Cardiovascular health in early adulthood predicts the development of coronary heart disease in individuals with type 1 diabetes: 25 year follow-up from the Pittsburgh Epidemiology of Diabetes Complications study.

AIMS/HYPOTHESIS: Type 1 diabetes increases CHD risk. We examined the use of the American Heart Association's cardiovascular health metrics (blood pressure, total cholesterol, glucose/HbA1c, BMI, physical activity, diet, smoking) to predict incidence of CHD among individuals with type 1 diabetes, with the hypothesis that a better American Heart Association health metric profile would be associated with lower incident CHD. METHODS: Prevalence of the seven cardiovascular health metrics was determined using first and second visits from adult participants (mean age 28.6 years) in the Epidemiology of Diabetes Complications prospective cohort study of childhood-onset type 1 diabetes. An ideal metric score (0-7) was defined as the sum of all metrics within the ideal range, and a total metric score (0-14) was calculated based on poor, intermediate and ideal categories for each metric. Incident CHD development (medical record-confirmed CHD death, myocardial infarction, revascularisation, ischaemic electrocardiogram changes or Epidemiology of Diabetes Complications physician-determined angina) over 25 years of follow-up was examined by metric scores. RESULTS: Among 435 participants, BMI, blood pressure, total cholesterol and smoking demonstrated the highest prevalence within the ideal range, while diet and HbA1c demonstrated the lowest. During 25 years of follow-up, 177 participants developed CHD. In Cox models, each additional metric within the ideal range was associated with a 19% lower risk (p = 0.01), and each unit increase in total metric score was associated with a 17% lower risk (p < 0.01) of CHD, adjusting for diabetes duration, estimated glomerular filtration rate, albumin excretion rate, triacylglycerols, depression and white blood cell count. CONCLUSIONS/INTERPRETATION: Among individuals with type 1 diabetes, higher cardiovascular health metric scores were associated with lower risk of incident CHD. The American Heart Association-defined cardiovascular health metrics provide straightforward goals for health promotion that may reduce CHD risk in the type 1 diabetes population. Graphical abstract.

The role of Sociodemographic factors on goal achievement in a community-based diabetes prevention program behavioral lifestyle intervention.

BACKGROUND: The Diabetes Prevention Program (DPP) behavioral lifestyle intervention was effective among a diverse sample of adults with prediabetes. Demonstrated effectiveness in translated versions of the DPP lifestyle intervention (such as Group Lifestyle Balance, DPP-GLB) led to widescale usage with national program oversight and reimbursement. However, little is known about the success of these DPP-translation programs across subgroups of sociodemographic factors. This current effort investigated potential disparities in DPP-translation program primary goal achievement (physical activity and weight) by key sociodemographic factors. METHODS: Data were combined from two 12-month community-based DPP-GLB trials among overweight/obese individuals with prediabetes and/or metabolic syndrome. We evaluated change in weight (kilograms and percent) and activity (MET-hrs/week) and goal achievement (yes/no; ≥5% weight loss and 150 min per week activity) after 6 and 12 months of intervention within and across subgroups of race/ethnicity (non-Hispanic white, non-Hispanic black), employment status, education, income, and gender. RESULTS: Among 240 participants (85%) with complete data, most sociodemographic subgroups demonstrated significant weight loss. However, non-Hispanic white lost more weight at both 6 and 12 months compared to non-Hispanic black participants [median weight loss (IQR), 6 months: 5.7% (2.7-9.0) vs. 1.5% (1.2-7.5) p = .01 and 12 months: 4.8% (1.1-9.6) vs. 1.1% (- 2.0-3.7) p = .01, respectively]. In addition, a larger percentage of non-Hispanic white demonstrated a 5% weight loss at 6 and 12 months. Employment was significantly related to 12-month weight loss, with retired participants being the most successful. Men, participants with graduate degrees, and those with higher income were most likely to meet the activity goal at baseline and 12 months. Differences in physical activity goal achievement across gender, education, and income groups were significant at baseline, attenuated after 6 months, then re-emerged at 12 months. CONCLUSIONS: The DPP-GLB was effective in promoting weight loss and helped to alleviate disparities in physical activity levels after 6 months. Despite overall program success, differences in weight loss achievement by race/ethnicity were found and disparities in activity re-emerged after 12 months of intervention. These results support the need for intervention modification providing more tailored approaches to marginalized groups to maximize the achievement and maintenance of DPP-GLB behavioral goals. TRIAL REGISTRATION: NCT01050205 , NCT02467881 .

