Effects of a Computerised Cognitive Stimulation Versus Stimulating Leisure Activities

Study Overview
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Brief Summary
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The aim of the study is to evaluate, at the level of global cognition, cognitive neuroconstructs, memory, verbal fluency, ADLs, IADLs, symptoms of depression and anxiety, the effectiveness of a personalised and adapted computerised cognitive stimulation programme (GI1) implemented from Primary Care versus stimulating leisure activities (GI2), in older adults aged 50 years and over with mild cognitive impairment living in the community.

Detailed Description
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A randomised controlled trial (RCT) will be conducted. The sample will consist of 90 participants aged 50 years and older, all of whom are patients in primary care practices. Intervention Intervention group 1 (IG1) will carry out personalised and adapted computerised CE through the stimulus platform; 30 minutes/day, 5 days/week, 8 weeks; 40 sessions. The following will be worked on: memory, orientation, language, praxis, gnosis, calculation, perception, logical reasoning, attention-concentration and executive functions. Stimulus is a CE platform, which allows individualised intervention through the use of ICTs with different populations. Intervention group 2 (IG2) will perform between 2 and 5 cognitively stimulating leisure activities for 8 weeks. These leisure activities will be selected from the adapted version of the Karp et al. 2006 questionnaire (Karp et al., 2006) taking into account the three components of leisure activities (mental, physical and social). The questionnaire contains 29 activities [1) reading, 2) arts and crafts, 3) crosswords and word search puzzles, 4) interest in politics, 5) playing cards or chess, 6) visiting the second home, 7) attending courses, 8) watching television, 9) going to the theatre or concerts, 10) playing sports, 11) going to exhibitions or museums, 12) meeting friends, 13) walking, 14) listening to the radio, 15) travelling, 16) gardening, 17) painting, drawing or taking photos, 18) participating in family or charity activities, 19) outdoor activities, 20) collecting stamps or other items, 21) cooking, 22) writing, 23) doing housework, 24) attending religious activities, 25) playing musical instruments, 26) playing solitaire, 27) following the stock market or investing, 28) playing bingo, 29) singing]. In addition to indicating which cognitively stimulating leisure activities they perform on a weekly basis, participants in IG2 will indicate their daily frequency (< 30 min, 30min-1 hour, 1-2 hours, > 2 hours), commenting on whether they have carried them out individually or in a group. It will also be taken into account whether these activities were previously carried out according to their stage of life. The control group (CG) will not receive any intervention during the study period. At the end of the study, the control group will be offered to participate in either of the following two interventions. There will be a pre-intervention, post-intervention assessment and two follow-ups at 6 and 12 months. Firstly, an assessment protocol will be used with ad hoc socio-demographic variables, referring to clinical characteristics and in relation to lifestyle. These variables will be collected in a socio-health record. In addition, if participants do not have a diagnosis of MCI, the MEC-35 will be used to apply the inclusion and exclusion criteria.

Official Title
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Effects of a Personalised and Tailored Computerised Cognitive Stimulation Programme Versus Stimulating Leisure Activities in Older Adults With Mild Cognitive Impairment: Randomised Controlled Trial

Conditions
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Randomized Controlled Trial, Mild Cognitive Impairment

Intervention / Treatment
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* Other: Cognitive stimulation
* Other: Stimulating leisure activities


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: ≥ 50 years old, resident in the community. Diagnosis of MCI or having between 24 and 27 points on the MEC-35 (this score seems to indicate the presence of MCI) (Calero, M. D and Navarro, 2006). Exclusion Criteria: Institutionalisation. Taking acetylcholinesterase inhibitors as they may act on global cognition and/or cognitive functions. Sensory deficits (deafness and blindness) preventing intervention. Agitation. Having received cognitive stimulation in the last 12 months.

