Ignite Creation Date:
2024-05-05 @ 11:25 AM
Last Modification Date:
2024-10-26 @ 9:07 AM
Study NCT ID:
NCT00032591
Status:
COMPLETED
Last Update Posted:
2014-04-15
First Post:
2002-03-27
Brief Title:
The Home INR Study
Sponsor:
US Department of Veterans Affairs
Organization:
VA Office of Research and Development
Study Overview
Official Title:
CSP 481 - The Home INR Study THINRS
Status:
COMPLETED
Status Verified Date:
2014-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
THINRS
Brief Summary:
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 hisher 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
Detailed Description:
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 hisher 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 3200 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 275 years of recruitment with a minimum of two years of 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 hisher 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 3200 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 275 years of recruitment with a minimum of two years of follow-up
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None