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ISRCTN
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ISRCTN55412871
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ClinicalTrials.gov identifier
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Public title
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A randomised controlled trial evaluation of structured routine follow-up after a disabling stroke
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Scientific title
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Acronym
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N/A
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Serial number at source
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N/A
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Study hypothesis
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Research questions:
1. The primary research question is to determine if protocol driven, routine reviews of disabled stroke patients promote improved clinical and health economic outcomes (independence, mood, carer burden, secondary prevention compliance, service resources used)
2. The secondary question investigates the effects of stroke review clinic context by a comparison between two types of clinic structure
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Ethics approval
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Not provided at time of registration
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Study design
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Randomised controlled trial
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Countries of recruitment
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United Kingdom
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Disease/condition/study domain
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Stroke
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Participants - inclusion criteria
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Patients with a new stroke associated with persisting disability and or language impairment at 4 months post-stroke onset. A persisting disability is defined as a Barthel Index score at 4 months lower than their pre-stroke score.
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Participants - exclusion criteria
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1. Patients without new disability
2. Patients whose main problem is vascular dementia
3. Patients considered to have a poor 6 month survival prognosis because of co-morbidity
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Anticipated start date
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01/06/2003
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Anticipated end date
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31/05/2006
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Status of trial
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Completed
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Patient information material
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Target number of participants
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220-230 over 15 months in two centres (Leeds & Bradford)
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Interventions
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The control group will receive existing care arrangements including a service information pack and a structured discharge summary to general practitioners detailing secondary prevention, rehabilitation goals, expected community care services and a new recommendation to the primary health care team that the patient should be contacted at 6 months in accord with the National Service Framework requirement. We believe that the latter recommendation creates a fairer and more realistic comparison group in the context of expected clinical behaviour changes associated with the National Service Framework implementation. At present about half of stroke patients will see their general practitioner by 6 months but the contact is brief, unstructured and of limited patient value.
The patients in the intervention group will receive existing care supplemented by a review clinic attendance at 5-6 months post-stroke onset (some flexibility is required for service operational reasons). Additional visits will be organised if indicated but the emphasis will be on co-ordination of inputs rather than frequent attendances. Two follow-up clinic approaches will be used:
1. An existing secondary care-based review clinic in Leeds. This clinic is medically-led, with some nursing support and established links to therapy and social care services.
2. Multidisciplinary review clinics in Bradford. These are being established in each of three Primary Care Trust, locality-based rehabilitation centres. A nurse (with some mental health training) and a therapist will jointly lead the clinics. Through joint working, it is anticipated that ‘new ways of working’ will evolve so the clinic will be truly ‘interdisciplinary’. Stroke consultant physician support will be available to the clinic through participation in post-clinic meetings, also attended by social service and relevant primary care staff.
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Primary outcome measure(s)
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Patient: extended activities of daily living (Frenchay Activities Index)
Carer: Well-being (General Health Questionnaire-28)
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Secondary outcome measure(s)
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Patient: disability (Barthel Index); mood (Hospital Anxiety and Depression Scale); health status (EQ-5D); service satisfaction (Homesat)
Carer: strain (Carer Strain Index)
Resource use: health, social and voluntary sector service use, and secondary prevention and psychotropic medication will be recorded using proforma questionnaires developed for our previous community stroke trials, supplemented by specific inquiry of service databases for high cost resources such as care home or hospital admissions
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Sources of funding
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Department of Health - Policy Research Programme to support the National Service Framework for Older People (Older People and their Use of Services - 'OPUS')
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Trial website
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Publications
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2009 results in http://www.ncbi.nlm.nih.gov/pubmed/19546253
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Contact name
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Dr
Anne
Forster
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Address
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Department of Health Care for the Elderly
St Luke's Hospital
Little Horton Lane
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City/town
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Bradford
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Zip/Postcode
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BD5 0NA
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Country
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United Kingdom
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Tel
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+44 (0)1274 365311
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Fax
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+44 (0)1274 365845
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Email
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a.forster@leeds.ac.uk
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Sponsor
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UK Department of Health - Policy Research Programme
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Address
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Department of Health
Room 716
Wellington House
133-135 Waterloo Road
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City/town
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London
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Zip/Postcode
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SE1 8UG
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Country
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United Kingdom
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Date applied
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09/09/2005
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Last edited
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25/08/2009
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Date ISRCTN assigned
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28/11/2005
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