Protocol for a randomised controlled trial to evaluate the effectiveness of the ‘Care for Stroke’ intervention in India: a smartphone-enabled, carer-supported, educational intervention for management of disabilities following stroke

INTRODUCTION: The rising prevalence of stroke and stroke-related disability witnessed globally over the past decades may cause an overwhelming demand for rehabilitation services. This situation is of concern for low-income and middle-income countries like India where the resources for rehabilitation are often limited. Recently, a smartphone-enabled carer-supported educational intervention for management of physical disabilities following stroke was developed in India. It was found to be feasible and acceptable, but evidence of effectiveness is lacking. Hence, as a step forward, this study intends to evaluate clinical effectiveness of the intervention through a randomised controlled trial. METHODS: The objective of the study is to evaluate whether the ‘Care for Stroke’ intervention is clinically and cost-effective for the reduction of dependency in activities of daily living among stroke survivors in an Indian setting. This study is designed as a randomised controlled trial comparing people who received the intervention to those receiving standard care. The trial will be pragmatic and outcome assessor-blinded. The primary outcome for the study is dependency in daily living measured by the Modified Rankin Scale (MRS). A total of 266 adult stroke survivors who fulfil the eligibility criteria will be randomised to receive either ‘Care for Stroke’ intervention or standard treatment and will be followed up for 6 weeks. The main analyses will compare participants allocated to the ‘Care for Stroke’ intervention versus those allocated to the standard treatment group on an ‘intention-to-treat’ basis, irrespective of whether the participants received the treatment allocated or not. The dichotomised MRS scores (0–3 and 4–6) in both the groups will be used to calculate the effect estimates with a measure of precision (95% CI) and presented in the results of the trial. ETHICS AND DISSEMINATION: The Indian Institute of Public Health-Hyderabad/Public Health Foundation of India – Independent Institutional Ethics Committee and the Ethics Committee of the London School of HygieneandTropical Medicine. Dissemination will be through peer-reviewed publications. TRIAL REGISTRATION NUMBER: Clinical Trial Registry of India CTRI/2017/07/009014.