Telephone-Delivered Behavioral Skills Intervention for African American Adults with Type 2 Diabetes: A Randomized Controlled Trial.

BACKGROUND: Diabetes disproportionately affects African Americans and is associated with poorer outcomes. Self-management is important for glycemic control; however, evidence in African Americans is limited. OBJECTIVE: To assess the efficacy of a combined telephone-delivered education and behavioral skills intervention (TBSI) in reducing hemoglobin A1c (HbA1c) levels in African Americans with type 2 diabetes, using a factorial design. DESIGN: This is a four-year randomized clinical trial, using a 2 x 2 factorial design.: Participants: African American adults ≥18 years) with poorly controlled type 2 diabetes (HbA1c ≥9%) were randomly assigned to one of four groups: 1) knowledge only, 2) skills only, 3) combined knowledge and skills (TBSI), or 4) control group. INTERVENTION: All participants received 12 telephone-delivered 30-min intervention sessions specific to their assigned group. Participants were assessed at baseline and 3, 6, and 12 months. MAIN MEASURE: The primary outcome was HbA1c at 12 months post-randomization in the intent-to-treat (ITT) population. KEY RESULTS: Two hundred fifty-five participants were randomly assigned to the four groups. Based on the ITT population after multiple imputation, the analysis of covariance with baseline HbA1c as the covariate showed that HbA1c at 12 months for the intervention groups did not differ significantly from that of the control group (knowledge: 0.49, p = 0.123; skills: 0.23, p = 0.456; combined: 0.48, p = 0.105). Absolute change from baseline at 12 months for all treatment arms was 0.6. Longitudinal mixed effects analysis showed that, on average, there was a significant decline in HbA1c over time for all treatment groups (-0.07, p < 0.001). However, the rates of decline for the intervention groups were not significantly different from that of the control group (knowledge: 0.06, p = 0.052; skills: 0.02, p = 0.448; combined: 0.05, p = 0.062). Results from per-protocol populations were similar. CONCLUSIONS: For African Americans with poorly controlled type 2 diabetes, combined education and skills training did not achieve greater reductions in glycemic control (i.e., HbA1c levels) at 12 months compared to the control group, education alone, or skills training alone. This trial is registered with ClinicalTrials.gov, identifier no. NCT00929838.

Comorbid depression is differentially associated with longitudinal medication nonadherence by race/ethnicity in patients with type 2 diabetes.

The aim of the study was to examine whether depression impacts medication nonadherence (MNA) over time and determine if race has a differential impact on MNA in patients with type 2 diabetes and comorbid depression.Generalized estimating equations were used with a longitudinal national cohort of 740,197 veterans with type 2 diabetes. MNA was the main outcome defined by <80% medication possession ratio for diabetes medications. The primary independent variable was comorbid depression. Analyses were adjusted for the longitudinal nature of the data and covariates including age, sex, marital status, and rural/urban residence.In adjusted models, MNA was higher in non-Hispanic blacks (NHBs) (odds ratio [OR] 1.58 [95% confidence interval-CI: 1.57, 1.59]), Hispanics (OR 1.34 [95% CI: 1.32, 1.35]), and the other/missing racial/ethnic group (OR 1.37 [95% CI: 1.36, 1.38]) than in non-Hispanic whites (NHWs). In stratified analyses, the odds of MNA associated with depression were highest in NHWs (OR 1.14 [95% CI: 1.12, 1.15]) and were significantly associated in the other 3 minority racial/ethnic groups. MNA was lower in rural than urban NHWs (OR 0.91 [95% CI: 0.90, 0.92]), NHBs (OR 0.92 [95% CI: 0.91, 0.94]), and the other/unknown racial/ethnic group (OR 0.89 [95% CI: 0.88, 0.90]), but higher in rural Hispanic patients (OR 1.12 [95% CI: 1.09, 1.14]).Depression was associated with increased odds of MNA in NHWs, as well as in minority groups, although associations were weaker in minority groups, perhaps as a result of the high baseline levels of MNA in minority groups. There were also differences by race/ethnicity in MNA in rural versus urban subjects.

Tablet-Aided BehavioraL intervention EffecT on Self-management skills (TABLETS) for Diabetes.

