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
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
-
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.