Effects of a Computerised Cognitive Stimulation Versus Stimulating Leisure Activities

March 11, 2024 updated by: Isabel Gómez-Soria, Universidad de Zaragoza

Effects of a Personalised and Tailored Computerised Cognitive Stimulation Programme Versus Stimulating Leisure Activities in Older Adults With Mild Cognitive Impairment and Subjective Cognitive Impairment: Randomised Controlled Trial

The aim of the study is to evaluate, at the level of global cognition, cognitive neuroconstructs, memory, verbal fluency, ADLs, IADLs, symptoms of depression and anxiety, the effectiveness of a personalised and adapted computerised cognitive stimulation programme (GI1) implemented from Primary Care versus stimulating leisure activities (GI2), in older adults aged 50 years and over with mild cognitive impairment and subjective cognitive impairment living in the community.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

A randomised controlled trial (RCT) will be conducted. The sample will consist of 59 participants aged 50 years and older, all of whom are patients in primary care practices.

Intervention Intervention group 1 (IG1) will carry out personalised and adapted computerised CE through the stimulus platform; 30 minutes/day, 5 days/week, 8 weeks; 40 sessions. The following will be worked on: memory, orientation, language, praxis, gnosis, calculation, perception, logical reasoning, attention-concentration and executive functions. Stimulus is a CE platform, which allows individualised intervention through the use of ICTs with different populations.

Intervention group 2 (IG2) will perform between 2 and 5 cognitively stimulating leisure activities for 8 weeks. These leisure activities will be selected from the adapted version of the Karp et al. 2006 questionnaire (Karp et al., 2006) taking into account the three components of leisure activities (mental, physical and social). The questionnaire contains 29 activities [1) reading, 2) arts and crafts, 3) crosswords and word search puzzles, 4) interest in politics, 5) playing cards or chess, 6) visiting the second home, 7) attending courses, 8) watching television, 9) going to the theatre or concerts, 10) playing sports, 11) going to exhibitions or museums, 12) meeting friends, 13) walking, 14) listening to the radio, 15) travelling, 16) gardening, 17) painting, drawing or taking photos, 18) participating in family or charity activities, 19) outdoor activities, 20) collecting stamps or other items, 21) cooking, 22) writing, 23) doing housework, 24) attending religious activities, 25) playing musical instruments, 26) playing solitaire, 27) following the stock market or investing, 28) playing bingo, 29) singing].

In addition to indicating which cognitively stimulating leisure activities they perform on a weekly basis, participants in IG2 will indicate their daily frequency (< 30 min, 30min-1 hour, 1-2 hours, > 2 hours), commenting on whether they have carried them out individually or in a group. It will also be taken into account whether these activities were previously carried out according to their stage of life.

The control group (CG) will not receive any intervention during the study period. At the end of the study, the control group will be offered to participate in either of the following two interventions.

There will be a pre-intervention, post-intervention assessment and two follow-ups at 6 and 12 months. Firstly, an assessment protocol will be used with ad hoc socio-demographic variables, referring to clinical characteristics and in relation to lifestyle. These variables will be collected in a socio-health record. In addition, if participants do not have a diagnosis of MCI, the MEC-35 will be used to apply the inclusion and exclusion criteria.

Study Type

Interventional

Enrollment (Estimated)

90

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • ≥ 50 years old, resident in the community.
  • Diagnosis of MCI or having between 24 and 27 points on the MEC-35 (this score seems to indicate the presence of MCI) (Calero, M. D and Navarro, 2006).
  • Subjective cognitive impairment (score between 28-31 points on the MEC-35) (Gómez-Soria et al. 2023)

Exclusion Criteria:

  • Institutionalisation.
  • Taking acetylcholinesterase inhibitors as they may act on global cognition and/or cognitive functions.
  • Sensory deficits (deafness and blindness) preventing intervention.
  • Agitation.
  • Having received cognitive stimulation in the last 12 months.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intervention group 1 (GI1)
Intervention group 1 (IG1) will carry out personalised and adapted computerised cognitive stimulation (CE) through the stimulus platform; 30 minutes/day, 5 days/week, 8 weeks; 40 sessions. The following will be worked on: memory, orientation, language, praxis, gnosis, calculation, perception, logical reasoning, attention-concentration and executive functions.
Other: Cognitive stimulation
Cognitive stimulation through the stimulus platform; 30 minutes/day, 5 days/week, 8 weeks; 40 sessions. The following will be worked on: memory, orientation, language, praxis, gnosis, calculation, perception, logical reasoning, attention-concentration and executive functions.
Experimental: Intervention group 2 (GI2)

Intervention group 2 (IG2) will perform between 2 and 5 cognitively stimulating leisure activities for 8 weeks. These leisure activities will be selected from the adapted version of the Karp et al. 2006 questionnaire (Karp et al., 2006) taking into account the three components of leisure activities (mental, physical and social). The questionnaire contains 29 activities.

In addition to indicating which cognitively stimulating leisure activities they perform on a weekly basis, participants in IG2 will indicate their daily frequency (< 30 min, 30min-1 hour, 1-2 hours, > 2 hours), commenting on whether they have carried them out individually or in a group. It will also be taken into account whether these activities were previously carried out according to their stage of life.
Other: Stimulating leisure activities

Intervention group 2 (IG2) will perform between 2 and 5 cognitively stimulating leisure activities for 8 weeks. These leisure activities will be selected from the adapted version of the Karp et al. 2006 questionnaire (Karp et al., 2006) taking into account the three components of leisure activities (mental, physical and social). The questionnaire contains 29 activities.

