Integrated collaborative care intervention for depression and obesity in primary care: translation from research to practice.

The objective of this study was to present lessons learned about engagement, delivery modality and pandemic impact while delivering a collaborative care intervention with a socioeconomically, racially and ethnically diverse sample. Participants completed a post-intervention survey (n = 41) on experiences and preferred intervention delivery modality, coronavirus 2019 (COVID-19) Impact Survey (n = 50) and provided open-ended feedback about the intervention (n = 27). Intervention process data included attendance, modality, and withdrawals. Data were analyzed using descriptive statistics and inductive content analyses. Of 71 intervention participants, 6 (8%) withdrew before session 1. Completers adhered to intervention timeline better than withdrawals. Participants liked the in-person interaction, efficient coach support, accountability of in-person and Zoom vs. phone sessions and the flexibility and convenience of phone and Zoom vs. in-person sessions. A majority of participants reported experiencing pandemic impacts such as heightened emotional distress, decreased activity engagement, poorer eating behaviors and being unable to meet basic needs. Participants deviating from intervention timelines may be re-engaged by targeted outreach attempts. Videoconference has the potential for providing as-needed coaching. Future interventions may be optimized to account for and address areas impacted by the pandemic. Findings revealed specific strategies that can be implemented in future interventions to improve emotional and physical health among diverse populations.

Sex Moderates Treatment Effects of Integrated Collaborative Care for Comorbid Obesity and Depression: The RAINBOW RCT.

BACKGROUND: Sex influences health and related behaviors due to biological and psychosocial/socioeconomic factors. Assessing sex-specific responses to integrated treatment for comorbid obesity and depression could inform intervention targeting. PURPOSE: To test (a) whether sex moderates the effects of integrated collaborative care on weight and depression outcomes through 24 months and (b) whether treatment response at 6 months predicts 12 and 24 month outcomes by sex. METHODS: Secondary data analyses on weight and depression severity (SCL-20) measured over 24 months among 409 adults with obesity and depression in the Research Aimed at Improving Both Mood and Weight trial. RESULTS: Men achieved significantly greater weight reductions in intervention versus usual care than women, whereas women achieved significantly greater percentage reductions in SCL-20 than men at both 12 and 24 months. In logistic models, at 80% specificity for correctly identifying participants not achieving clinically significant long-term outcomes, women who lost <3.0% weight and men who lost <4.1% weight at 6 months had ≥84% probability of not meeting 5% weight loss at 24 months. Similarly, at 80% specificity, women who reduced SCL-20 by <39.5% and men who reduced by <53.0% at 6 months had ≥82% probability of not meeting 50% decrease in SCL-20 at 24 months. CONCLUSIONS: Sex modified the integrated treatment effects for obesity and depression. Sex-specific responses at 6 months predicted clinically significant weight loss and depression outcomes through 24 months. Based on early responses, interventions may need to be tailored to address sex-specific barriers and facilitators to achieving healthy weight and depression outcomes at later time points. CLINICAL TRIAL REGISTRATION: NCT02246413 (https://clinicaltrials.gov/ct2/show/NCT02246413).

Feasibility of promoting physical activity using mHEALTH technology in rural women: the step-2-it study.

BACKGROUND: Rural women are more likely to be obese and have a higher risk for chronic disease than their non-rural counterparts. Inadequate physical activity (PA) at least in part contributes to this increased risk. Rural women face personal, social and environmental barriers to PA engagement. Interventions promoting walking among rural women have demonstrated success; however, few of these studies use text messaging to promote PA. METHODS: Step-2-It was a pilot study to assess the feasibility, acceptability, and effectiveness of text-messaging combined with a pedometer to promote PA, specifically walking among English-speaking women, aged 40 and older, living in a rural, northwest Illinois county. Enrolled participants completed baseline assessments, received pedometers and two types of automated text messages: motivational messages to encourage walking, and accountability messages to report pedometer steps. Participants engaged in 3, 6, 9, and 12-week follow-ups to download pedometer data, and completed post-intervention assessments at 12 weeks. RESULTS: Of the 44 enrolled participants, 35 participants (79.5%) completed the intervention. Among completers, the proportion meeting PA guidelines increased from 31.4% (11/35) at baseline to 48.6% (17/35) at post-intervention, those with no PA decreased from 20% (7/35) to 17.1% (6/35). During weeks 1-12, when participants received motivational text messages, average participant daily step count was 5926 ± 3590, and remained stable during the intervention. Pedometer readings were highly correlated with self-reported steps (r = 0.9703; p < 0.001). CONCLUSION: Step-2-It was a feasible and acceptable walking intervention for older rural women. Technology, including text messaging, should be investigated further as an enhancement to interventions for rural women. Trial Registration on Clinicaltrials.gov: NCT04812756, registered on March 22, 2021.

