Shweta J Verma

Family-led rehabilitation after stroke in India: the ATTEND trial, study protocol for a randomized controlled trial

BackgroundGlobally, most strokes occur in low- and middle-income countries, such as India, with many affected people having no or limited access to rehabilitation services. Western models of stroke rehabilitation are often unaffordable in many populations but evidence from systematic reviews of stroke unit care and early supported discharge rehabilitation trials suggest that some components might form the basis of affordable interventions in low-resource settings. We describe the background, history and design of the ATTEND trial, a complex intervention centred on family-led stroke rehabilitation in India.Methods/designThe ATTEND trial aims to test the hypothesis that a family-led caregiver-delivered home-based rehabilitation intervention, designed for the Indian context, will reduce the composite poor outcome of death or dependency at 6 months after stroke, in a multicentre, individually randomized controlled trial with blinded outcome assessment, involving 1200 patients across 14 hospital sites in India.DiscussionThe ATTEND trial is testing the effectiveness of a low-cost rehabilitation intervention that could be widely generalizable to other low- and middle-income countries.Trial registrationClinical Trials Registry-India CTRI/2013/04/003557. Australian New Zealand Clinical Trials Registry ACTRN12613000078752. Universal Trial Number U1111-1138-6707.

FAmily-Led RehabiliTaTion aftEr Stroke in INDia: the ATTEND pilot study

Background The aim of this pilot study was to determine the feasibility of a multicenter, randomized, controlled trial in India of a family-led, trained caregiver-delivered, home-based rehabilitation intervention vs. routine care. Methods A prospective, randomized (within seven-days of hospital admission), blinded outcome assessor, controlled trial of structured home-based rehabilitation delivered by trained and protocol-guided family caregivers (intervention) vs. routine care alone (control) was conducted in patients with residual disability. Key feasibility measures were recruitment, acceptance and adherence to assessment procedures, and follow-up of participants over six-months. CTRI/2014/10/005133. Results A total of 104 patients from the stroke unit at Christian Medical College, Ludhiana were recruited over nine-months. Recruitment was feasible and accepted by patients and their carers. Important observations were made regarding potential unblinding of the participants, contamination of therapy between the randomized groups, organization of home visits, and resources required for a multicenter study. Conclusion The pilot study established the feasibility of conducting a large-scale study of family-led, trained caregiver-delivered, home-based stroke rehabilitation in a low resource setting. The main phase of the trial ‘ATTEND’ is currently underway in over 10 centers in India.

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

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.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.

Incidence, short-term outcome, and spatial distribution of stroke patients in Ludhiana, India

Objective: To estimate the incidence, short-term outcome, and spatial distribution of stroke patients and to evaluate the completeness of case ascertainment in Ludhiana. Methods: This population-based prospective cohort study was conducted in Ludhiana, Punjab, Northwest India. All first-ever stroke patients (≥18 years) were included between March 2010 and March 2013 using WHO Stepwise Approach Surveillance methodology from the city. Stroke patient data were obtained from hospitals, scan centers, and general practitioners, and details of deaths from the Municipal Corporation. Results: Out of 7,199 stroke patients recruited, 3,441 were included in final analysis. The mean age was 59 ± 15 years. The annual incidence rate was 140/100,000 (95% confidence interval [CI] 133–147) and age-adjusted incidence rate was 130/100,000 (95% CI 123–137). The annual incidence rate for stroke in the young (18–49 years) was 46/100,000 (95% CI 41–51). The case fatality at 28 days was 22%. Patients above 60 years of age (p = 0.03) and patients who were managed in public hospitals had poor survival (p = 0.01). Hot spots for cumulative incidence were seen in central and southern parts of the city, and hot spots for poor outcome were seen in the outskirts of the city. Conclusions: The incidence rates are similar to other studies from India. Stroke patient survival is poor in public hospitals. The finding of spatial analysis is of public health significance for stroke prevention and strengthening of stroke services.

Establishment of population-based stroke registry in Ludhiana city, northwest India: feasibility and methodology.

Background/Aims: The Indian Council of Medical Research (ICMR) initiated the Task Force Project to evaluate the feasibility of conducting a population-based stroke registry in Ludhiana city, Punjab, Northwest India. Methods: All first-ever, stroke patients over 18 years from the city of Ludhiana were included in the study from March 26th 2010 to March 25th 2011. Stroke information was collected based on the WHO STEPS approach from the participating hospitals, scan centres and doctors. Modified Rankin Scale (mRS) was administered by telephonic interview at 28 days after stroke. The information on stroke deaths was obtained from the Municipal Corporation (MC) office. Results: A total of 905 first-ever stroke patients were documented. After excluding duplicate cases and patients from outside the city, 493 patients were included. The practical issues identified in data collection from these centres were reluctance to take informed consent, lack of willingness to share the data, difficulty to identify key persons from each centre, retrieving medical records from public hospitals and poor documentation of deaths in MC office. Conclusion: Population-based stroke registry was feasible in an urban population with the above methodology. The issues related to feasibility were identified and necessary changes were made for the main phase of the registry.

