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The Home INR Study (THINRS)

18. marts 2014 opdateret af: 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.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret 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.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

2922

Fase

  • Fase 4

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Forenede Stater
    • Alabama
      • Birmingham, Alabama, Forenede Stater, 35233
        • VA Medical Center, Birmingham
    • California
      • Fresno, California, Forenede Stater, 93703
        • VA Central California Health Care System, Fresno
      • Loma Linda, California, Forenede Stater, 92357
        • VA Medical Center, Loma Linda
      • Palo Alto, California, Forenede Stater, 94304-1290
        • VA Palo Alto Health Care System
      • West Los Angeles, California, Forenede Stater, 90073
        • VA Greater Los Angeles Healthcare System, West LA
    • Colorado
      • Denver, Colorado, Forenede Stater, 80220
        • VA Eastern Colorado Health Care System, Denver
    • Connecticut
      • West Haven, Connecticut, Forenede Stater, 06516
        • VA Connecticut Health Care System (West Haven)
    • Illinois
      • Hines, Illinois, Forenede Stater, 60141-5000
        • Edward Hines, Jr. VA Hospital
      • North Chicago, Illinois, Forenede Stater, 60064
        • VA Medical Center, North Chicago
    • Iowa
      • Iowa City, Iowa, Forenede Stater, 52246-2208
        • VA Medical Center, Iowa City
    • Maryland
      • Baltimore, Maryland, Forenede Stater, 21201
        • VA Maryland Health Care System, Baltimore
    • Michigan
      • Detroit, Michigan, Forenede Stater, 48201
        • John D. Dingell VA Medical Center, Detroit
    • Minnesota
      • Minneapolis, Minnesota, Forenede Stater, 55417
        • VA Medical Center, Minneapolis
    • Missouri
      • Kansas City, Missouri, Forenede Stater, 64128
        • VA Medical Center, Kansas City MO
    • Nevada
      • North Las Vegas, Nevada, Forenede Stater, 89036
        • Las Vegas
      • Reno, Nevada, Forenede Stater, 89502
        • VA Sierra Nevada Health Care System
    • New York
      • Bronx, New York, Forenede Stater, 10468
        • VA Medical Center, Bronx
      • Buffalo, New York, Forenede Stater, 14215
        • VA Western New York Healthcare System at Buffalo
      • Syracuse, New York, Forenede Stater, 13210
        • VA Medical Center, Syracuse
    • North Carolina
      • Durham, North Carolina, Forenede Stater, 27705
        • Durham VA Medical Center HSR&D COE
    • Ohio
      • Cleveland, Ohio, Forenede Stater, 44106
        • VA Medical Center, Cleveland
    • Oklahoma
      • Oklahoma City, Oklahoma, Forenede Stater, 73104
        • VA Medical Center, Oklahoma City
    • Pennsylvania
      • Pittsburgh, Pennsylvania, Forenede Stater, 15240
        • VA Pittsburgh Health Care System
    • Rhode Island
      • Providence, Rhode Island, Forenede Stater, 02908
        • VA Medical Center, Providence
    • Texas
      • Dallas, Texas, Forenede Stater, 75216
        • VA North Texas Health Care System, Dallas
      • San Antonio, Texas, Forenede Stater, 78229
        • VA South Texas Health Care System, San Antonio
    • Virginia
      • Salem, Virginia, Forenede Stater, 24153
        • VA Medical Center, Salem VA
    • Wisconsin
      • Madison, Wisconsin, Forenede Stater, 53705
        • Wlliam S. Middleton Memorial Veterans Hospital, Madison
  • Puerto Rico
      • San Juan, Puerto Rico, 00921
        • VA Medical Center, San Juan

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

Inclusion Criteria:

To be enrolled in this study, patients must:

  1. have AF and/or a MHV;
  2. be scheduled to receive warfarin indefinitely (operationally defined as 2 years);
  3. be using warfarin according to the criteria described in the Coumadin package insert (no off-label uses);
  4. be expected to survive for the duration of the study;
  5. not be suffering from intracranial bleeding (intracranial hemorrhage, subarachnoid hemorrhage, hemorrhagic stroke) or any other contraindication described in the Coumadin package insert;
  6. be willing to perform PST;
  7. be willing to be randomized;
  8. possess adequate cognitive and language skills to follow the protocol and all related instructions;
  9. be willing to participate for the full duration of the study;
  10. sign the informed consent form; and
  11. not be enrolled in another randomized clinical trial that involves a drug or device intervention.

Exclusion Criteria:

Patients are excluded in this study if:

  1. 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
  2. subject enrolled in another randomized clinical trial that involves a drug or device intervention
  3. subject is not able to follow the protocol and all related instructions, and does not have a caregiver with these skills

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Aktiv komparator: Arm 1
Patient Self-Testing (PST) of prothrombin time by international normalized ratio (PT-INR or INR) with weekly testing
Procedure: Weekly patient self-testing of prothrombin time
Andet: Arm 2
High quality anticoagulation management (HQACM) with conventional monthly testing
Andet: 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 navne:
  • HQACM

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
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
Foranstaltningsbeskrivelse
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
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
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

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

US Department of Veterans Affairs

Efterforskere

  • Studiestol: David B. Matchar, MD, Durham VA Medical Center HSR&D COE

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart

1. august 2003

Primær færdiggørelse (Faktiske)

1. maj 2008

Studieafslutning (Faktiske)

1. maj 2008

Datoer for studieregistrering

Først indsendt

27. marts 2002

Først indsendt, der opfyldte QC-kriterier

27. marts 2002

Først opslået (Skøn)

28. marts 2002

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

15. april 2014

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

18. marts 2014

Sidst verificeret

1. marts 2014

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • 481

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ingen

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

produkt fremstillet i og eksporteret fra U.S.A.

Ingen

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

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