A randomised controlled trial evaluation of structured routine follow-up after a disabling stroke

ISRCTN	ISRCTN55412871
DOI	https://doi.org/10.1186/ISRCTN55412871
Protocol serial number	N/A
Sponsor	UK Department of Health - Policy Research Programme
Funder	Department of Health - Policy Research Programme to support the National Service Framework for Older People (Older People and their Use of Services - 'OPUS')

Submission date: 09/09/2005
Registration date: 28/11/2005
Last edited: 25/08/2009

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Circulatory System

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Anne Forster
Scientific

Department of Health Care for the Elderly
St Luke's Hospital
Little Horton Lane
Bradford
BD5 0NA
United Kingdom

Phone	+44 (0)1274 365311
Email	a.forster@leeds.ac.uk

Study information

Primary study design	Interventional
Study design	Randomised controlled trial
Secondary study design	Randomised controlled trial
Scientific title
Study objectives	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
Ethics approval(s)	Not provided at time of registration
Health condition(s) or problem(s) studied	Stroke
Intervention	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.
Intervention type	Other
Primary outcome measure(s)	Patient: extended activities of daily living (Frenchay Activities Index) Carer: Well-being (General Health Questionnaire-28)
Key secondary outcome measure(s)	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
Completion date	31/05/2006

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	All
Target sample size at registration	230
Key inclusion criteria	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.
Key exclusion criteria	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
Date of first enrolment	01/06/2003
Date of final enrolment	31/05/2006

Locations

Countries of recruitment

United Kingdom
England

Study participating centre

Department of Health Care for the Elderly

Bradford
BD5 0NA
United Kingdom

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/09/2009		Yes	No