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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
Sponsor:
Collaborator:
Instituto de Salud Carlos III
Information provided by (Responsible Party):
Marta Sanchez-Celaya del Pozo, Gerencia de Atención Primaria, Madrid

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.

Condition or disease Intervention/treatment Phase
Renal Insufficiency Chronic Behavioral: Structured intervention Not Applicable

Detailed 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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 269 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
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

Arm Intervention/treatment
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




Primary Outcome Measures :
  1. 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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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).

Information from the National Library of Medicine

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


Locations
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Spain
Gerencia Atencion Primaria
Madrid, Spain, 28033
Sponsors and Collaborators
Gerencia de Atención Primaria, Madrid
Instituto de Salud Carlos III
Investigators
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Principal Investigator: Marta Sánchez-Celaya, Doctor Gerencia Atención Primaria. Madrid

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Responsible Party: Marta Sanchez-Celaya del Pozo, Phycisian doctor, Gerencia de Atención Primaria, Madrid
ClinicalTrials.gov Identifier: NCT01872468     History of Changes
Other Study ID Numbers: 09/90845
First Posted: June 7, 2013    Key Record Dates
Last Update Posted: April 13, 2015
Last Verified: April 2015

Keywords provided by Marta Sanchez-Celaya del Pozo, Gerencia de Atención Primaria, Madrid:
Glomerular filtration Rate.
Primary Health Care.
Cluster Clinical Trial.

Additional relevant MeSH terms:
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Renal Insufficiency
Kidney Diseases
Urologic Diseases