Marina Trento

Rethink Organization to iMprove Education and Outcomes (ROMEO): A multicenter randomized trial of lifestyle intervention by group care to manage type 2 diabetes

OBJECTIVE A trial was performed to establish whether our group care model for lifestyle intervention in type 2 diabetes can be exported to other clinics. RESEARCH DESIGN AND METHODS This study was a 4-year, two-armed, multicenter controlled trial in 13 hospital-based diabetes clinics in Italy (current controlled trials no. ISRCTN19509463). A total of 815 non–insulin-treated patients aged <80 years with ≥1 year known diabetes duration were randomized to either group or individual care. RESULTS After 4 years, patients in group care had lower A1C, total cholesterol, LDL cholesterol, triglycerides, systolic and diastolic blood pressure, BMI, and serum creatinine and higher HDL cholesterol (P < 0.001, for all) than control subjects receiving individual care, despite similar pharmacological prescriptions. Health behaviors, quality of life, and knowledge of diabetes had become better in group care patients than in control subjects (P < 0.001, for all). CONCLUSIONS The favorable clinical, cognitive, and psychological outcomes of group care can be reproduced in different clinical settings.

Quality of Care of People With Type 2 Diabetes in Eight European Countries: Findings from the Guideline Adherence to Enhance Care (GUIDANCE) study

OBJECTIVE We sought to determine levels of adherence in eight European countries to recommendations for the management of type 2 diabetes and to investigate factors associated with key intermediate outcomes. RESEARCH DESIGN AND METHODS GUIDANCE was a cross-sectional study including retrospective data extraction from the medical records of people with type 2 diabetes recruited, using a shared protocol, from primary and specialist care sites in the following eight European countries: Belgium, France, Germany, Italy, Ireland, Sweden, the Netherlands, and the United Kingdom. The dataset for analysis comprised 7,597 cases. Proportions meeting process and outcome criteria were determined, including between-country variations. Logistic regression was used to investigate potential predictors of meeting targets for HbA1c, blood pressure, and LDL cholesterol. RESULTS In the total sample, adherence to process recommendations was high for some measures, for example, HbA1c recorded in past 12 months in 97.6% of cases. Target achievement for intermediate outcome measures was lower, with only 53.6% having HbA1c <7%. Considerable between-country variation was identified for both processes and outcomes. The following characteristics were associated with an increased likelihood of meeting targets for all three measures considered (HbA1c, blood pressure, LDL cholesterol): shorter diagnosis of diabetes; having one or more macrovascular complications; lower BMI; being prescribed lipid-lowering medication; and no current antihypertensive prescribing. CONCLUSIONS Compared with earlier reports, we have suggested some encouraging positive trends in Europe in relation to meeting targets for the management of people with type 2 diabetes, but there is still scope for further improvement and greater between-country consistency.

The locus of control in patients with Type 1 and Type 2 diabetes managed by individual and group care

Aims  The locus of control theory distinguishes people (internals) who attribute events in life to their own control, and those (externals) who attribute events to external circumstances. It is used to assess self‐management behaviour in chronic illnesses. Group care is a model of systemic group education that improves lifestyle behaviour and quality of life in patients with Type 1 and Type 2 diabetes. This study investigated the locus of control in Type 1 and Type 2 diabetes and the possible differences between patients managed by group care and control subjects followed by traditional one‐to‐one care.

Estimating the Delay Between Onset and Diagnosis of Type 2 Diabetes From the Time Course of Retinopathy Prevalence

OBJECTIVE By correlating known diabetes duration with the prevalence of retinopathy, more than 10 years have been estimated to lapse between the onset and diagnosis of type 2 diabetes. Such calculations, however, assumed a linear model, included stages of retinopathy not specific to diabetes, and allowed 5 years for retinopathy to occur after the onset of diabetes. We calculated the duration of undiagnosed type 2 diabetes in outpatients screened for retinopathy in a hospital-based diabetes clinic after correcting these assumptions. RESEARCH DESIGN AND METHODS Diabetic patients (n = 12,074; 35,545 fundus examinations) were stratified into younger onset (YO; age at onset <30 years) or older onset (OO; age at onset ≥30 years), insulin treated (IT) or not IT (NIT), and with mild/more severe diabetic retinopathy (AnyDR) or moderate/more severe diabetic retinopathy (ModDR). The best-fitting equation correlating known duration among the OO-NIT group with the prevalence of ModDR was used to extrapolate time from appearance of retinopathy to diagnosis of type 2 diabetes. Time for retinopathy to develop after diabetes was calculated from the equation correlating the duration among the YO-IT group with appearance of ModDR. RESULTS There were 1,719 patients in the OO-NIT group with AnyDR and 685 with ModDR and 756 in the YO-IT group with AnyDR and 385 with ModDR. A linear model showed ModDR appeared 2.66 years before diagnosis among those in the OO-NIT group. A quadratic model suggested that ModDR appeared 3.29 years after diagnosis among those in the YO-IT group. The resulting estimate was 6.05 years (2.66 + 3.29) between the onset and diagnosis of diabetes, compared with 13.36 years using standard criteria. CONCLUSIONS Using best-fitting models and stratifying by glucose-lowering treatment and severity of retinopathy substantially lowers the estimated duration of undiagnosed type 2 diabetes.

Quality of Life, Coping Ability, and Metabolic Control in Patients With Type 1 Diabetes Managed By Group Care and a Carbohydrate Counting Program

Group care is a clinical-pedagogic model in which traditional routine visits are substituted by sessions of group education. This approach improves quality of life and metabolic control in patients with type 2 diabetes (1) but only quality of life in those with type 1 diabetes (2). The latter must match multiple daily insulin administrations with blood glucose monitoring, dietary intake, and energy expenditure (3). We hypothesized that to improve their coping strategies, patients with type 1 diabetes need more specific training in the technical aspects of day-to-day management of insulin therapy. To verify this, we studied the effects of embedding a carbohydrate counting program within group care on quality of life, knowledge …

A study of patients' perceptions of diabetes care delivery and diabetes: propositional analysis in people with type 1 and 2 diabetes managed by group or usual care.

