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Individualized Music Playlist Based on ISO-Principle for De-escalating Agitation of People Living With Dementia

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: NCT04236557
Recruitment Status : Not yet recruiting
First Posted : January 22, 2020
Last Update Posted : January 22, 2020
Sponsor:
Information provided by (Responsible Party):
Dr Daphne Cheung, The Hong Kong Polytechnic University

Brief Summary:

Abstract:

Agitation is exhibited by almost every dementia patient during the course of illness, and that leads to detrimental consequences on both patients and caregivers. Listening to preferred music is found useful in reducing the agitation frequency of people with dementia. However, the music intervention is usually provided regularly and the music psychotherapy ISO-Principle is ignored in published studies. The ISO-Principle that commonly adopted in music therapy using live-music, suggests that characteristics of music being played (e.g. tempo, melody and lyrics) should match with the current state (e.g. manic/depressive) of the client, and gradually modify these characteristics to the desired state. This randomized feasibility trial aims to evaluate the feasibility of using individualized music playlist with the music genres sequenced according to the ISO-Principle, for de-escalating agitation of people with dementia, and provide preliminary evidence on efficacy.

Eighty-four nursing home residents with agitation will be randomly allocated into music listening or control groups. Acceptability, implementation and practicality, as well as efficacy (in terms of agitation intensity, stress and mood states before and after the de-escalating music intervention or control condition; and occurrence of agitation and other behavioural and psychological symptoms of dementia before and after the 6-week observation period).

Feasibility indicators will be reported descriptively. The efficacy of (1) music listening in de-escalating symptoms and (2) reducing occurrence frequency of symptoms after 6 weeks, will be analysed with Generalized Estimating Equation. If the findings are positive, the intervention have a great potential to be adopted as the gold standard of care in the nursing homes to solve a common yet detrimental clinical problem.


Condition or disease Intervention/treatment Phase
Dementia Behavioral: Music listening Behavioral: Audio Book Listening Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 84 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Individualized Music Playlist Based on ISO-Principle for De-escalating Agitation of People Living With Dementia: A Randomized Controlled Feasibility Study
Estimated Study Start Date : February 2020
Estimated Primary Completion Date : January 2021
Estimated Study Completion Date : December 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Dementia

Arm Intervention/treatment
Experimental: Intervention Behavioral: Music listening
Other than usual care, subjects will listen to a 30-min individualized playlists with preferred music genres sequenced by a registered music therapist according to the ISO-Principle when agitated.

Placebo Comparator: Wait-list Control Behavioral: Audio Book Listening
Other than usual care, subjects will listen to to a 30-min audio-script of book reading in Cantonese (a common dialect in Hong Kong being spoken by most people) when agitated.




Primary Outcome Measures :
  1. Recruitment rate [ Time Frame: At baseline ]
    The percentage of eligible participants who finally agreed to join the project

  2. Attrition rate [ Time Frame: The 6th week ]
    The percentage of recruited participant dropped out from the project prematurely

  3. Satisfaction rate [ Time Frame: At the end of the 6th week ]
    Satisfaction of the intervention rated by staff using self-developed rating scale


Secondary Outcome Measures :
  1. State of Arousal [ Time Frame: During the 6-week study period, before and immediate after listening to the audio when agitated ]
    To be measured with Behavioural Activity Rating Scale (BARS): a single-item question indicating the condition of the participant in 7-point Likert-scale ranging from 1 - difficult or unable to rouse to 7 - violent, requires restraint. The inter-rater reliability was 0.999 and it is found sensitive in capturing the change of agitation after medication.

  2. Mood States [ Time Frame: During the 6-week study period, before and immediate after listening to the audio when agitated ]

    Mood scales derived from Diagnostic and Statistics Manual - Edition V. It consists of 16 items (8 items for negative mood and positive mood, respectively). with a 0-3 point rating on mood severity.

    the total score of subscale (negative and positive mood) will be calculated. Higher score refers to stronger mood observed.


  3. Agitation frequency [ Time Frame: Screening, Baseline, at the end of the project (i.e. the 6th week) ]

    Cohen-Mansfield Agitation Inventory (CMAI) will be used.

    The CMAI is a caregivers' rating questionnaire consisting of 29 agitated behaviors, each rated on a 7-point scale of frequency. Ratings pertain to the two weeks preceding the administration of the CMAI.

    total score of sub-scale of three factors (Aggressive behaviour, physical non-agggressive behviour, and verbal agitted behaviours) will be calculated. A higher score means more frequent agitation.


