Browsing by Subject "Glycated Hemoglobin"
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Item Open Access Antenatal haemoglobin A1c and risk of large-for-gestational-age infants in a multi-ethnic cohort of women with gestational diabetes.(Paediatric and perinatal epidemiology, 2012-05) Katon, Jodie; Reiber, Gayle; Williams, Michelle A; Yanez, David; Miller, EdithGestational diabetes mellitus (GDM) is a risk factor for delivering a large-for-gestational-age (LGA) infant. Haemoglobin A1c (A1C) is an indicator of glycaemic control. The objective of this study was to test whether higher A1C quartile at the time of diagnosis of GDM is associated with increased risk of delivering a LGA or macrosomic infant. Women with singleton pregnancies treated for GDM at a large diabetes and pregnancy programme located in Charlotte, North Carolina, were eligible for inclusion in this retrospective cohort study. Clinical information, including A1C at diagnosis, treatment, prior medical and obstetric history, and birth data were abstracted from medical records. LGA was defined as birthweight >90th percentile for gestational age and sex and macrosomia as birthweight >4000 g. Logistic regression was used to analyse the association of A1C at GDM diagnosis with risk of delivering LGA or macrosomic infants. This study included 502 women. Prevalences of LGA and macrosomia were 4% and 6% respectively. After adjustment there was no detectable trend of increased risk for LGA (P for trend = 0.12) or macrosomia (P for trend = 0.20) across increasing quartiles of A1C at GDM diagnosis. A1C at GDM diagnosis may not be linearly associated with LGA or macrosomia, possibly because of the mediating effect of strict glycaemic control in this clinical setting.Item Open Access Enhanced fitness: a randomized controlled trial of the effects of home-based physical activity counseling on glycemic control in older adults with prediabetes mellitus.(Journal of the American Geriatrics Society, 2012-09) Morey, MC; Pieper, CF; Edelman, DE; Yancy Jr, WS; Green, JB; Lum, H; Peterson, MJ; Sloane, R; Cowper, PA; Bosworth, HB; Huffman, KM; Cavanaugh, JT; Hall, KS; Pearson, MP; Taylor, GAOBJECTIVE: To determine whether a home-based multicomponent physical activity counseling (PAC) intervention is effective in reducing glycemic measures in older outpatients with prediabetes mellitus. METHODS: Controlled clinical trial. METHODS: Primary care clinics of the Durham Veterans Affairs (VA) Medical Center between September 29, 2008, and March 25, 2010. METHODS: Three hundred two overweight (body mass index 25-45 kg/m(2) ), older (60-89) outpatients with impaired glucose tolerance (fasting blood glucose 100-125 mg/dL, glycosylated hemoglobin (HbA1c)Item Open Access Factors associated with persistent poorly controlled diabetes mellitus: clues to improving management in patients with resistant poor control.(Chronic illness, 2014-12) Crowley, Matthew J; Holleman, Rob; Klamerus, Mandi L; Bosworth, Hayden B; Edelman, David; Heisler, MicheleObjectives
Patients with persistent poorly controlled diabetes mellitus (PPDM), defined as an uninterrupted hemoglobin A1c >8.0% for ≥1 year despite standard care, are at high risk for complications. Additional research to define patient factors associated with PPDM could suggest barriers to improvement in this group and inform the development of targeted strategies to address these patients' resistant diabetes.Methods
We analyzed patients with type 2 diabetes from a multi-site randomized trial. We characterized patients with PPDM relative to other patients using detailed survey data and multivariable modeling.Results
Of 963 patients, 118 (12%) had PPDM, 265 (28%) were intermittently poorly controlled, and 580 (60%) were well-controlled. Patients with PPDM had younger age, earlier diabetes diagnosis, insulin use, higher antihypertensive burden, higher low-density lipoprotein cholesterol, and lower statin use relative to well-controlled patients. Among patients with objective adherence data (Veterans Affairs patients), a larger oral diabetes medication refill gap was associated with PPDM.Discussion