Sleep variability, 6-sulfatoxymelatonin, and diabetic retinopathy.

PURPOSE: Recent evidence suggests that diabetic retinopathy (DR) is associated with abnormal melatonin regulation, possibly related to dysfunction of the melanopsin-expressing intrinsically photosensitive retinal ganglion cells. This study explored melatonin regulation in type 2 diabetes (T2D) patients with DR and its relation to sleep and circadian functioning. METHODS: Thirty-five participants (10 non-diabetic controls, 10 T2D without DR, and 15 T2D with DR) were recruited. Overnight urine 6-sulfatoxymelatonin (aMT6s) and objective sleep and wrist activity (7-day actigraphy) were obtained. RESULTS: After adjusting for covariates, having T2D with DR was significantly associated with lower urinary aMT6s (ß = - 1.369, p = 0.004) compared with controls, while having T2D without DR was not (p = 0.418). T2D patients with DR reported poorer sleep quality (p = 0.014) and had greater variability of sleep duration (p = 0.017) than others, while no differences were found in sleep duration, efficiency, and rest-activity rhythm. After adjusting for covariates, lower nocturnal aMT6s was significantly associated with greater sleep variability. CONCLUSION: T2D patients with DR exhibited low overnight production of aMT6s which likely contributed to sleep irregularities possibly due to weak circadian signaling. Whether or not melatonin supplementation could improve health in T2D patients with DR remains to be explored.

Trends in gender composition on editorial boards in leading medicine, nursing, and pharmacy journals.

OBJECTIVE: To investigate the proportions and trends in gender ratios of journal editorial boards in medicine, nursing, and pharmacy from 1995 to 2016. DESIGN: This was a pooled cross-sectional evaluation of 21 high-impact medical, nursing, and pharmacy journals. SETTING AND PARTICIPANTS: The gender composition of editorial boards for each discipline was obtained. Gender expression was based on the person's name or other information available on the Internet. OUTCOME MEASURES: The proportion of all editorial board member positions, including editorial leadership positions, occupied by the underrepresented gender, and trends over time were measured. RESULTS: A total of 5309 editorial board members and 312 editorial leadership positions were identified. From 1995 to 2016, women remained underrepresented across medicine and pharmacy journal editorial boards, whereas men remained underrepresented across nursing journal editorial boards. However, there were statistically significant increases in the representation of the underrepresented gender on editorial boards across all disciplines. Medicine was the only discipline to experience a statistically significant increase in the underrepresented gender of the editorial board being appointed to a leadership position; the proportion of women increased from 3% in 1995 to 35% in 2016. CONCLUSION: The gender gap in medicine and pharmacy journals appears to be narrowing. Although men continue to lag behind women in nursing journals, they are and have been overrepresented when considering the proportion of men practicing in the field. Overall, continued efforts are needed to resolve gender inequities in academic health sciences.

Clinical pharmacists in diabetes management: What do minority patients with uncontrolled diabetes have to say?