  4. Behavioural and psychological symptoms of dementia frequency [ Time Frame: Screening, Baseline, at the end of the project (i.e. the 6th week) ]

    The behavioural and psychological symptoms of dementia frequency will be assessed with Neuropsychiatric Inventory Questionnaire (NPI-Q).

    It consists of 12 items covering the following domains: Hallucinations, Delusions, Agitation/aggression, Dysphoria/depression, Anxiety, Irritability, Disinhibition, Euphoria, Apathy, Aberrant motor behavior, Sleep and night-time behavior change, and Appetite and eating change. Each NPI-Q item is rated by the caregiver as 0-3 points according to levels of increasing severity and the score maximums are determined by multiplying the number of items by 3.


  5. Heart rate [ Time Frame: Continuously during the 6-week study period ]
    Will be measured with wearable sensor

  6. Agitation Intensity [ Time Frame: During the 6-week study period, before and immediate after listening to the audio when agitated ]
    To be measured with Positive and Negative Syndrome Scale Excited Component (PANSS-EC). The PANSS-EC consists of 5 items: excitement, tension, hostility, uncooperativeness, and poor impulse control. The 5 items from the PANSS-EC are rated from 1 (not present) to 7 (extremely severe); scores range from 5 to 35; mean scores ≥ 20 clinically correspond to severe agitation. This set of items detects differences between drug and placebo when evaluating acute agitation and aggression in psychiatric patients [5,7-10] with different psychiatric pathologies.



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Ages Eligible for Study:   60 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Nursing home residents with medical diagnosed of any type of dementia; presented with significant agitation in the past two weeks before recruitment;
  • expected to be present in the facility every Monday to Friday during the study period; and
  • Aged 60 or above;

Exclusion Criteria:

  • Nursing home residents who were admitted to the nursing home for less than 3 months;
  • participating in other studies or experimental therapies, or blinded treatments;
  • those with comorbid psychiatric illness such as depression, schizophrenia;
  • or those with uncorrectable hearing impairment.

Notes:

  • Concurrent psychotropic medications over the study period is allowed but any change in the prescriptions will be monitore

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): NCT04236557


Contacts
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Contact: Daphne Sze Ki Cheung, PhD (852)27664534 daphne.cheung@polyu.edu.hk

Locations
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Hong Kong
School of Nursing, The Hong Kong Polytechnic University
Hong Kong, Hong Kong
Contact: Daphne Cheung, PhD    (852)27664534    daphne.cheung@polyu.edu.hk   
Principal Investigator: Xu Bai, PhD         
Sub-Investigator: Wing Leung Daniel Lai, PhD         
Sub-Investigator: Hong Paul Lee, PhD         
Sub-Investigator: Kam Yuk Claudia Lai, PhD         
Sub-Investigator: Hok Man Ken Ho, PhD         
Sponsors and Collaborators
The Hong Kong Polytechnic University
Investigators
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Principal Investigator: Daphne Sze Ki Cheung, PhD School of Nursing, The Hong Kong Polytechnic University
Publications:
Music & Memory. Impact report. New York.: Music & Memory;2017.
Wigram T. A comprehensive guide to music therapy : theory, clinical practice, research, and training. London: Jessica Kingsley Publishers; 2002.
Altshuler IM. FOUR YEARS'EXPERIENCE WITH MUSIC AS A THERAPEUTIC AGENT AT ELOISE HOSPITAL. American Journal of Psychiatry. 1944;100(7):792-794.

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Responsible Party: Dr Daphne Cheung, Assistant Professor, The Hong Kong Polytechnic University
ClinicalTrials.gov Identifier: NCT04236557    
Other Study ID Numbers: HSEARS20190731001
First Posted: January 22, 2020    Key Record Dates
Last Update Posted: January 22, 2020
Last Verified: January 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Dr Daphne Cheung, The Hong Kong Polytechnic University:
Music
Agitation
Dementia
De-escalation
Additional relevant MeSH terms:
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Dementia
Psychomotor Agitation
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Neurocognitive Disorders
Mental Disorders
Dyskinesias
Neurologic Manifestations
Psychomotor Disorders
Neurobehavioral Manifestations