Randomised Study of The Effectiveness Of A Training Programme In Everyday Cognition In Older Adults


 Background: Everyday cognition is the application of basic cognitive skills and knowledge of the specific domain for the resolution of problems that are integrated within the instrumental domains of functioning. The main objective to evaluate the effectiveness of a Training Programme in Everyday Cognition in order to improve the levels of everyday cognition and global cognitive performance in older adults.Methods: Experimental, randomised, stratified, prospective, longitudinal study using a fixed-assignment parallel scheme with an experimental group and a control group. The sample was composed of healthy older adults. The intervention of the experimental group consisted of an Everyday Cognition Training Programme, and the intervention of the control group consisted of a Traditional Cognitive Psycho-stimulation Programme. The Rapid Assessment of Cognitive Functions test (ERFC, for its acronym in French) and the Everyday Cognition Battery test (ECB) were used for the assessment.Results: Total sample (n=237) composed of 44 men and 223 women, with a mean age of 73.45 years. Statistically significant differences (p<0.001) were observed between both groups in both the ECB and the ERFC variables.Conclusion: The use of a Daily Cognition Training Programme presents greater benefits in terms of both global cognitive performance and everyday cognition than the use of a Traditional Cognitive Psycho-stimulation Programme in elderly adults.Trial registration: ClinicalTrials.gov: NCT04041999 (https://clinicaltrials.gov/ct2/show/NCT04041999)Retrospectively registered.


Background
In recent years, thanks to advances in medical techniques, life expectancy has increased greatly. As a result, the longevity of the population has led to a progressive increase in the incidence and prevalence of degenerative diseases such as mild cognitive impairment (MCI) and dementia [1,2], associated with such ageing.
Given the high number of older adults worldwide, the study of cognitive functions is gaining considerable importance.
In general, dementias are among the diseases of greatest clinical and health concern. However, there is a population group of older adults with undiagnosed cognitive impairment; MCI is still under-diagnosed and under-estimated, which makes these elderly people a population group at risk. Interest in cognitive assessment and intervention should be based on the impact of cognition on functioning and occupational performance, rather than on the assessment of individuals' intelligence and cognitive potential [3].
The interest in everyday cognition, a concept still little studied in Spain, arises from the previous statements.
Everyday cognition consists of the application of basic cognitive skills and knowledge of the speci c domain for the resolution of problems that are integrated within the instrumental activities of functioning [4,5].
Currently, there is no biomarker that allows the diagnosis of MCI or prodromal phase of dementia and determines the prognosis, so early diagnosis in clinical practice remains neuropsychological assessment [6,7].
Generally, cognitive screening tests, brief cognitive tests [8,9,10] or screening tests are used to evaluate a patient suspected of having cognitive impairment [11].
There are many instruments for assessing cognitive functions. However, not many do it by analysing the functional aspect [3].
It should be noted that the ability to successfully solve instrumental real-world problems is directly associated in the elderly with the ability to remain independent [12].Without a doubt, this functional independence and personal autonomy translates into a greater self-perception by the older adult in terms of quality of life.
Therefore, different researchers have argued that it is important to assess everyday cognition, instead of assessing cognitive performance with conventional measures, which are often out of context and not very objective [13].
For this purpose, there are tests that present cognitively challenging everyday problems and that have been designed to measure the ability to solve tasks related to instrumental activities of daily living (IADL) [14]. It should be noted that little use has been made in Spain of this type of measures. Among the existing assessment measures, we have selected the ECB (Everyday Cognition Battery) for our study.
Regarding cognitive intervention in older adults, the main objective has always been to stop, control or slow down the progression of cognitive impairment through different pharmacological therapies (PT) [15]. However, at present, numerous investigations highlight the role, both preventive and therapeutic, of Non-Pharmacological Therapies (NPT) in older adults [16]. Among NPT, cognitive psycho-stimulation has proved to be one of the most valid. Moreover, it plays a fundamental role due to its effects on the cognition and functionality of individuals.
