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

Abstract

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.

Keywords: clinical trials; disability; mhealth; rehabilitation medicine; stroke.

Figure 1

Flow chart of the Care for Stroke trial.