Electronic Health Record Population Health Management for Chronic Kidney Disease Care: A Cluster Randomized Clinical Trial.

Importance: Large gaps in clinical care in patients with chronic kidney disease (CKD) lead to poor outcomes. Objective: To compare the effectiveness of an electronic health record-based population health management intervention vs usual care for reducing CKD progression and improving evidence-based care in high-risk CKD. Design, Setting, and Participants: The Kidney Coordinated Health Management Partnership (Kidney CHAMP) was a pragmatic cluster randomized clinical trial conducted between May 2019 and July 2022 in 101 primary care practices in Western Pennsylvania. It included patients aged 18 to 85 years with an estimated glomerular filtration rate (eGFR) of less than 60 mL/min/1.73m2 with high risk of CKD progression and no outpatient nephrology encounter within the previous 12 months. Interventions: Multifaceted intervention for CKD comanagement with primary care clinicians included a nephrology electronic consultation, pharmacist-led medication management, and CKD education for patients. The usual care group received CKD care from primary care clinicians as usual. Main Outcomes and Measures: The primary outcome was time to 40% or greater reduction in eGFR or end-stage kidney disease. Results: Among 1596 patients (754 intervention [47.2%]; 842 control [52.8%]) with a mean (SD) age of 74 (9) years, 928 (58%) were female, 127 (8%) were Black, 9 (0.6%) were Hispanic, and the mean (SD) estimated glomerular filtration rate was 36.8 (7.9) mL/min/1.73m2. Over a median follow-up of 17.0 months, there was no significant difference in rate of primary outcome between the 2 arms (adjusted hazard ratio, 0.96; 95% CI, 0.67-1.38; P = .82). Angiotensin-converting enzyme inhibitor/angiotensin receptor blocker exposure was more frequent in intervention arm compared with the control group (rate ratio, 1.21; 95% CI, 1.02-1.43). There was no difference in the secondary outcomes of hypertension control and exposure to unsafe medications or adverse events between the arms. Several COVID-19-related issues contributed to null findings in the study. Conclusion and Relevance: In this study, among patients with moderate-risk to high-risk CKD, a multifaceted electronic health record-based population health management intervention resulted in more exposure days to angiotensin-converting enzyme inhibitors/angiotensin receptor blockers but did not reduce risk of CKD progression or hypertension control vs usual care. Trial Registration: ClinicalTrials.gov Identifier: NCT03832595.

A Comprehensive Exercise (COMEX) Intervention to Optimize Exercise Participation for Improving Patient-Centered Outcomes and Physical Functioning in Patients Receiving Hemodialysis: Development and Pilot Testing.

