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Clinical Care/Education/Nutrition/Psychosocial Research B R I E F R E P O R T Rethink Organization to iMprove Education and Outcomes (ROMEO) A multicenter randomized trial of lifestyle intervention by group care to manage type 2 diabetes LAURA TONUTTI, MD6 MARCO TOMALINO, MD1 PIERVINCENZO BONDONIO, MBA7 FRANCO CAVALLO, MD8 MASSIMO PORTA, MD, PHD1 FOR THE ROMEO INVESTIGATORS 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 ⱖ1 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. Diabetes Care 33:745–747, 2010 L ifestyle intervention reduces incidence of (1,2) and helps improve metabolic control in (3,4) type 2 diabetes. However, lifestyle advice given during individual consultations remains secondary to pharmacological intervention (5). We developed a model to deliver diabetes care as group education sessions, which improves clinical outcomes, patients’ quality of life (QoL), and clinicians’ satisfaction while optimizing use of the typically limited resources of busy clinics (6 – 8). The Rethink Organization to iMprove Education and Outcomes (ROMEO) trial was a multicenter trial (9) aimed at evaluating if setting and results of group care can be reproduced in other clinics. RESEARCH DESIGN AND METHODS — A total of 815 patients with non–insulin-treated type 2 diabetes of ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● From the 1Laboratory of Clinical Pedagogy, Department of Internal Medicine, University of Turin, Turin, Italy; the 2Unit for Endocrinology and Diabetes, Maria Vittoria Hospital, Turin, Italy; the 3Unit for Diabetes and Metabolic Diseases ASL 19, Asti, Italy; the 4Unit for Diabetes and Metabolic Diseases, Scandiano Hospital, Scandiano, Italy; the 5Unit for Diabetes and Metabolic Diseases ASL 12, Biella, Italy; the 6Unit for Diabetes and Metabolic Diseases, Udine Hospital, Udine, Italy; the 7Department of Political Sciences, University of Turin, Turin, Italy; and the 8Department of Public Health and Microbiology, University of Turin, Turin, Italy. Corresponding author: Marina Trento, [email protected]. Received 31 October 2009 and accepted 14 January 2010. Published ahead of print at http://care. diabetesjournals.org on 26 January 2010. DOI: 10.2337/dc09-2024. Clinical trial reg. no. ISRCTN 19509463, isrctn.org. © 2010 by the American Diabetes Association. Readers may use this article as long as the work is properly cited, the use is educational and not for profit, and the work is not altered. See http://creativecommons. org/licenses/by-nc-nd/3.0/ for details. The costs of publication of this article were defrayed in part by the payment of page charges. This article must therefore be hereby marked “advertisement” in accordance with 18 U.S.C. Section 1734 solely to indicate this fact. care.diabetesjournals.org ⱖ1 year known duration, aged ⬍80 years, were randomized to either group (case subjects) or traditional one-to-one (control subjects) care (online appendix Fig. 1 [available at http://care.diabetesjournals. org/cgi/content/full/dc09-2024/DC1]). Patients from 13 hospital-based clinics gave their informed consent (online appendix Table 1). ROMEO was approved by the ethics committee of the coordinating center in Turin. Power calculations indicated that 550 patients would allow to detect a decrease in A1C from 8.0 to 7.5%, with an ␣ ⫽ 0.05 and ␤ ⫽ 0.05. Randomization was done locally by random table numbers. Body weight, fasting glycemia, blood pressure, and A1C were measured every 3 months. Creatinine, total and HDL cholesterol, and triglycerides were measured yearly. LDL cholesterol was calculated by Friedewald’s formula (10). Health behaviors (Condotte di Riferimento ⫽ CdR) (8) and QoL (11) were measured by previously described specific questionnaires at baseline and years 2 and 4. Knowledge of diabetes (12) was measured at baseline and year 4 by the Italian Study Group for Diabetes Education (Gruppo Italiano di Studio Educazione e Diabete [GISED]). Group care sessions and individual visits were every 3 months by the same operators. The approach and curriculum were described previously (6 – 8). In