Cognitive Stimulation in Older With Mild Cognitive Impairment

Mild Cognitive Impairment Clinical Trial

— Cognitive  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03831061
• Other study ID #: School of Health Sciences
• Status: Completed
• Phase: N/A
• Start date: December 2011
• Est. completion date: December 2016

Study information

• Verified date: February 2019
• Source: Universidad de Zaragoza
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 122
• Est. completion date: December 2016
• Est. primary completion date: October 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 65 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Cognitive Dysfunction
• Mild Cognitive Impairment
• Randomized Controlled Trial

Intervention

Other:
• Cognitive stimulation

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Universidad de Zaragoza

References & Publications (15)

Arthur A, Jagger C, Lindesay J, Graham C, Clarke M. Using an annual over-75 health check to screen for depression: validation of the short Geriatric Depression Scale (GDS15) within general practice. Int J Geriatr Psychiatry. 1999 Jun;14(6):431-9. — View Citation

Goldberg D, Bridges K, Duncan-Jones P, Grayson D. Detecting anxiety and depression in general medical settings. BMJ. 1988 Oct 8;297(6653):897-9. — View Citation

Goldberg DP, Bridges K, Duncan-Jones P, Grayson D. Dimensions of neuroses seen in primary-care settings. Psychol Med. 1987 May;17(2):461-70. — View Citation

Lawton MP, Brody EM. Assessment of older people: self-maintaining and instrumental activities of daily living. Gerontologist. 1969 Autumn;9(3):179-86. — View Citation

Lobo A, Saz P, Marcos G, Día JL, de la Cámara C, Ventura T, Morales Asín F, Fernando Pascual L, Montañés JA, Aznar S. [Revalidation and standardization of the cognition mini-exam (first Spanish version of the Mini-Mental Status Examination) in the general geriatric population]. Med Clin (Barc). 1999 Jun 5;112(20):767-74. Spanish. Erratum in: Med Clin (Barc) 1999 Jul 10;113(5):197. — View Citation

Lobo A, Saz P, Marcos G, Día JL, De-la-Cámara C. The prevalence of dementia and depression in the elderly community in a southern European population. The Zaragoza study. Arch Gen Psychiatry. 1995 Jun;52(6):497-506. — View Citation

Loewen SC, Anderson BA. Reliability of the Modified Motor Assessment Scale and the Barthel Index. Phys Ther. 1988 Jul;68(7):1077-81. — View Citation

MAHONEY FI, BARTHEL DW. FUNCTIONAL EVALUATION: THE BARTHEL INDEX. Md State Med J. 1965 Feb;14:61-5. — View Citation

Moher D, Schulz KF, Altman D; CONSORT Group. The CONSORT Statement: revised recommendations for improving the quality of reports of parallel-group randomized trials 2001. Explore (NY). 2005 Jan;1(1):40-5. — View Citation

Montón C, Pérez Echeverría MJ, Campos R, García Campayo J, Lobo A. [Anxiety scales and Goldberg's depression: an efficient interview guide for the detection of psychologic distress]. Aten Primaria. 1993 Oct 15;12(6):345-9. Spanish. — View Citation

Petersen RC. Mild cognitive impairment clinical trials. Nat Rev Drug Discov. 2003 Aug;2(8):646-53. Review. — View Citation

Petersen RC. Mild Cognitive Impairment. Continuum (Minneap Minn). 2016 Apr;22(2 Dementia):404-18. doi: 10.1212/CON.0000000000000313. Review. — View Citation

Roley SS, DeLany JV, Barrows CJ, Brownrigg S, Honaker D, Sava DI, Talley V, Voelkerding K, Amini DA, Smith E, Toto P, King S, Lieberman D, Baum MC, Cohen ES, Cleveland PA, Youngstrom MJ; American Occupational Therapy Association Commission on Practice. Occupational therapy practice framework: domain & practice, 2nd edition. Am J Occup Ther. 2008 Nov-Dec;62(6):625-83. — View Citation

Shah S, Vanclay F, Cooper B. Improving the sensitivity of the Barthel Index for stroke rehabilitation. J Clin Epidemiol. 1989;42(8):703-9. — View Citation

Yesavage JA, Brink TL, Rose TL, Lum O, Huang V, Adey M, Leirer VO. Development and validation of a geriatric depression screening scale: a preliminary report. J Psychiatr Res. 1982-1983;17(1):37-49. — View Citation

* Note: There are 15 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The Spanish versions of the Mini-Mental State Examination (MEC-35),	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.	baseline and change in 1 week, 6 months, baseline and 12 moths
Secondary	The Barthel Index (Barthel)	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.	baseline and change in 1 week, 6 months, baseline and 12 moths
Secondary	The scale of Lawton & Brody (Lawton)	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).	baseline and change in 1 week, 6 months, baseline and 12 moths
Secondary	The Goldberg questionnaire (EADG)	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%	baseline and change in 1 week, 6 months, baseline and 12 moths
Secondary	The abbreviated Yesavage depression scale (GDS-15)	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%.	baseline and change in 1 week, 6 months, baseline and 12 moths