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

NCT06104436 | Not Yet Recruiting DMC

• 1 other identifier: A0047147
• Study Type: interventional
• Target: 81
• Locations: 1 country
• Sites: 1

Brief Summary

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).

Conditions

Dementia

Keywords

Dementia; Agitation; Music

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (2)

• Agitation occurrence

  6 weeks

• Emotional or psychological distress of carer

  6 weeks

Other Outcomes (1)

• Challenges and enablers in the implementation of the intervention

  6 weeks

Study Arms (3)

Individualized music playlist

EXPERIMENTAL

Composed of preferred music genres sequenced according to the ISO-Principle in addition to usual care.

Behavioral: Individualized music playlist; Behavioral: Usual care

Preferred music

ACTIVE COMPARATOR

Preferred music genres played in random sequence in addition to usual care.

Behavioral: Preferred music; Behavioral: Usual care

Treatment as usual

SHAM COMPARATOR

Usual care for agitation management.

Behavioral: Usual care

Interventions

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.

Individualized music playlist

Preferred music BEHAVIORAL

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

Preferred music

Usual care BEHAVIORAL

Usual technique for calming agitated older adults with dementia

Individualized music playlist; Preferred music; Treatment as usual

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• residents in long-term care facilities
• diagnosed with any type of dementia
• presented with significant agitation

You may not qualify if:

• 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

Sponsors & Collaborators

• The Hong Kong Polytechnic University: lead

Study Sites (1)

School of Nursing, The Hong Kong Polytechnic University

Hong Kong, Hong Kong

Location

MeSH Terms

Conditions

Dementia; Psychomotor Agitation

Condition Hierarchy (Ancestors)

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

Study Officials

• Daphne Sze Ki Cheung, PhD

  The Hong Kong Polytechnic University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Daphne Sze Ki Cheung, PhD

CONTACT

+852 27664534; daphne.cheung@polyu.edu.hk

Daphne Sze Ki Cheung, PhD

CONTACT

+852 27664535; daphne.s.k.cheung@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 28, 2023
• First Posted: October 27, 2023
• Study Start: March 1, 2024
• Primary Completion: December 31, 2025
• Study Completion (Estimated): December 31, 2026
• Last Updated: February 28, 2024

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share

Locations

HK (1)