Strategies are needed to target-specific barriers to improvement among patients whose diabetes is resistant to standard diabetes care. Our data suggest that strategies for targeting PPDM should accommodate younger patients' lifestyles, include medication management for insulin titration and comorbid disease conditions, and address barriers to self-management adherence.Item Open Access Heart matters: Gender and racial differences cardiovascular disease risk factor control among veterans.(Women's health issues : official publication of the Jacobs Institute of Women's Health, 2014-09) Goldstein, Karen M; Melnyk, S Dee; Zullig, Leah L; Stechuchak, Karen M; Oddone, Eugene; Bastian, Lori A; Rakley, Susan; Olsen, Maren K; Bosworth, Hayden BBackground
Cardiovascular disease (CVD) is the leading cause of mortality for U.S. women. Racial minorities are a particularly vulnerable population. The increasing female veteran population has an higher prevalence of certain cardiovascular risk factors compared with non-veteran women; however, little is known about gender and racial differences in cardiovascular risk factor control among veterans.Methods
We used analysis of variance, adjusting for age, to compare gender and racial differences in three risk factors that predispose to CVD (diabetes, hypertension, and hyperlipidemia) in a cohort of high-risk veterans eligible for enrollment in a clinical trial, including 23,955 men and 1,010 women.Findings
Low-density lipoprotein (LDL) values were higher in women veterans than men with age-adjusted estimated mean values of 111.7 versus 97.6 mg/dL (p < .01). Blood pressures (BPs) were higher among African-American than White female veterans with age-adjusted estimated mean systolic BPs of 136.3 versus 133.5 mmHg, respectively (p < .01), and diastolic BPs of 82.4 versus 78.9 mmHg (p < .01). African-American veterans with diabetes had worse BP, LDL values, and hemoglobin A1c levels, although the differences were only significant among men.Conclusions
Female veterans have higher LDL cholesterol levels than male veterans and African-American veterans have higher BP, LDL cholesterol, and A1c levels than Whites after adjusting for age. Further examination of CVD gender and racial disparities in this population may help to develop targeted treatments and strategies applicable to the general population.Item Open Access Implementation of an Intensive Telehealth Intervention for Rural Patients with Clinic-Refractory Diabetes.(Journal of general internal medicine, 2022-09) Kobe, Elizabeth A; Lewinski, Allison A; Jeffreys, Amy S; Smith, Valerie A; Coffman, Cynthia J; Danus, Susanne M; Sidoli, Elisabeth; Greck, Beth D; Horne, Leanne; Saxon, David R; Shook, Susan; Aguirre, Lina E; Esquibel, Mary G; Evenson, Clarene; Elizagaray, Christopher; Nelson, Vivian; Zeek, Amanda; Weppner, William G; Scodellaro, Stephanie; Perdew, Cassie J; Jackson, George L; Steinhauser, Karen; Bosworth, Hayden B; Edelman, David; Crowley, Matthew JBackground
Rural patients with type 2 diabetes (T2D) may experience poor glycemic control due to limited access to T2D specialty care and self-management support. Telehealth can facilitate delivery of comprehensive T2D care to rural patients, but implementation in clinical practice is challenging.Objective
To examine the implementation of Advanced Comprehensive Diabetes Care (ACDC), an evidence-based, comprehensive telehealth intervention for clinic-refractory, uncontrolled T2D. ACDC leverages existing Veterans Health Administration (VHA) Home Telehealth (HT) infrastructure, making delivery practical in rural areas.Design
Mixed-methods implementation study.Participants
230 patients with clinic-refractory, uncontrolled T2D.Intervention
ACDC bundles telemonitoring, self-management support, and specialist-guided medication management, and is delivered over 6 months using existing VHA HT clinical staffing/equipment. Patients may continue in a maintenance protocol after the initial 6-month intervention period.Main measures
Implementation was evaluated using the Reach, Effectiveness, Adoption, Implementation, and Maintenance (RE-AIM) framework. The primary effectiveness outcome was hemoglobin A1c (HbA1c).Key results
