE, Ezekowitz MD, Rickles F, Fiore L, Boardman K, Phibbs C, Fihn SD, Vertrees JE, Dolor R. The impact of patient self-testing of prothrombin time for managing anticoagulation: rationale and design of VA Cooperative Study #481--the Home INR Study (THINRS). J Thromb Thrombolysis. 2005 Jun;19(3):163-72. doi: 10.1007/s11239-005-1452-0.
- Phibbs CS, Love SR, Jacobson AK, Edson R, Su P, Uyeda L, Matchar DB; writing for the THINRS Executive Committee and Site Investigators. At-Home Versus In-Clinic INR Monitoring: A Cost-Utility Analysis from The Home INR Study (THINRS). J Gen Intern Med. 2016 Sep;31(9):1061-7. doi: 10.1007/s11606-016-3700-8. Epub 2016 May 27.
- Matchar DB, Love SR, Jacobson AK, Edson R, Uyeda L, Phibbs CS, Dolor RJ. The impact of frequency of patient self-testing of prothrombin time on time in target range within VA Cooperative Study #481: The Home INR Study (THINRS), a randomized, controlled trial. J Thromb Thrombolysis. 2015 Jul;40(1):17-25. doi: 10.1007/s11239-014-1128-8.
Dates d'enregistrement des études
Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.
Dates principales de l'étude
Début de l'étude
1 août 2003
Achèvement primaire (Réel)
1 mai 2008
Achèvement de l'étude (Réel)
1 mai 2008
Dates d'inscription aux études
Première soumission
27 mars 2002
Première soumission répondant aux critères de contrôle qualité
27 mars 2002
Première publication (Estimation)
28 mars 2002
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Estimation)
15 avril 2014
Dernière mise à jour soumise répondant aux critères de contrôle qualité
18 mars 2014
Dernière vérification
1 mars 2014
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- 481
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Non
Étudie un produit d'appareil réglementé par la FDA américaine
Non
produit fabriqué et exporté des États-Unis.
Non
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