Ages Eligible for Study
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Minimum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Parallel allocation Two intervention group (GI1 and GI2) and a control group (CG) with the same characteristics are included
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention group 1 (GI1)<br>Intervention group 1 (IG1) will carry out personalised and adapted computerised cognitive stimulation (CE) through the stimulus platform; 30 minutes/day, 5 days/week, 8 weeks; 40 sessions. The following will be worked on: memory, orientation, language, praxis, gnosis, calculation, perception, logical reasoning, attention-concentration and executive functions. | Other: Cognitive stimulation<br>* Cognitive stimulation through the stimulus platform; 30 minutes/day, 5 days/week, 8 weeks; 40 sessions. The following will be worked on: memory, orientation, language, praxis, gnosis, calculation, perception, logical reasoning, attention-concentration and executive functions.<br>|
| Experimental: Intervention group 2 (GI2)<br>Intervention group 2 (IG2) will perform between 2 and 5 cognitively stimulating leisure activities for 8 weeks. These leisure activities will be selected from the adapted version of the Karp et al. 2006 questionnaire (Karp et al., 2006) taking into account the three components of leisure activities (mental, physical and social). The questionnaire contains 29 activities. In addition to indicating which cognitively stimulating leisure activities they perform on a weekly basis, participants in IG2 will indicate their daily frequency (< 30 min, 30min-1 hour, 1-2 hours, > 2 hours), commenting on whether they have carried them out individually or in a group. It will also be taken into account whether these activities were previously carried out according to their stage of life. | Other: Stimulating leisure activities<br>* Intervention group 2 (IG2) will perform between 2 and 5 cognitively stimulating leisure activities for 8 weeks. These leisure activities will be selected from the adapted version of the Karp et al. 2006 questionnaire (Karp et al., 2006) taking into account the three components of leisure activities (mental, physical and social). The questionnaire contains 29 activities. In addition to indicating which cognitively stimulating leisure activities they perform on a weekly basis, participants in IG2 will indicate their daily frequency (< 30 min, 30min-1 hour, 1-2 hours, > 2 hours), commenting on whether they have carried them out individually or in a group. It will also be taken into account whether these activities were previously carried out according to their stage of life.<br>|
| No Intervention: Control Group (CG)<br>The control group (CG) will not receive any intervention during the study period. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Lobo Cognitive Mini-Test (MEC-35) | The MEC-35 is one of the most widely used short cognitive tests for the study of cognitive abilities in the primary care setting. The MEC-35 assesses eight cognitive functions: temporal and spatial orientation (10 items), fixation memory (3 items), attention (3 items), calculation (5 items), short-term memory (3 items) and language and praxis (11 items) (Lobo et al. 1999) (figure 1). Its sensitivity is 89.8% and its specificity 83.9% (Calero MD, Navarro E, Robles P, 2000). Unlike the MMSE, the MEC-35 includes a series of three digits to repeat two similar items in reverse order. Subtraction is performed 3 by 3 from 30, instead of 7 by 7 from 100 (Folstein et al., 1975). | Post-intervention (1 week), 3 months, 6 months, 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Test of Memory Alteration (T@M) | The maximum score for the T@M is 50 points; one point is awarded for each correct answer. All questions are oral and have only one possible answer. There are 5 sub-tests: encoding (5 points), orientation (10 points), semantic (15 points), free recall (10 points) and guided recall (10 points). It assesses temporal orientation and memory (episodic, textual and semantic). A score of 36 points has a sensitivity of 0.93 and a specificity of 1 (Rami et al., 2009). Its results are slightly influenced by educational level, so the cut-off points are 36/37 and 37/38 for subjects with <8 years and ≥8 years of education, respectively (Carnero-Pardo et al., 2011). | Post-intervention (1 week), 3 months, 6 months, 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cognitive Intervention, Leisure Activities, Mild Cognitive Impairment, Older adults, Elderly, Randomized Controlled Trial, Cognitive Stimulation, Cognitively Stimulating Leisure Activities