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

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ClinicalTrials.gov Identifier: NCT04417751
Recruitment Status : Recruiting
First Posted : June 5, 2020
Last Update Posted : July 21, 2020
Sponsor:
Information provided by (Responsible Party):
CEDIARA - Assoc. Solidariedade Social de Ribeira de Fráguas

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.

Condition or disease Intervention/treatment Phase
Neurocognitive Disorders Dementia Cognitive Impairment Cognitive Decline Cognitive Dysfunction Social Behavior Behavioral: Cognitive Stimulation Not Applicable

Detailed Description:

According to World Health Organization, between 2000 and 2050, the proportion of the planet's inhabitants over 60 years of age will double, from 11% to 22%. Specifically, this age group will increase from 605 million to 2000 million worldwide by the middle of the century.

As for Portugal, according to data from the National Statistics Institute, the resident population was composed by 21.5% of elderly people. This percentage was higher than the European Union average of 28 countries (EU28), which does not reach 20%, with Portugal being the fourth country with the highest percentage of elderly people.

Aging implies an increased risk for the development of biological, socioeconomic and psychosocial vulnerabilities, derived from biological decline and from an increase in pathologies associated with aging itself. In view of the current Covid-19 pandemic, the risk of vulnerability is heightened.

There are several chronic diseases that affect the elderly. Regarding mental disorders, the most frequent as age, are neurocognitive disorders. The diagnostic criteria for this pathology emphasize cognitive changes, and as such, it is clinically based on cognitive and memory decline.

There is evidence that in the early stages of neurocognitive disorders, people are able to learn and improve their cognitive function through interventions, such as cognitive stimulation. There are three types of cognitive intervention: cognitive stimulation, cognitive rehabilitation and cognitive training. Cognitive rehabilitation is an individual approach to cognitive impairment and improves daily functioning. Cognitive training is designed for the patient to perform a set of tasks in order to improve or maintain cognitive function through guided practice. Cognitive stimulation is an intervention where the cognitive domains are not used isolated, but rather integrated. Cognitive stimulation can be structured in an individual or group format. Individual cognitive stimulation includes activities designed to stimulate cognition, conducted only with the therapist and the patient.

In a Portuguese study, with participants in the same geographic area, who applied individual cognitive stimulation therapy to patients with mild neurocognitive disorder, over a year, a significant improvement was found in the intervention group in terms of cognitive performance and a reduction of depressive symptoms, with a moderate to large effect size, suggesting that cognitive stimulation therapy is effective in an individual format.

According to this evidence, the National Institute for Health and Clinical Excellence recommended cognitive stimulation as a non-pharmacological therapy for people with mild to moderate neurocognitive disorder.

In a systematic review about cognitive stimulation, studies showed a strong evidence that cognitive stimulation has a positive impact on cognitive performance, depression, activities of daily living and behavior in people with neurocognitive disorders.

Considering the previous information, the aim of this project is to apply cognitive stimulation in an individual format to improve cognitive status and performance, quality of life and functionality, and reduce depressive symptoms in non-institutionalized elderly people in a vulnerable social context with a diagnosis of neurocognitive disorder.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 59 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Care at 360º: A Long-term Individual Cognitive Stimulation Program for Older Adults With Neurocognitive Disorders, Non-Institutionalized and Socially Vulnerable
Actual Study Start Date : July 1, 2020
Estimated Primary Completion Date : July 31, 2021
Estimated Study Completion Date : July 31, 2021

Arm Intervention/treatment
Experimental: Intervention Group
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
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.

No Intervention: Control Group
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.



Primary Outcome Measures :
  1. Cognitive state evaluated through Mini-Mental State Examination [ Time Frame: Pre-intervention ]

    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.


  2. Change in cognitive state evaluated through Mini-Mental State Examination [ Time Frame: 6 months after the beginning of the intervention ]

    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.


  3. Change in cognitive state evaluated through Mini-Mental State Examination [ Time Frame: 12 months after the beginning of the intervention ]

    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.


  4. Cognitive performance evaluated through Montreal Cognitive Assessment [ Time Frame: Pre-intervention ]
    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.

  5. Change in cognitive performance evaluated through Montreal Cognitive Assessment [ Time Frame: 6 months after the beginning of the intervention ]
    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. Change in cognitive performance evaluated through Montreal Cognitive Assessment [ Time Frame: 12 months after the beginning of the intervention ]
    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.


