mHealth-based intervention by community workers to support family caregivers of persons with dementia living at home: study protocol for a cluster randomised controlled trial

Abstract

Background

India is undergoing a significant demographic shift with a growing older population, leading to an anticipated increase in people with dementia. Family caregivers, who are predominantly informal, carry the burden of care within households, facing numerous challenges that impact their well-being. Despite the cultural emphasis on family support, there is a lack of targeted interventions for caregivers in India. The WHO emphasises the importance of caregiver support, and recent advancements in information and communication technology, particularly mobile health (mHealth), offer promising avenues to address this need. This study protocol outlines an Indo-Sweden collaborative effort, funded by Indian Council of Medical Research (ICMR) Forte, to develop and assess the effectiveness of a mHealth application designed to improve caregiving skills, reduce caregiver burden and support family caregivers of persons with dementia.

Methods and analysis

The study will be conducted through a community-based cluster randomised controlled trial in Jodhpur, Rajasthan, with Accredited Social Health Activists (ASHAs) serving as the unit of randomisation. The methodology includes several key phases: a needs assessment to understand caregiver requirements, the development of the mHealth application, comprehensive training for ASHAs and a thorough evaluation of the intervention’s impact.

The effectiveness of the intervention will be measured through quantitative assessments of stress reduction, depressive symptoms and quality of life improvements, alongside qualitative insights from stakeholders. Additionally, usability and cost analyses will be conducted to evaluate the practicality and economic feasibility of the intervention.

The expected outcomes of this study include the creation of a scalable mHealth platform that facilitates remote support, bridges geographical gaps and enhances the well-being of caregivers in India’s evolving healthcare landscape.

Ethics and dissemination

Ethical approval has been obtained from the Institutional Ethical Committee of AIIMS Jodhpur (AIIMS/IEC/2022/4245).

Trial registration number

Clinical Trials Registry: CTRI/2022/12/048320.

Correspondence to Nitin Kumar Joshi; [email protected]

STRENGTHS AND LIMITATIONS OF THIS STUDY

• The study used a randomised controlled trial design, ensuring high internal validity.

• The involvement of community health workers (ASHAs) will provide culturally tailored support and increase intervention reach.

• Self-reported measures for caregiver burden might be influenced by social desirability bias.

• The study did not include a long-term follow-up, limiting the assessment of sustained effects of the intervention.

Introduction

Background and rationale

India is experiencing a significant demographic shift characterised by a growing older population. Projections indicate that individuals aged 60 and above will constitute 19.1% of the total population by 2050, reaching an estimated 320 million.¹ This demographic trend is anticipated to lead to a considerable rise in the prevalence of dementia, with an estimated 5.3 million Indians aged over 60 having Dementia in 2020, a number expected to escalate to 14 million by 2050.^{2 3}

In the Indian context, persons with dementia predominantly reside in their own homes, where informal caregivers, usually family members, provide the majority of care. Family caregiving is often attributed to the presence of a robust family and value system.⁴ While many caregivers express positivity about their caregiving experience, they also encounter challenges related to stress, coping mechanisms, depression, social networks and overall morbidity.

The WHO recommends caregiver support in community-based interventions for older people, emphasising the pivotal role of family members and informal caregivers.⁵ However, in India, despite the increasing evidence supporting the importance of family caregivers, there is a noticeable lack of interventions aimed at supporting them in their caregiving roles.⁶

Over the past two decades, interventions to alleviate caregiver stress have primarily been face-to-face, including the utilisation of daycare centres and psychological treatments. However, recent advancements in information and communication technology have opened new avenues for supporting caregivers, significantly when traditional face-to-face methods are hindered by geographical barriers or limited community resources.⁷ Current mobile health (mHealth) interventions for dementia care, such as technology-delivered psychosocial interventions (TPIs) and eHealth apps like FindMyApps, have shown promise in reducing caregiver burden and depression.⁷ TPIs particularly enhance self-efficacy and reduce anxiety, while FindMyApps helps caregivers use tablet apps to support social participation and self-management for people with dementia.⁷