BACKGROUND: Multiple randomized controlled trials (RCTs) show that behavioral lifestyle interventions are effective in improving diabetes management and that comprehensive risk factor management improves cardiovascular disease (CVD) outcomes. The role of technology has been gaining strong support as evidence builds of its potential to improve diabetes management; however, evaluation of its impact in minority populations is limited. This study intends to provide early evidence of a theory-driven intervention, Tablet-Aided BehavioraL intervention EffecT on Self-management skills (TABLETS), using real-time videoconferencing for education and skills training. We examine the potential for TABLETS to improve health risk behaviors and reduce CVD risk outcomes among a low-income African American (AA) population with poorly controlled type 2 diabetes. METHODS: The study is a two-arm, pilot controlled trial that randomizes 30 participants to the TABLETS intervention and 30 participants to a usual care group. Blinded outcome assessments will be completed at baseline, 2.5 months (immediate post-intervention), and 6.5 months (follow-up). The TABLETS intervention consists of culturally tailored telephone-delivered diabetes education and skills training delivered via videoconferencing on tablet devices, with two booster sessions delivered via tablet-based videoconferencing at 3 months and 5 months to stimulate ongoing use of the tablet device with access to intervention materials via videoconferencing slides and a manual of supplementary materials. The primary outcomes are physical activity, diet, medication adherence, and self-monitoring behavior, whereas the secondary outcomes are HbA1c, low-density lipoprotein cholesterol (LDL-C), BP, CVD risk, and quality of life. DISCUSSION: This study provides a unique opportunity to assess the feasibility and efficacy of a theory-driven, tablet-aided behavioral intervention that utilizes real-time videoconferencing technology for education and skills training on self-management behaviors and quality of life among a high-risk, low-income AA population with an uncontrolled dyad or triad of CVD risk factors (diabetes with or without hypertension or hyperlipidemia). The intervention leverages the use of novel technology for education and skill-building to foster improved diabetes self-management. The findings of this study will inform the process of disseminating the intervention to a broader and larger sample of people and can potentially be refined to align with clinical workflows that target a subsample of patients with poor diabetes self-management. TRIAL REGISTRATION: The trial was registered in April 2014 with the United States National Institutes of Health Clinical Trials Registry (ClinicalTrials.gov identifier NCT02128854), available online at: http://clinicaltrials.gov/ct2/show/NCT02128854 .

Meaning of Illness and Cardiovascular Risk Factors in Patients With Type 2 Diabetes.

PURPOSE: The purpose of this study was to examine the relationship between meaning of illness and cardiovascular disease risk factors in patients with type 2 diabetes. METHODS: The sample population was recruited from primary care clinics in the southeastern United States. The meaning of illness was assessed by a validated questionnaire with 5 subscales. The primary outcomes were cardiovascular disease (CVD) risk factors, assessed by A1C, systolic and diastolic blood pressure (SBP and DBP, respectively), and low-density lipoprotein cholesterol (LDL-C). Multivariate linear regression models investigated associations between the clinical outcomes and the 5 MIQ factors, controlling for possible confounders. RESULTS: The sample comprised 302 black and white participants of whom more than half were elderly (65+ years) and the vast majority were male (98%). Systolic blood pressure was positively associated with non-anticipated vulnerability. Diastolic blood pressure was negatively associated with degree of stress/change in commitments and positively associated with challenge/motivation/hope and non-anticipated vulnerability. Low-density lipoprotein cholesterol was significantly and negatively associated with degree of stress/change in commitments. CONCLUSIONS: Meaning of illness had a significant effect on measured outcomes of CVD risk. The specific factor included in the overarching concept of meaning of illness differed in its influence, with more positive views of stress/commitments associated with lower blood pressure and LDL but more positive views of the challenge/hope/motivation and negative views of non-anticipated vulnerability associated with diabetes associated with higher systolic and diastolic blood pressure.

Health locus of control and cardiovascular risk factors in veterans with type 2 diabetes.