Statistical analysis plan for the family-led rehabilitation after stroke in India (ATTEND) trial: A multicenter randomized controlled trial of a new model of stroke rehabilitation compared to usual care.

Background In low- and middle-income countries, few patients receive organized rehabilitation after stroke, yet the burden of chronic diseases such as stroke is increasing in these countries. Affordable models of effective rehabilitation could have a major impact. The ATTEND trial is evaluating a family-led caregiver delivered rehabilitation program after stroke. Objective To publish the detailed statistical analysis plan for the ATTEND trial prior to trial unblinding. Methods Based upon the published registration and protocol, the blinded steering committee and management team, led by the trial statistician, have developed a statistical analysis plan. The plan has been informed by the chosen outcome measures, the data collection forms and knowledge of key baseline data. Results The resulting statistical analysis plan is consistent with best practice and will allow open and transparent reporting. Conclusions Publication of the trial statistical analysis plan reduces potential bias in trial reporting, and clearly outlines pre-specified analyses. Clinical Trial Registrations India CTRI/2013/04/003557; Australian New Zealand Clinical Trials Registry ACTRN1261000078752; Universal Trial Number U1111-1138-6707.

Family-led rehabilitation in India (ATTEND)—Findings from the process evaluation of a randomized controlled trial

Background Training family carers to provide evidence-based rehabilitation to stroke patients could address the recognized deficiency of access to stroke rehabilitation in low-resource settings. However, our randomized controlled trial in India (ATTEND) found that this model of care was not superior to usual care alone. Aims This process evaluation aimed to better understand trial outcomes through assessing trial implementation and exploring patients’, carers’, and providers’ perspectives. Methods Our mixed methods study included process, healthcare use data and patient demographics from all sites; observations and semi-structured interviews with participants (22 patients, 22 carers, and 28 health providers) from six sampled sites. Results Intervention fidelity and adherence to the trial protocol was high across the 14 sites; however, early supported discharge (an intervention component) was not implemented. Within both randomized groups, some form of rehabilitation was widely accessed. ATTEND stroke coordinators provided counseling and perceived that sustaining patients’ motivation to continue with rehabilitation in the face of significant emotional and financial stress as a key challenge. The intervention was perceived as an acceptable community-based package with education as an important component in raising the poor awareness of stroke. Many participants viewed family-led rehabilitation as a necessary model of care for poor and rural populations who could not access rehabilitation. Conclusion Difficulty in sustaining patient and carer motivation for rehabilitation without ongoing support, and greater than anticipated access to routine rehabilitation may explain the lack of benefit in the trial. Nonetheless, family-led rehabilitation was seen as a concept worthy of further development.

Stroke profile and outcome between urban and rural regions of Northwest India: Data from Ludhiana population-based stroke registry

Introduction The objective of this study is to compare the clinical profile, risk factors, type and outcome of stroke patients in urban and rural areas of Punjab, India. Methods The primary data source was from the Ludhiana urban population-based stroke registry. The data of first-ever stroke patients with age ≥18 years were collected using WHO stepwise approach from all hospitals, general practitioners, physiotherapy and scan centres between 26 March 2011 and 25 March 2013. Results A total of 4989 patients were included and out of 4989 patients, 3469 (69%) were from urban areas. Haemorrhagic stroke was seen more in rural as compared to urban regions (urban 1104 (32%) versus rural 552 (36%); p = 0.01). There were significant differences seen in stroke risk factors; hypertension (urban 1923 (84%) versus rural 926 (89%); p = 0.001) and hyperlipidaemia (urban 397 (18%) versus rural 234 (23%); p = 0.001) between two groups. In the multivariable analysis the rural patients were more likely to be younger (age < 40 years) (OR: 1.82; 95% CI: 1.24–2.68; p = 0.002), Sikhs (OR: 2.57; 95% CI: 1.26–5.22; p = 0.009), farmers (OR: 9.41; 95% CI: 5.36–16.50; p < 0.001), housewives (OR: 2.71; 95% CI: 1.45–5.06; p = 0.002), and consumed alcohol (OR: 1.57; 95% CI: 1.19–2.06; p = 0.001) as compared to urban patients. In addition, use of imaging was higher in rural patients (OR: 1.99; 95% CI: 1.06–3.74; p = 0.03) as compared to urban patients. Discussion and Conclusion In this large cohort of patients, rural and urban differences were seen in risk factors and type of stroke. Stroke prevention strategies need to take into consideration these factors including regional sociocultural practices.