Based on a "Traditional Cognitive Stimulation Programme", however taking into account that the objective of any cognitive psycho-stimulation programme should not only be the improvement or maintenance of the basic cognitive functions, but the generalisation and transference of that improvement to the elderlies' daily life, we propose a mode of action based on an "Everyday Cognition Training Programme", as well as on the evaluation of such cognition. Speci cally, we will focus on the correct intake of medication and adherence to medical treatment, giving total priority to the gain in terms of independence.
Labra Pérez et al [17] carried out a study on the importance of the participation of older adults in cognitively demanding daily activities. The aim of the research was precisely to analyse the relationship between daily stimulation and cognitive functioning. The results showed that various cognitively demanding everyday tasks are related to cognitive processes. They also evidenced the importance of everyday activity as a protective mechanism against cognitive decline, together with the need to maintain an active ageing.
In the existing literature, we nd that there is signi cant inter-individual variability in cognitive ageing [18]. The degree of daily cognitive stimulation is among the related factors [19]. Several studies have shown that older adults who participate in intellectual activities, cultural events or cognitive training programmes can slow down their cognitive decline or maintain cognitive function [20].
The main objective of our study is to evaluate the effectiveness of an "Everyday Cognition Training Programme" as a novel tool for cognitive stimulation in the elderly, to improve levels of everyday cognition and global cognitive performance. Another objective is to analyse, in a secondary way, whether there is a difference between the fore mentioned programme and a "Traditional Cognitive Stimulation Programme" in terms of levels of everyday cognition and cognitive performance in older adults and to study the relationship between standard psychometric tests which measure cognitive performance and the ECB Everyday Cognition Battery Recognition Test (Declarative Memory), which measures everyday cognition.

TRIAL DESIGN
Experimental, randomised, strati ed, prospective, longitudinal study using a xed-assignment parallel scheme with an experimental group and a control group.

PARTICIPANTS
Healthy older adults of both sexes, not institutionalised, from the city of Salamanca, who voluntarily completed an Occupational Therapy Programme organised by the University of Salamanca. The programme was implemented in their corresponding Day Centre or Social Association for older people, during the years 2014-2018, and the participants met the following selection criteria.
Inclusion criteria: To be aged 60 or older and voluntarily enrol in the occupational therapy programme, to be accepted into the occupational therapy programme, to perform the initial assessment (A-1) and to voluntarily authorise their participation in the study.
Exclusion criteria: To present cognitive impairment with a clinical diagnosis, not having knowledge of reading and/or writing, not authorising their participation in the study, not meeting the inclusion criteria, to participate in another cognitive stimulation programme on a regular basis and not carrying out the initial assessments of any of the 4 stages of the study.
Withdrawal criteria: Not performing the nal assessments of any of the four stages of the study, not continuing in the study of their own free will and to quit the occupational therapy programme.
ORIGIN OF THE PARTICIPANTS: Ten municipal centres and associations for older people, assigned to the City Council of Salamanca (Spain).

INTERVENTIONS
To evaluate the effectiveness of a " Everyday Cognition Training Programm" as a novel tool for cognitive stimulation in the elderly and to analyze whether there is a difference between the aforementioned program and a "Traditional Cognitive Stimulation Programme" we carried out the interventions that we are going to proceed to develop.
The development of the study over four years (2014-2018) was as follows (FIGURE 1): 1. After being admitted to the Occupational Therapy Programme, meeting the selection criteria and signing the informed consent, the groups were randomised. 2. Initial assessment or Assessment 1 (A-1): before the intervention. It consisted in the formalisation of the clinical history and the performance of the indicated tests. 3. Intervention Phase 1 (IP-1): in each intervention phase, 20 sessions were carried out in each of the groups; two sessions per week were conducted, which means an approximate duration of 3 months.