Perceptions of control impact outcomes in veterans with chronic disease. The purpose of this study was to examine the association between control orientation and clinical and quality of life (QOL) outcomes in male veterans with type 2 diabetes (T2DM). Cross-sectional study of 283 male veterans from a primary care clinic in the southeastern US. Health locus of control (LOC) was the main predictor and assessed using the Multidimensional Health LOC Scale. Clinical outcomes were glycosylated hemoglobin A1c (HbA1c), systolic and diastolic blood pressure, and low-density lipoprotein cholesterol (LDL-C). Physical (PCS) and mental (MCS) health component scores for QOL were assessed using the Veterans RAND 12-Item Health Survey. Unadjusted and adjusted multivariate analyses were performed to assess associations between LOC and outcomes. Unadjusted analyses showed internal LOC associated with HbA1c (ß = 0.036; 95% CI 0.001, 0.071), external LOC:powerful others inversely associated with LDL-C (ß = -0.794; 95% CI -1.483, -0.104), and external LOC:chance inversely associated with MCS QOL (ß = -0.418; 95% CI -0.859, -0.173). These associations remained significant when adjusting for relevant covariates. Adjusted analyses also demonstrated a significant relationship between external LOC:chance and PCS QOL (ß = 0.308; 95% CI 0.002, 0.614). In this sample of male veterans with T2DM, internal LOC was significantly associated with glycemic control, and external was significantly associated with QOL and LDL-C, when adjusting for relevant covariates. Assessments of control orientation should be performed to understand the perceptions of patients, thus better equipping physicians with information to maximize care opportunities for veterans with T2DM.

Medical care expenditures associated with chronic kidney disease in adults with diabetes: United States 2011.

OBJECTIVE: Approximately 1 in 3 adults with diabetes have CKD. However, there are no recent national estimates of the association of CKD with medical care expenditures in individuals with diabetes. Our aim is to assess the association of CKD with total medical expenditures in US adults with diabetes using a national sample and novel cost estimation methodology. RESEARCH DESIGN AND METHODS: Data on 2,053 adults with diabetes in the 2011 Medical Expenditure Panel Survey (MEPS) was analyzed. Individuals with CKD were identified based on self-report. Adjusted mean health services expenditures per person in 2011 were estimated using a two-part model after adjusting for demographic and clinical covariates. RESULTS: Of the 2,053 individuals with diabetes, approximately 9.7% had self-reported CKD. Unadjusted mean expenditures for individuals with CKD were $20,726 relative to $9,689.49 for no CKD. Adjusted mean expenditures from the 2-part model for individuals with CKD were $8473 higher relative to individuals without CKD. Additional significant covariates were Hispanic/other race, uninsured, urban dwellers, CVD, stroke, high cholesterol, arthritis, and asthma. The estimated unadjusted total expenditures for individuals with CKD were estimated to be in excess of $43 billion in 2011. CONCLUSIONS: We showed that CKD is a significant contributor to the financial burden among individuals with diabetes, and that minorities and the uninsured with CKD may experience barriers in access to care. Our study also provides a baseline national estimate of CKD cost in Diabetes by which future studies can be used for comparison.

Meaning of illness and quality of life in patients with type 2 diabetes.

BACKGROUND: Investigations into personal factors influencing quality of life are important for those developing strategies to support patients with diabetes. This study aimed to investigate the influence of meaning of illness on quality of life in patients with type 2 diabetes. METHODS: Veterans from primary care clinics in the southeastern United States completed a questionnaire including questions from the validated 5-scale Meaning of Illness Questionnaire (MIQ). Unadjusted and adjusted linear regression models investigated the physical and mental components of quality of life with the 5 MIQ factors. RESULTS: The sample comprised 302 Black and White veterans. The physical component of quality of life (PCS) was positively associated with type of stress/attitude of harm (ß = 2.43, CI: 0.94 to 3.93) and challenge/motivation/hope (ß = 3.02, CI: 0.40 to 5.64) after adjustment, whereas the mental component of quality of life (MCS) was positively associated with the degree of stress/change in commitment (ß = 2.58, CI: 0.78 to 4.38), and negatively associated with challenge/motivation/hope (ß = -2.55, CI: -4.99 to -0.11). CONCLUSION: Attitudes of challenge, motivation and hope had opposite effects on mental and physical components of quality of life in this sample of veterans. Additionally, whereas, the type of stress and attitude towards harm or loss was associated with the physical component, the degree of stress and change in commitments was associated with the mental component. This suggests addressing the meaning of an illness may be complex but is an important consideration in improving both physical and mental components of quality of life in patients with type 2 diabetes.

Increasing prevalence of diabetes during pregnancy in South Carolina.

