Multisensory Stimulation in Dementia.

NCT04008342 | Completed

• 1 other identifier: Paulo Caramelli
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Dementia

Keywords

aged; nonpharmacological intervention; multisensory stimulation; neuropsychiatric symptoms; long-term care

Outcome Measures

Primary Outcomes (4)

• Effects on agitation

  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

  10-20 minutes

• Effects on neuropsychiatric symptoms

  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.

  10-20 minutes

• Effects on depression

  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.

  10-20 minutes

• Effects on apathy

  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

  5-10 minutes

Secondary Outcomes (1)

• Effect on functional status

  10-20 minutes

Study Arms (2)

Intervention group

EXPERIMENTAL

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

Other: Multisensory intervention

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.

Interventions

Multisensory intervention OTHER

The intervention group (IG) was submitted to 16 individual multisensory stimulation sessions that followed the protocol. In each session, at least two senses are stimulated in a safe, quiet and confidential environment. The sessions lasted 30 minutes and were conducted twice a week, on the same day and time whenever possible. Nonetheless, the session could be interrupted when the participant wished or if the therapist observed that the patient was uncomfortable. A nondirective approach and one-to-one intervention were adopted.

Intervention group

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;
• Formal caregivers involved in the direct care of these elderly patients;
• Formal caregivers did not have holidays during the intervention period.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Federal University of Minas Gerais: lead

Study Sites (1)

School of Medicine, Federal University of Minas Gerais

Belo Horizonte, Minas Gerais, 30130-000, Brazil

Location

MeSH Terms

Conditions

Dementia

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurocognitive Disorders; Mental Disorders

Study Officials

• Larissa S Serelli, PhD

  Federal University of Minas Gerais

  PRINCIPAL INVESTIGATOR

• Marcella G Assis, PhD

  Federal University of Minas Gerais

  PRINCIPAL INVESTIGATOR

• Paulo Caramelli, MD, PhD

  Federal University of Minas Gerais

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The evaluations were performed by a blind investigator.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Neurology

Model Details: 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.

Study Record Dates

• First Submitted: July 1, 2019
• First Posted: July 5, 2019
• Study Start: February 15, 2016
• Primary Completion: August 1, 2018
• Study Completion: August 1, 2018
• Last Updated: July 5, 2019

Record last verified: 2019-07

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)