Browsing by Author "Diamantidis, Clarissa J"
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Item Open Access Addressing Diabetes and Poorly Controlled Hypertension: Pragmatic mHealth Self-Management Intervention.(Journal of medical Internet research, 2019-04) Lewinski, Allison A; Patel, Uptal D; Diamantidis, Clarissa J; Oakes, Megan; Baloch, Khaula; Crowley, Matthew J; Wilson, Jonathan; Pendergast, Jane; Biola, Holly; Boulware, L Ebony; Bosworth, Hayden BBackground
Patients with diabetes and poorly controlled hypertension are at increased risk for adverse renal and cardiovascular outcomes. Identifying these patients early and addressing modifiable risk factors is central to delaying renal complications such as diabetic kidney disease. Mobile health (mHealth), a relatively inexpensive and easily scalable technology, can facilitate patient-centered care and promote engagement in self-management, particularly for patients of lower socioeconomic status. Thus, mHealth may be a cost-effective way to deliver self-management education and support.Objective
This feasibility study aimed to build a population management program by identifying patients with diabetes and poorly controlled hypertension who were at risk for adverse renal outcomes and evaluate a multifactorial intervention to address medication self-management. We recruited patients from a federally qualified health center (FQHC) in an underserved, diverse county in the southeastern United States.Methods
Patients were identified via electronic health record. Inclusion criteria were age between 18 and 75 years, diagnosis of type 2 diabetes, poorly controlled hypertension over the last 12 months (mean clinic systolic blood pressure [SBP] ≥140 mm Hg and/or diastolic blood pressure [DBP] ≥90 mm Hg), access to a mobile phone, and ability to receive text messages and emails. The intervention consisted of monthly telephone calls for 6 months by a case manager and weekly, one-way informational text messages. Engagement was defined as the number of phone calls completed during the intervention; individuals who completed 4 or more calls were considered engaged. The primary outcome was change in SBP at the conclusion of the intervention.Results
Of the 141 patients enrolled, 84.0% (118/141) of patients completed 1 or more phone calls and had follow-up SBP measurements for analysis. These patients were on average 56.9 years of age, predominately female (73/118, 61.9%), and nonwhite by self-report (103/118, 87.3%). The proportion of participants with poor baseline SBP control (50/118, 42.4%) did not change significantly at study completion (53/118, 44.9%) (P=.64). Participants who completed 4 or more phone calls (98/118, 83.1%) did not experience a statistically significant decrease in SBP when compared to those who completed fewer calls.Conclusion
We did not reduce uncontrolled hypertension even among the more highly engaged. However, 83% of a predominately minority and low-income population completed at least 67% of the multimodal mHealth intervention. Findings suggest that combining an automated electronic health record system to identify at-risk patients with a tailored mHealth protocol can provide education to this population. While this intervention was insufficient to effect behavioral change resulting in better hypertension control, it does suggest that this FQHC population will engage in low-cost population health applications with a potentially promising impact.Trial registration
ClinicalTrials.gov NCT02418091; https://clinicaltrials.gov/ct2/show/NCT02418091 (Archived by WebCite at http://www.webcitation.org/76RBvacVU).Item Open Access Clinical Outcomes Among High-Risk Primary Care Patients With Diabetic Kidney Disease: Methodological Challenges and Results From the STOP-DKD Study.(Medical care, 2024-07) Bosworth, Hayden B; Patel, Uptal D; Lewinski, Allison A; Davenport, Clemontina A; Pendergast, Jane; Oakes, Megan; Crowley, Matthew J; Zullig, Leah L; Patel, Sejal; Moaddeb, Jivan; Miller, Julie; Malone, Shauna; Barnhart, Huiman; Diamantidis, Clarissa JBackground/objective
