BACKGROUND:The mGlide RCT (randomized controlled trial) evaluated whether a pharmacist-led, mobile health technology facilitated care model improves hypertension control in diverse populations. METHODS:We recruited adult English, Spanish, or Hmong-speaking patients with uncontrolled hypertension from a large health care system and smaller community clinics serving low-income patients. Participants were randomized 1:1 to mGlide or usual care. The 6-month intervention included daily blood pressure (BP) self-monitoring using a smartphone and wireless monitor, automated app-based data sharing, and responsive medication adjustment by a pharmacist-led provider-team. Comparison participants received a digital monitor. Outcomes included mean 6-month systolic BP (SBP), 12-month sustained BP control, 24-hour ambulatory BP and patient activation. RESULTS:A total of 395 participants (mean age, 66.9 years; 46.6% women; mean [SD] SBP, 143.4 [16.5] mm Hg) were randomized to mGlide (n=198) or usual care (n=197). Mean (SD) 6-month SBP (mm Hg) was lower in the mGlide arm (128.1 [13.9] versus 134.0 [16.0]). The adjusted mean difference between groups for the primary outcome of 6-month SBP favored mGlide: -5.8 mm Hg (95% CI, -8.6 to -3.0), sustained at 12 months (-5.7 mm Hg [-8.7 to -2.6]). The mGlide arm also had a 4.8 mm Hg (P=0.014) lower 24-hour average ambulatory SBP. The 6-month intervention effect varied significantly by activation level, with a difference of -12.6 mm Hg (-20.5 to -4.8) SBP among the lowest versus -2.5 mm Hg (-6.5 to 1.6) among the highest activation level participants. CONCLUSIONS:A mobile health-facilitated care model with pharmacist-led medication adjustment was effective in lowering BP in diverse populations. Patients with low activation benefited more from the intervention; activation levels may inform efficient intervention selection. REGISTRATION:URL: https://www.clinicaltrials.gov; Unique identifier: NCT03612271.
Smoking cessation after an acute coronary syndrome (ACS) event is critical for reducing cardiovascular risk and mortality. However, most patients continue smoking post-hospitalization. Prior research with limited racial and sex diversity has overlooked how biopsychosocial factors may influence cessation outcomes in this high-risk group. The current study aimed to identify biopsychosocial predictors of 7-day smoking abstinence post-discharge in a diverse cohort of hospitalized ACS patients. Pre-randomization data from the Post-Acute Cardiac Event Smoking (PACES) trial, a randomized controlled trial of integrated smoking cessation and mood management treatment, were analyzed (N = 203, 69
Intentionally enhancing and supporting the early careers of individuals from populations underrepresented in science and medicine (URSM) is essential to achieving health equity. The Health Equity Leadership and Mentoring (HELM) Program at the University of Minnesota and the University of Utah is designed to foster academic excellence and build leadership capacity of postdoctoral fellows, clinical fellows, and early-career faculty who identify as URSM and/or who are committed to careers in health equity research and clinical care. HELM models a culture of psychosocial safety to create a sense of belonging and uses evidence-based and culturally aware mentoring and career development strategies with the goal of retaining diverse faculty. HELM proved agile and adaptive during the Covid-19 pandemic and has been successful in states with and without legislation limiting diversity programs. Across the 2 institutions, the HELM program has supported over 200 trainees and early-career faculty through mid-2024. Among HELM participants who joined the program as faculty, 85%-95% have remained in their faculty positions.
