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Trial registered on ANZCTR


Registration number
ACTRN12613000078752
Ethics application status
Approved
Date submitted
21/01/2013
Date registered
21/01/2013
Date last updated
13/09/2017
Type of registration
Prospectively registered

Titles & IDs
Public title
The ATTEND Trial: Family-Led Rehabilitation after stroke in India
Scientific title
The ATTEND Trial: The effects of a Family-Led Rehabilitation on death or dependency at six months in participants with stroke in India
Secondary ID [1] 281798 0
None
Universal Trial Number (UTN)
U1111-1138-6707
Trial acronym
ATTEND
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Stroke 288124 0
Condition category
Condition code
Stroke 288499 288499 0 0
Ischaemic
Stroke 288500 288500 0 0
Haemorrhagic
Physical Medicine / Rehabilitation 288501 288501 0 0
Other physical medicine / rehabilitation

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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.
Intervention code [1] 286342 0
Rehabilitation
Comparator / control treatment
The control patients will receive usual care. In general this usually consists of investigation and initial stabilisation of the patient, multidisciplinary assessment, a team meeting and formulation of a multidisciplinary plan, with an early discharge home and an offer of out-patient rehabilitation. Few (10%) patients are able to return to the out-patient rehabilitation service due to family commitments, and so some families pay for private physiotherapy in the home. It is likely that most patients in the control group will not have routine access to post-discharge stroke services.
Control group
Active

Outcomes
Primary outcome [1] 288657 0
Effects of treatment on death or dependency (on the modified Rankin Scale [mRS]) at 6 months post-randomisation (mRS 0-2 versus 3-6)
Timepoint [1] 288657 0
Six months after randomisation
Secondary outcome [1] 300704 0
Effect of treatment on shift of disability, as measured by the mRS, and analysed with shift (ordinal) analysis
Timepoint [1] 300704 0
Six months after randomisation
Secondary outcome [2] 300705 0
The simple validated recovery (“Have you made a complete recovery from your stroke?”) and dependency (“Do you need help from another person for everyday activities”) questions
Timepoint [2] 300705 0
Six months after randomisation
Secondary outcome [3] 300707 0
Place of residence will be noted at the face-to-face follow-up by the blinded assessor. Telephone follow-up will be performed if home visit not possible.
Timepoint [3] 300707 0
Six months after randomisation
Secondary outcome [4] 300708 0
The Barthel Index to measure activities of daily living
Timepoint [4] 300708 0
Six months after randomisation
Secondary outcome [5] 300709 0
Caregiver Strain Index
Timepoint [5] 300709 0
Six months after randomisation
Secondary outcome [6] 300710 0
Expected serious events: 1) deaths categorized as vascular (stroke, MI, other vascular), infection, fracture, other and 2) Hospitalisation (stroke, MI, other vascular, infection, fracture, other). The hospitalised events will be identified by clinical assessment at the routine 3 and 6 month face-to-face assessments by the blinded assessor. Telephone follow-up will be performed if home visit not possible.
Timepoint [6] 300710 0
Events occurring in the six months following randomisation. These will be assessed for two time periods: 3 and 6 months after randomisation.
Secondary outcome [7] 300711 0
Health-related quality of life (WHOQOL-BREF and EQ-5D)
Timepoint [7] 300711 0
Six months after randomisation
Secondary outcome [8] 300712 0
Patient and caregiver mood (Hospital Anxiety and Depression Scale)
Timepoint [8] 300712 0
Six months after randomisation
Secondary outcome [9] 300713 0
Extended activities of daily living (Nottingham Extended ADL Scale)
Timepoint [9] 300713 0
Six months after stroke
Secondary outcome [10] 300714 0
Health care resource use (visits to health professionals, hospitalization, and medication use) and direct (e.g. payment to the caregiver to act as carer for this patient, total direct costs of healthcare paid by the family since time of stroke). These events will be identified by clinical assessment at the routine 3 and 6 month face-to-face assessments by the blinded assessor. Telephone follow-up will be performed if home visit not possible.
Timepoint [10] 300714 0
These events will be identified by clinical assessment at the routine 3 and 6 month face-to-face assessments by the blinded assessor. Telephone follow-up will be performed if home visit not possible. Events up to six months following randomisation will be included, i.e. the end of the study for each participant.
Secondary outcome [11] 300715 0
Indirect costs (e.g. family member giving up paid employment to act as caregiver) on the family. The use of family member diaries will be encouraged to collect this data.
Timepoint [11] 300715 0
For the six month period following randomisation. These costs will be identified by assessment at the routine 3 and 6 month face-to-face visits by the blinded assessor. Telephone follow-up will be performed if home visit not possible.
Secondary outcome [12] 300716 0
Direct Medical Costs (e.g. total expenditure during hospital admission which includes first place where patient was taken, general or private admission, length of hospital stay, admission charges, investigation charges and drug treatment). Participants will be encouraged to keep copies of the bills for these items.
Timepoint [12] 300716 0
These costs will be collected for the admission that led to randomisation and all subsequent costs up to six months after randomisation. These costs will be identified by assessment at the routine 3 and 6 month face-to-face visits by the blinded assessor. Telephone follow-up will be performed if home visit not possible.
Secondary outcome [13] 300717 0
Non-medical direct cost (e.g. travelling costs). The use of family member diaries will be encouraged in order to collect these costs.
Timepoint [13] 300717 0
For the six months following randomisation. These costs will be identified by assessment at the routine 3 and 6 month face-to-face visits by the blinded assessor. Telephone follow-up will be performed if home visit not possible.
Secondary outcome [14] 300718 0
Additional secondary outcomes will include all our 6 month outcomes (both primary and secondary outcomes) measured at 3 months following randomisation.
Timepoint [14] 300718 0
3 months following randomisation. Our outcomes will be measured by our blinded assessor at a face-to-face visit, or telephone follow-up if a home visit was not possible.
Secondary outcome [15] 300748 0
Hospital length of stay
Timepoint [15] 300748 0
The length of hospital admission for the admission that included the date of randomisation will be determined by access to the medical records at the randomising hospital

