Clinical trial NCT06058611: Effects of a Computerised Cognitive Stimulation Versus Stimulating Leisure Activities
Official title: Effects of a Personalised and Tailored Computerised Cognitive Stimulation Programme Versus Stimulating Leisure Activities in Older Adults with Mild Cognitive Impairment and Subjective Cognitive Impairment: Randomised Controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Mild Cognitive Impairment
Randomized Controlled Trial
Subjective Cognitive Impairment
Keywords: Mild Cognitive Impairment
Older adults
Elderly
Randomized Controlled Trial
Cognitive Stimulation
Cognitive Intervention
Cognitively Stimulating Leisure Activities
Leisure Activities
Subjective Cognitive Impairment
Lead sponsor: Universidad de Zaragoza
Sponsor class: OTHER
First posted: 2023-09-28
Enrollment: 90
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Parallel allocation Two intervention group (GI1 and GI2) and a control group (CG) with the same characteristics are included
Primary purpose: TREATMENT

Brief summary: 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 and subjective cognitive impairment living in the community.

Detailed description: A randomised controlled trial (RCT) will be conducted. The sample will consist of 59 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.

Eligibility criteria: 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).
* Subjective cognitive impairment (score between 28-31 points on the MEC-35) (Gómez-Soria et al. 2023)

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.

Primary outcomes:
measure: Lobo Cognitive Mini-Test (MEC-35)
timeFrame: Post-intervention (1 week), 3 months, 6 months, 12 months
Secondary outcomes:
measure: Test of Memory Alteration (T@M)
timeFrame: Post-intervention (1 week), 3 months, 6 months, 12 months
Other outcomes:
measure: Set-Test (S-T)
timeFrame: Post-intervention (1 week), 3 months, 6 months, 12 months
measure: Activities of Daily Living Questionnaire T-ADLQ
timeFrame: Post-intervention (1 week), 3 months, 6 months, 12 months
measure: Lawton and Brody scale (L-B)
timeFrame: Post-intervention (1 week), 3 months, 6 months, 12 months
measure: 15-item version of the Yesavage Geriatric Depression Scale (GDS-15)
timeFrame: Post-intervention (1 week), 3 months, 6 months, 12 months
measure: Goldberg anxiety subscale
timeFrame: Post-intervention (1 week), 3 months, 6 months, 12 months
Locations:
city: Zaragoza
country: Spain
facility: Centro de Salud Arrabal
Study officials:
References:
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