- ICH GCP
- US-Register für klinische Studien
- Klinische Studie NCT00032591
The Home INR Study (THINRS)
CSP #481 - The Home INR Study (THINRS)
Studienübersicht
Status
Bedingungen
Detaillierte Beschreibung
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.
Studientyp
Einschreibung (Tatsächlich)
Phase
- Phase 4
Kontakte und Standorte
Studienorte
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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, Vereinigte Staaten, 35233
- VA Medical Center, Birmingham
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California
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Fresno, California, Vereinigte Staaten, 93703
- VA Central California Health Care System, Fresno
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Loma Linda, California, Vereinigte Staaten, 92357
- VA Medical Center, Loma Linda
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Palo Alto, California, Vereinigte Staaten, 94304-1290
- VA Palo Alto Health Care System
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West Los Angeles, California, Vereinigte Staaten, 90073
- VA Greater Los Angeles Healthcare System, West LA
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Colorado
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Denver, Colorado, Vereinigte Staaten, 80220
- VA Eastern Colorado Health Care System, Denver
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Connecticut
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West Haven, Connecticut, Vereinigte Staaten, 06516
- VA Connecticut Health Care System (West Haven)
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Illinois
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Hines, Illinois, Vereinigte Staaten, 60141-5000
- Edward Hines, Jr. VA Hospital
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North Chicago, Illinois, Vereinigte Staaten, 60064
- VA Medical Center, North Chicago
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Iowa
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Iowa City, Iowa, Vereinigte Staaten, 52246-2208
- VA Medical Center, Iowa City
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Maryland
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Baltimore, Maryland, Vereinigte Staaten, 21201
- VA Maryland Health Care System, Baltimore
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Michigan
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Detroit, Michigan, Vereinigte Staaten, 48201
- John D. Dingell VA Medical Center, Detroit
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Minnesota
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Minneapolis, Minnesota, Vereinigte Staaten, 55417
- VA Medical Center, Minneapolis
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Missouri
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Kansas City, Missouri, Vereinigte Staaten, 64128
- VA Medical Center, Kansas City MO
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Nevada
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North Las Vegas, Nevada, Vereinigte Staaten, 89036
- Las Vegas
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Reno, Nevada, Vereinigte Staaten, 89502
- VA Sierra Nevada Health Care System
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New York
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Bronx, New York, Vereinigte Staaten, 10468
- VA Medical Center, Bronx
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Buffalo, New York, Vereinigte Staaten, 14215
- VA Western New York Healthcare System at Buffalo
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Syracuse, New York, Vereinigte Staaten, 13210
- VA Medical Center, Syracuse
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North Carolina
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Durham, North Carolina, Vereinigte Staaten, 27705
- Durham VA Medical Center HSR&D COE
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Ohio
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Cleveland, Ohio, Vereinigte Staaten, 44106
- VA Medical Center, Cleveland
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Oklahoma
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Oklahoma City, Oklahoma, Vereinigte Staaten, 73104
- VA Medical Center, Oklahoma City
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Pennsylvania
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Pittsburgh, Pennsylvania, Vereinigte Staaten, 15240
- VA Pittsburgh Health Care System
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Rhode Island
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Providence, Rhode Island, Vereinigte Staaten, 02908
- VA Medical Center, Providence
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Texas
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Dallas, Texas, Vereinigte Staaten, 75216
- VA North Texas Health Care System, Dallas
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San Antonio, Texas, Vereinigte Staaten, 78229
- VA South Texas Health Care System, San Antonio
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Virginia
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Salem, Virginia, Vereinigte Staaten, 24153
- VA Medical Center, Salem VA
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Wisconsin
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Madison, Wisconsin, Vereinigte Staaten, 53705
- Wlliam S. Middleton Memorial Veterans Hospital, Madison
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Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
Akzeptiert gesunde Freiwillige
Studienberechtigte Geschlechter
Beschreibung
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
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Behandlung
- Zuteilung: Zufällig
- Interventionsmodell: Parallele Zuordnung
- Maskierung: Keine (Offenes Etikett)
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
---|---|
Aktiver Komparator: Arm 1
Patient Self-Testing (PST) of prothrombin time by international normalized ratio (PT-INR or INR) with weekly testing
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Sonstiges: 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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Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
---|---|---|
Time to First Event (Death, Stroke, Major Bleed)
Zeitfenster: 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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Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
---|---|---|
Time in Therapeutic Range Over Full Length of Follow-up (0 to 100 Percent)
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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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Mitarbeiter und Ermittler
Ermittler
- Studienstuhl: David B. Matchar, MD, Durham VA Medical Center HSR&D COE
Publikationen und hilfreiche Links
Allgemeine Veröffentlichungen
- 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.
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn
Primärer Abschluss (Tatsächlich)
Studienabschluss (Tatsächlich)
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Schätzen)
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Schätzen)
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
Zusätzliche relevante MeSH-Bedingungen
Andere Studien-ID-Nummern
- 481
Arzneimittel- und Geräteinformationen, Studienunterlagen
Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt
Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt
Produkt, das in den USA hergestellt und aus den USA exportiert wird
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