Condition category
Haematological Disorders
Date applied
12/09/2003
Date assigned
12/09/2003
Last edited
24/08/2015
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

Dr Dita Engova

ORCID ID

Contact details

Department of Pharmacy
Homerton University Hospital
Homerton Row
London
E9 6SR
United Kingdom
+44 (0)20 8510 7002
engovad@lsbu.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N0205114493

Study information

Scientific title

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

Acronym

Study hypothesis

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

Not provided at time of registration

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Other

Trial type

Not Specified

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

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

Phase

Not Specified

Drug names

warfarin

Primary outcome measures

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 trial start date

01/10/2002

Overall trial end date

31/03/2004

Reason abandoned

Eligibility

Participant 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.

Participant type

Patient

Age group

Not Specified

Gender

Not Specified

Target number of participants

200

Participant exclusion criteria

Does not match inclusion criteria

Recruitment start date

01/10/2002

Recruitment end date

31/03/2004

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Department of Pharmacy
London
E9 6SR
United Kingdom

Sponsor information

Organisation

Department of Health (UK)

Sponsor details

Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom

Sponsor type

Government

Website

http://www.doh.gov.uk

Funders

Funder type

Hospital/treatment centre

Funder name

Barts and The London NHS Trust (UK)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

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

Publication citations

Additional files

Editorial Notes