A Randomized 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 Rationale: To the best of our knowledge, there are no stroke rehabilitation interventions enabled through Mhealth platforms that are available and relevant to India, where the resources for rehabilitation are limited and the unmet needs of stroke survivors are substantial. As a part of my doctoral study, I developed a smartphone-enabled carer-supported educational intervention for management of disabilities following stroke and evaluated the intervention for its feasibility and acceptability in an Indian context. Findings from the pilot-testing showed that the ‘Care for Stroke’ intervention was feasible and acceptable in the Indian context. About 95% of the stroke survivors and all the caregivers (100%) rated the intervention to be excellent, based on its overall credibility, usability and user-friendliness. As a next step and as recommended by the Medical Research Council (MRC), it was decided to evaluate the effectiveness of this newly developed rehabilitation intervention in an Indian context through a randomized controlled trial. Objective: The Care for Stroke trial will provide reliable evidence as to whether a Smartphone-enabled Carer-supported educational intervention can reduce disability in patients with stroke. Methods: Overview This Trial will be a pragmatic, randomized, single-blind, controlled trial to quantify the effect of the Care for Stroke Intervention on disability in Stroke patients. A total of 320 adult stroke patients who fulfil the eligibility criteria will be randomized to receive either Care for stroke intervention or standard treatment. Setting Patients will be recruited through the information obtained about their stroke and their contact details in the Insurance claim data available at Aarogyasri Trust. A government run insurance scheme for people of Telangana. Eligible Participants: Inclusion Criteria 1. Adults (aged ≥18 years) 2. Recent diagnosis of ï¬rst-ever stroke as deï¬ned by the WHO (within 3-6 weeks prior to recruitment) 3. All kinds of stroke severity (score 1 - 42, according to NIH stroke scale) 4. Stroke survivor medically stable (reaching a point in medical treatment where life-threatening problems following stroke have been brought under control) 5. Post-stroke functional status of the stroke survivor: requiring assistance of at least one person to perform daily activities such as transfers, self-care and mobility (scoring less than the maximum score obtainable in one or more components of the Barthel Index) 6. Stroke survivor residing with a primary caregiver (family member) at home. Intervention The ‘Care for Stroke’ intervention will be delivered through a smartphone and it will include information about stroke and the ways to manage post-stroke disabilities. The intervention includes 2-3 minutes of several videos in vernacular language organized in five sections. The sections are information about stroke, home-based exercises, functional skills training, activities of daily living, and assistive devices. The intervention will also have an option for the stroke survivor or the identified caregiver to contact the intervention coordination centre for any support. Intervention Arm The stroke survivor and their caregiver will receive 45–60 min of training from a training administrator on access and use of the intervention (watching videos) via the smartphone. Participants will then be provided with a smartphone preloaded with the ‘Care for Stroke’ intervention and asked to try it out on their own. Three or more errorless attempts to retrieve the required part of the intervention from the smartphone will be considered successful training. After successful training, participants will be provided with a smartphone loaded with the intervention and will be asked to use this intervention at their discretion at home for 6 months. The identified caregivers of stroke survivors will be asked to support the stroke survivors as and when necessary to access the intervention from the Smartphone. The intervention administrator will make telephonic contact with the patient minimum once in a week during the intervention period to remind, support and obtain updates from the patient or identified caregiver on utilisation of the intervention. This conversation will be documented by the training administrator and the notes kept privately in a locked cupboard. Control Arm Standard post stroke rehabilitation: Usual stroke rehabilitation services available for stroke patients. The standard treatment will include provision of physiotherapy (45minutes to 60 minutes) at home or in a clinic facility for the patient based on goals set by the therapist. Outcome Measures Primary Outcome The primary outcome measure is the effect of treatment allocation on dependency measured by the modified Rankin Scale (MRS) at 3 and 6 months after randomization. The MRS scale measures the degree of disability or dependence in the activities of daily living of people who have suffered a stroke in six categories. The maximum score a patient can obtain is 6, which means the patient is dead. A patient without any disability would score zero. Sample size Estimation To evaluate the effects of the Smartphone-enabled educational intervention on dependency, I will need approximately 320 participants (160 in each group) to detect a 20% difference in patient dependency (using Modified Rankin Scale) between the treatment groups with 95% power at the 5 % level of statistical significance and with 20% attrition. Data Collection and Management The trial coordination center will be based in the Indian Institute of Public Health Hyderabad. A trial steering committee and an independent data monitoring committee will be set up oversee the conduct of the trial. Conclusion: Investigating the intervention effectiveness as a priority would provide immense insights for planning, implementation and the potential scalability of the intervention, especially in countries with limited resources for rehabilitation. |