From 2017 to 2020, ACDC was delivered to 230 patients across seven geographically diverse VHA sites; on average, patients were 59 years of age, 95% male, 80% white, and 14% Hispanic/Latinx. Patients completed an average of 10.1 of 12 scheduled encounters during the 6-month intervention period. Model-estimated mean baseline HbA1c was 9.56% and improved to 8.14% at 6 months (- 1.43%, 95% CI: - 1.64, - 1.21; P < .001). Benefits persisted at 12 (- 1.26%, 95% CI: - 1.48, - 1.05; P < .001) and 18 months (- 1.08%, 95% CI - 1.35, - 0.81; P < .001). Patients reported increased engagement in self-management and awareness of glycemic control, while clinicians and HT nurses reported a moderate workload increase. As of this submission, some sites have maintained delivery of ACDC for up to 4 years.Conclusions
When strategically designed to leverage existing infrastructure, comprehensive telehealth interventions can be implemented successfully, even in rural areas. ACDC produced sustained improvements in glycemic control in a previously refractory population.Item Open Access Improving health engagement and lifestyle management for breast cancer survivors with diabetes.(Contemporary clinical trials, 2020-05) Shelby, Rebecca A; Dorfman, Caroline S; Arthur, Sarah S; Bosworth, Hayden B; Corsino, Leonor; Sutton, Linda; Owen, Lynda; Erkanli, Alaattin; Keefe, Francis; Corbett, Cheyenne; Kimmick, GretchenBreast cancer survivors with type 2 diabetes are at high risk for cancer recurrence, serious health complications, more severe symptoms, psychological distress, and premature death relative to breast cancer survivors without diabetes. Maintaining glycemic control is critical for decreasing symptoms and preventing serious health problems. Many breast cancer survivors with type 2 diabetes have difficulty maintaining diabetes self-management behaviors and achieving glycemic control. Both cancer and diabetes-related symptoms (e.g., physical symptoms and psychological distress) are often barriers to engaging in diabetes self-management strategies. This study evaluates a novel diabetes coping skills training (DCST) intervention for improving breast cancer survivors' abilities to manage symptoms and adhere to recommended diabetes self-management behaviors. The telephone-based DCST protocol integrates three key theory-based strategies: coping skills training for managing symptoms, adherence skills training, and healthy lifestyle skills training. A randomized clinical trial will test the DCST intervention plus diabetes education by comparing it to diabetes education alone. Symptoms, distress, diabetes self-management behaviors, and self-efficacy will be assessed at baseline and 3, 6, and 12 months. Glycosylated hemoglobin (HbA1c) will be assessed at baseline, 6, and 12 months. This study addresses a critical gap in the care of breast cancer survivors by evaluating a novel behavioral intervention to improve the management of symptoms, adherence, and glycemic control in breast cancer survivors with type 2 diabetes. Special considerations for this medically underserved population are also provided. The findings of this study could lead to significant improvements in clinical care and beneficial outcomes for breast cancer survivors. Trials registration: ClinicalTrials.gov, NCT02970344, registered 11/22/2016.Item Open Access Long-Term Impact of an Electronic Health Record-Enabled, Team-Based, and Scalable Population Health Strategy Based on the Chronic Care Model.(AMIA ... Annual Symposium proceedings. AMIA Symposium, 2016-01) Kawamoto, Kensaku; Anstrom, Kevin J; Anderson, John B; Bosworth, Hayden B; Lobach, David F; McAdam-Marx, Carrie; Ferranti, Jeffrey M; Shang, Howard; Yarnall, Kimberly SHThe Chronic Care Model (CCM) is a promising framework for improving population health, but little is known regarding the long-term impact of scalable, informatics-enabled interventions based on this model. To address this challenge, this study evaluated the long-term impact of implementing a scalable, electronic health record (EHR)- enabled, and CCM-based population health program to replace a labor-intensive legacy program in 18 primary care practices. Interventions included point-of-care decision support, quality reporting, team-based care, patient engagement, and provider education. Among 