Multiple Intervention and AUdit in Renal Diseases to Optimize Care - Full Text View

Sponsored by:	National Research Council, Italy
Information provided by:	National Research Council, Italy
ClinicalTrials.gov Identifier:	NCT00566033

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 IV

Drug Information available for: Creatinine

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Single Blind (Caregiver), Placebo Control, Parallel Assignment, Efficacy Study
Official Title:	Multiple Intervention and AUdit in Renal Diseases to Optimize Care: the MAURO Study.

Further study details as provided by National Research Council, 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 ]

Estimated Enrollment:	660
Study Start Date:	January 2006
Estimated Study Completion Date:	November 2007

Arms	Assigned Interventions
1: Experimental	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.
2: No Intervention 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

Contacts

Contact: Carmine Zoccali, Prof.

0039-0965-397010

carmine.zoccali@tin.it

Locations

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

Sponsors and Collaborators

National Research Council, 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.

Responsible Party:	CNR-IBIM, Clin. Epid. and Physiopath. of Renal Dis. and Hypert. of Reggio Cal. ( Prof. Carmine Zoccali )
Study ID Numbers:	MAURO-001
Study First Received:	November 29, 2007
Last Updated:	November 29, 2007
ClinicalTrials.gov Identifier:	NCT00566033
Health Authority:	Italy: Ministry of Health

Keywords provided by National Research Council, Italy:

AUDIT
Chronic kidney disease
Clinical trial

Creatinine
Multiple intervents
Nephrology guidelines.

Study placed in the following topic categories:

Renal Insufficiency
Urologic Diseases
Renal Insufficiency, Chronic
Kidney Failure, Chronic
Kidney Diseases

ClinicalTrials.gov processed this record on January 16, 2009