INTRODUCTION:In the United States, 80% of adults experiencing homelessness smoke combustible cigarettes. Power to Quit 2 (PTQ2) was a randomized clinical trial to test the efficacy of a combined smoking cessation and alcohol abstinence biobehavioral intervention, Intensive Smoking plus Alcohol (IS + A), versus Usual Care (UC) for adults experiencing homelessness. METHODS:PTQ2 was conducted in two urban homeless shelters in the Upper Midwest (2014--2018). People who smoked and reported hazardous alcohol use (N = 344) were randomized to IS + A (10 sessions of cognitive behavioral therapy for smoking and alcohol cessation plus nicotine replacement therapy [NRT], n = 168) or UC (educational session on smoking and alcohol cessation plus NRT, n = 176). The primary hypothesis was that the intervention would result in greater biochemically verified 7-day point-prevalent smoking abstinence 26 weeks post-intervention compared with UC. Our secondary hypothesis was that the intervention would result in greater 30-day alcohol abstinence 26 weeks post-intervention compared with UC. RESULTS:At week 26, the IS + A intervention group did not differ from the UC group in expired carbon-monoxide-verified 7-day point-prevalent smoking abstinence (16.6% vs. 12.8%, P = .47) or rate of self-reported 30-day alcohol abstinence (91.1% vs. 90.2%, P = .75). CONCLUSIONS:The IS + A intervention did not result in significantly better smoking or alcohol cessation outcomes than UC. Nonetheless, trends in the smoking outcome data favored the intervention group, underscoring the importance of continued research into biobehavioral interventions that address smoking and alcohol use among adults experiencing homelessness. IMPLICATIONS:The study highlights the difficulty in observing changes in smoking outcomes in interventions tailored to concurrently address smoking and alcohol use among persons experiencing homelessness. The findings add to existing knowledge by providing evidence about the real-world complexities facing people who use tobacco and alcohol while experiencing homelessness.
Objectives/Goals: We aim to explore the associations of race/ethnicity and socioeconomic status (SES): 1) with grip strength, walking speed, and comorbidity index cross-sectionally and 2) with the change in comorbidity index and mortality risk over four years of follow-up in cancer survivors. Both aims will examine the potential mediating role of cytomegalovirus (CMV) infection. Methods/Study Population: This study includes 1,602 cancer survivors (mean age = 72 years, 10% Black, 54% female) from the Health and Retirement Study (HRS), a nationally representative U.S. sample followed for health outcomes until 2020. HRS measured CMV immunoglobulin G (IgG) antibody levels (from blood samples), grip strength, and walking speed in 2016. We will apply linear regression to examine the associations of race/ethnicity and SES with grip strength, walking speed, and comorbidity index cross-sectionally and with the change in comorbidity index over four years of follow-up. We will apply Cox proportional hazard regression to examine the associations of race/ethnicity and SES with mortality over four years of follow-up. In all models, we will investigate the potential mediating role of CMV infection in these associations. Results/Anticipated Results: We expect that CMV infection mediates the associations of race/ethnicity and SES with age-related health outcomes, including muscle weakness (measured by grip strength), decreased functional performance (measured by walking speed), comorbidity index, and mortality in elderly cancer survivors. Discussion/Significance of Impact: If our hypothesis is confirmed, the findings may inform physicians to closely monitor CMV infection among cancer survivors from socially disadvantaged groups and apply treatment if needed. Several oral medications for CMV exist, and CMV vaccines are currently undergoing testing in clinical trials. This will make the treatment for CMV more accessible.
We examined the associations of social network size and social support with biological age acceleration using a protein-based aging clock. A total of 11 719 participants (mean age, 57.1 +/- 5.7 years; 55.6% female) of the Atherosclerosis Risk in Communities (ARIC) study Visit 2 (1990-1992) were included. Biological age was calculated using a proteomic aging clock (PAC), and age acceleration was defined as the residuals after regressing the PAC on chronological age. The associations of self-reported social network size and level of support with standardized mean age acceleration were examined using multivariable linear regression. Size of social networks and level of support were inversely associated with age acceleration. The age accelerations of small, medium, and large social networks were 0.24, 0.08, and -0.05 (P for trend = 0.003), while for low, moderate, and high levels of support the age accelerations were 0.33, 0.19, and -0.06 (P for trend < 0.0001), respectively. Associations were modestly attenuated after adjusting for social and lifestyle factors. Findings of the benefit of social networks and support to biological aging processes provide evidence of potential physiological underpinnings of social interactions on health outcomes.