Secondary Outcome Measures :
  1. Depressive symptoms evaluated through Geriatric Depression Scale -15 [ Time Frame: Pre intervention ]
    Significant statistic improvement in the participant's test scores between pre-intervention, intra-intervention and postintervention assessments. Geriatric Depression Scale -15 is a screening test for depressive symptoms in elderly adults. Assesses depression in the elderly by distinguishing between depressive and dementia symptoms. This instrument does not include somatic conditions common to the elderly, such as appetite, sleep or sexual disturbances, or lower energy level. The overall score ranges from 0 to 15. The higher the score, the greater the severity of the depressive symptoms.

  2. Change in depressive symptoms evaluated through Geriatric Depression Scale -15 [ Time Frame: 6 months after the beginning of the intervention ]
    Significant statistic improvement in the participant's test scores between pre-intervention, intra-intervention and postintervention assessments. Geriatric Depression Scale -15 is a screening test for depressive symptoms in elderly adults. Assesses depression in the elderly by distinguishing between depressive and dementia symptoms. This instrument does not include somatic conditions common to the elderly, such as appetite, sleep or sexual disturbances, or lower energy level. The overall score ranges from 0 to 15. The higher the score, the greater the severity of the depressive symptoms.

  3. Change in depressive symptoms evaluated through Geriatric Depression Scale -15 [ Time Frame: 12 months after the beginning of the intervention ]
    Significant statistic improvement in the participant's test scores between pre-intervention, intra-intervention and postintervention assessments. Geriatric Depression Scale -15 is a screening test for depressive symptoms in elderly adults. Assesses depression in the elderly by distinguishing between depressive and dementia symptoms. This instrument does not include somatic conditions common to the elderly, such as appetite, sleep or sexual disturbances, or lower energy level. The overall score ranges from 0 to 15. The higher the score, the greater the severity of the depressive symptoms.

  4. Quality of life evaluated through Quality of Life - Alzheimer's Disease: score [ Time Frame: Pre-intervention ]
    Significant statistic improvement in the participant's test scores between pre-intervention assessment and postintervention assessment. Quality of Life - Alzheimer's Disease is an instrument to assess quality of life in people diagnosed with dementia, gathering information from the patient and the caregiver. It is composed by 13 items regarding perception of health, mood, functional abilities, interpersonal relationships and hobbies, decision making ability and life in general. It has good psychometric characteristics and it's use has been recommended to evaluate psychosocial interventions. Scores range between 13 - 52 points. Higher scores indicate better quality of life.

  5. Change in quality of life evaluated through Quality of Life - Alzheimer's Disease: score [ Time Frame: 6 months after the beginning of the intervention ]
    Significant statistic improvement in the participant's test scores between pre-intervention assessment and postintervention assessment. Quality of Life - Alzheimer's Disease is an instrument to assess quality of life in people diagnosed with dementia, gathering information from the patient and the caregiver. It is composed by 13 items regarding perception of health, mood, functional abilities, interpersonal relationships and hobbies, decision making ability and life in general. It has good psychometric characteristics and it's use has been recommended to evaluate psychosocial interventions. Scores range between 13 - 52 points. Higher scores indicate better quality of life.

  6. Change in quality of life evaluated through Quality of Life - Alzheimer's Disease: score [ Time Frame: 12 months after the beginning of the intervention ]
    Significant statistic improvement in the participant's test scores between pre-intervention assessment and postintervention assessment. Quality of Life - Alzheimer's Disease is an instrument to assess quality of life in people diagnosed with dementia, gathering information from the patient and the caregiver. It is composed by 13 items regarding perception of health, mood, functional abilities, interpersonal relationships and hobbies, decision making ability and life in general. It has good psychometric characteristics and it's use has been recommended to evaluate psychosocial interventions. Scores range between 13 - 52 points. Higher scores indicate better quality of life.

  7. Functional status is assessed using the Lawton and Brody Instrumental Activities of Daily Living. [ Time Frame: Pre-intervention ]
    It's an instrument that assesses the independence level of the elderly people regarding IADL's. A score is assigned according to the person's ability to perform a given task. A set of three, four or five options is suggested for each question, which is scored from 1 to 3, 1 to 4 or 1 to 5 points. The highest score corresponds to a greater degree of dependency. If a task does not apply because the person did not perform it in the pre-morbid period, the score for that task is not included in the total score, that is, the maximum possible score includes only the maximum scores of the tasks that the person performed. The score ranges from 8 to 30 points (a score of 8 points means that th person is independent; between 9 and 20 points means a moderate dependency; greater than 20 points means severe dependency).

