## Protocol Section
### Identification Module
**NCT ID:** NCT01869179

**Acronym:** COV

**Brief Title:** Community Choirs To Promote Healthy Aging; Community of Voices Chorus

**Official Title:** Community Choirs To Promote Healthy Aging And Independence Of Older Adults

#### Organization Study ID Info
**ID:** R01AG042526
**Link:** https://reporter.nih.gov/quickSearch/R01AG042526
**Type:** NIH
#### Organization
**Class:** OTHER
**Full Name:** University of California, San Francisco
### Status Module
#### Completion Date
**Date:** 2018-08-01

**Type:** ACTUAL

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2020-01-18

**Type:** ACTUAL

**Last Update Submit Date:** 2020-01-13

**Overall Status:** COMPLETED

#### Primary Completion Date
**Date:** 2016-12-01

**Type:** ACTUAL

#### Start Date
**Date:** 2013-02

**Type:** ACTUAL

**Status Verified Date:** 2020-01

#### Study First Post Date
**Date:** 2013-06-05
**Type:** ESTIMATED
**Study First Submit Date:** 2013-01-09
**Study First Submit QC Date:** 2013-05-30
### Sponsor Collaborators Module

#### Collaborators

**Class:** UNKNOWN

**Name:** San Francisco Community Music Center

**Class:** UNKNOWN

**Name:** Department of Aging and Adults Services San Francisco

#### Lead Sponsor

**Class:** OTHER

**Name:** University of California, San Francisco

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Oversight Has DMC:** False

### Description Module

**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.

### Conditions Module

**Conditions:**

- Well Being

**Keywords:**

- Well being

- Low income

- Choir singing

- Spanish speaking

- Community based

- Seniors

- 60+ aged adults

- health disparities

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** PARALLEL

**Intervention Model Description:** Cluster-randomized controlled design

##### Masking Info

**Masking:** NONE

**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

#### Enrollment Info

**Count:** 390

**Type:** ACTUAL

**Phases:**

- NA

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

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

**Intervention Names:**

- Behavioral: Community of Voices choir program

**Label:** Community of Voices choir program

**Type:** EXPERIMENTAL

#### Arm Group 2

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

**Intervention Names:**

- Behavioral: Community of Voices choir program

- Behavioral: Wait-list control group

**Label:** Wait-list control group

**Type:** EXPERIMENTAL

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Community of Voices choir program

- Wait-list control group

**Description:** 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.

**Name:** Community of Voices choir program

**Type:** BEHAVIORAL

#### Intervention 2

**Arm Group Labels:**

- Wait-list control group

**Name:** Wait-list control group

**Type:** BEHAVIORAL

### Outcomes Module

#### Primary Outcomes

**Description:** 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.

**Measure:** Physical function

**Time Frame:** up to 12 months

**Description:** 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.

**Measure:** Cognitive Function

**Time Frame:** up to 12 months

**Description:** 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.

**Measure:** Depressive Symptoms

**Time Frame:** up to 12 months

#### Secondary Outcomes

**Description:** 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

**Measure:** Health-Related Quality of Life

**Time Frame:** up to 12 months

**Description:** 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

**Measure:** Health Care Services Utilization

**Time Frame:** up to 12 months

**Description:** 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

**Measure:** Falls

**Time Frame:** up to 12 months

**Description:** We will ask three questions about shortness of breath based on Blazer and colleagues. Baseline, 6 months, 12 months

**Measure:** Shortness of breath

**Time Frame:** up to 12 months

**Description:** 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.

**Measure:** Balance and Endurance

**Time Frame:** up to 12 months

**Description:** 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.

**Measure:** Memory and Executive Function

**Time Frame:** up to 12 months

**Description:** 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.

**Measure:** Emotion

**Time Frame:** up to 12 months

### Eligibility Module

**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

**Healthy Volunteers:** True

**Minimum Age:** 60 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** San Francisco

**Country:** United States

**Facility:** UCSF Institute for Health & Aging

**State:** California

**Zip:** 94118

#### Overall Officials

**Official 1:**

**Affiliation:** University of California, San Francisco

**Name:** Julene K Johnson, PhD

**Role:** PRINCIPAL_INVESTIGATOR

### References Module

#### 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.

**PMID:** 26463176

**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.

**PMID:** 29399643

**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.

**PMID:** 30412233

**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.

**PMID:** 32778434

#### See Also Links

**Label:** Community of Voices trial website, including program manual

**URL:** https://cov.ucsf.edu/

## Derived Section

### Misc Info Module

- Version Holder: 2024-05-24