OBJECTIVE: Clinical pharmacist support for patients with type 2 diabetes mellitus (T2DM) can optimize patient outcomes and medication adherence. However, there is limited understanding of what pharmacist roles patients perceive as most helpful in T2DM management interventions. This study describes experiences of minority patients with uncontrolled T2DM in terms of perceived pharmacist helpfulness and specific roles found to be most helpful within diabetes management. DESIGN: A secondary analysis of a 2-year randomized, crossover trial was conducted. SETTING AND PARTICIPANTS: This study included 244 African American and Hispanic adults with uncontrolled T2DM who received clinical pharmacist support within a team-based model. OUTCOME MEASURES: The patients completed a mixed-methods survey regarding their experience with the intervention that included a general helpfulness rating on a 10-point unipolar Likert scale and described the support qualitatively, including their perception of the pharmacist roles. Thematic analysis guided coding of the responses. RESULTS: One hundred forty-seven (60%) patients completed the survey and had at least 1 encounter with a clinical pharmacist. Of these, 108 (74%) were African American, 39 (27%) were Hispanic, and 101 (69%) were women. The median rating of clinical pharmacist helpfulness was 10 (very helpful). Only 10 (7%) participants rated pharmacist helpfulness as 1 (not at all helpful). "Medication education and management" was the most frequently perceived supportive role of the clinical pharmacists, followed by "non-medication-related patient education," "social support," and "care coordination." Miscommunication related to scheduling was the most common reason cited for not meeting with the clinical pharmacist. CONCLUSION: This sample of minority patients with uncontrolled T2DM recognized many roles outlined within the American Pharmacists Association Medication Therapy Management framework. Patient experiences with clinical pharmacist T2DM support are crucial for developing effective programs, maximizing patient engagement, satisfying patient needs, and ensuring that a program's intended purpose aligns with the patient perspective.

Measuring Health-related Transportation Barriers in Urban Settings.

Access to reliable transportation is important for people with chronic diseases considering the need for frequent medical visits and for medications from the pharmacy. Understanding of the extent to which transportation barriers, including lack of transportation, contribute to poor health outcomes has been hindered by a lack of consistency in measuring or operationally defining "transportation barriers." The current study uses the Rasch measurement model to examine the psychometric properties of a new measure designed to capture types of transportation and associated barriers within an urban context. Two hundred forty-four adults with type 2 diabetes were recruited from within an academic medical center in Chicago and completed the newly developed transportation questions as part of a larger National Institutes of Health funded study (ClinicalTrials.gov identifier: NCT01498159). Results suggested a two subscale structure that reflected 1) general transportation barriers and 2) public transportation barriers.

Diabetes Screening in US Women With a History of Gestational Diabetes, National Health and Nutrition Examination Survey, 2007-2012.

INTRODUCTION: Women with a history of gestational diabetes mellitus (GDM) are at increased risk for developing type 2 diabetes mellitus. We examined individual, socioeconomic, and health care use characteristics of women with a history of GDM and the association of those characteristics with diabetes screening, and we estimated their rates of undiagnosed prediabetes and diabetes. METHODS: Using 3 cycles of the National Health and Nutrition Examination Survey (2007-2008, 2009-2010, and 2011-2012), we identified 284 women with a history of GDM who were eligible for diabetes screening. Screening status was defined by self-report of having had a blood test for diabetes within the prior 3 years. Undiagnosed prediabetes and diabetes were assessed by hemoglobin A1c measurement. RESULTS: Among women with a history of GDM, 67% reported diabetes screening within the prior 3 years. Weighted bivariate analyses showed screened women differed from unscreened women in measured body mass index (BMI) category (P = .01) and number of health visits in the prior year (P = .001). In multivariable analysis, screening was associated with a greater number of health visits in the prior year (1 visit vs 0 visits, adjusted odds ratio [AOR], 1.91; 95% confidence interval [CI], 0.71-5.18; 2 or 3 visits, AOR, 7.05; and ≥4 visits, AOR, 5.83). Overall, 24.4% (95% CI, 18.3%-31.7%) of women had undiagnosed prediabetes and 6.5% (95% CI, 3.7%-11.3%) had undiagnosed diabetes. CONCLUSION: More health visits in the prior year was associated with receiving diabetes screening. Fewer opportunities for screening may delay early detection, clinical management, and prevention of diabetes. Prediabetes in women with a history of GDM may be underrecognized and inadequately treated.

Pharmacists' perspectives on collaborating with community health workers in diabetes care.