BACKGROUND: The objective of our study was to examine the prevalence of diabetes during pregnancy at the population level in SC from January 1996 through December 2008. METHODS: The study included 387,720 non-Hispanic white (NHW), 232,278 non-Hispanic black (NHB), and 43,454 Hispanic live singleton births. Maternal inpatient hospital discharge codes from delivery (91.59%) and prenatal information (i.e., Medicaid [42.91%] and SC State Health Plan [SHP] [5.98%]) were linked to birth certificate data. Diabetes during pregnancy included gestational and preexisting, defined by prenatal and maternal inpatient International Classification of Diseases, Ninth Revision, Clinical Modification (ICD-9-CM) diagnostic codes (i.e., 64801-64802, 64881-64882, or 25000-25092) or report on the birth certificate. RESULTS: Diabetes prevalence from any source increased from 5.02% (95% confidence interval [CI]: 4.82-5.22) in 1996 to 8.37% (95% CI: 8.15-8.60) in 2008. Diabetes prevalence, standardized for maternal age and race/ethnicity from 1996 through 2008, increased from 3.38% (95% CI: 3.29-3.47) to 5.81% (95% CI: 5.71-5.91) using birth certificate data, from 3.99% (95% CI: 3.89-4.10) to 6.69% (95% CI: 6.58-6.80) using hospital discharge data, and from 4.74% (95% CI: 4.52-4.96) to 8.82% (95% CI: 8.61-9.03) using Medicaid data. Comparing birth certificate to hospital discharge, Medicaid, and SHP data, Cohen's kappa in 2008 was 0.73 (95% CI: 0.72-0.75), 0.64 (95% CI: 0.62-0.66), and 0.59 (95% CI: 0.54-0.65), respectively. CONCLUSIONS: An increasing prevalence of diabetes during pregnancy is reported, as well as substantial lack of agreement in reporting of diabetes prevalence across administrative databases. Prevalence of reported diabetes during pregnancy is impacted by screening, diagnostic, and reporting practices across different data sources, as well as by actual changes in prevalence over time.

Meaning of illness and self-care in patients with type 2 diabetes.

PURPOSE: The purpose of this study was to assess the relationship between meaning of illness, diabetes knowledge, self-care understanding, and behaviors in a group of individuals with type 2 diabetes. METHODS: Patients diagnosed with type 2 diabetes completed questionnaires with measures for diabetes knowledge, self-care understanding, diet adherence, and control problems based on the validated Diabetes Care Profile, as well as a 5-factor Meaning of Illness Questionnaire (MIQ) measure. Linear regression investigated the associations between self-care outcomes and the 5 MIQ factors. RESULTS: After adjustment for possible confounders, both diabetes self-care understanding and diet adherence were negatively and significantly associated with little effect of illness. Control problems were negatively associated with degree of stress/change in commitments. Diabetes knowledge was not significantly associated with meaning of illness. CONCLUSION: Aspects of the meaning attributed to illness were significantly associated with self-care in patients with type 2 diabetes. Therefore, cognitive appraisals may explain variances observed in self-care understanding and behaviors. Based on these results, it is important to understand the negative effect that diabetes could have when promoting self-care understanding and diet adherence. In addition, it shows that helping patients address the stress and changing commitments that result from diabetes may help decrease the amount of diabetes control problems, even if there is little effect on diabetes understanding. Taking these differences into account may help in creating more personalized and effective self-care education plans.

Geographic and racial/ethnic variations in patterns of multimorbidity burden in patients with type 2 diabetes.

BACKGROUND: Multimorbidity presents a significant public health challenge, but regional, rural/urban, and racial/ethnic differences in patterns of multimorbidity in diabetes are poorly understood. OBJECTIVE: To describe patterns of multimorbidity in medical and mental health by regional, rural/urban, and racial/ethnic variation in patients with type 2 diabetes mellitus. DESIGN: Retrospective cohort study from 2002 through 2006 PARTICIPANTS: A national cohort of 892,223 veterans with diabetes MAIN MEASURES: Multimorbidity was the main outcome defined as: the measure of multimorbidity and two categorical outcomes, with pattern of medical and mental health comorbidities combined and separately. KEY RESULTS: Among patients, 52% had 2+ comorbidities, 33% had a single comorbidity, and 14% had no comorbidity; 13.9% had both medical and mental health comorbidities, 70.3% had medical only, and 1.5% had mental health only. The odds of having 3+ comorbidities were nearly fourfold greater in patients 75 years and older relative to patients younger than 50 years (OR=3.95 [95% CI: 3.84, 4.06]). Compared to non-Hispanic whites, the odds of 3+ comorbidities among non-Hispanic blacks were 1.67 times greater (95% CI: 1.63, 1.71). Hispanics were more likely to have a mental health comorbidity alone (OR=1.20 [95% CI: 1.13, 1.28]) than non-Hispanic whites. For patients living in rural areas, the odds were higher of having 3+ comorbidities (OR=1.21 [95% CI: 1.19, 1.23]) and of having both medical and mental health comorbidities (OR=1.15 [95% CI: 1.13, 1.17]) compared to urban dwellers. CONCLUSIONS: Among individuals with diabetes, traditionally disadvantaged groups, including non-Hispanic blacks and rural patients, appear to bear the greatest burden and risk of multimorbidity. Significantly greater odds with increasing number of comorbidities were seen by race/ethnicity, rural residence, and geographic region.

