NCT01869179

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. 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. 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

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
390

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Feb 2013

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

Completed
23 days until next milestone

Study Start

First participant enrolled

February 1, 2013

Completed
4 months until next milestone

First Posted

Study publicly available on registry

June 5, 2013

Completed
3.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2016

Completed
1.7 years until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2018

Completed
Last Updated

January 18, 2020

Status Verified

January 1, 2020

Enrollment Period

3.8 years

First QC Date

January 9, 2013

Last Update Submit

January 13, 2020

Conditions

Keywords

Well beingLow incomeChoir singingSpanish speakingCommunity basedSeniors60+ aged adultshealth disparities

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

EXPERIMENTAL

Participants will receive the 12 month choir program as soon as possible after study enrollment.

Behavioral: Community of Voices choir program

Wait-list control group

EXPERIMENTAL

Waits six months, and at the end of the six months is offered the option of participating in the 12 month choir program.

Behavioral: Community of Voices choir programBehavioral: Wait-list control group

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.

Community of Voices choir programWait-list control group
Wait-list control group

Eligibility Criteria

Age60 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

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

Location

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: 26463176BACKGROUND
  • 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.

  • 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.

  • 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.

Related Links

Study Officials

  • Julene K Johnson, PhD

    University of California, San Francisco

    PRINCIPAL INVESTIGATOR

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
Model Details: Cluster-randomized controlled design
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

Locations