Beyond Listening: A Music-based Intervention

August 23, 2022 updated by: MJHS Institute for Innovation in Palliative Care

Beyond Listening: A Music-based Caregiver Intervention

Study will be conducted to determine if caregivers who use music at home will feel less burden and whether the person they are caring for will demonstrate decreased symptoms of dementia. Caregivers will participate in a series of psycho-educational trainings for six weeks. During this time, caregivers will learn how to use singing, music listening and music with movement with their family member. Caregivers should feel less stressed and a decreased sense of burden. The care recipient should appear happier with less occurrences of depression or restlessness.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Our study will incorporate caregivers and their care receivers who are diagnosed with dementia and agitation co-occurring depression. The primary study outcomes are the following: caregiver burden, measured with the Zarit Caregiver Burden Intervention; mood, measured with the Cornell-Brown Scale for Quality of Life; agitation, measured with the Neuropsychiatric Inventory Questionnaire; and focus group and diaries will be used to gain a descriptive account of caregiver experiences of facilitation of music intervention. Assessment time frame is focus group with caregivers, then pre-tests for baseline. Before the first workshop, caregivers will be asked to participate in a focus group with other caregivers.

Following pre-tests and focus group, caregivers will participate in a 6-week classroom workshop including the following topics: adding singing and music with movement to address mood or agitation, music listening to assist with transitions or difficult tasks, implementing background music for compliance during activities of daily living, creating individualized playlists/interventions to address undesirable behaviors, and the use of an MP3 player . The 6-week workshop will take place in person or via Zoom. Potential participants will be asked to meet for an hour, once weekly.

During the workshops, caregivers will be taught music-based interventions that involve adding singing and music with movement to address mood or agitation, music listening to assist with transitions or difficult tasks, background music for compliance and the creation of individualized playlists to address undesirable behaviors.

This psychosocial intervention will teach caregivers to incorporate a music-based intervention. The music-based intervention is a non-invasive program that involves singing, music with movement and music listening.

During these 6 weeks, caregivers will implement the music intervention with the care recipient and document weekly diaries. There will be a 3 month follow up designated for participants to repeat the completion of the questionnaires, Zarit Caregiver Burden Interview, Cornell-Brown Scale for Quality of Life, and Neuropsychiatric Inventory Questionnaire. These questions will be about participants' moods, agitation level or caregiver burden. This information will be collected in person at Menorah from potential caregiver participants. Principal Investigator will call to gather this data from the caregivers.

Study Type

Interventional

Enrollment (Anticipated)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Kendra Ray, PhD
  • Phone Number: 7183687927
  • Email: kray@mjhs.org

Study Locations

  • United States
    • New York
      • Brooklyn, New York, United States, 11235
        • Recruiting
        • Menorah Center for Nursing and Rehabilitation
        • Contact:
          • Kendra Ray, PhD, MPH
          • Phone Number: 7927 718-646-4441
          • Email: kray@mjhs.org
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • A diagnosis of dementia,
  • person with dementia exhibits neuropsychiatric symptoms of dementia such as agitation, restlessness, depressed mood, etc.,
  • A family member or close friend of a person with dementia,
  • Family member must be able to read or write in basic English.

Exclusion Criteria:

  • Diagnosis or history of mental illness
  • Inadequate hearing even with corrective device
  • History of psychosis or other mental disorders other than depression
  • History or presence of substance or alcohol abuse.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Music at home
Caregivers will use Singing, music listening, or moving with music twice a week for 30 minutes with their care recipient.
Behavioral: Music
During attendance at a one hour, 6-week psychosocial classroom or virtual training, caregivers will learn to use singing and other music-based interventions, implementing them each week before the informational session.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from Baseline in the Mean of 12-item Zarit Caregiver Burden Interview at Week 6. The minimum score is 0 and maximum score is 88.
Time Frame: Baseline, week 6 and month three
The Zarit Caregiver Burden is a validated, self-reported instrument assessing personal strain and role strain of family caregiver. Higher scores suggest more caregiver burden.
Baseline, week 6 and month three
Change from Baseline Quality of Life on the 19-item Cornell-Brown Scale for Quality of Life at Week 6. .
Time Frame: Baseline, week 6 and month three
The Cornell-Brown Scale for Quality of Life is a validated measure assessing mood related bi-polar items such as anxiety vs comfort, sadness vs happiness, irritability vs tolerance, etc. for care recipients. This is completed by the caregiver on behalf of the care recipient. The minimum score for this measure is -38 and the maximum score is 38. A higher score indicates higher quality of life.
Baseline, week 6 and month three
Change from baseline symptoms on the 12-item Neuropsychiatric Inventory Questionnaire at Week 6.
Time Frame: Baseline, week 6 and month three
The Neuropsychiatric Inventory Questionnaire is a validated measure completed by the caregiver on behalf of the care recipient assessing neuropsychiatric symptoms and behaviors associated with dementia. The scores range from 0 to 36 for individual symptoms. Higher scores indicate higher degrees of severity. Caregiver distress scores range from 0 to 55 with higher scores indicating higher distress.
Baseline, week 6 and month three

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Qualitative description of usefulness of music intervention
Time Frame: Diaries will be collected at week 6
Caregivers will be asked to keep weekly diaries of their use of music with care recipient.
Diaries will be collected at week 6

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

MJHS Institute for Innovation in Palliative Care

Collaborators

Alzheimer's Association

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 1, 2018

Primary Completion (Anticipated)

July 1, 2023

Study Completion (Anticipated)

July 1, 2023

Study Registration Dates

First Submitted

April 7, 2021

First Submitted That Met QC Criteria

April 7, 2021

First Posted (Actual)

April 9, 2021

Study Record Updates

Last Update Posted (Actual)

August 24, 2022

Last Update Submitted That Met QC Criteria

August 23, 2022

Last Verified

August 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MJHSPalliative

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

IPD Plan Description

All IPD that underlie results in a publication will be shared.

IPD Sharing Time Frame

The study protocol will be available following the study for one year.

IPD Sharing Access Criteria

Individuals interested in accessing the study protocol can reach out to the PI via email at kray@mjhs.org

IPD Sharing Supporting Information Type

  • Study Protocol

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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