Music & MEmory: A Pragmatic TRial for Nursing Home Residents With ALzheimer's Disease
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 990
- 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, music is preloaded on personalized music devices to increase nursing use of the music with residents. Details of the first parallel trial conducted under this funding mechanism are registered under "R33AG057451_part1."**
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
Principal investigator is blinded to allocation 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 a dementia diagnosis
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
Usual Care
Usual care for managing agitated and/or aggressive behaviors in the nursing home setting
Music & 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 at early signs of agitation
干预措施: Music & Memory (Behavioral)
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 (CMAI). Research staff interview nursing staff who know the resident well to ask how frequently 29 agitated/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 CMAI range from 29 to 203, with higher scores representing more frequent agitated/aggressive behaviors. The CMAI is administered at baseline and follow-up.
次要结局
- Frequency of Agitated and Aggressive Behaviors (Administrative Data)(4 months)
- Antipsychotic Use(4 months)
- Antianxietal Use(4 months)
- Antidepressant Use(4 months)
- Hypnotic Use(4 months)
- Depression(4 months)
研究者
Vincent Mor
Florence Pirce Grant University Professor, Professor of Health Services, Policy and Practice
Brown University