Technology-Intensified Diabetes Education Study (TIDES) in African Americans with type 2 diabetes: study protocol for a randomized controlled trial.

BACKGROUND: Compared to American Whites, African Americans have a higher prevalence of type 2 diabetes mellitus (T2DM), experiencing poorer metabolic control and greater risks for complications and death. Patient-level factors, such as diabetes knowledge, self-management skills, empowerment, and perceived control, account for >90% of the variance observed in outcomes between these racial groups. There is strong evidence that self-management interventions that include telephone-delivered diabetes education and skills training are effective at improving metabolic control in diabetes. Web-based home telemonitoring systems in conjunction with active care management are also effective ways to lower glycosylated hemoglobin A1c values when compared to standard care, and provide feedback to patients; however, there are no studies in African Americans with poorly controlled T2DM that examine the use of technology-based feedback to tailor or augment diabetes education and skills training. This study provides a unique opportunity to address this gap in the literature. METHODS: We describe an ongoing 4-year randomized clinical trial, which will test the efficacy of a technology-intensified diabetes education and skills training (TIDES) intervention in African Americans with poorly controlled T2DM. Two hundred male and female AfricanAmerican participants, 21 years of age or older and with a glycosylated hemoglobin A1c level ≥ 8%, will be randomized into one of two groups for 12 weeks of telephone interventions: (1) TIDES intervention group or (2) a usual-care group. Participants will be followed for 12 months to ascertain the effect of the interventions on glycemic control. Our primary hypothesis is that, among African Americans with poorly controlled T2DM, patients randomized to the TIDES intervention will have significantly greater reduction in glycosylated hemoglobin A1c at 12 months of follow-up compared to the usual-care group. DISCUSSION: Results from this study will add to the current literature examining how best to deliver diabetes education and skills training and provide important insight into effective strategies to improve metabolic control and hence reduce diabetes complications and mortality rates in African Americans with poorly controlled T2DM. TRIAL REGISTRATION: This study was registered with the National Institutes of Health Clinical Trials Registry on 13 March 2014 (ClinicalTrials.gov identifier# NCT02088658).

Impact of medical and psychiatric multi-morbidity on mortality in diabetes: emerging evidence.

BACKGROUND: Multi-morbidity, or the presence of multiple chronic diseases, is a major problem in clinical care and is associated with worse outcomes. Additionally, the presence of mental health conditions, such as depression, anxiety, etc., has further negative impact on clinical outcomes. However, most health systems are generally configured for management of individual diseases instead of multi-morbidity. The study examined the prevalence and differential impact of medical and psychiatric multi-morbidity on risk of death in adults with diabetes. METHODS: A national cohort of 625,903 veterans with type 2 diabetes was created by linking multiple patient and administrative files from 2002 through 2006. The main outcome was time to death. Primary independent variables were numbers of medical and psychiatric comorbidities over the study period. Covariates included age, gender, race/ethnicity, marital status, area of residence, service connection, and geographic region. Cox regression was used to model the association between time to death and multi-morbidity adjusting for relevant covariates. RESULTS: Hypertension (78%) and depression (13%) were the most prevalent medical and psychiatric comorbidities, respectively; 23% had 3+ medical comorbidities, 3% had 2+ psychiatric comorbidities and 22% died. Among medical comorbidities, mortality risk was highest in those with congestive heart failure (hazard ratio, HR = 1.92; 95% CI 1.89-1.95), Lung disease (HR = 1.42; 95% CI 1.40-1.44) and cerebrovascular disease (HR = 1.39; 95% CI 1.37-1.40). Among psychiatric comorbidities, mortality risk was highest in those with substance abuse (HR = 1.50; 95% CI 1.46-1.54), psychoses (HR = 1.16; 95% CI 1.14-1.19) and depression (HR = 1.05; 95% CI 1.03-1.07). There was an interaction between medical and psychiatric comorbidity (p = 0.003) so stratified analyses were performed. HRs for effect of 3+ medical comorbidity (2.63, 2.66, 2.15) remained high across levels of psychiatric comorbidities (0, 1, 2+), respectively. HRs for effect of 2+ psychiatric comorbidity (1.69, 1.63, 1.42, 1.38) declined across levels of medical comorbidity (0, 1, 2, 3+), respectively. CONCLUSIONS: Medical and psychiatric multi-morbidity are significant predictors of mortality among older adults (veterans) with type 2 diabetes with a graded response as multimorbidity increases.

