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Diabetes self-management education and support enhance self-efficacy and promote self-management behaviors essential for diabetes management. We investigated the mediating effect of self-efficacy on the association between diabetes education or care coordination and self-care activities. We surveyed a population-based sample of adults with type 2 diabetes (19-64 years of age) covered by Alabama Medicaid. We examined whether receipt of diabetes education or care coordination were associated with improvements in diabetes self-care activities. We then examined if improvements were mediated by self-efficacy. Models were adjusted for age, gender, race, education, insulin use, diabetes duration, and depressive symptoms. Results: A total of 1,318 participants were included in the study (mean age = 52.9 years, SD = 9.6; 72.5% female, 56.4% Black, 3.1% Hispanic). Diabetes education was associated with increases in self-care activity scores related to general diet, physical activity, glucose self-monitoring, and foot care; care coordination was associated with glucose self-monitoring. In addition, mediation analysis models confirmed that improvements in self-efficacy led to improved self-care activities scores, mediating the association of diabetes education and self-care activities. Conclusions: Diabetes education and self-efficacy were associated with better self-care. Receiving diabetes education led to a higher likelihood of engaging in self-care activities, driven in part by increases in self-efficacy. Future interventions that aim to improve diabetes self-management behaviors can benefit from targeting self-efficacy constructs and from the integration of diabetes education in the care coordination structure.

Physicians report a number of barriers to obesity counseling, among them low perceived competence in the ability to counsel. While there is increasing recognition of the need for resident training on counseling, implementation requires residency programs to have the necessary curricula and tools to evaluate training effectiveness. This study's objective was to describe the development and psychometric testing of the Perceived Competence for Obesity Counseling (PCOC) scale. Items were generated based on constructs from the 5A's counseling framework, review of the obesity literature, and expert opinion. The 20-item scale was piloted among 74 resident physicians. Exploratory factor analysis was conducted to identify the number and nature of factors in the scale. Pearson's correlation was used to assess scale validity of the total scores and sub-scale scores association with residents' overall confidence in counseling and outcome expectancy for obesity counseling. Analyses suggested a 3-factor solution. After the removal of cross loading items, eighteen items were retained; eleven items loaded on the first factor, four items on the second factor, and three on the third factor. Cronbach's alpha for the 18-item PCOC scale was 0.95 indicating internal consistency. The PCOC scale was significantly correlated with resident's overall confidence in counseling (r = 0.60, p < 0.01) and outcome expectancy for obesity counseling (r = 0.41, p < 0.01). This pilot study suggests PCOC holds promise as a valid and reliable measure of resident's perceived competence for obesity counseling. Future studies are needed to assess the scale's association with counseling skills.

PURPOSE Cognitive behavioral therapy (CBT)-based programs delivered by trained community members could improve functioning and pain in individuals who lack access to such programs. We tested the effectiveness of a peer-delivered diabetes self-management program integrating CBT principles in improving physical activity, functional status, pain, quality of life (QOL), and health outcomes in individuals with diabetes and chronic pain. METHODS In this community-based, cluster-randomized controlled trial, intervention participants received a 3-month, peer-delivered, telephone-administered program. Attention control participants received a peer-delivered general health advice program. Outcomes were changes in functional status and pain (Western Ontario and McMaster Universities Osteoarthritis Index), QOL (Short Form 12), and physiologic measures (hemoglobin A1c, systolic blood pressure, body mass index); physical activity was the explanatory outcome. RESULTS Of 195 participants with follow-up data, 80% were women, 96% African Americans, 74% had annual income CONCLUSION This peer-delivered CBT-based intervention improved functioning, pain, QOL, and self-reported physical activity despite pain in individuals with diabetes and chronic pain. Trained community members can deliver effective CBT-based interventions in rural and under-resourced communities. Key words: chronic pain; diabetes; community peer coaches; community health workers; cognitive behavioral therapy, INTRODUCTION Rural communities in the Southeastern United States have the highest prevalence of diabetes in the nation. (1) Area residents face considerable barriers to successful diabetes self-management, including lack of [...]

