Care at 360º: A Long-term Individual Cognitive Stimulation Program for Older Adults With Neurocognitive Disorders, Non-Institutionalized and Socially Vulnerable
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 59
- 试验地点
- 2
- 主要终点
- Cognitive state evaluated through Mini-Mental State Examination
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
结局指标
主要结局
Cognitive state evaluated through Mini-Mental State Examination
时间窗: 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.
Cognitive performance evaluated through Montreal Cognitive Assessment
时间窗: 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.
Change in cognitive performance evaluated through Montreal Cognitive Assessment
时间窗: 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.
Change in cognitive state evaluated through Mini-Mental State Examination
时间窗: 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.
次要结局
- Depressive symptoms evaluated through Geriatric Depression Scale -15(Pre 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)
- Functional status is assessed using the Lawton and Brody Instrumental Activities of Daily Living.(Pre-intervention)
- Change in quality of life evaluated through Quality of Life - Alzheimer's Disease: score(12 months after the beginning of the intervention)
- Change in functional status is assessed using the Lawton and Brody Instrumental Activities of Daily Living.(12 months after the beginning of the intervention)