Strategic multimodal intervention in at-risk elderly Indians for prevention of dementia (SMRUTHI INDIA): a cohort multiple randomised controlled trial (cmRCT) protocol
Strategic multimodal intervention in at-risk elderly Indians for prevention of dementia (SMRUTHI INDIA): a cohort multiple randomised controlled trial (cmRCT) protocol
Treating modifiable risk factors of dementia may prevent or delay dementia cases by up to 40%. The ‘Strategic Multimodal Intervention in at-risk Elderly Indians for Prevention of Dementia (SMRUTHI INDIA)’ study will be conducted to establish a trial-ready cohort of elderly Indians who are at high risk of developing dementia.
The main aim of the study is to create and study a cohort of individuals at high risk of dementia in rural India, where we can do multiple intervention trials. The study uses the ‘Cohort Multiple Randomised Controlled Trial’ (cmRCT) design, which combines a cohort study with in-built provisions to do multiple randomised controlled trials. A large rural cohort of size 10 000 (four zones of India, through established Indian Council of Medical Research - Model Rural Health Research Units) will be followed systematically with yearly neuropsychological evaluation for 5 years (the current funding supports first 3000 participants). The study also proposes to design a multimodal ‘care bundle’ for the prevention of dementia, which is culturally tailored and context-specific to the Indian population. This intervention will undergo testing for feasibility in the hospital setting at the central coordinating site through a pilot randomised controlled trial (6 months, 30 participants). In parallel, the care bundle will be culturally and linguistically adapted and pilot-tested in 20 participants in each zone. The final curated care bundle (first intervention that is planned) will then be tested for efficacy in phase 2 of the SMRUTHI INDIA cmRCT cohort.
The study has received ethical clearance at the central coordinating site and at each of the four clinical sites by the Institute Research Committee of each site. The outcomes of the study will be disseminated to various target audiences, including research participants, general public, scientific community and policy makers through national and international conferences and events, social media, various community engagement activities and publication in peer-reviewed journals.
The study protocol is registered in the Clinical Trial Registry of India (CTRI/2024/01/061172).
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Dementia is the fifth leading cause of death, and nearly 50 million people are suffering from the disease worldwide.1 It has a tremendous impact socially and economically as caregiving incurs psychological morbidity, physical ill health and financial hardship. Dementia care costs more than a trillion US dollars per year, which is a huge societal cost.2 Developing countries face even bigger challenges in the form of an ageing population and limited resources. By 2050, 20% of the Indian population will be more than 60 years old, which will be more than the total United States population.3 These global estimates compel opinion leaders and policy makers to call for action worldwide.
The pathophysiology of dementia starts years before the actual manifestation of symptoms, giving a window of opportunity to intervene and prevent or delay the clinical manifestations. It has been estimated that, if an intervention can delay the onset of dementia by 2 years, it will result in 2 million lesser cases in the United States alone by 2020.2 The Lancet Commission on Dementia Prevention, Intervention, and Care (using population attributable fractions (PAFs)) estimates that 39.7% of dementia cases worldwide are attributable to 12 potentially modifiable risk factors: less education, hypertension, diabetes, obesity, smoking, alcohol excess, physical inactivity, social isolation, depression, hearing loss, traumatic brain injury and air pollution.4 However, these risks vary between countries and within subpopulations. The risk factor prevalence estimates from India (10/66 survey data, 2004 participants) appraise a higher PAF (41.2% (39.1%–43.4%)) than high income countries and a greater prevalence and weightage for less childhood education, smoking, hypertension, obesity and diabetes compared with worldwide estimates.5 Many developed countries have already achieved around 20% reduction in age-specific dementia incidence or prevalence over the last two decades.6 The Framingham Heart Study has shown that there was a 23% decline in the risk of incidence of dementia per decade (1970–2010).7 This unexpected decline in age-specific dementia incidence or prevalence in some Western countries, probably due to better control of risk factors, has also added value to the concept of preventive strategies. On this note, the Finnish Geriatric Intervention Study to Prevent Cognitive Impairment and Disability (FINGER)8 trial was the first large-scale long-term randomised controlled trial to support the efficacy, feasibility and safety of a multidomain intervention targeting reduction in the risk of cognitive decline in the general population (elderly at risk individuals).9 Subsequently, a number of primary prevention trials have been initiated or completed globally.
