Ignite Creation Date:
2024-05-05 @ 11:59 AM
Last Modification Date:
2024-10-26 @ 9:18 AM
Study NCT ID:
NCT00205400
Status:
COMPLETED
Last Update Posted:
2016-10-27
First Post:
2005-09-13
Brief Title:
Comparison of Patient Outcomes Using Different Delivery Models of Anticoagulation Care
Sponsor:
University of Wisconsin Madison
Organization:
University of Wisconsin Madison
Study Overview
Official Title:
Comparison of Patient Outcomes Using Different Delivery Models of Anticoagulation Care
Status:
COMPLETED
Status Verified Date:
2016-10
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:
None
Brief Summary:
Hypothesis Does the time spent within the target INR range differ when patients are managed by AMD or IT models of anticoagulation care
Experimental Design The 36-month trial enrolled 192 eligible patients currently receiving chronic warfarin therapy at the William S Middleton Memorial VA Hospital Consenting patients are enrolled and randomized to 1 of 2 groups usual clinic care with face-to-face visits every 4 weeks AMS model or clinic visits every 3 months with interim laboratory visits and telephone follow-up every 4 weeks IT model At study conclusion the amount of time the INR is within target range will be compared between the two groups Thromboembolic and bleeding event rates patient knowledge quality of life and healthcare utilization will also be analyzed
Experimental Design The 36-month trial enrolled 192 eligible patients currently receiving chronic warfarin therapy at the William S Middleton Memorial VA Hospital Consenting patients are enrolled and randomized to 1 of 2 groups usual clinic care with face-to-face visits every 4 weeks AMS model or clinic visits every 3 months with interim laboratory visits and telephone follow-up every 4 weeks IT model At study conclusion the amount of time the INR is within target range will be compared between the two groups Thromboembolic and bleeding event rates patient knowledge quality of life and healthcare utilization will also be analyzed
Detailed Description:
None
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