DementiaSOUNDNCT06320093
Training Social and Health Care prOfessionals in mUsic-based Therapeutic iNterventions to Support Older People With Dementia
A study testing SOUND Intervention in people with Dementia and Older People, run by Istituto Nazionale di Ricovero e Cura per Anziani at 3 sites in 3 countries.
Trial summary
The study will investigate the effects of an inovative intervention based on the use of music on 45 professionals in the field of dementia, 45 elderly people with dementia. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Dementia, Older People
- What is being tested?
- SOUND Intervention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 3 sitesin 3 countries
- Study dates
- 3 Oct 2023to 20 Feb 2024
- 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 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- mild to moderate dementia
- no severe hearing and visual impairment or motor problems
Who cannot join
- no formal caregiver
- no informal caregiver
Trial locations and contacts
3 sites in 3 countries.
3 sites in 3 countries
About this study
The study will investigate the effects of an inovative intervention based on the use of music on 45 professionals in the field of dementia, 45 elderly people with dementia.
Read the detailed description
The study aims to develop an innovative therapeutic intervention (SOUND intervention) based on the use of music to improve behavior, mood, well-being, and maintain cognitive function in older people with dementia.
The study will investigate the effects of the SOUND intervention on 45 professionals in the field of dementia, 45 elderly people with dementia, and 5 family caregivers by monitoring quantitative outcome variables that will be measured through psychometric and qualitative scales interpreted through open-ended questions and observations.
- Conditions
- Dementia, Older People
- Being tested
- SOUND Intervention
- Keywords
- dementia, older people, music, caregiver
- Medical subject headings
- Dementia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SOUND InterventionOther
The intervention involved active (vocal and rhythmic production) and passive (listening to musical pieces) musical activities accompanied by motor coordination exercises. It consisted of 12 meetings (2 per week for 6 weeks) of 45 minutes each.
| Study group | Role | What they receive |
|---|---|---|
| Sound intervention | Experimental | the SOUND intervention is a new and innovative method of applying musical activities in a circle consisting of elderly people with mild-to-moderate dementia, caregivers, family caregivers and young people. Receives: Other: SOUND Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in mental wellbeing of patients with dementia
The World Health Organisation- Five Well-Being Index (WHO-5) is a short self-reported measure of current mental wellbeing.The WHO-5 consists of five statements, which respondents rate according to the scale below (in relation to the past two weeks): All of the time = 5; Most of the time = 4; More than half of the time = 3; Less than half of the time = 2 Some of the time = 1; At no time = 0. The total raw score, ranging from 0 to 25, is multiplied by 4 to give the final score, with 0 representing the worst imaginable well-being and 100 representing the best imaginable well-being.
Measured: baseline, 12 and 14 weeks later
Change in cognitive status of patients with dementia
The cognitive status has been evaluated by the Montreal Cognitive Assessment (MOCA) test. MOCA is an assessment tool used globally to detect early onset of dementia among people of old age. The tool is a one-page 30-point test that the physician can administer to check the memory, language, recall, and other markers of cognitive acuity of a patient. Normal cognition: 26-30 points; Mild Cognitive Impairment: 18-25 points; Moderate Cognitive Impairment: 10-17 points; Severe Cognitive Impairment: under 10 points.
Measured: baseline, 12 and 14 weeks later
Change in stress of health care providers
The Burnout Assessment Tool (BAT) is a self-assessment questionnaire that measures parameters associated with Burnout. All items are expressed as statements with five frequency-based response categories (1 = never, 2 = rarely, 3 = sometimes, 4 = often, 5 = always). The total burnout score is calculated as a mean of all 23 items, and a high score is indicative of high levels of burnout.
