Digital and Analogical Cognitive Stimulation in Older Adults With Alzheimer's Disease: Effects on Global Cognition, Well-being and Quality of Life Across Distinct Institutional and Sociogeographic Contexts
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 514
- 试验地点
- 38
- 主要终点
- Change in cognitive functioning assessed through Mini-Mental State Examination (MMSE)
研究概览
简要总结
This multicentre study, employing a randomised controlled repeated measures experimental design, will be conducted in several Portuguese institutions that provide care and support services for older adults diagnosed with mild to moderate Alzheimer's disease (AD). The primary aim is to evaluate the effects of two distinct cognitive stimulation modalities (digital vs physical/analogue).
The study will assess the impact of individual cognitive stimulation on multiple domains - specifically cognitive function (with an emphasis on memory and executive function), mood, and quality of life - and investigate how institutional and territorial characteristics influence these effects, considering geographical and organisational diversity as potential moderating factors.
详细描述
Population ageing has increased the prevalence of neurodegenerative diseases, with Alzheimer's disease (AD) being the most common form of dementia. Its wide-ranging impact on cognition, emotion, and daily function necessitates person-centred, multidimensional interventions. In Portugal, dementia affects around 9.5% of those aged 65+, underlining its public health relevance and the need for effective responses.
In the absence of a cure, non-pharmacological interventions like cognitive stimulation (CS) have gained prominence. CS is an evidence-based, psychosocial approach involving structured activities that enhance cognitive functions such as memory, language, attention, and reasoning. Broader and more relational than cognitive training or rehabilitation, CS is effective-especially in mild to moderate AD-in improving cognition, mood, and quality of life. Portuguese and international guidelines support its use, with studies showing potential in reducing depression and anxiety in older adults.
Behavioural and psychological symptoms of dementia (BPSD)-including agitation, apathy, aggression, anxiety, and sleep issues-are common in AD and often more disruptive than cognitive decline. These symptoms increase caregiver stress and the likelihood of institutionalisation. CS may alleviate BPSD through emotional engagement and behavioural regulation.
Assessing CS efficacy requires reliable tools. The Mini-Mental State Examination is widely used in Portugal for cognitive screening, while the Alzheimer's Disease Assessment Scale - Cognitive Subscale is often used in clinical trials. As AD notably impairs executive functions, CS targeting these domains can support autonomy and adaptive behaviour.
Contextual factors, such as institutional resources and geographic location, may influence CS outcomes. However, few studies consider these variables, despite their relevance for implementing sustainable, real-world interventions.
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
- •Age 65 or older.
- •Receive care/support services for at least three months.
- •A diagnosis of probable AD according to the criteria of the Diagnostic and Statistical Manual of Mental Disorders, fifth edition, text revision.
- •Preserved communication skills.
- •Native Portuguese speaker.
- •Total scores between 10 and 26 points on the Mini Mental State Examination.
排除标准
- •Cannot read and write.
- •Significant sensory or physical limitations.
- •Acute or chronic illness preventing participation.
- •Severe communication impairment.
- •Aggressive or disruptive behaviour.
- •Recent initiation (within two months) of neuroleptics, antipsychotics, or other psychoactive medications.
研究组 & 干预措施
Intervention group 1
Participants in the intervention group 1 will participate in two individual CS sessions per week for 12 weeks in addition to their treatment as usual. The sessions will include the same program in every participant site.
干预措施: Digital intervention (Behavioral)
Intervention group 2
Participants in the intervention group 2 will participate in two individual CS sessions per week for 12 weeks in addition to their treatment as usual. The sessions will include the same program in every participant site.
干预措施: Physical/Analogue Intervention (Behavioral)
Control group (No intervention)
Participants in the control group will receive treatment as usual (TAU) at the site, following the activities specified in their individual care plans.
结局指标
主要结局
Change in cognitive functioning assessed through Mini-Mental State Examination (MMSE)
时间窗: 12 weeks after the baseline
Change in cognitive functioning evaluated by the Mini-Mental State Examination (MMSE), a gold standard screening tool for assessing global cognitive function.Scores range from 0 to 30, with higher scores indicating better cognitive functioning.
Change in cognitive functioning assessed through Alzheimer's Disease Assessment Scale - Cognitive Subscale (ADAS-COG)
时间窗: 12 weeks after the baseline
Evaluates the severity of cognitive deficits in AD in the following domains: memory, orientation, language, praxis and constructive capacity. The total score in the Portuguese version of ADAS-Cog is composed of 11 subtests in the cognitive part and varies between 0 (better performance) and 68 points (worse performance), i.e., higher scores equals better performance.
Change in memory function evaluated through Memory Alteration Test (MAT)
时间窗: 12 weeks after the baseline
The MAT is used to assess memory function. It is an easy and quick instrument that assesses five memory domains: temporal orientation, encoding, semantic memory, free recall, and cued recall. Total scores range from 0 to 50, with higher scores indicating better memory. It has good psychometric properties and is highly sensitive to mild cognitive decline.
Change in executive functions assessed through Frontal Assessment Battery (FAB)
时间窗: 12 weeks after the baseline
FAB assesses executive functions such as abstract thinking, mental flexibility, motor programming, interference sensibility, inhibitory control and environmental independence. Scores range between 0 - 18 points with higher scores indicating better cognitive function.
Cognitive functioning assessed through Mini-Mental State Examination (MMSE)
时间窗: Baseline
Cognitive functioning assessed by the Mini-Mental State Examination (MMSE), a gold standard screening tool for assessing global cognitive function. Scores range from 0 to 30, with higher scores indicating better cognitive functioning.
Change in cognitive functioning assessed through Mini-Mental State Examination (MMSE)
时间窗: 24 weeks after the baseline
Change in cognitive functioning evaluated by the Mini-Mental State Examination (MMSE), a gold standard screening tool for assessing global cognitive function. Scores range from 0 to 30, with higher scores indicating better cognitive functioning.
Cognitive functioning assessed through Alzheimer's Disease Assessment Scale - Cognitive Subscale (ADAS-COG)
时间窗: Baseline
Evaluates the severity of cognitive deficits in AD in the following domains: memory, orientation, language, praxis and constructive capacity. The total score in the Portuguese version of ADAS-Cog is composed of 11 subtests in the cognitive part and varies between 0 (better performance) and 68 points (worse performance), i.e., higher scores equals better performance.
Change in cognitive functioning assessed through Alzheimer's Disease Assessment Scale - Cognitive Subscale (ADAS-COG)
时间窗: 24 weeks after the baseline
Evaluates the severity of cognitive deficits in AD in the following domains: memory, orientation, language, praxis and constructive capacity. The total score in the Portuguese version of ADAS-Cog is composed of 11 subtests in the cognitive part and varies between 0 (better performance) and 68 points (worse performance), i.e., higher scores equals better performance.
Memory function evaluated through Memory Alteration Test (MAT)
时间窗: Baseline
The MAT is used to assess memory function. It is an easy and quick instrument that assesses five memory domains: temporal orientation, encoding, semantic memory, free recall, and cued recall. Total scores range from 0 to 50, with higher scores indicating better memory. It has good psychometric properties and is highly sensitive to mild cognitive decline.
Change in memory function evaluated through Memory Alteration Test (MAT)
时间窗: 24 weeks after the baseline
The MAT is used to assess memory function. It is an easy and quick instrument that assesses five memory domains: temporal orientation, encoding, semantic memory, free recall, and cued recall. Total scores range from 0 to 50, with higher scores indicating better memory. It has good psychometric properties and is highly sensitive to mild cognitive decline.
Executive functions assessed through Frontal Assessment Battery (FAB)
时间窗: Baseline
FAB assesses executive functions such as abstract thinking, mental flexibility, motor programming, interference sensibility, inhibitory control and environmental independence. Scores range between 0 - 18 points with higher scores indicating better cognitive function.
Change in executive functions assessed through Frontal Assessment Battery (FAB)
时间窗: 24 weeks after the baseline
FAB assesses executive functions such as abstract thinking, mental flexibility, motor programming, interference sensibility, inhibitory control and environmental independence. Scores range between 0 - 18 points with higher scores indicating better cognitive function.
次要结局
- Change in mood assessed through the GDS-15(12 weeks after the baseline)
- Change in anxiety symptomatology assessed through the GAI(12 weeks after the baseline)
- Change in quality of life evaluated through QoL-AD(12 weeks after the baseline)
- Mood assessed through the Geriatric Depression Scale-15 (GDS-15)(Baseline)
- Change in mood assessed through the GDS-15(24 weeks after the baseline)
- Anxiety symptomatology assessed through the Geriatric Anxiety Inventory (GAI)(Baseline)
- Change in anxiety symptomatology assessed through the GAI(24 weeks after the baseline)
- Quality of life evaluated through Quality of Life - Alzheimer's Disease (QoL-AD)(Baseline)
- Change in quality of life evaluated through QoL-AD(24 weeks after the baseline)