Care at 360º: A Long-term Individual Cognitive Stimulation Program

NCT04417751 | Completed

• 1 other identifier: 23052020
• Study Type: interventional
• Target: 59
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of the intervention proposed in the present study is to assess the effect of a cognitive stimulation (CS) intervention program in an individual and long-term format, for non-institutionalized elderly people with neurocognitive disorders and in a situation of social vulnerability. Specifically, to test the effectiveness of CS on the global cognitive state, on mood state, on quality of life and on functional state. The program will be composed by 50 sessions, including three of assessment sessions (pre, intra and post-intervention). Each session will have a duration of 45 minutes with a weekly frequency. Control group participants will maintain their treatment as usual.

Conditions

Neurocognitive Disorders; Dementia; Cognitive Impairment; Cognitive Decline; Cognitive Dysfunction; Social Behavior

Keywords

older adults; cognitive stimulation; dementia; intervention; cognition; individual intervention; social vulnerability; quality of life; aged; non-pharmacological therapy; neurocognitive disorder; psychosocial

Outcome Measures

Primary Outcomes (6)

• Cognitive state evaluated through Mini-Mental State Examination

  Significant statistic improvement in the participant's test scores between pre-intervention, intra-intervention and postintervention assessments. Mini-Mental State Examination is a brief screening test for cognitive function. Assesses 6 cognitive functions: orientation, registration, attention and calculation, recall, language and visuoconstructive ability. Global score ranges from 0-30 points, higher scores indicate better cognitive function.

  Pre-intervention

• Change in cognitive state evaluated through Mini-Mental State Examination

  Significant statistic improvement in the participant's test scores between pre-intervention, intra-intervention and postintervention assessments. Mini-Mental State Examination is a brief screening test for cognitive function. Assesses 6 cognitive functions: orientation, registration, attention and calculation, recall, language and visuoconstructive ability. Global score ranges from 0-30 points, higher scores indicate better cognitive function.

  6 months after the beginning of the intervention

• Change in cognitive state evaluated through Mini-Mental State Examination

  Significant statistic improvement in the participant's test scores between pre-intervention, intra-intervention and postintervention assessments. Mini-Mental State Examination is a brief screening test for cognitive function. Assesses 6 cognitive functions: orientation, registration, attention and calculation, recall, language and visuoconstructive ability. Global score ranges from 0-30 points, higher scores indicate better cognitive function.

  12 months after the beginning of the intervention

• Cognitive performance evaluated through Montreal Cognitive Assessment

  It's a 32-item mild cognitive impairment screening instrument that assesses eight cognitive functions: visuospatial/executive, naming, memory, attention, language, abstraction, delayed recall and orientation. Montreal Cognitive Assessment score is calculated by adding the points of the tasks successfully completed, and it ranges from 0 to 30 points, being that higher scores indicate better cognitive performance.

  Pre-intervention

• Change in cognitive performance evaluated through Montreal Cognitive Assessment

  It's a 32-item mild cognitive impairment screening instrument that assesses eight cognitive functions: visuospatial/executive, naming, memory, attention, language, abstraction, delayed recall and orientation. Montreal Cognitive Assessment score is calculated by adding the points of the tasks successfully completed, and it ranges from 0 to 30 points, being that higher scores indicate better cognitive performance.

  6 months after the beginning of the intervention

• Change in cognitive performance evaluated through Montreal Cognitive Assessment

  It's a 32-item mild cognitive impairment screening instrument that assesses eight cognitive functions: visuospatial/executive, naming, memory, attention, language, abstraction, delayed recall and orientation. Montreal Cognitive Assessment score is calculated by adding the points of the tasks successfully completed, and it ranges from 0 to 30 points, being that higher scores indicate better cognitive performance.

  12 months after the beginning of the intervention

Secondary Outcomes (9)

• Depressive symptoms evaluated through Geriatric Depression Scale -15

  Pre intervention

• Change in depressive symptoms evaluated through Geriatric Depression Scale -15

  6 months after the beginning of the intervention

• Change in depressive symptoms evaluated through Geriatric Depression Scale -15

  12 months after the beginning of the intervention

• Quality of life evaluated through Quality of Life - Alzheimer's Disease: score

  Pre-intervention

• Change in quality of life evaluated through Quality of Life - Alzheimer's Disease: score

  6 months after the beginning of the intervention

Other Outcomes (2)

• Sociodemographic data collected through a sociodemographic questionnaire

  Pre-intervention

• Adherence to the intervention and dropouts evaluated through a session form

  [Pre, intra (6 months) and post intervention (12 months)]

Study Arms (2)

Intervention Group

EXPERIMENTAL

Intervention group will receive 47 sessions of individual CS and participate in 3 evaluation sessions. The CS program will last 1 year and each individual CS session will last approximately 45 minutes.

Behavioral: Cognitive Stimulation

Control Group

NO INTERVENTION

Participants assigned to the control group will maintain their usual treatment in the institution, participating in the activities previously assigned to their individual care plan.