Measured: baseline, 12 and 14 weeks later
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Mar 2024
- Study start3 Oct 2023
- Primary completion20 Feb 2024
- Study completion20 Feb 2024
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
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istituto Nazionale di Ricovero e Cura per Anziani
- Sponsor type
- University, hospital or other
- Collaborators
- European Union
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06320093
- Sponsor's protocol ID
- INRCA_002_2024
- Acronym
- SOUND
- Status last verified
- Mar 2024
- First submitted
- 13 Mar 2024
- Last updated
- 20 Mar 2024
- 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 20 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Training Social and Health Care prOfessionals in mUsic-based Therapeutic iNterventions to Support Older People With Dementia
- ClinicalTrials.gov ID
- NCT06320093
- Acronym / sponsor ID
- SOUND / INRCA_002_2024
- Conditions
- Dementia, Older People
- Keywords
- dementia, older people, music, caregiver
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- Istituto Nazionale di Ricovero e Cura per AnzianiUniversity, hospital or other
- Collaborators
- European Union
- Study start
- 3 Oct 2023 (actual)
- Primary completion
- 20 Feb 2024 (actual)
- Study completion
- 20 Feb 2024 (actual)
- First posted
- 20 Mar 2024 (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.
The study will investigate the effects of an inovative intervention based on the use of music on 45 professionals in the field of dementia, 45 elderly people with dementia.
Detailed description
The study aims to develop an innovative therapeutic intervention (SOUND intervention) based on the use of music to improve behavior, mood, well-being, and maintain cognitive function in older people with dementia.
The study will investigate the effects of the SOUND intervention on 45 professionals in the field of dementia, 45 elderly people with dementia, and 5 family caregivers by monitoring quantitative outcome variables that will be measured through psychometric and qualitative scales interpreted through open-ended questions and observations.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Sound intervention | Experimental | Other: SOUND Interventionthe SOUND intervention is a new and innovative method of applying musical activities in a circle consisting of elderly people with mild-to-moderate dementia, caregivers, family caregivers and young people. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (2 listed)
- mild to moderate dementia
- no severe hearing and visual impairment or motor problems
Key exclusion criteria (2 listed)
- no formal caregiver
- no informal caregiver
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 |
|---|---|---|
| SOUND InterventionThe intervention involved active (vocal and rhythmic production) and passive (listening to musical pieces) musical activities accompanied by motor coordination exercises. It consisted of 12 meetings (2 per week for 6 weeks) of 45 minutes each. | Other | Sound intervention |
Primary outcome
Change in mental wellbeing of patients with dementia
Time frame: baseline, 12 and 14 weeks later
The World Health Organisation- Five Well-Being Index (WHO-5) is a short self-reported measure of current mental wellbeing.The WHO-5 consists of five statements, which respondents rate according to the scale below (in relation to the past two weeks): All of the time = 5; Most of the time = 4; More than half of the time = 3; Less than half of the time = 2 Some of the time = 1; At no time = 0. The total raw score, ranging from 0 to 25, is multiplied by 4 to give the final score, with 0 representing the worst imaginable well-being and 100 representing the best imaginable well-being.
Change in cognitive status of patients with dementia
Time frame: baseline, 12 and 14 weeks later
The cognitive status has been evaluated by the Montreal Cognitive Assessment (MOCA) test. MOCA is an assessment tool used globally to detect early onset of dementia among people of old age. The tool is a one-page 30-point test that the physician can administer to check the memory, language, recall, and other markers of cognitive acuity of a patient. Normal cognition: 26-30 points; Mild Cognitive Impairment: 18-25 points; Moderate Cognitive Impairment: 10-17 points; Severe Cognitive Impairment: under 10 points.
Change in stress of health care providers
Time frame: baseline, 12 and 14 weeks later
The Burnout Assessment Tool (BAT) is a self-assessment questionnaire that measures parameters associated with Burnout. All items are expressed as statements with five frequency-based response categories (1 = never, 2 = rarely, 3 = sometimes, 4 = often, 5 = always). The total burnout score is calculated as a mean of all 23 items, and a high score is indicative of high levels of burnout.
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 20 Mar 2024.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
3 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SOUND Intervention in people with Dementia and Older People, run by Istituto Nazionale di Ricovero e Cura per Anziani at 3 sites in 3 countries.
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 2 inclusion and 2 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 20 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Italy, Portugal, Romania. 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?
Change in mental wellbeing of patients with dementia (time frame: baseline, 12 and 14 weeks later). The study lists 3 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 20 Mar 2024.