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Agitated BehavioR of Elderly and Alternative Simple Treatments: Individualized Music – a feasibility and pilot study (the ABrEAST-iM study)

Agitated BehavioR of Elderly and Alternative Simple Treatments: Individualized Music – a feasibility and pilot study (the ABrEAST-iM study)

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN37367520
Enrollment
15
Registered
2019-05-25
Start date
2016-02-15
Completion date
Unknown
Last updated
2020-06-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Older adults living in residential care facilities with diagnosis of mild to moderate dementia Mental and Behavioural Disorders Unspecified dementia

Interventions

The predetermined iM activity/intervention was delivered/implemented by an interventionist (i.e., staff or family) in a private area (e.g., resident room) between 10:00 am to 1:00 pm or 2:00 to 5:00 p

Sponsors

University of Victoria
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Mild to moderate dementia (i.e., a CPS score 2 to 4) using as a proxy of cognitive capability, the Cognitive Performance Scale (CPS) that is part of the Resident Assessment Instrument Minimum Data Set 2.0 (RAI-MDS 2.0) (reference period of seven days) 2. Manifested BPSD, when at least two indicators (e.g., resistance to care, abusiveness, aggressive or socially inappropriate behavior) are present in the last assessment as they are monitored in the RAI-MDS section E4 (i.e., a, b, c, d, e) (reference period of seven days) 3. Lived in the residential care home for at least one month (at the start of the study)

Exclusion criteria

Exclusion criteria: 1. Accompanying diagnosis of manic depressive – bipolar disorder or schizophrenia 2. Living in a hospice care program

Design outcomes

Primary

MeasureTime frame
1. Affect measured through direct observation of facial expression and body movement using Lawton’s Modified Behavior Stream (LMBS), which assesses positive affect (i.e., pleasure, interest, contentment) and negative affect (i.e., sadness, anxiety, anger); observation conducted a) before the iM intervention (for 5 min); b) during (for 10 min); c) immediately after the intervention was complete (for 5 min); and d) 10 min after the intervention was complete (for 5 min). For example, pleasure was noted when the participant smiled, laughed, or showed other outward manifestation of happiness using a 5-point Likert scale (1=never, 2= less than 16 seconds, 3= 17-59 seconds, 4= 1-3 minutes, and 5= more than 3 minutes of the observation time). Also, an option 6= “cannot tell” added for the observer. All affect and behavior measures represent duration (amount of time) and frequency. At the same time, resident behavior (i.e., non-verbal and verbal) was also recorded. 2. Quality of Life (QoL) measured using the Quality of Life–Alzheimer’s Disease Scale (QoL-AD) of 13-item (i.e., physical health, energy, mood, living situation, memory, family, marriage, friends, self as a whole, ability to do chores around the house, ability to do things for fun, money, and life as a whole) survey questionnaire with 4-point (1= poor to 4= excellent) Likert response scales through both self (via interview; about 10 min) and proxy (via family or caregiver self-administered survey; about 5 min) ratings for capturing both perspectives; the score ranges from 13 to 52 points. Measured at baseline and follow-up (after three weeks of the intervention).

Secondary

MeasureTime frame
1. Behavior and psychological symptoms of dementia (BPSD) measured using the Canadian version of the Resident Assessment Inventory Minimum Data Set version 2.0 (RAI-MDS 2.0) and administrative data to capture resident patterns of BPSD: wandering (i.e., E4a), verbally abusive behavior (i.e., E4b), physically abusive behavior (i.e., E4c), socially inappropriate or disruptive behavior (i.e., E4d), and resistance of care (i.e., E4e); and any potential change of them (i.e., E5) at baseline, during the intervention, and follow-up (after three weeks of the intervention). 2. Antipsychotics measured using administrative data (resident charts and nursing records of medications) such as the number, type and dose of medications (e.g., antipsychotics) administered to each resident-participant at baseline, during the intervention, and follow-up (after three weeks of the intervention). 3. Experiences and perceptions of the use of iM intervention recorded via face-to-face, one-on-one semi-structured interviews with family and caregivers in a private space within the facility (e.g., resident room) at baseline and follow-up.

Countries

Canada

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026