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OBJECTIVE To compare three interventions to reduce diabetes distress (DD) and improve self-management among non–clinically depressed adults with type 2 diabetes mellitus (T2DM). RESEARCH DESIGN AND METHODS In REDEEM, 392 adults with T2DM and DD were randomized to computer-assisted self-management (CASM), CASM plus DD-specific problem solving (CAPS), or a computer-administered minimal supportive intervention. Primary outcomes were Diabetes Distress Scale (DDS) total, the Emotional Burden (EB) and Regimen Distress (RD) DDS subscales, and diet, exercise, and medication adherence. RESULTS Significant and clinically meaningful reductions in DD (DDS, EB, and RD) and self-management behaviors occurred in all three conditions (P < 0.001), with no significant between-group differences. There was, however, a significant group × baseline distress interaction (P < 0.02), in which patients with high baseline RD in the CAPS condition displayed significantly larger RD reductions than those in the other two conditions. RD generated the most distress and displayed the greatest distress reduction as a result of intervention. The pace of DD reduction varied by patient age: older patients demonstrated significant reductions in DD early in the intervention, whereas younger adults displayed similar reductions later. Reductions in DD were accompanied by significant improvements in healthy eating, physical activity, and medication adherence, although not by change in HbA1c. CONCLUSIONS DD is malleable and highly responsive to intervention. Interventions that enhance self-management also reduce DD significantly, but DD-specific interventions may be necessary for patients with high initial levels of DD. Future research should identify the minimal, most cost-effective interventions to reduce DD and improve self-management.

Just as treatment guidelines for diabetes care were at the forefront of medical guideline development (1), diabetes has been a prominent focus of performance measurement and quality improvement initiatives for well over a decade. However, the constraints of pre-electronic health records (EHRs) data systems have consistently limited the clinical scope and sophistication of current diabetes quality measures. The U.S. health care system is nearing a tipping point in the use of more sophisticated EHR-based information systems, and widespread use of these systems will usher in a new era for diabetes quality measurement. New information system capabilities will enable improvements to existing measures and enable development of much more sophisticated measures that can accommodate personalization of clinical goals, patient preferences, and patient-reported data, thus moving both guidelines and measures toward personalization based on sophisticated assessment of the risks and benefits of certain clinical actions for a given patient at a given clinical encounter. To facilitate discussion of the future of performance measurement in diabetes in this era of rapid transition to EHRs, the American Diabetes Association (ADA) convened a consensus development conference in December 2010. Participating experts identified and discussed the following questions: 1. 1. What is the evidence that measuring quality, benchmarking, and providing feedback or incentives improve diabetes care? 2. 2. What are the limitations, burdens, and consequences (intended or unintended) of diabetes quality measures as currently structured? 3. 3. What should be the role of shared decision making, patient preferences, and patient-reported data in quality measures? 4. 4. What is the future of quality measurement in diabetes? 5. 5. How can quality monitoring be integrated into population surveillance efforts? This report summarizes the consensus meeting, and represents the expert opinion of its authors and not the official position of the ADA or any other participating organization. ### 1. What is the evidence that measuring quality, benchmarking, and providing feedback or incentives improve diabetes care? The first national effort to develop a …

OBJECTIVE To determine the concurrent, prospective, and time-concordant relationships among major depressive disorder (MDD), depressive symptoms, and diabetes distress with glycemic control. RESEARCH DESIGN AND METHODS In a noninterventional study, we assessed 506 type 2 diabetic patients for MDD (Composite International Diagnostic Interview), for depressive symptoms (Center for Epidemiological Studies-Depression), and for diabetes distress (Diabetes Distress Scale), along with self-management, stress, demographics, and diabetes status, at baseline and 9 and 18 months later. Using multilevel modeling (MLM), we explored the cross-sectional relationships of the three affective variables with A1C, the prospective relationships of baseline variables with change in A1C over time, and the time-concordant relationships with A1C. RESULTS All three affective variables were moderately intercorrelated, although the relationship between depressive symptoms and diabetes distress was greater than the relationship of either with MDD. In the cross-sectional MLM, only diabetes distress but not MDD or depressive symptoms was significantly associated with A1C. None of the three affective variables were linked with A1C in prospective analyses. Only diabetes distress displayed significant time-concordant relationships with A1C. CONCLUSIONS We found no concurrent or longitudinal association between MDD or depressive symptoms with A1C, whereas both concurrent and time-concordant relationships were found between diabetes distress and A1C. What has been called “depression” among type 2 diabetic patients may really be two conditions, MDD and diabetes distress, with only the latter displaying significant associations with A1C. Ongoing evaluation of both diabetes distress and MDD may be helpful in clinical settings.

