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NCT Number: NCT06104436

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

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).

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Key information

Conditions

Dementia Aberrant Motor Behavior in Dementia Behavior Behavioral Symptoms Brain Diseases Central Nervous System Diseases Dyskinesias Mental Disorders Nervous System Diseases Neurobehavioral Manifestations Neurocognitive Disorders Neurologic Manifestations Pathological Conditions, Signs and Symptoms Psychomotor Agitation Psychomotor Disorders Signs and Symptoms

Age range

50 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

School of Nursing, The Hong Kong Polytechnic University

Hong Kong

About this study

  • 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
  • Intensity of agitation measured with the Positive and Negative Syndrome Scale - Excited Component
  • 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Individualized music playlist

Behavioral

Individualized music playlist composed of preferred music genres sequenced according to the ISO-Principle. It will be played at the state of agitation.

Preferred music

Behavioral

Preferred music is composed of the genres selected by the participants, and to be played at random sequence.

Usual Care

Behavioral

Usual technique for calming agitated older adults with dementia

Primary outcomes

  1. Level of agitation

    Time frame: 6 weeks

    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.

  2. Intensity of agitation

    Time frame: 6 weeks

    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).

  3. Agitation status

    Time frame: 6 weeks

    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.

Secondary outcomes

  1. Agitation occurrence

    Time frame: 6 weeks

    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.

  2. Emotional or psychological distress of carer

    Time frame: 6 weeks

    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.

Other outcomes

  1. Challenges and enablers in the implementation of the intervention

    Time frame: 6 weeks

    Semi-structured focus group interviews with the carers will be conducted.

Study contacts

Contact information is provided by the study sponsor or research team.

Daphne Sze Ki Cheung, PhD

CONTACT

[email protected]

+852 27664534

Daphne Sze Ki Cheung, PhD

CONTACT

[email protected]

+852 27664535

Sponsors and collaborators

Lead sponsor

The Hong Kong Polytechnic University

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2025
Study completion
2026
First posted
Oct 27, 2023
Registry last updated
Feb 28, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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