The emerging mHealth field in India shows promise as a platform for intervention delivery to support caregivers.⁸ The Ayushman Bharat initiative, including health and wellness centres and Accredited Social Health Activists (ASHAs), presents an opportunity to integrate support services for individuals living with Dementia and their caregivers within their communities.⁹ Additionally, the Ayushman Bharat Digital Mission aims to establish the digital infrastructure necessary to support integrated healthcare across the country.¹⁰

In this proposed Indo-Sweden collaborative research study funded by Indian Council of Medical Research (ICMR) in India and the Swedish Research Council of Health, Working Life and Welfare in Sweden, the focus is on using mHealth to enhance the support provided by ASHAs to family caregivers taking care of persons with dementia at home. The intervention aims to strengthen both external and internal resources of caregivers. External resources will be bolstered through professional support facilitated by a mobile application, fostering a virtual network among family caregivers. The mobile app will also provide information on relevant services and self-care advice to enhance caregivers’ internal resources.

The proposed mHealth intervention represents a novel approach, particularly in the context of India’s expanding digital literacy. ASHA workers will play a crucial role in providing support to family caregivers through this interactive mobile-based platform. Unlike existing mobile applications, this intervention ensures direct communication between ASHA and family caregivers, creating an innovative and tailored support system.

Ultimately, the study protocol aims to test support provided by community workers through the proposed mobile application among family caregivers, aiming to relieve caregiving stress, reduce depressive symptoms and improve overall quality of life. The cost-effectiveness of delivering mHealth-based intervention by community health workers to family caregivers of people with dementia will also be assessed.

Methods

Trial design

This study is a community-based cluster randomised controlled trial with an aim to develop and assess the effectiveness of a mHealth application to improve caregiving skills, reduce caregiver burden and support family caregivers of persons with dementia.

Study setting

The study will take place in Jodhpur, Rajasthan, India. The selected urban health centres (UHCs) in Jodhpur will serve as clusters, ensuring that each cluster covers only the wards under a single UHC to avoid contamination.

Study participants

The study population consists of family caregivers of persons living with dementia. Participants will be recruited following informed consent. ASHAs will be trained to deliver the intervention through the mobile application.

Patient and public involvement

In this study, family caregivers of persons with dementia are involved in the research process. During the needs assessment phase, individual interviews will be conducted with caregivers to understand their challenges, support needs and preferences. The insights gained from these interviews will inform the development and customisation of the mHealth intervention, ensuring that it is culturally relevant and addresses the specific needs of the caregivers. The burden of the intervention will be assessed through caregiver postintervention interviews. The results of the study will be shared with participants through community meetings and summaries provided via the mHealth application.

Unit of randomisation

ASHAs will serve as the unit of randomisation. Four UHCs will be selected—two for the intervention group and two for the control group, with approximately eight ASHAs per UHC. This design ensures the intervention covers a population of about 123 000 individuals in each arm.

Study duration

The trial will be conducted over 3 years.

Study design

This is a community-based cluster randomised controlled study.

Sample size

For the purpose of study, the catchment area of UHC will serve as clusters. Selected clusters will have only those wards that are covered by one UHC to avoid contamination that might occur by knowledge sharing among ASHAs, who meet monthly at their UHCs during their scheduled meetings. Two UHCs (one intervention and one control) from the North and South will be selected.

A total of four UHCs (two interventions and two controls) will be selected for the study. There are approximately eight ASHAs per UHC. So, two UHCs with 16 ASHAs covering a population of approximately 123 000 will be in the intervention arm and two UHCs with 16 ASHAs covering a population of approximately 123 000 will be in the comparator arm. With a desired level of significance (α) set at 0.05 and a power (1-β) of 0.90, an allocation ratio of 1, and assuming proportions of 0.5 for group 1 and 0.35 for group 2, the calculated sample size for each group is 200, resulting in a total sample size of 400. The framework for the study is shown in figure 1.^1–3

Figure 1. The framework for the study.

Study tool

In this cluster randomised study, the effectiveness of a psycho-educational intervention will be assessed. This psycho-educational intervention will be delivered via mobile application by community workers (ie, ASHA in India) on the reduction of caregiving burden and depressive symptoms and enhancing caregiving competence and caregiver’s quality of life of family caregivers of persons with dementia.