Racial/ethnic differences in multiple diabetes outcomes in patients with type 2 diabetes in the southeastern United States.

OBJECTIVE: To determine racial/ethnic differences in control of multiple diabetes outcomes in a large, diverse primary care sample. METHODS: 661 adults with type 2 diabetes (T2DM) were recruited from three primary care settings. The primary outcomes were individual and composite control of multiple diabetes outcomes. Control of individual diabetes outcomes were defined as hemoglobin A1c (HbA1c) < 7%, blood pressure (BP) < 130/80 mmHg and low-density lipoprotein (LDL)-cholesterol < 100 mg/dL. Composite control was defined as having all three outcomes under control. Linear and logistic regression models were used to assess differences in individual means and individual and composite outcomes control between non-Hispanic Blacks (NHB) and Whites (NHW) adjusting for relevant covariates. RESULTS: NHBs were 67% of the sample, -61% earned < $20,000, and 78% earned < $35,000. Unadjusted mean HbA1c (8.0 vs 7.6, P = .024), SBP (134 vs 126 P < .001), DBP (76 vs 69, P < .001) and LDL (96 vs 87, P = .003) levels were significantly higher in NHBs. Adjusted linear regression showed that SBP (beta = 9.4; 4.5-8.6) and DBP (beta = 5.7; 3.5-7.9) were significantly higher in NHBs. 12.6% had composite control and NHBs had lower composite control (10.0% vs 17.6%). Adjusted logistic models showed that BP control (OR .45; .30-.67) and composite control (OR .57; .33-.98) were significantly lower in NHBs. CONCLUSIONS: In this diverse sample of primary care patients with T2DM, NHBs had significantly lower BP control and composite outcome control compared to NHWs adjusting for relevant confounding factors. Strategies are needed to optimize control of multiple outcomes and reduce disparities in patients with T2DM.

Gender differences in composite control of cardiovascular risk factors among patients with type 2 diabetes.

OBJECTIVE: Disparities in outcomes for cardiovascular disease (CVD) exist between men and women with type 2 diabetes mellitus (T2DM). We examined gender differences in composite control of cardiovascular risk factors in a sample of adults with T2DM. SUBJECTS AND METHODS: This was a cross-sectional study of 680 people recruited from three primary care settings. Primary outcomes were individual and composite control of CVD risk factors. Control of individual risk outcomes was defined as glycosylated hemoglobin A1c (HbA1c) level of <7%, blood pressure (BP) of <130/80 mm Hg, and low-density lipoprotein (LDL) cholesterol level of <100 mg/dL. Composite control was defined as having all three outcomes under control simultaneously. Linear and logistic regression models were used to assess differences in individual means and individual and composite outcomes control between men and women, while adjusting for relevant covariates. RESULTS: Men made up 56% of the sample, approximately 67% were non-Hispanic black, and 78% made less than $35,000 annually. Unadjusted mean systolic BP (134 mm Hg vs. 130 mm Hg, P=0.005) and LDL cholesterol (99.7 mg/dL vs. 87.6 mg/dL, P<0.001) levels were significantly higher in women than in men. Adjusted linear regression showed mean diastolic BP (ß=3.09; 95% confidence interval 0.56, 5.63) was significantly higher in women. Overall, 12.4% of the sample had composite control, and women had poorer composite control compared with men (5.9% vs. 17.3%). Adjusted logistic models showed that men were significantly more likely to have composite risk factor control (odds ratio 2.90; 95% confidence interval 1.37, 6.13) compared with women. CONCLUSIONS: In this sample of adults with T2DM, women had significantly lower composite control compared with men, when adjusting for relevant confounders. It is imperative that women are informed about CVD risk factors, educated on how to reduce them, and aggressively treated to avoid adverse outcomes. Additional research involving women is needed to explore and reduce disparities in CVD risk between men and women with T2DM.

Longitudinal effects of medication nonadherence on glycemic control.

