None listed
Conditions
Brief summary
This Project is to evaluate an affordable post-stroke rehabilitation program in a large randomised controlled trial (RCT), that, if shown to be effective, could be rolled out throughout India. Our study design is a multicentre, randomised, blinded outcome assessor, controlled trial of Early Supported Discharge (ESD) with a trained family-led caregiver-delivered, home-based stroke rehabilitation compared to usual care in at least 1200 patients with mild-moderate disability recruited from about 12 sites in India. Eligible patients will be adults (=18 years), with recent (<1 month) acute stroke, who have residual disability, are expected to survive to discharge from hospital with at least 6 month survival and are able (or by proxy) to provide informed consent. Randomisation: Eligible patients will be randomised within 7 days of hospital admission. Intervention arm: Patients allocated to ESD and family rehabilitation will have their family nominated caregiver trained by a specially trained stroke trial care coordinator health professional (i.e. nurse, therapist) using a designed structured assessment (cognition, language, function and mobility) and recommended rehabilitation package. The ‘package’ will include a structured check-list and culturally appropriate manual covering the key activities relevant to daily living (e.g. positioning, transfers, mobilisation, feeding, dressing, activity and motor practice, etc). Training will begin in hospital and is envisaged to take ~60 mins per day for 3 days, with the intention of accelerating the patient’s hospital discharge when it is safe to do so. The stroke trial care coordinator will visit (or arrange for other community workers to visit) the patient and caregivers up to 6 occasions to monitor progress post-discharge and will be available by telephone for support and guidance as the patient progresses over the next 3 months. The primary outcome measure will be independent survival measured at 6 months after randomisation.
Interventions
Patients allocated to Early Supported Discharge and family rehabilitation will have their family nominated caregiver trained by a specially trained stroke trial care coordinator health professional (i.e. nurse, therapist) using a designed structured assessment (cognition, language, function and mobility) and recommended rehabilitation package. The ‘package’ will include a structured check-list and culturally appropriate manual covering the key activities relevant to daily living (e.g. positioni
Patients allocated to Early Supported Discharge and family rehabilitation will have their family nominated caregiver trained by a specially trained stroke trial care coordinator health professional (i.e. nurse, therapist) using a designed structured assessment (cognition, language, function and mobility) and recommended rehabilitation package. The ‘package’ will include a structured check-list and culturally appropriate manual covering the key activities relevant to daily living (e.g. positioning, transfers, mobilisation, feeding, dressing, activity and motor practice, and monitoring of mood etc). Training will begin in hospital and is envisaged to take ~60 mins per day for up to 3 days, with the intention of accelerating the patient’s hospital discharge when it is safe to do so. The stroke trial care coordinator will visit (or arrange for other community workers to visit) the patient and caregivers, allocated Early Supported Discharge, up to 6 occasions to monitor progress post-discharge and will be available by telephone for support and guidance as the patient progresses over the next 3 months.
Sponsors
The George Institute for Global Health
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Adults (=18 years); Recent (<1 month) acute ischaemic/haemorrhagic/undifferentiated stroke; Residual disability (requiring help from another person for everyday activities). Expected to survive to discharge from hospital with a reasonable expectation of 6 month survival (i.e. not palliative, no evidence of widespread cancer etc.); Able (or by proxy) to provide informed consent.
Exclusion criteria
Unable to identify a suitable family-nominated caregiver for training and subsequent delivery of care; Those unwilling/unable to adhere to follow-up.
Outcome results
None listed