Status: Ongoing
First registered on:
24/01/2014
Last updated on:
12/02/2014
1. Study identification
EU PAS Register NumberEUPAS5668
Official titleEffectiveness of an Interventional to Improve the Adequacy of the Indication of Lipid Lowering Treatment in Primary Prevention: Randomized Clinical Trial
Study title acronymAdequacy of Lipid Treatment
Study typeClinical trial
Brief description of the studyTo evaluated the impact of an interention addressed to health professionals to improve the adequacy of lipid-lowering prescription in primary prevention of cardiovascular disease and reducing expenditure in this respect.
Was this study requested by a regulator?Don't know
Is the study required by a Risk Management Plan (RMP)?
Regulatory procedure number (RMP Category 1 and 2 studies only)
Other study registration identification numbers and URLs as applicable
2. Research centres and Investigator details
Coordinating study entity
Centre to which the investigator belongsIDIAPJGol
Department/Research group
Organisation/affiliationPrimary Care Research Institute Jordi Gol
Details of (Primary) lead investigator
Title Dr
Last name Bolíbar
First name Bonaventura
Is this study being carried out with the collaboration of a research network?
No
Other centres where this study is being conducted
Not applicable (single centre)
Countries in which this study is being conducted
National study
Spain
3. Study timelines: initial administrative steps, progress reports and final report
PlannedActual
Date when funding contract was signed31/01/2012
Start date of data collection30/09/2013
Start date of data analysis02/12/2013
Date of interim report, if expected
Date of final study report30/06/2014
4. Sources of funding
Please provide estimates of the percentage of funding by source for this study
Names(s)Approximate % funding
Pharmaceutical companies
Charities
Government body
Research councils
EU funding scheme
OtherAyuda para el fomento de la investigación clínica independiente. Ministerio de SAnidad SErvicios Sociales e Igualdad100
5. Contact details for enquiries
Scientific Enquiries
Title Dr
Last name Bolíbar
First name Bonaventura
Address line 1Gran Via Corts Catalanes, 587
Address line 2
Address line 3
CityBarcelona
Postcode08007
CountrySpain
Phone number (incl. country code)34-93-4824559
Alternative phone number
Fax number (incl. country code)
Public Enquiries
Title Dr
Last name Bolíbar
First name Bonaventura
Address line 1Gran Via Corts Catalanes, 587
Address line 2
Address line 3
CityBarcelona
Postcode08007
CountrySpain
Phone number (incl. country code)34-93-4824559
Alternative phone number
Fax number (incl. country code)
6. Study drug(s) information
Substance class (ATC Code)C10AA Inhibidores de la HMG CoA reductasa
7. Medical conditions to be studied
Medical condition(s)No
8. Population under study
Age
Adults (18 - 44 years)
Adults (45 - 64 years)
Adults (65 - 74 years)
Sex
Male
Female
9. Number of subjects
Estimated total number of subjects120000
10. Source of data
Is this study being carried out with an established data source?Yes
Data sources registered with ENCePP
Sources of data
Routine primary care electronic patient registry
11. Scope of the study
What is the scope of the study?
Drug utilisation study
Primary scope : Drug utilisation study
12. Main objective(s)
What is the main objective of the study?
To evaluate the impact of an international addressed to health professionals to improve the adequacy of lipid-lowering prescription in primary prevention of cardiovascular disease and reducing expenditure in the respect
Are there primary outcomes?No
Are there secondary outcomes?Yes
1.Description of demographic and clinical characteristics of patients with new lipid-lowering therapy.
2. To know the adequacy of lipid-lowering therapy in patients with treatment for primary prevention (no history of cardiovascular disease).
3. To Identify factors related to adequate pharmacological lipid-lowering treatment in primary prevention.
4. To analyze the level of cardiovascular risk
13. Study design
What is the design of the study?
Randomised controlled trial
14. Follow-up of patients
Will patients be followed up?Yes
Please describe duration of follow up
The research team identified during the study period (October 1, 2012 until September 30, 2013) new lipid-lowering treatments with no history of cardiovascular disease using electronic medical records
15. Data analysis plan
Please provide a brief summary of the analysis method
To assess the effect of the intervention model multilevel logistic regression analysis considering as dependent variable group intervention / control, adjusting for potential independent predictor variables and those considered clinically relevant, adjusting for baseline values were performed
16. ENCePP seal
Are you requesting the ENCePP seal for this study?
No
17. Full protocol
Not submitted
18. Study Results
Not submitted
Please list the 5 most relevant publications using data from your study
ReferenceLink to web-publication
None
19. Other relevant documents
Conflict(s) of interest of
investigator(s)Not submitted
Composition of Steering Group and
ObserversNot submitted
Other documentsNot
submitted
Signed Code of
Conduct Checklist
Not submitted
Signed Code of Conduct Declaration
Not submitted
Signed Checklist for Study
Protocols
Not submitted
