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

• 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:

• To evaluate the feasibility of the intervention in terms of recruitment, retention, and acceptability.
• To examine the preliminary effects of the intervention on participants' agitation, stress and emotion as compared to control group.
• To evaluate suitability of outcome assessment instruments.
• Methods:

• Design:

• A two arms randomized controlled feasibility trial.
• Participants and setting:

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

• 84 participants
• Randomization:

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

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