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

Gerencia de Atención Primaria, Madrid

Status: Completed

Conditions: Renal Insufficiency Chronic

Treatments: Behavioral: Structured intervention

Study type: Interventional

Funder types: Other

Identifiers

NCT01872468

09/90845

Details and patient eligibility

About

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.

Full 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.

Enrollment: 269 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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).

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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269 participants in 2 patient groups

Control

No Intervention group

Description:

There is not intervention in this group.

Structured intervention

Active Comparator group

Description:

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

Treatment:

Behavioral: Structured intervention