Slowing the progression of diabetic kidney disease (DKD) is critical. We conducted a randomized controlled trial to target risk factors for DKD progression.Methods
We evaluated the effect of a pharmacist-led intervention focused on supporting healthy behaviors, medication management, and self-monitoring on decline in estimated glomerular filtration rate (eGFR) for 36 months compared with an educational control.Results
We randomized 138 individuals to the intervention group and 143 to control. At baseline, mean (SD) eGFR was 80.7 (21.7) mL/min/1.73m2, 56% of participants had chronic kidney disease and a history of uncontrolled hypertension with a baseline SBP of 134.3 mm Hg. The mean (SD) decline in eGFR by cystatin C from baseline to 36 months was 5.0 (19.6) and 5.9 (18.6) mL/min/1.73m2 for the control and intervention groups, respectively, with no significant between-group difference (P=0.75).Conclusions
We did not observe a significant difference in clinical outcomes by study arm. However, we showed that individuals with DKD will engage in a pharmacist-led intervention. The potential explanations for a lack of change in DKD risk factors can be attributed to 5 broad issues, challenges: (1) associated with enrolling patients with low eGFR and poor BP control; (2) implementing the intervention; (3) limited duration during which to observe any clinical benefit from the intervention; (4) potential co-intervention or contamination; and (5) low statistical power.Item Open Access Evaluation of Allostatic Load as a Mediator of Sleep and Kidney Outcomes in Black Americans.(Kidney international reports, 2019-03) Lunyera, Joseph; Davenport, Clemontina A; Jackson, Chandra L; Johnson, Dayna A; Bhavsar, Nrupen A; Sims, Mario; Scialla, Julia J; Stanifer, John W; Pendergast, Jane; McMullan, Ciaran J; Ricardo, Ana C; Boulware, L Ebony; Diamantidis, Clarissa JIntroduction:Poor sleep associates with adverse chronic kidney disease (CKD) outcomes yet the biological mechanisms underlying this relation remain unclear. One proposed mechanism is via allostatic load, a cumulative biologic measure of stress. Methods:Using data from 5177 Jackson Heart Study participants with sleep measures available, we examined the association of self-reported sleep duration: very short, short, recommended, and long (≤5, 6, 7-8, or ≥9 hours per 24 hours, respectively) and sleep quality (high, moderate, low) with prevalent baseline CKD, and estimated glomerular filtration rate (eGFR) decline and incident CKD at follow-up. CKD was defined as eGFR <60 ml/min per 1.73 m2 or urine albumin-to-creatinine ratio ≥30 mg/g. Models were adjusted for demographics, comorbidities, and kidney function. We further evaluated allostatic load (quantified at baseline using 11 biomarkers from neuroendocrine, metabolic, autonomic, and immune domains) as a mediator of these relations using a process analysis approach. Results:Participants with very short sleep duration (vs. 7-8 hours) had greater odds of prevalent CKD (odds ratio [OR] 1.31, 95% confidence interval [CI] 1.03-1.66). Very short, short, or long sleep duration (vs. 7-8 hours) was not associated with kidney outcomes over a median follow-up of 8 years. Low sleep quality (vs. high) associated with greater odds of prevalent CKD (OR 1.26, 95% CI 1.00-1.60) and 0.18 ml/min per 1.73 m2 (95% CI 0.00-0.36) faster eGFR decline per year. Allostatic load did not mediate the associations of sleep duration or sleep quality with kidney outcomes. Conclusions:Very short sleep duration and low sleep quality were associated with adverse kidney outcomes in this all-black cohort, but allostatic load did not appear to mediate these associations.Item Open Access Low use of routine medical care among African Americans with high CKD risk: the Jackson Heart Study.