DementiaNCT04293263
The Effect of Shared Listening to Personalized Music on Symptoms of Behavioral Disorders in the Elderly With Advanced Dementia
A study testing 2gether app used by trained personal in people with Dementia, run by 2gether.
Trial summary
This study is of great importance because it uses a method that has not been tested in the past. To date, various interventions have been examined that use music for patients with dementia. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Dementia
- What is being tested?
- 2gether app used by trained personal
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- No sites listed yet
- Study dates
- 1 Apr 2020to 1 Apr 2021
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Hospitalized in the Department of Mental Disorders at the Mental Health Center in Be'er Sheva aged 18 and over.
- Patients who have been diagnosed with dementia for the issue.
- Patients whose guardian gave consent for the study.
Who cannot join
- Hearing-impaired patients.
Trial locations and contacts
No sites are listed yet.
About this study
This study is of great importance because it uses a method that has not been tested in the past. To date, various interventions have been examined that use music for patients with dementia. At the same time, no intervention was conducted that integrates an additional person who shares personalized music with the patient.
If the combination of another person who shares the positive effect of the music with the patient is found to enhance the positive effect of the music, it can change the routine of work with dementia patients and may even reduce the use of tranquilizers among them.
Read more
In many cases, it has been found that one of the biggest challenges for family members who treat patients with dementia is the lack of content in the sessions and as a result, the growing sense of alienation between the patient and his family.
Listening to music can be a significant tool in the hands of the family, the main caregiver, the medical staff, and any person who comes in contact with the patient, a tool that can strengthen the sense of connection and connection between them.
- Conditions
- Dementia
- Being tested
- 2gether app used by trained personal
- Keywords
- music therapy
- Medical subject headings
- Dementia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
2gether app used by trained personalCombination product
Also called Listen to random music twice a week for about 40 minutes each time, on personal headphones.
each of the elderly in the study group will listen to personalized music twice a week for an hour each time together with a musical partner. Joint listening is performed with 2 pairs of headphones that connect via a splitter to the partner's cell phone. A listening session will take place in a period of 30 minutes and not more than 60 minutes.
Musical partner - A person trained in the program's work plan, which includes contact with empathic listening and the use of a dedicated application developed for it. A musical partner will meet with the same elderly person throughout the study period.
Empathetic listening - a situation in which a person listens to music with another person, while the music enables contact and deepening the connection between people.
| Study group | Role | What they receive |
|---|---|---|
| MCI patients hospitalised in the research departments | Experimental | each of the elderly in the study group will listen to personalized music twice a week for an hour each time together with a musical partner. Joint listening is performed with 2 pairs of headphones that connect via a splitter to the partner's cell phone. A listening session will take place in a period of 30 minutes and not more than 60 minutes. Receives: Combination Product: 2gether app used by trained personal |
| MCI patients hospitalized in the research departments | Active comparator | each of the elderly in the control group will Listen to random music twice a week for about 40 minutes each time, on personal headphones. Receives: Combination Product: 2gether app used by trained personal |
What is being measured
The primary outcome is the main question the study is designed to answer.
change in BPSD measure among patients in the department. we use the Neuropsychiatric Inventory (NPI) (Cummings et al., 1994.) which detects changes in BPSD.
the measured scale estimates 10 out of 12 common behavioural disorders in Dementia: delusions, hallucinations, depression, anxiety, agitation, aggression, euphoria, inhibitions, irritability or instability, , Abnormal motor activity. A higher score indicates a larger severity of these behaviours. min-0 max-140. The follow-up will be performed by a nurse in both departments on a weekly basis during 8 months of the study.
Measured: 8 month
Secondary outcomes (2)
change in the professional caregivers impression of the treatment
We will use a global improvement subclass. This is a scale of 7 points, "1" - the situation has improved greatly and "7" - the situation has worsened greatly.
Measured: 8 month
change vigor measures of the department's staff (nursing staff)
burnout is a common challenge among caregivers of dementia patients. we use Shirom-Melamed Vigor Measure (SMVM) tool. a 12-item tool with a minimum score indicating a higher incidence of wear.
