Actively Recruiting

Phase Not Applicable
Age: 50Years +
All Genders
Healthy Volunteers
ID06058611

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

Led by Universidad de Zaragoza · Updated on 2024-12-12

90

Participants Needed

1

Research Sites

73 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are evaluating the effectiveness of a personalised and adapted computerised cognitive stimulation program compared to stimulating leisure activities in adults aged 50 years and older who have mild cognitive impairment (MCI) or subjective cognitive impairment. The study focuses on improving global cognition, memory, verbal fluency, daily living activities, and symptoms of depression and anxiety in community-dwelling older adults. This trial is a randomised controlled design involving primary care patients. Participants in the first intervention group will use a computerised cognitive stimulation platform for 30 minutes per day, five days a week, over eight weeks (totaling 40 sessions). This program targets cognitive areas such as memory, orientation, language, calculation, attention, and executive functions. The second group will engage in between two and five cognitively stimulating leisure activities drawn from a questionnaire covering mental, physical, and social activities, performed individually or in groups over the same eight-week period. A control group will receive no intervention during the study but will be offered participation in one of the two interventions afterward. Throughout the study, participants undergo assessments before and after the intervention, with follow-ups at 6 and 12 months. Evaluations include cognitive testing with the Lobo Cognitive Mini-Test (MEC-35) and the Test of Memory Alteration (T@M), alongside questionnaires on lifestyle and clinical characteristics. The study includes socio-demographic data collection and monitors cognitive changes and functional abilities. Total participation spans more than a year with multiple evaluation points to track outcomes and changes over time.

CONDITIONS

Brief Title

Effects of a Computerised Cognitive Stimulation Versus Stimulating Leisure Activities

Who Can Participate

Age: 50Years +
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Age 50 years or older, living in the community
  • Diagnosis of mild cognitive impairment or MEC-35 score between 24 and 27 indicating mild cognitive impairment
  • Subjective cognitive impairment with MEC-35 score between 28 and 31
Not Eligible

You will not qualify if you...

  • Living in an institution
  • Taking acetylcholinesterase inhibitors
  • Deafness or blindness preventing participation
  • Agitation
  • Received cognitive stimulation treatment in the last 12 months

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

Duration - 8 weeks

Participants in Intervention group 1 carry out personalised and adapted computerised cognitive stimulation for 30 minutes per day, 5 days per week, over 8 weeks. Participants in Intervention group 2 perform between 2 and 5 cognitively stimulating leisure activities for 8 weeks, tracking frequency and group participation. Control group participants do not receive any intervention during this period.

40 sessions for Intervention group 1; frequency varies for Intervention group 2

Follow-up

Duration - 12 months

Participants undergo assessments at 1 week post-intervention, and then at 3, 6, and 12 months to monitor cognitive function and memory.

4 visits (1 week post-intervention, 3 months, 6 months, and 12 months)

Trial Site Locations

Total: 1 location

1

Centro de Salud Arrabal

Zaragoza, Zaragoza, Spain, 50015

Actively Recruiting

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How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

3

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Published Research Related To This Trial

[Revalidation and standardization of the cognition mini-exam (first Spanish version of the Mini-Mental Status Examination) in the general geriatric population].

A Lobo, P Saz, G Marcos...

https://pubmed.ncbi.nlm.nih.gov/10422057

[Discriminatory validity and association of the mini-mental test (MMSE) and the memory alteration test (M@T) with a neuropsychological battery in patients with amnestic mild cognitive impairment and Alzheimer's disease].

L Rami, B Bosch, C Valls-Pedret...

https://pubmed.ncbi.nlm.nih.gov/19621317

Diagnostic accuracy, effectiveness and cost for cognitive impairment and dementia screening of three short cognitive tests applicable to illiterates.

Cristóbal Carnero-Pardo, Beatriz Espejo-Martínez, Samuel López-Alcalde...

https://pubmed.ncbi.nlm.nih.gov/22073256