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Rehabilitation Using Mobile Health for Older Adults With Ischemic Heart Disease in the Home Setting (RESILIENT): Protocol for a Randomized Controlled Trial

Dodson, John A; Schoenthaler, Antoinette; Sweeney, Greg; Fonceva, Ana; Pierre, Alicia; Whiteson, Jonathan; George, Barbara; Marzo, Kevin; Drewes, Wendy; Rerisi, Elizabeth; Mathew, Reena; Aljayyousi, Haneen; Chaudhry, Sarwat I; Hajduk, Alexandra M; Gill, Thomas M; Estrin, Deborah; Kovell, Lara; Jennings, Lee A; Adhikari, Samrachana
BACKGROUND:Participation in ambulatory cardiac rehabilitation remains low, especially among older adults. Although mobile health cardiac rehabilitation (mHealth-CR) provides a novel opportunity to deliver care, age-specific impairments may limit older adults' uptake, and efficacy data are currently lacking. OBJECTIVE:This study aims to describe the design of the rehabilitation using mobile health for older adults with ischemic heart disease in the home setting (RESILIENT) trial. METHODS:RESILIENT is a multicenter randomized clinical trial that is enrolling patients aged ≥65 years with ischemic heart disease in a 3:1 ratio to either an intervention (mHealth-CR) or control (usual care) arm, with a target sample size of 400 participants. mHealth-CR consists of a commercially available mobile health software platform coupled with weekly exercise therapist sessions to review progress and set new activity goals. The primary outcome is a change in functional mobility (6-minute walk distance), which is measured at baseline and 3 months. Secondary outcomes are health status, goal attainment, hospital readmission, and mortality. Among intervention participants, engagement with the mHealth-CR platform will be analyzed to understand the characteristics that determine different patterns of use (eg, persistent high engagement and declining engagement). RESULTS:As of December 2021, the RESILIENT trial had enrolled 116 participants. Enrollment is projected to continue until October 2023. The trial results are expected to be reported in 2024. CONCLUSIONS:The RESILIENT trial will generate important evidence about the efficacy of mHealth-CR among older adults in multiple domains and characteristics that determine the sustained use of mHealth-CR. These findings will help design future precision medicine approaches to mobile health implementation in older adults. This knowledge is especially important in light of the COVID-19 pandemic that has shifted much of health care to a remote, internet-based setting. TRIAL REGISTRATION/BACKGROUND:ClinicalTrials.gov NCT03978130; https://clinicaltrials.gov/ct2/show/NCT03978130. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID)/UNASSIGNED:DERR1-10.2196/32163.
PMID: 35238793
ISSN: 1929-0748
CID: 5174552

Neighborhood Socioeconomic Environment and Risk of Type 2 Diabetes: Associations and Mediation Through Food Environment Pathways in Three Independent Study Samples

Thorpe, Lorna E; Adhikari, Samrachana; Lopez, Priscilla; Kanchi, Rania; McClure, Leslie A; Hirsch, Annemarie G; Howell, Carrie R; Zhu, Aowen; Alemi, Farrokh; Rummo, Pasquale; Ogburn, Elizabeth L; Algur, Yasemin; Nordberg, Cara M; Poulsen, Melissa N; Long, Leann; Carson, April P; DeSilva, Shanika A; Meeker, Melissa; Schwartz, Brian S; Lee, David C; Siegel, Karen R; Imperatore, Giuseppina; Elbel, Brian
OBJECTIVE:We examined whether relative availability of fast-food restaurants and supermarkets mediates the association between worse neighborhood socioeconomic conditions and risk of developing type 2 diabetes (T2D). RESEARCH DESIGN AND METHODS/METHODS:As part of the Diabetes Location, Environmental Attributes, and Disparities Network, three academic institutions used harmonized environmental data sources and analytic methods in three distinct study samples: (1) the Veterans Administration Diabetes Risk (VADR) cohort, a national administrative cohort of 4.1 million diabetes-free veterans developed using electronic health records (EHRs); (2) Reasons for Geographic and Racial Differences in Stroke (REGARDS), a longitudinal, epidemiologic cohort with Stroke Belt region oversampling (N = 11,208); and (3) Geisinger/Johns Hopkins University (G/JHU), an EHR-based, nested case-control study of 15,888 patients with new-onset T2D and of matched control participants in Pennsylvania. A census tract-level measure of neighborhood socioeconomic environment (NSEE) was developed as a community type-specific z-score sum. Baseline food-environment mediators included percentages of (1) fast-food restaurants and (2) food retail establishments that are supermarkets. Natural direct and indirect mediating effects were modeled; results were stratified across four community types: higher-density urban, lower-density urban, suburban/small town, and rural. RESULTS:Across studies, worse NSEE was associated with higher T2D risk. In VADR, relative availability of fast-food restaurants and supermarkets was positively and negatively associated with T2D, respectively, whereas associations in REGARDS and G/JHU geographies were mixed. Mediation results suggested that little to none of the NSEE-diabetes associations were mediated through food-environment pathways. CONCLUSIONS:Worse neighborhood socioeconomic conditions were associated with higher T2D risk, yet associations are likely not mediated through food-environment pathways.
PMID: 35104336
ISSN: 1935-5548
CID: 5153512

