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

Renal Insufficiency Chronic Clinical Trial

— RENAP  

Official title:

Effectiveness of an Structured Intervention in Patients With Chronic Kidney Failure to Reduce the Progression of the Illness.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01872468
• Other study ID #: 09/90845
• Status: Completed
• Phase: N/A
• First received: June 3, 2013
• Last updated: April 10, 2015
• Start date: September 2011
• Est. completion date: January 2014

Study information

• Verified date: April 2015
• Source: Gerencia de Atención Primaria, Madrid
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: Comité Ético de Investigación Clínica
• Study type: Interventional

Clinical Trial 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.

Description:

Main objective: 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, stages 3, is more effective than the current follow-up in slowing the disease progression measured by the glomerular filtration rate .

Secondary objectives: Determining the effectiveness of the intervention to improve the blood pressure control of the patients with chronic kidney failure and to improve the degree of control of the glucose levels and glycosylated haemoglobin of the diabetic patients with chronic kidney failure.

Design: A clinical trial controlled with a random assignment by conglomerates with parallel groups.

Setting: Multi-centre study in Primary Care Health Centres(Madrid Health Service).

Subjects of the study: 540 patients over 18 years old, diagnosed of light-moderate chronic kidney failure that consent to participate.

Data collection: The variable of the main answer will be the creatinine clearance measured in ml/min. Demographic variables of morbidity and prognosis: clinical, analytical, anthropometrical, adherence to processing and consumption of medicines will be collected.

Intervention: Initial educational session based on the significant learning and quarterly follow-up in surgery of medicine and nursing for 2 years.

Analysis: By intention of treating. Descriptive statistics of each variable and statistical analytical univariate and multivariate (multiple linear regression) will be carried out. The explanatory variable in the analysis multivariate will be the intervention group.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 269
• Est. completion date: January 2014
• Est. primary completion date: January 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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).

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Renal Insufficiency
• Renal Insufficiency Chronic

Intervention

Behavioral:
• Structured intervention
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

Locations

Country	Name	City	State
Spain	Gerencia Atencion Primaria	Madrid

Sponsors (2)

Lead Sponsor	Collaborator
Gerencia de Atención Primaria, Madrid	Instituto de Salud Carlos III

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No