OBJECTIVES: To qualitatively assess pharmacists' perspectives on the barriers and facilitators of collaborating with community health workers (CHWs) when caring for patients with diabetes. METHODS: Eight pharmacists were invited to participate in a focus group. All pharmacists had worked with CHWs for 12 months as part of a larger study. Seven pharmacists participated in a single focus group while one pharmacist participated in an individual interview. Data were analyzed by two investigators to identify common themes. RESULTS: Perceived barriers included issues associated with maintaining patient confidentiality, pharmacists' level of comfort with CHWs, uncertainty about CHW roles, and inconsistent communication between pharmacists and CHWs. However, pharmacists reported that the care model fostered improvement in patient-pharmacist communication, patient adherence to medication, and assessment of patients' overall condition. CONCLUSION: Pharmacists expressed positive attitudes and experiences in working with CHWs caring for a minority patient population with poorly controlled diabetes. Most believed that CHWs acted as facilitators and aided them in producing positive clinical outcomes by addressing the multiple psychosocial and contextual dimensions of patient health. Developing approaches for more frequent and effective communication between pharmacists and CHWs was the primary perceived challenge.

Health care provider practices, barriers, and facilitators for weight management for individuals with spinal cord injuries and disorders.

BACKGROUND: Even though weight management is essential for the health of individuals with spinal cord injuries and disorders (SCI/D), little is known about current practices, barriers, and facilitators. OBJECTIVE: To describe weight management delivery in the Veterans Affairs (VA) SCI/D System of Care, including barriers and facilitators experienced by health care providers. METHODS: Qualitative focus groups were conducted in person at 4 geographically dispersed VA medical facilities delivering care to Veterans with SCI/D. Thirty-two employees involved in weight management efforts participated. Audio-recordings were transcribed and analyzed using qualitative content analysis techniques. RESULTS: Participants at SCI centers reported that weight management treatment was delivered through the center by a multidisciplinary team using education (eg, written materials) and counseling/consults. Participants at SCI spoke facilities generally depended on facility-level programs (eg, MOVE!) to deliver treatment. Spoke facilities discussed barriers to delivering treatment through their SCI team, including staff shortages and resource and structural issues. MOVE! staff discussed barriers, including limited wheelchair space in classrooms. Staff participants across facilities noted that Veterans with SCI/D were hesitant to use facility-level programs, because of nonspecific SCI-relevant information and discomfort attending sessions with general Veterans. Other barriers, for both centers and spoke facilities, included necessary medications that increase weight, lack of evidence-based guidelines for weight management, safety concerns, and facility layout/accessibility. Facilitators included facility leadership support, provider involvement/prioritization, and community resources. CONCLUSIONS: Weight management programs delivered through the SCI team, with peers and SCI-relevant content, are likely more acceptable and beneficial to individuals with SCI/D. Program classrooms should provide ample space for individuals with SCI/D.

Global scientific trends in healthy aging in the early 21st century: A data-driven scientometric and visualized analysis.

Background: According to the World Health Organization (WHO), healthy aging is the process of developing and maintaining the functional capacity for health in old age. A rapidly growing number of research studies on healthy aging have been conducted worldwide. The purpose of this research work is to explore global scientific landscape of healthy aging research over the last 22 years. Methods: Scientific publications on healthy aging from January 1, 2000 to October 11, 2022 were retrieved from the Web of Science Core Collection (WoSCC) on October 11, 2022. A total of 6420 publications were included in the scientometric analysis. VOSviewer (1.6.18) was used to conduct scientometric and visualized analysis. Results: The publication growth rate was 35.68 from 2000 to 2021. The United States of America (USA) led in both productivity and citations. PROCEEDINGS OF THE NATIONAL ACADEMY OF SCIENCES OF THE UNITED STATES OF AMERICA was prominent in terms of both the highest citation count and the highest average citation count. The National Institute on Aging (NIA) and Evans, Michele K. were the most influential organization and author, respectively. Research hotspots in healthy aging were identified based on the co-occurrence analysis of keywords: (1) physical activity and mental health of older adults; (2) diseases impacting the health and lifespan of older adults; and (3) neuroscience. Our analysis indicates that gut microbiota, loneliness, frailty, mitochondria and resilience were the emerging themes in healthy aging research. Conclusions: The quantity of annual publications on healthy aging has rapidly increased over the past 22 years, especially during 2018-2021. This analysis identified the status, trends, hot topics, and frontiers of healthy aging research. These findings will help researchers quickly understand the global representation of healthy aging research, influence resource dissemination, promote international collaborations, guide policy formulation, and improve health services for older adults.