(BMC nephrology, 2019-01-10) Diamantidis, Clarissa J; Davenport, Clemontina A; Lunyera, Joseph; Bhavsar, Nrupen; Scialla, Julia; Hall, Rasheeda; Tyson, Crystal; Sims, Mario; Strigo, Tara; Powe, Neil R; Boulware, L EbonyBACKGROUND:Use of routine medical care (RMC) is advocated to address ethnic/racial disparities in chronic kidney disease (CKD) risks, but use is less frequent among African Americans. Factors associated with low RMC use among African Americans at risk of renal outcomes have not been well studied. METHODS:We examined sociodemographic, comorbidity, healthcare access, and psychosocial (discrimination, anger, stress, trust) factors associated with low RMC use in a cross-sectional study. Low RMC use was defined as lack of a physical exam within one year among participants with CKD (estimated glomerular filtration rate < 60 mL/min/1.73m2 or urine albumin-to-creatinine ratio > 30 mg/g) or CKD risk factors (diabetes or hypertension). We used multivariable logistic regression to estimate the odds of low RMC use at baseline (2000-2004) for several risk factors. RESULTS:Among 3191 participants with CKD, diabetes, or hypertension, 2024 (63.4%) were ≥ 55 years of age, and 700 (21.9%) reported low RMC use. After multivariable adjustment, age < 55 years (OR 1.61 95% CI 1.31-1.98), male sex (OR 1.71; 1.41-2.07),Item Open Access Multiple, objectively measured sleep dimensions including hypoxic burden and chronic kidney disease: findings from the Multi-Ethnic Study of Atherosclerosis(Thorax) Jackson, Chandra L; Umesi, Chizoba; Gaston, Symielle A; Azarbarzin, Ali; Lunyera, Joseph; McGrath, John A; Jackson Ii, W Braxton; Diamantidis, Clarissa J; Boulware, Ebony; Lutsey, Pamela L; Redline, SusanBackgroundPoor sleep may contribute to chronic kidney disease (CKD) through several pathways, including hypoxia-induced systemic and intraglomerular pressure, inflammation, oxidative stress and endothelial dysfunction. However, few studies have investigated the association between multiple objectively measured sleep dimensions and CKD.MethodsWe investigated the cross-sectional association between sleep dimensions and CKD among 1895 Multi-Ethnic Study of Atherosclerosis Sleep Ancillary Study participants who completed in-home polysomnography, wrist actigraphy and a sleep questionnaire. Using Poisson regression models with robust variance, we estimated separate prevalence ratios (PR) and 95% CIs for moderate-to-severe CKD (glomerular filtration rate <60 mL/min/1.73 m2 or albuminuria >30 mg/g) among participants according to multiple sleep dimensions, including very short (≤5 hours) sleep, Apnoea−Hypopnoea Index and sleep apnoea-specific hypoxic burden (SASHB) (total area under the respiratory event-related desaturation curve divided by total sleep duration, %min/hour)). Regression models were adjusted for sociodemographic characteristics, health behaviours and clinical characteristics.ResultsOf the 1895 participants, mean age was 68.2±9.1 years, 54% were women, 37% were white, 28% black, 24% Hispanic/Latino and 11% Asian. Several sleep metrics were associated with higher adjusted PR of moderate-to-severe CKD: very short versus recommended sleep duration (PR=1.40, 95% CI 1.06 to 1.83); SASHB (Box-Cox transformed SASHB: PR=1.06, 95% CI 1.02 to 1.12); and for participants in the highest quintile of SASHB plus sleep apnoea: PR=1.28, 95% CI 1.01 to 1.63.ConclusionsSleep apnoea associated hypoxia and very short sleep, likely representing independent biological mechanisms, were associated with a higher moderate-to-severe CKD prevalence, which highlights the potential role for novel interventions.Item Open Access Primary Care Providers' Acceptance of Pharmacists' Recommendations to Support Optimal Medication Management for Patients with Diabetic Kidney Disease.(Journal of general internal medicine, 2020-01) Zullig, Leah L; Jazowski, Shelley A; Davenport, Clemontina A; Diamantidis, Clarissa J; Oakes, Megan M; Patel, Sejal; Moaddeb, Jivan; Bosworth, Hayden BBackground
Patients with diabetic kidney disease (DKD) often struggle with blood pressure control. In team-based models of care, pharmacists and primary care providers (PCPs) play important roles in supporting patients' blood pressure management.Objective
