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Completed

NCT Number: NCT03831061

Cognitive Stimulation in Older With Mild Cognitive Impairment

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.

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Key information

Conditions

Mild Cognitive Impairment Cognition Disorders Cognitive Dysfunction Mental Disorders Neurocognitive Disorders Randomized Controlled Trial

Age range

65 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

cognitive stimulation

Other

Primary outcomes

  1. The Spanish versions of the Mini-Mental State Examination (MEC-35),

    Time frame: baseline and change in 1 week, 6 months, baseline and 12 moths

    It is a reliable and used instrument for the evaluation of cognitive impairment. It meets criteria of "feasibility", "content validity", "procedural" and "construction". Test-retest reliability: weighted kappa = 0.667, sensitivity = 89.8%, and specificity = 83.9%; with the cutoff point 23/24. A score of 28 is considered the lower limit of normal performance in adult population; scores equal or less than 27 would denote cognitive deficits.

Secondary outcomes

  1. The Barthel Index (Barthel)

    Time frame: baseline and change in 1 week, 6 months, baseline and 12 moths

    Developed by Mahoney & Barthel (1965), assesses the level of independence in ten Basic Activities of Daily Living (BADLs) and is an indicator of skills for people with reduced mobility. Its internal consistency is 0.89-0.92; obtains intra-observer reliability with kappa indexes between 0.47 to 1.0. Values the ability to perform ten BADLs: feeding, bathing, dressing, grooming, bowel control, bladder control, toilet use, transfers chair-bed, mobility and stairs use. A score is assigned to each item (0, 5, 10, 15) as a function of time and help needed. The final score varies from 0 (completely dependent) to 100 (completely independent). Above 60 points there is a high probability of continuing to live in the community.

  2. The scale of Lawton & Brody (Lawton)

    Time frame: baseline and change in 1 week, 6 months, baseline and 12 moths

    Assesses the degree of autonomy in eight Instrumental Activity Daily Livings (IADLs) necessary for living independently in the community. Its reliability is = 0.85 , sensitivity = 0.57 and specificity = 0.92. In a study in Spanish population the internal consistency was 0.94; Regarding the convergent validity all the correlation coefficients were higher than 0.40. A summary score ranges from 0 (low function, dependent) to 8 (high function, independent) for women, and 0 through 5 for men (historically, for men, the areas of food preparation, housekeeping, laundering are excluded).

  3. The Goldberg questionnaire (EADG)

    Time frame: baseline and change in 1 week, 6 months, baseline and 12 moths

    Evaluates the mood referred to anxiety and depresión. The original questionnaire was developed by Goldberg and consisted of 18 items. Consists of two sub-scales, one of anxiety and other of depression. The last 5 questions of the EADG are only formulated if there are positive answers to the first 4 questions, which are obligatory. The higher the number, the more severe your depression is likely to be. Of all the cutoff points, the most suitable result for the sub-scale of anxiety is 4 points and for the sub-scale of depression is 2 point. The Spanish version of EADG has demonstrated its reliability and validity in the field of Primary Care; with a sensitivity of 83.1%, a specificity of 81.8%, a misclassified index of 17.7% and a positive predictive value of 95.3% .

    The investigators used the sub-scale of anxiety; its overall specificity = 91% and its sensitivity = 86%

  4. The abbreviated Yesavage depression scale (GDS-15)

    Time frame: baseline and change in 1 week, 6 months, baseline and 12 moths

    Evaluates the mood referred to depression. The first version consisted of 30 items . Subsequently, abbreviated version (GDS-15) was published with 15 questions; for use in older people living in the community. For cut-off point 4/5 the sensitivity rates vary between 92.7% and 97.0%, the specificity between 54.8% and 65.2%; the positive predictive value between 69.6% and 82.6% and the negative between 83.3% and 94.4%.

Sponsors and collaborators

Lead sponsor

Universidad de Zaragoza

Other

Registry information

Official study title

Intervention Through Cognitive Stimulation in People Aged 65 or Older With Mild Cognitive Impairment in Primary Care

Acronym: Cognitive

Important dates

Study start
2011
Primary completion
2012
Study completion
2016
First posted
Feb 5, 2019
Registry last updated
Feb 5, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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