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

Dementia Clinical Trial

Official title:

Individualized Music Playlist Based on ISO-Principle for De-escalating Agitation of People Living With Dementia: A Randomized Controlled Feasibility Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04236557
• Other study ID #: HSEARS20190731001
• Status: Completed
• Phase: N/A
• Start date: November 1, 2022
• Est. completion date: June 30, 2023

Study information

• Verified date: September 2023
• Source: The Hong Kong Polytechnic University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

2. Methods:

1. Design:

• A two arms randomized controlled feasibility trial.

2. Participants and setting:

• The study participants will be recruited from participating residential care homes for the elderly in Hong Kong.

3. 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.

4. 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.

5. 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

6. Sample size:

• 84 participants

7. Randomization:

• Participants will be randomly assigned to either intervention or control group at 1:1 ratio.

8. 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.

9. 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: June 30, 2023
• Est. primary completion date: June 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 60 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Dementia
• Psychomotor Agitation

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.
• 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.

Locations

Country	Name	City	State
Hong Kong	School of Nursing, The Hong Kong Polytechnic University	Hong Kong

Sponsors (1)

Lead Sponsor	Collaborator
The Hong Kong Polytechnic University

Country where clinical trial is conducted

Hong Kong, 

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* Note: There are 43 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Recruitment rate	The percentage of eligible participants who finally agreed to join the project	At baseline
Primary	Attrition rate	The percentage of recruited participant dropped out from the project prematurely	The 6th week
Primary	Satisfaction rate	Satisfaction of the intervention rated by staff using self-developed rating scale	At the end of the 6th week
Secondary	State of Arousal	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.	During the 6-week study period, before and immediate after listening to the audio when agitated
Secondary	Mood States	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.	During the 6-week study period, before and immediate after listening to the audio when agitated
Secondary	Agitation frequency	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.	Screening, Baseline, at the end of the project (i.e. the 6th week)
Secondary	Behavioural and psychological symptoms of dementia frequency	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.	Screening, Baseline, at the end of the project (i.e. the 6th week)
Secondary	Heart rate	Will be measured with wearable sensor	Continuously during the 6-week study period
Secondary	Agitation Intensity	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.	During the 6-week study period, before and immediate after listening to the audio when agitated