Digital solution for Salutogenic Brain health intervention

A digital intervention to address brain health problems upstream for the at-risk population could be a scalable solution. However, such a solution is still lacking in Singapore. ‘Train Your Brain’ (TYB) is a group-based cognitive intervention programme initially delivered in-person for elderly Singaporeans with mild cognitive impairments.11 TYB equips participants with knowledge on cognition and brain health, provides cognitive coping strategies in performing daily tasks, boosts their confidence and maintains independence in daily activities. The TYB programme has been shown to be promising with preliminary efficacy and has since been adapted to community-dwelling stroke survivors to promote brain health.11 12

However, the in-person TYB programme demands more clinical resources and time compared with a digital delivery mode. The COVID-19 pandemic expedited the adoption of digital health solutions.13 Hence, this pilot study will focus on the digital delivery of TYB, that is, Digital solution for Salutogenic Brain health (DiSaB). The DiSaB intervention will be delivered via ZOOM which is easily accessible. Additionally, the DiSaB intervention will be implemented in primary healthcare settings as a routine service led by nurses. The DiSaB intervention is based on the following conceptual frameworks: the Salutogenic approach to health which focuses on origins of health and their supportive factors,14 the Transtheoretical Model (Stages of Change)15 and Bandura’s Social Learning Theory.16 17 It is designed to empower middle-aged individuals for effective self-care, a therapeutic lifestyle and adopting strategies for better cognitive health outcomes.

Theoretical framework

The Reach, Effectiveness, Adoption, Implementation, and Maintenance (RE-AIM) evaluation framework will be used to guide this study.22 The RE-AIM model is one of the most commonly used frameworks for dissemination and implementation research. It allows researchers to pragmatically evaluate and plan the implementation, which is crucial for implementation evaluation and optimisation.23 The RE-AIM framework supports ongoing identification and rectification and can be applied to every stage of the intervention implementation, from discovery, planning, implementation and even the evaluation stages of the intervention.24 Such flexibility will help in identifying crucial delivery points of the DiSaB intervention requiring changes to improve its effectiveness and implementation. The framework will also allow us to evaluate DiSaB with a mixed-method design systematically, in that all the outcome measures can be categorised into the components of RE-AIM.

Study aims

This pilot study aims to, first, evaluate the clinical effectiveness of the DiSaB intervention in improving participants’ cognitive functions, clinical measures (blood pressure, lipids and haemoglobin A1c (HbA1c) levels) and psychosocial health (quality of life, self-care for chronic conditions and mood).

The secondary aim is to evaluate the implementation of the DiSaB intervention in primary healthcare settings co-facilitated by local champions via a mixed-method approach.

Hypotheses

It is hypothesised that the DiSaB intervention implementation will be feasible, practical and effective in empowering middle-aged adults to gain knowledge in brain health, take ownership and identify community resources and personal capacities to adopt a healthy lifestyle for better health outcomes.

Furthermore, the DiSaB intervention will be a value-added service in the community, offering nurses a novel intervention to better manage at-risk patients with cognitive complaints and alleviating the issue of manpower shortage.

Table 1

Description of DTR elements in intervention-armed group using SMART study design

Randomisation

Block sizes of 2 and 4 will be used to randomly assign 160 participants in batches of 40 participants to two groups (intervention and control) with 1:1 allocation. For example, the first batch of 40 participants recruited will be randomised to either intervention (n=20) or control group (n=20), and likewise subsequently. For reproducibility, a random seed will be used. https://www.sealedenvelope.com/simple-randomiser/v1/lists will be used to generate the randomisation and a .csv file will be generated.29 30 The .csv file will include the block identifier, block size and sequence within block and treatment group. Contents will be copied directly to an existing Excel sheet containing participant ID to allocate randomisation to participants by a research team member/research assistant (RA).

Sample size

As this is a pilot study, we did not complete a formal sample size calculation. Based on the study’s funding, resources and research sites available, this study will recruit a total of 160 participants across both the intervention and control arms.

Session 1

Participants will be introduced to the programme. They are encouraged to share their experiences and thoughts with each other and participate in activities during the session, complete homework tasks and set Specific, Measurable, Achievable, Realistic and Timed (SMART) goals at the end of every session. Each session will begin with a recap of the previous session. In this session, participants will learn about normal ageing and to identify common cognitive problems related to chronic conditions. They will then receive psychoeducation about the causes and effects of memory and thinking difficulties and be encouraged to share if they experience changes in cognition (eg, being slower at work). Lastly, they will set SMART goals for retention and improvement of cognition.

