Clinical trial NCT01869179: Community Choirs To Promote Healthy Aging; Community of Voices Chorus
Official title: Community Choirs To Promote Healthy Aging And Independence Of Older Adults
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Well Being
Keywords: Well being
Low income
Choir singing
Spanish speaking
Community based
Seniors
60+ aged adults
health disparities
Lead sponsor: University of California, San Francisco
Sponsor class: OTHER
Collaborators: name: San Francisco Community Music Center
name: Department of Aging and Adults Services San Francisco
First posted: 2013-06-05
Enrollment: 390
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Cluster-randomized controlled design
Primary purpose: OTHER

Brief summary: 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:

1. 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.
2. 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.


Eligibility criteria: Inclusion Criteria:

* 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)

Exclusion Criteria:

* 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

Primary outcomes:
measure: Physical function
timeFrame: up to 12 months
measure: Cognitive Function
timeFrame: up to 12 months
measure: Depressive Symptoms
timeFrame: up to 12 months
Secondary outcomes:
measure: Health-Related Quality of Life
timeFrame: up to 12 months
measure: Health Care Services Utilization
timeFrame: up to 12 months
measure: Falls
timeFrame: up to 12 months
measure: Shortness of breath
timeFrame: up to 12 months
measure: Balance and Endurance
timeFrame: up to 12 months
measure: Memory and Executive Function
timeFrame: up to 12 months
measure: Emotion
timeFrame: up to 12 months
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: UCSF Institute for Health & Aging
state: California
Study officials:
affiliation: University of California, San Francisco
name: Julene K Johnson, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Johnson JK, Napoles AM, Stewart AL, Max WB, Santoyo-Olsson J, Freyre R, Allison TA, Gregorich SE. Study protocol for a cluster randomized trial of the Community of Voices choir intervention to promote the health and well-being of diverse older adults. BMC Public Health. 2015 Oct 13;15:1049. doi: 10.1186/s12889-015-2395-9.
citation: Johnson JK, Gregorich SE, Acree M, Napoles AM, Flatt JD, Pounds D, Pabst A, Stewart AL. Recruitment and baseline characteristics of the Community of Voices choir study to promote the health and well-being of diverse older adults. Contemp Clin Trials Commun. 2017 Dec;8:106-113. doi: 10.1016/j.conctc.2017.09.006. Epub 2017 Sep 17.
citation: Johnson JK, Stewart AL, Acree M, Napoles AM, Flatt JD, Max WB, Gregorich SE. A Community Choir Intervention to Promote Well-Being Among Diverse Older Adults: Results From the Community of Voices Trial. J Gerontol B Psychol Sci Soc Sci. 2020 Feb 14;75(3):549-559. doi: 10.1093/geronb/gby132.
citation: Allison TA, Napoles AM, Johnson JK, Stewart AL, Rodriguez-Salazar M, Peringer J, Sherman S, Ortez-Alfaro J, Villero O, Portacolone E. Multi-cultural perspectives on group singing among diverse older adults. Geriatr Nurs. 2020 Nov-Dec;41(6):1006-1012. doi: 10.1016/j.gerinurse.2020.07.011. Epub 2020 Aug 8.