Clinical trial NCT03831061: Cognitive Stimulation in Older With Mild Cognitive Impairment
Official title: Intervention Through Cognitive Stimulation in People Aged 65 or Older With Mild Cognitive Impairment in Primary Care
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Mild Cognitive Impairment
Randomized Controlled Trial
Keywords: Mild Cognitive Impairment
Elderly
Randomized Controlled Trial
Cognitive Stimulation
Cognitive Intervention
Lead sponsor: Universidad de Zaragoza
Sponsor class: OTHER
First posted: 2019-02-05
Enrollment: 122
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: An intervention group and a control group with the same characteristics are included.
Primary purpose: TREATMENT

Brief summary: The participants who carry out our program of cognitive stimulation, deteriorate at a cognitive level more slowly and can improve their score of the Spanish version of 35 points of Mini-mental State of Folstein; Mini-exam Cognoscitive of Lobo.

Detailed description: The aim of our research is to evaluate the effect of a cognitive stimulation program in people aged 65 or older with mild cognitive impairment (MCI) and compare it, in the short, medium and long term, with the evolution of other people, with the same characteristics and for which this intervention has not been carried out.

The significant increase in the number of people over 65 years of age in relation to the total population, suggests a significant increase in age-related pathologies. The problem that entails population aging increases when cognitive deterioration appears.

From an economic perspective, the cognitive deterioration of the elderly person is estimated to contribute to health expenses of almost ten times more compared to people of the same age with cognitive functions preserved. Different studies show that a considerable proportion of people with MCI have a high risk of developing dementia and Alzheimer's disease.

Cognitive stimulation is a treatment that has shown profitability and has been recommended as the treatment of choice in MCI.

Our research is based on a cognitive stimulation that uses the Red Book of Mental Activation. The book consists of 4 practical exercises that work 10 cognitive aspects (memory, orientation, language, praxis, gnosis, calculation, perception, reasoning, attention and programming); in total 40 exercises. The models on which the notebook is based is the cognitive model and the human occupation model.

In the Health Center San José Norte-Centro of Zaragoza (Spain), assessments were made to 416 volunteer candidates, of which 294 were excluded for not meeting the inclusion criteria; being a total of 122 participants that have been part of the randomized controlled trial. Of the 122 participants; 54 have carried out the intervention as an intervention group and 68 as the control group. The control group did not perform any type of intervention.

The intervention was carried out at the La Caridad de Zaragoza Foundation (Spain), consisting of 10 sessions of 45 minutes/week during 10 weeks. The conceptual framework of this intervention is formed by the International Classification of Functioning and Disability (CIF), the framework for practice of Occupational Therapy , the cognitive model and the human occupation model of Gary Kielhofner .

To homogenize both the assessments and the intervention, a standardized training was carried out for the occupational therapists who carried them out and consisted of a theoretical part and a practical part of 10 hours each.

The study began in December 2011, obtained the authorization of the Directorate of Primary Care of the Zaragoza II Sector and the approval of the project by the Research Ethics Committee of the Government of Aragon (CEICA). This study has followed the ethical standards recognized by the Declaration of Helsinki. The initial assessments began this month. The necessary sample size was reached in October 2012 and, from that moment on, randomization and intervention with the selected participants was carried out. Three other assessments were made, both for the intervention group and for the control group, immediately after the intervention, six months and one year after the intervention.

Eligibility criteria: Inclusion Criteria:

* Older adults (age ≥ 65)
* Community (not institutionalized)
* Mini-Examen Cognoscitive (MEC) score 24-27 points
* Barthel index \> 60 points
* No received cognitive stimulation in the last year
* Hearing problems that interfere with the intervention
* Blindness or vision problems that interfere with the intervention
* Neuropsychiatric disorders (agitation, delusions or hallucinations)
* Motor difficulties that interfere with the intervention.

Exclusion Criteria:

- No agree to participate and no sign the informed consent.

Primary outcomes:
measure: The Spanish versions of the Mini-Mental State Examination (MEC-35),
timeFrame: baseline and change in 1 week, 6 months, baseline and 12 moths
Secondary outcomes:
measure: The Barthel Index (Barthel)
timeFrame: baseline and change in 1 week, 6 months, baseline and 12 moths
measure: The scale of Lawton & Brody (Lawton)
timeFrame: baseline and change in 1 week, 6 months, baseline and 12 moths
measure: The Goldberg questionnaire (EADG)
timeFrame: baseline and change in 1 week, 6 months, baseline and 12 moths
measure: The abbreviated Yesavage depression scale (GDS-15)
timeFrame: baseline and change in 1 week, 6 months, baseline and 12 moths
Other outcomes:
Locations:
Study officials:
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