OBJECTIVE—Health policies are important determinants of clinician and patient behavior, and an important policy issue is what items are included in healthcare quality and performance measures. There is consensus that patient-centered care and self-management support are essential evidence-based components of good diabetes care. However, most major diabetes performance measures such as the National Committee for Quality Assurance (NCQA)/American Diabetes Association (ADA) Provider Recognition Program indexes have not included self-management or psychosocial items. RESEARCH DESIGN AND METHODS AND RESULTS—We review the case for and propose a set of patient-centered, self-management indicators to be included as a standard part of diabetes quality indicators. The proposed indicators include: patient self-management goal(s), measures of health behaviors (e.g., healthy eating, medication taking, physical activity, and smoking status), quality of life, and patient-centered collaborative care. We discuss the evidence and the concerns about patient-report measures and summarize successful incorporation of such patient-centered measures in other countries and by the American Association of Diabetes Educators (AADE). CONCLUSIONS—The adage that “what gets measured, gets done” applies to diabetes management and many other areas of healthcare. Inclusion of the proposed indicators in national diabetes performance measures would be consistent with Institute of Medicine (IOM), ADA, Centers for Disease Control (CDC), Diabetes Attitudes, Wishes, and Needs (DAWN), AADE, and Society of Behavioral Medicine (SBM) recommendations. Such action would enhance both the priority and delivery of quality, patient-centered care, and diabetes self-management support.

Research has clearly demonstrated that reductions in hyperglycemia, blood pressure, and lipids through medication and healthy living can retard diabetes progression and reduce cardiovascular risk (1). The Diabetes Prevention Program (2) has convincingly shown that healthy living and appropriate medication can reduce or even halt the progression to full diabetes for individuals with pre-diabetes. These studies used large samples of individuals who were able to adhere to the lifestyle change and medication protocols included in these clinical trials so that the effects of the interventions could be adequately documented. Applying the results of these landmark studies to the world of clinical practice has been somewhat more difficult than anticipated (3). Providing access to care for all patients, incorporating guideline-based care in clinical practice, motivating patients to initiate and sustain the essential healthy-living life changes that diabetes requires, helping patients cope with diabetes-related distress and depression, and addressing the competing priorities in health care have slowed the full application of knowledge gained by these and related studies. In clinical practice, at national meetings, and in the literature, the question most often voiced by practicing clinicians across the diabetes-related health professions is, “How do I help activate or empower my patients to take better care of their diabetes?” Despite the general consensus that weight control, balanced diet, regular physical activity, blood glucose self-monitoring, medication management, and good diabetes emotional coping and problem solving are some of the primary, evidence-based dimensions of good diabetes self-care, most patients with diabetes continue to have chronic or episodic problems achieving these goals. These problems lead to increased morbidity and mortality, high health care costs, and often high frustration among both patients and practitioners. Despite the enormous advances in sophisticated medications and diabetes-related devices based on recent advances in genetics, biotechnology, and bio-engineering, we are left with …

OBJECTIVE—We sought to determine differences between structured interviews, symptom questionnaires, and distress measures for assessment of depression in patients with diabetes. RESEARCH DESIGN AND METHODS—We assessed 506 diabetic patients for major depressive disorder (MDD) by a structured interview (Composite International Diagnostic Interview [CIDI]), a questionnaire for depressive symptoms (Center for Epidemiological Studies Depression Scale [CESD]), and on the Diabetes Distress Scale. Demographic characteristics, two biological variables (A1C and non-HDL cholesterol), and four behavioral management measures (kilocalories, calories of saturated fat, number of fruit and vegetable servings, and minutes of physical activity) were assessed. Comparisons were made between those with and without depression on the CIDI and the CESD. RESULTS—Findings showed that 22% of patients reached CESD ≥16, and 9.9% met a CIDI diagnosis of MDD. Of those above CESD cut points, 70% were not clinically depressed, and 34% of those who were clinically depressed did not reach CESD scores ≥16. Those scoring ≥16, compared with those CONCLUSIONS—Most patients with diabetes and high levels of depressive symptoms are not clinically depressed. The CESD may be more reflective of general emotional and diabetes-specific distress than clinical depression. Most treatment of distress, however, is based on the depression literature, which suggests the need to consider different interventions for distressed but not clinically depressed diabetic patients.

