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

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ClinicalTrials.gov Identifier: NCT03481686
Recruitment Status : Recruiting
First Posted : March 29, 2018
Last Update Posted : February 3, 2021
Sponsor:
Information provided by (Responsible Party):
Rennes University Hospital

Study Description
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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.


Condition or disease Intervention/treatment Phase
Renal Insufficiency, Chronic Organ Graft Device: Patients with injections of ESA Not Applicable

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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: SelfEPO - Therapeutic Education of Chronic Renal or Renal Transplant Patient in the Management of EPO Injections
Actual Study Start Date : September 21, 2018
Estimated Primary Completion Date : March 2022
Estimated Study Completion Date : March 2022

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Patients with injections of ESA
Patients with injections of ESA
 Device: Patients with injections of ESA
Patients will perform ASE injections themselves or by their spouses


Outcome Measures
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Primary Outcome Measures :
  1. Number of patients performing all their injections themselves and / or their spouse [ Time Frame: 6 months ]

Secondary Outcome Measures :
  1. Number of patients performing all their injections themselves [ Time Frame: 1 month ]
  2. Number of patients performing all their injections themselves [ Time Frame: 3 months ]
  3. Percentage of injections performed by the nurse vs by themselves and / or their spouse before empowerment [ Time Frame: 6 months ]
  4. Number of patients who performed all their injections by their spouse [ Time Frame: 6 months ]
  5. Number of injections performed on the number of prescribed injections [ Time Frame: 6 months ]
    Treatment compliance

  6. Injection site pain [ Time Frame: 6 months ]
    pain assessment with a visual analog scale (0 = no pain, 10 = maximum pain)

  7. Side effects of ESA injection [ Time Frame: 6 months ]
  8. Number of patients stopping self-injections [ Time Frame: 6 months ]
  9. Reason for stopping self-injections [ Time Frame: 6 months ]
    evaluation of reason for stopping self-injections with a questionnaire

  10. Number of patients refusing therapeutic education [ Time Frame: 6 months ]
  11. Reason for refusing therapeutic education [ Time Frame: 6 months ]
    evaluation of reason for refusing therapeutic education with a questionnaire


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03481686


Contacts
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Contact: Cécile VIGNEAU 299284396 ext +0033 cecile.vigneau@chu-rennes.fr
Contact: Anne GANIVET 2992855525 ext +0033 anne.ganivet@chu-rennes.fr

Locations
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France
CHU de Rennes Recruiting
Rennes, France, 35000
Contact: Cécile Vigneau    02.99.28.43.96    cecile.vigneau@chu-rennes.fr   
Sponsors and Collaborators
Rennes University Hospital
Investigators
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Principal Investigator: Cécile VIGNEAU CHU Rennes
Study Chair: Hugoline BOULAY CHU Rennes
More Information
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Responsible Party: Rennes University Hospital
ClinicalTrials.gov Identifier: NCT03481686    
Other Study ID Numbers: 35RC16_9864_SELFEPO
2017-A00295-48 ( Other Identifier: N° ID - RCB )
First Posted: March 29, 2018    Key Record Dates
Last Update Posted: February 3, 2021
Last Verified: February 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Rennes University Hospital:
Erythropoiesis
stimulating
agents
 therapeutic
education
program
Additional relevant MeSH terms:
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Renal Insufficiency
Renal Insufficiency, Chronic
Kidney Diseases
Urologic Diseases