NCT04293263

Brief 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. 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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
42

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Apr 2020

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 16, 2020

Completed
16 days until next milestone

First Posted

Study publicly available on registry

March 3, 2020

Completed
29 days until next milestone

Study Start

First participant enrolled

April 1, 2020

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2021

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2021

Completed
Last Updated

March 4, 2020

Status Verified

February 1, 2020

Enrollment Period

10 months

First QC Date

February 16, 2020

Last Update Submit

March 3, 2020

Conditions

Keywords

music therapy

Outcome Measures

Primary Outcomes (1)

  • 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.

    8 month

Secondary Outcomes (2)

  • change in the professional caregivers impression of the treatment

    8 month

  • change vigor measures of the department's staff (nursing staff)

    8 month

Study Arms (2)

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.

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.

Combination Product: 2gether app used by trained personal

Interventions

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.

Also known as: Listen to random music twice a week for about 40 minutes each time, on personal headphones.
MCI patients hospitalised in the research departmentsMCI patients hospitalized in the research departments

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • Hearing-impaired patients.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Dementia

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNervous System DiseasesNeurocognitive DisordersMental Disorders

Central Study Contacts

Oron Azulay, MA

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 16, 2020

First Posted

March 3, 2020

Study Start

April 1, 2020

Primary Completion

February 1, 2021

Study Completion

April 1, 2021

Last Updated

March 4, 2020

Record last verified: 2020-02