A randomised controlled trial of patient self management of oral anticoagulation compared to standard care
| ISRCTN | ISRCTN19313375 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN19313375 |
| Secondary identifying numbers | G9900263 |
- Submission date
- 23/10/2000
- Registration date
- 23/10/2000
- Last edited
- 21/07/2011
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Haematological Disorders
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Mr A Fitzmaurice
Scientific
Scientific
The Department of Primary Care and General Practice
The Medical School
The University of Birmingham
Birmingham
B15 2TT
United Kingdom
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Not specified |
| Study type | Not Specified |
| 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 | 1. Therapeutic international normalised ratio (INR) control 2. Bleeding and thrombotic complications |
| Secondary outcome measures | Not provided at time of registration |
| Overall study start date | 01/09/2000 |
| Completion date | 30/06/2003 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 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 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
The Department of Primary Care and General Practice
Birmingham
B15 2TT
United Kingdom
B15 2TT
United Kingdom
Sponsor information
Medical Research Council (MRC) (UK)
Research council
Research council
20 Park Crescent
London
W1B 1AL
United Kingdom
| Phone | +44 (0)20 7636 5422 |
|---|---|
| clinical.trial@headoffice.mrc.ac.uk | |
| Website | http://www.mrc.ac.uk |
Funders
Funder type
Research council
Medical Research Council (UK)
Government organisation / National government
Government organisation / National government
- Alternative name(s)
- Medical Research Council (United Kingdom), UK Medical Research Council, MRC
- Location
- United Kingdom
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol article | protocol | 18/09/2003 | Yes | No | |
| Results article | results | 05/11/2005 | Yes | No | |
| Results article | results | 01/04/2011 | Yes | No |
