Music & MEmory: A Pragmatic TRial for Nursing Home Residents With ALzheimer's Disease_part1
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 1,073
- 试验地点
- 4
- 主要终点
- Frequency of Agitated and Aggressive Behaviors (Staff Report)
研究概览
简要总结
The purpose of this trial is to test the effects of a personalized music intervention (Music and Memory, Inc.) on agitated and aggressive behaviors for nursing home residents with dementia.
详细描述
The purpose of this study is to conduct a parallel, pragmatic, cluster randomized control trial of personalized music (Music and Memory) for nursing home residents with moderate to severe dementia living in 54 nursing homes (27 treatment, 27 control) from 4 nursing home corporations. Music and Memory is a personalized music program that uses portable music players to deliver individualized music to people with dementia at times when agitated behaviors are likely.
**This funding mechanism sponsored two parallel trials with different implementation strategies. In this trial, nursing home staff identify the music a resident with dementia may have preferred when s/he was young by asking family members and testing individual songs with the resident. Details of the second parallel trial conducted under this funding mechanism are registered under "R33AG057451_part2."**
The aims of this study are: 1. To use a train-the-trainer model to implement the intervention with ongoing monitoring of the program's adoption and acceptance by nursing home residents with dementia; 2. To estimate the impact of Music and Memory on agitated and aggressive behaviors; and 3. To examine factors associated with variation in providers' adherence to the implementation of Music and Memory.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (Investigator)
盲法说明
The principal investigator is blinded to random assignment of nursing homes to treatment or control conditions
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •for Nursing Homes:
- •Owned by partnering health care corporations
- •Medicare / Medicaid-certified
- •Have at least 20 eligible residents
- •Inclusion Criteria for Residents in Eligible Nursing Homes
- •Reside in eligible nursing home for last 90 days
- •Have advanced dementia, defined by the presence of a dementia diagnosis and moderately or severely impaired daily decision-making
排除标准
- •for Nursing Homes:
- •recent situations that may affect implementation (for example, bad state or federal quality assurance surveys, leadership turnover, or other competing demands)
- •previous use of Music and Memory
- •Exclusion Criteria for Residents in Eligible Nursing Homes:
- •dislikes music
- •completely deaf
研究组 & 干预措施
Music and Memory
Music and Memory is a personalized music program in which nursing home staff provide people with dementia with music playlists tailored to their personal history of music preferences.
干预措施: Music and Memory (Behavioral)
Usual Care
Usual care for managing agitated and/or aggressive behaviors in the nursing home setting.
结局指标
主要结局
Frequency of Agitated and Aggressive Behaviors (Staff Report)
时间窗: 4-months
The tool used to interview staff about resident behaviors is the Cohen-Mansfield Agitation Inventory. Research staff interview a nursing staff member who knows the resident well to ask how frequently 29 agitated and/or aggressive behaviors occurred in the past week. There are seven response choices for each item, anchored from never (1) to several times per hour (7). Total scores on the Cohen-Mansfield Agitation Inventory range from 29 to 203, with higher scores representing more frequent agitated and/or aggressive behaviors. Adjusted mean overall scores will be compared for treatment and control populations.
次要结局
- Frequency of Verbal Agitated and Aggressive Behaviors (Direct Observation)(4-months)
- Antipsychotic Use(4-months)
- Depression(4-months)
- Frequency of Physical Agitated and Aggressive Behaviors (Direct Observation)(4-months)
- Hypnotic Use(4-months)
- Frequency of Agitated and Aggressive Behaviors (Administrative Data)(4-months)
- Antianxietal Use(4-months)
- Antidepressant Use(4-months)
- Observed Pleasure(4-months)
- Observed Anger(4-months)
- Observed Sadness(4-months)
- Observed Alertness(4-months)
- Observed Anxiety(4-months)
研究者
Vincent Mor
Florence Pirce Grant University Professor, Professor of Health Services, Policy and Practice
Brown University