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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 August 19, 2014