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

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

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).

Study Overview

• Status: Not yet recruiting
• Conditions: Dementia
• Intervention / Treatment: Behavioral: Individualized music playlist; Behavioral: Usual care; Behavioral: Preferred music

Detailed Description

1. Study design

   - Randomized controlled trial

2. Participants

   - Eighty-one older adults living with dementia and demonstrate significant agitation

3. Setting:

   - Residential care home

4. 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.

5. 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

6. 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
7. Focus group interviews with the care staff will be conducted as a process evaluation for identifying the potential facilitators and barriers related to implementation.

• Study Type: Interventional
• Enrollment (Estimated): 81
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Daphne Sze Ki Cheung, PhD; Phone Number: +852 27664534; Email: daphne.cheung@polyu.edu.hk
• Study Contact Backup: Name: Daphne Sze Ki Cheung, PhD; Phone Number: +852 27664535; Email: daphne.s.k.cheung@gmail.com

Study Locations

• Hong Kong
  • Hong Kong, Hong Kong
    • School of Nursing, The Hong Kong Polytechnic University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

3

Arms and Interventions

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

What is the study measuring?

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Challenges and enablers in the implementation of the intervention	Semi-structured focus group interviews with the carers will be conducted.	6 weeks

Collaborators and Investigators

• Sponsor: The Hong Kong Polytechnic University
• Investigators: Principal Investigator: Daphne Sze Ki Cheung, PhD, The Hong Kong Polytechnic University

Study record dates

Study Major Dates

• Study Start (Estimated): March 1, 2024
• Primary Completion (Estimated): December 31, 2025
• Study Completion (Estimated): December 31, 2026

Study Registration Dates

• First Submitted: September 28, 2023
• First Submitted That Met QC Criteria: October 26, 2023
• First Posted (Actual): October 27, 2023

Study Record Updates

• Last Update Posted (Actual): February 28, 2024
• Last Update Submitted That Met QC Criteria: February 27, 2024
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Keywords: Dementia; Agitation; Music
• Additional Relevant MeSH Terms: Mental Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurologic Manifestations; Neurobehavioral Manifestations; Neurocognitive Disorders; Dyskinesias; Psychomotor Disorders; Psychomotor Agitation; Dementia
• Other Study ID Numbers: A0047147

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No