The Home INR Study (THINRS)
CSP #481 - The Home INR Study (THINRS)
調査の概要
状態
条件
詳細な説明
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.
研究の種類
入学 (実際)
段階
- フェーズ 4
連絡先と場所
研究場所
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Alabama
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Birmingham、Alabama、アメリカ、35233
- VA Medical Center, Birmingham
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California
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Fresno、California、アメリカ、93703
- VA Central California Health Care System, Fresno
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Loma Linda、California、アメリカ、92357
- VA Medical Center, Loma Linda
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Palo Alto、California、アメリカ、94304-1290
- VA Palo Alto Health Care System
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West Los Angeles、California、アメリカ、90073
- VA Greater Los Angeles Healthcare System, West LA
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Colorado
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Denver、Colorado、アメリカ、80220
- VA Eastern Colorado Health Care System, Denver
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Connecticut
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West Haven、Connecticut、アメリカ、06516
- VA Connecticut Health Care System (West Haven)
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Illinois
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Hines、Illinois、アメリカ、60141-5000
- Edward Hines, Jr. VA Hospital
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North Chicago、Illinois、アメリカ、60064
- VA Medical Center, North Chicago
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Iowa
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Iowa City、Iowa、アメリカ、52246-2208
- VA Medical Center, Iowa City
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Maryland
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Baltimore、Maryland、アメリカ、21201
- VA Maryland Health Care System, Baltimore
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Michigan
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Detroit、Michigan、アメリカ、48201
- John D. Dingell VA Medical Center, Detroit
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Minnesota
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Minneapolis、Minnesota、アメリカ、55417
- VA Medical Center, Minneapolis
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Missouri
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Kansas City、Missouri、アメリカ、64128
- VA Medical Center, Kansas City MO
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Nevada
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North Las Vegas、Nevada、アメリカ、89036
- Las Vegas
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Reno、Nevada、アメリカ、89502
- VA Sierra Nevada Health Care System
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New York
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Bronx、New York、アメリカ、10468
- VA Medical Center, Bronx
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Buffalo、New York、アメリカ、14215
- VA Western New York Healthcare System at Buffalo
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Syracuse、New York、アメリカ、13210
- VA Medical Center, Syracuse
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North Carolina
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Durham、North Carolina、アメリカ、27705
- Durham VA Medical Center HSR&D COE
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Ohio
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Cleveland、Ohio、アメリカ、44106
- VA Medical Center, Cleveland
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Oklahoma
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Oklahoma City、Oklahoma、アメリカ、73104
- VA Medical Center, Oklahoma City
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Pennsylvania
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Pittsburgh、Pennsylvania、アメリカ、15240
- VA Pittsburgh Health Care System
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Rhode Island
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Providence、Rhode Island、アメリカ、02908
- VA Medical Center, Providence
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Texas
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Dallas、Texas、アメリカ、75216
- VA North Texas Health Care System, Dallas
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San Antonio、Texas、アメリカ、78229
- VA South Texas Health Care System, San Antonio
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Virginia
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Salem、Virginia、アメリカ、24153
- VA Medical Center, Salem VA
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Wisconsin
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Madison、Wisconsin、アメリカ、53705
- Wlliam S. Middleton Memorial Veterans Hospital, Madison
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San Juan、プエルトリコ、00921
- VA Medical Center, San Juan
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参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
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
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：処理
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
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アクティブコンパレータ：Arm 1
Patient Self-Testing (PST) of prothrombin time by international normalized ratio (PT-INR or INR) with weekly testing
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他の：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.
他の名前：
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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Time to First Event (Death, Stroke, Major Bleed)
時間枠：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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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Time in Therapeutic Range Over Full Length of Follow-up (0 to 100 Percent)
時間枠：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
時間枠：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
時間枠：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
時間枠：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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協力者と研究者
捜査官
- スタディチェア：David B. Matchar, MD、Durham VA Medical Center HSR&D COE
出版物と役立つリンク
一般刊行物
- 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.
研究記録日
主要日程の研究
研究開始
一次修了 (実際)
研究の完了 (実際)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (見積もり)
学習記録の更新
投稿された最後の更新 (見積もり)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。