4. After the intervention, Assessment 2 (A-2) was performed, with the same tests as in A-1.
The time between A-1 and A-2 is the 1st STAGE.
1. After A-2, a period was established in which participants did not receive intervention. We call this period the Non-Intervention Phase 1 (NIP-1).
Each non-intervention phase lasted approximately one year.
University of Salamanca and has experience in this type of intervention aimed at maintaining / improving cognitive functions.
The task training interventions were carried out face-to-face in municipal centres and associations for older people, assigned to the City Council of Salamanca. The rooms of the centers for the elderly where the interventions were carried out were similar in terms of infrastructure. All of them have tables and chairs for all participants, good acoustics and light and a suitable environment free of distracting stimuli.
The intervention was carried out in the regular course of Occupational Therapy Programme organised by the University of Salamanca in 10 groups/day centre, of which 5 belonged to the experimental group and 5 to the control group. Each group consisted of a maximum of 25-30 participants. Although the explanation of the tasks carried out in the sessions was given to the entire group, each participant had to do it individually afterwards. In each of the 10 groups, 20 intervention sessions with a duration of 50 minutes were carried out (2 sessions/week on alternate days on the scheduled morning); therefore, a total of 200 sessions were carried out in each intervention phase. As the study was composed of 4 intervention phases, a total of 800 sessions were conducted throughout the study. FIGURE 2 shows the distribution in time of the groups. We can say that, as all the participants in the nal sample had completed the 4 stages of the study, each of them received a total of 80 sessions.
Although the number of sessions and their duration was the same in the two groups; the sessions differed in terms of the procedures used, a different intervention program was used in each of the study groups: 1. Control group: An intervention based on a "Traditional Cognitive Stimulation Programme" was carried out.
In the "Traditional Cognitive Stimulation Programme", tasks were carried out to exercise various cognitive functions: orientation, gnosis, executive functions (mainly working memory, decision making, planning, reasoning and time estimation), praxis, attention, language and memory.
The material used in the "Traditional Cognitive Stimulation Programme" was mainly stationery (sheets, pens, pencils, etc.). In addition, in some sessions computers were used, which were available in all the centers for older people.
1. Experimental group: An intervention based on an "Everyday Cognition Training Programme" was conducted.
In the "Everyday Cognition Training Programme", the older adults had to perform different IADLs. All the activities performed involved the application of cognitive processes such as working memory, processing speed, attention, reasoning or planning.
Speci cally, we focused on tasks related to medication taking and adherence to treatment, due to the great importance of this activity in older adults, the di culty it sometimes implies for them and the various consequences that incorrect taking could entail.
Some of the tasks carried out were: handling a medical prescription; controlling the expiration of medications; understanding medical prescriptions, guidelines for the correct taking of medication (dose, schedules...) and indications and contraindications; lling pill boxes; recalling medical check-ups; and prospective memory of medical management.
For this purpose, materials similar or equal to those that the older adult could nd in daily tasks or when facing the resolution of daily problems were used, thus bringing the intervention closer to real life. For example, medication pill boxes, documents designed to be as close to reality as prescription drugs, package lea et of the medicinal product, medical reports, follow-ups and medical appointments, etc.
The big difference between an everyday cognition training programme and a conventional cognitive stimulation programme, such as the one carried out in the control group, is that in the former the subjects exercise different cognitive functions during the development of different IADLs, whereas in the latter subjects exercise these functions by performing tasks that are far from being able to be generalised to the daily routine.
The intervention was not modi ed during the course of the study, thanks to the previous performance of a pilot study. Thus avoiding possible biases or differences in the different evaluation tests and in the nal results of the study.

Results
All prospectively selected patients who met the inclusion criteria were included in the study. The study has a nal sample of 237 individuals: 137 individuals in the experimental group and 130 individuals in the control group (FIGURE 3).
