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

Overview

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.

Interventions

• Other Cognitive stimulation
  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.
• Other Stimulating leisure activities
  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

Primary outcome measures

• Lobo Cognitive Mini-Test (MEC-35) [Time frame: Post-intervention (1 week), 3 months, 6 months, 12 months]

Secondary outcome measures (1)

• Test of Memory Alteration (T@M) [Time frame: Post-intervention (1 week), 3 months, 6 months, 12 months]

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Single blind

Primary purpose

Treatment

Study locations

Spain · 1 center

• Centro de Salud Arrabal — Zaragoza

Publications

• Lobo A, Saz P, Marcos G, Dia JL, de la Camara C, Ventura T, Morales Asin F, Fernando Pascual L, Montanes JA, Aznar S. [Revalidation and standardization of the cognition mini-exam (first Spanish version of the Mini-Mental Status Examination) in the general geriatric population]. Med Clin (Barc). 1999 Jun 5;112(20):767-74. Spanish. PMID 10422057
• Calero MD, Navarro E, Robles P, Garcia-Berben TM. [[Validity of the Cognitive Mini-Exam of Lobo et al. for the detection of dementia-associated cognitive deterioration] ]. Neurologia. 2000 Oct;15(8):337-42. Spanish. PMID 11143500
• Rami L, Bosch B, Valls-Pedret C, Caprile C, Sanchez-Valle Diaz R, Molinuevo JL. [Discriminatory validity and association of the mini-mental test (MMSE) and the memory alteration test (M@T) with a neuropsychological battery in patients with amnestic mild cognitive impairment and Alzheimer's disease]. Rev Neurol. 2009 Aug 16-31;49(4):169-74. Spanish. PMID 19621317
• Carnero-Pardo C, Espejo-Martinez B, Lopez-Alcalde S, Espinosa-Garcia M, Saez-Zea C, Hernandez-Torres E, Navarro-Espigares JL, Vilchez-Carrillo R. Diagnostic accuracy, effectiveness and cost for cognitive impairment and dementia screening of three short cognitive tests applicable to illiterates. PLoS One. 2011;6(11):e27069. doi: 10.1371/journal.pone.0027069. Epub 2011 Nov 2. PMID 22073256
• Pascual Millan LF, Martinez Quinones JV, Modrego Pardo P, Mostacero Miguel E, Lopez del Val J, Morales Asin F. [The set-test for diagnosis of dementia]. Neurologia. 1990 Mar;5(3):82-5. Spanish. PMID 2361045
• Munoz-Neira C, Lopez OL, Riveros R, Nunez-Huasaf J, Flores P, Slachevsky A. The technology - activities of daily living questionnaire: a version with a technology-related subscale. Dement Geriatr Cogn Disord. 2012;33(6):361-71. doi: 10.1159/000338606. Epub 2012 Jul 11. PMID 22797087
• Terwee CB, Bot SD, de Boer MR, van der Windt DA, Knol DL, Dekker J, Bouter LM, de Vet HC. Quality criteria were proposed for measurement properties of health status questionnaires. J Clin Epidemiol. 2007 Jan;60(1):34-42. doi: 10.1016/j.jclinepi.2006.03.012. Epub 2006 Aug 24. PMID 17161752
• Pfeffer RI, Kurosaki TT, Harrah CH Jr, Chance JM, Filos S. Measurement of functional activities in older adults in the community. J Gerontol. 1982 May;37(3):323-9. doi: 10.1093/geronj/37.3.323. PMID 7069156

Identifiers

NCT: NCT06058611 · U

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