Effectiveness of a Structured Intervention to Reduce the Progression of Chronic Kidney (RENAP Study)

NCT01872468 | Completed DMC

• 1 other identifier: 09/90845
• Study Type: interventional
• Target: 269
• Locations: 1 country
• Sites: 1

Brief Summary

The propose of study is to study if an informative intervention and a structured follow-up carried out in health centres of primary care in patients with chronic kidney failure, stage 3, is more effective than the current follow-up in slowing the disease progression measured by the glomerular filtration rate.

Conditions

Renal Insufficiency Chronic

Keywords

Glomerular filtration Rate.; Primary Health Care.; Cluster Clinical Trial.

Outcome Measures

Primary Outcomes (1)

• Creatinine clearance

  Glomerular filtration rate measured by Modification of Diet in Renal Disease (MDRD)formula and expressed in ml/min. The MDRD formula estimates the glomerular filtrate through the levels of creatinine plasma, sex and age.

  2 years

Study Arms (2)

Control

NO INTERVENTION

There is not intervention in this group.

Structured intervention

ACTIVE COMPARATOR

Initial training session based on significant learning and follow up visits every four months at physicians and nurses´ offices over a two-year period

Behavioral: Structured intervention

Interventions

Structured intervention BEHAVIORAL

Initial training session based on patient personal experiences and reflexion (30 minutes). CKD learning session (30 minutes). Personal plan of actions to cope with own disease (30 minutes. Discussion of doubts (30 minutes). Follow up visits every four months at physicians and nurses´ offices over a two-year period

Structured intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients 18 years of age or older
• Willing and able to give informed consent for participation in the study.
• Ability to understand study procedures and to comply with them for the entire length of the study.
• Registered episode on electronic medical records in Primary Care with the diagnosis of Chronic Kidney Disease (CKD) stage 3 or confirmation of CKD by a second blood sample in risk patients with suspected CKD( owing to a blood sample taken at least three months before

You may not qualify if:

• Inability or unwillingness to give written informed consent.
• Severe psychiatric conditions including depression and major affective disorders registered on medical records.
• Disabled and unable to attend Health Centre.
• Severe CKD, defined as glomerular filtration rate (GFR) \< 30 ml/min/1,73m2.
• Patients undergoing dialysis or kidney transplantation.
• Patients hemodynamically unstable with impaired kidney function (Eg. Cardiac Failure, unstable angina pectoris).
• Acute kidney failure.
• Patients with an episode of impaired kidney perfusion on the last month (Eg. Severe hemorrhage, burns, dehydration, major trauma).

Sponsors & Collaborators

• Gerencia de Atención Primaria, Madrid: lead
• Instituto de Salud Carlos III: collaborator

Study Sites (1)

Gerencia Atencion Primaria

Madrid, Madrid, 28033, Spain

Location

MeSH Terms

Conditions

Renal Insufficiency, Chronic

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Marta Sánchez-Celaya, Doctor

  Gerencia Atención Primaria. Madrid

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Phycisian doctor

Study Record Dates

• First Submitted: June 3, 2013
• First Posted: June 7, 2013
• Study Start: September 1, 2011
• Primary Completion: January 1, 2014
• Study Completion: January 1, 2014
• Last Updated: April 13, 2015

Record last verified: 2015-04

Locations

ES (1)