The Home INR Study (THINRS)
18. mars 2014 oppdatert av: 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.
Studieoversikt
Status
Fullført
Forhold
Detaljert beskrivelse
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
Intervensjonell
Registrering (Faktiske)
2922
Fase
- Fase 4
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
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Alabama
-
Birmingham, Alabama, Forente stater, 35233
- VA Medical Center, Birmingham
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California
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Fresno, California, Forente stater, 93703
- VA Central California Health Care System, Fresno
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Loma Linda, California, Forente stater, 92357
- VA Medical Center, Loma Linda
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Palo Alto, California, Forente stater, 94304-1290
- VA Palo Alto Health Care System
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West Los Angeles, California, Forente stater, 90073
- VA Greater Los Angeles Healthcare System, West LA
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-
Colorado
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Denver, Colorado, Forente stater, 80220
- VA Eastern Colorado Health Care System, Denver
-
-
Connecticut
-
West Haven, Connecticut, Forente stater, 06516
- VA Connecticut Health Care System (West Haven)
-
-
Illinois
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Hines, Illinois, Forente stater, 60141-5000
- Edward Hines, Jr. VA Hospital
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North Chicago, Illinois, Forente stater, 60064
- VA Medical Center, North Chicago
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Iowa
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Iowa City, Iowa, Forente stater, 52246-2208
- VA Medical Center, Iowa City
-
-
Maryland
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Baltimore, Maryland, Forente stater, 21201
- VA Maryland Health Care System, Baltimore
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Michigan
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Detroit, Michigan, Forente stater, 48201
- John D. Dingell VA Medical Center, Detroit
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Minnesota
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Minneapolis, Minnesota, Forente stater, 55417
- VA Medical Center, Minneapolis
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Missouri
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Kansas City, Missouri, Forente stater, 64128
- VA Medical Center, Kansas City MO
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Nevada
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North Las Vegas, Nevada, Forente stater, 89036
- Las Vegas
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Reno, Nevada, Forente stater, 89502
- VA Sierra Nevada Health Care System
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New York
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Bronx, New York, Forente stater, 10468
- VA Medical Center, Bronx
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Buffalo, New York, Forente stater, 14215
- VA Western New York Healthcare System at Buffalo
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Syracuse, New York, Forente stater, 13210
- VA Medical Center, Syracuse
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North Carolina
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Durham, North Carolina, Forente stater, 27705
- Durham VA Medical Center HSR&D COE
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Ohio
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Cleveland, Ohio, Forente stater, 44106
- VA Medical Center, Cleveland
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Oklahoma
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Oklahoma City, Oklahoma, Forente stater, 73104
- VA Medical Center, Oklahoma City
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Pennsylvania
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Pittsburgh, Pennsylvania, Forente stater, 15240
- VA Pittsburgh Health Care System
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Rhode Island
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Providence, Rhode Island, Forente stater, 02908
- VA Medical Center, Providence
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Texas
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Dallas, Texas, Forente stater, 75216
- VA North Texas Health Care System, Dallas
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San Antonio, Texas, Forente stater, 78229
- VA South Texas Health Care System, San Antonio
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Virginia
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Salem, Virginia, Forente stater, 24153
- VA Medical Center, Salem VA
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Wisconsin
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Madison, Wisconsin, Forente stater, 53705
- Wlliam S. Middleton Memorial Veterans Hospital, Madison
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San Juan, Puerto Rico, 00921
- VA Medical Center, San Juan
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Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
18 år og eldre (Voksen, Eldre voksen)
Tar imot friske frivillige
Nei
Kjønn som er kvalifisert for studier
Alle
Beskrivelse
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
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Aktiv komparator: Arm 1
Patient Self-Testing (PST) of prothrombin time by international normalized ratio (PT-INR or INR) with weekly testing
|
|
|
Annen: Arm 2
High quality anticoagulation management (HQACM) with conventional monthly testing
|
HQACM with testing every 4 weeks and as indicated for out of range values, medication/clinical changes.
Andre navn:
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Time to First Event (Death, Stroke, Major Bleed)
Tidsramme: Time to event
|
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
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Time in Therapeutic Range Over Full Length of Follow-up (0 to 100 Percent)
Tidsramme: Full length of follow-up; average of 3 years
|
Time in target range (TTR) based on Prothrombin Time standardized to the International Normalized Ratio
|
Full length of follow-up; average of 3 years
|
|
DASS at 2 Years of Follow-up
Tidsramme: At two years of follow-up
|
Satisfaction with care was quantified using the Duke Anticoagulation Satisfaction Scale (DASS).
Scores range from 25 to 225, with lower scores indicating higher satisfaction.
|
At two years of follow-up
|
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Cumulative Gain in Health Utilities at 2 Year
Tidsramme: After 2 years of follow-up for each subject
|
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.
|
After 2 years of follow-up for each subject
|
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Health Care Costs at 2 Year
Tidsramme: After 2 years of follow-up for each subject
|
After 2 years of follow-up for each subject
|
Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Etterforskere
- Studiestol: David B. Matchar, MD, Durham VA Medical Center HSR&D COE
Publikasjoner og nyttige lenker
Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.
Generelle publikasjoner
- 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.
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart
1. august 2003
Primær fullføring (Faktiske)
1. mai 2008
Studiet fullført (Faktiske)
1. mai 2008
Datoer for studieregistrering
Først innsendt
27. mars 2002
Først innsendt som oppfylte QC-kriteriene
27. mars 2002
Først lagt ut (Anslag)
28. mars 2002
Oppdateringer av studieposter
Sist oppdatering lagt ut (Anslag)
15. april 2014
Siste oppdatering sendt inn som oppfylte QC-kriteriene
18. mars 2014
Sist bekreftet
1. mars 2014
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- 481
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
Nei
Studerer et amerikansk FDA-regulert enhetsprodukt
Nei
produkt produsert i og eksportert fra USA
Nei
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