Oral Health, Diabetes, and Inflammation: Effects of Oral Hygiene Behaviour

Luo, Huabin; Wu, Bei; Kamer, Angela R; Adhikari, Samrachana; Sloan, Frank; Plassman, Brenda L; Tan, Chenxin; Qi, Xiang; Schwartz, Mark D
INTRODUCTION/BACKGROUND:The aim of this research was to assess the association between inflammation and oral health and diabetes, as well as the mediating role of oral hygiene practice in this association. METHODS:Data were from the 2009-2010 National Health and Nutrition Examination Survey. The analytical sample consisted of 2,191 respondents aged 50 and older. Poor oral health was clinically defined by significant tooth loss (STL) and periodontal disease (PD). Diabetes mellitus (DM) was determined by glycemic levels. The outcome variable was serum C-reactive protein (CRP) level, dichotomised as ≥1 mg/dL (elevated CRP) vs <1 mg/dL (not elevated CRP). Two path models, one using STL and DM as the independent variable, the other using PD and DM as the independent variable, were estimated to assess the direct effects of having poor oral health and DM on elevated CRP and the mediating effects of dental flossing. RESULTS:In path model 1, individuals having both STL and DM (adjusted odds ratio [AOR], 1.92; 95% confidence interval [CI], 1.30-2.82) or having STL alone (AOR, 2.30; 95% CI, 1.68-3.15) were more likely to have elevated CRP than those with neither STL nor DM; dental flossing (AOR, 0.92, 95% CI, 0.88-0.96) was associated with lower risk of elevated CRP. In path model 2, no significant association was found between having both PD and DM and elevated CRP; dental flossing (AOR, 0.91; 95% CI:, 0.86-0.94) was associated with lower risk of elevated CRP. CONCLUSIONS:Findings from this study highlight the importance of improving oral health and oral hygiene practice to mitigate inflammation. Further research is needed to assess the longer-term effects of reducing inflammation.
PMID: 34857389
ISSN: 1875-595x
CID: 5066322

Impact of Laboratory Work Up and Supplementation on Alopecia Patients: A Single-Center Retrospective Chart Review

