Main
|
Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
Register:
|
ISRCTN |
Last refreshed on:
|
13 January 2015 |
Main ID: |
ISRCTN92166461 |
Date of registration:
|
23/01/2004 |
Prospective Registration:
|
No |
Primary sponsor: |
|
Public title:
|
Assessment of anticoagulant control in primary care using near patient testing and computerised decision support.
|
Scientific title:
|
|
Date of first enrolment:
|
01/10/1994 |
Target sample size:
|
368 |
Recruitment status: |
Completed |
URL:
|
http://isrctn.com/ISRCTN92166461 |
Study type:
|
Interventional |
Study design:
|
Randomised controlled trial (Other)
|
Phase:
|
|
|
Countries of recruitment
|
United Kingdom
| | | | | | | |
Contacts
|
Name:
|
|
Address:
|
|
Telephone:
|
|
Email:
|
|
Affiliation:
|
|
|
Name:
|
FDR
Hobbs |
Address:
|
The Department of Primary Care and General Practice
Medical School
University of Birmingham
Edgbaston
B15 2TT
Birmingham
United Kingdom |
Telephone:
|
+44 (0)121 414 3765 |
Email:
|
f.d.r.hobbs@bham.ac.uk |
Affiliation:
|
|
| |
Key inclusion & exclusion criteria
|
Inclusion criteria: Patients receiving warfarin therapy (n=368)
Exclusion criteria: Does not meet inclusion criteria
Age minimum:
Age maximum:
Gender:
Not Specified
|
Health Condition(s) or Problem(s) studied
|
Thromboembolic disease Circulatory System Arterial embolism and thrombosis
|
Intervention(s)
|
A randomised controlled trial using 12 primary care practices in Birmingham, UK (9 intervention and 3 control). The study used 2 control populations; patients individually randomly allocated as controls in the intervention practices (intra-practice controls), and all patients in the 3 control practices (inter-practice controls), included to estimate any Hawthorne effect amongst the intervention controls. Patients from the 9 intervention practices were randomised to intervention (practice based anticoagulation clinic) or control (traditional attendance at hospital clinic).
|
Primary Outcome(s)
|
The main outcome measure used was INR control determined by; number of tests performed within target INR range; point prevalence of patients achieving individual therapeutic INR targets; and individual proportion of time spent within therapeutic target range.
|
Secondary Outcome(s)
|
Not provided at time of registration
|
Source(s) of Monetary Support
|
NHS Primary and Secondary Care Interface National Research and Development Programme (UK)
|
Results
|
Results available:
|
|
Date Posted:
|
|
Date Completed:
|
|
URL:
|
|
|
|