Eligibility
Key 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.
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key 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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Eligible patients will be randomised within 7 days of hospital admission, using a secure, central, password protected, internet-based computerised system.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
The computerised randomisation system will be based at The George Institute for Global Health with a random allocation stratified by centre and stroke severity
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 2 / Phase 3
Type of endpoint(s)
Efficacy
Statistical methods / analysis
The intention to treat (ITT) principle will be applied in all analyses. The primary end-point is the proportion of those dead or dependent (as measured on the modified Rankin score (mRS)) at 6 months. This will be analysed using an unadjusted logistic regression model. Binary secondary outcomes will be analysed similarly, with analysis of variance (t-tests) used for continuous variables. For the shift analysis of mRS using all seven categories (including “6” for death), ordinal logistic regression, after verifying the proportional odds assumption, will be used.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment outside Australia
Country [1] 4806 0
India
State/province [1] 4806 0

Funding & Sponsors
Funding source category [1] 286582 0
Government body
Name [1] 286582 0
National Health and Medical Research Council of Australia (NHMRC)
Address [1] 286582 0
National Health and Medical Research Council
GPO Box 1421
Canberra ACT 2601
Country [1] 286582 0
Australia
Primary sponsor type
Other Collaborative groups
Name
The George Institute for Global Health
Address
PO Box M201
Missenden Rd
NSW 2050
Australia
Country
Australia
Secondary sponsor category [1] 285366 0
None
Name [1] 285366 0
Address [1] 285366 0
Country [1] 285366 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 288668 0
Institutional Ethics Committee, Christian Medical College and Hospital, Ludhiana
Ethics committee address [1] 288668 0
Christian Medical College, Ludhiana - 141 008
Punjab
India
Ethics committee country [1] 288668 0
India
Date submitted for ethics approval [1] 288668 0
Approval date [1] 288668 0
12/12/2012
Ethics approval number [1] 288668 0
N/A
Ethics committee name [2] 296022 0
University of Sydney
Ethics committee address [2] 296022 0
Level 6 Jane Foss Russell Building
The University of Sydney
NSW2006
Ethics committee country [2] 296022 0
Australia
Date submitted for ethics approval [2] 296022 0
25/03/2013
Approval date [2] 296022 0
09/04/2013
Ethics approval number [2] 296022 0
2013/248

Summary
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.
Trial website
Trial related presentations / publications
Statistical analysis plan for the family-led rehabilitation after stroke in India (ATTEND) trial: A multicentre randomized controlled trial of a new model of stroke rehabilitation compared to usual care. Billot L, Lindley RI, Harvey LA, Maulik PK, Hackett ML, Murthy GVS, Anderson CS, Shamanna BR, Jan S, Walker M, Forster A, Langhorne P, Verma SJ, Felix C, Alim M, Gandhi DBC Pandian JD. Int J Stroke 2017; 12: 208-210
Family-led rehabilitation after stroke in India: A Randomized Controlled Trial. Lindley RI, et al.. Lancet 2017. Published Online June 27, 2017 http://dx.doi.org/10.1016/ S0140-6736(17)31447-2. Lancet 2017; 390: 588-599.
Public notes

Contacts
Principal investigator
Name 37150 0
Prof Richard Iain Lindley
Address 37150 0
The George Institute for Global Health and The University of Sydney
PO Box M201
Missenden Rd
NSW 2050
Australia
Country 37150 0
Australia
Phone 37150 0
+61 2 9845 5080
Fax 37150 0
+61 2 96570301
Email 37150 0
rlindley@georgeinstitute.org.au
Contact person for public queries
Name 37151 0
Prof Richard Iain Lindley
Address 37151 0
The George Institute for Global Health and The University of Sydney
PO Box M201
Missenden Rd
NSW 2050
Australia
Country 37151 0
Australia
Phone 37151 0
+61 2 9845 5080
Fax 37151 0
+61 2 96570301
Email 37151 0
rlindley@georgeinstitute.org.au
Contact person for scientific queries
Name 37152 0
Prof Richard Iain Lindley
Address 37152 0
The George Institute for Global Health and The University of Sydney
PO Box M201
Missenden Rd
NSW 2050
Australia
Country 37152 0
Australia
Phone 37152 0
+61 404 866 007
Fax 37152 0
+61 2 96570301
Email 37152 0
rlindley@georgeinstitute.org.au

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary