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STUDY OBJECTIVES: Text messaging (TM) may provide an inexpensive and convenient method for self-reported sleep assessment. This pilot study evaluated the feasibility of a TM sleep diary among a racial/ethnic minority population with uncontrolled type 2 diabetes. METHODS: A convenience sample of 40 participants with uncontrolled type 2 diabetes was recruited. Participants wore an Actiwatch (Philips Spectrum Plus, Philips Respironics, Murrysville, Pennsylvania) for 7 consecutive days during both wake and sleep intervals and completed a daily TM sleep diary including 10 questions adapted from the Consensus Sleep Diary. The relationships between sleep measures from TMs and actigraphy were explored through Bland-Altman plots and correlations. RESULTS: Of the 40 participants enrolled, 34 were African American and 6 were Latino. The mean age was 52.2 years (standard deviation = 8.2), and the mean hemoglobin A1c was 9.0% (standard deviation = 1.5). All but 1 participant attempted to complete the TM sleep diary. With a maximum of 70 TM replies possible, the median number of responses per participant was 66 (interquartile range = 59.5–69). Actigraphy and TM measures were related for total sleep time (median = 382 vs 393 min, respectively [r = .71; P < .01]), sleep onset latency (median = 31.4 vs 27.5 min [r = .61; P < .01]), time in bed (433.3 vs 489.3 min [r = .74; P < .01]), and sleep efficiency (77% vs 86% [r = .45; P = .005]). The measure of wake after sleep onset was higher from actigraphy than from TM, with a weak relationship between the 2 measures (median 47.9 vs 6.0 min [r = .31; P = .05]). CONCLUSIONS: TM is a novel and feasible method for sleep assessment in racial/ethnic minority adults with uncontrolled type 2 diabetes. CITATION: Biggers A, Henkins J, Barton I, et al. Feasibility of text message sleep assessment in African American and Latino patients with type 2 diabetes. J Clin Sleep Med. 2021;17(1):69–78.

Background Aggressive management of blood glucose, blood pressure, and cholesterol through medication and lifestyle adherence is necessary to minimize the adverse health outcomes of type 2 diabetes. However, numerous psychosocial and environmental barriers to adherence prevent low-income, urban, and ethnic minority populations from achieving their management goals, resulting in diabetes complications. Health coaches working with clinical pharmacists represent a promising strategy for addressing common diabetes management barriers. Mobile health (mHealth) tools may further enhance their ability to support vulnerable minority populations in diabetes management. Objective The aim of this study is to evaluate the impact of an mHealth clinical pharmacist and health coach–delivered intervention on hemoglobin A1c (HbA1c, primary outcome), blood pressure, and low-density lipoprotein (secondary outcomes) in African-Americans and Latinos with poorly controlled type 2 diabetes. Methods A 2-year, randomized controlled crossover study will evaluate the effectiveness of an mHealth diabetes intervention delivered by a health coach and clinical pharmacist team compared with usual care. All patients will receive 1 year of team intervention, including lifestyle and medication support delivered in the home with videoconferencing and text messages. All patients will also receive 1 year of usual care without team intervention and no home visits. The order of the conditions received will be randomized. Our recruitment goal is 220 urban African-American or Latino adults with uncontrolled type 2 diabetes (HbA1c ≥8%) receiving care from a largely minority-serving, urban academic medical center. The intervention includes the following: health coaches supporting patients through home visits, phone calls, and text messaging and clinical pharmacists supporting patients through videoconferences facilitated by health coaches. Data collection includes physiologic (HbA1c, blood pressure, weight, and lipid profile) and survey measures (medication adherence, diabetes-related behaviors, and quality of life). Data collection during the second year of study will determine the maintenance of any physiological improvement among participants receiving the intervention during the first year. Results Participant enrollment began in March 2017. We have recruited 221 patients. Intervention delivery and data collection will continue until November 2021. The results are expected to be published by May 2022. Conclusions This is among the first trials to incorporate health coaches, clinical pharmacists, and mHealth technologies to increase access to diabetes support among urban African-Americans and Latinos to achieve therapeutic goals. International Registered Report Identifier (IRRID) DERR1-10.2196/17170

African Americans report higher rates of chronic stress compared to non-Hispanic Whites. Consequently, chronic stress contributes to disproportionately higher rates of poor health outcomes among African Americans. Mindfulness meditation is a well-established and studied strategy to reduce stress and potentially improve health outcomes. However, the practice of mindfulness meditation is largely underutilized in African American communities despite its potential health benefits. In this commentary, we will discuss the relevance of mindfulness interventions, limited research available, reasons for low representation, and cultural adaptations for mindfulness meditation in African American communities. We also provide additional strategies to guide future mindfulness research that target African Americans.

BACKGROUND The US Preventive Services Task Force (USPSTF) endorses routine screening for genetic risk of breast and/or ovarian cancer as a component of primary health care. Implementation of this recommendation may prove challenging, especially in clinics serving disadvantaged communities. METHODS The authors tested the feasibility of implementing the USPSTF mandate at a federally qualified health center (FQHC) to identify women who were eligible for genetic counseling (GC). A 12-month usual-care phase was followed by a 12-month intervention phase, during which time cancer genetic risk assessment (CGRA) was systematically performed for all women aged 25 to 69 years who presented for an annual examination. Women who were eligible for GC were recruited to participate in the study. RESULTS After initiating CGRA, 112 women who were eligible for GC consented to study participation, and 56% of them received a referral for GC from their primary care physician. A subgroup of 50 participants were seen by the same primary care physician during both the usual-care and intervention phases. None of these patients was referred for GC during usual care, compared with 64% after the initiation of CGRA (P

Objective: We analyzed two cohorts of people with type 2 diabetes to evaluate the relationships between depression, sleep quality, and history of hypoglycemia. Research design and methods: Two adult cohorts from Chicago (n = 193) and Bangkok, Thailand (n = 282) with type 2 diabetes completed questionnaires to assess sleep quality, depressive symptoms, and hypoglycemia frequency. Proportional odds logistic regression models for each cohort adjusted for duration of therapy, insulin and sulfonylurea management, and other factors. Results: Those with hypoglycemia in both cohorts had a longer duration of diabetes, greater use of insulin, and worse sleep quality. The Chicago cohort used less sulfonylureas but had higher depressive symptom scores. The Thailand cohort had greater sulfonylurea use. In the final Thailand regression model, depressive symptoms were independently associated with hypoglycemia frequency. In both final Chicago and Thailand models, sleep quality was not associated with hypoglycemia frequency. Conclusions: In the Thailand cohort, depressive symptoms were associated with hypoglycemia frequency. Keywords: Diabetes mellitus, Type 2, Hypoglycemia, Depression, Sleep

BACKGROUND Aggressive management of blood glucose, blood pressure, and cholesterol through medication and lifestyle adherence is necessary to minimize the adverse health outcomes of type 2 diabetes. However, numerous psychosocial and environmental barriers to adherence prevent low-income, urban, and ethnic minority populations from achieving their management goals, resulting in diabetes complications. Health coaches working with clinical pharmacists represent a promising strategy for addressing common diabetes management barriers. Mobile health (mHealth) tools may further enhance their ability to support vulnerable minority populations in diabetes management. OBJECTIVE The aim of this study is to evaluate the impact of an mHealth clinical pharmacist and health coach–delivered intervention on hemoglobin A1c (HbA1c, primary outcome), blood pressure, and low-density lipoprotein (secondary outcomes) in African-Americans and Latinos with poorly controlled type 2 diabetes. METHODS A 2-year, randomized controlled crossover study will evaluate the effectiveness of an mHealth diabetes intervention delivered by a health coach and clinical pharmacist team compared with usual care. All patients will receive 1 year of team intervention, including lifestyle and medication support delivered in the home with videoconferencing and text messages. All patients will also receive 1 year of usual care without team intervention and no home visits. The order of the conditions received will be randomized. Our recruitment goal is 220 urban African-American or Latino adults with uncontrolled type 2 diabetes (HbA1c ≥8%) receiving care from a largely minority-serving, urban academic medical center. The intervention includes the following: health coaches supporting patients through home visits, phone calls, and text messaging and clinical pharmacists supporting patients through videoconferences facilitated by health coaches. Data collection includes physiologic (HbA1c, blood pressure, weight, and lipid profile) and survey measures (medication adherence, diabetes-related behaviors, and quality of life). Data collection during the second year of study will determine the maintenance of any physiological improvement among participants receiving the intervention during the first year. RESULTS Participant enrollment began in March 2017. We have recruited 221 patients. Intervention delivery and data collection will continue until November 2021. The results are expected to be published by May 2022. CONCLUSIONS This is among the first trials to incorporate health coaches, clinical pharmacists, and mHealth technologies to increase access to diabetes support among urban African-Americans and Latinos to achieve therapeutic goals. CLINICALTRIAL INTERNATIONAL REGISTERED REPORT DERR1-10.2196/17170

