ArticlesFamily-led rehabilitation after stroke in India (ATTEND): a randomised controlled trial
Introduction
Stroke rates are rising in low-income and middle-income countries (LMICs) but services are scarce.1 Task shifting rehabilitation activities to unpaid caregivers might offer a sustainable alternative to conventional rehabilitation, and provide an affordable strategy to meet the health demands both in high-income countries and LMICs.2, 3, 4, 5 India, with a sixth of the world's population, has only around 35 stroke units, located mainly in urban centres.6, 7 Consequently, most people have no access to specialised stroke care and little access to conventional rehabilitation programmes. Given that LMICs have only about 3% equivalent purchasing power to spend on health care compared with high-income countries, any new model of stroke rehabilitation should be both sustainable and effective.8, 9 Our hypothesis was that family caregiver-delivered rehabilitation would increase independence and survival after stroke unit admission. We report the results of the Family-led Rehabilitation after Stroke in India (ATTEND) trial, which assessed a rehabilitation training programme to deliver family-led rehabilitation after stroke.
Section snippets
Methods
Study design and participants
ATTEND was a prospectively randomised open trial with blinded endpoint (PROBE) done across 14 hospitals in India. Approvals were obtained from the ethics committees of the University of Sydney, Australia, and at each participating hospital. Permission was also obtained from the Health Ministry Screening Committee, New Delhi, India. The trial methods were piloted in Ludhiana (Punjab, India)10 and the protocol was published before unblinding.11
Patients were eligible
Results
Between Jan 13, 2014, and Feb 12, 2016, 4832 patients were screened, of which 1250 were randomly assigned to the intervention group (n=623) or the control group (n=627; figure 1). Baseline characteristics are shown in table 1. At hospital discharge, we found no between-group differences in mRS scores (562 [90%] of 622 patients in the intervention group vs 567 [90%] of 627 controls, p=0·96) nor in the Barthel Index scores (mean 43·0 [SD 23·17] in the intervention group vs 43·2 [23·39] in
Discussion
Our study showed that the addition of family-led rehabilitation training to usual stroke unit care did not decrease death or dependency at 6 months, nor was there any benefit noted at the 3-month assessment. Additionally, the training did not influence any of the other physical, emotional, or quality-of-life outcomes. The intervention was safe, with an observed non-significant reduction in deaths, and no increase in caregiver burden. The training was delivered as planned with a mean of 3·0 h
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