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临床试验/NCT04658394
NCT04658394已完成不适用

Effect of Individual Reminiscence Therapy in the Elderly People With Neurocognitive Disorders: A Multicentre Randomised Controlled Trial in Azores Archipelago

Rsocialform - Geriatria, Lda22 个研究点 分布在 1 个国家目标入组 122 人开始时间: 2021年2月11日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
122
试验地点
22
主要终点
Change in cognitive functioning evaluated through Mini-Mental State Examination [MMSE]

研究概览

简要总结

This research aims to evaluate the ability of individual reminiscence therapy (RT), using a simple reminiscence format, to improve the overall cognitive function, memory, emotional status and quality of life (QoL) of older adults with neurocognitive disorders (NCD) attending social care and support services. A multicentre randomised controlled trial (RCT) is proposed in Azores archipelago with repeated measures (pre-intervention, post-intervention and follow-up). Intervention group will hold 26 individual RT sessions, twice a week for 13 weeks. Control group participants will maintain their treatment as usual. Make a subsample analysis of the main clinical diagnoses, and compare the results of sample and subsample with a previous study that had the same intervention protocol.

详细描述

Neurocognitive disorder (NCD) is one of the main causes of disability among older adults and its prevalence is increasing due to the ageing of the population. It is estimated that globally, neurocognitive disorders affect 44.35 million people and it is expected that by the year 2050 the number of those affected worldwide will triple up to 135.46 million.

The absence of an effective pharmacological treatment that halts or delays the development of the disease has aroused interest in non-pharmacological therapies (NPT) as a complement to pharmacological treatment that can improve the quality of life of people with neurocognitive disorders. One of the most researched NPT and with the greatest tradition in this field is Reminiscence Therapy (RT).

RT implies the discussion of past activities, events and experiences, usually with the help of triggers (e.g., photographs, home objects and other familiar items from the past, music, any object or stimulus) that serve to stimulate memories. In its application to dementias, RT is based on the fact that the memory deficit of people with dementia implies that they are able to remember events from their past life, especially from childhood to early adulthood, but not newer facts. It focuses on preserved capacities and memories, promotes communication and enables the person to connect with his past and recover his sense of personal identity. In this way, the RT can be understood as an intervention on the edge of those of cognitive orientation and those centred on emotion, with potential interactive effects on autobiographical memory and psychological well-being.

In simplified form, there are at least two approaches to RT. The first approach as a "life review" where participants are guided through significant experiences of their biography trying to give meaning to their lives. This type of RT is more structured and is usually conducted in an individual format. It may involve the production of "life books". This approach is considered to have an integrative function aimed at achieving a sense of validation, coherence and reconciliation with one's past. Another approach that call general or simple reminiscence, implies the stimulation of autobiographical memory during conversations on specific themes of the past (e.g, holidays, food and drink, work) using stimulus to trigger memories. It has been described as an unstructured autobiographical memory narration. This reminiscence format can be conducted both individually and in groups and promotes communication between participants who share their memories and stories.

In either format that RT is applied on, the introduction of triggering stimulus (e.g., photographs, music, old objects) to help memory is considered fundamental. These triggers can be generic, reflecting common experiences in the lives of people relevant to their age group (e.g., a school manual can serve as a reminder of the experience during their school stage), or specific, with stimulus related to the person's own experiences (e.g., photographs of an important vital event such as their wedding day or a journey during their youth).

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

入选标准

  • Having a formal diagnosis of a neurocognitive disorder according to Diagnostic and Statistical Manual of Mental Disorders, fifth edition [DSM-5] criteria (participants diagnosis will be confirm in their health records at the institution).
  • Having delivered the informed consent form, duly completed and signed, after prior information.
  • Being able to communicate and understand.
  • Possibility of gathering information about the participant's life history through family members or usual caregivers, using the socio-family questionnaire designed for that purpose.
  • Being 65 years of age or older.
  • Being a native Portuguese speaker.
  • Regularly attending an institution that provides social care and support services for older adults (including people living in long-term care centres, people attending day and social centres and people receiving home support services).

排除标准

  • Suffering from an acute or severe illness that prevent participation in the intervention sessions.
  • Severe sensory and physical limitations that prevent participation.
  • Low level of consciousness and minimal attention span.
  • Presence of severe neuropsychiatric symptoms, such as agitation, psychosis, severe depressive and anxiety symptoms, apathy, or presence of uncontrolled delirium that prevent participation in the sessions.
  • Traumatic life history or marked by adverse events that discourage participation in RT sessions; history of adverse reactions during RT sessions or similar activities.
  • Have a serious or total functional dependence (assessed through the Barthel index).

结局指标

主要结局

Change in cognitive functioning evaluated through Mini-Mental State Examination [MMSE]

时间窗: 12 weeks after end of intervention

Cognitive functioning is assessed using the MMSE which is a gold standard for assessing global cognitive function. Scores range from 0 to 30, with higher scores indicating better cognitive functioning.

Cognitive functioning evaluated through Mini-Mental State Examination [MMSE]

时间窗: baseline

Cognitive functioning is assessed using the MMSE which is a gold standard for assessing global cognitive function. Scores range from 0 to 30, with higher scores indicating better cognitive functioning.

次要结局

  • Change in quality of life evaluated through Quality of Life - Alzheimer's Disease [QoL-AD](12 weeks after end of intervention)
  • Quality of life evaluated through Quality of Life - Alzheimer's Disease [QoL-AD](baseline)
  • Executive functions evaluated throught Frontal Assessment Battery [FAB](baseline)
  • Anxiety symptomatology assessed through the Geriatric Anxiety Inventory [GAI](baseline)
  • Mood assessed through the Geriatric Depression Scale-15 [GDS-15](baseline)
  • Change in mood assessed through the Geriatric Depression Scale-15 [GDS-15](12 weeks after end of intervention)
  • Change in executive functions evaluated throught Frontal Assessment Battery [FAB](12 weeks after end of intervention)
  • Change in anxiety symptomatology assessed through the Geriatric Anxiety Inventory [GAI](12 weeks after end of intervention)
  • Memory function evaluated through Memory Alteration Test [MAT](baseline)
  • Change in memory function evaluated through Memory Alteration Test [MAT](12 weeks after end of intervention)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (22)

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