Dementia Clinical Trial
Official 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
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).
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. ;
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