Dataset Information

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.

SUBMITTER: Sureshkumar K

PROVIDER: S-EPMC5942432 | biostudies-literature | 2018 May

REPOSITORIES: biostudies-literature

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Publications

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.

Sureshkumar K K Murthy G V S GVS Kuper Hannah H

BMJ open 20180509 5

<h4>Introduction</h4>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 f ...[more]

PMID: 29743322

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Project description:BackgroundBurden is well documented among carers of stroke survivors, yet current evidence is insufficient to determine if any strategies reduce this negative outcome. Existing interventions for carers of stroke survivors typically involve supporting carers according to their individual needs through face-to-face interactions and provision of information including workbooks or educational guides. To date, no interventions have been developed using a method which systematically incorporates evidence, behaviour change theories, and stakeholder involvement to change the behaviours of carers and relevant individuals who support carers. This study aimed to develop a programme plan for a theory and evidence-based intervention to reduce burden in carers of stroke survivors.MethodsInformed by evidence from two systematic reviews and 33 qualitative interviews, the first four stages of Intervention Mapping were used to guide the intervention development process: 1) needs assessment; 2) identifying outcomes and objectives; 3) selecting theoretical methods and practical applications; and 4) creating a programme plan. Structured and facilitated involvement from stakeholders, including carers, researchers, and professionals from health and community services was integral to the intervention development process. Stakeholders helped to prioritise the focus of the intervention, develop the goals, outcomes and objectives for the programme, and generate and refine intervention ideas.ResultsStakeholders prioritised the need for carers to feel prepared before and during the transition from hospital to home as key to reducing burden. The proposed intervention 'Preparing is Caring' targets this need and involves providing and signposting carers to relevant information and support for practical and emotional needs. This is to be delivered before, during, and immediately after the stroke survivor's transition from hospital to home by a person taking on a single point of contact role. It is comprised of multiple theory-based components including: training packages for information and support providers working with carers and wider staff teams, plus elements to support carers to feel prepared.ConclusionsWe have developed a comprehensive programme plan for a multiple-component, theory and evidence informed behaviour change intervention aimed at preparing carers before and during the transition from hospital to home. Future work is required to refine, implement and evaluate the Preparing is Caring intervention.

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Project description:The rising prevalence of overweight and obesity has a direct correlation with increasing prevalence of hypertension, dyslipidaemia, type 2 diabetes, metabolic syndrome (MetS) and cardiovascular diseases. Most of the previous studies have been cross-sectional in nature and have looked at the prevalence of metabolic syndrome. Despite the clinical and public health importance of this phenomenon, not enough work has been carried out so far to study and remedy this situation. The objectives of the proposed study is to develop an innovative user-centred informatics platform that will facilitate delivery of a multifactorial intervention after taking into account user sociodemographics, health behaviour, prior disease state and knowledge attitudes and practices.The objective of the proposed study is to develop an innovative user-centred informatics platform that will facilitate delivery of a multifactorial intervention after taking into account users' sociodemographics, health behaviour, prior disease state and knowledge, attitudes and behaviour.A randomised two-group repeated-measures clinical trial design will be used, on 750 subjects from urban, rural and slum areas, in an Indian setting. The study participants will be randomly assigned to either the intervention (computer-based MetS Program, CBMP) or control (printed educational material, PEM) group. Both the groups will undergo screening, learning and evaluation assessments at the time of the visit and at follow-up visits 30, 60 and 90 days after the first visit.The outcomes expected in the intervention group include improvement in Mets-related knowledge, adherence to self-care practices, better quality of life and increased satisfaction with medical care.The study has been approved by the Institutional Review Board of Asian Institute of Public Health (IRB#621). The proposed study will also help us assess the usefulness and challenges of technology to disseminate health education among diverse users. Findings will be disseminated through peer-reviewed publications and national and international conference presentations to various stakeholders and local community health leaders. The ClinicalTrials.gov Identifier is NCT01713465.

Project description:BackgroundThe current evidence for occupational therapy practice, teaching, and research is replicated and implemented significantly from high-income countries in India. Therefore, a systematic review and an evaluation of existing evidence for occupational therapy (OT) to reduce disabilities including impairments, activity limitations, and participation restriction in persons with disabilities (PWD) in India are warranted.ObjectivesThe objective of this review was to evaluate the effectiveness of OT interventions for reducing disabilities in PWD in India.Study designSystematic review.MethodsWe searched the Cochrane CENTRAL, MEDLINE, Embase, CINAHL, PsycINFO, AMED, and Web of Science. A hand search was also carried out in selected Indian journals, OT-specific databases, and repositories, such as Indian Journal of Occupational Therapy, Indian Journal of Physiotherapy and Occupational Therapy, OT Seekers, World Federation of Occupational Therapy Bulletin, Asia Pacific Occupational Therapists Regional Group, and clinical trials registers. The search was restricted to published studies conducted in India during 2000-2021. We included randomized controlled trials (RCTs) of an occupational therapy intervention delivered by OTs for PWD, where the effects of the intervention were evaluated using any relevant disability outcome measure. Studies without access to full text were excluded. Two review authors independently completed screening, and one author reviewed the full text of the screened studies. Another pair of authors extracted data from included studies for prespecified disability outcomes, and two authors assessed the risk of bias in the included studies.ResultsWe identified seven RCTs of occupational therapy interventions for PWD in India with 305 participants in total. All seven studies were very different in terms of their objective, participants, comparison, and outcomes. Allocation concealment and blinding and risk of bias were high in five trials. All the trials reported impairment outcomes with a statistically significant difference between the experimental arm and the control arm in terms of their primary outcomes except one. Given the sample size and the risk of bias in each of the included trials, the effect size has to be understood and interpreted with utmost caution.ConclusionOverall, this review establishes the paucity of evidence for occupational therapy for PWD in India. Building the capacity for rigorous and relevant scientific research in occupational therapy would enable bridging the gaps in evidence for occupational therapy in India.

Dataset Information

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

Methods

Ethics and dissemination

Trial registration number

Publications

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.

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