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

Официальное название

Analysis of the Effectiveness of a Computerized Cognitive Stimulation Program Designed from Occupational Therapy According to the Level of Cognitive Reserve in Older Adults in Primary Care: Stratified Randomized Clinical Trial Protocol

Обзор

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.

Вмешательства

• Поведенческое 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 Reser
• Поведенческое 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.

Первичные конечные точки

• MEC-35 (Spanish version of Folstein's Mini-Mental) [Срок оценки: 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) [Срок оценки: 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.]

Вторичные конечные точки (5)

• Set-Test [Срок оценки: 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 [Срок оценки: 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) [Срок оценки: 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) [Срок оценки: 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) [Срок оценки: 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.]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Поддерживающая терапия

Центры проведения

Испания · 1 центр

• Centro de Salud Arrabal — Zaragoza

Публикации

• 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 PMID 41060253

Идентификаторы

NCT: NCT06279325 · C.I. PI23/637

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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