Sworn law enforcement personnel in the United States face high rates of work-related stress. Yet, the well-being of more than 300,000 non-sworn personnel, particularly regarding work-related trauma and stress, remains underexplored. This study aims to test the hypothesis that non-sworn personnel experience lower levels of stress, comparing stress and probable post-traumatic stress disorder (PTSD) between sworn and non-sworn personnel. The study recruited 283 sworn and 85 non-sworn personnel from two large urban law enforcement agencies in the Twin Cities, Minnesota, between May and October 2021, coinciding with the COVID-19 pandemic and the civil unrest following the murder of George Floyd. Participants completed an online survey measuring perceived work-related stress (organizational and operational) and PTSD validated by PTSD Checklist for DSM-5 (PCL-5) questionnaire. The study considered different intensities of exposure to COVID and civil unrest, demographics, and worker characteristics as covariates in linear regression models, comparing stress outcomes among sworn and non-sworn personnel. The results showed no significant difference in operational and organizational stress levels between groups, except regarding pension eligibility (non-sworn < 5 years, sworn < 10 years). Non-sworn personnel not yet pension-eligible reported lower organizational stress (β = -10.1, CI = -18.84, -1.36). PCL-5 scores averaged 20.2 ± 17.4 for sworn and 23.6 ± 19.1 for non-sworn personnel, indicating no significant difference in probable PTSD (β = 3.24, CI = -4.19, 10.67). Both groups experienced similar stress levels, though non-sworn personnel ineligible for pension benefits showed lower organizational stress. These findings underscore the importance of targeted interventions and enhanced mental health services for all law enforcement personnel, regardless of classification.
PURPOSE:To present information on the feasibility and acceptability of a Stroke Champion "train-the-trainer" program, including lessons learned, for dissemination of stroke prevention knowledge and resources among African Americans (AA) residing within the Minneapolis-St. Paul, MN metropolitan area. DESIGN:One arm pre-post-test design. METHODS:Twelve AA "Stroke Champions" were recruited to assess the feasibility and acceptability of an online stroke prevention education curriculum and peer-to-peer education. RESULTS:We successfully designed, developed, and implemented a stroke prevention education website for community use. All Stroke Champions completed initial training and evaluation, and reported the usefulness and usability of the website., However, they also reported that they needed more facilitation support from our research team to deliver education in the community. CONCLUSION:Engaging Stroke Champions is potentially beneficial in increasing stroke prevention knowledge. However, Stroke Champions need more support to effectively engage, educate, and disseminate knowledge among peers.
Background: Suboptimal HTN control is a widespread problem particularly among minorities and socioeconomically disadvantaged groups. Objective: To determine if a mobile health (mHealth) intervention facilitating an active partnership between inter-professional care teams (including pharmacists) and patients improves HTN control in patients with uncontrolled HTN. Methods: mGlide is an NIH-funded, 2-arm RCT evaluating HTN control between a mHealth intervention (mGlide) vs. state-of-clinical-care (comparison) groups using a PROBE (Prospective Randomized Open Blinded End-point) design. Table 1 shows intervention components. High CVD risk patients with uncontrolled HTN identified by EHR query were randomized 1:1 to either mGlide or to comparison for a 6-month intervention followed by a 6-month observation period. Recruitment sites include primary care clinics and specialty stroke service in an integrated health system, community clinics (CC) and federally qualified health centers (FQHC). The FQHC and CC serve low income and minority (Hmong and Latino) patients. The primary aim tested clinical effectiveness of mGlide in reducing SBP at 6 months. Secondary outcomes include resource utilization, adverse events and medication side-effects. Results: Recruitment started in 2019. N=395 participants enrolled by August 2023. The pandemic impacted enrollment; however enrollment recovered after vaccine availability (Figure). Primary outcome was available in March 2024 on everyone except in those lost to follow-up (n=38; 9.6%). We used multiple imputation for those missing 6 month SBP. Baseline mean SBP was 143.2 vs. 143.6 mm Hg in mGlide vs. comparison. The intervention led to better HTN control (Table 2). Mean 6-month SBP was 128.1 (mGlide) vs. 134 mm Hg (comparison). Adjusting for baseline SBP and study strata, 6-month mean SBP was 5.7 mm Hg (95% CI 2.9-8.4; p = 0.0001) lower in mGlide vs. comparison. The odds of HTN control defined as “alive and SBP < 130 mm Hg”, was 60% higher in the mGlide arm (OR 1.6; 95% CI 1.03-2.48; p=0.035). There was one death in each study arm. The mGlide arm had fewer ER visits (16% vs. 25%; p=0.024), fewer hospitalizations (7% vs. 13%; p=0.044) and more medication side effects (39% vs. 26%, p=0.008). Conclusions: An inexpensive mHealth intervention that used the patient’s own phone (Table 1) was implemented in diverse health systems and significantly reduced SBP and was associated with less resource utilization at 6 months (Table 2).
