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

NCT ID: NCT06104436

Last Updated: 2024-02-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

81 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-03-01

Study Completion Date

2026-12-31

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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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.

Conditions

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Dementia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

TRIPLE

Caregivers Investigators Outcome Assessors

Study Groups

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Individualized music playlist

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

Group Type EXPERIMENTAL

Individualized music playlist

Intervention Type BEHAVIORAL

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

Usual care

Intervention Type BEHAVIORAL

Usual technique for calming agitated older adults with dementia

Preferred music

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

Group Type ACTIVE_COMPARATOR

Preferred music

Intervention Type BEHAVIORAL

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

Usual care

Intervention Type BEHAVIORAL

Usual technique for calming agitated older adults with dementia

Treatment as usual

Usual care for agitation management.

Group Type SHAM_COMPARATOR

Usual care

Intervention Type BEHAVIORAL

Usual technique for calming agitated older adults with dementia

Interventions

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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.

Intervention Type BEHAVIORAL

Preferred music

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

Intervention Type BEHAVIORAL

Usual care

Usual technique for calming agitated older adults with dementia

Intervention Type BEHAVIORAL

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
Minimum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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The Hong Kong Polytechnic University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Daphne Sze Ki Cheung, PhD

Role: PRINCIPAL_INVESTIGATOR

The Hong Kong Polytechnic University

Locations

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School of Nursing, The Hong Kong Polytechnic University

Hong Kong, , Hong Kong

Site Status

Countries

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Hong Kong

Central Contacts

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Daphne Sze Ki Cheung, PhD

Role: CONTACT

+852 27664534

Daphne Sze Ki Cheung, PhD

Role: CONTACT

+852 27664535

Other Identifiers

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A0047147

Identifier Type: -

Identifier Source: org_study_id

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