Multiple Intervention and AUdit in Renal Diseases to Optimize Care (MAURO)

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

Carmine Zoccali, National Research Council, Italy

ClinicalTrials.gov Identifier:

NCT00566033

First received: November 29, 2007

Last updated: January 27, 2012

Last verified: January 2012

History of Changes

Purpose

Test whether the intensive intervention improves renal and cardiovascular outcomes in patients with chronic renal insufficiency.

Test whether a multi-method intensive intervention including clinical Audit improves adherence to a series of quality indicators relevant to hypertension control, proteinuria, treatment of dyslipidemia, anemia, calcium and phosphate alterations in patients with chronic renal insufficiency.

Condition	Intervention	Phase
Renal Insufficiency	Behavioral: Audit-driven intervention	Phase 4

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Caregiver) Primary Purpose: Treatment
Official Title:	Multiple Intervention and AUdit in Renal Diseases to Optimize Care: the MAURO Study.

Resource links provided by NLM:

MedlinePlus related topics: Chronic Kidney Disease High Blood Pressure

U.S. FDA Resources

Further study details as provided by Fondazione C.N.R./Regione Toscana "G. Monasterio", Pisa, Italy:

Primary Outcome Measures:

A composite renal and cardiovascular (CV) end point, i.e. >30% decrease in the GFR, dialysis, transplantation, death or CV event. [ Time Frame: 3 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

The primary renal unit-level outcome is the percentage of performance targets achieved. The primary patient-level outcome is the percentage of patients for whom the recommended process measures occurs. [ Time Frame: 3 years ] [ Designated as safety issue: No ]

Enrollment:	788
Study Start Date:	January 2006
Study Completion Date:	August 2011
Primary Completion Date:	August 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: 1	Behavioral: Audit-driven intervention Patients included in this arm will undergo to the multi-method quality improvement intervention (intensive intervention) that adds practice visits, telephone and e-mail contacts (for quality improvement facilitation) and audits to the approach of periodic guideline dissemination and feedback on demand used in the less intensive intervention.
No Intervention: 2 Patients in this arm (arm 2) will undergo to standard care.

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Eligibility

Ages Eligible for Study:	18 Years to 75 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Creatinine >1.5 -4.0 mg/dL (males) and >1.3-3.5 mg/dL (females).
Age range :18 - 75 years

Exclusion Criteria:

Transplanted
Pregnant
Affected by cancer or diseases in the terminal phase
Non acute or rapidly evolving renal diseases.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00566033

Locations

Italy
Nephrology Units participating to the MAURO study in the
Calabrian, Sicily, Puglia and Sardenia Regions, Italy

Sponsors and Collaborators

Fondazione C.N.R./Regione Toscana "G. Monasterio", Pisa, Italy

Investigators

Study Director:

Carmine Zoccali, Prof.

CNR-IBIM & Nephrology Unit of Reggio Calabria

More Information

Publications:

Hayward RS. Clinical practice guidelines on trial. CMAJ. 1997 Jun 15;156(12):1725-7. No abstract available.

De Nicola L, Minutolo R, Chiodini P, Zoccali C, Castellino P, Donadio C, Strippoli M, Casino F, Giannattasio M, Petrarulo F, Virgilio M, Laraia E, Di Iorio BR, Savica V, Conte G; TArget Blood Pressure LEvels in Chronic Kidney Disease (TABLE in CKD) Study Group. Global approach to cardiovascular risk in chronic kidney disease: reality and opportunities for intervention. Kidney Int. 2006 Feb;69(3):538-45.

Kerry SM, Bland JM. The intracluster correlation coefficient in cluster randomisation. BMJ. 1998 May 9;316(7142):1455. Review. No abstract available.

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Leonardis D, Mallamaci F, Enia G, Postorino M, Tripepi G, Zoccali C; MAURO Study Investigators. The MAURO study: baseline characteristics and compliance with guidelines targets. J Nephrol. 2012 Nov-Dec;25(6):1081-90. doi: 10.5301/jn.5000239.

Responsible Party:	Carmine Zoccali, Prof., National Research Council, Italy
ClinicalTrials.gov Identifier:	NCT00566033 History of Changes
Other Study ID Numbers:	MAURO-001
Study First Received:	November 29, 2007
Last Updated:	January 27, 2012
Health Authority:	Italy: Ministry of Health

Keywords provided by Fondazione C.N.R./Regione Toscana "G. Monasterio", Pisa, Italy:

AUDIT
Chronic kidney disease
Clinical trial

Creatinine
Multiple intervents
Nephrology guidelines.

Additional relevant MeSH terms:

Kidney Diseases
Renal Insufficiency
Urologic Diseases

ClinicalTrials.gov processed this record on May 19, 2013

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