Kakpovbia, Efe; Ugonabo, Nkemjika; Chen, Alan; Adhikari, Samrachana; Ogbechie-Godec, Oluwatobi A; Sicco, Kristen Lo; Shapiro, Jerry
Evaluation of alopecia often includes laboratory testing for ferritin, thyroid stimulating hormone, vitamin D, and zinc as previous studies have found associations between non-scarring alopecia and vitamin deficiencies. These studies are limited by small sample sizes, and subsequent analyses showed conflicting results. This study aims to explore laboratory abnormalities in non-scarring alopecia and examine whether supplementation is associated with increased hair growth. A total of 131 patients completed at least two visits by a hair specialist at NYU&rsquo;s Faculty Group Practice. They had quantitative hair measurements taken at each visit and laboratory tests performed at the first visit. There were 20 (15.3%) patients with abnormal lab results. The most common vitamin deficiency was ferritin (6.5%). Forty-two (32%) patients received supplementations that specifically addressed their vitamin or hormone deficiency. Multivariate regression analysis showed that supplementation did not significantly impact hair density or diameter (P=0.73; P=0.96, respectively). Baseline hair density and diameter were positively associated with change in hair density and diameter, respectively (standardized coefficient [&beta;] 0.57, P&lt;0.01; &beta; 0.61, P&lt;0.01). The number of prescribed oral medications was negatively associated with change in hair diameter (&beta; -6.60, P=0.04). Limitations of this study include the single-center, retrospective design and the short followup interval. However, our findings suggest that vitamin supplementation may not lead to improved outcomes in non-scarring alopecia, thus limiting the utility of laboratory testing. Additional large-scale prospective studies are needed to improve our management of alopecia. J Drugs Dermatol. 2021;20(7):807-809. doi:10.36849/JDD.5886.
PMID: 34231996
ISSN: 1545-9616
CID: 5686742

EFFECTS OF THE CO-OCCURRENCE OF DIABETES AND TOOTH LOSS ON COGNITIVE FUNCTION [Meeting Abstract]

Luo, Huabin; Tan, Chenxin; Plassman, Brenda; Sloan, Frank; Schwartz, Mark; Adhikari, Samrachana; Qi, Xiang; Wu, Bei
ISI:000842009901050
ISSN: 2399-5300
CID: 5388252

THE IMPACT OF DIABETES AND EDENTULISM ON ALL-CAUSE MORTALITY: RACIAL AND ETHNIC DISPARITIES [Meeting Abstract]

Tan, Chenxin; Luo, Huabin; Sloan, Frank; Plassman, Brenda; Adhikari, Samrachana; Schwartz, Mark; Qi, Xiang; Wu, Bei
ISI:000842009901049
ISSN: 2399-5300
CID: 5388242

Methotrexate hampers immunogenicity to BNT162B2 mRNA COVID-19 vaccine in immune-mediated inflammatory disease [Meeting Abstract]

Haberman, R; Herati, R; Simon, D; Samanovic, M; Tuen, M; Blank, R; Koralov, S; Atreya, R; Tascilar, K; Allen, J; Castillo, R; Cornelius, A; Rackoff, P; Solomon, G; Adhikari, S; Azar, N; Rosenthal, P; Izmirly, P; Samuels, J; Golden, B; Reddy, S; Neurath, M; Abramson, S B; Schett, G; Mulligan, M; Scher, J
Background/Purpose: Patients with immune mediated inflammatory disorders (IMIDs) have an inherently heightened susceptibility to infection and may be considered high risk for developing COVID-19. While data regarding the COVID-19 vaccine's immunogenicity in an immunocompetent adult population is rapidly emerging, the ability of IMID patients to adequately respond to these vaccines is not known. Here, we investigate the humoral and cellular immune response to mRNA COVID-19 vaccines in patients with IMIDs on immunomodulatory treatment Methods: Patients with immune mediated inflammatory disorders (IMIDs) have an inherently heightened susceptibility to infection and may be considered high risk for developing COVID-19. While data regarding the COVID-19 vaccine's immunogenicity in an immunocompetent adult population is rapidly emerging, the ability of IMID patients to adequately respond to these vaccines is not known. Here, we investigate the humoral and cellular immune response to mRNA COVID-19 vaccines in patients with IMIDs on immunomodulatory treatment.
Result(s): The NY cohort baseline characteristics are found in Table 1. The Erlangen cohort consisted of 182 healthy subjects, 11 subjects with IMID receiving TNFi monotherapy, and 20 subjects with IMID on MTX monotherapy. In both cohorts, healthy individuals and those with IMID not on MTX were similar in age, while those IMID patients receiving MTX were generally older. In the NY cohort, of the healthy participants, 96.3% demonstrated adequate humoral immune response. Patients with IMID not on MTX achieved a similar rate of high antibody response rate (91.8%), while those on MTX had a lower rate of adequate humoral response (75.0%) (Figure 1A). This remains true even after the exclusion of patients who had evidence of prior COVID-19 infection (P= 0.014). Of note, 3 out of the 4 IMID patients receiving rituximab did not produce an adequate response. Similarly, in the Erlangen validation cohort, 98.3% of healthy controls, 90.9% of patients with IMID receiving TNFi monotherapy, and 50.0% receiving MTX monotherapy achieved adequate immunogenicity (Figure 1B). These differences remain significant when combining the cohorts, using a stricter definition of adequate response, and in a subgroup analysis by age. Cellular response was also analyzed in a subgroup of the NY cohort before and after second vaccination. Activated CD8+ T cells (CD8+ T cells expressing Ki67 and CD38) and the granzyme B-producing subset of these activated CD8+ T cells, were induced in immunocompetent adults and those with IMID not on MTX, but not induced in patients receiving MTX (Figure 2).
Conclusion(s): In two independent cohorts of IMID patients, MTX, a widely used immunomodulator for the treatment of several IMIDs, adversely affected humoral and cellular immune response to COVID-19 mRNA vaccines. Although precise cut offs for immunogenicity that correlate with vaccine efficacy are yet to be established, our findings suggest that different strategies may need to be explored in patients with IMID taking MTX to increase the chances of immunization efficacy against SARS-CoV-2, as has been demonstrated for other viral vaccines
PMCID:
EMBASE:637275567
ISSN: 2326-5205
CID: 5164692

