Clinical trial NCT04417751: 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
Overall status: COMPLETED
Phase: NA
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
Lead sponsor: CEDIARA - Assoc. Solidariedade Social de Ribeira de Fráguas
Sponsor class: OTHER
First posted: 2020-06-05
Enrollment: 59
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Cognitive state evaluated through Mini-Mental State Examination
timeFrame: Pre-intervention
measure: Change in cognitive state evaluated through Mini-Mental State Examination
timeFrame: 6 months after the beginning of the intervention
measure: Change in cognitive state evaluated through Mini-Mental State Examination
timeFrame: 12 months after the beginning of the intervention
measure: Cognitive performance evaluated through Montreal Cognitive Assessment
timeFrame: Pre-intervention
measure: Change in cognitive performance evaluated through Montreal Cognitive Assessment
timeFrame: 6 months after the beginning of the intervention
measure: Change in cognitive performance evaluated through Montreal Cognitive Assessment
timeFrame: 12 months after the beginning of the intervention
Secondary outcomes:
measure: Depressive symptoms evaluated through Geriatric Depression Scale -15
timeFrame: Pre intervention
measure: Change in depressive symptoms evaluated through Geriatric Depression Scale -15
timeFrame: 6 months after the beginning of the intervention
measure: Change in depressive symptoms evaluated through Geriatric Depression Scale -15
timeFrame: 12 months after the beginning of the intervention
measure: Quality of life evaluated through Quality of Life - Alzheimer's Disease: score
timeFrame: Pre-intervention
measure: Change in quality of life evaluated through Quality of Life - Alzheimer's Disease: score
timeFrame: 6 months after the beginning of the intervention
measure: Change in quality of life evaluated through Quality of Life - Alzheimer's Disease: score
timeFrame: 12 months after the beginning of the intervention
measure: Functional status is assessed using the Lawton and Brody Instrumental Activities of Daily Living.
timeFrame: Pre-intervention
measure: Change in functional status is assessed using the Lawton and Brody Instrumental Activities of Daily Living.
timeFrame: 6 months after the beginning of the intervention
measure: Change in functional status is assessed using the Lawton and Brody Instrumental Activities of Daily Living.
timeFrame: 12 months after the beginning of the intervention
Other outcomes:
measure: Sociodemographic data collected through a sociodemographic questionnaire
timeFrame: Pre-intervention
measure: Adherence to the intervention and dropouts evaluated through a session form
timeFrame: [Pre, intra (6 months) and post intervention (12 months)]
Locations:
city: Ribeira de Fráguas
country: Portugal
facility: Cediara - Social Solidarity Association of Ribeira de Fráguas
state: Albergaria-a-Velha
Study officials:
affiliation: Health Sciences Research Unit: Nursing (UICISA: E), ESEnfC
name: Susana I Justo Henriques, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: CEDIARA - Assoc. Solidariedade Social de Ribeira de Fráguas
name: Ana E Marques Castro, MSc
role: PRINCIPAL_INVESTIGATOR
affiliation: National Reference Centre for Alzheimer's and Dementia Care, Imserso
name: Enrique Pérez Sáez, PhD
role: PRINCIPAL_INVESTIGATOR
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