Association between obesity and statin use on mortality and hospital encounters in atrial fibrillation.

Background: Obesity increases risk of atrial fibrillation (AF) at least in part due to pro-inflammatory effects, but has been paradoxically associated with improved mortality. Although statins have pleiotropic anti-inflammatory properties, their interaction with obesity and clinical outcomes in AF is unknown. We explored the relationship between BMI, statin use, and all-cause mortality and AF/congestive heart failure (CHF)-related encounters, hypothesizing that statin exposure may be differentially associated with improved outcomes in overweight/obesity. Methods: This was a single center retrospective cohort study of adults with AF diagnosed between 2011-2018. Patients were grouped by body mass index (BMI) and statin use at time of AF diagnosis. Outcomes included all-cause mortality and ED or inpatient encounters for AF or CHF. Results and Conclusions: A total of 2503 subjects were included (median age 66 years, 43.4 % female, median BMI 29.8 kg/m2, 54.6 % on baseline statin therapy). Increasing BMI was associated with decreased mortality hazard but not associated with AF/CHF encounter risk. Adjusting for statin-BMI interaction, demographics, and cardiovascular comorbidities, overweight non-statin users experienced improved mortality (adjusted hazard ratio [aHR] 0.55, 95 % CI 0.35-0.84) compared to statin users (aHR 0.98, 95 % CI 0.69-1.40; interaction P-value = 0.013). Mortality hazard was consistently lower in obese non-statin users than in statin users, however interaction was insignificant. No significant BMI-statin interactions were observed in AF/CHF encounter risk. In summary, statin use was not differentially associated with improved mortality or hospitalization risk in overweight/obese groups. These findings do not support statins for secondary prevention of adverse outcomes based on overweight/obesity status alone.

Performance of and Severe Acute Respiratory Syndrome Coronavirus 2 Diagnostics Based on Symptom Onset and Close Contact Exposure: An Analysis From the Test Us at Home Prospective Cohort Study.

Background: Understanding changes in diagnostic performance after symptom onset and severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) exposure within different populations is crucial to guide the use of diagnostics for SARS-CoV-2. Methods: The Test Us at Home study was a longitudinal cohort study that enrolled individuals across the United States between October 2021 and February 2022. Participants performed paired antigen-detection rapid diagnostic tests (Ag-RDTs) and reverse-transcriptase polymerase chain reaction (RT-PCR) tests at home every 48 hours for 15 days and self-reported symptoms and known coronavirus disease 2019 exposures immediately before testing. The percent positivity for Ag-RDTs and RT-PCR tests was calculated each day after symptom onset and exposure and stratified by vaccination status, variant, age category, and sex. Results: The highest percent positivity occurred 2 days after symptom onset (RT-PCR, 91.2%; Ag-RDT, 71.1%) and 6 days after exposure (RT-PCR, 91.8%; Ag-RDT, 86.2%). RT-PCR and Ag-RDT performance did not differ by vaccination status, variant, age category, or sex. The percent positivity for Ag-RDTs was lower among exposed, asymptomatic than among symptomatic individuals (37.5% (95% confidence interval [CI], 13.7%-69.4%) vs 90.3% (75.1%-96.7%). Cumulatively, Ag-RDTs detected 84.9% (95% CI, 78.2%-89.8%) of infections within 4 days of symptom onset. For exposed participants, Ag-RDTs detected 94.0% (95% CI, 86.7%-97.4%) of RT-PCR-confirmed infections within 6 days of exposure. Conclusions: The percent positivity for Ag-RDTs and RT-PCR tests was highest 2 days after symptom onset and 6 days after exposure, and performance increased with serial testing. The percent positivity of Ag-RDTs was lowest among asymptomatic individuals but did not differ by sex, variant, vaccination status, or age category.