Interventions

Cognitive Stimulation BEHAVIORAL

The intervention includes 50 sessions, over the course of one year, being that 3 of those sessions will be the pretest, intratest and posttest evaluations. The intervention sessions will last approximately 45 minutes and they will be developed according to the following structure: welcoming and greeting the participants (5 minutes); reality orientation therapy (10 minutes), cognitive stimulation \[CS\] activity (25 minutes); return to calm and closure of the session, and session evaluation (5 minutes). CS sessions will be conducted in an individual intervention format. The intervention sessions will include several activities based on different non-pharmacological therapies (e.g., reminiscence therapy, reality orientation therapy, cognitive training) whose effectiveness in older adults with neurocognitive disorders has been scientifically proven. All individual CS sessions will be conducted by one therapist (clinical psychologist) with more than five years of experience in CS.

Intervention Group

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• Being flagged as a person in a socially vulnerable context.
• Being 65 years of age or over.
• Having a neurocognitive disorder according to the diagnostic criteria of the Diagnostic and Statistical Manual of Mental Disorders, 5th edition (DSM-5) (2014).
• Being a native Portuguese speaker.
• Residing in the region of Ribeira de Fráguas.

You may not qualify if:

• Not having preserved the ability to communicate and understand.
• To suffer from a severe or acute illness that makes the participation in the sessions impossible.
• Presence of severe neuropsychiatric symptoms that prevent participation in the sessions or uncontrolled psychotic conditions.
• Being institutionalized.

Sponsors & Collaborators

• CEDIARA - Assoc. Solidariedade Social de Ribeira de Fráguas: lead

Study Sites (1)

Cediara - Social Solidarity Association of Ribeira de Fráguas

Ribeira de Fráguas, Albergaria-a-Velha, 3850-705, Portugal

Location

Related Publications (23)

• Apóstolo JLA, Bobrowicz-Campos EM, Reis, IAC, Henriques SJ., Correia CAV. Exploring the screening capacity of the European Portuguese version of the 15-item Geriatric Depression Scale. Revista de Psicopatología y Psicología Clínica. 2018; 23(2): 99-107. https://doi.org/10.5944/rppc.vol.23.num.2.2018.21050

  BACKGROUND

• Apóstolo JL, Loureiro LMJ, Carvalho IA, Alves I, Batista DF, Sfetcu R. Contribution to the adaptation of the Geriatric Depression Scale-15 into Portuguese. Revista de Enfermagem Referencia. 2014; IV(3): 65-73. https://doi.org/10.12707/RIV14033

  BACKGROUND

• Barrios H, Verdelho A, Narciso S, Goncalves-Pereira M, Logsdon R, de Mendonca A. Quality of life in patients with cognitive impairment: validation of the Quality of Life-Alzheimer's Disease scale in Portugal. Int Psychogeriatr. 2013 Jul;25(7):1085-96. doi: 10.1017/S1041610213000379. Epub 2013 Mar 27.

  PMID: 23534370 BACKGROUND

• Clare L, Woods RT. Cognitive training and cognitive rehabilitation for people with early-stage Alzheimer's disease: A review. Neuropsychological Rehabilitation. 2004; 14: 385-401. https://doi.org/10.1080/09602010443000074

  BACKGROUND

• Clare L, Wilson BA, Carter G, Breen K, Gosses A, Hodges JR. Intervening with everyday memory problems in dementia of Alzheimer type: an errorless learning approach. J Clin Exp Neuropsychol. 2000 Feb;22(1):132-46. doi: 10.1076/1380-3395(200002)22:1;1-8;FT132.

  PMID: 10649552 BACKGROUND

• Davis RN, Massman PJ, Doody RS. Cognitive intervention in Alzheimer disease: a randomized placebo-controlled study. Alzheimer Dis Assoc Disord. 2001 Jan-Mar;15(1):1-9. doi: 10.1097/00002093-200101000-00001.

  PMID: 11236819 BACKGROUND

• Filipin F, Feldman M, Taragano FE, Martelli M, Sánchez V, García V, … Dillon C. The efficacy of cognitive stimulation on depression and cognition in elderly patients with cognitive impairment: A retrospective cohort study. AIMS Medical Science. 2015; 3(1): 1-14. https://doi.org/10.3934/medsci.2016.1.1

  BACKGROUND

• Folstein MF, Folstein SE, McHugh PR. "Mini-mental state". A practical method for grading the cognitive state of patients for the clinician. J Psychiatr Res. 1975 Nov;12(3):189-98. doi: 10.1016/0022-3956(75)90026-6. No abstract available.

  PMID: 1202204 BACKGROUND

• Freitas S, Simoes MR, Alves L, Santana I. The Relevance of Sociodemographic and Health Variables on MMSE Normative Data. Appl Neuropsychol Adult. 2015;22(4):311-9. doi: 10.1080/23279095.2014.926455. Epub 2014 Dec 22.

  PMID: 25531579 BACKGROUND

• Guerreiro M, Silva AP, Botelho MA, Leitão O, Castro-Caldas A, Garcia C. Adaptação à população portuguesa da tradução do Mini Mental State Examination (MMSE). Revista Portuguesa de Neurologia. 1994; 1: 9-10.