Measured: 8 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2020
- Study start1 Apr 2020 (estimated)
- Primary completion1 Feb 2021 (estimated)
- Study completion1 Apr 2021 (estimated)
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
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 42 participants (estimated)
Sponsor and investigators
- Lead sponsor
- 2gether
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04293263
- Sponsor's protocol ID
- 001
- Status last verified
- Feb 2020
- First submitted
- 16 Feb 2020
- Last updated
- 4 Mar 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Shared Listening to Personalized Music on Symptoms of Behavioral Disorders in the Elderly With Advanced Dementia
- ClinicalTrials.gov ID
- NCT04293263
- Acronym / sponsor ID
- 001
- Conditions
- Dementia
- Keywords
- music therapy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 42 participants (estimated)
- Lead sponsor
- 2getherIndustry (pharma, biotech, devices)
- Study start
- 1 Apr 2020 (estimated)
- Primary completion
- 1 Feb 2021 (estimated)
- Study completion
- 1 Apr 2021 (estimated)
- First posted
- 3 Mar 2020 (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.
This study is of great importance because it uses a method that has not been tested in the past. To date, various interventions have been examined that use music for patients with dementia. At the same time, no intervention was conducted that integrates an additional person who shares personalized music with the patient.
If the combination of another person who shares the positive effect of the music with the patient is found to enhance the positive effect of the music, it can change the routine of work with dementia patients and may even reduce the use of tranquilizers among them.
In many cases, it has been found that one of the biggest challenges for family members who treat patients with dementia is the lack of content in the sessions and as a result, the growing sense of alienation between the patient and his family.
Listening to music can be a significant tool in the hands of the family, the main caregiver, the medical staff, and any person who comes in contact with the patient, a tool that can strengthen the sense of connection and connection between them.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| MCI patients hospitalised in the research departments | Experimental | Combination Product: 2gether app used by trained personaleach of the elderly in the study group will listen to personalized music twice a week for an hour each time together with a musical partner. Joint listening is performed with 2 pairs of headphones that connect via a splitter to the partner's cell phone. A listening session will take place in a period of 30 minutes and not more than 60 minutes. |
| MCI patients hospitalized in the research departments | Active comparator | Combination Product: 2gether app used by trained personaleach of the elderly in the control group will Listen to random music twice a week for about 40 minutes each time, on personal headphones. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Hospitalized in the Department of Mental Disorders at the Mental Health Center in Be'er Sheva aged 18 and over.
- Patients who have been diagnosed with dementia for the issue.
- Patients whose guardian gave consent for the study.
Key exclusion criteria (1 listed)
- Hearing-impaired patients.
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 |
|---|---|---|
| 2gether app used by trained personalAlso: Listen to random music twice a week for about 40 minutes each time, on personal headphones.each of the elderly in the study group will listen to personalized music twice a week for an hour each time together with a musical partner. Joint listening is performed with 2 pairs of headphones that connect via a splitter to the partner's cell phone. A listening session will take place in a period of 30 minutes and not more than 60 minutes. Musical partner - A person trained in the program's work plan, which includes contact with empathic listening and the use of a dedicated application developed for it. A musical partner will meet with the same elderly person throughout the study period. Empathetic listening - a situation in which a person listens to music with another person, while the music enables contact and deepening the connection between people. | Combination product | MCI patients hospitalised in the research departments, MCI patients hospitalized in the research departments |
Primary outcome
change in BPSD measure among patients in the department. we use the Neuropsychiatric Inventory (NPI) (Cummings et al., 1994.) which detects changes in BPSD.
Time frame: 8 month
the measured scale estimates 10 out of 12 common behavioural disorders in Dementia: delusions, hallucinations, depression, anxiety, agitation, aggression, euphoria, inhibitions, irritability or instability, , Abnormal motor activity. A higher score indicates a larger severity of these behaviours. min-0 max-140. The follow-up will be performed by a nurse in both departments on a weekly basis during 8 months of the study.
2 secondary outcomes
change in the professional caregivers impression of the treatment
Time frame: 8 month
change vigor measures of the department's staff (nursing staff)
Time frame: 8 month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Mar 2020.
- Individual participant dataSharing planned: Undecided
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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.
Questions about this trial
What is this clinical trial studying?
A study testing 2gether app used by trained personal in people with Dementia, run by 2gether.
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 3 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 4 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Oron Azulay, MA (972525402281, oron@2gether.fun), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
change in BPSD measure among patients in the department. we use the Neuropsychiatric Inventory (NPI) (Cummings et al., 1994.) which detects changes in BPSD. (time frame: 8 month). 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 4 Mar 2020.