Effects of a Computerized Cognitive Stimulation Intervention Adapted to the Level of Cognitive Reserve

NCT06279325 | Recruiting

• 1 other identifier: C.I. PI23/637
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

Normal ageing presents subtle cognitive changes that can be detected before meeting the criteria for Mild cognitive impairment (MCI). Older people with low cognitive reserve and who receive limited cognitive stimulation are at greater risk of deterioration. In this regard, cognitive stimulation (CS) has been identified as an intervention that reduces this risk, provided that its design considers the differences in the level of cognitive reserve (CR) acquired throughout life and the baseline level of cognitive functioning. The general objective of this study is to evaluate, through a randomized clinical trial, the effectiveness of a computerized cognitive stimulation program, designed and adapted from Occupational Therapy based on the level of cognitive reserve in older adults in Primary Care. 100 participants will be randomized in a stratified manner according to the level of cognitive reserve (high/low), assigning 50 participants to the control group and 50 participants to the intervention group. The intervention group will carry out a computerized cognitive stimulation intervention designed and adapted from occupational therapy according to the level of cognitive reserve, through the "stimulus" platform. The main result expected to be achieved is the improvement of higher brain functions. As secondary results, the investigators expect that those cognitive aspects most vulnerable to ageing will decrease more slowly (in areas such as memory, executive function, attention and processing speed) and that the cognitive reserve of the participants will increase, in addition to being able to balance gender differences in these aspects. The investigators think that these results can positively impact the creation of adapted, meaningful and stimulating CS programs in older adults to prevent MCI and experience healthier ageing.

Conditions

Mild Cognitive Impairment; Cognitive Dysfunction

Outcome Measures

Primary Outcomes (2)

• MEC-35 (Spanish version of Folstein's Mini-Mental)

  The primary outcome variable is MEC-35 (Spanish version of Folstein's Mini-Mental): the most widely used cognitive test in Primary Care, adapted by Lobo to the Spanish population (Lobo, A., et al 1979). It evaluates 8 components: temporal orientation, spatial orientation, fixation memory, attention, calculation, short-term memory, language and praxis. Its sensitivity is 85-90% and its specificity 69% (Lobo, A. et al 1999). Although its cut-off point for detecting cognitive impairment is 24, in NC, scores between 28-35 points are considered (Friedman et al., 2012; Vinyoles Bargalló et al., 2002).

  An initial evaluation (pre), post-intervention (in a period of 2 to 7 days after the last intervention session) and two follow-up evaluations (at 6 and 12 months) will be carried out.

• Cognitive Reserve Questionnaire (CRQ)

  To determine the level of cognitive reserve (Landenberger et al., 2019) the most suitable questionnaire is the Cognitive Reserve Questionnaire (CRQ) (Rami et al., 2011). It has eight items with between three and six response options. Each item relieves a CR factor: schooling, parental schooling, courses, occupation, musical training, languages, reading and intellectual games. The maximum score is 25 points. Between 7 and 9 points is considered a medium-low range of CR. Between 10-14 points medium-high range, and ≥15 points, high CR. It is an instrument with high reliability and acceptable convergent validity (Martino et al., 2021).

  An initial evaluation (pre), post-intervention (in a period of 2 to 7 days after the last intervention session) and two follow-up evaluations (at 6 and 12 months) will be carried out.

Secondary Outcomes (5)

• Set-Test

  An initial evaluation (pre), post-intervention (in a period of 2 to 7 days after the last intervention session) and two follow-up evaluations (at 6 and 12 months) will be carried out.

• The SDMT or Symbols and Digits Test

  An initial evaluation (pre), post-intervention (in a period of 2 to 7 days after the last intervention session) and two follow-up evaluations (at 6 and 12 months) will be carried out.

• Color Word Stroop Test (CWST)

  An initial evaluation (pre), post-intervention (in a period of 2 to 7 days after the last intervention session) and two follow-up evaluations (at 6 and 12 months) will be carried out.