India is a socio-culturally and ethnically diverse population, with a very high burden of vascular risk factors. Few longitudinal cohort studies to identify risk and protective factors of dementia are now ongoing in the country.1 However, no large-scale intervention studies focusing on dementia prevention are yet available. These intervention studies would need adaptation to the specific socio-cultural milieu of the country and provide economically viable, scalable and sustainable solutions.
Through ‘Strategic Multimodal Intervention in at-risk Elderly Indians for Prevention of Dementia (SMRUTHI-INDIA)’, we plan to develop a new strategy of ‘Cohort Multiple Randomised Controlled Trial’ (cmRCT) where we will set up a large cohort of population with risk factors for dementia and follow them systematically with yearly neuropsychological evaluation to look for the incidence of mild cognitive impairment (MCI) or dementia.10 We propose to design a multimodal ‘care bundle’ for the prevention of dementia, which is culturally tailored and context-specific to the Indian population and can be implemented nationally at the level of primary health centres or ‘wellness clinics’ (a Government of India initiative under the National Health Protection Scheme).11 The care bundle, which can be delivered by a nurse/multipurpose worker/medical/paramedical personnel, will include psychoeducation material explaining the life course risk factors and protective factors for dementia, information on nutritional options (akin to Mediterranean diet) in the Indian setting, physical exercise and/or yoga (with videos), options for cognitive exercises (feasible in Indian setting), and motivation for regular monitoring of blood pressure, blood sugar and smoking/alcoholism cessation. In this cohort, we will be able to conduct randomised controlled trials for intervention strategies, and the first intervention we would test is the efficacy of a culturally sensitive multimodal intervention for the prevention of dementia. Since 65% of the Indian population resides in rural areas (Economic Survey 2022–23)12 and previous studies on dementia have mainly focused on the urban population; we are recruiting the rural population (including tribal) with diverse cultural and linguistic backgrounds from four zones of India.
With nearly one-fifth of the world population residing in India and 8 million individuals (aged 60 years and above) living with dementia, a preventive strategy for dementia is the need of the hour.13 14
We will use the design of cmRCT which combines a cohort study with in-built provisions to do multiple randomised controlled trials.9
The study will be carried out in two phases. In Phase 1, we aim to establish a prospective longitudinal cohort of cognitively normal population in the community (55 years and above) with multiple risk factors (Cardiovascular Risk Factors, Ageing and Incidence of Dementia (CAIDE) score≥6) and develop and validate a multimodal “care bundle” intervention. In Phase 2, we will evaluate the efficacy of the possible interventional strategies and the first intervention to be tested will be the multimodal ‘care bundle’ in the prevention of dementia among the established cohort.
The main aim of the study is to create and study a cohort of individuals at high risk of dementia in rural India, where we can do multiple intervention trials. The primary hypothesis of the first intervention study (planned in phase 2) is that lifestyle interventions in the high-risk population can reduce cognitive decline in rural India.
The community cohort will be established in the rural areas of four zones across India (figure 1). The establishment of the cohort will be done through Model Rural Health Research Units (MRHRUs), already functioning under the Department of Health Research (DHR), Ministry of Health and Family Welfare, Government of India, in different parts of the country (East, West, North and South). The field practice area of the healthy facility associated with MRHRU would be the study population. The selected MRHRUs include Haroli, Una in Himachal Pradesh (North India), Kherengbar Hospital, Khumulwng in Madhapur Tripura (East India), Khanpur Kalan, Jaipur, Rajasthan (West India) and Sirwar, Raichur, Karnataka (South India).
The establishment of the cohort will be monitored by the central site at All India Institute of Medical Sciences, New Delhi (tertiary care hospital, North India). The team here would include neurologists, neuropsychologists, clinical psychologists, nutritionists, physiotherapists, mental health professionals and biostatisticians. This team will monitor the validity and quality of the data collected at each of the four sites. Data are entered and stored into REDCap (a secure, password-protected platform) by each site to ensure quality and security. Trained staff collect data, the central team reviews it regularly and weekly meetings are held to address queries and implement corrections. The central team will also prepare a ‘multimodal care bundle’ module and test it for feasibility in a pilot RCT conducted in the hospital setting. In parallel, the care bundle will be culturally and linguistically adapted (for the different zones) and pilot tested for acceptability (in the rural community) in 20 participants in each zone. If the care bundle is safe and feasible, its efficacy will be tested in phase two in the community as the first randomised controlled trial.