Purpose To investigate the role of out-of-pocket cost supports through the Medicare Part D Low-Income Subsidy on disparities in breast cancer hormonal therapy persistence and adherence by race or ethnicity. Methods A nationwide cohort of women age ≥ 65 years with a breast cancer operation between 2006 and 2007 and at least one prescription filled for oral breast cancer hormonal therapy was identified from all Medicare D enrollees. The association of race or ethnicity with nonpersistence (90 consecutive days with no claims for a hormonal therapy prescription) and nonadherence (medication possession rate < 80%) was examined. Survival analyses were used to account for potential differences in age, comorbidity, or intensity of other treatments. Results Among the 25,111 women in the study sample, 77% of the Hispanic and 70% of the black women received a subsidy compared with 21% of the white women. By 2 years, 69% of black and 70% of Hispanic patients were persistent compared with 61% of white patients. In adjusted analyses, patients in all three unsubsidized race or ethnicity groups had greater discontinuation than subsidized groups (white patients: hazard ratio [HR], 1.83; 95% CI, 1.70 to 1.95; black patients: HR, 2.09; 95% CI, 1.73 to 2.51; Hispanic patients: HR, 3.00; 95% CI, 2.37 to 3.89). Racial or ethnic persistence disparities that were present for unsubsidized patients were not present or reversed among subsidized patients. All three subsidized race or ethnicity groups also had higher adherence than all three unsubsidized groups, although with the smallest difference occurring in black women. Conclusion Receipt of a prescription subsidy was associated with substantially improved persistence to breast cancer hormonal therapy among white, black, and Hispanic women and lack of racial or ethnic disparities in persistence. Given high subsidy enrollment among black and Hispanic women, policies targeted at low-income patients have the potential to also substantially reduce racial and ethnic disparities.

The US Preventive Services Task Force (USPSTF) endorses routine screening for genetic risk of breast and/or ovarian cancer as a component of primary health care. Implementation of this recommendation may prove challenging, especially in clinics serving disadvantaged communities.The authors tested the feasibility of implementing the USPSTF mandate at a federally qualified health center (FQHC) to identify women who were eligible for genetic counseling (GC). A 12-month usual-care phase was followed by a 12-month intervention phase, during which time cancer genetic risk assessment (CGRA) was systematically performed for all women aged 25 to 69 years who presented for an annual examination. Women who were eligible for GC were recruited to participate in the study.After initiating CGRA, 112 women who were eligible for GC consented to study participation, and 56% of them received a referral for GC from their primary care physician. A subgroup of 50 participants were seen by the same primary care physician during both the usual-care and intervention phases. None of these patients was referred for GC during usual care, compared with 64% after the initiation of CGRA (P .001). Only 16% of referred participants attended a GC session.Implementing USPSTF recommendations for CGRA as a standard component of primary health care in FQHCs is feasible and improves referral of minority women for GC, but more work is needed to understand the beliefs and barriers that prevent many underserved women from accessing cancer genetic services.

A Public Health Action Plan to Prevent Heart Disease and Stroke charts a course for the Centers for Disease Control and Prevention (CDC) and collaborating public health agencies, with all interested partners and the public at large, to help in promoting achievement of national goals for preventing heart disease and stroke over the next 2 decades--through 2020 and beyond. The Action Plan was released in April 2003 and includes 24 recommendations and 69 proposed action steps to be implemented now and in the years ahead. To set priorities for action and to define a limited set of concrete tasks for immediate implementation, a process was undertaken that included CDC and lead partners, the American Heart Association/American Stroke Association and Association of State and Territorial Health Officials, as well as the Action Plan Working Group and other members of the National Forum for Heart Disease and Stroke Prevention. This report presents details of the methods used and discussion of this process and its outcome. The process was facilitated by Concept Systems, Inc. and began with refinement of proposed action steps to yield a final list of 75 items. Next, the Action Plan Working Group and the full National Forum membership were invited to rate each proposed action step as to its relation to the mission and capacity of the organization represented by each respondent. This process, with review and discussion of results by the Working Group in January 2004, identified a subset of 22 priority action steps. The National Forum then met in April 2004 to discuss these priorities and ultimately adopted eight concrete tasks for immediate implementation.

