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

Renal Insufficiency, Chronic Clinical Trial

— SELFEPO  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03481686
• Other study ID #: 35RC16_9864_SELFEPO
• Secondary ID: 2017-A00295-48
• Status: Completed
• Phase: N/A
• Start date: September 21, 2018
• Est. completion date: February 9, 2022

Study information

• Verified date: June 2022
• Source: Rennes University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 9
• Est. completion date: February 9, 2022
• Est. primary completion date: February 9, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Organ Graft
• Renal Insufficiency
• Renal Insufficiency, Chronic

Intervention

Device:
• Patients with injections of ESA
Patients will perform ASE injections themselves or by their spouses

Locations

Country	Name	City	State
France	CHU de Rennes	Rennes

Sponsors (1)

Lead Sponsor	Collaborator
Rennes University Hospital

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of patients performing all their injections themselves and / or their spouse		6 months
Secondary	Number of patients performing all their injections themselves		1 month
Secondary	Number of patients performing all their injections themselves		3 months
Secondary	Percentage of injections performed by the nurse vs by themselves and / or their spouse before empowerment		6 months
Secondary	Number of patients who performed all their injections by their spouse		6 months
Secondary	Number of injections performed on the number of prescribed injections	Treatment compliance	6 months
Secondary	Injection site pain	pain assessment with a visual analog scale (0 = no pain, 10 = maximum pain)	6 months
Secondary	Side effects of ESA injection		6 months
Secondary	Number of patients stopping self-injections		6 months
Secondary	Reason for stopping self-injections	evaluation of reason for stopping self-injections with a questionnaire	6 months
Secondary	Number of patients refusing therapeutic education		6 months
Secondary	Reason for refusing therapeutic education	evaluation of reason for refusing therapeutic education with a questionnaire	6 months