OBJECTIVE We investigated the perceptions of diabetes care and diabetes in patients followed long-term by group or usual care. RESEARCH DESIGN AND METHODS Three open questions were administered to 120 patients (43 with T1DM and 77 with T2DM) who had been randomized at least 2 years before to be followed by group care and 121 (41 T1DM and 80 T2DM) who had always been on usual care. The responses were analyzed by propositional analysis, by identifying the focal nuclei, i.e., the terms around which all sentences are organized, and then other predicates, according to their hierarchical relationship to the nuclear proposition. Specific communicative units were arbitrarily classified into three categories: attitudes, empowerment, and locus of control. RESULTS Patients on group care showed more positive attitudes, higher sense of empowerment, and more internal locus of control than those on usual care. In addition, they expressed a wider and more articulated range of concepts associated with the care received and made less use of medical terminology (P < 0.001, all). Higher HbA1c was associated with negative attitudes (P = 0.025) and negative empowerment (P = 0.055). CONCLUSIONS Group treatment reinforces communication and peer identification and may achieve its clinical results by promoting awareness, self-efficacy, positive attitudes toward diabetes and the setting of care, an internal locus of control, and, ultimately, empowerment in the patients.

Perceptions of diabetic retinopathy and screening procedures among diabetic people

Aims To assess how diabetic patients perceive retinopathy, screening for sight‐threatening lesions and their own role in preventing blindness.

Carbohydrate counting improves coping ability and metabolic control in patients with Type 1 diabetes managed by Group Care.

Background and aims: To assess, in patients with Type 1 diabetes (T1 DM), the effects of adding a carbohydrate counting programme (CCP) to continuing education by Group Care on coping ability, quality of life (QoL), knowledge of diabetes, and metabolic control. Materials and methods: Out of 56 patients with T1 DM followed by Group Care, 27 were randomized to receive an 8-session CCP and 29 controls continued Group Care without a CCP. QoL, knowledge, and coping ability were assessed at baseline and after 30 months. Glycated hemoglobin (HbA1c), body weight, blood glucose, hypoglycemic episodes, and insulin dosages were checked every 3 months. Results: QoL improved (p<0.0001) in both CCP (88.7±9.2 vs78.0±9.9) and control patients (88.7±12.5 vs 80.4±11.7). At the end of study, patients on CCP had better scores in knowledge [difference 0.72 (95% CI 0.44; 0.99), p<0.0001] and the 3 coping areas [problem solving: 1.75 (1.2; 2.3), p<0.0001; social support seeking: −1.4 (−2.3; −0.48) p<0.005; avoidance: −1.59 (−2.6; −0.56), p<0.005] than controls. All variables showed a greater, although not statistically significant, improvement in patients with poor schooling. At 30 months, HbA1c was lower in the CCP patients than controls (7.2±0.9 vs 7.9±1.4), p<0.05. There were no changes in insulin dosage, hypoglycemic episodes or blood lipids. Conclusions: This study confirms that Group Care improves QoL in people with T1 DM, but suggests that specific educational and psychological supports are needed to modify adaptation to the disease. The CCP we developed appears effective in promoting change, also in patients with poor schooling.

A randomised controlled clinical trial of nurse-, dietitian- and pedagogistled Group Care for the management of Type 2 diabetes

Aim: To verify if Group Care, a model to manage Type 2 diabetes (T2DM) by systemic continuing group education, can be administered by nurses and dieticians under pedagogic guidance, and improve metabolic control, quality of life, Locus of Control, and insulin resistance. Material and subjects: Twenty-five patients with non-insulin-treated T2DM were randomized to Group Care and 24 to continued habitual individual care and education delivered by a diabetes specialist and pedagogist, respectively. Six nurses and 1 dietician received training by an accredited programme, a detailed operating manual and pedagogical supervision throughout the study. Follow-up was for 2 yr and included measurements of fasting blood glucose, glycated hemoglobin (HbA1c), body mass index, waist circumference, lipids, creatinine, blood pressure, serum insulin, homeostasis model assessment (HOMA) index of insulin resistance, health behaviors, quality of life, state and trait anxiety, and Locus of Control. Results: One patient on Group Care and 3 controls dropped out. At the end of study, the patients on Group Care had lower HbA1c (7.6± 0.8 vs 8.4± 1.3, p<0.05), insulin (18.0± 9.6 vs 24.3± 13.7, p<0.001), HOMA index (6.9± 5.4 vs 9.2± 6.6, p<0.05), and fatalistic attitude (17.2± 5.9 vs 24.9± 4.2, p<0.001) and better quality of life (65.0± 11.0 vs 78.4± 19.6, p<0.001) than controls. Conclusions: Group Care delivered by trained nurses and dietitan is associated with better outcomes than those obtained by a medically and pedagogically qualified team. It may offer a model for health operators to re-organize clinical practice and for patients to improve lifestyle and strengthen the therapeutic alliance with their carers.

ROMEO: rethink organization to improve education and outcomes

Aims  Scarcity of resources, expertise and evidence‐based models have so far limited delivery of patient‐centred diabetes education. We have developed and validated a group care approach that is applicable to everyday clinical practice and cost‐effective in improving metabolic control, knowledge of diabetes, health behaviours, and quality of life in Type 2 diabetes. A clinical trial (ROMEO) was planned to evaluate applicability and reproducibility of group care in other outpatients facilities and assess its impact on a larger patient population.