brief, seven 1-h sessions were held over 2 years and repeated. Education involved mainly group work, hands-on activities, problem solving, real-life simulations, and role playing (online appendix 2). All patients received individual consultations at least yearly, whenever deemed necessary by operators, or upon request. Trial investigators were trained in our laboratory on principles of adult education and analysis of the intervention program and were supported in transferring group care to their clinics. Operating manual (available in an online appendix), teaching materials, logistical support, and supervision were provided throughout the study. Individual visits remained based upon local clinical practice. DIABETES CARE, VOLUME 33, NUMBER 4, APRIL 2010 745 Downloaded from http://diabetesjournals.org/care/article-pdf/33/4/745/605445/zdc00410000745.pdf by guest on 21 January 2022 MARINA TRENTO, MEDSCI, BPSYCHOL, MBA1 SILVIA GAMBA, MD2 LUIGI GENTILE, MD3 GIORGIO GRASSI, MD1 VALERIO MISELLI, MD4 GABRIELMORONE, MD5 PIETRO PASSERA, MD1 746 DIABETES CARE, VOLUME 33, NUMBER 4, APRIL 2010 Data are n (%), unless otherwise indicated. *Odds ratios have been estimated by a logistic model, where being at target at 4 years was considered as the dependent variable and belonging to the group of case or control subjects, age, sex, duration of diabetes, familiarity, and situation at baseline were the independent variables. †McNemar test for paired samples. ‡Friedwald formula: LDL cholesterol ⫽ total cholesterol ⫺ HDL cholesterol ⫺ triglycerides/5 (only patients with triglycerides ⬍4.5 mmol/l included). §A1C ⱕ7.0% ⫹ systolic blood pressure ⱕ130 mmHg ⫹ diastolic blood pressure ⱕ80 mmHg ⫹ LDL cholesterol ⱕ2.58 mmol/l (100 mg/dl). P ⬍ 0.05 P ⬍ 0.001 P ⬍ 0.001 P ⬍ 0.001 P ⬍ 0.01 1.5 (1.02–2.1) 4.0 (2.5–6.4) 2.3 (1.5–3.4) 2.9 (1.9–4.4) 14.5 NS NS NS NS NS 74/266 (27.8) 37/264 (14.0) 145/264 (54.9) 53/262 (20.2) 1/270 (0.4) 101/394 (25.6) 77/394 (19.5) 212/394 (53.8) 92/385 (23.9) 10/393 (2.5) 105/295 (35.6) 107/308 (34.7) 226/309 (73.1) 115/305 (37.7) 15/308 (4.9) 93/411 (22.6) 74/421 (17.6) 251/421 (59.6) 81/414 (19.6) 10/418 (2.4) P ⬍ 0.001 P ⬍ 0.001 P ⬍ 0.001 P ⬍ 0.001 P ⬍ 0.05 29.4 (14.2–60.8) 82.08 (11.1–616.5) 1.4 (0.9–1.9) 1.2 (0.8–1.82) P ⬍ 0.001 P ⬍ 0.001 NS NS 10/270 (3.7) 0/270 (0) 84/266 (31.6) 185/266 (69.5) 116/375 (30.9) 69/375 (18.4) 117/394 (29.7) 255/394 (64.7) P ⬍ 0.001 NS P ⬍ 0.002 P ⬍ 0.001 135/315 (42.9) 58/315 (18.4) 113/295 (38.3) 212/295 (71.9) 150/420 (35.7%) 99/420 (23.6) 111/411 (27) 236/411 (57.4) A1C ⱕ7.0% (percent of available data) A1C ⱕ6.5% (percent of available data) Systolic blood pressure Diastolic blood pressure 80 mmHg Systolic blood pressure ⱕ130 and diastolic blood pressure ⱕ80 mmHg Total cholesterol ⱕ4.0 mmol/l (175 mg/dl) Triglyceride ⱕ1.7 mmol/l (150 mg/dl) LDL cholesterol ⱕ2.58 mmol/l (100 mg/dl)‡ Patients at target for all variables§ P Baseline 4 years P† (baseline vs. 4 years) Ba90 baseline 4 years P† (baseline vs. 4 years) Odds ratio (95% CI) of being at target for case versus control subjects All patients* Control subjects Group care Table 1—Patients at target RESULTS — Two clinics did not complete the trial. Case (n ⫽ 106) and control (n ⫽ 128) dropouts had similar baseline variables. In the case subjects, BMI, fasting glycemia, A1C, total cholesterol, triglycerides, LDL cholesterol, and systolic and diastolic blood pressure decreased from baseline to year 4, while HDL cholesterol increased (P ⬍ 0.001, for all) and creatinine did not change (online appendix Table 2). BMI, A1C, triglycerides, and creatinine increased in control subjects, whereas total, HDL, and LDL cholesterol and systolic blood pressure did not change and diastolic blood pressure decreased. At study end, case subjects had higher HDL cholesterol (1.42 ⫾ 0.29 vs. 1.29 ⫾ 0.33 mmol/l) and lower A1C (7.3 ⫾ 0.9 vs. 8.8 ⫾ 1.2%), fasting glycemia (8.78 ⫾ 2.27 vs. 9.44 ⫾ 2.89 mg/dl), total cholesterol (4.88 ⫾ 0.96 vs. 5.47 ⫾ 0,94 mmol/l), LDL cholesterol (2.79 ⫾ 0.94 vs. 3.31 ⫾ 0,97 mmol/l), triglycerides (1.46 ⫾ 0.59 vs. 1.94 ⫾ 1.17 mmol/ l), systolic blood pressure (138.0 ⫾ 16.1 vs. 143.6 ⫾ 18.5 mmHg), diastolic blood pressure (79.1 ⫾ 9.4 vs. 80.6 ⫾ 8.4 mmHg), body weight (80.4 ⫾ 14.6 vs. 82.1 kg), BMI (30.1 ⫾ 5.0 vs. 30.4 ⫾ 5.8 kg/m2), and creatinine (76.0 ⫾ 23.0 vs. 85.7 ⫾ 26.5 mmol/l) than control subjects (P ⬍ 0.001, for all). Health behaviors, QoL, and knowledge improved in case subjects (P ⬍ 0.001, for all). Health behaviors did not Downloaded from http://diabetesjournals.org/care/article-pdf/33/4/745/605445/zdc00410000745.pdf by guest on 21 January 2022 Analysis was by intention to treat. Descriptive data are shown as absolute frequencies if categorical and means ⫾ SD if continuous variables. Differences between groups at baseline were checked by ␹2 or t test for independent data, as applicable. Differences between baseline and year 4 were tested by t test for dependent data. Results are expressed as differences and 95% CI between treatment groups. Differences between case and control subjects were adjusted for center, sex, family history for diabetes, schooling, occupation, years of attendance in clinic, and baseline values of the dependent variable. The different frequencies of patients reaching clinical targets at baseline and year 4 were tested by the McNemar test for paired samples. Odds ratios of being at target at year 4 being a case rather than a control subject were estimated by a multivariate logistic model adjusted for age, sex, duration of diabetes, family history, and baseline value for the considered variable. Differences were considered significant for P ⬍ 0.05. P ⬍ 0.001 P ⬍ 0.001 NS NS ROMEO lifestyle intervention in type 2 diabetes care.diabetesjournals.org Trento and Associates CONCLUSIONS — Lifestyle intervention requires delivery of continuing patient education and care without increasing clinical workload and with measurable outcomes. In our experience, reorganizing working practice as routinely delivered group care is a feasible and cost-effective approach to improve metabolic control and QoL in type 2 diabetes (6 – 8). ROMEO, a multicenter controlled trial, showed that group care is transferable and confirmed its efficacy. A1C and lipids improved and, at study end, the share of case subjects achieving currently recommended clinical targets (5) increased from baseline, the opposite being true for control subjects. That improvement occurred without additional medication strongly suggests that healthier behaviors were induced by group care. As the acronym ROMEO suggests, group care requires reallocation of tasks, roles, and resources and a change in providers’ attitudes from the traditional prescriptive approach to a more empathic role of facilitator. This may limit its transferability, as one clinic did not start the trial and another withdrew after 2 years. Previous studies of education in diabetes management varied in approach, were shorter, and measured less outcomes (13,14). The Diabetes Education and Self-Management for Ongoing and Newly Diagnosed (DESMOND), the only care.diabetesjournals.org other multicenter trial of education in type 2 diabetes, did not register improvements in A1C or QoL over a 1-year follow-up in newly diagnosed patients (15). Continuing interactive patient-centered education by group care is reproducible and improves diabetes management and outcomes. Acknowledgments — No potential conflicts of interest relevant to this article were reported. We gratefully acknowledge Dr. Marion Franz and Dr. Simon Heller for insightful help in revising this manuscript. Thanks to Enrica Borgo for her valuable assistance in the preparation and running of the trial. We thank the patients who participated in the study and the investigators, physicians, nurses, and dietitians for recruiting the participants and completing the trial documentation. References 1. Tuomilehto J, Lindström J, Eriksson JG, Valle TT, Hämäläinen H, Ilanne-Parikka P, Keinänen-Kiukaanniemi S, Laakso M, Louheranta A, Rastas M, Salminen V, Uusitupa M, the Finnish Diabetes Prevention Study Group. Prevention of type 2 diabetes mellitus by changes in lifestyle among subjects with impaired glucose tolerance. N Engl J Med 2001;344:1343– 1350 2. Knowler