The Home INR Study (THINRS)
CSP #481 - The Home INR Study (THINRS)
研究概览
地位
条件
详细说明
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.
研究类型
注册 (实际的)
阶段
- 第四阶段
联系人和位置
学习地点
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San Juan、波多黎各、00921
- VA Medical Center, San Juan
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Alabama
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Birmingham、Alabama、美国、35233
- VA Medical Center, Birmingham
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California
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Fresno、California、美国、93703
- VA Central California Health Care System, Fresno
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Loma Linda、California、美国、92357
- VA Medical Center, Loma Linda
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Palo Alto、California、美国、94304-1290
- VA Palo Alto Health Care System
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West Los Angeles、California、美国、90073
- VA Greater Los Angeles Healthcare System, West LA
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Colorado
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Denver、Colorado、美国、80220
- VA Eastern Colorado Health Care System, Denver
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Connecticut
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West Haven、Connecticut、美国、06516
- VA Connecticut Health Care System (West Haven)
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Illinois
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Hines、Illinois、美国、60141-5000
- Edward Hines, Jr. VA Hospital
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North Chicago、Illinois、美国、60064
- VA Medical Center, North Chicago
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Iowa
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Iowa City、Iowa、美国、52246-2208
- VA Medical Center, Iowa City
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Maryland
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Baltimore、Maryland、美国、21201
- VA Maryland Health Care System, Baltimore
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Michigan
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Detroit、Michigan、美国、48201
- John D. Dingell VA Medical Center, Detroit
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Minnesota
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Minneapolis、Minnesota、美国、55417
- VA Medical Center, Minneapolis
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Missouri
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Kansas City、Missouri、美国、64128
- VA Medical Center, Kansas City MO
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Nevada
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North Las Vegas、Nevada、美国、89036
- Las Vegas
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Reno、Nevada、美国、89502
- VA Sierra Nevada Health Care System
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New York
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Bronx、New York、美国、10468
- VA Medical Center, Bronx
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Buffalo、New York、美国、14215
- VA Western New York Healthcare System at Buffalo
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Syracuse、New York、美国、13210
- VA Medical Center, Syracuse
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North Carolina
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Durham、North Carolina、美国、27705
- Durham VA Medical Center HSR&D COE
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Ohio
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Cleveland、Ohio、美国、44106
- VA Medical Center, Cleveland
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Oklahoma
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Oklahoma City、Oklahoma、美国、73104
- VA Medical Center, Oklahoma City
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Pennsylvania
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Pittsburgh、Pennsylvania、美国、15240
- VA Pittsburgh Health Care System
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Rhode Island
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Providence、Rhode Island、美国、02908
- VA Medical Center, Providence
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Texas
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Dallas、Texas、美国、75216
- VA North Texas Health Care System, Dallas
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San Antonio、Texas、美国、78229
- VA South Texas Health Care System, San Antonio
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Virginia
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Salem、Virginia、美国、24153
- VA Medical Center, Salem VA
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Wisconsin
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Madison、Wisconsin、美国、53705
- Wlliam S. Middleton Memorial Veterans Hospital, Madison
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
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
学习计划
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
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有源比较器：Arm 1
Patient Self-Testing (PST) of prothrombin time by international normalized ratio (PT-INR or INR) with weekly testing
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其他：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.
其他名称：
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
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Time to First Event (Death, Stroke, Major Bleed)
大体时间：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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次要结果测量
结果测量 |
措施说明 |
大体时间 |
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Time in Therapeutic Range Over Full Length of Follow-up (0 to 100 Percent)
大体时间：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
大体时间：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
大体时间：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
大体时间：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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合作者和调查者
调查人员
- 学习椅：David B. Matchar, MD、Durham VA Medical Center HSR&D COE
出版物和有用的链接
一般刊物
- 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.
研究记录日期
研究主要日期
学习开始
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (估计)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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