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document
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 . METHODS Multicentre , randomized , controlled clinical trial of group vs. individual care in the routine management of Type 2 diabetes . Nine hundred patient aged < 80 , with diabetes of > or =1 year known duration , treated by either diet alone or diet and oral agents , will be recruited in 15 centres and followed for 4 years . Training of physicians , nurses and dietitians included preparation of operating manual and videos , interactive sessions , and evaluation of local facilities and resources . RESULTS PRIMARY MEASUREMENTS 3-monthly HbA1c , fasting blood glucose , body weight , waist-hip ratio , yearly blood lipids , and bi-yearly assessment of knowledge of diabetes , health behaviours and quality of life . SECONDARY OUTCOMES systolic and diastolic blood pressure , evaluation of ECG for ischaemia and QT interval , hypoglycaemic and anti-hypertensive medication and cardiovascular events . Analysis will be by intention-to-treat . DISCUSSION If ROMEO confirms that group care can be successfully implemented in different clinics , a novel clinico-pedagogic tool will have been acquired to support patient-centred education , improve lifestyle and outcomes , support team work , enhance providers ' attitudes and competencies and ameliorate diabetes care organization .
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Intervention_Educational
group
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Intervention_Psychological
individual care
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Intervention_Pharmacological
diet alone
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Intervention_Pharmacological
diet and oral agents
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Intervention_Educational
Training of physicians , nurses and dietitians included preparation of operating manual and videos , interactive sessions , and evaluation of local facilities and resources
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Outcome_Physical
metabolic control
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Outcome_Physical
knowledge of diabetes
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Outcome_Physical
health behaviours
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Outcome_Physical
quality of life
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Outcome_Physical
3-monthly HbA1c
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Outcome_Physical
fasting blood glucose
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Outcome_Physical
body weight
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Outcome_Physical
waist-hip ratio
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Outcome_Physical
yearly blood lipids
17022
Outcome_Physical
bi-yearly assessment of knowledge of diabetes
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Outcome_Mental
health behaviours
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Outcome_Physical
quality of life
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Outcome_Physical
systolic and diastolic blood pressure
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Outcome_Physical
evaluation of ECG for ischaemia and QT interval
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Outcome_Physical
hypoglycaemic and anti-hypertensive medication
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Outcome_Physical
cardiovascular events
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Outcome_Mental
improve lifestyle
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Outcome_Mental
support team work
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Outcome_Mental
enhance providers ' attitudes
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Participant_Condition
larger patient population .
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Participant_Condition
Nine hundred
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Participant_Age
< 80
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Participant_Condition
diabetes