WC, Barrett-Connor E, Fowler SE, Hamman RF, Lachin JM, Walker EA, Nathan DM, the Diabetes Prevention Program Research Group. Reduction in the incidence of type 2 diabetes with lifestyle intervention or metformin. N Engl J Med 2002;346:393– 403 3. Gaede P, Lund-Andersen H, Parving H-H, Pedersen O. Effect of a multifactorial intervention on mortality in type 2 diabetes. N Engl J Med 2008;358:580 –591 4. Holman RR, Paul SK, Bethel MA, Matthews DR, Neil HA. 10-year follow-up of intensive blood glucose control in type 2 diabetes. N Engl J Med 2008;359:1577– 1589 5. Nathan DM, Buse JB, Davidson MB, Ferrannini E, Holman RR, Sherwin R, Zinman B, the American Diabetes Association, the European Association for Study of Diabetes. Medical management of hyperglycemia in type 2 diabetes: a consensus algorithm for the initiation and adjustment of therapy. A consensus statement of the American Diabetes Association and the European Association for the Study of Diabetes. Diabetes Care 2009;32:193–203 6. Trento M, Passera P, Tomalino M, Bajardi M, Pomero F, Allione A, Vaccari P, Molinatti GM, Porta M. Group visits improve metabolic control in type 2 diabetes: a 2-year follow-up. Diabetes Care 2001;24: 995–1000 7. Trento M, Passera P, Bajardi M, Tomalino M, Grassi G, Borgo E, Donnola C, Cavallo F, Bondonio P, Porta M. Lifestyle intervention by group care prevents deterioration of type 2 diabetes: a 4-year randomized controlled clinical trial. Diabetologia 2002;45:1231– 1239 8. Trento M, Passera P, Borgo E, Tomalino M, Bajardi M, Cavallo F, Porta M. A 5-year randomized controlled study of learning, problem solving ability and quality of life modifications in people with type 2 diabetes managed by group care. Diabetes Care 2004;27:670 – 675 9. Porta M, Trento M. Romeo: Rethink Organization to iMprove Education and Outcomes. Diabet Med 2004;21:644 – 645 10. Warnick GR, Knopp RH, Fitzpatrick V, Branson L. Estimating low-density lipoprotein cholesterol by the Friedewald equation is adequate for classifying patients on the basis of nationally recommended cutpoints. Clin Chem 1990;36: 15–19 11. The DCCT Research Group. Reliability and validity of a diabetes quality-of-life measure for the Diabetes Control and Complications Trial (DCCT). Diabetes Care 1998;11:725–732 12. Vespasiani G, Nicolucci A, Erle G, Trento M, Miselli V. Validazione del questionario sulla conoscenza del diabete GISED 2001. Giorn It Diabetol 2002;22:109 –120 [in Italian] 13. Deakin T, McShane CE, Cade JE, Williams RD. Group based training for self management strategies in people with type 2 diabetes mellitus. Cochrane Database Syst Rev 2005;18:CD003417 14. Loveman E, Frampton GK, Clegg AJ. The clinical effectiveness of diabetes education models for type 2 diabetes: a systematic review. Health Technol Assess 2008; 12:1–116 15. Davies MJ, Heller S, Skinner TC, Campbell MJ, Carey ME, Cradock S, Dallosso HM, Daly H, Doherty Y, Eaton S, Fox C, Oliver L, Rantell K, Rayman G, Khunti K. Effectiveness of the Diabetes Education and Self Management for Ongoing and Newly Diagnosed (DESMOND) programme for people with newly diagnosed type 2 diabetes: cluster randomised controlled trial. Br Med J 2008;336:491– 495 DIABETES CARE, VOLUME 33, NUMBER 4, APRIL 2010 747 Downloaded from http://diabetesjournals.org/care/article-pdf/33/4/745/605445/zdc00410000745.pdf by guest on 21 January 2022 change in control subjects, whereas QoL and knowledge worsened. At study end, health behaviors (15.24 ⫾ 2.62 vs. 11.07 ⫾ 3.00), QoL (63.22 ⫾ 10.27 vs. 77.88 ⫾ 13.14), and knowledge (48.37 ⫾ 13.42 vs. 38.69 ⫾ 14.07) were better in the case subjects (P ⬍ 0.001, all). The proportion of cases with A1C ⱕ7.0%, systolic pressure ⱕ130 mmHg, diastolic pressure ⱕ80 mmHg, and LDL cholesterol ⱕ2.58 mmol/l (100 mg/dl) at year 4 increased from baseline, and those who met all targets doubled (Table 1). Control subjects remained stable or worsened. Prescriptions of hypoglycemic, antihypertensive, and lipid-lowering medications were similar for case and control subjects. A total of 50 of 315 case subjects (15.87%) and 56 of 266 control subjects (21.05%) were on insulin at study end.