Trial of lifestyle intervention by group care in the management of type 2 diabetes (ROMEO Trial)
| ISRCTN | ISRCTN19509463 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN19509463 |
| Secondary identifying numbers | N/A |
- Submission date
- 28/01/2009
- Registration date
- 10/02/2009
- Last edited
- 26/08/2014
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Nutritional, Metabolic, Endocrine
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Prof Massimo Porta
Scientific
Scientific
Laboratory of Clinical Pedagogy
Department of Internal Medicine
University of Turin
Torino
I-10126
Italy
Study information
| Study design | Randomised controlled multi-centre trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Other |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| 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 |
| Study acronym | ROMEO |
| Study objectives | 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(s) | 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). |
| Health condition(s) or problem(s) studied | 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 |
| Primary outcome measure | 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 study start date | 09/05/2000 |
| Completion date | 14/07/2007 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 532 |
| Key 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 |
| Key exclusion criteria | 1. New diagnosis of diabetes 2. Age <40 or >80 3. Insulin treatment 4. Established psychiatric problems 5. Presence of terminal illness |
| Date of first enrolment | 09/05/2000 |
| Date of final enrolment | 14/07/2007 |
Locations
Countries of recruitment
- Italy
Study participating centre
Laboratory of Clinical Pedagogy
Torino
I-10126
Italy
I-10126
Italy
Sponsor information
University of Turin (Italy)
University/education
University/education
c/o Prof Massimo Porta
Laboratory of Clinical Pedagogy
Department of Internal Medicine
Torino
I-10126
Italy
| Website | http://www.unito.it |
|---|---|
"ROR" |
https://ror.org/048tbm396 |
Funders
Funder type
Industry
European Foundation for the Study of Diabetes/Juvenile Diabetes Research Foundation (EFSD/JDRF)/Novo Nordisk Type 2 Diabetes Research Grant (Denmark)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol article | protocol in: | 01/06/2004 | Yes | No | |
| Results article | results | 01/04/2010 | Yes | No | |
| Results article | results | 01/09/2014 | Yes | No |
