Clinical trial NCT03481686: Therapeutic Education of Chronic Renal or Renal Transplant Patient in the Management of EPO Injections
Official title: SelfEPO - Therapeutic Education of Chronic Renal or Renal Transplant Patient in the Management of EPO Injections
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Renal Insufficiency, Chronic
Organ Graft
Keywords: Erythropoiesis
stimulating
agents
therapeutic
education
program
Lead sponsor: Rennes University Hospital
Sponsor class: OTHER
First posted: 2018-03-29
Enrollment: 9
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

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.

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.

Primary outcomes:
measure: Number of patients performing all their injections themselves and / or their spouse
timeFrame: 6 months
Secondary outcomes:
measure: Number of patients performing all their injections themselves
timeFrame: 1 month
measure: Number of patients performing all their injections themselves
timeFrame: 3 months
measure: Percentage of injections performed by the nurse vs by themselves and / or their spouse before empowerment
timeFrame: 6 months
measure: Number of patients who performed all their injections by their spouse
timeFrame: 6 months
measure: Number of injections performed on the number of prescribed injections
timeFrame: 6 months
measure: Injection site pain
timeFrame: 6 months
measure: Side effects of ESA injection
timeFrame: 6 months
measure: Number of patients stopping self-injections
timeFrame: 6 months
measure: Reason for stopping self-injections
timeFrame: 6 months
measure: Number of patients refusing therapeutic education
timeFrame: 6 months
measure: Reason for refusing therapeutic education
timeFrame: 6 months
Other outcomes:
Locations:
city: Rennes
country: France
facility: CHU de Rennes
Study officials:
affiliation: CHU Rennes
name: Cécile VIGNEAU
role: PRINCIPAL_INVESTIGATOR
affiliation: CHU Rennes
name: Hugoline BOULAY
role: STUDY_CHAIR
References: