Cross-Cultural Adaptation and Psychometric Properties of Version 8 of the Montreal Cognitive Assessment (MOCA) In Detecting Mild Cognitive Impairment and Dementia among Older People in Tanzania, A Methodological study/Diagnostic accuracy comparative study

doi:10.21203/rs.3.rs-4850672/v1

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Cross-Cultural Adaptation and Psychometric Properties of Version 8 of the Montreal Cognitive Assessment (MOCA) In Detecting Mild Cognitive Impairment and Dementia among Older People in Tanzania, A Methodological study/Diagnostic accuracy comparative study

https://doi.org/10.21203/rs.3.rs-4850672/v1

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Background

The early detection of cognitive deficits in older individuals in Tanzania, particularly those in urban areas with higher levels of education, requires the use of standardized and internationally recognized assessment tools. MoCA version 8, which assesses eight cognitive domains, has been modified to enhance scoring precision and includes instructions on calculating the memory index score (MIS). Additionally, the verbal fluency and abstraction tasks have been revised to facilitate the design of targeted interventions. This study aims to culturally adapt MoCA 8 into Swahili and evaluate its validity, reliability, and diagnostic accuracy for assessing cognitive function in older Tanzanians.

Method/design

In this methodological study, 240 older individuals (aged ≥50 years) will be recruited from ten randomly chosen villages in both rural and urban areas of the Dodoma region. The MoCA version 8 will serve as the primary screening test, while the MoCA-5minutes protocol will be used as the reference standard screening test. The diagnostic accuracy (power) of the MoCA version 8 will be assessed by comparing its scores with the diagnosis made by a Neurologist using DSM-5 criteria. Data collection will commence after obtaining informed consent to confirm participants' eligibility for the study. The main areas of interest include the Swahili version, validity, reliability, and diagnostic accuracy of MoCA version 8.

The Validity, Reliability, Sensitivity, Specificity, Predictive (positive and negative) values will also be reported.

Discussion

The results of this study will determine whether MoCA 8 is a valid, reliable and accurate screening tool in detecting cognitive function of older people in Tanzania, this will serve as a study to inform the literature and to indicate the manner in which early detection of cognitive impairment will inform early intervention to improve cognitive function.

Screening

Diagnostic accuracy

validity

reliability

sensitivity

specificity

positive predictive values

negative predictive values

Background

Dementia is a brain disease or injury associated with a progressive loss of memory, language, problem-solving and other thinking abilities that are severe enough to interfere with daily life [1], [2]. Dementia (a Major cognitive impairment) is a clinical and irreversible stage following a Mild cognitive impairment ( pre-clinical stage) with which the symptoms are less severe and can be reversible if early and appropriate interventions are instituted [3].

Currently there are estimated 50 million people living with dementia worldwide; with 10 million people developing dementia per year ,there will be 152 million cases by the year 2050, Nearly 60% of cases will live in low and middle income countries (LMICs) [4].

Low-income countries in the sub-Saharan Africa (SSA), particularly Tanzania have relatively low proportion of older people above 60 years (8%) [5], and the rate of aging is slower than in developed countries due to high fertility rate (5.02 births per woman) [6]. However, the present number of older people above 60 years exceeds 2.6 million, with a notable increase among those with some levels of education in the urban settings [7]. The numbers will increase significantly over the next decades [4].

This population of older people in Tanzania can be at a greater risk of developing dementia due to a multiple risk factors including low cognitive reserve as caused by low level of education, depression [8], [9] lack of early intervention due to delayed detection of pre-clinical stage of the disease and poor preparedness, characterized by shortage of specialists (doctors and nurses) and inadequate medical resources to treat patients with dementia [10].

The prevalence of dementia in Tanzania has been underreported except on one region of Kilimanjaro (in Hai District) which was 6.3% in the year 2013, and this value was expected to rise by three in the year 2020 [11], due to a lack of early intervention as caused by a delayed detection of the disease as caused by the lack of a gold standard tool to screen people with dementia as aging increases[12], [13], Early detection of dementia is crucial for the implementation of therapeutic strategies in the earliest disease stages, and the reliable cognitive screening tools play an important role in this process of identifying individuals with cognitive impairment (Dementia, especially in its Milder form, since it is reversible, interventions can begin as soon as possible) [14].

Presently in Tanzania, two instruments that are internationally recognized have been tested for their psychometric properties and accuracy in detecting both mild cognitive impairment and dementia among rural older population. The first was the 7th version of the Montreal Cognitive Assessment (MoCA), this instrument was found not suitable in testing the cognitive function of the rural older people with low level of education as several items including trail making, cube drawing, clock drawing, and verbal fluency were not applicable among this population. These items are very important as are being designed to test attention, language and abstraction cognitive domains of the brain [10].

The second instrument was the Montreal Cognitive Assessment − 5 minutes Protocol (MoCA-5-min) which is a brief version of the 30 items MoCA. On the other hand this instrument was found to be reliable, valid and accurate in measuring cognitive function among older population in the rural settings of Tanzania [15], indeed MoCA-5-min excluded the tasks requiring participants to draw, write, or attempt the phonemic fluency tests which could be less feasible for illiterate responders [16], however, due to its brevity, it is not able to detect the deficits in various cognitive domains as compared to a longer version of MoCA [17]. Moreover, the current version of MoCA (MoCA-Version 8) has been slightly modified and contains additional scoring precision, instructions on how to calculate the memory index score (MIS) which is a sub score, and a revised instruction verbatim for the verbal fluency and abstraction tasks [18], that would be pertinent for designing appropriate domain specific interventions.

For early detection of deficits in various cognitive domains among older people in Tanzania, especially among urban older people who somewhat have better level of education that are increasing in number, a standardized and internationally recognized instrument such as MoCA version 8 is required [19]. The version 8 of MoCA would be translated to Swahili Language, culturally adapted, and tested for its Reliability, Validity, and Diagnostic accuracy and be available for routine screening of cognitive functions of older people in Tanzania.

Study aim

The aim of this study is to use forward and backward approach as suggested by Brislin [20], [21] to translate MoCA version 8 into Swahili language and test its psychometric properties among Older people including those with low level of education, with some and those with good level of education in Dodoma region.

Objectives

To conduct a cross-cultural adaptation and examine psychometric properties of version 8 of the Montreal Cognitive Assessment (MoCA) in detecting MCI and dementia among older people in Tanzania

MoCA version 8 will be used as the index screening (new) test in this study
MoCA-5-minutes protocol will be used as the reference standard screening test in this study.
Validity, Reliability, Sensitivity, Specificity, Positive predictive value, Negative Predictive value and Diagnostic accuracy will be reported in this study (Table 1)
Demographic characteristics (age, gender, education) and other variables will be tested for their impact on the ability of MoCA version 8 to correctly screen for the disease.

Table 1

Definition of the features of the screening and diagnostic test
Validity	The ability of a screening test to measure what is supposed to measure
Reliability:	The ability of a screening test to give the same results on repetition
Sensitivity:	The ability of a test to test positive for the truly affected people
Specificity:	The ability of a test to test negative for unaffected people
PPV:	The possibility of having a disease after testing positive
NPV:	The possibility of not having a disease after testing negative.
Note: PPV = positive predictive values and NPV = negative predictive values

Study design

This is the screening and diagnostic accuracy (SDA) study, the investigational methodology is designed based on the STANDARD tools recommended to be used in screening and diagnostic accuracy studies. In which all older people aged 50 years and above will be screened for Mild cognitive impairment (MCI) and dementia. Ethical approval will be sought and obtained from the University of Dodoma department of research and publication prior to the study.

Setting and study population

Older people of urban and rural (from ten randomly selected Villages) areas of Dodoma region will be selected to take part in the study.

In which older adults aged between 50 years and above will be randomly selected in the sample. After screening for the eligibility criteria everyone will be tested by both screening test and a diagnostic test (DSM-5) with other comparing tests along with this study.

Inclusion criteria for participating in the study:

The research assistant should be:

Medical personnel or a student of medical studies
Trained on the use of research tools and equipment

Translation team should consist of:

Individuals who are bilinguals i.e. Fluent in both English and Swahili

Where by one of the languages should be the primary language of the translators.

Reviewers and commentators should be experts both in mental health and research.

Inclusion and exclusion criteria for participating in this study

The inclusion criteria of this study will be:

Older people who speak Swahili Language
Older people who will be available at the time when the study will be taking place
Patients with general medical problems, well-controlled diabetes, essential hypertension, or mild impairment of vision or hearing due to aging will be included if the impairment does not restrict their ability to perform the tests and provide the consent

Exclusion criteria of this study will be

Severe physical, mental and surgical illness
Those who do not speak Swahili Language
Any mental or physical disease that may affect cognitive functioning, such as alcohol or other substance abuse, history of infarction, any evidence of central nervous system disorders or brain damage
Patients with severe major depressive disorders,
Altered state of consciousness like delirium, severe loss of hearing or sight, or language disorders.

Participant recruitment process

At least 240 older people dwelling in urban and rural areas of Dodoma region will be recruited to take part in the study, in which the primary inclusion criteria will be age between 50 years and above. The principal investigator, and the research assistants will obtain informed consent before conducting the eligibility criteria of being included in the study, the individuals with MCI/Dementia can still provide an informed consent, and confidentiality will be assured by the use of participant’s ID numbers, and not the actual names (Fig. 1.).

Reference standard and its rationale

Patients will be screened by both a new (MoCA version 8) test and a reference standard (MoCA-5-minute protocol) test for concurrent validity, along with other comparing instruments (MHI-5, Lawton IADL scale, GDS-FS) for construct validity and by Diagnostic and statistical manual of Mental disorders (DSM-5) edition 5, as a gold standard diagnostic test.

The results of reference tests above will be compared to a new test; this will explain how Valid, Reliable and Accurate MoCA version 8 is.

Technical specification and definition

Pearson correlation coefficient (r) will give the results for concurrent validity, the multivariate regression model for construct validity, Cronbach alpha for internal consistency and test-retest reliability and comprehensive neurocognitive test battery for diagnostic accuracy of MoCA version 8.

Participants screening process

Just like in data collection process, the researcher will approach the potential participants and obtain the informed consent before conducting the screening against the eligibility criteria the one with no literacy thumb will be printed on the consent forms after a full description about research procedures.

Then the researcher will administer two cognitive tests including the MoCA 8 and the MoCA-5-min protocol cognitive screening to each participant through face-to-face interview. This will be followed by administering the questionnaires for measuring the comparing constructs including depression and instrumental activities of daily living (IADL). The participants will also be assessed by The Diagnostic and statistical manual of Mental disorders (DSM-5) edition 5, to evaluate the diagnostic accuracy of MoCA 8. The Cognitive reassessment using MoCA 8 will also be done to a subgroup of participants (n = 40) in three weeks later for assessing the test-retest reliability.

Training and calibration of personnel/ Research assistant recruitment

All the research assistants will undergo a compulsory three days training on how to use the research tools and on overall involvement in research process, the training on ethical principles that must be adhered during any research study involving human subjects will be mandatory. Before any direct contact with the research subjects is made, the principal investigator shall make sure that the research assistants have well understood the theory and practice of different research tools that will be used throughout the study.

Mitigation of confounders

Certain variables such as age, Level of education and some medical, surgical and mental illnesses could also be the potential confounders to affect the accuracy of the screening process.

To address the impact of potential confounders each investigator will be asked to record basic information encountered during data collection.

Table 2

Potential factors affecting the accuracy of screening process
Factor	Inference	YES	NO
Age	≥ 50 years
Education	> 12 years
Mental illness Surgical/medical Conditions	Impairing judgement to give consent
Note that :( ≥) = It means greater than or equal to, (>) = It means greater than, YES = presence of inferential factors, NO = absence of inferential factors

Sample size calculation

The power analysis actually is used to calculate Sample size required for multivariate analysis in validation studies to examine construct validity of MoCA version 8 [22]–[24].

The number of subjects for bivariate correlations (r > 0.2, α = 0.05 and β = 0.2) to predict the concurrent validity of the index (new) and a reference (gold standard) scale is 200 as calculated per the recommendation by Anthoine et al. [25]. It is also recommended by Hanley, Mcneil, & Ph, ( 1982)[26] a minimum of sample size of 73 is required for criterion validity using area under the receiver operating characteristics (AUROC) to predict the diagnostic accuracy (power) of MoCA version 8, say the level of significance is 5% and power of 80%, at least 25% of the sample will have MCI and the diagnostic accuracy of MoCA version 8 to detect MCI will be moderate (i.e. AUC = 70%)[26]

Statistical results and analysis

After collecting data, the data will be entered and analyzed by using SPSS version 26. Descriptive statistics will be used to summarize sociodemographic characteristics of the sample through the measure of CT and DS e.g. mean and SD. Cronbach’s alpha (α) and item analysis will be computed to determine the internal consistency of MoCA 8. The concurrent validity of MoCA 8 will be examined by comparing its correlation with the MoCA-5-min protocol cognitive tests using the Pearson’s correlation coefficient. The construct validity will be examined by a multivariate regression model of MoCA 8 against three validated tests LIADL (Lawton instrumental activities of daily living scale) MHI-5 (Mental health inventory-5 scale) and GDS-FS (Geriatric depression scale) with the hypothesis that older people with MCI and or dementia exhibit both mood impairment, activities of daily living and psychological wellbeing (Emotional) deterioration. Finally, the diagnostic accuracy of MoCA 8 will be examined by using one-way ANOVA and Receiver Operating Characteristics (ROC) curve analysis.

The study will be carried out on older people of rural and urban settings of Dodoma Region Tanzania, the collected data will be analyzed and the results will be reported with immediate effect by the use of STARD (Standard diagram for reporting diagnostic accuracy studies) diagram.

The results of this study will determine whether MoCA version 8 is a valid, reliable and accurate screening tool in detecting cognitive function of older people in Tanzania, this will serve as a study to inform the literature and indicate the manner in which early detection of cognitive impairments will inform early intervention to improve cognitive

Function among all older people.

Human Ethics and consent to participate

The ethics committee of the University of Dodoma accepted this work under the code of ethics MA.84/261/02/A/10. It is worth noting that after presenting themselves to participants, the researchers will describe the study aims and assure them that participation will be optional, that they will have the opportunity to withdraw from the study. Informed consent will be obtained. All techniques followed the declaration's relevant standards and requirements will be applied.

Competing interests

The authors declare that they have no competing interests against one another.

Author’s contributions

All authors provided a consensus conception and design of this protocol; however the structure of the protocol has been vastly developed by RN, who has been also responsible in developing this protocol, all authors therefore agreed on the final manuscript of this protocol.

Conflict Of Interest

All authors declare no conflict of interest.

Authors Contribution

All authors provided a substantial intellectual contribution to the conception and drafting of this protocol, and therefore they all approved the final manuscript for publication.

Research funding

This research study has no funding source, however, the development and the publication process are merely at the expenses of the author

Acknowledgement

This paper will be published in full in cognitive function assessment, however the views expressed in this study are purely author’s own ideas and not that of any individual. The University of Dodoma has played a large part in this study by granting the ethical approval to allow its operation.

Authors’ details

Recton Gaspar Nyika

School of Nursing and public health, University of Dodoma, College of Health and Allied Sciences (Chas), Dodoma, Tanzania

Mobile: +255683 216 403/+255762 958 246

Email: [email protected]

Co-author

Dr. Golden M. Masika (PhD).

Academic Coordinator, School of Nursing and Public health, College of Health Sciences, University of Dodoma (UDOM), Dodoma, Tanzania

Mobile: +255717 813 222

Email: [email protected]

Corresponding author

Recton Gaspar Nyika

School of Nursing and public health, University of Dodoma, College of Health and Allied Sciences (Chas), Dodoma, Tanzania

Mobile: +255683 216 403/+255762 958 246

Email: [email protected]

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No competing interests reported.

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Cross-Cultural Adaptation and Psychometric Properties of Version 8 of the Montreal Cognitive Assessment (MOCA) In Detecting Mild Cognitive Impairment and Dementia among Older People in Tanzania, A Methodological study/Diagnostic accuracy comparative study

Status:

Version 1

Abstract

Figures

Introduction

Background

Study aim

Objectives

Method/Design

Study design

Setting and study population

Inclusion criteria for participating in the study:

Translation team should consist of:

Inclusion and exclusion criteria for participating in this study

Exclusion criteria of this study will be

Participant recruitment process

Technical specification and definition

Participants screening process

Training and calibration of personnel/ Research assistant recruitment

Mitigation of confounders

Sample size calculation

Statistical results and analysis

Conclusion

Declarations

References

Additional Declarations

Status:

Version 1