Rationale & Objective: To address the need for an intradialytic exercise program that is easily delivered in clinical setting, engaging and scalable, we developed a novel COMprehensive EXercise (COMEX) program based on input from patients receiving hemodialysis (HD), dialysis staff members and nephrologists. The objective of this study was to determine the feasibility, safety, and acceptance of COMEX during HD. Study Design: Single-arm prospective pilot feasibility study. Setting & Participants: Seventeen patients receiving in-center HD. Intervention: Three-month participation in the COMEX program, which included video-based dialysis chair exercises (aerobic and resistance) integrated with educational and motivational components. Outcomes: Data on recruitment, adherence, safety and acceptability were collected. Additional assessments were performed to evaluate changes in physical functioning, patient-reported symptoms, and objectively measured sleep and physical activity. We also examined the feasibility of obtaining skeletal muscle biopsies and blood samples to explore molecular mechanisms of muscle atrophy and to assess platelet mitochondrial function and adaptation to exercise during HD. Results: Thirteen of the 17 (76%) participants completed the 3-month intervention. The mean participant age was 63.6 ± 15.1 years. In total, 46% of participants were males, and 55% were White. The mean body mass index was 38.7 ± 11.6 kg/m2. There were no reported adverse effects, and the adherence rate to exercise sessions was high with 88% of the sessions completed. Patient satisfaction was high, as 100% of the patients would recommend the program to other dialysis patients. It was feasible to collect data on physical functioning, patient-reported symptoms, and objective sleep and physical activity and to obtain muscle biopsies and blood samples. Limitations: Small sample size, lack of an onsite exercise professional, and technological issues with telemedicine behavioral motivation. Conclusions: The COMEX intradialytic exercise intervention is safe and acceptable to patients, and outcome measures were feasible to obtain. Future studies should consider including exercise professionals to facilitate progression through a personalized exercise protocol. Funding Source: This work is supported by pilot award from P30 DK079307 (PI, Jhamb). Trial Registration: ClinicalTrials.gov, NCT03055299. Plain-Language Summary: We tested a new COMprehensive EXercise (COMEX) program to deliver exercise during dialysis. This 3-month program included video-based dialysis chair exercises (aerobic and resistance) integrated with educational and motivational components. Our study shows COMEX was feasible, had high satisfaction and adherence, and was safe. It was feasible to collect data on physical functioning, patient-reported symptoms, and objective sleep and physical activity and to obtain muscle biopsies and blood samples. Future studies should consider including exercise professionals to facilitate progression through a personalized exercise protocol.

Effects of Technology Assisted Stepped Collaborative Care Intervention to Improve Symptoms in Patients Undergoing Hemodialysis: The TACcare Randomized Clinical Trial.

Importance: Patients with end-stage kidney disease (ESKD) undergoing long-term hemodialysis often experience a high burden of debilitating symptoms for which effective treatment options are limited. Objective: To compare the effectiveness of a stepped collaborative care intervention vs attention control for reducing fatigue, pain, and depression among patients with ESKD undergoing long-term hemodialysis. Design, Setting, and Participants: Technology Assisted Stepped Collaborative Care (TACcare) was a parallel-group, single-blinded, randomized clinical trial of adult (≥18 years) patients undergoing long-term hemodialysis and experiencing clinically significant levels of fatigue, pain, and/or depression for which they were considering treatment. The trial took place in 2 US states (New Mexico and Pennsylvania) from March 1, 2018, to June 31, 2022. Data analyses were performed from July 1, 2022, to April 10, 2023. Interventions: The intervention group received 12 weekly sessions of cognitive behavioral therapy delivered via telehealth in the hemodialysis unit or patient home, and/or pharmacotherapy using a stepped approach in collaboration with dialysis and primary care teams. The attention control group received 6 telehealth sessions of health education. Main Outcomes and Measures: The coprimary outcomes were changes in fatigue (measured using the Functional Assessment of Chronic Illness Therapy Fatigue), average pain severity (Brief Pain Inventory), and/or depression (Beck Depression Inventory-II) scores at 3 months. Patients were followed up for 12 months to assess maintenance of intervention effects. Results: There were 160 participants (mean [SD] age, 58 [14] years; 72 [45%] women and 88 [55%] men; 21 [13%] American Indian, 45 [28%] Black, 28 [18%] Hispanic, and 83 [52%] White individuals) randomized, 83 to the intervention and 77 to the control group. In the intention-to-treat analyses, when compared with controls, patients in the intervention group experienced statistically and clinically significant reductions in fatigue (mean difference [md], 2.81; 95% CI, 0.86 to 4.75; P = .01) and pain severity (md, -0.96; 95% CI, -1.70 to -0.23; P = .02) at 3 months. These effects were sustained at 6 months (md, 3.73; 95% CI, 0.87 to 6.60; P = .03; and BPI, -1.49; 95% CI, -2.58 to -0.40; P = .02). Improvement in depression at 3 months was statistically significant but small (md -1.73; 95% CI, -3.18 to -0.28; P = .02). Adverse events were similar in both groups. Conclusions and Relevance: This randomized clinical trial found that a technology assisted stepped collaborative care intervention delivered during hemodialysis led to modest but clinically meaningful improvements in fatigue and pain at 3 months vs the control group, with effects sustained until 6 months. Trial Registration: ClinicalTrials.gov Identifier: NCT03440853.