Session 2

Participants will be provided with psychoeducation about the importance of a healthy lifestyle to improve cognition. They will also learn about common risk factors impacting brain health including chronic diseases (eg, diabetes, heart disease, high blood pressure and cholesterol), poor sleep and diet, lack of physical activity, low social engagement and mood difficulties. They will learn how to address these risk factors and adopt techniques to improve their lifestyle habits (eg, improving their diet, sleep strategies).

Session 3

This session will focus on psychoeducation of the relationship between mood, fatigue and cognitive difficulties. Participants will learn how to recognise physical and behavioural symptoms of common mood issues, including depression, anxiety and stress. Participants will engage in a group discussion to share their emotional journeys of learning and coping with their chronic diseases. They will also learn how mood issues will impact their daily cognitive functioning.

Session 4

Participants will learn techniques and strategies to manage their mood and fatigue to consequently manage their cognitive functioning, including cognitive behavioural therapy theories and mindfulness techniques. The facilitator will conduct a mindfulness exercise and provide psychoeducation on engaging in mindfulness activities independently. Participants will finally be tasked to set a goal to have a ‘Better Mood, Sharper Brain’ and to execute their chosen plan.

Session 5

This session will focus on memory and attention. Participants will receive psychoeducation about the different types of attention, including sustained, selective and divided attention. The facilitator will share strategies and practical skills on improving focus, including following a routine, setting the most appropriate time for activities, concentrating on one task at a time, minimising distractions and managing mood. Participants will learn about the importance of attention and memory processes.

Session 6

This session will focus on executive functioning (ie, higher-order thinking skills), including working memory, planning and organisation. Participants will learn about how executive functioning difficulties impact other cognitive skills, such as memory. Facilitators will provide psychoeducation about the importance of planning and organisational skills and teach strategies on improving these skills.

Session 7

This session will involve discussing the application of cognitive strategies learnt thus far. Participants will engage in a group discussion on the common cognitive difficulties they experience in their daily lives and at work, and the steps taken to improve these difficulties. The facilitator will encourage participants to build awareness and acceptance of their new cognitive issues. Participants will also reflect on what new cognitive strategies they can potentially implement into their daily lives; common cognitive strategies include building routines and structures, improving the environment around us and managing mood. Furthermore, the facilitator will encourage participants to set SMART goals to apply these skills (eg, in the workplace or home).

Session 8

Participants will be asked to share their progress and experiences with the group, while referencing concepts and skills learnt during the programme. They will be given one final review of the takeaways from previous sessions and be encouraged to continue practising the strategies learnt during the programme for better brain health.

Each session will consist of 20–22 participants and 2 local champions and will take approximately 1 hour (see figure 1 for DiSaB intervention arm workflow). The eight sessions will take place on the same day each week, and participants will remain in the same group throughout. Due to time constraints, local champions would only be present at four out of the eight sessions; in the intervention arm, they will observe four sessions of the intervention and receive training by the clinical neuropsychologists. Subsequently, non-responders will be randomly assigned to ‘individualised’ health education or ‘group’ DiSaB booster sessions via Zoom as DTRs. Participants in the ‘individualised’ group will receive a single one-on-one health education feedback session within 1–2 months post-DiSaB intervention, while participants in ‘group’ health education sessions will receive three group DiSaB-based booster sessions over a period of 3 months (ie, once per month).

Participants in the waitlist/control arm will receive the DiSaB intervention facilitated by local champions at a later time (see figure 3 for DiSaB control arm workflow). All local champions will have received training, supervision and shadowing (during the earlier intervention arm) before executing the intervention in the waitlist arm independently with some supervision from trained neuropsychologists. During local champions’ independent execution of the intervention, regular consultancy and supervision with the clinical neuropsychologists will be held weekly to support them and address any difficulties or queries.

Potential limitations of the DiSaB intervention include technology glitches, such as poor internet connection, which could affect the quality of the intervention executed by local champions. Some middle-aged adults may also not be as tech-savvy and could have some difficulties manoeuvring the Zoom app. Furthermore, participants may drop out during the intervention cycle due to time constraints in completing all sessions. This may demotivate the local champions, and consequently possibly slow down implementation; therefore, exploring how best to maintain engagement of both providers and patients will be a critical aspect of studying the implementation of DiSaB.

To increase awareness of the DiSaB intervention among healthcare workers and communities, posters will be placed around the various NUPs. Email newsletters will also be circulated to share with clinicians and allied healthcare workers about the programme. We are particularly interested in reaching out to nurses and doctors to create awareness on the DiSaB intervention to refer patients with chronic conditions into the programme as a routine service, to start developing a post-trial implementation pathway assuming successful completion of the study and positive results. Presentations will also be conducted during the in-service meetings at NUPs on a regular basis or roll call to encourage scaling up and sustaining the DiSaB intervention.