For the longitudinal cohort, participants will be recruited from the community who are 55 years or older (no upper limit for age), have a CAIDE score ≥6 and are cognitively normal at baseline. The participants should be permanent residents of the defined area and should consent to participate and complete all study-related activities for 5 years. People who have dementia or MCI; significant vision, hearing or communication problems or head injury (deemed to affect neuropsychological testing); known cases of psychiatric illness (major depressive disorder or psychosis or intellectual disability); any type of stroke or structural brain abnormality or known case of epilepsy; or those with significant medical illness like decompensated liver disease, end stage renal disease or systemic malignancy will be excluded.
The present study was started on 30 December 2012. The current funding provides support of 3 years and the tentative end date is 29 December 2025. For the pilot testing of the prepared module, participants fulfilling the above inclusion and exclusion criteria will be were recruited from 1 July 2024 in the hospital setting at the central site. Their 6-month follow-ups have been completed and the results are currently being analysed. Based on the feasibility and safety of the pilot study, the start date of the main trial will be decided by the evaluation task force of the funding agency, which isthe Indian Council of Medical Research.
Baseline assessments include collecting information on the demographic profile, risk and protective factors of dementia (table 1) and a detailed neuropsychological assessment (table 2). As we are including illiterate/low-literacy participants in the cohort to maintain representativeness of the rural Indian population, for neuropsychological testing, validated tools from the Indian Council of Medical Research (ICMR) Neuro Cognitive Toolbox that cater to linguistically and culturally diverse populations, including those with low literacy, will be used.15 16 For screening too, we will be using the Addenbrooke’s Cognitive Examination III (ACE III) illiterate (developed specifically for the illiterate or low literate Indian population17) or literate18 version as appropriate. Participants with less than 8 years of formal school education will be considered low literate. The assessment scales planned to be used in the study are available in the public domain, and necessary permissions have been obtained wherever required.
Table 1
Predictor variables with definitions and measurement scales
Table 2
Details of neuropsychological assessment
For outcome analysis, the syndromal staging of the cognitive continuum from the National Institute of Ageing Alzheimer’s Association 2018 criteria19 will be used. This staging system highlights the importance of clinical judgement from all available information and circumvents overinterpretation of formal neuropsychological batteries and their normative data to diagnose cognitive impairment in the illiterate/low literate populations. The definitions of outcome variables are given in table 3. A detailed diagnostic algorithm for cognitive syndromes based on clinical judgement is given in online supplemental appendix (SA table 1).
Table 3
Outcome variables with definitions
The primary outcome will be incident of all-cause probable dementia or MCI yearly till 5 years. The secondary outcomes include incidence of dementia yearly till 5 years, incidence of MCI yearly till 5 years, time to first occurrence of diagnosis of MCI, time to first occurrence of diagnosis of dementia, change in composite and domain Z scores yearly till 5 years, change in Lifestyle for Brain health (LIBRA) index yearly till 5 years, mortality yearly till 5 years, composite outcome of occurrence of stroke, myocardial infarction (MI), MCI or dementia yearly till 5 years, and composite outcome of occurrence of stroke or MI yearly till 5 years.
The first phase of the study will include cohort recruitment in the community and preparation of the multimodal care bundle (figure 2).
Figure 2
Study workflow. Anthro, anthropometry; CACE, Complier Average Causal Effect; cmRCT, cohort multiple randomised controlled trial; SMRUTHI, Strategic Multimodal Intervention in at-risk Elderly Indians for Prevention of Dementia.
Cohort recruitment
Sample selection
We will follow an area sampling strategy with mapping of the catchment area. We will approach eligible individuals to recruit 10 000 subjects. The details of the sampling strategy of each geographic zone are given in the online supplemental appendix.
