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Eames 2010 (Continued) Comparator: standard care: the usual contact that clients and their caregivers/family members would receive from the hospital’s treating team members. This would include medical assessment and treatment, nursing care, assessment and/or treatment from allied health staff, discharge planning and any information or education associated with this treatment. The control group will receive no information or intervention from the principal researcher Outcomes Primary outcome: stroke-related knowledge as determined by a stroke knowledge questionnaire Secondary outcomes: stroke risk factor awareness, self efficacy, stroke risk-related behaviour change and readiness to change these behaviours, anxiety and depression (Hospital Anxiety and Depression Scale), client quality of life and caregiver burden (using the Caregiver Strain Index), satisfaction Starting date 1 September 2008 Contact information Sally Eames, PhD Candidate, Division of Occupational Therapy, School of Health and Rehabilitation Sciences, Services Road, University of Queensland, St Lucia, Australia Tel: + 61 7 3365 2870 Email: s.eames@uq.edu.au Notes ACTRN12608000469314; http://www.anzctr.org.au/trial˙view.aspx?ID=83109 Forster 2007 Trial name or title Training Caregivers after Stroke (TRACS): a cluster randomised controlled trial of a structured training programme for caregivers of in-patients after stroke Methods Pragmatic multicentre cluster-RCT with blinded follow-up Participants Inclusion criteria: (1) Stroke rehabilitation units: a stroke rehabilitation unit will be defined according to the definition provided by the Royal College of Physicians of London for the National Sentinel Stroke Audit 2004 by the presence of 4/5 of the following criteria: consultant physician with responsibility for stroke, formal links with patient and caregiver organisations, multidisciplinary meetings at least weekly to plan patient care, provision of information to patients about stroke, continuing education programmes for staff (2) Patient: primary diagnosis of new stroke, medically stable (defined as sitting out of bed for at least 4 hours per day), likely discharge destination home of home but with residual disability (defined as a modified Rankin score of ≥ 3), have a caregiver available (defined as the main person, other than health, social, or voluntary care provider, helping with activities of daily living and advocating on behalf of the patient, who has no notable disability (defined as a modified Rankin score of 0 to 2) and who is willing and able to provide support after discharge), written informed patient consent/relative assent and caregiver consent will be obtained prior to any trial specific procedures (3) Caregiver: caregiver is willing and able to provide support after discharge; fulfils the trial definition of a caregiver: if discharge is planned within 1 week of admission to the stroke rehabilitation unit (insufficient time to instigate the intervention); if the patient is in need of palliative care; if the patient or caregiver were registered to the trial on a previous admission Exclusion criteria: if discharge is planned within 1 week of admission to the stroke rehabilitation unit (insufficient time to instigate the intervention), if the patient is in need of palliative care, if the patient or caregiver were registered to the trial on a previous admission Non-pharmacological interventions for caregivers of stroke survivors (Review) Copyright © 2011 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd. 40
Forster 2007 (Continued) Interventions This is a cluster-RCT that aims to recruit 900 patients and caregivers in 36 stroke rehabilitation units. The intervention is known as the London Stroke Carer Training Course (LSCTC) and comprises a number of caregiver training sessions, competency assessment and 1 follow-up session after discharge. The multidisciplinary teams (MDTs) in the units randomised to the intervention group will be trained to deliver the LSCTC, whilst those randomised to the control group will continue to provide usual care as per the National Guidelines Outcomes Current secondary outcome measure(s) as of 19 March 2008: Patient: Hospital Anxiety and Depression Scale (HADS) (mood), Euro-quality of life (EQ-5D) (health state), Barthel Index (activities of daily living), death, institutionalisation, re-admission, Stroke Impact Scale (functional ability and health-related quality of life), costs based on Client Service Receipt Inventory Caregiver: compliance with intervention, Frenchay Activities Index (social restriction), HADS, EQ-5D, death, hospitalisation, institutionalisation, costs based on Client Service Receipt Inventory Starting date 18 February 2008 Contact information Dr Anne Forster, Academic Unit of Elderly Care and Rehabilitation, Temple Bank House, Bradford, BD9 6RJ, UK Tel: +44 (0)1274 383 406/401 Email: a.forster@leeds.ac.uk Notes Forster 2008 Trial name or title Stroke system of care trial: a cluster randomised trial evaluation of a patient and carer-centred system of Longer-Term Stroke Care (LoTS Care) Methods A pragmatic, multicentre cluster-RCT Participants Inclusion criteria: (1) 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: consultant physician with responsibility for stroke, formal links with patient and caregiver organisations, multidisciplinary meetings at least weekly to plan patient care, provision of information to patients about stroke, continuing education programmes for staff (2) Stroke care co-ordinators (SCC): a registered healthcare professional with documented experience in stroke care, undertakes a community-based liaison or co-ordinating role for stroke patients, co-ordinates a range of longer-term care inputs on the patients’ and caregivers’ behalf (e.g. signposting, carrying out assessments), works within a stroke service as above (3) Patients: confirmed primary diagnosis of stroke, referred to a SCC on discharge home from hospital or within 6 weeks of stroke, waiting for their first SCC assessment visit, provide written informed consent or caregiver assent (4) Carers: identified by the patient, eligible for this study Exclusion criteria Patients: unlikely to survive for more than 3 months, discharge to/resident in a nursing or residential home, previously registered to the trial, taking part in other stroke research network adopted studies which involve 6 and 12-month follow-up questionnaires Non-pharmacological interventions for caregivers of stroke survivors (Review) Copyright © 2011 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd. 41
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