6,768 patients with diabetes receiving care over 4 years, hemoglobin A1c levels remained stable during the 2-year pre-intervention and post-intervention periods (0.03% and 0% increases, respectively), compared to a 0.42% increase expected based on A1c progression observed in the United Kingdom Prospective Diabetes Study long-term outcomes cohort. The results indicate that an EHR-enabled, team- based, and scalable population health strategy based on the CCM may be effective and efficient for managing population health.Item Open Access Patient Characteristics Associated with Telemedicine Use for Diabetes Mellitus Care: Experience of a University Health System.(Southern medical journal, 2024-01) Hari, Krupal; O'Connell, Nathaniel; Taylor, Yhenneko J; Moore, Justin B; Bosworth, Hayden; Hanchate, Amresh; Pokharel, YashashwiObjectives
The objective was to understand the characteristics of patients who used telemedicine for diabetes management to inform future implementation of telemedicine.Methods
We examined patient characteristics associated with telemedicine use for diabetes mellitus (DM) care between March 1, 2020 and April 1, 2021 (the coronavirus disease 2019 pandemic period) in a large university health system when telemedicine visits increased rapidly. Logistic regression models assessed patient characteristics associated with telemedicine visits and delays in DM process measures (hemoglobin A1c checks, nephropathy, and retinopathy evaluations) during the pandemic period after adjusting for potential confounders and corresponding values before the pandemic period (March 1, 2019-February 29, 2020).Results
A total of 45,159 patients were seen from 987,791 visits during the pandemic period. The number of visits averaged one visit less during the pandemic period than before the pandemic period. Approximately 5.4% of patients used telemedicine during the pandemic period from 42,750 visits. The mean (standard deviation) telemedicine visit was 1.28 (0.91). Men, Asian, Black, and other race (vs White), having Medicare or uninsured (vs private insurance), were less likely to use telemedicine. Patients with more visits before the pandemic period were more likely to use telemedicine and less likely to experience a delay in DM process measures during the pandemic period. Telemedicine users were 18% less likely to experience a delay in nephropathy visits than nonusers, but without difference for other process measures.Conclusions
Race, sex, insurance, and prepandemic in-person visits were associated with telemedicine use for DM management in a large health system. Telemedicine use was not associated with delays in hemoglobin A1c testing, nephropathy, and retinopathy assessments. Understanding reasons for not using telemedicine is important to be able to deliver equitable DM care.Item Open Access Practical telehealth to improve control and engagement for patients with clinic-refractory diabetes mellitus (PRACTICE-DM): Protocol and baseline data for a randomized trial.(Contemporary clinical trials, 2020-11) Kobe, Elizabeth A; Edelman, David; Tarkington, Phillip E; Bosworth, Hayden B; Maciejewski, Matthew L; Steinhauser, Karen; Jeffreys, Amy S; Coffman, Cynthia J; Smith, Valerie A; Strawbridge, Elizabeth M; Szabo, Steven T; Desai, Shivan; Garrett, Mary P; Wilmot, Theresa C; Marcano, Teresa J; Overby, Donna L; Tisdale, Glenda A; Durkee, Melissa; Bullard, Susan; Dar, Moahad S; Mundy, Amy C; Hiner, Janette; Fredrickson, Sonja K; Majette Elliott, Nadya T; Howard, Teresa; Jeter, Deborah H; Danus, Susanne; Crowley, Matthew JBackground
Persistent poorly-controlled type 2 diabetes mellitus (PPDM), or maintenance of a hemoglobin A1c (HbA1c) ≥8.5% despite receiving clinic-based diabetes care, contributes disproportionately to the national diabetes burden. Comprehensive telehealth interventions may help ameliorate PPDM, but existing approaches have rarely been designed with clinical implementation in mind, limiting use in routine practice. We describe a study testing a novel telehealth intervention that comprehensively targets clinic-refractory PPDM, and was explicitly developed for practical delivery using existing Veterans Health Administration (VHA) clinical infrastructure.Methods
