Condition category
Haematological Disorders
Date applied
11/02/2003
Date assigned
11/02/2003
Last edited
15/08/2008
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

Ms Ellen Murray

ORCID ID

Contact details

Department of Primary Care and General Practice
University of Birmingham
Edgbaston
B15 2TT
United Kingdom
+44 (0)121 414 3761
e.t.murray@bham.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

G106/970

Study information

Scientific title

Acronym

QAASM

Study hypothesis

Aim:
To evaluate three different methods of external quality assurance (EQA) for home management.

Primary objective:
To compare patients' treatment related quality of life in relation to external quality assurance for home anticoagulation management, with or without supervision.

Secondary objective:
To compare three different methods of EQA, one unsupervised and two supervised in terms of:
1. Reliability of EQA results
2. Impact on international normalised ratio (INR) control
3. Costs associated with each method of EQA

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

Patients from the SMART trial (Self-management of warfarin: a randomised trial) will be randomly allocated to two main groups at practice level for supervised or non-supervised External Quality Control (EQA). Twenty-four practices into groups 1 and 2.

The practices randomised to supervised EQA will then be further randomly allocated to different methods of supervised EQA, Groups 2A and 2B.

Unsupervised group: formal EQA scheme (National Quality Assessment Scheme NEQAS).

Supervised groups: International normalised ratio (INR) results from venous samples sent to the local laboratory will be compared with contemporaneous near patient testing (NPT) capillary samples at the practice using the patient's NPT system, or INR results from patient NPT system capillary sample tests will be compared to results from an NPT system weekly quality control tested using samples from NEQAS at the practice, NPT to NPT.

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

Difference in treatment related quality of life scores between non supervised and supervised EQA models

Secondary outcome measures

1. Comparison of EQA results between three models of EQA
2. Comparison of therapeutic INR control in terms of the percentage of time spent within therapeutic range
3. Cost comparison of EQA models

Overall trial start date

01/08/2000

Overall trial end date

31/07/2004

Reason abandoned

Eligibility

Participant inclusion criteria

1. Patients aged 18 or over
2. A long term (greater than 12 months) indication for oral anticoagulation
3. Have taken warfarin for at least six months
4. Are willing (or in the case of dependent patients both they and their carer are willing) to participate in the study

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

260

Participant exclusion criteria

1. Patients with a short-term indication (less than 12 months) for warfarin therapy
2. Aged under 18 years
3. Housebound patients
4. Patients confined to a nursing home

Recruitment start date

01/08/2000

Recruitment end date

31/07/2004

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Department of Primary Care and General Practice
Edgbaston
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 (MRC) (UK) - Special Training Fellowship in HSR

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

Results in http://www.ncbi.nlm.nih.gov/pubmed/12401823

Publication citations

  1. Results

    Fitzmaurice DA, Murray ET, Gee KM, Allan TF, Hobbs FD, A randomised controlled trial of patient self management of oral anticoagulation treatment compared with primary care management., J. Clin. Pathol., 2002, 55, 11, 845-849.

Additional files

Editorial Notes