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.

BACKGROUND: Older adults are the fastest growing segment of the United States population. There is an immediate need to identify novel, cost-effective community-based approaches that promote health and well-being for older adults, particularly those from diverse racial/ethnic and socioeconomic backgrounds. Because choral singing is multi-modal (requires cognitive, physical, and psychosocial engagement), it has the potential to improve health outcomes across several dimensions to help older adults remain active and independent. The purpose of this study is to examine the effect of a community choir program (Community of Voices) on health and well-being and to examine its costs and cost-effectiveness in a large sample of diverse, community-dwelling older adults. METHOD/DESIGN: In this cluster randomized controlled trial, diverse adults age 60 and older were enrolled at Administration on Aging-supported senior centers and completed baseline assessments. The senior centers were randomly assigned to either start the choir immediately (intervention group) or wait 6 months to start (control). Community of Voices is a culturally tailored choir program delivered at the senior centers by professional music conductors that reflects three components of engagement (cognitive, physical, and psychosocial). We describe the nature of the study including the cluster randomized trial study design, sampling frame, sample size calculation, methods of recruitment and assessment, and primary and secondary outcomes. DISCUSSION: The study involves conducting a randomized trial of an intervention as delivered in "real-world" settings. The choir program was designed using a novel translational approach that integrated evidence-based research on the benefits of singing for older adults, community best practices related to community choirs for older adults, and the perspective of the participating communities. The practicality and relatively low cost of the choir intervention means it can be incorporated into a variety of community settings and adapted to diverse cultures and languages. If successful, this program will be a practical and acceptable community-based approach for promoting health and well-being of older adults. TRIAL REGISTRATION: ClinicalTrials.gov NCT01869179 registered 9 January 2013.

Interferon gamma release assay compared with the tuberculin skin test for latent tuberculosis detection in pregnancy.

OBJECTIVE: To estimate agreement and correlation between the tuberculin skin test and an interferon gamma release assay for detecting latent tuberculosis (TB) infection in pregnant women. METHODS: We conducted a cross-sectional study of pregnant women initiating prenatal care at a university-affiliated public hospital between January 5, 2009, and March 15, 2010. Eligible women received a questionnaire about TB history and risk factors as well as the tuberculin skin test and phlebotomy for the interferon gamma release assay. Agreement and correlation between tests were estimated, and different cutoffs for interferon gamma release assay positivity were used to assess effect on agreement. Furthermore, predictors of test positivity and test discordance were evaluated using multivariable analysis. RESULTS: Of the 220 enrolled women, 199 (90.5%) returned for tuberculin skin test evaluation. Over 70% were Hispanic and 65% were born in a country with high TB prevalence. Agreement between the tuberculin skin test and interferon gamma release assay was 77.39 (κ=0.26). This agreement was not significantly changed using different cutoffs for the assay. Birth bacille Calmette-Guérin vaccination was associated with tuberculin skin test positivity (odds ratio [OR] 4.33, 95% confidence interval [CI] 1.4-13.48, P=.01), but not interferon gamma release assay positivity. There were no statistically significant predictors of the tuberculin skin test and interferon gamma release assay result discordance; however, birth in a high-prevalence country was marginally associated with tuberculin skin test-positive and interferon gamma release assay-negative results (OR 2.94, 95% CI 0.86-9.97 P=.08). CONCLUSION: Comparing the tuberculin skin test and interferon gamma release assay results in pregnancy, concordance and agreement were poor. Given that much is still unknown about the performance of interferon gamma release assays in pregnancy, further research is necessary before the tuberculin skin test is abandoned for screening of latent TB infection in pregnancy. LEVEL OF EVIDENCE: III.

An innovative multiphased strategy to recruit underserved adults into a randomized trial of a community-based diabetes risk reduction program.

PURPOSE: To conduct and evaluate a two-phased community-based approach to recruit lower socioeconomic status, minority, or Spanish-speaking adults at risk of developing diabetes to a randomized trial of a lifestyle intervention program delivered by a public health department. DESIGN: Within geographic areas comprising our target population, 4 community organizations provided local space for conducting the study and program. Phase I-outreach in venues surrounding these organizations-included diabetes education, a short diabetes risk appraisal (DRA), and diabetes risk screening based on a fasting fingerstick glucose test. Phase II-trial recruitment-began concurrently for those found to be at risk of developing diabetes in Phase I by explaining the study, lifestyle program, and research process. Those interested and eligible enrolled in the 1-year study. RESULTS: Over 2 years, approximately 5,110 individuals received diabetes education, 1,917 completed a DRA, and 1,164 were screened of which 641 (55%) had an elevated fingerstick result of ≥ 106 mg/dl. Of the study sampling frame-persons over age 25 at risk of developing diabetes (N = 544)-238 (43%) enrolled in the trial; of those who were study eligible (n = 427), 56% enrolled. In the final sample, mean age was 56 years (SD = 17), 78% were ethnic minorities, 32% were Spanish-speaking, and 15% had a high school education or less. IMPLICATIONS: Providing diabetes health education and screening prior to study recruitment may help overcome barriers to research participation in underserved communities, thus helping address difficulties recruiting minority and older populations into research, particularly research pertaining to chronic disease risk factors.