Evaluation of two models of delivering anticoagulant care to house bound patients in the community: a multidisciplinary study

ISRCTN	ISRCTN24180077
DOI	https://doi.org/10.1186/ISRCTN24180077
Secondary identifying numbers	N0205114493

Submission date: 12/09/2003
Registration date: 12/09/2003
Last edited: 13/10/2017

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Haematological Disorders

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Dita Engova
Scientific

Department of Pharmacy
Homerton University Hospital
Homerton Row
London
E9 6SR
United Kingdom

Phone	+44 (0)20 8510 7002
Email	engovad@lsbu.ac.uk

Study information

Study design	Randomised controlled trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Other
Study type	Not Specified
Participant information sheet	Not available in web format, please use the contact details below to request a patient information sheet
Scientific title	Evaluation of two models of delivering anticoagulant care to house bound patients in the community: a multidisciplinary study
Study objectives	We aim to evaluate two models of delivering anticoagulant care to house-bound patients in the community. The study will evaluate the proposed models in terms of patients clinical outcome, patient and professional satisfaction and health economics, and compare them with the traditional hospital-based model.
Ethics approval(s)	Not provided at time of registration
Health condition(s) or problem(s) studied	Anticoagulation therapy
Intervention	Randomised controlled crossover study. Two models of outreach anticoagulation service will be compared with the traditional hospital based model.
Intervention type	Drug
Pharmaceutical study type(s)
Phase	Not Specified
Drug / device / biological / vaccine name(s)	warfarin
Primary outcome measure	1. Clinical: 1.1. Time spent in the therapeutic range. 1.2. The incidence of adverse events (bleeding, thrombotic events) 2. Satisfaction: 2.1. Patients: Consumer Satisfaction Questionnaire (CSQ-8) and 4 structured original questions 2.2. Professionals: semi-structured interview 3. Health economic evaluation
Secondary outcome measures	Not provided at time of registration
Overall study start date	01/10/2002
Completion date	31/03/2004

Eligibility

Participant type(s)	Patient
Age group	Not Specified
Sex	Not Specified
Target number of participants	200
Key inclusion criteria	The approximately 200 patients presently anticoagulated with warfarin at Barts and The London NHS Trust anticoagulation clinic with mobility impairment will be invited to participate and consenters randomly assigned to one of the two anticoagulation service provision schemes, i.e. model A followed by model B, or model B followed by model A.
Key exclusion criteria	Does not match inclusion criteria
Date of first enrolment	01/10/2002
Date of final enrolment	31/03/2004

Locations

Countries of recruitment

England
United Kingdom

Study participating centre

Department of Pharmacy

London
E9 6SR
United Kingdom

Sponsor information

Department of Health (UK)
Government

Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom

Website	http://www.doh.gov.uk

Funders

Funder type

Hospital/treatment centre

Barts and The London NHS Trust (UK)

No information available

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

Editorial Notes

13/10/2017: No publications found in PubMed, verifying study status with principal investigator.