To describe whether PCPs' acceptance of pharmacists' recommendations impacts systolic blood pressure (SBP) at 36 months.Design
An observational analysis of a subset of participants randomized to the intervention arm of the Simultaneous risk factor control using Telehealth to slOw Progression of Diabetic Kidney Disease (STOP-DKD) study.Participants
STOP-DKD participants for whom (1) the pharmacist made at least one recommendation to the PCP; (2) there were available data regarding the PCP's corresponding action; and (3) there were SBP measurements at baseline and 36 months.Intervention
Participants received monthly telephone calls with a pharmacist addressing health behaviors and medication management. Pharmacists made medication-related recommendations to PCPs.Main measures
We fit an unadjusted generalized linear mixed model to assess the association between the number of pharmacists' recommendations for DKD and blood pressure management and PCPs' acceptance of such recommendations. We used a linear regression model to evaluate the association between PCP acceptance and SBP at 36 months, adjusted for baseline SBP.Key results
Pharmacists made 176 treatment recommendations (among 59 participants), of which 107 (61%) were accepted by PCPs. SBP significantly declined by an average of 10.5 mmHg (p < 0.01) among 47 of 59 participants who had valid measurements at baseline and 36 months. There was a significant association between the number of pharmacist recommendations and the odds of PCP acceptance (OR 1.19; 95%CI 1.00, 1.42; p < 0.05), but no association between the number of accepted recommendations and SBP.Conclusions
Pharmacists provided actionable medication-related recommendations. We identified a significant decline in SBP at 36 months, but this reduction was not associated with recommendation acceptance.Trial registration
NCT01829256.Item Open Access Racial differences in nocturnal dipping status in diabetic kidney disease: Results from the STOP-DKD (Simultaneous Risk Factor Control Using Telehealth to Slow Progression of Diabetic Kidney Disease) study.(Journal of clinical hypertension (Greenwich, Conn.), 2017-12) Zullig, Leah L; Diamantidis, Clarissa J; Bosworth, Hayden B; Bhapkar, Manjushri V; Barnhart, Huiman; Oakes, Megan M; Pendergast, Jane F; Miller, Julie J; Patel, Uptal DWhile racial variation in ambulatory blood pressure (BP) is known, patterns of diurnal dipping in the context of diabetic kidney disease have not been well defined. The authors sought to determine the association of race with nocturnal dipping status among participants with diabetic kidney disease enrolled in the STOP-DKD (Simultaneous Risk Factor Control Using Telehealth to Slow Progression of Diabetic Kidney Disease) trial. The primary outcome was nocturnal dipping-percent decrease in average systolic BP from wake to sleep-with categories defined as reverse dippers (decrease <0%), nondippers (0%-<10%), and dippers (≥10%). Twenty-four-hour ambulatory BP monitoring was completed by 108 participants (54% were nondippers, 24% were dippers, and 22% were reverse dippers). In adjusted models, the common odds of reverse dippers vs nondippers/dippers and reverse dippers/nondippers vs dippers was 2.6 (95% confidence interval, 1.2-5.8) times higher in blacks than in whites. Without ambulatory BP monitoring data, interventions that target BP in black patients may be unable to improve outcomes in this high-risk group.Item Open Access Racial Differences in the Effectiveness of a Multifactorial Telehealth Intervention to Slow Diabetic Kidney Disease.(Medical care, 2020-11) Kobe, Elizabeth A; Diamantidis, Clarissa J; Bosworth, Hayden B; Davenport, Clemontina A; Oakes, Megan; Alexopoulos, Anastasia-Stefania; Pendergast, Jane; Patel, Uptal D; Crowley, Matthew JBackground
African Americans are significantly more likely than non-African Americans to have diabetes, chronic kidney disease, and uncontrolled hypertension, increasing their risk for kidney function decline.Objective