Electronic health record based population health management to optimize care in CKD: Design of the Kidney Coordinated HeAlth Management Partnership (K-CHAMP) trial.

Primary care physicians (PCPs) provide the majority of medical care to patients with non-dialysis dependent CKD. However, PCPs report numerous limitations to providing expert CKD care, including poor patient education, inadequate diagnostic evaluation, suboptimal use of medications, and time limitations. The Kidney Coordinated HeAlth Management Partnership (Kidney CHAMP) trial is a cluster randomized controlled trial to evaluate the effectiveness of a novel centralized electronic health records (EHR)-delivered population health management (PHM) strategy for high-risk CKD patients on patient care, safety, and other outcomes of interest to patients, providers, and payors. Over a 42-month period, the trial will compare the effectiveness of a multifaceted intervention that combines early identification of high-risk patients, timely nephrology guidance, pharmacist-led medication management services, and CKD patient education to usual care and enroll 1650 high-risk CKD patients from 100 primary care practices. The primary outcome will be ≥40% decline in estimated glomerular filtration rate (eGFR) or end stage kidney disease. Key secondary outcomes will include blood pressure, renin-angiotensin aldosterone system inhibitors use, and exposure to potentially unsafe medications. If successful, our treatment approach could improve CKD care delivery and safety, resource allocation, and adoption of evidence-based CKD guideline-concordant care.

The Likely Underestimated Impact of Lifestyle Intervention: Diabetes Prevention Program Translation Examples.

INTRODUCTION: Lifestyle interventions promoting weight loss and physical activity are important elements of prevention efforts with the evaluation of program impact typically limited to weight loss. Unfortunately, diabetes/cardiovascular disease risk factors and activity are infrequently reported and inconsistent in findings when examined. This inconsistency may partially be due to a lack of consideration for ceiling effects because of broad risk profile inclusion criteria in community translation efforts. To demonstrate this, change in each individual cardiometabolic risk factor limited to those who, at baseline, had a clinically defined abnormal value for that risk factor was examined in 2 cohorts using identical community translations of the Diabetes Prevention Program lifestyle intervention. METHODS: For both studies (2010-2014, 2014-2019), adults with prediabetes and/or metabolic syndrome were recruited through community centers. Outcome measures collected at baseline and 6 months included BMI, activity, blood pressure, lipids, and fasting glucose. Data analyses examined pre-post change in each variable after 6 months of intervention and change within randomized groups at 6 months. RESULTS: Change results were examined for the entire cohort and separately for participants with baseline values outside the recommended range for that risk factor. Whether assessing the pre-post intervention change or change within the randomized groups at 6 months, often the risk factor-specific approach demonstrated a greater effect size for that variable and sometimes newly reached statistical significance. CONCLUSIONS: When examining the effectiveness of community translation efforts, consideration of the individual's baseline profile with risk factor-specific analysis is suggested to understand the full extent of the impact of the intervention.

The Impact of a Yearlong Diabetes Prevention Program-Based Lifestyle Intervention on Cardiovascular Health Metrics.