OBJECTIVE—There is a well-documented gap between diabetes care guidelines and the services received by patients in most health care settings. This report presents 12-month follow-up results from a computer-assisted, patient-centered intervention to improve the level of recommended services patients received from a variety of primary care settings. RESEARCH DESIGN AND METHODS—A total of 886 patients with type 2 diabetes under the care of 52 primary care physicians participated in the Diabetes Priority Program. Physicians were stratified and randomized to intervention or control conditions and evaluated on two primary outcomes: number of recommended laboratory screenings and recommended patient-centered care activities completed from the National Committee on Quality Assurance/American Diabetes Association Provider Recognition Program (PRP). Secondary outcomes were evaluated using the Problem Areas in Diabetes 2 quality of life scale, lipid and HbA1c levels, and the Patient Health Questionnaire-9 depression scale. RESULTS—The program was well implemented and significantly improved both the number of laboratory assays and patient-centered aspects of diabetes care patients received compared with those in the control condition. There was overall improvement on secondary outcomes of lipids, HbA1c, quality of life, and depression scores; between-condition differences were not significant. CONCLUSIONS—Staff in small, mixed-payer primary care offices can consistently implement a patient-centered intervention to improve PRP measures of quality of diabetes care. Alternative explanations for why these process improvements did not lead to improved outcomes, and suggested directions for future research are discussed.

Diabetes and its care have captured the attention of clinicians, managed care, regulatory agencies, and the media. Several successful trials over the past decade have brought the issue of translating evidence-based findings on diabetes care into practice to the forefront of health care discussions (1–3). Despite these promising advances, it is well documented that there is a large gap between what is known about diabetes care and what is commonly practiced (4–6). Studies of the level of diabetes care provided in the real world, and especially in primary care practices where the vast majority of patients are seen, consistently show that performance levels fall short of what is recommended (4–7). Even relatively simple actions, such as ordering a blood sample for analysis or regularly checking HbA1c, are performed far less frequently than recommended (5,6). Adherence to behaviorally oriented aspects of good diabetes and preventive care are performed even less often (with the possible exception of smoking cessation advice) (4,7). Diabetes Care has devoted a series of articles to the discussion of translation issues and different perspectives on this topic (8–10). This article contributes to the discussion by 1 ) discussing changes needed in the conduct of research studies if we are to reduce the gap between research and practice, and 2 ) identifying specific areas for future translation research. There have been two positive examples of the adoption of research-based innovations. First, there has been a paradigm shift in the approach to self-management education and behavior change, both within diabetes education and the broader behavioral science community. This shift has been from provider-centered “compliance” approaches to more patient-centered “empowerment” methods (11–13). The second change that has become widely adopted, at least within leading …

OBJECTIVE—Few multiple lifestyle behavior change programs have been designed to reduce the risk of coronary heart disease in postmenopausal women with type 2 diabetes. This study tested the effectiveness of the Mediterranean Lifestyle Program (MLP), a comprehensive lifestyle self-management program (Mediterranean low–saturated fat diet, stress management training, exercise, group support, and smoking cessation), in reducing cardiovascular risk factors in postmenopausal women with type 2 diabetes. RESEARCH DESIGN AND METHODS—Postmenopausal women with type 2 diabetes (n = 279) were randomized to either usual care (control) or treatment (MLP) conditions. MLP participants took part in an initial 3-day retreat, followed by 6 months of weekly meetings, to learn and practice program components. Biological end points were changes in HbA1c, lipid profiles, BMI, blood pressure, plasma fatty acids, and flexibility. Impact on quality of life was assessed. RESULTS—Multivariate ANCOVAs revealed significantly greater improvements in the MLP condition compared with the usual care group on HbA1c, BMI, plasma fatty acids, and quality of life at the 6-month follow-up. Patterns favoring intervention were seen in lipids, blood pressure, and flexibility but did not reach statistical significance. CONCLUSIONS—These results demonstrate that postmenopausal women with type 2 diabetes can make comprehensive lifestyle changes that may lead to clinically significant improvements in glycemic control, some coronary heart disease risk factors, and quality of life.

