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

Mild Cognitive Impairment Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06279325
• Other study ID #: C.I. PI23/637
• Status: Recruiting
• Phase: N/A
• Start date: April 1, 2024
• Est. completion date: January 15, 2025

Study information

• Verified date: May 2024
• Source: Universidad de Zaragoza
• Contact: Rosa Magallón Botaya
• Phone: +34 622 71 97 59
• Email: gaiap.contacto[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: January 15, 2025
• Est. primary completion date: May 31, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 60 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Cognitive Dysfunction
• Mild Cognitive Impairment

Intervention

Behavioral:
• 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.
• 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.

Locations

Country	Name	City	State
Spain	Centro de Salud Arrabal	Zaragoza

Sponsors (1)

Lead Sponsor	Collaborator
Universidad de Zaragoza

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.
Primary	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	Set-Test	-Set-Test (Pascual, L., Martinez, J., Modrego, P., Mostacero, E., Lopez del Val, J., & Morales, 1990): measures verbal fluency of categorical type: colors, animals, fruits and cities, asking the patient to say elements of the 4 categories in one minute. It presents a sensitivity of 87% and a specificity of 67%.	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	The SDMT or Symbols and Digits Test	The SDMT or Symbols and Digits Test measures EF, processing speed and attention. It is a test with good accuracy, sensitivity and specificity, useful for predicting future MCI. The SDMT card consists of a header with a key that relates the numbers from 1 to 9 with different symbols; the participant has 90 seconds to match a specific number with a particular geometric figure. The response can be written or verbal, and the maximum total response time is five minutes. The ideal cut-off point is 44 points, although 38 points can be used for a more specific result (Baudouin et al., 2009).	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	Color Word Stroop Test (CWST)	Color Word Stroop Test (CWST) (Cheng et al., 2012) assesses perseveration, cognitive flexibility, EF and attention (Uttl & Graf, 1997). It consists of naming a color with and without the presence of conflicting or incongruent stimuli. The test consists of three sheets: in the first one, colors written in black ink are repeated, in the second one colors with their geometric figure, and in the third one colors written in different ink. The correct answers in the three sheets are collected. This test shows a decrease by age and gender (the most impaired EF in men) (Periáñez et al., 2021; Van der Elst et al., 2008). The limits considered normal are 35-65 points (Graf et al., 1995).	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	Verbal Learning Test (TAVEC)	Verbal Learning Test (TAVEC) Spanish version of the California Verbal Learning Test (CVLT). It evaluates learning and episodic memory capacity. The test consists of memorizing a list of 16 words (list A), belonging to four semantic categories, and their subsequent recall. Five trials are repeated and a second list of 16 words (list B) is administered. Subsequently, recall of list A and recall by semantic categories is requested. After about 20 minutes, free recall of word list A and recall by semantic categories is requested again. Both Spearman's coefficient and Cronbach's a indicate high reliability (Nieto Barco et al., 2014).	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	Mobile Device Proficiency Questionnaire in Short Form (MDPQ-16)	Mobile Device Proficiency Questionnaire in Short Form (MDPQ-16). Tests experience and aptitude for using mobile devices in eight domains: mobile device basics, communication, data and file storage, Internet, calendar, entertainment, privacy, troubleshooting, and software management. Each of the domains is scored on a 5-point scale (e.g., 1 = never tried , 2 = not at all , 3 = not very easily , 4 = somewhat easily , 5 = very easily). The total score ranges from 8 to 40, with higher scores reflecting greater competence. Internal consistency is excellent (Cronbach's a=.96).(Roque & Boot, 2018).	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.