跳至主要内容
临床试验/NCT04008342
NCT04008342已完成不适用

Effectiveness of a Multisensory Stimulation Intervention on Neuropsychiatric Symptoms in Moderate to Advanced Dementia: a Randomized Controlled Clinical Trial

Federal University of Minas Gerais2 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2016年2月15日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
60
试验地点
2
主要终点
Effects on agitation

研究概览

简要总结

Dementia is one of the main causes of disability in the elderly. It is characterized by cognitive, functional and social impairment, as well as behavioral changes. Neuropsychiatric symptoms (NPS) are experienced by patients and observed by caregivers during the natural course of dementia. These symptoms, such as apathy, depression and agitation, are a heterogeneous group of noncognitive symptoms and behaviors. When these symptoms are present, it is more likely that the elderly will be institutionalized as the caregivers will be overloaded with demands. Pharmacological treatment presents little efficacy for the adequate control of these symptoms, and nonpharmacological interventions have been recommended as the first line of treatment. Multisensory stimulation (MSS), a nonpharmacological intervention, is one of the possibilities for intervention in people with dementia and NPS. MSS aims to stimulate the five primary senses, namely, hearing, sight, taste, smell and touch, through pleasurable sensory experiences, in a safe and relaxed environment. This work aims to investigate the effects of an MSS protocol in aged people with dementia living in long-term care institutions in Brazil.

详细描述

Background: Neuropsychiatric symptoms (NPS) in people with dementia frequently evolve with progression of the disorder. Nonpharmacological interventions are the first-line treatment to control NPS in dementia. Multisensory stimulation (MSS) is a nonpharmacological intervention that is conducted by stimulating one or more of the five senses of the body with pleasant sensory experiences. This work aims to investigate the effects of a MSS protocol in elderly people with moderate to advanced dementia living in long-term care institutions in Brazil.

Methods: A specific MSS protocol was developed by the researchers for the study. Sixty elderly people with moderate to advanced dementia (Clinical Dementia Rating of 2 or 3 and a Mini-Mental State Examination score ≤17) were randomly allocated to intervention (n=30) and control (n=30) groups. The sample size estimation was established with a paired bilateral t-test with a 0.05 significance level. This sample size would have 80% power to detect a mean difference of 9.50 in the NPI scores from pre- to post-intervention and a standard deviation of 17.28, as proposed by Fu et al. (2013). The intervention group participated in 16 individual 30-minute sessions over eight weeks in a quiet room, and the control group received usual care.

The MSS program includes eight sessions. During these sessions, the five body senses (sight, taste, hearing, smell, and feeling) are stimulated using songs, fruits, fiber optic lamps, natural scents, among other stimuli, to promote interactions between the participants and the therapist, as well as the objects. In each session, at least two senses are stimulated in a safe, quiet and confidential environment. The sessions last 30 minutes and are conducted twice a week, on the same day and time whenever possible. Nonetheless, the session can be interrupted when the participant wishes or if the therapist observes that the patient is uncomfortable. A nondirective approach and one-to-one intervention were adopted.The MSS protocol was conducted by an occupational therapist. In this study, the eight-session protocol was used twice, that is, the protocol was repeated from the ninth session forward, but the protocol was customized for each participant by consideration of the participants' interests in previous sessions and the protocol rules.

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
Single (Outcomes Assessor)

盲法说明

The evaluations were performed by a blind investigator.

入排标准

年龄范围
60 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • elderly person;
  • moderate or advanced dementia diagnosis (Clinical Dementia Rating (CDR) of 2 or 3);
  • score equal to or less than 17 on the Mini-Mental State Examination;
  • Inclusion Criteria caregivers:
  • Formal caregivers involved in the direct care of these elderly patients;
  • Formal caregivers did not have holidays during the intervention period.

排除标准

  • profound vision and hearing loss;
  • presence of any additional psychiatric or neurological diagnosis (e.g., schizophrenia or intellectual disability);
  • plan to relocate to another residence in less than three months.

研究组 & 干预措施

Intervention group

Experimental

The intervention group (IG) was submitted to 16 multisensory sessions that followed the protocol.

干预措施: Multisensory intervention (Other)

Control group

No Intervention

The control group (CG) received usual care with routine interventions and services in the LTC, such as bath, hygiene care, watching TV and so on.

结局指标

主要结局

Effects on agitation

时间窗: 10-20 minutes

To measure agitation, the Cohen-Mansfield Agitation Inventory (CMAI) was used. The maximum score was 144 points and a higher score indicated more frequent symptoms

Effects on neuropsychiatric symptoms

时间窗: 10-20 minutes

The frequency and intensity of neuropsychiatric symptoms (NPS) were assessed by the Neuropsychiatric Inventory (NPI). The scale considered 12 domains and the total score (0-144) was calculated by multiplying the frequency (1-4) and the severiity (1-3) of the symptoms. A higher score indicated more severe NPS. Assessment results are presented for the total score and the four neuropsychiatric subsyndromes of the NPI: hyperactivity, psychosis, affective symptoms and apathy.

Effects on depression

时间窗: 10-20 minutes

The Cornell Scale for Depression in Dementia (CSDD) was employed to evaluate depressive symptoms. Each item was scored as zero (absent), one (mild), two (severe), or unable to evaluate, and the total score (0-38) was calculated by adding the item scores. The scale is divided into five subscales: mood-related signs, behavioral disturbance, physical signs, cyclic functions and ideational disturbance. The total score ranged from 0 to 38; a higher score indicated greater levels of depression.

Effects on apathy

时间窗: 5-10 minutes

The Apathy Scale (AS) was used as a measure of apathy symptoms. The maximum score was 42 points, and higher scores indicated greater intensity of these symptoms

次要结局

  • Effect on functional status(10-20 minutes)

研究者

发起方
Federal University of Minas Gerais
申办方类型
Other
责任方
Principal Investigator
主要研究者

Paulo Caramelli

Professor of Neurology

Federal University of Minas Gerais

研究点 (2)

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