The mGlide randomized clinical trial (RCT) is an NIH-funded study, evaluating whether a mobile health (mHealth)-based intervention that facilitates an active partnership between interprofessional health-care teams and patients results better hypertension (HTN) control than a state-of-clinical-care comparison in patients with uncontrolled HTN. The intervention uses readily available smartphone technology. The mGlide RCT was implemented in diverse health systems and was ongoing during the pandemic. The protocol was previously published. We describe the differential impact of the pandemic and consequent protocol updates and study timeline changes. We enrolled participants with uncontrolled HTN who were stroke survivors or primary care patients with elevated cardiovascular disease (CVD) risk from diverse health systems. Planned recruitment sites included primary care clinics and specialty stroke service in an integrated academic health system as well as university-affiliated community clinics and federally qualified health centers (FQHC). The FQHC and community clinics predominantly serve low-income patients and diverse racial/ethnic minorities - including African American, Hmong, and Latino patients. The primary aim tests the clinical effectiveness of reducing SBP of the 6-month mHealth intervention versus standard of care. Secondary aims evaluate sustained HTN control at 12 months, provider experiences of system usability, patient experiences, (including medication adherence, medication use self-efficacy, self-rated health, and quality of life), and adverse event rates. Trial recruitment commenced in 2019 and enrollment of 395 participants was completed in August 2023. The last follow-up will be completed in August 2024. The pandemic severely disrupted trial operations. On 3/16/2020, a moratorium on active clinical research was enacted within our health system in order to minimize in-person contact. All mGlide recruitment, enrollment, and follow-up activities ceased. Subsequently, the research team developed remote enrollment and follow-up processes that were utilized until COVID-19 vaccines became available in early 2021. A differential pandemic impact on health system research capacity was noted. The standalone FQHC had the highest rates of study drop-outs and was not able to recover its research capacity post-pandemic. Many clinics, however, including community clinics were impacted in the short-term but recovered their research capacity. Enrollments at the integrated health system were least impacted. Some rural clinics that were added for recruitment later in the study, (September 2022), showed robust participation. The Data Safety Monitoring Board reviewed two interim analyses (December 2021 and October 2022) and recommended that the primary analysis use a continuous endpoint of mean systolic blood pressure difference between the two arms in addition to a dichotomous endpoint of <140 mm Hg. Consequently, the needed sample size was lowered. We describe the dynamics of implementing a technology-based intervention with real-world challenges when participants and healthcare systems are significantly impacted by a disruptive pandemic. Clinicaltrials.gov: NCT03612271 https://clinicaltrials.gov/study/NCT03612271
Growing research shows psychosocial factors are associated with blood pressure (BP) control among individuals with hypertension. To date, little research has examined multiple psychosocial factors simultaneously to identify distinguishing profiles among individuals with hypertension. The association of psychosocial profiles and BP control remains unknown. To characterize the psychosocial profiles of individuals with hypertension and assess whether they are associated with BP control over 14 years. We included 2,665 MESA participants with prevalent hypertension in 2002–2004. Nine psychosocial variables