BACKGROUND: Medication nonadherence is known to worsen glycemic control. Few studies have examined this relationship over several years. OBJECTIVE: The aim of this study was to examine the longitudinal effect of medication nonadherence on glycemic control among a large cohort of veterans. METHODS: Analysis was performed on a cohort of 11 272 veterans with type 2 diabetes followed from April 1994 to May 2006. The primary outcome measures were mean glycosylated hemoglobin A1c (A1C) and proportion in poor control (A1C > 8%) over time. The main predictor was medication nonadherence based on medication possession ratio (MPR). Other covariates included sociodemographics and ICD-9 coded medical and psychiatric comorbidities. Generalized linear mixed models (GLMMs) were used to assess the relationship between MPR and A1C after adjusting for covariates. RESULTS: Mean follow-up was 5.4 years. In the linear mixed model, after adjusting for baseline A1C and other confounding variables, mean A1C decreased by 0.24 (P < 0.001) for each 10% increase in MPR (95% CI = -0.27, -0.21). In the fully adjusted GLMM, each percentage increase in MPR was associated with a 48% lower likelihood of having poor glycemic control (odds ratio = 0.52; 95% CI = 0.4, 0.6). In both continuous and dichotomized A1C analyses, average A1C showed a decreasing trend over the study period (P < 0.001). CONCLUSIONS: In patients with type 2 diabetes, glycemic control worsens over time in the presence of medication nonadherence. Future studies need to take into account the complexity of patient- and system-level factors affecting long-term medication adherence to improve diabetes-related outcomes.

Impact of diabetes control on mortality by race in a national cohort of veterans.

PURPOSE: The association between glycated hemoglobin (HbA1c), medication use/adherence, and mortality stratified by race/ethnicity was examined in a national cohort of veterans with type 2 diabetes. METHODS: A total of 892,223 veterans with diabetes in 2002 were followed through 2006. HbA1c category was the main exposure (i.e., HbA1c <7%, HbA1c 7%-8% [reference], HbA1c 8%-9%, and HbA1c >9%). Covariates included age, sex, marital status, rural/urban residence, geographic region, number of comorbidities, and diabetes medication use/adherence (i.e., adherent, medication possession ratio ≥80%; nonadherent; and nonusers). HbA1c and medication use/adherence varied over time, and Cox regression models accounting for time-varying variables were used. RESULTS: In nonmedication users, HbA1c greater than 9% predicted higher mortality risk relative to HbA1c of 7%-8% in non-Hispanic whites (hazard ratio [HR], 1.55; 95% confidence interval [95% CI], 1.43-1.69), non-Hispanic blacks (NHB) (HR, 1.58; 95% CI, 1.34-1.87), and Hispanics (HR, 2.22; 95% CI, 1.75-2.82). In contrast, in nonadherent medication users, HbA1c less than 7% predicted higher mortality risk in NHB (HR, 1.12; 95% CI, 1.05-1.20), whereas HbA1c greater than 9% only predicted mortality in non-Hispanic whites (HR, 1.11; 95% CI, 1.06-1.16). In adherent medication users, HbA1c less than 7% predicted higher mortality in NHB (HR, 1.18; 95% CI, 1.07-1.31), whereas HbA1c greater than 9.0% predicted higher mortality risk across all race/ethnic groups. CONCLUSION: We found evidence for racial/ethnic differences in the association between glycemic control and mortality, which varied by medication use/adherence.

Differential impact of longitudinal medication non-adherence on mortality by race/ethnicity among veterans with diabetes.

OBJECTIVE: To examine the differential effect of medication non-adherence over time on all-cause mortality by race/ethnicity. RESEARCH DESIGN AND METHODS: Data on a longitudinal cohort of veterans with type 2 diabetes was examined. The main outcome was time to death. Primary independent variables were race/ethnicity and mean medication possession ratio (MPR) categorized into quintiles over the study period. Cox regression was used to model the association between time to death and MPR quintiles and race/ethnicity, adjusting for relevant covariates. RESULTS: The cohort of 629,563 veterans was followed for 5 years. After adjusting for all covariates, the hazard ratios (HR) for subjects in the lowest versus highest MPR quintile was 12.21 (95 % CI 11.89, 12.55) for non-Hispanic white (NHW), 10.01 (95 % CI 9.18, 10.91) for non-Hispanic black (NHB), 12.65 (95 % CI 11.10, 14.43) for Hispanic and 10.41 (95 % CI 9.06, 11.96) for Other race veterans. Furthermore, type of diabetes therapy (oral versus insulin) maintained a significant relationship with mortality that varied by racial/ethnic group. CONCLUSIONS: This study demonstrates the differential impact of medication non-adherence on mortality by race. It also demonstrates that type of diabetes therapy (insulin with or without oral agents) is associated with mortality and varies by racial/ethnic group.

