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
Protocol serial number	N/A
Sponsor	Agency for Public Health, Lazio Region, Italy (Agenzia di Sanità Pubblica della Regione Lazio)
Funder	Ministry of Health Lazio Region (Italy)

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

Via di Santa Costanza 53
Rome
00198
Italy

Study information

Primary study design	Interventional
Study design	Randomised controlled trial
Secondary study design	Randomised controlled trial
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(s)	The proportion of patients who were prescribed three measurements of glycosylated haemoglobin with at least two months interval per year.
Key secondary outcome measure(s)	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)
Completion date	31/12/2004

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	Not Specified
Target sample size at registration	252
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

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	Results	04/06/2007		Yes	No
Protocol article	Protocol	14/06/2004		Yes	No