• Verbal Learning Test (TAVEC)

  An initial evaluation (pre), post-intervention (in a period of 2 to 7 days after the last intervention session) and two follow-up evaluations (at 6 and 12 months) will be carried out.

• Mobile Device Proficiency Questionnaire in Short Form (MDPQ-16)

  An initial evaluation (pre), post-intervention (in a period of 2 to 7 days after the last intervention session) and two follow-up evaluations (at 6 and 12 months) will be carried out.

Study Arms (2)

Cognitive Stimulation program

EXPERIMENTAL

Behavioral: Computerized cognitive stimulation program

Control Group

ACTIVE COMPARATOR

Behavioral: Face-to-face training-explanatory session

Interventions

Computerized cognitive stimulation program BEHAVIORAL

* The cognitive stimulation (CS) program, for the IG, will be previously designed by 2 Occupational Therapy (OT) of the team, and adapted to the computerized format through a platform specialized in cognitive neurorehabilitation. The activities will be designed under OT models: human occupation model and cognitive-perceptual model, so that the different professions, interests and roles are represented, and allow to express different levels of complexity, according to the level of Cognitive Reserve (CR). * The cognitive aspects to be worked on are: memory, orientation, language, praxis, gnosis, calculation, perception, logical reasoning, attention-concentration and executive functions. * In addition, reinforcement, EF, episodic memory, attention and information processing speed activities will be designed, also according to the CR level.

Cognitive Stimulation program

Face-to-face training-explanatory session BEHAVIORAL

The CG will undergo a group and face-to-face training-explanatory session, where the importance of maintaining the usual level of cognitive activity will be emphasized.

Control Group

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age: ≥ 60 years.
• With score in Lobo's Mini-cognitive Examination (MEC-35) (Lobo, A., Escolar, V., Ezquerra, J., \& Seva Díaz, 1979) between: 28-35 points (Friedman et al., 2012; Vinyoles Bargalló et al., 2002).
• Non-institutionalized persons, belonging to the health centers where the study was conducted.
• With a minimum educational level (knowing how to read and write).
• Who do not present hearing, visual or communication difficulties that would prevent them from completing the cognitive training.

You may not qualify if:

• People with mild cognitive impairment or Alzheimer's disease (AD).
• People with significant functional impairment.
• People who have received any type of professionalized cognitive stimulation therapy in the last year.
• People with significant psychiatric conditions, such as major depressive disorder or schizophrenia.
• People who are taking medications that may adversely affect cognitive function, such as anticholinergics, tranquilizers and anticonvulsants.

Sponsors & Collaborators

• Universidad de Zaragoza: lead

Study Sites (1)

Centro de Salud Arrabal

Zaragoza, Zaragoza, 50015, Spain

RECRUITING

Related Publications (1)

• Calatayud E, Olivan-Blazquez B, Aguilar-Latorre A, Cuenca-Zaldivar JN, Magallon-Botaya RM, Gomez-Soria I. Digital Competence and Cognitive Reserve in Relation to Different Domains of Cognitive Functioning in Older Adults and Factors Modulating This Association: A Cross-Sectional Study of a Randomized Clinical Trial. Geriatr Gerontol Int. 2025 Nov;25(11):1525-1535. doi: 10.1111/ggi.70199. Epub 2025 Oct 8.

  PMID: 41060253 DERIVED

MeSH Terms

Conditions

Cognitive Dysfunction

Condition Hierarchy (Ancestors)

Cognition Disorders; Neurocognitive Disorders; Mental Disorders

Central Study Contacts

Rosa Magallón Botaya

CONTACT

+34 622 71 97 59; gaiap.contacto@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD program in Health Sciences

Study Record Dates

• First Submitted: February 14, 2024
• First Posted: February 28, 2024
• Study Start: April 1, 2024
• Primary Completion: May 31, 2024
• Study Completion: January 15, 2025
• Last Updated: December 12, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL

Locations

ES (1)