Protocolo del estudio CARE: evaluación cognitiva basada en juegos a través de la participación recreativa en...

Cognitive Assessment Games (CAGs) represent an emerging area of research. To date, most evidence regarding the efficacy of these games comes from studies conducted in Western, high-income countries. However, evidence from low- and middle-income countries (LMICs), including India, remains limited. Given the ongoing epidemiological and demographic transition in India, and the projected growth in the population aged 60 years and above, it is vital to assess the efficacy of such games in the Indian context. A previous study evaluated such games in healthy young adults; however, it is necessary to examine their use in populations for whom cognitive assessments are most relevant. The proposed study aims to evaluate the validity of the game-derived scores against standard neuropsychological assessments in Indian older adults (aged 60 years and above) with Mild Cognitive Impairment (MCI). Additionally, the study will collect feedback on the usability and acceptability of these games from the older participants.

In this prospective, single-centre, 10-months cross-sectional study, we will recruit 70 patients aged over 60 years, diagnosed with MCI according to the Petersen criteria. Each participant will complete three games: a Virtual Reality-based Hand-Eye Coordination Game, and two tablet-based games-one assessing memory and other evaluating shopping ability. Traditional neuropsychological assessments will include the Addenbrooke's Cognitive Examination III (ACE-III), Trail Making Test A and B, Digit Symbol Substitution Test (DSST), Verbal Learning Test, Line-Bisection Test, and the Instrumental Activities of Daily Living-Elderly (IADL-E). Information Questionnaire for Cognitive Decline in the Elderly (IQ CODE) will be administered to the informant or the caretaker of the patient. Game-related feedback will be collected using standard Cybersickness, System Usability, and Virtual Reality Presence questionnaires. Personal interviews will be conducted to gain contextual insights into each participant's experience and feedback. All procedures will be completed in a single session, lasting approximately two hours for each participant.

The primary validity endpoint would be the intended correlation of 0.40 between the Shopping game-based Quality-Weighted Efficiency Score (QWES) and Trail Making Test Part (TMT)-B. Six secondary validity endpoints have been pre-specified for assessing the convergent validity of the games, with multiplicity corrected using the False Discovery Rate (FDR) via the Benjamini-Hochberg procedure. Usability of the games will be assessed using the System Usability Scale (SUS), with a mean score exceeding 70 defined as the threshold of acceptable usability. Moderation analysis will be conducted to examine the role of technology proficiency and fatigue in impacting the primary and secondary correlations. Incremental validity analysis will be conducted to examine non-redundancy and ecological validity of the game-based scores. Finally, the inductive thematic analysis approach will be used to analyse the interview transcripts.

To our knowledge, this is the first study in India to examine game-based cognitive assessments among participants with MCI. It also offers a unique socio-cultural perspective from India on such games, which is currently absent from the global evidence base. The findings will offer insights into the use of CAGs as an alternative modality for cognitive assessment in the clinical settings, and inform the methodology, planning, and procedures for large-scale, multi-centric studies on games for cognitive assessment, ultimately contributing to the development of generalizable evidence.

Ongoing.

Clinical Trial Registry-India (CTRI Registration number: CTRI/2025/04/085745).