Individualized Music Playlist Based on ISO Principle for De-escalation of Agitation in Dementia

Study Overview
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Brief Summary
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The goal of this clinical trial is to evaluate the efficacy of an Individualized Music Playlist (InMP) composed of preferred music genres sequenced according to the ISO-Principle, for the immediate de-escalation of agitation in dementia, compared with preferred music (PM) and treatment as usual (TAU).

Detailed Description
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Study design - Randomized controlled trial Participants - Eighty-one older adults living with dementia and demonstrate significant agitation Setting: - Residential care home Intervention - Individualized music listening intervention played with an iPad and a wireless neckband speaker for 30 minutes when agitation begins in addition to usual care. Comparison conditions Preferred music listening group: Preferred music listening played with an iPad and a wireless neckband speaker for 30 minutes when agitation begins in addition to usual care. Usual care group: usual care Outcomes Level of agitation measured with the Pittsburgh Agitation Scale Agitation occurrence frequency measured with Cohen-Mansfield Agitation Inventory Distress of formal caregivers related to agitation measured with Neuropsychiatric Inventory Focus group interviews with the care staff will be conducted as a process evaluation for identifying the potential facilitators and barriers related to implementation.

Official Title
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The Effects of an Individualized Music Playlist Based on the ISOPrinciple for the Immediate De-escalation of Agitation in People With Dementia: a Randomized Controlled Trial

Conditions
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Dementia

Intervention / Treatment
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* Behavioral: Individualized music playlist
* Behavioral: Preferred music
* Behavioral: Usual care


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: residents in long-term care facilities diagnosed with any type of dementia presented with significant agitation Exclusion Criteria: had been admitted to the facility for less than three months are participating in other studies or experimental therapies have a comorbid psychiatric illness have physical illness that prevents them from listening to music

Ages Eligible for Study
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Minimum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Individualized music playlist<br>Composed of preferred music genres sequenced according to the ISO-Principle in addition to usual care. | Behavioral: Individualized music playlist<br>* Individualized music playlist composed of preferred music genres sequenced according to the ISO-Principle. It will be played at the state of agitation.<br>Behavioral: Usual care<br>* Usual technique for calming agitated older adults with dementia<br>|
| Active Comparator: Preferred music<br>Preferred music genres played in random sequence in addition to usual care. | Behavioral: Preferred music<br>* Preferred music is composed of the genres selected by the participants, and to be played at random sequence.<br>Behavioral: Usual care<br>* Usual technique for calming agitated older adults with dementia<br>|
| Sham Comparator: Treatment as usual<br>Usual care for agitation management. | Behavioral: Usual care<br>* Usual technique for calming agitated older adults with dementia<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Level of agitation | Positive and Negative Syndrome Scale - Excitatory Component will be used for assessing the level of agitation. It 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. | 6 weeks | 
| Intensity of agitation | Pittsburgh Agitation Scale will be used to assess the intensity of agitation. It is a brief measure of agitation that measures the severity of agitation in four general categories: aberrant vocalisation, motor agitation, aggressiveness and resisting care, on a scale from 0 (not present) to 4 (highest level). | 6 weeks | 
| Agitation status | Behavioural Activity Rating Scale will be used to assess the agitation status. It contains a single-item question consisting of seven categories: 1=difficult or unable to rouse; 2=asleep, but responds normally to verbal or physical contact; 3=drowsy, appears sedated; 4=quiet and awake (normal level of activity); 5=signs of overt (physical or verbal) activity, calms down with instruction; 6=extremely or continuously active, not requiring restraint; 7=violent, requires restraint. | 6 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Agitation occurrence | Cohen-Mansfield Agitation Inventory will be used to assess the agitation occurence. A total CMAI score is obtained by summing all the individual items, giving a range from 29 to 203. A total score of >45 is usually regarded as clinically significant agitation. | 6 weeks | 
| Emotional or psychological distress of carer | Neuropsychiatry Inventory Questionnaire will be used to assess the distress of caregivers. Caregiver distress is rated for each positive neuropsychiatric symptom domain on a scale anchored by scores from 0 to 5 points (0=no distress; 1=minimal distress; 2=mild distress; 3=moderate distress; 4=severe distress; and 5=very severe distress), giving a maximum score of 60. | 6 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Dementia, Agitation, Music