The objective of this study was to compare how African Americans and non-African Americans with diabetes responded to a multifactorial telehealth intervention designed to slow kidney function decline.Research design
Secondary analysis of a randomized trial. Primary care patients (N=281, 56% African American) were allocated to either: (1) a multifactorial, pharmacist-delivered phone-based telehealth intervention focused on behavioral and medication management of diabetic kidney disease; or (2) an education control.Measures
The primary study outcome was change in estimated glomerular filtration rate (eGFR). Linear mixed models were used to explore the moderating effect of race on the relationship between study arm and eGFR decline over time; the mean annual rate of eGFR decline was estimated by race and study arm.Results
Findings demonstrated a differential intervention effect on kidney function over time by race (Pinteraction=0.005). Among African Americans, the intervention arm had significantly greater preservation of eGFR over time than the control arm (difference in the annual rate of eGFR decline=1.5 mL/min/1.73 m; 95% confidence interval: 0.04, 3.02). For non-African Americans, the intervention arm had a faster decline in eGFR over time than the control arm (difference in the annual rate of eGFR decline=-1.7 mL/min/1.73 m; 95% confidence interval: -3.3, -0.02).Conclusion
A multifactorial, pharmacist-delivered telehealth intervention for diabetic kidney disease may be more effective for slowing eGFR decline among African Americans than non-African Americans.Item Open Access Simultaneous Risk Factor Control Using Telehealth to slOw Progression of Diabetic Kidney Disease (STOP-DKD) study: Protocol and baseline characteristics of a randomized controlled trial.(Contemporary clinical trials, 2018-06) Diamantidis, Clarissa J; Bosworth, Hayden B; Oakes, Megan M; Davenport, Clemontina A; Pendergast, Jane F; Patel, Sejal; Moaddeb, Jivan; Barnhart, Huiman X; Merrill, Peter D; Baloch, Khaula; Crowley, Matthew J; Patel, Uptal DDiabetic kidney disease (DKD) is the leading cause of end-stage kidney disease (ESKD) in the United States. Multiple risk factors contribute to DKD development, yet few interventions target more than a single DKD risk factor at a time. This manuscript describes the study protocol, recruitment, and baseline participant characteristics for the Simultaneous Risk Factor Control Using Telehealth to slOw Progression of Diabetic Kidney Disease (STOP-DKD) study. The STOP-DKD study is a randomized controlled trial designed to evaluate the effectiveness of a multifactorial behavioral and medication management intervention to mitigate kidney function decline at 3 years compared to usual care. The intervention consists of up to 36 monthly educational modules delivered via telephone by a study pharmacist, home blood pressure monitoring, and medication management recommendations delivered electronically to primary care physicians. Patients seen at seven primary care clinics in North Carolina, with diabetes and [1] uncontrolled hypertension and [2] evidence of kidney dysfunction (albuminuria or reduced estimated glomerular filtration rate [eGFR]) were eligible to participate. Study recruitment completed in December 2014. Of the 281 participants randomized, mean age at baseline was 61.9; 52% were male, 56% were Black, and most were high school graduates (89%). Baseline co-morbidity was high- mean blood pressure was 134/76 mmHg, mean body mass index was 35.7 kg/m2, mean eGFR was 80.7 ml/min/1.73 m2, and mean glycated hemoglobin was 8.0%. Experiences of recruiting and implementing a comprehensive DKD program to individuals at high risk seen in the primary care setting are provided.Trial registration
