Condition category
Haematological Disorders
Date applied
23/10/2000
Date assigned
23/10/2000
Last edited
21/07/2011
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Mr A Fitzmaurice

ORCID ID

Contact details

The Department of Primary Care and General Practice
The Medical School
The University of Birmingham
Birmingham
B15 2TT
United Kingdom

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 measures

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

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 20 7636 5422
clinical.trial@headoffice.mrc.ac.uk

Sponsor type

Research council

Website

http://www.mrc.ac.uk

Funders

Funder type

Research council

Funder name

Medical Research Council (UK)

Alternative name(s)

MRC

Funding Body Type

private sector organisation

Funding Body Subtype

other non-profit

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

Results - basic reporting

Publication summary

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

  1. 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.

  2. 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.

  3. 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.

Additional files

Editorial Notes