Traveling towards disease: transportation barriers to health care access.

Transportation barriers are often cited as barriers to healthcare access. Transportation barriers lead to rescheduled or missed appointments, delayed care, and missed or delayed medication use. These consequences may lead to poorer management of chronic illness and thus poorer health outcomes. However, the significance of these barriers is uncertain based on existing literature due to wide variability in both study populations and transportation barrier measures. The authors sought to synthesize the literature on the prevalence of transportation barriers to health care access. A systematic literature search of peer-reviewed studies on transportation barriers to healthcare access was performed. Inclusion criteria were as follows: (1) study addressed access barriers for ongoing primary care or chronic disease care; (2) study included assessment of transportation barriers; and (3) study was completed in the United States. In total, 61 studies were reviewed. Overall, the evidence supports that transportation barriers are an important barrier to healthcare access, particularly for those with lower incomes or the under/uninsured. Additional research needs to (1) clarify which aspects of transportation limit health care access (2) measure the impact of transportation barriers on clinically meaningful outcomes and (3) measure the impact of transportation barrier interventions and transportation policy changes.

ACE inhibitor and ARB medication use among Medicaid enrollees with diabetes.

OBJECTIVE: To examine ace-inhibitor (ACEI) and angiotensin receptor blockers (ARB) prescription and adherence patterns by race in diabetic public aid recipients. DESIGN, PARTICIPANTS, AND MEASURES: We analyzed prescription records of 27,529 adults aged 18-64 with diabetes who had at least one clinical indication for receiving an ACEI/ ARB prescription and were enrolled in the State of Illinois public aid program during 2007. We calculated proportion of days covered (PDC) to assess adherence. Multivariate models adjusted for age, sex, ACEI/ARB indication, and any significant interaction terms. RESULTS: Only 47.4% of individuals with at least one indication for ACEI/ARB had filled an ACEI/ARB prescription. African American men were more likely than Caucasian men to ever fill an ACEI/ARB prescription (adjusted odds ratio, [AOR] [95% CI] 1.69 [1.55-1.83]). Hispanic English and Spanish speaking men were also more likely than Caucasian men to ever fill an ACEI/ARB prescription (AOR [95% CI] 1.37 [1.16-1.62] and 1.27 [1.05-1.53], respectively). Similarly, African American and Hispanic English and Spanish speaking women were more likely than Caucasian women to ever fill an ACEI/ARB prescription (AOR [95% CI] 1.70 [1.59-1.81], 1.55 (1.36-1.76), and 1.98 (1.73-2.28), respectively. However, African Americans and Hispanics were less likely than Caucasians to achieve a PDC> or =80%. Compared to Caucasians, Hispanic Spanish speakers were the least likely to be adherent (AOR [95% CI] .49 [.41-.58]). Furthermore, older individuals were more likely to achieve a PDC> or =80% than younger individuals. CONCLUSION: African Americans and Hispanics with diabetes receiving public aid in Illinois were more likely than Caucasians to have filled at least one ACEI/ARB prescription. However, they were less adherent with these medications. Future studies should assess barriers to medication adherence in this population.

The association between rest-activity parameters and hemoglobin A1c in patients with prediabetes.

Circadian abnormalities can adversely affect glucose metabolism. This study determined whether behavioral circadian parameters, as assessed by rest-activity rhythm, were predictors of glycemic control in patients with prediabetes. Seventy-nine patients with prediabetes participated. Nonparametric rest-activity rhythm parameters, sleep duration and efficiency were obtained from 7-d actigraphy recordings. Sleep-disordered breathing severity was assessed using a home sleep apnea test. Hemoglobin A1c (HbA1c) was obtained to evaluate glycemic control. The results revealed that shorter sleep duration, lower relative amplitude and higher L5 (average activity of the least active 5-h period) were associated with higher HbA1c, while other sleep variables were not related to HbA1c. Multiple stepwise regression analysis adjusting for age, sex, body mass index and sleep duration revealed that lower relative amplitude, but not L5, was independently associated with higher HbA1c (B = -0.027, p = 0.031). In summary, among patients with prediabetes, an abnormal circadian rhythm was associated with higher HbA1c, implying a greater risk of developing diabetes. These results support the role of circadian rhythmicity in glucose control among those with prediabetes.

