Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Beyond Listening: A Music-based Intervention

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04840173
Recruitment Status : Recruiting
First Posted : April 9, 2021
Last Update Posted : April 14, 2021
Sponsor:
Collaborator:
Alzheimer's Association
Information provided by (Responsible Party):
MJHS Institute for Innovation in Palliative Care

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Alzheimer's Disease (Incl Subtypes) Depressive Symptoms Behavioral: Music Not Applicable

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Beyond Listening: A Music-based Caregiver Intervention
Actual Study Start Date : August 1, 2018
Estimated Primary Completion Date : March 1, 2022
Estimated Study Completion Date : March 1, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Caregivers

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.




Primary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.


Secondary Outcome Measures :
  1. 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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04840173


Contacts
Layout table for location contacts
Contact: Kendra Ray, PhD 7183687927 kray@mjhs.org

Locations
Layout table for location information
United States, New York
Menorah Center for Nursing and Rehabilitation Recruiting
Brooklyn, New York, United States, 11235
Contact: Kendra Ray, PhD, MPH    718-646-4441 ext 7927    kray@mjhs.org   
Contact: Marion Kaiser, MS    7186464441    mkaiser@mjhs.org   
Sponsors and Collaborators
MJHS Institute for Innovation in Palliative Care
Alzheimer's Association
Publications of Results:
Other Publications:
Layout table for additonal information
Responsible Party: MJHS Institute for Innovation in Palliative Care
ClinicalTrials.gov Identifier: NCT04840173    
Other Study ID Numbers: MJHSPalliative
First Posted: April 9, 2021    Key Record Dates
Last Update Posted: April 14, 2021
Last Verified: April 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: All IPD that underlie results in a publication will be shared.
Supporting Materials: Study Protocol
Time Frame: The study protocol will be available following the study for one year.
Access Criteria: Individuals interested in accessing the study protocol can reach out to the PI via email at kray@mjhs.org

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by MJHS Institute for Innovation in Palliative Care:
Music Therapy
Music Interventions
Caregiver Singing
Family Caregivers
Dementia
Alzheimer's Disease
ADRD
Neuropsychiatric symptoms
Therapeutic music
Non-pharmacological interventions
Creative arts therapy
Vascular dementia
Behavioral and Psychological symptoms of dementia
Caregiver Burden
Depression
Agitation
Mood
Pleasure
Additional relevant MeSH terms:
Layout table for MeSH terms
Alzheimer Disease
Depression
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Tauopathies
Neurodegenerative Diseases
Neurocognitive Disorders
Mental Disorders
Behavioral Symptoms