Recruitment
Field investigators will do a house-to-house survey to select the eligible population. Those who fulfil the inclusion–exclusion criteria will be included in the cohort study after written informed consent. A structured Performa will be used to collect the demographic, risk factor profile and neuropsychological performance. Neuropsychological testing will be done by psychologists trained in the administration of cognitive tests. The history of cognitive decline and the informant section of the questionnaires will be taken from reliable informants identified at the home visit. Those found to have cognitive impairment at baseline testing (MCI or dementia) will be excluded from the cohort and referred to the physician/neurologist in the medical college/hospital attached to the MRHRU for further evaluation. These MRHRUs are already functioning healthcare structures in respective rural areas and have a good rapport with the local communities. In addition, the Accredited Social Health Activist (ASHA workers), a female community health worker in India, who delivers National health programmes, will be contacted to facilitate house to house recruitment and retention of participants during the cohort and trial follow-up.
To ensure confidentiality, only participants’ initials and the last four digits of their National Unique Identification Number (Aadhaar) are recorded as the central team has access to all data; each site can access only its own.
Assessments
The participants will undergo optional blood investigations (complete blood count, liver function tests, kidney function tests, fasting lipid profile, thyroid profile and glycated haemoglobin (HbA1C)) in a fasting state at the MRHRU or associated health facility wherever feasible. Only mandatory investigations will be fasting or random blood glucose and total cholesterol.
Follow-up
The participants will undergo 6 monthly telephonic follow-up for any self-reported events (memory problems, MI, stroke, hospitalisation, surgery and death), and this will be verified by the field investigator during in-person follow-up visit. An annual reassessment will be done for the predictors and outcome variables to document changes and outcomes.
Development and validation of SMRUTHI Multimodal Care Bundle
The multimodal care bundle will be developed at the nodal centre by a team comprising neurologists, neuropsychologists, nutritionists, physiotherapists, yoga therapists and deaddiction psychiatrists. This process will involve three phases – (a) preparatory phase to develop the content of the multimodal care bundle, (b) acceptability and adaptability phase where the content will be refined with the help of stakeholders and (c) feasibility phase which will include a feasibility pilot RCT at the central site (AIIMS New Delhi).
Preparatory phase
An extensive literature review will be conducted on the lifestyle interventions in the prevention of dementia, including the various primary prevention programmes running world-wide. The team will create a model that constitutes psychoeducation about dementia and its life course risk and protective factors, culturally appropriate nutritional guidance, physical exercise or yoga, cognitive enhancement (via cognitive activities) and motivation for de-addiction and vascular risk factor control. A booklet will be created to disseminate knowledge on the above care model components with videos to support the exercise and yoga training (SA table 2). We will design an adherence measurement tool that can track objective and self-reported measures of adherence to the care bundle. The adherence measurement tool will be tested in the feasibility stage.
Acceptability and adaptability phase
The draft module will be made in English and Hindi during the preparatory phase and shared with the four sites for feedback. The site teams will discuss the cultural acceptability and share the feedback with the central site. The suggested changes will be discussed by the central team, and the care bundle will be finalised after required changes for the feasibility study.
Feasibility phase
A feasibility study (a pilot RCT) will be conducted at the central site on 30 patients satisfying the inclusion criteria with 6 months follow-up. The pilot RCT will assess the issues with recruitment, acceptability, uptake and retention of the care bundle. A preintervention and postintervention questionnaire will be evaluated before and after the study period. The adherence measurement tool designed in the preparatory phase will be tested on the recruited participants. The module will be translated to local languages and also pilot-tested for acceptability in the community in each zone. Finally, a process evaluation will be conducted, and remaining issues will be solved and incorporated into the final care bundle module (CBM) before testing for efficacy in phase 2 in the community.
Phase 2
Phase 2 of the study will be conducted in the prospectively recruited cohort using the cmRCT design. The first intervention planned for the efficacy testing will be the multimodal care bundle in prevention of dementia, which will be compared with standard health advice given through existing national health programmes for non-communicable diseases. The intervention will be delivered by the field investigators. Thetemplate for intervention description and replication checklist is provided in the online supplemental checklist. The detailed protocol for phase 2 testing of the care bundle will be finalised after funding approval.