OBJECTIVE: Diabetes is associated with reduced health-related quality of life (HRQoL). Information on the relationship between HRQoL and glucose-lowering medications in recently diagnosed type 2 diabetes (T2D) is limited. We assessed changes in HRQoL in participants with T2D receiving metformin plus one of four glucose-lowering medications in Glycemia Reduction Approaches in Diabetes: A Comparative Effectiveness Study (GRADE). RESEARCH DESIGN AND METHODS: A total of 5,047 participants, baseline mean age 57 years, with <10 years T2D duration and glycated hemoglobin level 6.8–8.5% and taking metformin monotherapy, were randomly assigned to glargine, glimepiride, liraglutide, or sitagliptin. HRQoL was evaluated at baseline for 4,885 participants, and at years 1, 2, and 3, with use of the self-administered version of the Quality of Well-being Scale (QWB-SA) and SF-36 physical (PCS) and mental (MCS) component summary scales. Linear models were used to analyze changes in HRQoL over time in intention-to-treat analyses. RESULTS: None of the medications worsened HRQoL. There were no differences in QWB-SA or MCS by treatment group at any time point. PCS scores improved with liraglutide versus other groups at year 1 only. Greater weight loss during year 1 explained half the improvement in PCS scores with liraglutide versus glargine and glimepiride. Liraglutide participants in the upper tertile of baseline BMI showed the greatest improvement in PCS scores at year 1. CONCLUSIONS: Adding liraglutide to metformin in participants within 10 years of T2D diagnosis showed improvement in the SF-36 PCS in comparisons with the other medications at 1 year, which was no longer significant at years 2 and 3. Improvement was related to weight loss and baseline BMI. [ABSTRACT FROM AUTHOR]

OBJECTIVE: To evaluate whether baseline levels of depressive symptoms and diabetes-specific distress are associated with glycemic control in Glycemia Reduction Approaches in Diabetes: A Comparative Effectiveness Study (GRADE), a large randomized controlled trial comparing the metabolic effects of four common glucose-lowering medications when combined with metformin in individuals with type 2 diabetes mellitus (T2DM). RESEARCH DESIGN AND METHODS: The primary and secondary outcomes were defined as an HbA1c value ≥7%, subsequently confirmed, and an HbA1c value >7.5%, subsequently confirmed, respectively. Separate Cox proportional hazards models assessed the association between baseline levels of each exposure of interest (depressive symptoms measured with the eight-item Patient Health Questionnaire and diabetes distress measured with the Diabetes Distress Scale) and the subsequent risk of metabolic outcomes. RESULTS: This substudy included 1,739 participants (56% of whom were non-Hispanic White, 18% non-Hispanic Black, 17% Hispanic, and 68% male; mean [SD] age 58.0 [10.2] years, diabetes duration 4.2 [2.8] years, and HbA1c 7.5% [0.48%]). A total of 1,157 participants reached the primary outcome, with time to event of 2.1 years on average, while 738 participants reached the secondary outcome at 3 years on average. With adjustment for sex, race/ethnicity, treatment group, baseline age, duration of T2DM, BMI, and HbA1c, there were no significant associations between the depressive symptoms or diabetes distress and the subsequent risk of the primary or secondary outcomes. CONCLUSIONS: The current findings suggest that, at least for individuals with diabetes of relatively short duration, baseline levels of emotional distress are not associated with glycemic control over time. [ABSTRACT FROM AUTHOR]

OBJECTIVE: We evaluated whether adding basal insulin to metformin in adults with early type 2 diabetes mellitus (T2DM) would increase emotional distress relative to other treatments. RESEARCH DESIGN AND METHODS: The Glycemia Reduction Approaches in Diabetes: A Comparative Effectiveness Study (GRADE) of adults with T2DM of <10 years' duration, HbA1c 6.8–8.5%, and taking metformin monotherapy randomly assigned participants to add insulin glargine U-100, sulfonylurea glimepiride, the glucagon-like peptide-1 receptor agonist liraglutide, or the dipeptidyl peptidase 4 inhibitor sitagliptin. The Emotional Distress Substudy enrolled 1,739 GRADE participants (mean [SD] age 58.0 [10.2] years, 32% female, 56% non-Hispanic White, 18% non-Hispanic Black, 17% Hispanic) and assessed diabetes distress and depressive symptoms every 6 months. Analyses examined differences at 1 year and over the 3-year follow-up. RESULTS: Across treatments, diabetes distress (−0.24, P < 0.0001) and depressive symptoms (−0.67, P < 0.0001) decreased over 1 year. Diabetes distress was lower at 1 year for the glargine group than for the other groups combined (−0.10, P = 0.002). Diabetes distress was also lower for liraglutide than for glimepiride or sitagliptin (−0.10, P = 0.008). Over the 3-year follow-up, there were no significant group differences in total diabetes distress; interpersonal diabetes distress remained lower for those assigned to liraglutide. No significant differences were observed for depressive symptoms. CONCLUSIONS: Contrary to expectations, this randomized trial found no evidence for a deleterious effect of basal insulin on emotional distress. Glargine lowered diabetes distress modestly at 1 year rather than increasing it. Liraglutide also reduced diabetes distress at 1 year. Results can inform treatment decisions for adults with early T2DM. [ABSTRACT FROM AUTHOR]

