Community Choirs To Promote Healthy Aging; Community of Voices Chorus
COV
1 other identifier
interventional
390
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Feb 2013
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 9, 2013
CompletedStudy Start
First participant enrolled
February 1, 2013
CompletedFirst Posted
Study publicly available on registry
June 5, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2018
CompletedJanuary 18, 2020
January 1, 2020
3.8 years
January 9, 2013
January 13, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
Physical function
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.
up to 12 months
Cognitive Function
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.
up to 12 months
Depressive Symptoms
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.
up to 12 months
Secondary Outcomes (7)
Health-Related Quality of Life
up to 12 months
Health Care Services Utilization
up to 12 months
Falls
up to 12 months
Shortness of breath
up to 12 months
Balance and Endurance
up to 12 months
- +2 more secondary outcomes
Study Arms (2)
Community of Voices choir program
EXPERIMENTALParticipants will receive the 12 month choir program as soon as possible after study enrollment.
Wait-list control group
EXPERIMENTALWaits six months, and at the end of the six months is offered the option of participating in the 12 month choir program.
Interventions
Attend weekly choir sessions for 12 months at the Senior Center. All choir sessions will include activities that focus on cognitive, psychosocial, and physical engagement components Choir sessions will last 90 minutes each with a 10 minute break. Take part in 3-4 informal choir concerts.
Eligibility Criteria
You may qualify if:
- 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)
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
UCSF Institute for Health & Aging
San Francisco, California, 94118, United States
Related Publications (4)
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.
PMID: 26463176BACKGROUNDJohnson 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.
PMID: 29399643RESULTJohnson 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.
PMID: 30412233RESULTAllison 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.
PMID: 32778434DERIVED
Related Links
Study Officials
- PRINCIPAL INVESTIGATOR
Julene K Johnson, PhD
University of California, San Francisco
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Masking Details
- Randomization assignment was not revealed to study personnel or study participants until after baseline assessments were completed for each pair of centers.
- Purpose
- OTHER
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 9, 2013
First Posted
June 5, 2013
Study Start
February 1, 2013
Primary Completion
December 1, 2016
Study Completion
August 1, 2018
Last Updated
January 18, 2020
Record last verified: 2020-01