Condition category
Nutritional, Metabolic, Endocrine
Date applied
05/03/2004
Date assigned
21/04/2004
Last edited
07/02/2008
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

Dr Amina Pasquarella

ORCID ID

Contact details

Via di Santa Costanza 53
Rome
00198
Italy

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Acronym

IMPLEMEG

Study hypothesis

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

Not provided at time of registration

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Treatment

Patient information sheet

Condition

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

Phase

Not Specified

Drug names

Primary outcome measures

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 trial start date

01/01/2004

Overall trial end date

31/12/2004

Reason abandoned

Eligibility

Participant inclusion criteria

252 General Practitioners (GPs) taking part in an electronically-linked diseases surveillance network.

Participant type

Patient

Age group

Adult

Gender

Not Specified

Target number of participants

252 GPs

Participant exclusion criteria

1. Patients aged less than 40
2. Patients with complications
3. Diabetic pregnancy

Recruitment start date

01/01/2004

Recruitment end date

31/12/2004

Locations

Countries of recruitment

Italy

Trial participating centre

Via di Santa Costanza 53
Rome
00198
Italy

Sponsor information

Organisation

Agency for Public Health, Lazio Region, Italy (Agenzia di Sanità Pubblica della Regione Lazio)

Sponsor details

Via di Santa Costanza 53
Rome
00198
Italy
+39 (0)6 83060429
segrdir@asplazio.it

Sponsor type

Government

Website

Funders

Funder type

Government

Funder name

Ministry of Health Lazio Region (Italy)

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

Protocol in: http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=pubmed&dopt=Abstract&list_uids=15196307

Results in: http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=pubmed&dopt=Abstract&list_uids=17547760

Publication citations

  1. Protocol

    Perria C, , Strategies for the introduction and implementation of a guideline for the treatment of type 2 diabetics by general practitioners (GPs) of the Lazio region of Italy (IMPLEMEG study): protocol for a cluster randomised controlled trial [ISRCTN80116232]., BMC Health Serv Res, 2004, 4, 1, 13, doi: 10.1186/1472-6963-4-13.

  2. Results

    Perria C, Mandolini D, Guerrera C, Jefferson T, Billi P, Calzini V, Fiorillo A, Grasso G, Leotta S, Marrocco W, Suraci C, Pasquarella A, Implementing a guideline for the treatment of type 2 diabetics: results of a cluster-randomized controlled trial (C-RCT)., BMC Health Serv Res, 2007, 7, 79, doi: 10.1186/1472-6963-7-79.

Additional files

Editorial Notes