Practical Telehealth to Improve Control and Engagement for Patients with Clinic-Refractory Diabetes Mellitus (PRACTICE-DM) is an ongoing randomized controlled trial comparing two 12-month interventions: 1) standard VHA Home Telehealth (HT) telemonitoring/care coordination; or 2) the PRACTICE-DM intervention, a comprehensive HT-delivered intervention combining telemonitoring, self-management support, diet/activity support, medication management, and depression management. The primary outcome is HbA1c. Secondary outcomes include diabetes distress, self-care, self-efficacy, weight, depressive symptoms, implementation barriers/facilitators, and costs. We hypothesize that the PRACTICE-DM intervention will reduce HbA1c by >0.6% versus standard HT over 12 months.Results
Enrollment for this ongoing trial concluded in January 2020; 200 patients were randomized (99 to standard HT and 101 to the PRACTICE-DM intervention). The cohort has a mean age of 58 and is 23% female and 72% African American. Mean baseline HbA1c and BMI were 10.2% and 34.8 kg/m2.Conclusions
Because it comprehensively targets factors underlying PPDM using existing clinical infrastructure, the PRACTICE-DM intervention may be well suited to lower the complications and costs of PPDM in routine practice.Item Open Access Predicting health outcomes with intensive longitudinal data collected by mobile health devices: a functional principal component regression approach.(BMC medical research methodology, 2024-03) Yang, Qing; Jiang, Meilin; Li, Cai; Luo, Sheng; Crowley, Matthew J; Shaw, Ryan JBackground
Intensive longitudinal data (ILD) collected in near real time by mobile health devices provide a new opportunity for monitoring chronic diseases, early disease risk prediction, and disease prevention in health research. Functional data analysis, specifically functional principal component analysis, has great potential to abstract trends in ILD but has not been used extensively in mobile health research.Objective
To introduce functional principal component analysis (fPCA) and demonstrate its potential applicability in estimating trends in ILD collected by mobile heath devices, assessing longitudinal association between ILD and health outcomes, and predicting health outcomes.Methods
fPCA and scalar-to-function regression models were reviewed. A case study was used to illustrate the process of abstracting trends in intensively self-measured blood glucose using functional principal component analysis and then predicting future HbA1c values in patients with type 2 diabetes using a scalar-to-function regression model.Results
Based on the scalar-to-function regression model results, there was a slightly increasing trend between daily blood glucose measures and HbA1c. 61% of variation in HbA1c could be predicted by the three preceding months' blood glucose values measured before breakfast (P < 0.0001, [Formula: see text]).Conclusions
Functional data analysis, specifically fPCA, offers a unique tool to capture patterns in ILD collected by mobile health devices. It is particularly useful in assessing longitudinal dynamic association between repeated measures and outcomes, and can be easily integrated in prediction models to improve prediction precision.Item Open Access Secondary prevention risk interventions via telemedicine and tailored patient education (SPRITE): a randomized trial to improve postmyocardial infarction management.(Circulation. Cardiovascular quality and outcomes, 2011-03) Shah, Bimal R; Adams, Martha; Peterson, Eric D; Powers, Benjamin; Oddone, Eugene Z; Royal, Kira; McCant, Felicia; Grambow, Steven C; Lindquist, Jennifer; Bosworth, Hayden BBackground
Secondary prevention by risk factor modification improves patient outcomes, yet it is often not achieved in clinical practice. Reasons for failure stem from challenges of prioritizing risk factor reduction and engaging patients in changing their behaviors. We hypothesize that a novel telemedicine intervention with tailored patient education could improve cardiovascular risk factors.Methods
