Romeo: Rethink Organization To Improve Education And Outcomes. A Multicentre Randomised Trial Of Lifestyle Intervention By Group Care To Manage Type 2 Diabetes.
- Marina Trento, M.Ed.Sci, B.Psychol, MBA (marina.trento{at}unito.it)1,
- Silvia Gamba, MD2,
- Luigi Gentile, MD3,
- Giorgio Grassi, MD1,
- Valerio Miselli, MD4,
- Gabriella Morone, MD5,
- Pietro Passera, MD1,
- Laura Tonutti, MD6,
- Marco Tomalino, MD1,
- Piervincenzo Bondonio, MBA7,
- Franco Cavallo, MD8,
- Massimo Porta, MD, PhD1 and
- for the ROMEO investigators
- 1Laboratory of Clinical Pedagogy, Department of Internal Medicine, University of Turin
- 2Unit for Endocrinology and Diabetes, Maria Vittoria Hospital, Turin
- 3Unit for Diabetes and Metabolic Diseases ASL 19 Asti
- 4Unit for Diabetes and Metabolic Diseases, Scandiano (RE) Hospital
- 5Unit for Diabetes and Metabolic Diseases ASL 12 Biella
- 6Unit for Diabetes and Metabolic Diseases, Udine Hospital
- 7Department of Political Sciences, University of Turin
- 8Department of Public Health and Microbiology, University of Turin
Abstract
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: Four-year two-armed, multicentre controlled trial in 13 hospital-based diabetes clinics in Italy (Current Controlled Trials ISRCTN19509463). 815 non insulin-treated patients aged <80, with ≥1 year known diabetes duration were randomised to either group or individual care.
Results: After 4 years, patients in Group Care had lower HbA1c, total cholesterol, LDL cholesterol, triglyceride, systolic and diastolic blood pressure, body mass index and serum creatinine, and higher HDL cholesterol (p<0.001, all) than controls receiving individual care, despite similar pharmacological prescriptions. Health behaviours, quality of life and knowledge of diabetes had become better in Group Care patients than controls (p<0.001, all).
Conclusions: The favourable clinical, cognitive and psychological outcomes of Group Care can be reproduced in different clinical settings.
Footnotes
-
- Received October 31, 2009.
- Accepted January 14, 2010.
- Copyright © American Diabetes Association