OBJECTIVE—Because of other competing priorities, physical activity (PA) is seldom addressed in a consistent way in either primary care or diabetes education . This 8-week pilot study evaluated the short-term benefits of an Internet-based supplement to usual care that focused on providing support for sedentary patients with type 2 diabetes to increase their PA levels. RESEARCH DESIGN AND METHODS—A total of 78 type 2 diabetic patients (53% female, average age 52.3 years) were randomized to the Diabetes Network (D-Net) Active Lives PA Intervention or an Internet information-only condition. The intervention condition received goal-setting and personalized feedback, identified and developed strategies to overcome barriers, received and could post messages to an on-line “personal coach,” and were invited to participate in peer group support areas. Key outcomes included minutes of PA per week and depressive symptomatology. RESULTS—There was an overall moderate improvement in PA levels within both intervention and control conditions, but there was no significant improvement in regard to condition effects. There was substantial variability in both site use and outcomes within the intervention and control conditions. Internal analyses revealed that among intervention participants, those who used the site more regularly derived significantly greater benefits, whereas those in the control condition derived no similar benefits with increased program use. CONCLUSIONS—Internet-based self-management interventions for PA and other regimen areas have great potential to enhance the care of diabetes and other chronic conditions. We conclude that greater attention should be focused on methods to sustain involvement with Internet-based intervention health promotion programs over time.

As one of four work groups for the November 1999 conference on Behavioral Science Research in Diabetes, sponsored by the National Institute on Diabetes and Digestive and Kidney Diseases, the health care delivery work group evaluated the status of research on quality of care, patient-provider interactions, and health care systems' innovations related to improved diabetes outcomes. In addition, we made recommendations for future research. In this article, which was developed and modified at the November conference by experts in health care delivery, diabetes and behavioral science, we summarize the literature on patient-provider interactions, diabetes care and self-management support among underserved and minority populations, and implementation of chronic care management systems for diabetes. We conclude that, although the quality of care provided to the vast majority of diabetic patients is problematic, this is principally not the fault of either individual patients or health care professionals. Rather, it is a systems issue emanating from the acute illness model of care, which still predominates. Examples of proactive population-based chronic care management programs incorporating behavioral principles are discussed. The article concludes by identifying barriers to the establishment of a chronic care model(e.g., lack of supportive policies, understanding of population-based management, and information systems) and priorities for future research in this area needed to overcome these barriers.

OBJECTIVETo evaluate associations between psychosocial and social-environmental variables and diabetes self-management, and diabetes control.RESEARCH DESIGN AND METHODSBaseline data from a type 2 diabetes self-management randomized trial with 463 adults having elevated BMI (M = 34.8 kg/m2) were used to investigate relations among demographic, psychosocial, and social-environmental variables; dietary, exercise, and medication-taking behaviors; and biologic outcomes.RESULTSSelf-efficacy, problem solving, and social-environmental support were independently associated with diet and exercise, increasing the variance accounted for by 23 and 19%, respectively. Only diet contributed to explained variance in BMI (β = −0.17, P = 0.0003) and self-rated health status (β = 0.25, P < 0.0001); and only medication-taking behaviors contributed to lipid ratio (total–to–HDL) (β = −0.20, P = 0.0001) and A1C (β = −0.21, P < 0.0001).CONCLUSIONSInterventions should focus on enhancing self-efficacy, problem solving, and social-environmental support to improve self-management of diabetes.

OBJECTIVE To clarify previous findings that diabetes distress is related to glycemic control and self-management whereas measures of depression are not, using both binary and continuous measures of depression. RESEARCH DESIGN AND METHODS Four hundred and sixty-three type 2 patients completed measures of diabetes distress (Diabetes Distress Scale [DDS]) and clinical depression (Patient Health Questionnaire 8 [PHQ8]). PHQ8 was employed as either a binary (≥10) or continuous variable. Dependent variables were A1C, diet, physical activity (PA), and medication adherence (MA). RESULTS The inclusion of a binary or continuous PHQ8 score yielded no differences in any equation. DDS was significantly associated with A1C and PA, whereas PHQ8 was not; both DDS and PHQ8 were significantly and independently associated with diet and MA. CONCLUSIONS The lack of association between depression and glycemic control is not due to the use of a binary measure of depression. Findings further clarify the significant association between distress and A1C.