The psycho-educational intervention is based on cognitive behavioural therapy. This intervention is developed based on WHO iSupport programme tested in Western countries, Hong Kong and Taiwan.^{11 12} In order to use this tool in India, customisation would be needed before its application in the field. The customisation would be based on the needs assessment of family caregivers, which will be done in the Phase I of the study.

In Phase I, the needs assessment and the customisation of modules developed by the Swedish team for Indian settings will be done. Individual interviews with family caregivers and ASHAs will be conducted to assess caregiving burdens, existing support systems and needs. The interview guide will include questions on barriers, challenges and perceptions of mHealth solutions. The sample size for these interviews will be 10–15 participants per group. The qualitative data collected will inform the customisation of modules, ensuring they are culturally appropriate and relevant.

Based on the data collected, a round of discussions will be held with experts working in dementia care to provide a solution to address caregiver burden while considering the modules developed by Swedish partners that need customisation. A team of IT experts will be invited to develop the mHealth application to be used in India.

In Phase II, based on the findings from Phase I, the mHealth application will be developed with input from IT experts. The app will feature modules on dementia care, daily living management and caregiver well-being, with user-friendly navigation. The mHealth application’s content framework will consist of modules on dementia and related care, managing daily living activities, and caregiver’s health and well-being. User-friendly navigation features, such as touch and slide options, will be included.

In Phase III, training workshops for ASHAs will be conducted. Interactive methodologies in training will be used to enthuse and orient them about mHealth application, processes and their roles. Piloting will be carried out to check the feasibility of the application. Feedback and suggestions will be taken to improve the process further.

In Phase IV, implementation and assessment will be carried out. After obtaining informed consent, the ASHAs will be eligible participants and will be randomised to either an intervention group or a control group. The family caregiver of a person living with dementia in the intervention group would receive support from ASHAs via mobile application while the family caregiver of a person living with dementia in the control group would receive the existing care. Assessment will be carried out at the baseline (T1), directly after the 10-week-long intervention (T2) and 4 weeks after the completion of the intervention (T3).

The intervention will be delivered in 10 weekly sessions with specific subjects for each session based on the WHO’s recommendation of support for family caregivers such as introduction to dementia, being a caregiver, mental strategies and mindset, activities, eat and sleep and where to find resources in the community.¹² The family caregiver will receive a booklet, presenting each topic and a minor task which will be followed up in the next session with the community worker. One of the 10 sessions will be kept as an open choice for the family caregiver to bring up any matter of relevance in their specific situation. This form of intervention was developed by our research team at Karolinska Institute together with counterparts in a Malaysian university for implementation in Malaysia. The intervention programme will be adapted to Indian contexts. The adaptation will be based on consultative workshops with community workers in the two countries as well as selected family caregivers of people with dementia.

In addition to delivering the intervention through the chat feature on the mobile application, other features include the following:

• Interaction with community workers: Using the chat feature, family caregivers will be able to communicate directly with the community workers on a one-on-one basis throughout the 10-week intervention period.

• Relevant services: A collection of web links of relevant services in their communities will be available.

• Well-being: Mindfulness exercises will be available for the family caregivers.

Training of community workers

All 16 community workers, that is, ASHA, will receive 2 days of education in the field of dementia. Community workers will be provided mobile devices by the research team to deliver the intervention.

Evaluation of the intervention and data collection

The intervention group will receive support via the mobile app over 10 weekly sessions, each focusing on a specific topic related to dementia care. In addition to the chat feature, the app will include links to relevant services and mindfulness exercises. Evaluation will occur at baseline (T1), postintervention (T2) and 4 weeks postintervention (T3). Data collection tools will include the Zarit Burden Interview (ZBI), the Patient Health Questionnaire (PHQ) and the CarerQol-7D questionnaire. Interviews will gather qualitative data on user experiences and acceptability.^{13 14}

Quantitative assessment of outcomes

The quantitative data will be collected to capture the impact of the intervention implemented by community workers on alleviating stress and depressive symptoms and improving caregiving competence and quality of life of family caregivers.

Background information about the family caregivers such as age, sex, social network and relationship with the person with dementia will be included. Outcomes will be measured in both the intervention and control groups at baseline prior to delivery of the intervention (T1), after the completion of the 10-week intervention in the intervention group (T2) and 4 weeks after the completion of the 10-week intervention (T3).

