Therapeutic Education of Chronic Renal or Renal Transplant Patient in the Management of EPO Injections

NCT ID: NCT03481686

Last Updated: 2022-06-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 9 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-09-21
• Study Completion Date: 2022-02-09

Brief Summary

In chronic kidney disease, ESAs (Erythropoiesis-stimulating agents) are used to treat anemia. This anemia is due to decreased renal production of erythropoietin (EPO), a hormone that stimulates the production of red blood cells in the bone marrow. Treatment of anemia increases survival, decreases morbidity and improves quality of life and exercise tolerance.

Self-administration of ASE has been encouraged for many years, notably with pens for injection, but only few patients are educated in the injection technique.

The investigators therefore wish to lead a study in the Nephrology department of Rennes University Hospital to educate the patient, or his or her spouse, on ESA injections during hospitalization, in order to empower the patient in his care, and with the second aim of reducing the costs of chronic renal insufficiency.

Detailed Description

Erythropoiesis-stimulating agents (ESAs) are numerous and prescribed, depending on the molecule, once a week to once a month. They have improved the management of pre-dialysis patients, increased their hemoglobin and decreased transfusion needs, improving their morbidity and mortality and quality of life.

They are administered in pre-dialysis or post-renal transplantation most often by subcutaneous injection, which can be done by the patient himself, a member of his family or a nurse. Self-administration of ASE has been encouraged for many years, notably with pens for injection, but only few pilot studies show the feasibility of these auto-injections of ASE and patient satisfaction.

In 2012, the investigators conducted a practice study whose main objective was to have a picture of ESA injection practices for pre-dialysis patients. It is an observational, epidemiological, prospective and multicentric study, carried out by a questionnaire completed by the nephrologist during a consultation.

At the end of a 6-month collection period, 143 records were collected. All the patients questioned were followed for chronic renal insufficiency, not yet dialysed and not transplanted.

The majority of patients enrolled in this study were in the maintenance phase for ASE prescription (86% versus 14% in the correction phase), the mean age was 66.4 +/- 16.9 years. In 70.2% of cases the injection is done by a nurse, compared to 24.8% of injections made by the patient himself and 4.9% by his spouse. For 86.7%, the injection was done at home, and for 60% without other associated care. The nurse therefore came only for the injection of ASE. Not surprisingly, at an equal ASE cost, the resort to a nurse is significantly more expensive.

Conditions

Renal Insufficiency, Chronic; Organ Graft

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Patients with injections of ESA

Patients with injections of ESA

Group Type: EXPERIMENTAL

Patients with injections of ESA

Intervention Type: DEVICE

Patients will perform ASE injections themselves or by their spouses

Interventions

Patients with injections of ESA

Patients will perform ASE injections themselves or by their spouses

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• Patients monitored for chronic renal failure, or for renal transplantation regardless of clearance level;
• Patients whose disease requires regular injections of ESA (before hospitalization or since hospitalization);
• Patients who did not realize their injection themselves before hospitalization;
• Patients hospitalized in the nephrology department at Rennes university hospital ;
• Obtaining free, informed and written consent;
• Affiliation to social security.

Exclusion Criteria

• Major incapable persons and persons deprived of their liberty;
• Dialysis patients or for whom dialysis is envisaged within 3 months;
• Pregnant or nursing mothers;
• Patients who are already performing their ASE injections alone;
• Simultaneous participation in another research protocol involving the human person.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Rennes University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Cécile VIGNEAU

Role: PRINCIPAL_INVESTIGATOR

CHU Rennes

Hugoline BOULAY

Role: STUDY_CHAIR

CHU Rennes

Locations

CHU de Rennes

Rennes, , France

Countries

France

Other Identifiers

2017-A00295-48

Identifier Type: OTHER

Identifier Source: secondary_id

35RC16_9864_SELFEPO

Identifier Type: -

Identifier Source: org_study_id