OBJECTIVE: To review reliability, validity, and normative data from 7 different studies, involving a total of 1,988 people with diabetes, and provide a revised version of the Summary of Diabetes Self-Care Activities (SDSCA) measure. RESEARCH DESIGN AND METHODS: The SDSCA measure is a brief self-report questionnaire of diabetes self-management that includes items assessing the following aspects of the diabetes regimen: general diet, specific diet, exercise, blood-glucose testing, foot care, and smoking. Normative data (means and SD), inter-item and test-retest reliability, correlations between the SDSCA subscales and a range of criterion measures, and sensitivity to change scores are presented for the 7 different studies (5 randomized interventions and 2 observational studies). RESULTS: Participants were typically older patients, having type 2 diabetes for a number of years, with a slight preponderance of women. The average inter-item correlations within scales were high (mean = 0.47), with the exception of specific diet; test-retest correlations were moderate (mean = 0.40). Correlations with other measures of diet and exercise generally supported the validity of the SDSCA subscales (mean = 0.23). CONCLUSIONS: There are numerous benefits from standardization of measures across studies. The SDSCA questionnaire is a brief yet reliable and valid self-report measure of diabetes self-management that is useful both for research and practice. The revised version and its scoring are presented, and the inclusion of this measure in studies of diabetes self-management is recommended when appropriate.

OBJECTIVE The specific aims of the present study were to report on the level of personal beliefs and social and environmental barriers across different regimen areas and patient subgroups and on the relationship of personal models and perceived barriers to the level of self-management. RESEARCH DESIGN AND METHODS This study focused on several issues related to personal models (representations of illness) and perceived barriers to diabetes self-management among a large heterogeneous survey sample of 2,056 adults throughout the U.S. RESULTS Respondents felt that diabetes was a serious disease and that their self-management activities will control their diabetes and reduce the likelihood of long-term complications. Most frequently reported barriers were related to dietary adherence, followed by exercise and glucose testing barriers. Both personal models and barriers significantly predicted level of self-management in all three regimen areas studied (diet, exercise, and glucose testing) after controlling for the influence of demographic and medical history factors. Regimen-specific models and barriers proved to be stronger predictors than more global measures. Differences on personal models and barriers were observed among different patient groups (e.g., age, health insurance, and insulin-taking status). Possible reasons for these differences and implications for intervention and future research are discussed. CONCLUSIONS Both the personal-model and barriers scales had good internal consistency and predicted variance in each of the self-management variables after controlling for demographic and medical history factors. These brief self-report personal-model scales demonstrated good internal reliability and were as predictive of self-management as the lengthier interview-based measures in previous studies. The assessment of the treatment effectiveness component of personal models may be sufficient for most clinical purposes.

This article discusses an evolving conceptual model of diabetes self-management and patient education. The model contains three primary levels or stages: 1) social environment and contextual factors, which have received little research attention; 2) patient-health care provider interactions, self-management behaviors, and short-term physiological outcomes, which constitute an ongoing cycle of care feedback system; and 3) longer term health and quality-of-life outcomes, which include the major societal costs of treating diabetes complications. The assessment and intervention implications of factors within each of these levels are discussed, with emphasis on both low-cost system-wide activities appropriate for all patients and higher cost activities and resources (e.g., intensive management à la the Diabetes Control and Complications Trial) for appropriately targeted or higher risk patients. I hope that such a systems approach to diabetes management can help reduce victim blaming (whether the victim is the noncompliant patient or the insensitive provider). Such conceptual models, if practically oriented, may help accelerate the development, evaluation, and dissemination of programs that facilitate both patient and health care team adherence to recommended guidelines for diabetes care.

This article reviews the published literature on diabetes education evaluations and makes recommendations for outcome measures to be used in future research. We conclude that program evaluations to date have focused too narrowly on assessing knowledge and GHb outcomes to the exclusion of other important variables. To reflect the changing emphasis and conceptual basis of diabetes education, we recommend that future evaluations do the following: 1) report on the program's target population, recruitment methods, and representativeness of participants; 2) collect measures of self-efficacy and patient-provider interaction; 3) include quality of life and patient-functioning outcomes; and 4) use more standardized and objective measures of diabetes management behaviors. We close by providing practical examples of feasible collection measures for most settings and references to studies that have done so.