Table 2

COM-B model and application in DiSaB intervention study

Primary and secondary effectiveness outcomes

The primary effectiveness outcome is the change in participants’ cognition after the DiSaB intervention, as measured by the change in MoCA and SDMT scores preintervention and postintervention. The MoCA (Singaporean version34) is a brief standardised cognitive test which scores individuals on their ability in visuo-executive functioning, naming, attention, language proficiency, abstraction ability, delayed recall and orientation. Better cognitive performance is reflected by higher MoCA scores, with a maximum score of 30. SDMT35 is another standardised test assessing individuals’ cognitive ability, particularly in the attention and information processing speed domains. Test takers are presented with a key on the top of the page where each digit from 1 to 9 is represented by a unique symbol. The rest of the page shows multiple rows of symbols with empty boxes below each symbol, and individuals are given 90 s to write down as many corresponding numbers in the empty boxes as they can, as fast as possible. Once again, better performance is reflected by a higher score. The MoCA has been shown to have high reliability and validity, and when used together with SDMT provides a more accurate reflection of cognitive impairment.36 37 The MoCA and SDMT will be administered by RAs trained by a clinical neuropsychologist.

Secondary outcomes include the proportion of participants who respond to DiSaB, as well as changes in their quality of life, psychosocial health and clinical measures when compared between preintervention and postintervention, as mood, physical health and cognitive function have been shown to be highly intercorrelated. The percentage of participants whose MoCA scores increase by at least 2, 6 months after the intervention, would be used to evaluate the proportion of participants who respond to DiSaB.

Quality of life and psychosocial health will be measured by the following questionnaires: EuroQoL 5-Dimension 5-Level (EQ-5D-5L)38; Depression, Anxiety and Stress Scale-2139; Eight-item Informant Interview to Differentiate Ageing and Dementia,40 and a Self-care of Chronic Illness Inventory.41 These questionnaires are highly used internationally and have been validated across multiple contexts.42 43 These questionnaires have been chosen to evaluate a comprehensive range of psychosocial functions in participants recruited in this study. Clinical measures to be collected include systolic and diastolic blood pressure, and total lipid, high-density lipoprotein (HDL), low-density lipoprotein (LDL), triglycerides and HbA1c levels.

Implementation outcomes of DiSaB intervention

Analysis plan for effectiveness

The effectiveness of the intervention will be addressed by the SMART using two comparisons: (1) the effectiveness of DiSaB vs waitlist for patients and (2) the effectiveness of the following two DTRs versus waitlist:

1. First-stage treatment by DiSaB; if patients respond to DiSaB, then continue with usual care; if patients do not respond to DiSaB, then give individual education.

All continuous outcomes addressing the first comparison will be measured as mean difference (MD) and estimated by general linear regression models, adjusting for key prognostic factors, while all continuous outcomes addressing the second question will be measured as MD and estimated by inverse-probability-weighted general linear regression models, accounting for the under-representation of patients who do not respond to the first-stage DiSaB and adjusting for key prognostic factors.

All binary outcomes addressing the first question will be measured as risk ratio (RR) analysed by log binomial regression models, adjusting for key prognostic factors, while all binary outcomes addressing the second primary question will be measured as RR and estimated by inverse-probability-weighted log binomial regression models, accounting for the under-representation of patients who do not respond to the first-stage DiSaB. The subject of the analyses for these outcomes (ie, patient participants or local champions) is in online supplemental table 1.

We will collect the cost of the intervention and the quality-of-life measures of patients to assess the feasibility of a formal cost-effectiveness analysis. The cost of the intervention will be measured by a cost survey and analysed as mean and SD. Quality of life will be measured by EQ-5D-5L, transformed to health-related quality of life using a value set developed for Malaysians—there is no existing value set for Singaporeans, hence we will use the value set from culturally similar Malaysia—and measured by mean and SD.45 No further comparisons will be conducted as we will not be performing a formal cost-effectiveness analysis.

Analysis plan for implementation outcomes

Quantitative implementation outcome measures from the baseline, RE-AIM and COM-B survey results will be analysed using descriptive statistics. We will extract the mean score of the survey results (on a scale of 1–5). Percentages will be calculated for outcome measures relating to proportion and representativeness. Fidelity and quality of the intervention will be analysed from the eNACT checklist overall score, taken by totalling the scores across items and dividing by the number of applicable items. Each item can receive a possible score of 0, 1 or 2. FGDs will be recorded on Zoom and transcribed in full before being analysed using thematic analysis in NVivo according to best-practice guidelines by Braune and Clarke.46 Transcripts will be coded by study team members and organised into themes and subthemes based on codes that frequently appear. We will engage in an iterative process of reviewing and refining the codes and themes as part of a mind map, then define each theme clearly and report on the finalised set of themes. The subject of the analyses for these implementation outcomes (ie, patient participants or local champions) is in online supplemental table 1.