  8. Change in functional status is assessed using the Lawton and Brody Instrumental Activities of Daily Living. [ Time Frame: 6 months after the beginning of the intervention ]
    It's an instrument that assesses the independence level of the elderly people regarding IADL's. A score is assigned according to the person's ability to perform a given task. A set of three, four or five options is suggested for each question, which is scored from 1 to 3, 1 to 4 or 1 to 5 points. The highest score corresponds to a greater degree of dependency. If a task does not apply because the person did not perform it in the pre-morbid period, the score for that task is not included in the total score, that is, the maximum possible score includes only the maximum scores of the tasks that the person performed. The score ranges from 8 to 30 points (a score of 8 points means that th person is independent; between 9 and 20 points means a moderate dependency; greater than 20 points means severe dependency).

  9. Change in functional status is assessed using the Lawton and Brody Instrumental Activities of Daily Living. [ Time Frame: 12 months after the beginning of the intervention ]
    It's an instrument that assesses the independence level of the elderly people regarding IADL's. A score is assigned according to the person's ability to perform a given task. A set of three, four or five options is suggested for each question, which is scored from 1 to 3, 1 to 4 or 1 to 5 points. The highest score corresponds to a greater degree of dependency. If a task does not apply because the person did not perform it in the pre-morbid period, the score for that task is not included in the total score, that is, the maximum possible score includes only the maximum scores of the tasks that the person performed. The score ranges from 8 to 30 points (a score of 8 points means that th person is independent; between 9 and 20 points means a moderate dependency; greater than 20 points means severe dependency).


Other Outcome Measures:
  1. Sociodemographic data collected through a sociodemographic questionnaire [ Time Frame: Pre-intervention ]
    Sociodemographic data will be collected using a sociodemographic questionnaire, designed specifically for this study, regarding information about age, gender, literacy, health conditions, among others.

  2. Adherence to the intervention and dropouts evaluated through a session form [ Time Frame: [Pre, intra (6 months) and post intervention (12 months)] ]
    Adherence to the intervention and dropouts will be assessed using a session form, designed specifically for this study, completed by the technician after each session, regarding the attendance and mood/behavior of the participants throughout the intervention sessions.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   65 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04417751


Contacts
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Contact: Susana I Justo Henriques, PhD 00351234541487 cediara.dir.tec@gmail.com
Contact: Tânia Silva, Bs 00351234541487 cediara.dir.tec@gmail.com

Locations
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Portugal
Cediara - Social Solidarity Association of Ribeira de Fráguas Recruiting
Ribeira de Fráguas, Albergaria-a-Velha, Portugal, 3850-705
Contact: Susana I Justo Henriques, PhD    00351234541487    cediara.dir.tec@gmail.com   
Contact: Tânia Silva, Bs    00351234541487    cediara.dir.tec@gmail.com   
Sponsors and Collaborators
CEDIARA - Assoc. Solidariedade Social de Ribeira de Fráguas
Investigators
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Principal Investigator: 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
Publications:
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
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
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
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
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.
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
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.
Morgado J, Rocha CS, Maruta C, Guerreiro M, Martins IP. Novos valores normativos do Mini-Mental Sate Examination. Sinapse. 2009; 2: 10-16.
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
Wilson B. Towards a comprehensive model of cognitive rehabilitation. Neuropsychological Rehabilitation. 2002; 12(2): 97-110. https://doi.org/10.1080/09602010244000020

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Responsible Party: CEDIARA - Assoc. Solidariedade Social de Ribeira de Fráguas
ClinicalTrials.gov Identifier: NCT04417751    
Other Study ID Numbers: 23052020
First Posted: June 5, 2020    Key Record Dates
Last Update Posted: July 21, 2020
Last Verified: July 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by CEDIARA - Assoc. Solidariedade Social de Ribeira de Fráguas:
older adults
cognitive stimulation
dementia
intervention
cognition
individual intervention
social vulnerability
quality of life
aged
non-pharmacological therapy
neurocognitive disorder
psychosocial
Additional relevant MeSH terms:
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Dementia
Cognitive Dysfunction
Neurocognitive Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Mental Disorders
Cognition Disorders