The recruitment of the study participants was carried out by the Elderly Department of the Salamanca City Council between 2014-2018, which was in charge of promoting the participation in the programme among the different associations and day centres for older people. Therefore, it can be considered a convenience sampling.
The sample (n = 237) is composed of 44 men and 223 women, and the mean age of the total sample is 73.45 years (± 6.45). Regarding their level of education, most of the participants have at least primary education (78.70%).
We observe there are no between-group differences on any measure at baseline: The experimental group (n = 137) is composed of 22 men and 115 women, with a mean age of 73.89 years (± 6.38). In the experimental group 78.10% of the subjects had primary studies, 15.30% secondary studies and 6.60% higher studies. The control group (n = 130) is composed of 22 men and 108 women, with a mean age of 72.99 years (± 6.51). In the control group 79.20% of the subjects had primary studies, 6.20% secondary studies and 14.20% higher studies. Table 1 shows the results of the descriptive statistics of the scores obtained in the ERFC Questionnaire and the ECB Battery in the 8 evaluations carried out. By analysing the ERFC scores, it can be observed that in the 4 stages, in both groups, there was an increase in the scores after the intervention, but in the experimental group the increase was greater. The same applies to the ECB Battery, but in this case, the increase in the score was notably greater in the experimental group than in the control group.  The descriptive statistics results table shows the scores obtained in the ERFC Questionnaire and the ECB Battery, in the 8 evaluations carried out throughout the 4 study stages, in the experimental group and in the control group. We can observe the scores before and after the intervention in both questionnaires.
To check whether the implementation of different interventions in each of the groups produced differences in the cognitive performance and everyday cognition of the participants, the following actions were taken: First, a comparison of the mean scores of the initial and nal assessments was made, in both groups separately. These mean scores took into account both the initial assessment made at the beginning of the study (1-PRE) and the last assessment made at the end of the study (8-POST). The initial and nal assessments at each stage of the study were also taken into account, both from the ERFC Questionnaire and the ECB Battery (Table 2). Statistically signi cant differences were found in both the control group and the experimental group between the 1-PRE and 8-POST assessment, as well as between the initial and nal assessments at each stage of the study in "ERFC" (p 0.001) and "ECB" (p 0.001).    The table shows the comparison of ranges between initial and nal assessments in the 4 stages of the study; and in the 8-POST and 1-PRE assessment in ERFC Questionnaire and ECB Battery in the CONTROL GROUP and in the EXPERIMENTAL GROUP; and comparison between CONTROL GROUP-EXPERIMENTAL GROUP of the variable "difference of the 4 stages of the study" and the variable "difference 1-PRE − 8-POST" of the ERFC Questionnaire and ECB Battery.
Observing these results, we can point out that in both groups there was a signi cant increase in 8-POST with respect to 1-PRE, as well as in all stages of intervention. Although the Z value in the experimental group is notably higher, especially in the ECB, we do not know the amount of this increase, nor can we say whether one group increases more than the other.
Secondly, the comparison between the two groups was made. For this purpose, the variables "difference between 1-PRE and 8-POST" and "difference between the initial and nal assessment of each of the 4 stages of the study" were generated. As analysed in Table 2, in the case of ERFC, statistically signi cant differences were obtained between the control group and the experimental group in the variable difference 1-PRE and 8-POST (p 0.001) and in the variable difference between the initial and nal assessments in all the stages of the study (p 0.001), except in the 3rd stage. In the case of ECB, statistically signi cant differences were obtained between the control group and the experimental group, in all variables under study (p 0.001).
