A randomised controlled trial of patient self management of oral anticoagulation compared to standard care

ISRCTN	ISRCTN19313375
DOI	https://doi.org/10.1186/ISRCTN19313375
Protocol serial number	G9900263
Sponsor	Medical Research Council (MRC) (UK)
Funder	Medical Research Council (UK)

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Mr A Fitzmaurice
Scientific

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

Primary study design	Interventional
Study design	Randomised controlled trial
Secondary study design	Randomised controlled trial
Scientific title
Study acronym	SMART: Self-Management of Anticoagulation, a Randomised Trial
Study objectives	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(s)	Not provided at time of registration
Health condition(s) or problem(s) studied	Anticoagulant therapy
Intervention	The intervention comprises a training programme to enable patients to undertake oral anticoagulation monitoring at home.
Intervention type	Other
Primary outcome measure(s)	1. Therapeutic international normalised ratio (INR) control 2. Bleeding and thrombotic complications
Key secondary outcome measure(s)	Not provided at time of registration
Completion date	30/06/2003

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	All
Target sample size at registration	512
Key inclusion criteria	All patients aged over 18 receiving warfarin therapy
Key exclusion criteria	Not provided at time of registration
Date of first enrolment	01/09/2000
Date of final enrolment	30/06/2003

The Department of Primary Care and General Practice

Birmingham
B15 2TT
United Kingdom

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Output type	Details	Date created	Peer reviewed?	Patient-facing?
Results article	results	05/11/2005	Yes	No
Results article	results	01/04/2011	Yes	No
Protocol article	protocol	18/09/2003	Yes	No