representing individual, interpersonal, and neighborhood factors were included. BP control was achieved if systolic blood pressure (SBP) < 140 mmHg and diastolic blood pressure (DBP) < 9090 mmHg. Latent profile analysis (LPA) revealed an optimal model of three psychosocial profile groups (AIC 121,229; entropy = .88) “Healthy”, “Psychosocially Distressed” and “Discriminated Against”. Overall, there were no significant differences in systolic and diastolic BP control combined, across the profiles. Participants in the “Discriminated Against” profile group were significantly less likely [OR= 0.60; 95
The prevalence of combustible cigarette smoking in populations experiencing homelessness in the United States is five times that of the general population. The psychosocial well-being of persons who smoke and experience homelessness is poorer if such persons also use alcohol heavily. The PTQ2 study was a randomized clinical trial among persons experiencing homelessness who were also current smokers and heavy alcohol consumers. Secondary data analysis of the PTQ2 baseline data was conducted to examine associations among psychosocial variables (anxiety, depression, hopelessness, social network size), heaviness of smoking (cigarettes/day) and alcohol consumption (drinking days/month), and duration and frequency of homelessness. Among the 420 participants, the majority were male (75%), black (70%) and non-Hispanic (94%) with a mean age of 46.6 years (SD = 11.6). Bivariate analyses show that heaviness of smoking was positively correlated with social network size (r = 0.16, p = .001). Heaviness of drinking was positively correlated with the MINI anxiety score (r = 0.13, p = .009) and marijuana use (median total number of drinks in past 30 days among those who used marijuana in past 30 days vs. did not use: 50 vs. 24, p < .0001), and associated with frequency of homelessness (median total number of drinks in past 30 days among those experiencing homelessness once vs. >1 time: 30 vs. 44, p = .022). The findings highlight the psychosocial factors that warrant consideration when addressing heavy smoking and alcohol consumption in persons experiencing homelessness.
Background Approximately 400,000 people who smoke cigarettes survive Acute Coronary Syndrome (ACS; unstable angina, ST and non-ST elevation myocardial infarction) each year in the US. Continued smoking following ACS is an independent predictor of mortality. Depressed mood post-ACS is also predictive of mortality, and smokers with depressed mood are less likely to abstain from smoking following an ACS. A single, integrated treatment targeting depressed mood and smoking could be effective in reducing post-ACS mortality. Method/design The overall aim of the current study is to conduct a fully powered efficacy trial enrolling 324 smokers with ACS and randomizing them to 12 weeks of an integrated smoking cessation and mood management treatment [Behavioral Activation Treatment for Cardiac Smokers (BAT-CS)] or control (smoking cessation and general health education). Both groups will be offered 8 weeks of the nicotine patch if medically cleared. Counseling in both arms will be provided by tobacco treatment specialists. Follow-up assessments will be conducted at end-of-treatment (12-weeks) and 6, 9, and 12 months after hospital discharge. We will track major adverse cardiac events and all- cause mortality for 36 months post-discharge. Primary outcomes are depressed mood and biochemically validated 7-day point prevalence abstinence from smoking over 12 months. Discussion Results of this study will inform smoking cessation treatments post-ACS and provide unique data on the impact of depressed mood on success of post-ACS health behavior change attempts. Trial registration ClinicalTrials.gov, NCT03413423. Registered 29 January 2018. https://beta.clinicaltrials.gov/study/ NCT03413423.
