The Home INR Study (THINRS)
18 maart 2014 bijgewerkt door: 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.
Studie Overzicht
Toestand
Voltooid
Conditie
Gedetailleerde beschrijving
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.
Studietype
Ingrijpend
Inschrijving (Werkelijk)
2922
Fase
- Fase 4
Contacten en locaties
In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.
Studie Locaties
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San Juan, Puerto Rico, 00921
- VA Medical Center, San Juan
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Alabama
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Birmingham, Alabama, Verenigde Staten, 35233
- VA Medical Center, Birmingham
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California
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Fresno, California, Verenigde Staten, 93703
- VA Central California Health Care System, Fresno
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Loma Linda, California, Verenigde Staten, 92357
- VA Medical Center, Loma Linda
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Palo Alto, California, Verenigde Staten, 94304-1290
- VA Palo Alto Health Care System
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West Los Angeles, California, Verenigde Staten, 90073
- VA Greater Los Angeles Healthcare System, West LA
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Colorado
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Denver, Colorado, Verenigde Staten, 80220
- VA Eastern Colorado Health Care System, Denver
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Connecticut
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West Haven, Connecticut, Verenigde Staten, 06516
- VA Connecticut Health Care System (West Haven)
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Illinois
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Hines, Illinois, Verenigde Staten, 60141-5000
- Edward Hines, Jr. VA Hospital
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North Chicago, Illinois, Verenigde Staten, 60064
- VA Medical Center, North Chicago
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Iowa
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Iowa City, Iowa, Verenigde Staten, 52246-2208
- VA Medical Center, Iowa City
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Maryland
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Baltimore, Maryland, Verenigde Staten, 21201
- VA Maryland Health Care System, Baltimore
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Michigan
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Detroit, Michigan, Verenigde Staten, 48201
- John D. Dingell VA Medical Center, Detroit
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Minnesota
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Minneapolis, Minnesota, Verenigde Staten, 55417
- VA Medical Center, Minneapolis
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Missouri
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Kansas City, Missouri, Verenigde Staten, 64128
- VA Medical Center, Kansas City MO
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Nevada
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North Las Vegas, Nevada, Verenigde Staten, 89036
- Las Vegas
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Reno, Nevada, Verenigde Staten, 89502
- VA Sierra Nevada Health Care System
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New York
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Bronx, New York, Verenigde Staten, 10468
- VA Medical Center, Bronx
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Buffalo, New York, Verenigde Staten, 14215
- VA Western New York Healthcare System at Buffalo
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Syracuse, New York, Verenigde Staten, 13210
- VA Medical Center, Syracuse
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North Carolina
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Durham, North Carolina, Verenigde Staten, 27705
- Durham VA Medical Center HSR&D COE
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Ohio
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Cleveland, Ohio, Verenigde Staten, 44106
- VA Medical Center, Cleveland
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Oklahoma
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Oklahoma City, Oklahoma, Verenigde Staten, 73104
- VA Medical Center, Oklahoma City
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Pennsylvania
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Pittsburgh, Pennsylvania, Verenigde Staten, 15240
- VA Pittsburgh Health Care System
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Rhode Island
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Providence, Rhode Island, Verenigde Staten, 02908
- VA Medical Center, Providence
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Texas
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Dallas, Texas, Verenigde Staten, 75216
- VA North Texas Health Care System, Dallas
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San Antonio, Texas, Verenigde Staten, 78229
- VA South Texas Health Care System, San Antonio
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Virginia
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Salem, Virginia, Verenigde Staten, 24153
- VA Medical Center, Salem VA
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Wisconsin
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Madison, Wisconsin, Verenigde Staten, 53705
- Wlliam S. Middleton Memorial Veterans Hospital, Madison
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Deelname Criteria
Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
18 jaar en ouder (Volwassen, Oudere volwassene)
Accepteert gezonde vrijwilligers
Nee
Geslachten die in aanmerking komen voor studie
Allemaal
Beschrijving
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
Studie plan
Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Behandeling
- Toewijzing: Gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Geen (open label)
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
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Actieve vergelijker: Arm 1
Patient Self-Testing (PST) of prothrombin time by international normalized ratio (PT-INR or INR) with weekly testing
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Ander: 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.
Andere namen:
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Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
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Time to First Event (Death, Stroke, Major Bleed)
Tijdsspanne: 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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Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
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Time in Therapeutic Range Over Full Length of Follow-up (0 to 100 Percent)
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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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Medewerkers en onderzoekers
Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.
Onderzoekers
- Studie stoel: David B. Matchar, MD, Durham VA Medical Center HSR&D COE
Publicaties en nuttige links
De persoon die verantwoordelijk is voor het invoeren van informatie over het onderzoek stelt deze publicaties vrijwillig ter beschikking. Dit kan gaan over alles wat met het onderzoek te maken heeft.
Algemene publicaties
- 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.
Studie record data
Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.
Bestudeer belangrijke data
Studie start
1 augustus 2003
Primaire voltooiing (Werkelijk)
1 mei 2008
Studie voltooiing (Werkelijk)
1 mei 2008
Studieregistratiedata
Eerst ingediend
27 maart 2002
Eerst ingediend dat voldeed aan de QC-criteria
27 maart 2002
Eerst geplaatst (Schatting)
28 maart 2002
Updates van studierecords
Laatste update geplaatst (Schatting)
15 april 2014
Laatste update ingediend die voldeed aan QC-criteria
18 maart 2014
Laatst geverifieerd
1 maart 2014
Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- 481
Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
Nee
Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct
Nee
product vervaardigd in en geëxporteerd uit de V.S.
Nee
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