Effectiveness of a Structured Intervention to Reduce the Progression of Chronic Kidney (RENAP Study) (RENAP)
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|ClinicalTrials.gov Identifier: NCT01872468|
Recruitment Status : Completed
First Posted : June 7, 2013
Last Update Posted : April 13, 2015
|Condition or disease||Intervention/treatment||Phase|
|Renal Insufficiency Chronic||Behavioral: Structured intervention||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||269 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Effectiveness of an Structured Intervention in Patients With Chronic Kidney Failure to Reduce the Progression of the Illness.|
|Study Start Date :||September 2011|
|Actual Primary Completion Date :||January 2014|
|Actual Study Completion Date :||January 2014|
No Intervention: Control
There is not intervention in this group.
Active Comparator: Structured intervention
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
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
- Creatinine clearance [ Time Frame: 2 years ]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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01872468
|Gerencia Atencion Primaria|
|Madrid, Spain, 28033|
|Principal Investigator:||Marta Sánchez-Celaya, Doctor||Gerencia Atención Primaria. Madrid|