Association between sleep hygiene practices scale and sleep quality in Black and Latinx patients with uncontrolled type 2 diabetes.

Objective: We explored the relationship between the Sleep Hygiene Practices Scale (SHPS) and sleep quality and sleep-related impairment in Black and Latinx adults with type 2 diabetes (T2DM). Methods: Forty Black and Latinx adults with T2DM participated. Self-reported measures include the Pittsburg Sleep Quality Index (PSQI), Patient Reported Outcomes Measurement Information System (PROMIS) Sleep Disturbance (SD) and Sleep-Related Impairment (SRI) measures, and SHPS (domains include sleep schedule and timing, arousal-related behaviors, poor eating/drinking habits prior to sleep, and poor sleep environment). Results: SHPS Cronbach's alpha coefficients were 0.58 (schedule), 0.78 (arousal), 0.29 (eating), 0.81 (environment) and 0.88 (overall for four domains). SHPS scores correlated with PSQI (Pearson correlation r = 0.67, 95% CI [0.44, 0.81], PROMIS-SD (r = 0.61 [0.36-0.77]), and PROMIS-SRI (r = 0.43, [0.13-0.65]). There remained a significant relationship between sleep hygiene and both sleep quality and sleep-related impairment adjusting for hemoglobin A1c, age, and body mass index in regression models. Conclusions: We observed moderate correlations between sleep quality and sleep-related impairment with sleep hygiene using the SHPS in Black and Latinx adults with T2DM.

Mobile Health Intervention in Patients With Type 2 Diabetes: A Randomized Clinical Trial.

Importance: Clinical pharmacists and health coaches using mobile health (mHealth) tools, such as telehealth and text messaging, may improve blood glucose levels in African American and Latinx populations with type 2 diabetes. Objective: To determine whether clinical pharmacists and health coaches using mHealth tools can improve hemoglobin A1c (HbA1c) levels. Design, Setting, and Participants: This randomized clinical trial included 221 African American or Latinx patients with type 2 diabetes and elevated HbA1c (≥8%) from an academic medical center in Chicago. Adult patients aged 21 to 75 years were enrolled and randomized from March 23, 2017, through January 8, 2020. Patients randomized to the intervention group received mHealth diabetes support for 1 year followed by monitored usual diabetes care during a second year (follow-up duration, 24 months). Those randomized to the waiting list control group received usual diabetes care for 1 year followed by the mHealth diabetes intervention during a second year. Interventions: The mHealth diabetes intervention included remote support (eg, review of glucose levels and medication intensification) from clinical pharmacists via a video telehealth platform. Health coach activities (eg, addressing barriers to medication use and assisting pharmacists in medication reconciliation and telehealth) occurred in person at participant homes and via phone calls and text messaging. Usual diabetes care comprised routine health care from patients' primary care physicians, including medication reconciliation and adjustment. Main Outcomes and Measures: Outcomes included HbA1c (primary outcome), blood pressure, cholesterol, body mass index, health-related quality of life, diabetes distress, diabetes self-efficacy, depressive symptoms, social support, medication-taking behavior, and diabetes self-care measured every 6 months. Results: Among the 221 participants (mean [SD] age, 55.2 [9.5] years; 154 women [69.7%], 148 African American adults [67.0%], and 73 Latinx adults [33.0%]), the baseline mean (SD) HbA1c level was 9.23% (1.53%). Over the initial 12 months, HbA1c improved by a mean of -0.79 percentage points in the intervention group compared with -0.24 percentage points in the waiting list control group (treatment effect, -0.62; 95% CI, -1.04 to -0.19; P = .005). Over the subsequent 12 months, a significant change in HbA1c was observed in the waiting list control group after they received the same intervention (mean change, -0.57 percentage points; P = .002), while the intervention group maintained benefit (mean change, 0.17 percentage points; P = .35). No between-group differences were found in adjusted models for secondary outcomes. Conclusions and Relevance: In this randomized clinical trial, HbA1c levels improved among African American and Latinx adults with type 2 diabetes. These findings suggest that a clinical pharmacist and health coach-delivered mobile health intervention can improve blood glucose levels in African American and Latinx populations and may help reduce racial and ethnic disparities. Trial Registration: ClinicalTrials.gov Identifier: NCT02990299.

