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

NCT ID: NCT06279325

Last Updated: 2024-12-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-04-01

Study Completion Date

2025-01-15

Brief Summary

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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.

Detailed Description

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Conditions

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Mild Cognitive Impairment Cognitive Dysfunction

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Cognitive Stimulation program

Group Type EXPERIMENTAL

Computerized cognitive stimulation program

Intervention Type 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.

Control Group

Group Type ACTIVE_COMPARATOR

Face-to-face training-explanatory session

Intervention Type 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.

Interventions

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Computerized cognitive stimulation program

* 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.

Intervention Type BEHAVIORAL

Face-to-face training-explanatory session

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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* 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.

Exclusion Criteria

* 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.
Minimum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Universidad de Zaragoza

OTHER

Sponsor Role lead

Responsible Party

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Estela Calatayud

PhD program in Health Sciences

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Centro de Salud Arrabal

Zaragoza, Zaragoza, Spain

Site Status RECRUITING

Countries

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Spain

Central Contacts

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Rosa Magallón Botaya

Role: CONTACT

Phone: +34 622 71 97 59

Email: [email protected]

Facility Contacts

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Rosa Magallón Botaya

Role: primary

References

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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 Oct 8. doi: 10.1111/ggi.70199. Online ahead of print.

Reference Type DERIVED
PMID: 41060253 (View on PubMed)

Other Identifiers

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C.I. PI23/637

Identifier Type: -

Identifier Source: org_study_id