COV: Community Choirs To Promote Healthy Aging; Community of Voices Chorus

Sponsor

University of California, San Francisco (Other)

Overall Status

Completed

CT.gov ID

NCT01869179

Collaborator

San Francisco Community Music Center (Other), Department of Aging and Adults Services San Francisco (Other)

390

Enrollment

Location

Arms

65.9

Actual Duration (Months)

5.9

Patients Per Site Per Month

Study Details

Study Description

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:

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.

Condition or Disease	Intervention/Treatment	Phase
Well Being	Behavioral: Community of Voices choir program Behavioral: Wait-list control group	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

390 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

Cluster-randomized controlled designCluster-randomized controlled design

Masking:

None (Open Label)

Masking Description:

Randomization assignment was not revealed to study personnel or study participants until after baseline assessments were completed for each pair of centers.

Primary Purpose:

Other

Official Title:

Community Choirs To Promote Healthy Aging And Independence Of Older Adults

Actual Study Start Date :

Feb 1, 2013

Actual Primary Completion Date :

Dec 1, 2016

Actual Study Completion Date :

Aug 1, 2018

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Community of Voices choir program Participants will receive the 12 month choir program as soon as possible after study enrollment.	Behavioral: Community of Voices choir program 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.
Experimental: Wait-list control group 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 program 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. Behavioral: Wait-list control group

Arm

Intervention/Treatment

Experimental: Community of Voices choir program

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

Behavioral: Community of Voices choir program

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.

Experimental: Wait-list control group

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 program

Behavioral: Wait-list control group

Outcome Measures

Primary Outcome Measures

Physical function [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 [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 [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.

Secondary Outcome Measures

Health-Related Quality of Life [up to 12 months]
We will use the brief, self-report European Quality of Life (EQ-5D) to measure health-related quality of life. It has versions in both English and Spanish and also alternate and phone versions. It covers five dimensions of health: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Baseline, 6 months, 12 months
Health Care Services Utilization [up to 12 months]
We will track utilization of health care services for cost analysis. The list of health care services is modified from the Chronic Disease Self-Management study and includes visits to a doctor, mental health provider (e.g., counselor, psychologist), other health providers (e.g., home health nurse, physical therapist), and emergency room and hospitalizations (and reason for stay). Participants (including those on the wait-list) will be contacted by phone every three months to complete the form about health care services used in the prior three months. Baseline, 6 months, 12 months
Falls [up to 12 months]
We will query frequency of falls using a single question commonly used in several large diverse studies about falls. Falls will also be assessed by phone every three months. Baseline, 6 months, 12 months
Shortness of breath [up to 12 months]
We will ask three questions about shortness of breath based on Blazer and colleagues. Baseline, 6 months, 12 months
Balance and Endurance [up to 12 months]
We will use the NIH Toolbox Motor to assess endurance (4 Meter Walk Gait Speed Test) and balance (Standing Balance Test). Baseline, 6 months, 12 months.
Memory and Executive Function [up to 12 months]
As secondary cognitive outcomes, we will use the NIH Toolbox to assess executive function and attention (NIH Toolbox Flanker Inhibitory Control and Attention Test) and verbal memory (NIH Toolbox Auditory Verbal Learning Test - Rey). Baseline, 6 months, 12 months.
Emotion [up to 12 months]
We will also be using the NIH Toolbox to assess additional aspects of emotion, including psychological well-being (Positive Affect), Self-Efficacy, social relationships (Emotional Support, Friendship, Loneliness), negative affect (Fear-Affect, Sadness), Medical Outcomes Study (MOS) social support, and Apathy. Baseline, 6 months, 12 months.

Eligibility Criteria

Criteria

Ages Eligible for Study:

60 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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