Disabling Stroke Circulatory System Stroke
Conditions
Interventions
Current interventions as of 19/03/2008:
This is a cluster, randomised, controlled trial and aims to recruit 900 patients and caregivers in 36 stroke rehabilitation units. The intervention developed by
Sponsors
University of Leeds (UK)
Eligibility
Inclusion criteria
Inclusion criteria: Current inclusion criteria as of 19/03/2008: 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: 1. Consultant physician with responsibility for stroke 2. Formal links with patient and caregiver 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 Patient: 1. Patient has a confirmed primary diagnosis of new stroke 2. Is medically stable 3. Is likely to return home but with residual disability 4. Have a caregiver available, defined as the main person, other than health, social or voluntary care provider, helping with activities of daily living and/or advocating on behalf of the patient 5. Written informed consent/caregiver assent and caregiver consent will be obtained prior to any trial specific procedures Caregiver: 1. Caregiver is willing and able to provide support after discharge 2. Fulfils the trial definition of a caregiver Previous inclusion criteria: 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: 1. Consultant physician with responsibility for stroke 2. Formal links with patient and caregiver 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 An additional criterion will be that the majority of patients on the unit will have a diagnosis of stroke. Patients with the following characteristics are eligible for this trial: 1. Have a confirmed primary diagnosis of new stroke 2. Are medically stable (defined as sitting out of bed for at least four hours per day) 3. Are likely to return home but with residual disability (defined as a modified Rankin score of >=3) 4. 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 0-2) and who is willing and able to provide support after discharge 5. Written informed patient consent/relative assent and caregiver consent will be obtained prior to any trial specific procedures
Exclusion criteria
Exclusion criteria: Current exclusion criteria as of 19/03/2008: 1. If discharge is planned within one week of admission to the stroke rehabilitation unit (insufficient time to instigate the intervention) 2. If the patient is in need of palliative care 3. If the patient or caregiver were registered to the trial on a previous admission Previous exclusion criteria: 1. If discharge is planned within 96 hours of admission to the stroke rehabilitation unit (insufficient time to instigate the LSCTC) 2. If the patient has a concurrent illness requiring, or likely to require, palliative care 3. If the patient or caregiver was registered to the trial on a previous admission
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Current primary outcome measure(s) as of 19/03/2008: Patient: Nottingham Extended Activities of Daily Living (NEADL) Caregiver: Caregivers Burden Scale Primary outcomes are measured at six months after recruitment. Previous primary outcome measure(s): The primary outcome is Nottingham Extended Activities of Daily Living (NEADL) for patients at 6 months after recruitment. | — |
Secondary
| Measure | Time frame |
|---|---|
| Current secondary outcome measure(s) as of 19/03/2008: Patient: 1. Hospital Anxiety and Depression Scale (HADS) (mood) 2. Euro-quality of life (EQ-5D) (health state) 3. Barthel Index (activities of daily living) 4. Death 5. Institutionalisation 6. Re-admission 7. Stroke Impact Scale (functional ability and health related quality of life) 8. Costs based on Client Service Receipt Inventory Caregiver: 1. Compliance with intervention 2. Frenchay activities index (social restriction) 3. HADS 4. EQ-5D 5. Death 6. Hospitalisation 7. Institutionalisation 8. Costs based on Client Service Receipt Inventory Secondary outcomes measured at the final follow up at 12 months. Previous secondary outcome measure(s): The secondary outcome measures for patients at 6 months and 12 months are: 1. Hospital Anxiety and Depression Scale (HADS) (mood) 2. EQ - 5D (health state) 3. Barthel Index (activities of daily living) 4. Stroke Impact Scale (functional ability and health related quality of life) 5. Costs based on the Client Service Receipt Inventory (CSRI) 6. Death 7. Institutionalisation 8. Re-admission The Nottingham Extended Activities of Daily Living (NEADL) at 12 months is also a patient secondary outcome measure to assess whether any intervention effect is sustained. The secondary outcome measures for caregivers at 6 and 12 months are: 1. Compliance with the intervention (LSCTC, measured by number of training sessions, time taken, competencies signed off) 2. Caregivers Burden Scale 3. Frenchay activities index (social restriction) 4. HADS (mood) 5. EQ-5D (health state) 6. Death 7. Hospitalisation 8. Institutionalisation | — |
Countries
United Kingdom
Outcome results
None listed