Medication nonadherence in diabetes: longitudinal effects on costs and potential cost savings from improvement.

OBJECTIVE: To examine the longitudinal effects of medication nonadherence (MNA) on key costs and estimate potential savings from increased adherence using a novel methodology that accounts for shared correlation among cost categories. RESEARCH DESIGN AND METHODS: Veterans with type 2 diabetes (740,195) were followed from January 2002 until death, loss to follow-up, or December 2006. A novel multivariate, generalized, linear, mixed modeling approach was used to assess the differential effect of MNA, defined as medication possession ratio (MPR) ≥0.8 on healthcare costs. A sensitivity analysis was performed to assess potential cost savings at different MNA levels using the Consumer Price Index to adjust estimates to 2012 dollar value. RESULTS: Mean MPR for the full sample over 5 years was 0.78, with a mean of 0.93 for the adherent group and 0.58 for the MNA group. In fully adjusted models, all annual cost categories increased ∼3% per year (P = 0.001) during the 5-year study time period. MNA was associated with a 37% lower pharmacy cost, 7% lower outpatient cost, and 41% higher inpatient cost. Based on sensitivity analyses, improving adherence in the MNA group would result in annual estimated cost savings ranging from ∼$661 million (MPR <0.6 vs. ≥0.6) to ∼$1.16 billion (MPR <1 vs. 1). Maximal incremental annual savings would occur by raising MPR from <0.8 to ≥0.8 ($204,530,778) among MNA subjects. CONCLUSIONS: Aggressive strategies and policies are needed to achieve optimal medication adherence in diabetes. Such approaches may further the so-called "triple aim" of achieving better health, better quality care, and lower cost.

Association between spirituality and depression in adults with type 2 diabetes.

PURPOSE: The purpose of the study was to examine the association between spirituality and depression among patients with type 2 diabetes. METHODS: This study included 201 adult participants with diabetes from an indigent clinic of an academic medical center. Participants completed validated surveys on spirituality and depression. The Daily Spiritual Experience (DSE) Scale measured a person's perception of the transcendent (God, the divine) in daily life. The Center for Epidemiologic Studies-Depression scale assessed depression. Linear regression analyses examined the association of spirituality as the predictor with depression as the outcome, adjusted for confounding variables. RESULTS: Greater spirituality was reported among females, non-Hispanic blacks, those with lower educational levels, and those with lower income. The unadjusted regression model showed greater spirituality was associated with less depression. This association was mildly diminished but still significant in the final adjusted model. Depression scores also increased (greater depression risk) with females and those who were unemployed but decreased with older age and non-Hispanic black race/ethnicity. CONCLUSIONS: Treatment of depression symptoms may be facilitated by incorporating the spiritual values and beliefs of patients with diabetes. Therefore, faith-based diabetes education is likely to improve self-care behaviors and glycemic control.

Effect of perceived control on quality of life in indigent adults with type 2 diabetes.

PURPOSE: To examine the relationship between perceived control of diabetes and physical and mental health components of quality of life in indigent adults with diabetes. METHODS: The primary variables, perceived control of diabetes and quality of life, were evaluated among188 patients from a low-income clinic located at an academic medical center. Over a 12-month period, consenting subjects completed the surveys to assess perceived control of diabetes and health-related quality of life. Sociodemographic factors (age, gender, race/ethnicity, income, education, employment, marital status, and insurance status) were collected as well as clinical factors like comorbid conditions and use of insulin therapy. Multiple linear regression models were used to assess the independent association of perceived control on quality of life. RESULTS: The sample largely comprised middle-aged women with diabetes, a majority being black; nearly two-thirds had at least a high school education and almost three-quarters were unemployed. Mean quality of life scores were generally below national population means. Correlation results indicated a positive relationship between perceived control and both physical and mental quality of life. Regression results supported the positive association between perceived control and quality of life, even when controlling for sociodemographics and comorbidity in the final model. CONCLUSION: Increasing perceived control, perhaps by a combination of education and skills building (ie, self-efficacy), will result in higher perceived quality of life (QOL) among disadvantaged populations with diabetes.