OBJECTIVE: We examined longitudinal associations between emotional distress (specifically, depressive symptoms and diabetes distress) and medication adherence in Glycemia Reduction Approaches in Diabetes: A Comparative Effectiveness Study (GRADE), a large randomized controlled trial comparing four glucose-lowering medications added to metformin in adults with relatively recent-onset type 2 diabetes mellitus (T2DM). RESEARCH DESIGN AND METHODS: The Emotional Distress Substudy assessed medication adherence, depressive symptoms, and diabetes distress in 1,739 GRADE participants via self-completed questionnaires administered biannually up to 3 years. We examined baseline depressive symptoms and diabetes distress as predictors of medication adherence over 36 months. Bidirectional visit-to-visit relationships were also examined. Treatment satisfaction, beliefs about medication, diabetes care self-efficacy, and perceived control over diabetes were evaluated as mediators of longitudinal associations. RESULTS: At baseline, mean ± SD age of participants (56% of whom were White, 17% Hispanic/Latino, 18% Black, and 66% male) was 58.0 ± 10.2 years, diabetes duration 4.2 ± 2.8 years, HbA1c 7.5% ± 0.5%, and medication adherence 89.9% ± 11.1%. Higher baseline depressive symptoms and diabetes distress were independently associated with lower adherence over 36 months (P < 0.001). Higher depressive symptoms and diabetes distress at one visit predicted lower adherence at the subsequent 6-month visit (P < 0.0001) but not vice versa. Treatment assignment did not moderate relationships. Patient-reported concerns about diabetes medications mediated the largest percentage (11.9%–15.5%) of the longitudinal link between emotional distress and adherence. CONCLUSIONS: Depressive symptoms and diabetes distress both predict lower adherence to glucose-lowering medications over time among adults with T2DM. Addressing emotional distress and concerns about anticipated negative effects of taking these treatments may be important to support diabetes treatment adherence. [ABSTRACT FROM AUTHOR]

This article discusses the use of Medicare administrative claims data to examine trends in the prescribing of diabetes medications to patients without a diabetes diagnosis code from 2007 to 2019. The study found that the number of prescriptions for glucose-lowering medications, particularly metformin, increased over time. Interestingly, most beneficiaries who were prescribed these medications did not have a diagnosis of prediabetes, metabolic syndrome, obesity, or a family history of diabetes. The findings suggest that definitions of diabetes based on medication use may need to be reevaluated periodically to reflect changes in prescribing patterns. [Extracted from the article]

Background/Aims: We present and describe recruitment strategies implemented from 2013 to 2017 across 45 clinical sites in the United States, participating in the Glycemia Reduction Approaches in Diabetes: A Comparative Effectiveness Study, an unmasked, randomized controlled trial evaluating four glucose-lowering medications added to metformin in individuals with type 2 diabetes mellitus (duration of diabetes <10 years). We examined the yield of participants recruited through Electronic Health Records systems compared to traditional recruitment methods to leverage access to type 2 diabetes patients in primary care. Methods: Site selection criteria included availability of the study population, geographic representation, the ability to recruit and retain a diverse pool of participants including traditionally underrepresented groups, and prior site research experience in diabetes clinical trials. Recruitment initiatives were employed to support and monitor recruitment, such as creation of a Recruitment and Retention Committee, development of criteria for Electronic Health Record systems queries, conduct of remote site visits, development of a public screening website, and other central and local initiatives. Notably, the study supported a dedicated recruitment coordinator at each site to manage local recruitment and facilitate screening of potential participants identified by Electronic Health Record systems. Results: The study achieved the enrollment goal of 5000 participants, meeting its target with Black/African American (20%), Hispanic/Latino (18%), and age ≧60 years (42%) subgroups but not with women (36%). Recruitment required 1 year more than the 3 years originally planned. Sites included academic hospitals, integrated health systems, and Veterans Affairs Medical Centers. Participants were enrolled through Electronic Health Record queries (68%), physician referral (13%), traditional mail outreach (7%), TV, radio, flyers, and Internet (7%), and other strategies (5%). Early implementation of targeted Electronic Health Record queries yielded a greater number of eligible participants compared to other recruitment methods. Efforts over time increasingly emphasized engagement with primary care networks. Conclusion: Glycemia Reduction Approaches in Diabetes: A Comparative Effectiveness successfully recruited a diverse study population with relatively new onset of type 2 diabetes mellitus, relying to a large extent on the use of Electronic Health Record to screen potential participants. A comprehensive approach to recruitment with frequent monitoring was critical to meet the recruitment goal. [ABSTRACT FROM AUTHOR]

