Abstract
BackgroundKerala is known as the diabetes mellitus (DM) and hypertension (HTN) capital of the world, thus compelling health professionals to model strategies, addressing their social, behavioural, and cognitive risk factors and eliminating various barriers to management. This paper describes the protocol of our study that aims to examine the effectiveness and sustainability of an integrated care model for the management of chronic conditions and their risk factors through a family-based intervention. The proposed care model targets to modify systems and processes that predispose to chronic conditions by enhancing social cohesion and social networks, preventing lifestyle risks, developing iterative cognitive interventions, and engaging the family into customised treatment adherence strategies navigated by community health social workers (CHSWs).MethodsA cluster randomised controlled trial (RCT) in selected participants will be conducted involving additional assessments prior to the baseline assessment. The assessment will identify and categorise patients into four risk groups, namely behavioural, social, cognitive, and multiple, based on dominant risks identified. Eligible participants will be randomly allocated (at a ratio of 1:1) into the intervention or control arm. The intervention arm will receive social, behavioural, and cognitive or multiple interventions corresponding to the identified risk groups, whereas the control arm will receive general intervention. Both the groups will be followed up at 6 months and 12 months post baseline to measure outcomes. The primary outcome will be the control of HTN and DM, and secondary outcomes include decreased depression and anxiety and improved functioning, social cohesion, and social network linkages. The sustainability and scalability of this intervention will be assessed through cost effectiveness, acceptability, and user friendliness of the integrated approach by performing a qualitative evaluation.DiscussionThis RCT will inform the potential paradigm shift from a medical model of chronic condition management to a multidimensional, multisystem, and multidisciplinary convergence model navigated by CHSWs. Such a model is not currently considered in the management of chronic conditions in Kerala.Trial registrationTrial has been prospectively registered on Clinical Trial Registry of India- CTRI/2020/12/029474 on 1st December 2020.
Highlights
Kerala is known as the diabetes mellitus (DM) and hypertension (HTN) capital of the world, compelling health professionals to model strategies, addressing their social, behavioural, and cognitive risk factors and eliminating various barriers to management
Saju et al BMC Family Practice (2021) 22:15 (Continued from previous page). This randomised controlled trial (RCT) will inform the potential paradigm shift from a medical model of chronic condition management to a multidimensional, multisystem, and multidisciplinary convergence model navigated by community health social workers (CHSWs)
Treatment arm We propose to utilise existing healthcare resources such as Primary Health Centre (PHC), Accredited Social Health Activist (ASHA) workers, nongovernmental organisation (NGO), and family counselling centres, which are already functioning in the community, for the intervention
Summary
To incorporate lifestyle modifications to manage diabetes and hypertension in patients. Intervention implementation: behavioural Behavioural interventions are proposed for lifestyle modifications to manage DM and HTN and are widely used to gain control over chronic illnesses [15]. Cognitive interventions will include (1) video interventions highlighting risk factors associated with various chronic conditions, symptoms of anxiety and depression, and cognitive and behavioural steps to manage anxiety and depression and (2) strategies to improve social cohesion and communication, such as encouraging common meals, family routines, etc. Monitoring and coordination will be conducted by the research team and CHSWs. Two-day training will be provided to all ASHA workers prior to the implementation of the interventions. The intention-to-treat analysis will be used to observe changes occurred throughout the year during follow-up in participants assigned to the Swāsthya intervention and usual care. All changes in the trial protocol will be informed to the institutional review board
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