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

Sponsor
The Hong Kong Polytechnic University (Other)
Overall Status
Unknown status
CT.gov ID
NCT04236557
Collaborator
(none)
84
Enrollment
1
Location
2
Arms
22
Anticipated Duration (Months)
3.8
Patients Per Site Per Month

Study Details

Study Description

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
  • Behavioral: Music listening
  • Behavioral: Audio Book Listening
 N/A

Detailed Description

  1. Aims and objectives:

This study is to evaluate the feasibility of the individualized music playlist based on ISO-Principle for de-escalating agitation of nursing home residents living with dementia.

Objectives are as below:

  1. To evaluate the feasibility of the intervention in terms of recruitment, retention, and acceptability.

  2. To examine the preliminary effects of the intervention on participants' agitation, stress and emotion as compared to control group.

  3. To evaluate suitability of outcome assessment instruments.

  4. Methods:

  5. Design:

  • A two arms randomized controlled feasibility trial.
  1. Participants and setting:
  • The study participants will be recruited from participating residential care homes for the elderly in Hong Kong.
  1. Intervention group
  • Will receive usual care and a 30-minute personalized playlist with the preferred music sequenced according to ISO-Principle will be provided when the participant become agitated during the 6-week project period.
  1. Control group
  • Will receive usual care and a 30-minute audio recording of book reading wen the participant become agitated during the 6-week project period. They will receive a personalized playlist with the preferred music sequenced according to ISO-Principle when all the data collection is done.
  1. Outcomes:

  • recruitment rate, attrition rate, acceptability (field observation, comments from staffs), practicality (adherence to the intervention protocol), and any adverse reactions.

  • agitation severity (Behavioural Activity Rating Scale, Positive and Negative Syndrome Scale Excited Component), heart rate, emotional states (Mood scales derived from DSM-V), before and after listening to the playlist

  • agitation frequency (Cohen-Mansfield Agitation Inventory) and behavioral and psychological symptoms of dementia frequency (Neuropsychiatric Inventory- Questionnaire), at baseline and after 6 weeks

  1. Sample size:
  • 84 participants
  1. Randomization:
  • Participants will be randomly assigned to either intervention or control group at 1:1 ratio.
  1. Data analysis strategies:

  • Descriptive statistics will be used to report the feasibility indicators.

  • The treatment effect on agitation intensity, stress and mood as compared to control group before and after listening to music or control condition for 30 minutes during agitated state, will be analysed using Generalized Estimating Equation (GEE) method.

  • For evaluating the efficacy of music listening in reducing the occurrence frequency of agitation and other behavioural and psychological symptoms of dementia, the scores at baseline and post-intervention (i.e. after 6 weeks) between two groups will be analysed with Mixed ANOVA.

  • Significance level is set at p<.05 with 95% Confidence Interval.

  1. Ethical consideration:

Ethics approval will be obtained from the University before recruiting the participants. Proxies and participants will be informed about the possible risks and benefits of the participation, and it is voluntary and free to withdraw at any time. Procedural consent will be sought too.

Study Design

Study Type:
Interventional
Anticipated 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
Anticipated Study Start Date :
Feb 1, 2020
Anticipated Primary Completion Date :
Jan 1, 2021
Anticipated Study Completion Date :
Dec 1, 2021

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

  1. Recruitment rate [At baseline]

    The percentage of eligible participants who finally agreed to join the project

  2. Attrition rate [The 6th week]

    The percentage of recruited participant dropped out from the project prematurely

  3. Satisfaction rate [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 [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 [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 [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 [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 [Continuously during the 6-week study period]

    Will be measured with wearable sensor

  6. Agitation Intensity [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
60 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 School of Nursing, The Hong Kong Polytechnic University Hong Kong Hong Kong

Sponsors and Collaborators

  • The Hong Kong Polytechnic University

Investigators

  • Principal Investigator: Daphne Sze Ki Cheung, PhD, School of Nursing, The Hong Kong Polytechnic University

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Dr Daphne Cheung, Assistant Professor, The Hong Kong Polytechnic University
ClinicalTrials.gov Identifier:
NCT04236557
Other Study ID Numbers:
  • HSEARS20190731001
First Posted:
Jan 22, 2020
Last Update Posted:
Jan 22, 2020
Last Verified:
Jan 1, 2020
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Dr Daphne Cheung, Assistant Professor, The Hong Kong Polytechnic University
Music
Agitation
Dementia
De-escalation
Additional relevant MeSH terms:
Dementia
Psychomotor Agitation

Study Results

No Results Posted as of Jan 22, 2020