Aims: Diabetes distress is positively associated with HbA1c and may mediate the relationship between depressive symptoms and HbA1c. This study examined these relationships in a geographically, socioeconomically, and ethnically diverse sample of adults with type 2 diabetes. Methods: Using data from five US sites evaluating peer support for diabetes management (n = 917), Structural Equation Modeling (SEM) examined whether diabetes distress (four items from Diabetes Distress Scale) mediated the relationship between depressive symptoms (PHQ‐8) and HbA1c. Sites compared interventions of varying content and duration with control conditions. Time from Baseline Assessment to Final Assessment varied from six to 18 months. Site characteristics were controlled by entering site as a covariate along with age, sex, education, diabetes duration, insulin use, and intervention/control assignment. Results: Depressive symptoms, diabetes distress, and HbA1c were all intercorrelated cross‐sectionally and from Baseline to Final Assessment (rs from 0.10 to 0.57; ps <0.05). In SEM analyses, diabetes distress at Final Assessment mediated the relationship between Baseline depressive symptoms and HbA1c at Final Assessment (indirect effect: b = 0.031, p < 0.001), controlling for Baseline HbA1c and covariates. Parallel analysis of whether depressive symptoms mediated the relationship between Baseline diabetes distress and HbA1c at Final Assessment was not significant. Conclusions: In this diverse sample, diabetes distress mediated the influence of depressive symptoms on HbA1c but the reverse, depressive symptoms mediating the effect of distress, was not found. These findings add to the evidence that diabetes distress is a worthy intervention target to improve clinical status and quality of life among individuals with type 2 diabetes. [ABSTRACT FROM AUTHOR]

Background High rates of hypertension and poverty in the rural south contribute to health disparities with Black adults experiencing higher rates of cardiovascular disease than White adults, underscoring the need to identify prevention strategies. Methods The equity in prevention and progression of hypertension by addressing barriers to nutrition and physical activity (EPIPHANY) study is a cluster randomized controlled trial testing a multilevel intervention to reduce barriers to a healthy lifestyle to lower blood pressure (BP) among rural, Black adults. Health education fairs offered to 20 churches in the Alabama Black Belt are being used to screen and enroll adults with elevated BP or stage 1 hypertension (systolic BP 120–139 mmHg and diastolic BP < 90 mmHg) who are not recommended for antihypertensive medication, according to the 2017 American College of Cardiology/American Heart Association BP guideline. Participants (n = 240) in churches randomized to the control condition are offered access to online resources including cooking and exercise classes. Participants (n = 240) in churches randomized to the intervention are receiving access to online resources; telephone-based peer support for lifestyle modification; funding for churches to develop programs to address food access and/or barriers to physical activity; and training of church members to serve as church champions to deliver training for church members on lifestyle modification. We will employ a Type 1 hybrid implementation-effectiveness design to assess effectiveness and implementation. Conclusions The EPIPHANY study is designed to prevent hypertension among rural, Black adults by addressing structural and individual barriers to lifestyle modification through peer support. [ABSTRACT FROM AUTHOR]

BACKGROUND The American Heart Association funded a Health Equity Research Network on the prevention of hypertension, the RESTORE Network, as part of its commitment to achieving health equity in all communities. This article provides an overview of the RESTORE Network. METHODS The RESTORE Network includes five independent, randomized trials testing approaches to implement non-pharmacological interventions that have been proven to lower blood pressure (BP). The trials are community-based, taking place in churches in rural Alabama, mobile health units in Michigan, barbershops in New York, community health centers in Maryland, and food deserts in Massachusetts. Each trial employs a hybrid effectiveness-implementation research design to test scalable and sustainable strategies that mitigate social determinants of health (SDOH) that contribute to hypertension in Black communities. The primary outcome in each trial is change in systolic BP. The RESTORE Network Coordinating Center has five cores: BP measurement, statistics, intervention, community engagement, and training that support the trials. Standardized protocols, data elements and analysis plans were adopted in each trial to facilitate cross-trial comparisons of the implementation strategies, and application of a standard costing instrument for health economic evaluations, scale up, and policy analysis. Herein, we discuss future RESTORE Network research plans and policy outreach activities designed to advance health equity by preventing hypertension. CONCLUSIONS The RESTORE Network was designed to promote health equity in the US by testing effective and sustainable implementation strategies focused on addressing SDOH to prevent hypertension among Black adults. [ABSTRACT FROM AUTHOR]