With regard to the study of correlations, we took as valid those with a positive statistical signi cance, with signi cance indices of p < 0.05. The results revealed signi cant positive relationships between all the variables studied, regarding the scores corresponding to ERFC and the scores corresponding to ECB. Furthermore, we can add that this signi cance was obtained in all the situations studied, both in the initial assessment at the beginning of the study (1-PRE) and in the nal assessment after 4 periods of intervention (8-PRE) ( Table 3).  The table shows, on the one hand, the correlation of the variable "ERFC" with variable "ECB", both with the score obtained in the Initial Assessment (1-PRE) and in that obtained in the Last Assessment , and on the other hand, the correlation between the sociodemographic variables "Age" and "Educational Level" with the score obtained in the ERFC Questionnaire and in the ECB Battery, both with the score obtained in the Initial Assessment (1-PRE) and in the obtained in the Last Assessment (8-POST).
As for the correlation of these variables with the socio-demographic variables, signi cance was again obtained in all the cases studied (Table 3). On the one hand, a signi cant and positive correlation was observed between "Level of education" and "ERFC 1-PRE" (p < .001), and "Level of education" and "ERFC 8-POST" (p < .001), as well as between "Level of education" and "ECB 1-PRE" (p < .001), and "Level of education" and "ECB 1-POST" (p = .003).

Discussion
The realization of this research arose from the need to study the evolution at a cognitive level of a population of non-institutionalised older adults who participated in an Occupational Therapy Programme, lived in the town of Salamanca (Spain) and received cognitive psycho-stimulation.
The data from our study re ect a good balance between the characteristics of both groups, having studied the initial equality of all variables in all cases. This means there were not signi cant differences prior to the intervention that could affect the results.
With regard to cognitive performance (ERFC Test) we observe that, taking into account the results achieved when analysing each group separately and comparing the initial and nal scores, we can point out that in both groups there was a signi cant increase in the 8-POST score with respect to the 1-PRE score, as well as in the nal scores with respect to the initial scores at all stages of intervention.
As can be seen, when analysing each group independently, both groups obtained an improvement in their global cognitive performance; this may be due to the fact that in both groups the intervention was directly aimed at the cognitive function of individuals. However, it should be noted that the experimental group obtained a greater increase. Furthermore, this data indicates that cognitive psycho-stimulation in general, independently of the procedure carried out in each group, is indeed a useful tool to improve the global cognitive performance of older adults, as all the studies we have previously analysed point out [22,23].
However, when comparing the control group against the experimental group, statistically signi cant differences were found in the difference between A-1 and A-8 in ERFC. These results lead us to a rm that, although it is true that the implementation of a traditional cognitive psycho-stimulation programme improves the global cognitive performance in older adults, the implementation of a programme of everyday cognition seems to report greater bene ts.
Regarding the analysis of everyday cognition (through ECB), the results obtained were even more conclusive: it was observed that both groups improved their everyday cognition after the intervention, but clearly the individuals in the experimental group obtained a notably greater increase than those in the control group. Moreover, when comparing both groups, statistically signi cant differences were obtained in the difference between the Initial Assessment made at the beginning of the study and Assessment 8 made at the end of the study, and also after the intervention in all the stages of the study.
These last data con rm that those people who have bene ted from speci c training in everyday cognition notably improve their cognitive capacity to solve everyday problems: this is the most relevant nding we have obtained. In addition, as we have already pointed out, they also signi cantly improve their global cognitive performance.
As for the individuals in the control group, we can observe that there is also an improvement in their cognitive performance, consistent with the traditional cognitive psycho-stimulation programme from which they have bene ted, but the difference in everyday cognition is less. This leads us to wonder whether this improvement could eventually be transferred to their everyday life, since this group of individuals who did not bene t from speci c training in everyday cognition might experience a functional improvement.
Another aspect to highlight is that we observed a signi cant and positive correlation between the ERFC scores and the ECB scores in both A-1 and A-8. Indeed, the better the cognitive performance of the individuals in our sample, the better their everyday cognition and vice versa. In addition, a positive and signi cant correlation was also found within each of the scales at time 1-PRE and time 8-POST. That is, between ERFC TOTAL 1-PRE and ERFC TOTAL 8-POST, and between ECB 1-PRE and ECB 8-POST.
