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

Primary Purpose

Renal Insufficiency, Chronic, Organ Graft

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Patients with injections of ESA
Sponsored by
Rennes University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Renal Insufficiency, Chronic focused on measuring Erythropoiesis, stimulating, agents, therapeutic, education, program

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • CHU de Rennes

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Patients with injections of ESA

Arm Description

Patients with injections of ESA

Outcomes

Primary Outcome Measures

Number of patients performing all their injections themselves and / or their spouse

Secondary Outcome Measures

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

Full Information

First Posted
March 19, 2018
Last Updated
June 22, 2022
Sponsor
Rennes University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT03481686
Brief Title
Therapeutic Education of Chronic Renal or Renal Transplant Patient in the Management of EPO Injections
Acronym
SELFEPO
Official Title
SelfEPO - Therapeutic Education of Chronic Renal or Renal Transplant Patient in the Management of EPO Injections
Study Type
Interventional

2. Study Status

Record Verification Date
June 2022
Overall Recruitment Status
Completed
Study Start Date
September 21, 2018 (Actual)
Primary Completion Date
February 9, 2022 (Actual)
Study Completion Date
February 9, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Rennes University Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Renal Insufficiency, Chronic, Organ Graft
Keywords
Erythropoiesis, stimulating, agents, therapeutic, education, program

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
9 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Patients with injections of ESA
Arm Type
Experimental
Arm Description
Patients with injections of ESA
Intervention Type
Device
Intervention Name(s)
Patients with injections of ESA
Intervention Description
Patients will perform ASE injections themselves or by their spouses
Primary Outcome Measure Information:
Title
Number of patients performing all their injections themselves and / or their spouse
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Number of patients performing all their injections themselves
Time Frame
1 month
Title
Number of patients performing all their injections themselves
Time Frame
3 months
Title
Percentage of injections performed by the nurse vs by themselves and / or their spouse before empowerment
Time Frame
6 months
Title
Number of patients who performed all their injections by their spouse
Time Frame
6 months
Title
Number of injections performed on the number of prescribed injections
Description
Treatment compliance
Time Frame
6 months
Title
Injection site pain
Description
pain assessment with a visual analog scale (0 = no pain, 10 = maximum pain)
Time Frame
6 months
Title
Side effects of ESA injection
Time Frame
6 months
Title
Number of patients stopping self-injections
Time Frame
6 months
Title
Reason for stopping self-injections
Description
evaluation of reason for stopping self-injections with a questionnaire
Time Frame
6 months
Title
Number of patients refusing therapeutic education
Time Frame
6 months
Title
Reason for refusing therapeutic education
Description
evaluation of reason for refusing therapeutic education with a questionnaire
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Cécile VIGNEAU
Organizational Affiliation
CHU Rennes
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Hugoline BOULAY
Organizational Affiliation
CHU Rennes
Official's Role
Study Chair
Facility Information:
Facility Name
CHU de Rennes
City
Rennes
ZIP/Postal Code
35000
Country
France

12. IPD Sharing Statement

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

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