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Beyond Listening: A Music-based Intervention

Primary Purpose

Alzheimer's Disease (Incl Subtypes), Depressive Symptoms

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Music
Sponsored by
MJHS Institute for Innovation in Palliative Care
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Alzheimer's Disease (Incl Subtypes) focused on measuring 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

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)FemaleAccepts Healthy Volunteers

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.

Sites / Locations

  • Menorah Center for Nursing and RehabilitationRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Music at home

Arm Description

Caregivers will use Singing, music listening, or moving with music twice a week for 30 minutes with their care recipient.

Outcomes

Primary Outcome Measures

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.
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.
Change from Baseline Quality of Life on the 19-item Cornell-Brown Scale for Quality of Life at Week 6. .
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.
Change from baseline symptoms on the 12-item Neuropsychiatric Inventory Questionnaire at Week 6.
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

Qualitative description of usefulness of music intervention
Caregivers will be asked to keep weekly diaries of their use of music with care recipient.

Full Information

First Posted
April 7, 2021
Last Updated
August 23, 2022
Sponsor
MJHS Institute for Innovation in Palliative Care
Collaborators
Alzheimer's Association
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1. Study Identification

Unique Protocol Identification Number
NCT04840173
Brief Title
Beyond Listening: A Music-based Intervention
Official Title
Beyond Listening: A Music-based Caregiver Intervention
Study Type
Interventional

2. Study Status

Record Verification Date
August 2022
Overall Recruitment Status
Recruiting
Study Start Date
August 1, 2018 (Actual)
Primary Completion Date
July 1, 2023 (Anticipated)
Study Completion Date
July 1, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
MJHS Institute for Innovation in Palliative Care
Collaborators
Alzheimer's Association

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alzheimer's Disease (Incl Subtypes), Depressive Symptoms
Keywords
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

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Music at home
Arm Type
Experimental
Arm Description
Caregivers will use Singing, music listening, or moving with music twice a week for 30 minutes with their care recipient.
Intervention Type
Behavioral
Intervention Name(s)
Music
Intervention Description
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 Measure Information:
Title
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.
Description
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.
Time Frame
Baseline, week 6 and month three
Title
Change from Baseline Quality of Life on the 19-item Cornell-Brown Scale for Quality of Life at Week 6. .
Description
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.
Time Frame
Baseline, week 6 and month three
Title
Change from baseline symptoms on the 12-item Neuropsychiatric Inventory Questionnaire at Week 6.
Description
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.
Time Frame
Baseline, week 6 and month three
Secondary Outcome Measure Information:
Title
Qualitative description of usefulness of music intervention
Description
Caregivers will be asked to keep weekly diaries of their use of music with care recipient.
Time Frame
Diaries will be collected at week 6

10. Eligibility

Sex
Female
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Kendra Ray, PhD
Phone
7183687927
Email
kray@mjhs.org
Facility Information:
Facility Name
Menorah Center for Nursing and Rehabilitation
City
Brooklyn
State/Province
New York
ZIP/Postal Code
11235
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kendra Ray, PhD, MPH
Phone
718-646-4441
Ext
7927
Email
kray@mjhs.org
First Name & Middle Initial & Last Name & Degree
Marion Kaiser, MS
Phone
7186464441
Email
mkaiser@mjhs.org

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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
Citations:
PubMed Identifier
17997624
Citation
Ziv N, Granot A, Hai S, Dassa A, Haimov I. The effect of background stimulative music on behavior in Alzheimer's patients. J Music Ther. 2007 Winter;44(4):329-43. doi: 10.1093/jmt/44.4.329.
Results Reference
background
PubMed Identifier
24175165
Citation
Gerdner LA. Individualized music for dementia: Evolution and application of evidence-based protocol. World J Psychiatry. 2012 Apr 22;2(2):26-32. doi: 10.5498/wjp.v2.i2.26.
Results Reference
result
PubMed Identifier
11001602
Citation
Kaufer DI, Cummings JL, Ketchel P, Smith V, MacMillan A, Shelley T, Lopez OL, DeKosky ST. Validation of the NPI-Q, a brief clinical form of the Neuropsychiatric Inventory. J Neuropsychiatry Clin Neurosci. 2000 Spring;12(2):233-9. doi: 10.1176/jnp.12.2.233.
Results Reference
result
PubMed Identifier
26519453
Citation
Ray KD, Mittelman MS. Music therapy: A nonpharmacological approach to the care of agitation and depressive symptoms for nursing home residents with dementia. Dementia (London). 2017 Aug;16(6):689-710. doi: 10.1177/1471301215613779. Epub 2015 Oct 29.
Results Reference
result
PubMed Identifier
12040306
Citation
Ready RE, Ott BR, Grace J, Fernandez I. The Cornell-Brown Scale for Quality of Life in dementia. Alzheimer Dis Assoc Disord. 2002 Apr-Jun;16(2):109-15. doi: 10.1097/00002093-200204000-00008.
Results Reference
result
PubMed Identifier
24009169
Citation
Sarkamo T, Tervaniemi M, Laitinen S, Numminen A, Kurki M, Johnson JK, Rantanen P. Cognitive, emotional, and social benefits of regular musical activities in early dementia: randomized controlled study. Gerontologist. 2014 Aug;54(4):634-50. doi: 10.1093/geront/gnt100. Epub 2013 Sep 5.
Results Reference
result
PubMed Identifier
7203086
Citation
Zarit SH, Reever KE, Bach-Peterson J. Relatives of the impaired elderly: correlates of feelings of burden. Gerontologist. 1980 Dec;20(6):649-55. doi: 10.1093/geront/20.6.649. No abstract available.
Results Reference
result

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Beyond Listening: A Music-based Intervention

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