Strategies for the introduction and implementation of a guideline for the treatment by family physicians of diabetics in the Lazio region of Italy
| ISRCTN | ISRCTN80116232 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN80116232 |
| Secondary identifying numbers | N/A |
- Submission date
- 05/03/2004
- Registration date
- 21/04/2004
- Last edited
- 07/02/2008
- 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
Dr Amina Pasquarella
Scientific
Scientific
Via di Santa Costanza 53
Rome
00198
Italy
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Not specified |
| Study type | Treatment |
| Scientific title | |
| Study acronym | IMPLEMEG |
| Study objectives | The primary objective of the study is to assess the effectiveness of different strategies for the implementation of an evidence-based guideline for the management of non-complicated type 2 diabetes mellitus (DM) among GPs of the Lazio region. |
| Ethics approval(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | Type 2 non-complicated diabetes |
| Intervention | Different strategies for the implementation of a guideline of non-complicated type 2 diabetes mellitus in the region of Lazio (Italy). Eighty four GPs in each arm were randomised in the care of type 2 diabetes mellitus to: Arm 1. Undergo a training module and administration of the guideline. Arm 2. Receive the guideline without training. Arm 3. Continue current practice. |
| Intervention type | Other |
| Primary outcome measure | The proportion of patients who were prescribed three measurements of glycosylated haemoglobin with at least two months interval per year. |
| Secondary outcome measures | 1. Process of care variables on metabolic control and prevention of micro-macrovascular complications (ie proportion of overweight/obese diabetics who were prescribed methformin in monotherapy as first-choice therapy) 2. Proportion of diabetics with a complete lipid assessment per year 3. Proportion of diabetics with an eye examination or a fundus per year) |
| Overall study start date | 01/01/2004 |
| Completion date | 31/12/2004 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Not Specified |
| Target number of participants | 252 GPs |
| Key inclusion criteria | 252 General Practitioners (GPs) taking part in an electronically-linked diseases surveillance network. |
| Key exclusion criteria | 1. Patients aged less than 40 2. Patients with complications 3. Diabetic pregnancy |
| Date of first enrolment | 01/01/2004 |
| Date of final enrolment | 31/12/2004 |
Locations
Countries of recruitment
- Italy
Study participating centre
Via di Santa Costanza 53
Rome
00198
Italy
00198
Italy
Sponsor information
Agency for Public Health, Lazio Region, Italy (Agenzia di Sanità Pubblica della Regione Lazio)
Government
Government
Via di Santa Costanza 53
Rome
00198
Italy
| Phone | +39 (0)6 83060429 |
|---|---|
| segrdir@asplazio.it |
Funders
Funder type
Government
Ministry of Health Lazio Region (Italy)
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 | 14/06/2004 | Yes | No | |
| Results article | Results | 04/06/2007 | Yes | No |
