Community Choirs To Promote Healthy Aging And Independence Of Older Adults
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 390
- 试验地点
- 2
- 主要终点
- Physical function
研究概览
简要总结
The investigators will recruit 450 older adults and will utilize 12 Administration on Aging (AoA)-supported senior centers to implement a multisite, cluster randomized (by center), wait-list clinical trial. Centers will be randomized to receive the choir program immediately (intervention group) or after a 6-month delayed intervention phase (control group). The community choirs will be led by professional music directors. The investigators will assess both primary and secondary outcomes at baseline, 6 and 12 months, with the main intervention group comparison being at 6 months. The investigators will also evaluate the start-up and ongoing program costs for senior centers, including cost/person served and determine quality adjusted life years.
The hypotheses are:
- Compared to delayed intervention controls, participation in a community choir program will be associated with improvements/maintenance on the primary outcomes of physical function (balance, walking speed, strength), depressive symptoms, and cognition (executive function and memory) at 6 months. The investigators also predict within-group improvements on these primary outcomes at 12 months.
- Compared to delayed intervention controls, participation in a community choir program will be associated with improvements in the secondary outcomes of well-being (depressive symptoms, loneliness, resilience, social participation, health-related quality of life, shortness of breath, functional status, falls, and health services use) at 6 months. The investigators also predict within-group improvements on these secondary outcomes at 12 months.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
盲法说明
Randomization assignment was not revealed to study personnel or study participants until after baseline assessments were completed for each pair of centers.
入排标准
- 年龄范围
- 60 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age 60 and older
- •Living independently
- •Have adequate visual and auditory acuity (with correction) to complete testing
- •Speak English or Spanish (including both bilingual and monolingual Spanish speakers)
排除标准
- •A baseline diagnosis of dementia, determined by the screening tool or self-report of diagnosis
- •Have an unstable or serious medical condition that would limit participation in the weekly choir sessions or assessments, including current (but not prior) severe psychiatric disorder
- •Currently singing in a choir, within the last 6 months
- •Plans to move out of the area within 12 months
结局指标
主要结局
Physical function
时间窗: up to 12 months
We will measure several physical function outcomes. The Short Physical Performance Battery (SPPB) chair stands will be the primary outcome measure. Baseline, 6 months, 12 months. Additional motor function outcomes using the NIH Toolbox are listed below.
Cognitive Function
时间窗: up to 12 months
We will use the Trailmaking Test as a primary outcome of executive function. Baseline, 6 months, 12 months. Additional tests of executive function and memory are listed as secondary outcomes.
Depressive Symptoms
时间窗: up to 12 months
We will use the Patient Health Questionnaire (PHQ-8) as a primary measure of depressive symptoms. Baseline, 6 months, 12 months. Additional NIH Toolbox Emotion measures are listed as secondary outcomes.
次要结局
- Health Care Services Utilization(up to 12 months)
- Falls(up to 12 months)
- Health-Related Quality of Life(up to 12 months)
- Shortness of breath(up to 12 months)
- Balance and Endurance(up to 12 months)
- Emotion(up to 12 months)
- Memory and Executive Function(up to 12 months)