Qualitative assessment of ‘stakeholders’ experiences and insights

By way of process evaluation of the intervention delivered by the community workers, in-depth interviews will be conducted with the two groups of key stakeholders of the project: (1) family caregivers to get an understanding of their experiences of receiving support from the community workers through the mobile application including areas of improvement and (2) community workers to evaluate delivery of the intervention via the mobile application in terms of use and practicality of the mobile application and particularly in combination to their regular responsibilities. Community workers and family caregivers will also be evaluated for acceptance of providing and receiving support through a mobile application. The interviews will be undertaken using a semistructured interview guide shortly after the 10 week intervention cycle.

The following parameters will assess the usability of the intervention delivered through the mobile application:

• Usage of the mobile application as indicated below (derived from mobile application data):

  • Frequency of communication between family caregivers and the community worker through chat.

  • Use of collection of web links of relevant services.

  • Use of mindfulness exercises.

• User experience in terms of satisfaction level of the mobile application interface and the intervention’s content (interviews with family caregivers and community workers).

• User experience in terms of ease of usage of the mobile application (interviews with family caregivers and community workers).

Ethics review

Ethical approval has been obtained from the Institutional Ethical Committee of AIIMS Jodhpur. Informed consent will be obtained from all participants in each phase, ensuring confidentiality and voluntary participation. Anonymity of the participants in the presentation of the results will be guaranteed, information collected will be kept confidential and participation in the study will be voluntary.

Data collection and analysis plan

The intervention

An assessment context for this mHealth intervention will include effectiveness in terms of appropriate outcomes and an economic component in the form of cost comparison of the intervention with standard care.

Effective analysis

An effectiveness analysis will be used to compare the outcomes of this intervention with the existing support system. The feasibility and effectiveness of implementing this mHealth intervention will be compared with the existing service.

Outcome analysis

The outcome analysis of the intervention will include an assessment of caregiver burden, depression, competence of the caregiver and the quality of life. For the assessment of caregiver’s burden and depressive symptoms, Zarit Burden Interview (ZARIT) tool and Patient Health Questionnaire will be used, respectively.^{13 14} Caregiver competence will be measured using the competence questionnaire developed by the research team at Karolinska Institute. ‘Caregivers’ quality of life will be assessed using the quality of life CarerQol-7D questionnaire.¹⁵ Data on caregiver burden, depression, competence and quality of life will be collected using validated tools. Statistical analysis will include descriptive statistics, paired t-tests and regression analysis to compare group outcomes. Interviews will be analysed thematically to explore the experiences of caregivers and ASHAs. Data will be transcribed, coded and analysed using appropriate software.

Cost analysis

Process‐based costing will be used to calculate the pragmatic cost of the intervention. All resources used in the designing and planning phase (application development) and intervention implementation will be quantified and valued. After assessing the average number of years for which a product could be used, capital costs will be annualised. Shared or joint costs will be apportioned for the time value a resource was used under intervention. The annual cost of implementing the intervention and unit cost per caregiver will be estimated.

Expected outcomes

The mobile application tested in this study can be an essential tool for community workers in providing support to family caregivers of persons with dementia. The intervention in the project provides a platform for the community workers to support the rising digitally literate family caregivers in their homes through an interactive digital platform, irrespective of the physical distance between them.

We extend our gratitude to the family caregivers and ASHA workers whose insights are invaluable in shaping the intervention. We also thank ICMR-Forte and Dr. Neha Dahiya for the support.

Ethics statements

Patient consent for publication

Not applicable.

Footnote

Contributors Conceptualisation and design: PB, NKJ, MKG and SKS. Development of protocol: PB, NKJ, MKG, NN, AS and MT. Review and feedback on protocol: HK, ÅGC, ZNK and AS. Drafting of the manuscript: NKJ and PB. Critical revision of the manuscript: PB and MT. Final approval of the manuscript: all authors. Guarantor: PB.

Funding Indian Council of Medical Research (54/5/GER/Indo-Sweden/2022-NCD-11)

Competing interests None declared.

Patient and public involvement Patients and/or the public were involved in the design, or conduct, or reporting, or dissemination plans of this research. Refer to the Methods section for further details.

Provenance and peer review Not commissioned; externally peer reviewed.

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