Elsevier

The Lancet

Volume 390, Issue 10094, 5–11 August 2017, Pages 588-599
The Lancet

Articles
Family-led rehabilitation after stroke in India (ATTEND): a randomised controlled trial

https://doi.org/10.1016/S0140-6736(17)31447-2Get rights and content

Summary

Background

Most people with stroke in India have no access to organised rehabilitation services. The effectiveness of training family members to provide stroke rehabilitation is uncertain. Our primary objective was to determine whether family-led stroke rehabilitation, initiated in hospital and continued at home, would be superior to usual care in a low-resource setting.

Methods

The Family-led Rehabilitation after Stroke in India (ATTEND) trial was a prospectively randomised open trial with blinded endpoint done across 14 hospitals in India. Patients aged 18 years or older who had had a stroke within the past month, had residual disability and reasonable expectation of survival, and who had an informal family-nominated caregiver were randomly assigned to intervention or usual care by site coordinators using a secure web-based system with minimisation by site and stroke severity. The family members of participants in the intervention group received additional structured rehabilitation training—including information provision, joint goal setting, carer training, and task-specific training—that was started in hospital and continued at home for up to 2 months. The primary outcome was death or dependency at 6 months, defined by scores 3–6 on the modified Rankin scale (range, 0 [no symptoms] to 6 [death]) as assessed by masked observers. Analyses were by intention to treat. This trial is registered with Clinical Trials Registry-India (CTRI/2013/04/003557), Australian New Zealand Clinical Trials Registry (ACTRN12613000078752), and Universal Trial Number (U1111-1138-6707).

Findings

Between Jan 13, 2014, and Feb 12, 2016, 1250 patients were randomly assigned to intervention (n=623) or control (n=627) groups. 33 patients were lost to follow-up (14 intervention, 19 control) and five patients withdrew (two intervention, three control). At 6 months, 285 (47%) of 607 patients in the intervention group and 287 (47%) of 605 controls were dead or dependent (odds ratio 0·98, 95% CI 0·78–1·23, p=0·87). 72 (12%) patients in the intervention group and 86 (14%) in the control group died (p=0·27), and we observed no difference in rehospitalisation (89 [14%]patients in the intervention group vs 82 [13%] in the control group; p=0·56). We also found no difference in total non-fatal events (112 events in 82 [13%] intervention patients vs 110 events in 79 [13%] control patients; p=0·80).

Interpretation

Although task shifting is an attractive solution for health-care sustainability, our results do not support investment in new stroke rehabilitation services that shift tasks to family caregivers, unless new evidence emerges. A future avenue of research should be to investigate the effects of task shifting to health-care assistants or team-based community care.

Funding

The National Health and Medical Research Council of Australia.

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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