To evaluate this intervention, we propose enrolling 450 patients with a recent myocardial infarction and hypertension into a 3-arm randomized, controlled trial. The first arm (n=150) will receive home blood pressure (BP) monitors plus a nurse-delivered, telephone-based tailored patient education intervention and will be enrolled into HealthVault, a Microsoft electronic health record platform. The second arm (n=150) will also receive BP monitors plus a tailored patient education intervention and be enrolled in HeartVault. However, the patient education intervention will be delivered by a Web-based program and will cover topics identical to those in the nurse-delivered intervention. Both arms will be compared with a control group receiving standard care (n=150). All participants will have an in-person assessment at baseline and at completion of the study, including standardized measurements of BP, LDL cholesterol, and glycosylated hemoglobin (in diabetic subjects). The study design will allow assessment of a telephone-based, nurse-administered disease management program versus standard care. The main outcome of interest is the reduction in systolic BP in each intervention group compared with the control group at 12 months. Secondary outcomes assessed will include reductions in LDL cholesterol, body weight, and glycosylated hemoglobin, as well as adherence to evidence-based therapies and improvement in health behaviors.Conclusion
If successful in optimizing BP control, managing other coronary heart disease risk factors, and demonstrating a lower cost, the Web-based disease management tool has the potential to enhance coronary artery disease management, quality of care, and ultimately, patient outcomes. Clinical Trial Registration- URL: http://www.clinicaltrials.gov. Unique identifier: NCT00901277.Item Open Access Tailored Case Management for Diabetes and Hypertension (TEACH-DM) in a community population: study design and baseline sample characteristics.(Contemporary clinical trials, 2013-09) Crowley, Matthew J; Bosworth, Hayden B; Coffman, Cynthia J; Lindquist, Jennifer H; Neary, Alice M; Harris, Amy C; Datta, Santanu K; Granger, Bradi B; Pereira, Katherine; Dolor, Rowena J; Edelman, DavidBackground
Despite recognition of the benefits associated with well-controlled diabetes and hypertension, control remains suboptimal. Effective interventions for these conditions have been studied within academic settings, but interventions targeting both conditions have rarely been tested in community settings. We describe the design and baseline results of a trial evaluating a behavioral intervention among community patients with poorly-controlled diabetes and comorbid hypertension.Methods
Tailored Case Management for Diabetes and Hypertension (TEACH-DM) is a 24-month randomized, controlled trial evaluating a telephone-delivered behavioral intervention for diabetes and hypertension versus attention control. The study recruited from nine community practices. The nurse-administered intervention targets 3 areas: 1) cultivation of healthful behaviors for diabetes and hypertension control; 2) provision of fundamentals to support attainment of healthful behaviors; and 3) identification and correction of patient-specific barriers to adopting healthful behaviors. Hemoglobin A1c and blood pressure measured at 6, 12, and 24 months are co-primary outcomes. Secondary outcomes include self-efficacy, self-reported medication adherence, exercise, and cost-effectiveness.Results
Of 377 randomized patients, 193 were allocated to the intervention and 184 to attention control. The cohort is balanced in terms of gender, race, education level, and income. The cohort's mean baseline hemoglobin A1c and blood pressure are above goal, and mean baseline body mass index falls in the obese range. Baseline self-reported non-adherence is high for diabetes and hypertension medications. Trial results are pending.Conclusions
If effective, the TEACH-DM intervention's telephone-based delivery strategy and nurse administration make it well-suited for rapid implementation and broad dissemination in community settings.Item Open Access The Cholesterol, Hypertension, And Glucose Education (CHANGE) study: results from a randomized controlled trial in African Americans with diabetes.(American heart journal, 2013-07) Crowley, Matthew J; Powers, Benjamin J; Olsen, Maren K; Grubber, Janet M; Koropchak, Celine; Rose, Cynthia M; Gentry, Pamela; Bowlby, Lynn; Trujillo, Gloria; Maciejewski, Matthew L; Bosworth, Hayden BBackground
