Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
G9900263
Study information
Scientific title
Acronym
SMART: Self-Management of Anticoagulation, a Randomised Trial
Study hypothesis
The null hypothesis is that patients managing their own anticoagulation can achieve as good therapeutic control as patients receiving standard care.
Please note that as of 07/02/2007 this record was updated to include the current target number of participants. The previous target number of participants at the time of registration was 660.
Ethics approval
Not provided at time of registration
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Not specified
Trial type
Not Specified
Patient information sheet
Condition
Anticoagulant therapy
Intervention
The intervention comprises a training programme to enable patients to undertake oral anticoagulation monitoring at home.
Intervention type
Other
Phase
Not Specified
Drug names
Primary outcome measure
1. Therapeutic international normalised ratio (INR) control
2. Bleeding and thrombotic complications
Secondary outcome measures
Not provided at time of registration
Overall trial start date
01/09/2000
Overall trial end date
30/06/2003
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
All patients aged over 18 receiving warfarin therapy
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
512
Participant exclusion criteria
Not provided at time of registration
Recruitment start date
01/09/2000
Recruitment end date
30/06/2003
Locations
Countries of recruitment
United Kingdom
Trial participating centre
The Department of Primary Care and General Practice
Birmingham
B15 2TT
United Kingdom
Sponsor information
Organisation
Medical Research Council (MRC) (UK)
Sponsor details
20 Park Crescent
London
W1B 1AL
United Kingdom
+44 (0)20 7636 5422
clinical.trial@headoffice.mrc.ac.uk
Sponsor type
Research council
Website
Funders
Funder type
Research council
Funder name
Medical Research Council (UK)
Alternative name(s)
MRC
Funding Body Type
government organisation
Funding Body Subtype
National government
Location
United Kingdom
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list
1. 2003 protocol in http://www.ncbi.nlm.nih.gov/pubmed/13678426
2. 2005 results in http://www.ncbi.nlm.nih.gov/pubmed/16216821
3. 2011 results in http://www.ncbi.nlm.nih.gov/pubmed/21068191
Publication citations
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Results
McCahon D, Murray ET, Murray K, Holder RL, Fitzmaurice DA, Does self-management of oral anticoagulation therapy improve quality of life and anxiety?, Fam Pract, 2011, 28, 2, 134-140, doi: 10.1093/fampra/cmq089.
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McCahon D, Fitzmaurice DA, Murray ET, Fuller CJ, Hobbs RF, Allan TF, Raftery JP, SMART: self-management of anticoagulation, a randomised trial [ISRCTN19313375]., BMC Fam Pract, 2003, 4, 11, doi: 10.1186/1471-2296-4-11.
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Fitzmaurice DA, Murray ET, McCahon D, Holder R, Raftery JP, Hussain S, Sandhar H, Hobbs FD, Self management of oral anticoagulation: randomised trial., BMJ, 2005, 331, 7524, 1057, doi: 10.1136/bmj.38618.580903.AE.