  BACKGROUND

• Justo-Henriques SI, Marques-Castro AE, Otero P, Vazquez FL, Torres AJ. [Long-term individual cognitive stimulation program in patients with mild neurocognitive disorder: a pilot study]. Rev Neurol. 2019 Apr 1;68(7):281-289. doi: 10.33588/rn.6807.2018321. Spanish.

  PMID: 30906977 BACKGROUND

• Lawton MP, Brody EM. Assessment of older people: self-maintaining and instrumental activities of daily living. Gerontologist. 1969 Autumn;9(3):179-86. No abstract available.

  PMID: 5349366 BACKGROUND

• Lobbia A, Carbone E, Faggian S, Gardini S, Piras F, Spector E, Borella E. The efficacy of cognitive stimulation therapy (CST) for people with mild-to-moderate dementia: A review. European Psychologist. 2018; 24(3): 257-277. https://doi.org/10.1027/1016-9040/a000342

  BACKGROUND

• Loewenstein DA, Acevedo A, Czaja SJ, Duara R. Cognitive rehabilitation of mildly impaired Alzheimer disease patients on cholinesterase inhibitors. Am J Geriatr Psychiatry. 2004 Jul-Aug;12(4):395-402. doi: 10.1176/appi.ajgp.12.4.395.

  PMID: 15249277 BACKGROUND

• Logsdon RG, Gibbons LE, McCurry SM, Teri L. Quality of life in Alzheimer's disease: Patient and caregiver reports. Journal of Mental Health and Aging. 1999; 5: 21-32.

  BACKGROUND

• Moniz-Cook E, Vernooij-Dassen M, Woods R, Verhey F, Chattat R, De Vugt M, Mountain G, O'Connell M, Harrison J, Vasse E, Droes RM, Orrell M; INTERDEM group. A European consensus on outcome measures for psychosocial intervention research in dementia care. Aging Ment Health. 2008 Jan;12(1):14-29. doi: 10.1080/13607860801919850.

  PMID: 18297476 BACKGROUND

• Morgado J, Rocha CS, Maruta C, Guerreiro M, Martins IP. Novos valores normativos do Mini-Mental Sate Examination. Sinapse. 2009; 2: 10-16.

  BACKGROUND

• Nasreddine ZS, Phillips NA, Bedirian V, Charbonneau S, Whitehead V, Collin I, Cummings JL, Chertkow H. The Montreal Cognitive Assessment, MoCA: a brief screening tool for mild cognitive impairment. J Am Geriatr Soc. 2005 Apr;53(4):695-9. doi: 10.1111/j.1532-5415.2005.53221.x.

  PMID: 15817019 BACKGROUND

• Rodrigues NO, Neri AL. [Social, individual and programmatic vulnerability among the elderly in the community: data from the FIBRA Study conducted in Campinas, Sao Paulo, Brazil]. Cien Saude Colet. 2012 Aug;17(8):2129-39. doi: 10.1590/s1413-81232012000800023. Portuguese.

  PMID: 22899153 BACKGROUND

• Sheikh JI, Yesavage JA. Geriatric depression scale (GDS): Recent evidence and development of a shorter version. Clinical Gerontologist. 1986; 5(1-2): 165-173. https://doi.org/10.1300/j018v05n01_09

  BACKGROUND

• Wilson B. Towards a comprehensive model of cognitive rehabilitation. Neuropsychological Rehabilitation. 2002; 12(2): 97-110. https://doi.org/10.1080/09602010244000020

  BACKGROUND

• Woods B, Aguirre E, Spector AE, Orrell M. Cognitive stimulation to improve cognitive functioning in people with dementia. Cochrane Database Syst Rev. 2012 Feb 15;(2):CD005562. doi: 10.1002/14651858.CD005562.pub2.

  PMID: 22336813 BACKGROUND

• Justo-Henriques SI, Perez-Saez E, Marques-Castro AE, Carvalho JO. Effectiveness of a year-long individual cognitive stimulation program in Portuguese older adults with cognitive impairment. Neuropsychol Dev Cogn B Aging Neuropsychol Cogn. 2023 May;30(3):321-335. doi: 10.1080/13825585.2021.2023458. Epub 2022 Jan 11.

  PMID: 35012439 DERIVED

MeSH Terms

Conditions

Neurocognitive Disorders; Dementia; Cognitive Dysfunction; Social Behavior

Condition Hierarchy (Ancestors)

Mental Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Cognition Disorders; Behavior

Study Officials

• Susana I Justo Henriques, PhD

  Health Sciences Research Unit: Nursing (UICISA: E), ESEnfC

  PRINCIPAL INVESTIGATOR

• Ana E Marques Castro, MSc

  CEDIARA - Assoc. Solidariedade Social de Ribeira de Fráguas

  PRINCIPAL INVESTIGATOR

• Enrique Pérez Sáez, PhD

  National Reference Centre for Alzheimer's and Dementia Care, Imserso

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 27, 2020
• First Posted: June 5, 2020
• Study Start: July 1, 2020
• Primary Completion: July 26, 2021
• Study Completion: July 26, 2021
• Last Updated: July 27, 2021

Record last verified: 2020-07

Data Sharing

• IPD Sharing: Will not share

Locations

PT (1)