Randomisation
Randomisation in cmRCT design is different from traditional RCT designs. The purpose of randomisation is to create two or more groups whose selection and management should not have been influenced by anything other than chance, and all known and unknown prognostic variables are evenly distributed among the groups. In the conventional design, there is random allocation of all eligible (NA) participants into multiple groups. In the cmRCT design, there is random selection of nA participants from all (NA) eligible participants, and this has nearly the same effect as conventional design because the selection is purely based on chance. Moreover, random selection of nA from NA gives two groups: nA and NA–nA, where all known and unknown prognostic variables are distributed by chance alone. The advantage of this method of randomisation is that consent for RCT is required only for those randomly selected to the intervention (nA), and others (NA-nA) have already given prior consent for cohort study, and they don’t need consent for intervention as they are in the control arm. This helps prevent the disappointment bias among those not selected for receiving the intervention.
Allocation concealment
A computer-generated list will be used for random selection of patients for the intervention arm at each site. The statistician from the central team will generate the allocation sequence, while the field investigators and psychologists at each MRHRU will enrol participants.
Blinding
The outcome assessors and statistical analyst will be blinded to the patients receiving the intervention or care as usual (details in online supplemental appendix).
Intervention duration and outcome assessment
The detailed framework, design, allocation ratio, duration of intervention and outcomes will depend on the nature of future interventions planned for testing in cmRCT.
Withdrawal from trial
A participant may be withdrawn from the intervention if it is the wish of the participant or if it is medically necessary (as per the investigator). If a participant misses a scheduled visit, every effort will be made to contact the participant. The reason for withdrawal from the study will be clearly documented in the case record form. If the participant wishes, he can continue in the ongoing cohort study.
Phase 1
The calculation of sample size to establish a cohort (that will facilitate in obtaining the incidence of dementia and the conduct of RCT(s) if found suitable) has been done using two approaches, resulting in similar sample sizes as presented below:
Phase 2
The sample size of any future RCT will depend on the nature of future interventions planned for testing in this cmRCT study.
Age-specific incidence of dementia will be calculated using the person-years approach. A person–time incidence rate of all-cause dementia will be calculated by dividing the number of cases with onset of dementia by the total person-years at risk during the follow-up period. The data of the last follow-up (with neuropsychological evaluation) will be considered as the end point for those participants who die or drop out. Gender-specific incidence rates will also be presented along with 95% confidence intervals (CI) obtained under Poisson distribution. The individuals diagnosed with dementia will be evaluated for the number of years (in specified intervals) taken to develop dementia after the baseline examination. Age-specific ‘number of years taken to develop dementia after entry to cohort’ will also be presented. The characteristics of individuals who developed dementia will be compared with the individuals who remained free of dementia till the end of the follow-up period. These comparisons will be performed using independent samples t-test (or Mann–Whitney U test) and Fisher’s exact test wherever applicable. Risk factors will be examined using Cox proportional hazards regression models, and a Kaplan–Meier curve will also be performed for time-to-event data. The risk factor results will be reported as ratios of incidence rates. A sensitivity analysis will be conducted to evaluate the potential effects on incidence if participants who died or dropped out were likely to have dementia. Intention to treat and complier average causal effect analysis will be performed.9
‘We have replaced “disabling stroke” with any type of stroke’, added ‘intellectual disability’ under psychiatric illness, added ‘head injury’ and ‘known case of epilepsy’ in the exclusion criteria, and added option of random blood glucose and total cholesterol to the blood sampling as a mandatory investigation.
Public feedback on the care bundle module will be taken from each geographic area and once study is completed, the results will be communicated to the participants and general public though our website and social media accounts.
India is witness to a significant epidemiological shift in non-communicable diseases (NCDs)21, and 65% of the Indian population resides in rural India,22 where people have more barriers to healthcare access and may be more susceptible to modifiable dementia risk factors. Through SMRUTHI INDIA, we intend to establish a cohort of such individuals at high risk of dementia in socio-culturally different zones of rural India; do a detailed risk factor and cognitive assessment at baseline and an yearly follow-up (with risk factor and neuropsychological testing) till 5 years; create a CBM based on multimodal lifestyle interventions targeting the risk and protective factors of dementia which is culturally appropriate; and test the efficacy and real-world adaptability of this CBM (in Phase II of our study).
