Individualized Music Playlist Based on ISO Principle for De-escalation of Agitation in Dementia
Study Details
Study Description
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).
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Detailed Description
- Study design
- Randomized controlled trial
- Participants
- Eighty-one older adults living with dementia and demonstrate significant agitation
- Setting:
- Residential care home
- 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.
- 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
- Outcomes
-
Level of agitation measured with the Pittsburgh Agitation Scale
-
Agitation occurrence frequency measured with Cohen-Mansfield Agitation Inventory
-
Distress of formal caregivers related to agitation measured with Neuropsychiatric Inventory
- 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 Design
Arms and Interventions
| 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: Preferred music
Preferred music is composed of the genres selected by the participants, and to be played at random sequence.
Behavioral: Usual care
Usual technique for calming agitated older adults with dementia
|
| Sham Comparator: Treatment as usual Usual care for agitation management. |
Behavioral: Usual care
Usual technique for calming agitated older adults with dementia
|
Outcome Measures
Primary Outcome Measures
- 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).
- 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.
Secondary Outcome Measures
- 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.
Other Outcome Measures
- Challenges and enablers in the implementation of the intervention [6 weeks]
Semi-structured focus group interviews with the carers will be conducted.
Eligibility Criteria
Criteria
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | School of Nursing, The Hong Kong Polytechnic University | Hong Kong | Hong Kong |
Sponsors and Collaborators
- The Hong Kong Polytechnic University
Investigators
- Principal Investigator: Daphne Sze Ki Cheung, PhD, The Hong Kong Polytechnic University
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- A0047147