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临床试验/NCT06079216
NCT06079216招募中不适用

Making Connections Thru Music: A Group Music Therapy-Based Intervention for Persons With Dementia

Hopeful Aging4 个研究点 分布在 1 个国家目标入组 196 人开始时间: 2025年12月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
196
试验地点
4
主要终点
Menorah Park Engagement Scale

研究概览

简要总结

Healthcare systems around the world, including within the United States, have long-established shortages of trained caregivers. The American Health Care Association states that "the health care system has experienced a shortage of trained caregivers for critical roles for some time." This scarcity directly impacts the 45,800 Long-Term Care (LTC) communities throughout the U.S.

Concurrent with this staff shortage, more than half of LTC residents have some form of dementia. These two issues create a serious public health concern, since dementia is associated with a variety of behavioral expressions, such as aggression, anxiety, and agitation. Behavioral expressions of dementia can be successfully managed with the use of tailored, psychosocial interventions and communication support. Unfortunately, existing staff shortages make the facilitation of such interventions challenging.

One powerful and often-overlooked approach to ameliorating staffing shortages involves the utilization of retired volunteers to facilitate interventions for persons with dementia (PWD). Based on the nearly universal love of music and a promising pilot study, the product to be developed and tested in this STTR will build upon the combined prior work of the Principal Investigators. Making Connections Thru Music (MCTM), an urgently needed product, will enable retired volunteers to facilitate an evidence-based music and discussion intervention with PWD. MCTM aims to improve engagement, enhance quality of life, and reduce behavioral expressions in PWD. The intervention will consist of two main components: (1) a comprehensive online training course for volunteers, which will provide a general overview of dementia, demonstrate effective communication strategies to use with PWD, and instruct volunteers to effectively facilitate MCTM sessions, and (2) an app containing a structured MCTM intervention protocol and toolkit, which will be the means by which volunteers facilitate MCTM. MCTM will be marketed to LTC communities.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 103 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Volunteers must be aged 55+ and speak/read conversational English.
  • Staff participants must be at least 18 years old, work within a residential care facility participating in the study, and speak and read English.

排除标准

  • Volunteers will be excluded if they are diagnosed with dementia based on self-report and/or if they score 23 or lower on theMini Mental State Exam (MMSE; Folstein et al., 1975). Such a score would be indicative of possible cognitive impairment.
  • Staff members will be excluded if they work third shift only. PWD Residents with dementia must be diagnosed with dementia (any type), score 10 or above on the MMSE, be aged 65+, and speak/read conversational English.
  • PWD will be excluded if they show signs of rapid physical or cognitive decline (based upon staff report or as evidenced by information gained during screening).

研究组 & 干预措施

MCTM Intervention

Experimental

Activity sessions will be led by activity volunteers

干预措施: Volunteer Led Making Connections Thru Music (Behavioral)

Control

Active Comparator

Activity sessions will be led by activity professionals

干预措施: Staff Led Making Connections Thru Music (Behavioral)

结局指标

主要结局

Menorah Park Engagement Scale

时间窗: Baseline (weeks 1-4) Treatment (weeks 5-12)

The MPES is an observational scale that measures four types of engagement: Constructive Engagement, Passive Engagement, Distracted Engagement, and Non-Engagement / Apathy The MPES also measures Pleasure, defined as clearly observable smiling or laughing. For each item, the minimum possible value is 0 (not at all) and the maximum possible value is 2 (more than half of the time). For Constructive Engagement, Passive Engagement, and Pleasure, higher scores would represent a better outcome. For Distracted Engagement and Non-Engagement, higher scores would represent a worse outcome.

次要结局

  • Alzheimer's Disease Knowledge Scale(Baseline (weeks 1-4) Treatment (weeks 5-12))
  • Neuropsychiatric Inventory - Nursing Home.(Baseline (weeks 1-4) Treatment (weeks 5-12))
  • Geriatric Depression Scale- Short Form. Scores can range from zero to 15. Higher scores suggest a worse outcome(Baseline (weeks 1-4) Treatment (weeks 5-12))

研究者

发起方
Hopeful Aging
申办方类型
Industry
责任方
Principal Investigator
主要研究者

Gregg Gorzelle

Associate Director of Research

Hopeful Aging

研究点 (4)

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