In addition to indicating which cognitively stimulating leisure activities they perform on a weekly basis, participants in IG2 will indicate their daily frequency (< 30 min, 30min-1 hour, 1-2 hours, > 2 hours), commenting on whether they have carried them out individually or in a group. It will also be taken into account whether these activities were previously carried out according to their stage of life.
No Intervention: Control Group (CG)
The control group (CG) will not receive any intervention during the study period.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Lobo Cognitive Mini-Test (MEC-35)
Time Frame: Post-intervention (1 week), 3 months, 6 months, 12 months
The MEC-35 is one of the most widely used short cognitive tests for the study of cognitive abilities in the primary care setting. The MEC-35 assesses eight cognitive functions: temporal and spatial orientation (10 items), fixation memory (3 items), attention (3 items), calculation (5 items), short-term memory (3 items) and language and praxis (11 items) (Lobo et al. 1999) (figure 1). Its sensitivity is 89.8% and its specificity 83.9% (Calero MD, Navarro E, Robles P, 2000). Unlike the MMSE, the MEC-35 includes a series of three digits to repeat two similar items in reverse order. Subtraction is performed 3 by 3 from 30, instead of 7 by 7 from 100 (Folstein et al., 1975).
Post-intervention (1 week), 3 months, 6 months, 12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Test of Memory Alteration (T@M)
Time Frame: Post-intervention (1 week), 3 months, 6 months, 12 months
The maximum score for the T@M is 50 points; one point is awarded for each correct answer. All questions are oral and have only one possible answer. There are 5 sub-tests: encoding (5 points), orientation (10 points), semantic (15 points), free recall (10 points) and guided recall (10 points). It assesses temporal orientation and memory (episodic, textual and semantic). A score of 36 points has a sensitivity of 0.93 and a specificity of 1 (Rami et al., 2009). Its results are slightly influenced by educational level, so the cut-off points are 36/37 and 37/38 for subjects with <8 years and ≥8 years of education, respectively (Carnero-Pardo et al., 2011).
Post-intervention (1 week), 3 months, 6 months, 12 months

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Set-Test (S-T)
Time Frame: Post-intervention (1 week), 3 months, 6 months, 12 months
The Set-Test (S-T) assesses semantic fluency across four categories: colours, animals, fruits and cities. Scores range from 0 to 40, with 0 being the minimum score and 40 the maximum. The cut-off point is 27 points, and a lower score indicates dementia. This questionnaire has a sensitivity of 79% and a specificity of 82% (Pascual Millán, LF, Martínez Quiñones, JV, Modrego Pardo, P, Mostacero Miguel, E, López del Val, J, Morales Asín, 1990).
Post-intervention (1 week), 3 months, 6 months, 12 months
Activities of Daily Living Questionnaire T-ADLQ
Time Frame: Post-intervention (1 week), 3 months, 6 months, 12 months
The Activities of Daily Living Questionnaire T-ADLQ assesses 7 ADL areas: self-care (6 items), home care and management (6 items), work and leisure (4 items), shopping and money (3 items), travel (3), communication (5 items) and technology (5 items) (Figure 4). Each item has a score, where 0 is no problem for the activity up to 3 indicating that the activity cannot be performed. It is flexible in that it does not score aspects that are not part of the patient's activities (Muñoz-Neira et al., 2012). The internal consistency of the 33 items is high (Cronbach's α coefficient 0.848). The internal consistency of each of the 7 subscales was either low (Cronbach's α value of 0.396 for Travel and 0.539 for Employment and Leisure) or high (Cronbach's α value of 0.688 for Shopping and Money and 0.739 for Employment and Leisure ,780 for Home Care, 0.739 for Self-Care Activities and 0.862 for the Technology subscale) (Terwee et al., 2007).
Post-intervention (1 week), 3 months, 6 months, 12 months
Lawton and Brody scale (L-B)
Time Frame: Post-intervention (1 week), 3 months, 6 months, 12 months
Autonomy in eight IADLs required for independent living will be assessed with the Lawton and Brody (L-B) scale. Scores range from 0 (dependent) to 8 (independent). The sensitivity of the scale is 57% and its specificity 82% when a respondent observes dependence in three activities (Pfeffer et al., 1982).
Post-intervention (1 week), 3 months, 6 months, 12 months
15-item version of the Yesavage Geriatric Depression Scale (GDS-15)
Time Frame: Post-intervention (1 week), 3 months, 6 months, 12 months
The 15-item version of the Yesavage Geriatric Depression Scale (GDS-15) will be used to assess symptoms of depression. This scale is considered suitable for community-dwelling older adults. Scores range from 0 to 15, and a total score > 5 is interpreted as "probable depression". In older adults, with a cut-off point of 5 points, the sensitivity is 71.8% and the specificity 78.2% (Marc et al., 2008).
Post-intervention (1 week), 3 months, 6 months, 12 months
Goldberg anxiety subscale
Time Frame: Post-intervention (1 week), 3 months, 6 months, 12 months
To assess the level of anxiety, the Goldberg anxiety subscale with nine dichotomous response items (yes/no answers) will be administered. A separate score is given for each scale, with one point per affirmative response. The cut-off value is ≥ 4 for the anxiety subscale, indicating "probable anxiety". This scale shows a specificity of 91% and a sensitivity of 86% (Goldberg et al., 1988).
Post-intervention (1 week), 3 months, 6 months, 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Universidad de Zaragoza

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

April 1, 2024

Primary Completion (Estimated)

May 1, 2024

Study Completion (Estimated)

September 30, 2025

Study Registration Dates

First Submitted

September 16, 2023

First Submitted That Met QC Criteria

September 21, 2023

First Posted (Actual)

September 28, 2023

Study Record Updates

Last Update Posted (Actual)

March 13, 2024

Last Update Submitted That Met QC Criteria

March 11, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • U

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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