DementiaNCT04008342
Multisensory Stimulation in Dementia.
A study testing Multisensory intervention in people with Dementia, run by Federal University of Minas Gerais at 1 site in Brazil.
Trial 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. Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Dementia
- What is being tested?
- Multisensory intervention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteBrazil
- Study dates
- 15 Feb 2016to 1 Aug 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Brazil1 site
School of Medicine, Federal University of Minas Gerais
Belo Horizonte, Minas Gerais, 30130-000
About this study
Official title: Effectiveness of a Multisensory Stimulation Intervention on Neuropsychiatric Symptoms in Moderate to Advanced Dementia: a Randomized Controlled Clinical Trial
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.
Read the 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.
- Conditions
- Dementia
- Being tested
- Multisensory intervention
- Keywords
- aged, nonpharmacological intervention, multisensory stimulation, neuropsychiatric symptoms, long-term care
- Medical subject headings
- Dementia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Multisensory interventionOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Experimental | The intervention group (IG) was submitted to 16 multisensory sessions that followed the protocol. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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.
Measured: 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.
Measured: 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
Measured: 5-10 minutes
Secondary outcomes (1)
Effect on functional status
The Barthel Index was used to assess functional independence and mobility in daily life activities. The total score ranged from 0-100 points, and higher scores indicated more independence.
Measured: 10-20 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jul 2019
- Study start15 Feb 2016
- Primary completion1 Aug 2018
- Study completion1 Aug 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DementiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Federal University of Minas Gerais
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Paulo Caramelli, Federal University of Minas Gerais
- Investigators
- Larissa S Serelli, PhD, Principal investigator, Federal University of Minas GeraisMarcella G Assis, PhD, Principal investigator, Federal University of Minas GeraisPaulo Caramelli, MD, PhD, Principal investigator, Federal University of Minas Gerais
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04008342
- Sponsor's protocol ID
- Paulo Caramelli
- Status last verified
- Jul 2019
- First submitted
- 1 Jul 2019
- Last updated
- 5 Jul 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of a Multisensory Stimulation Intervention on Neuropsychiatric Symptoms in Moderate to Advanced Dementia: a Randomized Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT04008342
- Acronym / sponsor ID
- Paulo Caramelli
- Conditions
- Dementia
- Keywords
- aged, nonpharmacological intervention, multisensory stimulation, neuropsychiatric symptoms, long-term care
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Federal University of Minas GeraisUniversity, hospital or other
- Study start
- 15 Feb 2016 (actual)
- Primary completion
- 1 Aug 2018 (actual)
- Study completion
- 1 Aug 2018 (actual)
- First posted
- 5 Jul 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Other: Multisensory interventionThe intervention group (IG) was submitted to 16 multisensory sessions that followed the protocol. |
| 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. |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Multisensory interventionThe 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. | Other | Intervention group |
Primary outcome
Effects on agitation
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
1 secondary outcome
Effect on functional status
Time frame: 10-20 minutes
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jul 2019.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Larissa S Serelli, PhD principal investigator
Federal University of Minas Gerais
Marcella G Assis, PhD principal investigator
Federal University of Minas Gerais
Paulo Caramelli, MD, PhD principal investigator
Federal University of Minas Gerais
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Multisensory intervention in people with Dementia, run by Federal University of Minas Gerais at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Effects on agitation (time frame: 10-20 minutes). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jul 2019.