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| Name | Class |
|---|---|
| San Francisco Community Music Center | UNKNOWN |
| Department of Aging and Adults Services San Francisco | UNKNOWN |
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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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Community of Voices choir program | Experimental | Participants will receive the 12 month choir program as soon as possible after study enrollment. |
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| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Community of Voices choir program | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Julene K Johnson, PhD | University of California, San Francisco | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UCSF Institute for Health & Aging | San Francisco | California | 94118 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26463176 | Background | 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. | |
| 29399643 | Result | 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. |
| Label | URL |
|---|---|
| Community of Voices trial website, including program manual | View source |
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Cluster-randomized controlled design
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Randomization assignment was not revealed to study personnel or study participants until after baseline assessments were completed for each pair of centers.
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| Wait-list control group | Behavioral |
|
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 30412233 | Result | 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. |
| 32778434 | Derived | 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. |