SMRUTHI India aligns with global initiatives like FINGER,8 US-POINTER,23 MIND-CHINA24 and others in its approach to dementia prevention and stands out for its focus on the rural Indian population and the culturally specific multimodal intervention that it provides. Comparable Indian studies include the ‘Longitudinal Aging Study in India–Diagnostic Assessment of Dementia (LASI-DAD)’,25 which examines cognition and health among 3224 participants across urban and rural areas, and the ‘Tata Longitudinal Study on Aging (TLSA)’,26 a cohort study (1000 ageing participants) from urban Bangalore that assesses cognitive health via advanced neuroimaging and genetics. A related rural counterpart, the ‘Srinivaspura Aging, Neuro Senescence and COGnition (SANSCOG)’ study27 focuses on agricultural communities (projected n=10 000). Another study ‘Advancing Approaches for Dementia and Associated Research (AADAR)’1 aims to investigate dementia risk factors across diverse Indian populations, encompassing both rural and tribal groups, while Longitudinal Cognition and Aging Research on Population of the National Capital Region (LoCARPoN)28 is a prospective population-based Indian cohort to study incident stroke and dementia in an urban upper-middle class population in India, integrating sociodemographic, lifestyle, anthropometric, dental, biochemical and neuropsychological measurements with MRI, neuroimaging and genomics. Each of these studies enhances understanding of cognitive decline, ageing and dementia risk within India, addressing both rural and urban health challenges. They emphasise the need for culturally tailored interventions and explore key factors like hypertension, education and socioeconomic status, all of which may contribute to cognitive health disparities across the country’s diverse populations. The part, which is unique to SMRUTHI India, is that we are simultaneously working on a culturally tailored multimodal intervention strategy for primary prevention of dementia. Current dementia prevention models, such as the Finnish FINGER study,8 have demonstrated efficacy but are largely based on interventions specific to the West. This study assesses the risk and protective factors specific to the Indian rural population, representing the four zones of the country, and intends to fill the key gaps in dementia prevention by developing a multimodal care bundle accounting for diverse linguistic, cultural and nutritional practices. This is both relevant and critical to dementia prevention efforts in India as the existing dementia research has focused mainly on urban populations.
The study has some limitations as well. We are not assessing the participants in midlife, so we cannot study the evolution of the risk factor profile from mid-life to late life and its impact on cognitive decline. However, as NCDs in India presented a decade earlier, we are enrolling participants who are aged 55 or above.1 We are using a short battery to cover most cognitive domains and are not assessing executive and praxis-related functions in detail (low literacy in the target population, dearth of culturally valid neuropsychological tests and participant cooperation for lengthy analysis are specific hindrances). Also, we have funding limitations to reach the projected sample size of 10 000 participants, and with the current funding, we would be able to reach one-third of the projected sample size. The study findings may not be generalisable to the urban population and those at low risk of dementia.
To conclude, there is limited large-scale longitudinal research in India that focuses on cognitive decline with ageing and strategies to prevent it. SMRUTHI India is a step forward in this direction.
Ethics approval has been sought from the nodal and all participating centres (IEC NUMBERS- New Delhi: IEC-211/04.03.2022; Tripura: ECR/937/Inst/2017; Himachal Pradesh: IEC/010/2021; Karnataka: IHEC/NITM/IHEC approval/2022-AUG/009; Jaipur: IEC-NIIRNCD/2022/ER/003). A written consent will be taken from all participants during recruitment to the cohort study. The consent process will be in line with the cmRCT study design. All participants while enrolling into the cohort will also be consenting for the data to be used for treatment strategies that may be used in the future in this cohort for prevention of dementia. In phase 2 of the study, if any participant is randomly selected for an intervention (for example, multimodal care bundle), consent will be again taken to participate in that particular RCT. An example of the consent forms for recruitment and main trial has been attached in the supplementary material. These have been translated to regional languages for use at respective sites. Also, the findings of the research will be disseminated to participants, general public, policy makers, and scientific community via publication in peer-reviewed journals, presentations in national and international events and conferences, social media, and community-based activities.
The study protocol (V.3.2 dated 1 April 2025) is registered in the Clinical Trial Registry of India (CTRI/2024/01/061172). The trial protocol is also freely searchable from the WHO’s search portal ICTRP or the international clinical registry platform.
Not applicable.
We acknowledge the role of ICMR scientists, Dr Ashu Grover, Dr Ravinder Singh, Dr S Meenakshi and Dr Dhaliwal in supporting the trial protocol.