INTRODUCTION: The American Heart Association created "Life's Simple Seven" metrics to estimate progress toward improving US cardiovascular health in a standardized manner. Given the widespread use of federally funded Diabetes Prevention Program (DPP)-based lifestyle interventions such as the Group Lifestyle Balance (DPP-GLB), evaluation of change in health metrics within such a program is of national interest. This study examined change in cardiovascular health metric scores during the course of a yearlong DPP-GLB intervention. METHODS: Data were combined from 2 similar randomized trials offering a community based DPP-GLB lifestyle intervention to overweight/obese individuals with prediabetes and/or metabolic syndrome. Pre/post lifestyle intervention participation changes in 5 of the 7 cardiovascular health metrics were examined at 6 and 12 months (BMI, blood pressure, total cholesterol, fasting plasma glucose, physical activity). Smoking was rare and diet was not measured. RESULTS: Among 305 participants with complete data (81.8% of 373 eligible adults), significant improvements were demonstrated in all 5 risk factors measured continuously at 6 and 12 months. There were significant positive shifts in the "ideal" and "total" metric scores at both time points. Also noted were beneficial shifts in the proportion of participants across categories for BMI, activity, and blood pressure. CONCLUSION: AHA-metrics could have clinical utility in estimating an individual's cardiovascular health status and in capturing improvement in cardiometabolic/behavioral risk factors resulting from participation in a community-based translation of the DPP lifestyle intervention.

Data driven patterns of nutrient intake and coronary artery disease risk in adults with type 1 diabetes.

AIMS: Dietary intake provides a potential intervention target to reduce the high risk for coronary artery disease (CAD) in type 1 diabetes. This effort aimed to identify patterns of nutrient intake in young/middle-aged adults with type 1 diabetes and to examine associations between those patterns and development of CAD. METHODS: Principal component analysis was used to derive nutrient intake patterns among 514 individuals with childhood-onset (<17 years old) type 1 diabetes aged 18+ years and free of CAD (defined as CAD death, myocardial infarction, revascularization, ischemia, or study physician diagnosed angina). Cox models were used to assess the association between nutrient patterns and CAD incidence over 30-years of follow-up. RESULTS: Three nutrient principal components (PC) were identified: PC1 (high caffeine and saccharin intake), PC2 (high alcohol and caffeine, lower intake of essential nutrients) and PC3 (higher fiber/micronutrients, low alcohol). In unadjusted Cox models, only PC1 (negatively) and PC2 (positively) were associated with CAD risk. These associations were no longer significant after adjusting for diabetes duration. CONCLUSIONS: Important dietary components underlying the three patterns identified may have been influenced by diabetes duration or age. Future research can continue to explore patterns of nutrient intake over time and CAD development in type 1 diabetes.

Impact of Maintenance Session Attendance and Early Weight Loss Goal Achievement on Weight Loss Success in a Community-Based Diabetes Prevention Program Intervention.

PURPOSE: The purpose of this study was to examine how maintenance session attendance and 6-month weight loss (WL) goal achievement impacted 12-month 5% WL success in older adults participating in a community-based Diabetes Prevention Program (DPP) lifestyle intervention. METHODS: Data were combined from 2 community trials that delivered the 12-month DPP-based Group Lifestyle Balance (GLB) to overweight/obese adults (mean age = 62 years, 76% women) with prediabetes and/or metabolic syndrome. Included participants (n = 238) attended ≥4 core sessions (months 0-6) and had complete data on maintenance attendance (≥4 of 6 sessions during months 7-12) and 6- and 12-month WL (5% WL goal, yes/no). Multivariate logistic regression was used to estimate the odds of 12-month 5% WL associated with maintenance attendance and 6-month WL. Associations between age (Medicare-eligible ≥65 vs <65 years) and WL and attendance were examined. RESULTS: Both attending ≥4 maintenance sessions and meeting the 6-month 5% WL goal increased the odds of meeting the 12-month 5% WL goal. For those not meeting the 6-month WL goal, maintenance session attendance did not improve odds of 12-month WL success. Medicare-eligible adults ≥65 years were more likely to meet the 12-month WL goal (odds ratio = 3.03, 95% CI, 1.58-5.81) versus <65 years. CONCLUSIONS: The results of this study provide important information regarding participant attendance and WL for providers offering DPP-based lifestyle intervention programs across the country who are seeking Medicare reimbursement. Understanding Medicare reimbursement-defined success will allow these providers to focus on and develop strategies to enhance program effectiveness and sustainability.