There is a dearth of information on the extent to which diabetic patients receive care congruent with the chronic care model (CCM) and evidence-based behavioral counseling. This study evaluates a new instrument to fill this gap.A heterogeneous sample of 363 type 2 diabetic patients completed the original Patient Assessment of Chronic Illness Care (PACIC), along with additional items that allowed it to be scored according to the "5As" (ask, advise, agree, assist, and arrange) model of behavioral counseling. We evaluated relationships between survey scores and patient characteristics, quality of diabetes care, and self-management.Findings replicated those of the initial PACIC validation study but with a much larger sample of diabetic patients and more Latinos. Areas of CCM activities reported least often were goal setting/intervention tailoring and follow-up/coordination. The 5As scoring revealed that patients were least likely to receive assistance with problem solving and arrangement of follow-up support. Few demographic or medical characteristics were related to PACIC or 5As scores, but survey scores were significantly related to quality of diabetes care received and level of physical activity.The PACIC and the new 5As scoring method appear useful for diabetic patients. Its use is encouraged in future research and quality improvement studies.

“IDDK’s mission is to conduct and support research on diseases such as diabetes in order to increase knowledge to improve the public’s health. NIDDK’s goals will not be completely achieved until the knowledge gained from the research it supports is translated and fully applied.”—Allen Spiegel, MD, Director, National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), 27 September 2002 (1). Tremendous advances have occurred in diabetes research over the past decade. Landmark clinical trials such as the Diabetes Control and Complications Trial (DCCT) and U.K. Prospective Diabetes Study (UKPDS) have demonstrated that tight glycemic and blood pressure control reduce the rate of complications (2,3,4). More recently the Diabetes Prevention Program (DPP) showed that lifestyle interventions incorporating healthy diets and exercise, as well as treatment with the drug metformin, delay or prevent the development of diabetes in people with impaired glucose tolerance (5). Armed with such knowledge, health care providers and public health professionals have the potential to prevent morbidity and enhance quality of life in a cost-effective manner (6). Unfortunately, little of this potential has been realized. Numerous studies in a variety of settings indicate that real-world diabetes care frequently does not adhere to evidence-based practice standards for glycemic, blood pressure, and lipid levels and for providing recommended processes of care such as the Diabetes Quality Improvement Project indicators (7,8). The challenges of adhering to recommendations regarding diet, physical activity, medications, and other medical care are formidable. A complex array of social, financial, behavioral, and organizational barriers impede the application of high-quality diabetes care. These multifactorial barriers can be daunting, but significant advances have occurred in learning how to translate research findings from the clinical research setting into real-world practice. In September 2002 the Diabetes Mellitus Interagency Coordinating Committee, which …

Few multiple lifestyle behavior change programs have been designed to reduce the risk of coronary heart disease in postmenopausal women with type 2 diabetes. This study tested the effectiveness of the Mediterranean Lifestyle Program (MLP), a comprehensive lifestyle self-management program (Mediterranean low-saturated fat diet, stress management training, exercise, group support, and smoking cessation), in reducing cardiovascular risk factors in postmenopausal women with type 2 diabetes.Postmenopausal women with type 2 diabetes (n = 279) were randomized to either usual care (control) or treatment (MLP) conditions. MLP participants took part in an initial 3-day retreat, followed by 6 months of weekly meetings, to learn and practice program components. Biological end points were changes in HbA(1c), lipid profiles, BMI, blood pressure, plasma fatty acids, and flexibility. Impact on quality of life was assessed.Multivariate ANCOVAs revealed significantly greater improvements in the MLP condition compared with the usual care group on HbA(1c), BMI, plasma fatty acids, and quality of life at the 6-month follow-up. Patterns favoring intervention were seen in lipids, blood pressure, and flexibility but did not reach statistical significance.These results demonstrate that postmenopausal women with type 2 diabetes can make comprehensive lifestyle changes that may lead to clinically significant improvements in glycemic control, some coronary heart disease risk factors, and quality of life.