Effects of the Co-occurrence of Diabetes Mellitus and Tooth Loss on Cognitive Function

Luo, Huabin; Tan, Chenxin; Adhikari, Samrachana; Plassman, Brenda L; Kamer, Angela R; Sloan, Frank A; Schwartz, Mark D; Qi, Xiang; Wu, Bei
OBJECTIVE:Both diabetes mellitus (DM) and poor oral health are common chronic conditions and risk factors of Alzheimer's disease and related dementia among older adults. This study assessed the effects of DM and complete tooth loss (TL) on cognitive function, accounting for their interactions. METHODS:Longitudinal data were obtained from the 2006, 2012, and 2018 waves of the Health and Retirement Study. This cohort study included 7,805 respondents aged 65 years or older with 18,331 person-year observations. DM and complete TL were self-reported. Cognitive function was measured by the Telephone Interview for Cognitive Status. Random-effect regressions were used to test the associations, overall and stratified by sex. RESULTS:Compared with older adults without neither DM nor complete TL, those with both conditions (b = -1.35, 95% confidence interval [CI]: -1.68, -1.02), with complete TL alone (b = -0.67, 95% CI: -0.88, -0.45), or with DM alone (b = -0.40, 95% CI: -0.59, -0.22), had lower cognitive scores. The impact of having both conditions was significantly greater than that of having DM alone (p < .001) or complete TL alone (p = 0.001). Sex-stratified analyses showed the effects were similar in males and females, except having DM alone was not significant in males. CONCLUSION/CONCLUSIONS:The co-occurrence of DM and complete TL poses an additive risk for cognition. Healthcare and family-care providers should pay attention to the cognitive health of patients with both DM and complete TL. Continued efforts are needed to improve older adults' access to dental care, especially for individuals with DM.
PMID: 34951384
ISSN: 1875-5828
CID: 5109162

Correction to: Bridging the evidence-to-practice gap: a stepped-wedge cluster randomized controlled trial evaluating practice facilitation as a strategy to accelerate translation of a multi-level adherence intervention into safety net practices

Schoenthaler, Antoinette; De La Calle, Franzenith; Soto, Amanda; Barrett, Derrel; Cruz, Jocelyn; Payano, Leydi; Rosado, Marina; Adhikari, Samrachana; Ogedegbe, Gbenga; Rosal, Milagros
PMID: 34674755
ISSN: 2662-2211
CID: 5080342

Validation of EHR medication fill data obtained through electronic linkage with pharmacies

Blecker, Saul; Adhikari, Samrachana; Zhang, Hanchao; Dodson, John A; Desai, Sunita M; Anzisi, Lisa; Pazand, Lily; Schoenthaler, Antoinette M; Mann, Devin M
PMID: 34595945
ISSN: 2376-1032
CID: 5050062