NCT01829256.Item Open Access The relationship between Pittsburgh Sleep Quality Index subscales and diabetes control.(Chronic illness, 2019-09) Telford, Onala; Diamantidis, Clarissa J; Bosworth, Hayden B; Patel, Uptal D; Davenport, Clemontina A; Oakes, Megan M; Crowley, Matthew JOBJECTIVES:: Data suggest that poor sleep quality as measured by the Pittsburgh Sleep Quality Index (PSQI) contributes to suboptimal diabetes control. How the subscales comprising the PSQI individually relate to diabetes control is poorly understood. METHODS:: In order to explore how PSQI subscales relate to diabetes control, we analyzed baseline data from a trial of a telemedicine intervention for diabetes. We used multivariable modeling to examine: (1) the relationship between the global PSQI and hemoglobin A1c (HbA1c); (2) the relationships between the 7 PSQI subscales and HbA1c; and (3) medication nonadherence as a possible mediating factor. RESULTS:: Global PSQI was not associated with HbA1c (n = 279). Only one PSQI subscale, sleep disturbances, was associated with HbA1c after covariate adjustment; HbA1c increased by 0.4 points for each additional sleep disturbances subscale point (95%CI 0.1 to 0.8). Although the sleep disturbances subscale was associated with medication nonadherence (OR 2.04, 95%CI 1.27 to 3.30), a mediation analysis indicated nonadherence does not mediate the sleep disturbances-HbA1c relationship. DISCUSSION:: The sleep disturbances subscale may drive the previously observed relationship between PSQI and HbA1c. The mechanism for the relationship between sleep disturbances and HbA1c remains unclear, as does the impact on HbA1c of addressing sleep disturbances.Item Open Access Urine tricarboxylic acid cycle signatures of early-stage diabetic kidney disease.(Metabolomics : Official journal of the Metabolomic Society, 2021-12) Lunyera, Joseph; Diamantidis, Clarissa J; Bosworth, Hayden B; Patel, Uptal D; Bain, James; Muehlbauer, Michael J; Ilkayeva, Olga; Nguyen, Maggie; Sharma, Binu; Ma, Jennie Z; Shah, Svati H; Scialla, Julia JIntroduction
Urine tricarboxylic acid (TCA) cycle organic anions (OAs) are elevated in diabetes and may be biomarkers for diabetic kidney disease (DKD) progression.Objectives
We assessed associations of 10 urine TCA cycle OAs with estimated glomerular filtration rate (eGFR) and eGFR slope.Methods
This study is ancillary to the Simultaneous Risk Factor Control Using Telehealth to SlOw Progression of Diabetic Kidney Disease (STOP-DKD) Trial-a randomized trial of pharmacist-led medication and behavior management in 281 patients with early to moderate DKD at Duke from 2014 to 2015. We used linear mixed models to assess associations of urine TCA cycle OAs with outcomes and modelled TCA cycle OAs as: (1) the average of z-scores for each OA; and (2) principal component (PC) scores derived by principal component analysis (PCA). Untargeted urine metabolomics were added for additional discovery.Results
Among 132 participants with 24 h urine samples (50% men; 58% Black; mean age 64 years [SD 9]; mean eGFR 74 ml/min/1.73m2 [SD 21] and median urine albumin-to-creatinine [UACR] 20 mg/g [IQR 8-95]), PCA identified 3 OA metabolite PCs. Malate, fumarate, pyruvate, α-ketoglutarate, lactate, succinate and citrate/isocitrate loaded positively on PC1; methylsuccinate, ethylmalonate and succinate loaded positively on PC2; and methylmalonate, ethylmalonate and citrate/isocitrate loaded negatively on PC3. Over a median follow-up of 1.8 years (IQR, 1.2 to 2.2), higher average OA z-score was strongly associated with higher eGFR after covariate adjustment (p = 0.01), but not with eGFR slope (p = 0.9). Higher PC3, but not other PCs, was associated with lower eGFR (p < 0.001). Conditional random forests and smooth clipped absolute deviation models confirmed methylmalonate, citrate/isocitrate, and ethylmalonate, and added lactate as top ranked metabolites in models of baseline eGFR (R-squared 0.32 and 0.33, respectively). Untargeted urine metabolites confirmed association of urine TCA cycle OAs with kidney function.Conclusion
Thus, lower urine TCA cycle OAs, most notably lower methylmalonate, ethylmalonate and citrate/isocitrate, are potential indicators of kidney impairment in early stage DKD.