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

Not Applicable

Not yet recruiting

• Conditions: Dementia

• Registration Number: NCT06104436
• Lead Sponsor: The Hong Kong Polytechnic University

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).

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 Timeline

• Status Verified: 2023-09
• Study First Submitted: 2023-09-28
• Study First Submitted QC: 2023-10-26
• Study First Posted: 2023-10-27
• Last Update Submitted: 2024-02-27
• Last Update Posted: 2024-02-28
• Study Start: 2024-03-01
• Primary Completion: 2025-12-31
• Study Completion: 2026-12-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 81

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Agitation status	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.
Level of agitation	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.
Intensity of agitation	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).

Secondary Outcome Measures

Name	Time	Method
Agitation occurrence	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.
Emotional or psychological distress of carer	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.

Trial Locations

Locations (1)

School of Nursing, The Hong Kong Polytechnic University; 🇭🇰 Hong Kong, Hong Kong