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
  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:


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.

  Show Detailed Description

  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:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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 April 22, 2014