Effects of a virtual voice-based coach delivering problem-solving treatment on emotional distress and brain function: a pilot RCT in depression and anxiety.

Consumer-based voice assistants have the ability to deliver evidence-based treatment, but their therapeutic potential is largely unknown. In a pilot trial of a virtual voice-based coach, Lumen, delivering problem-solving treatment, adults with mild-to-moderate depression and/or anxiety were randomized to the Lumen intervention (n = 42) or waitlist control (n = 21). The main outcomes included changes in neural measures of emotional reactivity and cognitive control, and Hospital Anxiety and Depression Scale [HADS] symptom scores over 16 weeks. Participants were 37.8 years (SD = 12.4), 68% women, 25% Black, 24% Latino, and 11% Asian. Activation of the right dlPFC (neural region of interest in cognitive control) decreased in the intervention group but increased in the control group, with an effect size meeting the prespecified threshold for a meaningful effect (Cohen's d = 0.3). Between-group differences in the change in activation of the left dlPFC and bilateral amygdala were observed, but were of smaller magnitude (d = 0.2). Change in right dlPFC activation was also meaningfully associated (r ≥ 0.4) with changes in self-reported problem-solving ability and avoidance in the intervention. Lumen intervention also led to decreased HADS depression, anxiety, and overall psychological distress scores, with medium effect sizes (Cohen's d = 0.49, 0.51, and 0.55, respectively), compared with the waitlist control group. This pilot trial showed promising effects of a novel digital mental health intervention on cognitive control using neuroimaging and depression and anxiety symptoms, providing foundational evidence for a future confirmatory study.

Mediating Effects of Neural Targets on Depression, Weight, and Anxiety Outcomes of an Integrated Collaborative Care Intervention: The ENGAGE-2 Mechanistic Pilot Randomized Clinical Trial.

Background: Integrated treatments for comorbid depression (often with anxiety) and obesity are lacking; mechanisms are poorly investigated. Methods: In a mechanistic pilot trial, adults with body mass index ≥30 and Patient Health Questionnaire-9 scores ≥10 were randomized to usual care (n = 35) or an integrated behavioral intervention (n = 71). Changes at 6 months in body mass index and Depression Symptom Checklist-20 scores were co-primary outcomes, and Generalized Anxiety Disorder Scale-7 score was a secondary outcome. Changes at 2 months in the activation and functional connectivity of regions of interest in the negative affect circuit were primary neural targets, and secondary targets were in the cognitive control, default mode, and positive affect circuits. Results: Participants were 47.0 years (SD = 11.9 years), 76% women, 55% Black, and 20% Latino. Depression Symptom Checklist-20 (between-group difference, -0.3 [95% CI: -0.6 to -0.1]) and Generalized Anxiety Disorder Scale-7 (-2.9 [-4.7 to -1.1]) scores, but not body mass index, decreased significantly at 6 months in the intervention versus usual care groups. Only Generalized Anxiety Disorder Scale-7 score changes at 6 months significantly correlated with neural target changes at 2 months in the negative affect (anterior insula, subgenual/pregenual anterior cingulate cortex, amygdala) and cognitive control circuits (dorsal lateral prefrontal cortex, dorsal anterior cingulate cortex). Effects were medium to large (0.41-1.18 SDs). Neural target changes at 2 months in the cognitive control circuit only differed by treatment group. Effects were medium (0.58-0.79 SDs). Conclusions: Compared with usual care, the study intervention led to significantly improved depression but not weight loss, and the results on neural targets were null for both outcomes. The significant intervention effect on anxiety might be mediated through changes in the cognitive control circuit, but this warrants replication.