Condition category
Circulatory System
Date applied
09/09/2005
Date assigned
28/11/2005
Last edited
25/08/2009
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

Dr Anne Forster

ORCID ID

Contact details

Department of Health Care for the Elderly
St Luke's Hospital
Little Horton Lane
Bradford
BD5 0NA
United Kingdom
+44 (0)1274 365311
a.forster@leeds.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Acronym

Study hypothesis

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

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

Not Specified

Patient information sheet

Condition

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

Phase

Not Specified

Drug names

Primary outcome measures

Patient: extended activities of daily living (Frenchay Activities Index)

Carer: Well-being (General Health Questionnaire-28)

Secondary outcome measures

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

Overall trial start date

01/06/2003

Overall trial end date

31/05/2006

Reason abandoned

Eligibility

Participant 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.

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

220-230 over 15 months in two centres (Leeds & Bradford)

Participant 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

Recruitment start date

01/06/2003

Recruitment end date

31/05/2006

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Department of Health Care for the Elderly
Bradford
BD5 0NA
United Kingdom

Sponsor information

Organisation

UK Department of Health - Policy Research Programme

Sponsor details

Department of Health
Room 716
Wellington House
133-135 Waterloo Road
London
SE1 8UG
United Kingdom

Sponsor type

Government

Website

Funders

Funder type

Government

Funder name

Department of Health - Policy Research Programme to support the National Service Framework for Older People (Older People and their Use of Services - 'OPUS')

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

2009 results in http://www.ncbi.nlm.nih.gov/pubmed/19546253

Publication citations

  1. Results

    Forster A, Young J, Green J, Patterson C, Wanklyn P, Smith J, Murray J, Wild H, Bogle S, Lowson K, Structured re-assessment system at 6 months after a disabling stroke: a randomised controlled trial with resource use and cost study., Age Ageing, 2009, 38, 5, 576-583, doi: 10.1093/ageing/afp095.

Additional files

Editorial Notes