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Community Choirs To Promote Healthy Aging; Community of Voices Chorus (COV)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01869179
Recruitment Status : Completed
First Posted : June 5, 2013
Last Update Posted : January 18, 2020
Sponsor:
Collaborators:
San Francisco Community Music Center
Department of Aging and Adults Services San Francisco
Information provided by (Responsible Party):
University of California, San Francisco

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.

Condition or disease Intervention/treatment Phase
Well Being Behavioral: Community of Voices choir program Behavioral: Wait-list control group Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 390 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Cluster-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 : February 2013
Actual Primary Completion Date : December 1, 2016
Actual Study Completion Date : August 1, 2018

Resource links provided by the National Library of Medicine


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



Primary Outcome Measures :
  1. Physical function [ Time Frame: 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.

  2. Cognitive Function [ Time Frame: 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.

  3. Depressive Symptoms [ Time Frame: 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 :
  1. Health-Related Quality of Life [ Time Frame: 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

  2. Health Care Services Utilization [ Time Frame: 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

  3. Falls [ Time Frame: 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

  4. Shortness of breath [ Time Frame: up to 12 months ]
    We will ask three questions about shortness of breath based on Blazer and colleagues. Baseline, 6 months, 12 months

  5. Balance and Endurance [ Time Frame: 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.

  6. Memory and Executive Function [ Time Frame: 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.

  7. Emotion [ Time Frame: 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   60 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01869179


Locations
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United States, California
UCSF Institute for Health & Aging
San Francisco, California, United States, 94118
Sponsors and Collaborators
University of California, San Francisco
San Francisco Community Music Center
Department of Aging and Adults Services San Francisco
Investigators
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Principal Investigator: Julene K Johnson, PhD University of California, San Francisco
Additional Information:
Publications of Results:
Other Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: University of California, San Francisco
ClinicalTrials.gov Identifier: NCT01869179    
Other Study ID Numbers: R01AG042526 ( U.S. NIH Grant/Contract )
First Posted: June 5, 2013    Key Record Dates
Last Update Posted: January 18, 2020
Last Verified: January 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University of California, San Francisco:
Well being
Low income
Choir singing
Spanish speaking
Community based
Seniors
60+ aged adults
health disparities