Cardiovascular disease (CVD) and diabetes account for one-third of the mortality difference between African American and white patients. We evaluated the effect of a CVD risk reduction intervention in African Americans with diabetes.Methods
We randomized 359 African Americans with type 2 diabetes to receive usual care or a nurse telephone intervention. The 12-month intervention provided monthly self-management support and quarterly medication management facilitation. Coprimary outcomes were changes in systolic blood pressure (SBP), hemoglobin A1c (HbA1c), and low-density lipoprotein cholesterol (LDL-C) over 12 months. We estimated between-intervention group differences over time using linear mixed-effects models. The secondary outcome was self-reported medication adherence.Results
The sample was 72% female; 49% had low health literacy, and 37% had annual income <$10,000. Model-based estimates for mean baseline SBP, HbA1c, and LDL-C were 136.8 mm Hg (95% CI 135.0-138.6), 8.0% (95% CI 7.8-8.2), and 99.1 mg/dL (95% CI 94.7-103.5), respectively. Intervention patients received 9.9 (SD 3.0) intervention calls on average. Primary providers replied to 76% of nurse medication management facilitation contacts, 18% of these resulted in medication changes. There were no between-group differences over time for SBP (P = .11), HbA1c (P = .66), or LDL-C (P = .79). Intervention patients were more likely than those receiving usual care to report improved medication adherence (odds ratio 4.4, 95% CI 1.8-10.6, P = .0008), but adherent patients did not exhibit relative improvement in primary outcomes.Conclusions
This intervention improved self-reported medication adherence but not CVD risk factor control among African Americans with diabetes. Further research is needed to determine how to maximally impact CVD risk factors in African American patients.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 Track: A randomized controlled trial of a digital health obesity treatment intervention for medically vulnerable primary care patients.(Contemporary clinical trials, 2016-05) Foley, Perry; Steinberg, Dori; Levine, Erica; Askew, Sandy; Batch, Bryan C; Puleo, Elaine M; Svetkey, Laura P; Bosworth, Hayden B; DeVries, Abigail; Miranda, Heather; Bennett, Gary GIntroduction
Obesity continues to disproportionately affect medically vulnerable populations. Digital health interventions may be effective for delivering obesity treatment in low-resource primary care settings.Methods
Track is a 12-month randomized controlled trial of a digital health weight loss intervention in a community health center system. Participants are 351 obese men and women aged 21 to 65years with an obesity-related comorbidity. Track participants are randomized to usual primary care or to a 12-month intervention consisting of algorithm-generated tailored behavior change goals, self-monitoring via mobile technologies, daily self-weighing using a network-connected scale, skills training materials, 18 counseling phone calls with a Track coach, and primary care provider counseling. Participants are followed over 12months, with study visits at baseline, 6, and 12months. Anthropometric data, blood pressure, fasting lipids, glucose and HbA1C and self-administered surveys are collected. Follow-up data will be collected from the medical record at 24months.Results
Participants are 68% female and on average 50.7years old with a mean BMI of 35.9kg/m(2). Participants are mainly black (54%) or white (33%); 12.5% are Hispanic. Participants are mostly employed and low-income. Over 20% of the sample has hypertension, diabetes and hyperlipidemia. Almost 27% of participants currently smoke and almost 20% score above the clinical threshold for depression.Conclusions
Track utilizes an innovative, digital health approach to reduce obesity and chronic disease risk among medically vulnerable adults in the primary care setting. Baseline characteristics reflect a socioeconomically disadvantaged, high-risk patient population in need of evidence-based obesity treatment.