Clinical trial NCT04008342: Multisensory Stimulation in Dementia.
Official title: Effectiveness of a Multisensory Stimulation Intervention on Neuropsychiatric Symptoms in Moderate to Advanced Dementia: a Randomized Controlled Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dementia
Keywords: aged
nonpharmacological intervention
multisensory stimulation
neuropsychiatric symptoms
long-term care
Lead sponsor: Federal University of Minas Gerais
Sponsor class: OTHER
First posted: 2019-07-05
Enrollment: 60
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: An experimental pre- and postintervention design was used. The participants were recruited from philanthropic LTC institutions for aged people and allocated in experimental group and control group.
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria residents:

* 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.

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Effects on agitation
timeFrame: 10-20 minutes
measure: Effects on neuropsychiatric symptoms
timeFrame: 10-20 minutes
measure: Effects on depression
timeFrame: 10-20 minutes
measure: Effects on apathy
timeFrame: 5-10 minutes
Secondary outcomes:
measure: Effect on functional status
timeFrame: 10-20 minutes
Other outcomes:
Locations:
city: Belo Horizonte
country: Brazil
facility: School of Medicine, Federal University of Minas Gerais
state: Minas Gerais
Study officials:
affiliation: Federal University of Minas Gerais
name: Larissa S Serelli, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Federal University of Minas Gerais
name: Marcella G Assis, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Federal University of Minas Gerais
name: Paulo Caramelli, MD, PhD
role: PRINCIPAL_INVESTIGATOR
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