There are over twenty oral antineoplastics currently approved in the United States and dozens more on the horizon (1). Adjuvant tamoxifen therapy for hormone receptor–positive breast cancer was one of the earliest developed long-term oncologic therapies. When taken for five to 10 years, it reduces long-term breast cancer mortality by one-third to one-half (2–4). The newer aromatase inhibitors anastrozole, letrozole, and exemestane reduce cancer recurrence by an additional 50% (5) but also need to be taken either alone or after tamoxifen for at least five total years of endocrine therapy (5). Unfortunately, many breast cancer patients prescribed long-term oral therapies have trouble adhering to them (6). One-third to one-half of patients prescribed adjuvant endocrine therapy (ET) outside of clinical trials either discontinue or adhere poorly to their medication within the first three years of therapy (7–15). Endocrine therapy nonadherence has clinically important effects. In one large breast cancer cohort, poor adherence to tamoxifen or aromatase inhibitors as measured by prescription fills was associated with a reduction in survival of 4% to 8% (16). There is increasing evidence that patient out-of-pocket costs play an important role in endocrine therapy nonadherence (17,18). The aromatase inhibitors (AIs) are substantially more costly than the generic tamoxifen, and many insurers are requiring that patients pay higher out-of-pocket costs for more expensive medications (17,18). In one recent study, 27% of patients in 2005 to 2008 with commercial insurance paid over $30 monthly out-of-pocket for their adjuvant aromatase inhibitor; adherence in this high-copay group was 18% to 28% lower than for patients paying $10 or less (17). In July 2010, an opportunity for reversal of these trends arose with the patent expiration of anastrozole. In contrast to some generic medications that face little competition when first released, thirteen generic manufacturers had generic anastrozole approved by the month after patent expiration, offering the potential for competition by cost. Shortly thereafter (April 2011), generic letrozole and exemestane were also released. Medicare D pharmaceutical program enrollees comprise an ideal national, population-based cohort in which to examine the adherence effects of this natural experiment. The Medicare D program required that all antineoplastic agents be on plan formularies. Furthermore, it provided a low-income subsidy (LIS) program to a substantial number of Medicare D enrollees, providing premium, deductible, and copayment support (including during the coverage gap or “donut hole” period) for enrollees with household incomes up to 150% of the federal poverty line. LIS recipients who experienced small or no effects upon out-of-pocket costs as generics became available thus could be compared with those without such supports, who experienced substantial changes in costs (18). The purpose of this study was to examine the effect of the introduction of generic versions of aromatase inhibitors on adherence to endocrine therapy among a nationally representative sample of elderly women with incident breast cancer using a quasi-experimental pre-post study design. We hypothesized that the well-documented rate of decline in adherence over time would be substantially attenuated after generic AIs became available. We further hypothesized that the effects would be larger for those not enrolled in the low-income subsidy program for pharmaceutical coverage.

A Public Health Action Plan to Prevent Heart Disease and Stroke charts a course for the Centers for Disease Control and Prevention (CDC) and collaborating public health agencies, with all interested partners and the public at large, to help in promoting achievement of national goals for preventing heart disease and stroke over the next 2 decades--through 2020 and beyond. The Action Plan was released in April 2003 and includes 24 recommendations and 69 proposed action steps to be implemented now and in the years ahead. To set priorities for action and to define a limited set of concrete tasks for immediate implementation, a process was undertaken that included CDC and lead partners, the American Heart Association/American Stroke Association and Association of State and Territorial Health Officials, as well as the Action Plan Working Group and other members of the National Forum for Heart Disease and Stroke Prevention. This report presents details of the methods used and discussion of this process and its outcome. The process was facilitated by Concept Systems, Inc. and began with refinement of proposed action steps to yield a final list of 75 items. Next, the Action Plan Working Group and the full National Forum membership were invited to rate each proposed action step as to its relation to the mission and capacity of the organization represented by each respondent. This process, with review and discussion of results by the Working Group in January 2004, identified a subset of 22 priority action steps. The National Forum then met in April 2004 to discuss these priorities and ultimately adopted eight concrete tasks for immediate implementation.

2 Background: Breast cancer outcomes are worse among black than white women, but the role of income and out-of-pocket costs (OOPCs) in these disparities is understudied. The Medicare D program provided medication insurance for older women and also included a low-income subsidy (LIS) which eliminated or reduced OOPCs among women with low assets and limited income (based on federal poverty level). We examined differences in adherence to HT by race/ethnicity among a Medicare D population, hypothesizing that LIS might reduce racial disparities in HT adherence. Methods: With data collected from a national sample of women enrolled in Medicare Parts A, B, and D, we identified Medicare Part D enrollees ≥65 years diagnosed with breast cancer who underwent mastectomy or breast conserving surgery in 2006-07 and received either tamoxifen or an AI (anastrozole, letrozole, or exemestane) within one year of surgery. Nonadherence rates (medication possession rate of >0.80) were calculated by race and LIS status for each year after first fill up through December 2011. The association of race with HT adherence was examined in unadjusted Chi-square analyses and in regression models adjusted for age, comorbidity, chemotherapy use, and zip code level- income and education. All models utilized GEE to account for within-patient clustering. Results: Among a sample of 23,299 women (50.6% age 65-74, 40.9% age 75-84), 27.2% received LIS. LIS (but not AI use) varied substantially by race, so that 20.6% of white women and 69.7% of black women received the subsidy. In the first year of therapy, differences in adherence by race were statistically significant, but small (64.2% for white, 63.2% for black and 66.7% for Hispanic). Adherence dropped during years 2-3 of the study, but reductions were much smaller among LIS recipients. Results were confirmed in adjusted models. Conclusions: Enrollment in the Medicare D LIS was high among black and Hispanic breast cancer patients, and disparities in adherence to breast cancer HT among these women were small and remained so over three years. Our study offers important information about the role of medication subsidies and SES in adherence, and suggests their potential to reduce the breast cancer outcomes gap by race.