Condition category
Circulatory System
Date applied
23/01/2004
Date assigned
23/01/2004
Last edited
04/12/2009
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

Prof Michael Modell

ORCID ID

Contact details

Primary Care & Population Sciences
Royal Free & University College Medical School
Level 2
Holborn Union Building
London
N19 3UA
United Kingdom
+44 (0)20 7 288 3247
m.modell@ucl.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

PSI03-26

Study information

Scientific title

Acronym

Study hypothesis

To investigate the feasibility of improving screening for carriers of the recessively inherited haemoglobin disorders (thalassaemia and sickle cell disorders) in general practice, by using a nurse facilitator to work with primary care teams and the relevant haematology laboratories. To identify problems in communication between all those involved in delivering the service, and to implement solutions.

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

GP practices

Trial type

Screening

Patient information sheet

Condition

Genetic screening for haemoglobin disorders

Intervention

The 13 intervention practices were given: posters, and leaflets to explain to the members of the relevant ethnic groups why carrier testing is advisable and how it can be obtained, an aide-memoire card for GPs¿ consulting rooms listing groups to whom screening should be offered, and a practice reference manual containing background information. Intervention practices were offered three formal practice-based 30-60 minute training sessions from the nurse facilitator during the intervention year. Screening requests from study, control and non-participating practices were recorded using computerised hospital haematology laboratory records.

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

The main outcome measure was the change in the number of requests for screening tests for haemoglobin disorders made by control and intervention practices in the baseline and intervention years. We also recorded the numbers of requests from the non-participating practices. For the 2 year follow-up trial the main outcome measure was the number of requests for screening tests from each intervention practice in 1997 and 1998.

Secondary outcome measures

Not provided at time of registration

Overall trial start date

01/04/1995

Overall trial end date

01/04/1997

Reason abandoned

Eligibility

Participant inclusion criteria

It took place in an area of North London where 29% of residents and 43% of births are in the ethnic groups at risk for haemoglobin disorders (mainly Camden, Islington, Haringey and Enfield). Twenty six of the 93 practices using the services of the Whittington haematology laboratory agreed to take part, and were divided into 13 control and 13 intervention practices.

Participant type

Patient

Age group

Other

Gender

Both

Target number of participants

Randomised at practise level, 13 intervention practices, 13 control practices

Participant exclusion criteria

Does not meet inclusion criteria

Recruitment start date

01/04/1995

Recruitment end date

01/04/1997

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Primary Care & Population Sciences
London
N19 3UA
United Kingdom

Sponsor information

Organisation

Record Provided by the NHS R&D 'Time-Limited' National Programme Register - Department of Health (UK)

Sponsor details

The Department of Health
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom

Sponsor type

Government

Website

http://www.doh.gov.uk

Funders

Funder type

Government

Funder name

NHS Primary and Secondary Care Interface National Research and Development Programme (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

1998 results in http://www.ncbi.nlm.nih.gov/pubmed/9740569

Publication citations

  1. Results

    Modell M, Wonke B, Anionwu E, Khan M, Tai SS, Lloyd M, Modell B, A multidisciplinary approach for improving services in primary care: randomised controlled trial of screening for haemoglobin disorders., BMJ, 1998, 317, 7161, 788-791.

Additional files

Editorial Notes