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Stroke system of care trial: a cluster randomised trial evaluation of a patient and carer-centred system of Longer-Term Stroke Care

Stroke system of care trial: a cluster randomised trial evaluation of a patient and carer-centred system of Longer-Term Stroke Care

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN67932305
Enrollment
800
Registered
2008-05-09
Start date
2008-06-01
Completion date
Unknown
Last updated
2016-10-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Stroke Circulatory System Cerebrovascular diseases

Interventions

Stroke services will be randomised into intervention or control groups using the stratification factors of quality of the stroke unit
referral rate and SCCs working alone versus within a community multidisciplinary team. SCCs in stroke services randomised to the intervention group will be trained to deliver a system of care center

Sponsors

Bradford Teaching Hospitals NHS Foundation Trust (UK)
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: The trial is evaluating a complex intervention delivered by the Stroke Care Co-ordinator (SCC) within a stroke service and eligibility criteria apply at three levels - the stroke service, the stroke unit and the SCC. A stroke service will only be considered for inclusion in the trial if it includes a stroke unit which fulfils the Royal College of Physicians guidelines definition of a stroke unit, that is, by the presence of 4/5 of the following criteria: 1. Consultant physician with responsibility for stroke 2. Formal links with patient and carer organisations 3. Multidisciplinary meetings at least weekly to plan patient care 4. Provision of information to patients about stroke 5. Continuing education programmes for staff Stroke Care Co-ordinators (SCC) will be eligible if they fulfill the following criteria: 1. A registered healthcare professional with documented experience in stroke care 2. Undertakes a community based liaison or co-ordinating role for stroke patients 3. Co-ordinates a range of longer-term care inputs on the patients' and carers' behalf (e.g., signposting, carrying out assessments) 4. Works within a stroke service as above Patients with the following characteristics will be eligible for the trial: 1. Have a confirmed primary diagnosis of stroke 2. Are referred to a SCC on discharge home from hospital or within six weeks of stroke 3. Are still waiting for their first SCC assessment visit 4. Provide written informed consent or carer assent All carers with the following characteristics are eligible for this study: 1. Identified by the patient 2. Eligible for this study 3. Provides the patient with practical support on at least a weekly basis

Exclusion criteria

Exclusion criteria: Patients will be excluded from the trial if: 1. They are unlikely to survive for more than three months 2. Are being discharged to/resident in a nursing or residential home 3. Have been previously registered to the trial 4. They are taking part in other stroke research network adopted studies which involve 6- and 12-month follow-up questionnaires

Design outcomes

Primary

MeasureTime frame
General Health Questionnaire 12 (GHQ12) completed by the patient 6 months after recruitment

Secondary

MeasureTime frame
The secondary outcome measures for patients at 6 and 12 months are: 1. Frenchay Activities Index 2. Barthel Index 3. EQ-5D 4. Stroke Impact Scale 5. Longer-term Unmet Need in Stroke 6. Satisfaction 7. Death 8. Hospital re-admission 9. Institutionalisation 10. Total costs 11. Cost-effectiveness/cost-utility The GHQ12 at 12 months is also a patient secondary outcome measure to assess whether any intervention effect is sustained. The secondary outcome measures for carers at 6 and 12 months are: 1. GHQ12 2. Carer Burden Scale 3. Satisfaction 4. Death 5. Institutionalisation

Countries

United Kingdom

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Mar 7, 2026