search
Back to results

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

Primary Purpose

Neurocognitive Disorders, Dementia, Cognitive Impairment

Status
Completed
Phase
Not Applicable
Locations
Portugal
Study Type
Interventional
Intervention
Cognitive Stimulation
Sponsored by
CEDIARA - Assoc. Solidariedade Social de Ribeira de Fráguas
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Neurocognitive Disorders focused on measuring older adults, cognitive stimulation, dementia, intervention, cognition, individual intervention, social vulnerability, quality of life, aged, non-pharmacological therapy, neurocognitive disorder, psychosocial

Eligibility Criteria

65 Years - undefined (Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Cediara - Social Solidarity Association of Ribeira de Fráguas

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Intervention Group

Control Group

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.
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.
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.
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.
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.
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.

Secondary Outcome Measures

Depressive symptoms evaluated through Geriatric Depression Scale -15
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.
Change in depressive symptoms evaluated through Geriatric Depression Scale -15
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.
Change in depressive symptoms evaluated through Geriatric Depression Scale -15
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.
Quality of life evaluated through Quality of Life - Alzheimer's Disease: score
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.
Change in quality of life evaluated through Quality of Life - Alzheimer's Disease: score
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.
Change in quality of life evaluated through Quality of Life - Alzheimer's Disease: score
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.
Functional status is assessed using the Lawton and Brody Instrumental Activities of Daily Living.
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).
Change in functional status is assessed using the Lawton and Brody Instrumental Activities of Daily Living.
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).
Change in functional status is assessed using the Lawton and Brody Instrumental Activities of Daily Living.
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).

Full Information

First Posted
May 27, 2020
Last Updated
July 26, 2021
Sponsor
CEDIARA - Assoc. Solidariedade Social de Ribeira de Fráguas
search

1. Study Identification

Unique Protocol Identification Number
NCT04417751
Brief Title
Care at 360º: A Long-term Individual Cognitive Stimulation Program
Official Title
Care at 360º: A Long-term Individual Cognitive Stimulation Program for Older Adults With Neurocognitive Disorders, Non-Institutionalized and Socially Vulnerable
Study Type
Interventional

2. Study Status

Record Verification Date
July 2020
Overall Recruitment Status
Completed
Study Start Date
July 1, 2020 (Actual)
Primary Completion Date
July 26, 2021 (Actual)
Study Completion Date
July 26, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
CEDIARA - Assoc. Solidariedade Social de Ribeira de Fráguas

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
59 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intervention Group
Arm Type
Experimental
Arm Description
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.
Arm Title
Control Group
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Cognitive Stimulation
Intervention Description
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.
Primary Outcome Measure Information:
Title
Cognitive state evaluated through Mini-Mental State Examination
Description
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.
Time Frame
Pre-intervention
Title
Change in cognitive state evaluated through Mini-Mental State Examination
Description
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.
Time Frame
6 months after the beginning of the intervention
Title
Change in cognitive state evaluated through Mini-Mental State Examination
Description
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.
Time Frame
12 months after the beginning of the intervention
Title
Cognitive performance evaluated through Montreal Cognitive Assessment
Description
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.
Time Frame
Pre-intervention
Title
Change in cognitive performance evaluated through Montreal Cognitive Assessment
Description
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.
Time Frame
6 months after the beginning of the intervention
Title
Change in cognitive performance evaluated through Montreal Cognitive Assessment
Description
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.
Time Frame
12 months after the beginning of the intervention
Secondary Outcome Measure Information:
Title
Depressive symptoms evaluated through Geriatric Depression Scale -15
Description
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.
Time Frame
Pre intervention
Title
Change in depressive symptoms evaluated through Geriatric Depression Scale -15
Description
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.
Time Frame
6 months after the beginning of the intervention
Title
Change in depressive symptoms evaluated through Geriatric Depression Scale -15
Description
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.
Time Frame
12 months after the beginning of the intervention
Title
Quality of life evaluated through Quality of Life - Alzheimer's Disease: score
Description
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.
Time Frame
Pre-intervention
Title
Change in quality of life evaluated through Quality of Life - Alzheimer's Disease: score
Description
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.
Time Frame
6 months after the beginning of the intervention
Title
Change in quality of life evaluated through Quality of Life - Alzheimer's Disease: score
Description
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.
Time Frame
12 months after the beginning of the intervention
Title
Functional status is assessed using the Lawton and Brody Instrumental Activities of Daily Living.
Description
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).
Time Frame
Pre-intervention
Title
Change in functional status is assessed using the Lawton and Brody Instrumental Activities of Daily Living.
Description
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).
Time Frame
6 months after the beginning of the intervention
Title
Change in functional status is assessed using the Lawton and Brody Instrumental Activities of Daily Living.
Description
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).
Time Frame
12 months after the beginning of the intervention
Other Pre-specified Outcome Measures:
Title
Sociodemographic data collected through a sociodemographic questionnaire
Description
Sociodemographic data will be collected using a sociodemographic questionnaire, designed specifically for this study, regarding information about age, gender, literacy, health conditions, among others.
Time Frame
Pre-intervention
Title
Adherence to the intervention and dropouts evaluated through a session form
Description
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.
Time Frame
[Pre, intra (6 months) and post intervention (12 months)]

10. Eligibility

Sex
All
Minimum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Susana I Justo Henriques, PhD
Organizational Affiliation
Health Sciences Research Unit: Nursing (UICISA: E), ESEnfC
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Ana E Marques Castro, MSc
Organizational Affiliation
CEDIARA - Assoc. Solidariedade Social de Ribeira de Fráguas
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Enrique Pérez Sáez, PhD
Organizational Affiliation
National Reference Centre for Alzheimer's and Dementia Care, Imserso
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cediara - Social Solidarity Association of Ribeira de Fráguas
City
Ribeira de Fráguas
State/Province
Albergaria-a-Velha
ZIP/Postal Code
3850-705
Country
Portugal

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
Citation
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
Results Reference
background
Citation
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
Results Reference
background
PubMed Identifier
23534370
Citation
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.
Results Reference
background
Citation
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
Results Reference
background
PubMed Identifier
10649552
Citation
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.
Results Reference
background
PubMed Identifier
11236819
Citation
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.
Results Reference
background
Citation
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
Results Reference
background
PubMed Identifier
1202204
Citation
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.
Results Reference
background
PubMed Identifier
25531579
Citation
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.
Results Reference
background
Citation
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.
Results Reference
background
PubMed Identifier
30906977
Citation
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.
Results Reference
background
PubMed Identifier
5349366
Citation
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.
Results Reference
background
Citation
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
Results Reference
background
PubMed Identifier
15249277
Citation
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.
Results Reference
background
Citation
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.
Results Reference
background
PubMed Identifier
18297476
Citation
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.
Results Reference
background
Citation
Morgado J, Rocha CS, Maruta C, Guerreiro M, Martins IP. Novos valores normativos do Mini-Mental Sate Examination. Sinapse. 2009; 2: 10-16.
Results Reference
background
PubMed Identifier
15817019
Citation
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. Erratum In: J Am Geriatr Soc. 2019 Sep;67(9):1991.
Results Reference
background
PubMed Identifier
22899153
Citation
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.
Results Reference
background
Citation
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
Results Reference
background
Citation
Wilson B. Towards a comprehensive model of cognitive rehabilitation. Neuropsychological Rehabilitation. 2002; 12(2): 97-110. https://doi.org/10.1080/09602010244000020
Results Reference
background
PubMed Identifier
22336813
Citation
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.
Results Reference
background

Learn more about this trial

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

We'll reach out to this number within 24 hrs