Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
ROMEO: Rethink Organisation to iMprove Education and Outcomes. A randomised controlled multi-centre trial of lifestyle intervention by group care in the management of type 2 diabetes
Acronym
ROMEO
Study hypothesis
Scarcity of resources, expertise and evidence-based models have so far limited delivery of patient-centred therapeutic education in clinical routine. We have developed and validated a Group Care approach that is applicable to everyday practice and cost-effective in improving metabolic control, knowledge of diabetes, health behaviours and quality of life in type 2 diabetes. A clinical trial (Rethink Organisation to iMprove Education and Outcomes [ROMEO]) was planned to evaluate the applicability and reproducibility of Group Care in other centres and in a larger patient population.
Ethics approval
Ethics Committee of the Molinette san Giovanni Battista University Hospital and Maria Adelaide Hospital, Torino (Comitato Etico Interaziendale AOU San Giovanni Battista di Torino e AO CTO Maria Adelaide di Torino), approved on 27/01/2009 (ref: 0006703).
Study design
Randomised controlled multi-centre trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Other
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Type 2 diabetes
Intervention
Participants were randomly allocated to the following two groups:
Intervention group: Group Care, consisting of a clinical approach in which diabetes care is routinely delivered as group sessions built upon a systemic education programme whereas individual care is dedicated to emerging clinical problems, yearly checks for complications or patients' explicit requests. Each group session lasted on average 50 min.
Control group: Traditional one-to-one visits delivered by the same physicians/ nurses/ dieticians/ educators involved in Group Care. Each control individual visit lasted on average 15 min.
Visits took place every 3 months for 4 years. Total duration of follow-up: 4 years.
Intervention type
Other
Phase
Not Applicable
Drug names
Primary outcome measures
1. Clinical outcomes
1.1.Glycated haemoglobin, measured every 3 months for 4 years
1.2. Low-density lipoprotein (LDL) cholesterol, assessed yearly for 4 years
1.3. Systolic and diastolic blood pressure, measured every 3 months for 4 years
2. Cognitive and psychological outcomes
2.1. Quality of life, assessed yearly for 4 years
2.2. Knowledge of diabetes, assessed every 2 years for 4 years
2.3. Health behaviours, assessed yearly for 4 years
Secondary outcome measures
1. Cardiovascular events, followed up for 4 years
2. Cost-effectiveness analysis at 4 years
Overall trial start date
09/05/2000
Overall trial end date
14/07/2007
Reason abandoned
Eligibility
Participant inclusion criteria
1. Outpatients with non insulin-treated type 2 diabetes millitus (T2DM) of at least 1 year known duration
2. Both males and females, aged <80
3. Normally followed in a diabetes centre
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
532
Participant exclusion criteria
1. New diagnosis of diabetes
2. Age <40 or >80
3. Insulin treatment
4. Established psychiatric problems
5. Presence of terminal illness
Recruitment start date
09/05/2000
Recruitment end date
14/07/2007
Locations
Countries of recruitment
Italy
Trial participating centre
Laboratory of Clinical Pedagogy
Torino
I-10126
Italy
Sponsor information
Organisation
University of Turin (Italy)
Sponsor details
c/o Prof Massimo Porta
Laboratory of Clinical Pedagogy
Department of Internal Medicine
Torino
I-10126
Italy
Sponsor type
University/education
Website
Funders
Funder type
Industry
Funder name
European Foundation for the Study of Diabetes/Juvenile Diabetes Research Foundation (EFSD/JDRF)/Novo Nordisk Type 2 Diabetes Research Grant (Denmark)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary
2004 protocol in: in http://www.ncbi.nlm.nih.gov/pubmed/15154956
2010 results in: http://www.ncbi.nlm.nih.gov/pubmed/20103547
2014 results in: http://www.ncbi.nlm.nih.gov/pubmed/25147259
Publication citations
-
Results
Trento M, Gamba S, Gentile L, Grassi G, Miselli V, Morone G, Passera P, Tonutti L, Tomalino M, Bondonio P, Cavallo F, Porta M, , Rethink Organization to iMprove Education and Outcomes (ROMEO): a multicenter randomized trial of lifestyle intervention by group care to manage type 2 diabetes., Diabetes Care, 2010, 33, 4, 745-747, doi: 10.2337/dc09-2024.
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Results
Sicuro J, Charrier L, Berchialla P, Cavallo F, Merlo S, Mazzeo A, Porta M, Trento M, , Self-management Education by Group Care Reduces Cardiovascular Risk in Patients With Type 2 Diabetes: Analysis of the ROMEO Clinical Trial., Diabetes Care, 2014, 37, 9, e192-3, doi: 10.2337/dc14-1054.
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Porta M, Trento M, , ROMEO: rethink organization to improve education and outcomes., Diabet. Med., 2004, 21, 6, 644-645, doi: 10.1111/j.1464-5491.2004.01170.x.