Community Choirs To Promote Healthy Aging; Community of Voices Chorus

Well Being Clinical Trial

— COV  

Official title:

Community Choirs To Promote Healthy Aging And Independence Of Older Adults

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01869179
• Other study ID #: R01AG042526
• Status: Completed
• Phase: N/A
• Start date: February 2013
• Est. completion date: August 1, 2018

Study information

• Verified date: January 2020
• Source: University of California, San Francisco
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 390
• Est. completion date: August 1, 2018
• Est. primary completion date: December 1, 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 60 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Well Being

Intervention

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.
• Wait-list control group

Locations

Country	Name	City	State
United States	UCSF Institute for Health & Aging	San Francisco	California

Sponsors (3)

Lead Sponsor	Collaborator
University of California, San Francisco	Department of Aging and Adults Services San Francisco, San Francisco Community Music Center

Country where clinical trial is conducted

United States, 

References & Publications (3)

Johnson JK, Gregorich SE, Acree M, Nápoles 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 Commu — View Citation

Johnson JK, Nápoles 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. — View Citation

Johnson JK, Stewart AL, Acree M, Nápoles 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. 2018 Nov 9. doi: 10 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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	Health-Related Quality of Life	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	up to 12 months
Secondary	Health Care Services Utilization	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	up to 12 months
Secondary	Falls	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	up to 12 months
Secondary	Shortness of breath	We will ask three questions about shortness of breath based on Blazer and colleagues. Baseline, 6 months, 12 months	up to 12 months
Secondary	Balance and Endurance	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.	up to 12 months
Secondary	Memory and Executive Function	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.	up to 12 months
Secondary	Emotion	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.	up to 12 months

External Links

•   Community of Voices trial website, including program manual