Similar results have been described in other research, such as a prospective epidemiological study by Allaire and Willis [24], which demonstrated a relationship between both types of measures. Or in the study by Menor J et al [17], in which, in addition to using measures of everyday cognition and global cognitive performance, they employed scales to assess speci c cognitive functions (comprehension, reasoning, semantic memory, executive functions and working memory).
In addition to the indicated ndings, our results inform us of the existence of a signi cant negative correlation between age, and cognitive performance and everyday cognition. Other works analysed show similar results [25,26]. The opposite occurs with the level of education of individuals. With the results obtained, we can a rm that there is a positive and signi cant relationship between the level of studies of our older adults and their cognitive performance and everyday cognition. Menor J et al [26], in their study on the development of an instrument to evaluate everyday cognition -which we have already mentioned and whose results we have been comparing with ours, as it is one of the few studies on everyday cognition carried out in Spain-again found similar results to ours.
In the review of the literature, we found consensus on the importance of evaluating both functional independence [27] and cognitive status in older people [28]. However, in Spain, the evidence on the use of tests that assess everyday cognition is very limited. Therefore, we believe it is important to promote the use of this type of tool. Some authors [29], make direct reference to the usefulness that this type of tests may have; speci cally, in the eld of geriatrics, since they can complete the geriatric exploration or establish the degree of functionality of some IADLs.
We agree that maintaining cognitive functions in the elderly is highly important [28]. However, it is indisputable that people who are cognitively capable of memorising and correctly applying the dose of medication they have to take each day, or are able to interpret without the help of another person the recommendations or contraindications of a patient information lea et, will achieve greater personal autonomy. And we believe the same would happen with any other instrumental activity.
As noted above, studies have been conducted, although very few in Spain [26], which have used, along with conventional measures, measures of everyday cognition, such as the studies by Allaire JC and Willis SL 2006 [24] and Kennedy SW et al 2012 [30].
There are also several studies [27,[31][32][33], although most outside Spain, that have studied and used different tests of everyday cognition, relating these tests to different variables.
However, it should be noted that little use has been made of programmes in which a direct intervention on everyday cognition is carried out after cognitive assessment.
To conclude, our results lead us to think that people who have bene ted from a traditional cognitive psycho-stimulation programme (control group) do indeed improve their cognitive status, but not so much their everyday cognition. On the other hand, those people who have bene ted from a training programme in everyday cognition (experimental group) obtain a remarkable improvement in their global cognitive function and also in their everyday cognition [34]. Therefore, the application of an intervention focused on everyday cognition should provide more bene ts in older adults when it comes to applying the gains achieved to the performance of their daily tasks or to the resolution of problems that may arise in their daily lives.
These results would support those of authors such as Allaire JC and Marsiske M [13], who have long used measures of assessment of the older adult during the resolution of complex tasks of daily life, rather than evaluations out of context and which they consider to be unobjective.
In short, we believe that assessment and intervention methods in older adults with cognitive problems or at risk should be rethought. A less theoretical and more applied approach to reality can be bene cial for them not only in terms of improving assessment test scores, but also as a re ection in their daily lives.
We can point out as a possible limitation of the study that the assessments were carried out by ve quali ed occupational therapists, of whom only one carried out the intervention in both research groups. Therefore, the study cannot be referred to as double-blind, but as has been pointed out before, we tried to control for possible interference in the results by having an external evaluator perform 80% of the assessments carried out.

Conclusions
Main conclusion The use of a Programme of Training in Everyday Cognition presents greater bene ts in terms of both global cognitive performance and everyday cognition in older adults than the use of a Programme of Traditional Cognitive Psycho-stimulation.
Secondary conclusions: 1. There is a signi cant correlation between the standard psychometric tests that measure cognitive performance and the Everyday Cognition Battery (ECB) Recognition Test (declarative memory).
2. There is a signi cant negative correlation between age, and global cognitive performance and everyday cognition of older adults.