Clinical trial NCT06279325: Effects of a Computerized Cognitive Stimulation Intervention Adapted to the Level of Cognitive Reserve
Official title: 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Mild Cognitive Impairment
Cognitive Dysfunction
Lead sponsor: Universidad de Zaragoza
Sponsor class: OTHER
First posted: 2024-02-28
Enrollment: 100
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.


Eligibility criteria: 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.

Primary outcomes:
measure: MEC-35 (Spanish version of Folstein's Mini-Mental)
timeFrame: 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.
measure: Cognitive Reserve Questionnaire (CRQ)
timeFrame: 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:
measure: Set-Test
timeFrame: 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.
measure: The SDMT or Symbols and Digits Test
timeFrame: 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.
measure: Color Word Stroop Test (CWST)
timeFrame: 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.
measure: Verbal Learning Test (TAVEC)
timeFrame: 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.
measure: Mobile Device Proficiency Questionnaire in Short Form (MDPQ-16)
timeFrame: 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.
Other outcomes:
Locations:
city: Zaragoza
country: Spain
facility: Centro de Salud Arrabal
Study officials:
References: