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13 May 2008
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| [ Print-friendly version ] |
| Stroke system of care trial: a cluster randomised trial evaluation of a patient and carer-centred system of Longer-Term Stroke Care |
| ISRCTN | ISRCTN67932305 |
| ClinicalTrials.gov identifier | |
| Public title | Stroke system of care trial: a cluster randomised trial evaluation of a patient and carer-centred system of Longer-Term Stroke Care |
| Scientific title | |
| Acronym | LoTS Care |
| Serial number at source | RP-PG-0606-1128 |
| Study hypothesis |
The hypothesis for LoTS Care is that a system of care delivered by a Stroke Care Co-ordinator (SCC) to patients and carers living at home, in the community, will improve psychological and functional outcomes compared to usual SCC practice.
The primary objective of the trial is to determine whether the system of care improves psychological outcomes for patients requiring long term care at home. The secondary objectives include: 1. Improved functional outcomes for patients requiring long-term support at home 2. Improved psychological and functional outcomes for carers of patients requiring long term support at home 3. Cost effectiveness |
| Ethics approval | Ethics approval submitted to Leeds West Research Ethics Committee for review on the 9th May 2008. |
| Study design |
A pragmatic, multi-centre cluster randomised controlled trial
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| Countries of recruitment | United Kingdom |
| Disease/condition/study domain | Stroke |
| Participants - 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 |
| Participants - 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 |
| Anticipated start date | 01/06/2008 |
| Anticipated end date | 30/04/2012 |
| Status of trial | Ongoing |
| Patient information material | Not available in web format, please use the contact details below to request a patient information sheet |
| Target number of participants | 800 patients (and carers if applicable) |
| 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 centered on key problems identified as of central importance to stroke patients and their carers. The assessment schedule is presented in a manual comprising 16 questions (patient) and 11 questions (carer) representing the identified problem areas, linked to reference guides containing educational text with algorithms of evidence based treatment options and associated patient carer action plans. Implementation of the assessment system is supported by a specific training programme. SCCs in stroke services randomised to the control group will continue to deliver current community-based practice as determined by local policy and practice. The SCC will undertake a primary assessment of patients (and carer if appropriate) using the system of care and instigate service responses, with additional follow-up and monitoring visits as appropriate to the needs of individual patients. Therefore there are no specified treatment times for either arms. Follow up of both the control and intervention arms of the patients (and carers if applicable) will be followed up at 6 and 12 months. |
| Primary outcome measure(s) |
The primary outcome measure is General Health Questionnaire 12 (GHQ12) completed by the patient six months after recruitment.
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| Secondary outcome measure(s) |
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 |
| Sources of funding |
1. National Institute of Health Research (UK) - Programme Grant for Applied Research
2. The Stroke Association (UK) |
| Trial website | |
| Publications | |
| Contact name | Prof Anne Forster |
| Address |
Academic Unit of Elderly Care and Rehabilitation
Bradford Institute for Health Research Temple Bank House Bradford Royal Infirmary Duckworth Lane |
| City/town | Bradford |
| Zip/Postcode | BD9 6RJ |
| Country | United Kingdom |
| Tel | +44 (0)1274 383 406 |
| Fax | +44 (0)1274 382 766 |
| a.forster@leeds.ac.uk | |
| Sponsor | Bradford Teaching Hospitals NHS Foundation Trust (UK) |
| Address |
c/o John Wright
Bradford Royal Infirmary Duckworth Lane |
| City/town | Bradford |
| Zip/Postcode | BD9 6RJ |
| Country | United Kingdom |
| Tel | +44 (0)1274 364279 |
| j.wright@bradfordhospitals.nhs.uk | |
| Sponsor website: | http://www.bradfordhospitals.nhs.uk/ |
| Date applied | 04/04/2008 |
| Last edited | 09/05/2008 |
| Date ISRCTN assigned | 09/05/2008 |
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