Condition category
Circulatory System
Date applied
19/07/2005
Date assigned
07/09/2005
Last edited
07/12/2010
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 Charles Wolfe

ORCID ID

Contact details

Division of Health & Social Care Research
King's College London
7th Floor Capital House
42 Weston Street
London
SE1 3QD
United Kingdom
+44 (0)20 7848 6608
charles.wolfe@kcl.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

1824/1845

Study information

Scientific title

Acronym

Stop Stroke

Study hypothesis

To test the efficacy of a complex secondary prevention intervention on improving post stroke risk factor control. The study uses a cluster randomised controlled trial design with 120 general practices randomised at the start of the trial. All participants at a given practice (patients, carers and primary care staff) receive either the intervention or usual care.

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

Prevention

Patient information sheet

Condition

Stroke

Intervention

Intervention: Computer algorithms are used to systematically transform data collected by an ongoing stroke register (SLSR) into individually tailored secondary prevention plans for patients, carers and the primary care team. The plans include details of the patient's current risk factor control and evidence based advice on how to improve risk factor management. Plans are updated and distributed at three time points.
Control: Usual care.

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

Prevalence of uncontrolled key modifiable risk factors for stroke (hypertension, smoking, aspirin adherence) measured at one year post stroke.

Secondary outcome measures

Prevalence of other uncontrolled risk factors for stroke (cholesterol, diabetes, atrial fibrillation, obesity, heavy drinking); stroke recurrence rate.

Overall trial start date

21/07/2003

Overall trial end date

01/01/2007

Reason abandoned

Eligibility

Participant inclusion criteria

All patients with a diagnosis of first-in-a-lifetime stroke living in Lambeth and Southwark.

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

450 patients

Participant exclusion criteria

Patients must be alive six weeks post stroke, identified by the study team within six months of stroke and registered with a general practitioner.

Recruitment start date

21/07/2003

Recruitment end date

01/01/2007

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Division of Health & Social Care Research
London
SE1 3QD
United Kingdom

Sponsor information

Organisation

King's College London (UK)

Sponsor details

Division of Health and Social Care Research
7th Floor Capital House
42 Weston Street
London
SE1 3QD
United Kingdom
+44 (0)207848 6651/4113
lesley.higgins@kcl.ac.uk

Sponsor type

University/education

Website

http://www.kcl.ac.uk

Funders

Funder type

Not defined

Funder name

The Health Foundation 1824/1845,

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

The Stroke Association TSA G1,

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Medical Research Council Special Training Fellowship Award G106/1105, Department of Health Career Scientist Award PHCSA02/07.

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

1. 2010 results in http://www.ncbi.nlm.nih.gov/pubmed/20864664

Publication citations

  1. Results

    Wolfe CD, Redfern J, Rudd AG, Grieve AP, Heuschmann PU, McKevitt C, Cluster randomized controlled trial of a patient and general practitioner intervention to improve the management of multiple risk factors after stroke: stop stroke., Stroke, 2010, 41, 11, 2470-2476, doi: 10.1161/STROKEAHA.110.588046.

Additional files

Editorial Notes