Condition category
Nutritional, Metabolic, Endocrine
Date applied
28/01/2009
Date assigned
10/02/2009
Last edited
26/08/2014
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Prof Massimo Porta

ORCID ID

Contact details

Laboratory of Clinical Pedagogy
Department of Internal Medicine
University of Turin
Torino
I-10126
Italy

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

http://www.unito.it

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

  1. 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.

  2. 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.

  3. 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.

Additional files

Editorial Notes