Objective. Patients with cancer experience symptoms of post-traumatic stress disorder (PTSD) more com-monly than the general population. The objective of this study was to identify single nucleotide polymorphisms (SNPs) associated with increased risk of post-traumatic stress disorder (PTSD) in patients with gynecologic cancer.Methods. A prospective cohort study recruited 181 gynecologic cancer survivors receiving care at the Univer-sity of Minnesota between 2017 and 2020 who completed PTSD DSM-V surveys to self-report their symptoms of PTSD and provided saliva samples. DNA samples were genotyped for 11 SNPs in 9 genes involved in dopaminer-gic, serotonergic, and opioidergic systems previously associated with risk of PTSD in populations without cancer.Results. Most participants had either ovarian (42.5%) or endometrial (46.4%) cancer; fewer had cervical (7.7%) or vaginal/vulvar (3.3%) cancer. Two SNPS were identified as statistically significantly associated with higher PTSD scores: rs622337 in HTR2A and rs510769 in OPRM1.Conclusions. Genetic variation likely plays a role in development of PTSD. HTR2A is involved in the serotonin pathway, and OPRM1 is involved in the opioid receptor pathway. This information can be used by oncologic pro-viders to identify patients at greater risk of developing PTSD and may facilitate referral to appropriate consultants and resources early in their treatment.(c) 2023 Elsevier Inc. All rights reserved.
OBJECTIVE:Perimenopausal women experience a steep increase in low-density lipoprotein cholesterol (LDL-C) that is related to a higher risk of carotid plaque later in life. Low-density lipoprotein subclasses have been linked to cardiovascular diseases beyond LDL-C, promising a better risk stratification. We aim to characterize changes in LDL subclasses and assess their associations with presence of coronary artery calcium (CAC score ≥10) and carotid intima-media thickness (cIMT) over the menopausal transition (MT) and by menopause stage.METHODS:Nuclear magnetic resonance spectroscopy LDL subclasses were measured for a maximum of five time points. Coronary artery calcification and cIMT were measured for a maximum of two time points. LOESS (locally weighted regression with scatter smoothing) plots, linear mixed-effects models, and generalized estimating equations were used for analyses.RESULTS:The study included 471 women (baseline: age, 50.2 ± 2.7 years; 79.0% premenopausal/early perimenopausal), of whom 221 had data on CAC or cIMT. Low-density lipoprotein subclasses increased over the MT, whereas intermediate density-lipoprotein particles declined. In adjusted models, higher total LDL particles (LDL-P) and apolipoprotein B were associated with greater CAC prevalence and greater cIMT. Although none of the associations were modified by menopause stage, higher LDL-C, apolipoprotein B, and total LDL-P were associated with greater cIMT during the perimenopause or postmenopause stages, whereas higher LDL-C and small LDL-P were associated with greater CAC prevalence, mainly during perimenopause.CONCLUSIONS:During the MT, women experience significant increases in LDL subclasses found to be related to greater cIMT levels and CAC prevalence. Whether these changes could better predict future risk of hard cardiovascular disease events beyond LDL-C remains a research question to address.
Background:Personal Health literacy (PHL) is essential in cardiovascular risk management. Hindrances in PHL can lead to poor cardiovascular outcomes. Purpose:To investigate whether limited PHL is associated with lower likelihoods of i) overall cardiovascular health and ii) individual cardiovascular health components as defined by the American Heart Association's Life Simple (LS7). Methods:Multi-Ethnic Study of Atherosclerosis participants (N=3719; median age[range]: 59[45-84]) completed a PHL questionnaire in 2016-2018. PHL was classified as limited (score ≥10) or adequate (score <10). LS7 components were measured in 2000-2002. Robust Poisson regression was employed to compute prevalence ratios and 95% confidence intervals (PR[95%CI]) of LS7 measures. Results:14.7% of participants had limited PHL. Limited PHL was associated with lower likelihoods of optimal LS7 (0.69[0.50, 0.95], p=0.02) and average LS7 (0.95[0.88, 1.02], p=0.15) after adjustment. Limited PHL was significantly associated with a 7% lower likelihood of ideal fasting blood glucose level after adjustment (0.93[0.89, 0.98], p<0.01). Discussion:Limited PHL was modestly associated with suboptimal cardiovascular health and elevated blood glucose, independent of income and education. Translation to Health Education Practice:Health educators and providers should equitably address PHL barriers to improve cardiovascular management and quality of care for patients and communities.