Impact of Hospital Pharmacist Intervention on Medication Management in Dialysis Patients
- Conditions
- Renal DialysisHealth Literacy LevelKidney Disease, Chronic
- Registration Number
- NCT06692231
- Lead Sponsor
- Centre Hospitalier de Vichy
- Brief Summary
The goal of this clinical trial is to learn if an intervention of a hospital pharmacist could help, dialysis patients managed his treatment. In a first time, the health literacy level will be assed.
The main questions it aims to answer are:
What is the impact of the clinical pharmacist intervention on the understanding level and management level of his treatment by the patient? Does the intervention of the pharmacist has an effect on the biologicals parameters of the patient? Researchers will compare a group with a pharmacist intervention VS a group without pharmacist intervention for dialysis patients.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 70
- Patient over 18 years of age
- On dialysis (peritoneal dialysis, hemodialysis) for at least 3 months
- Prescription for at least 5 daily medications
- Patient who has not received any pharmaceutical consultation from a hospital pharmacist as part of his or her treatment for chronic renal failure.
- Patient does not speak and/or understand French
- Patient's cognitive state does not permit an interview
- Patient not autonomous in managing his or her daily medication (e.g.: patient in nursing home)
- Patient refusal
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Level of understanding and treatment management 12 months Assessment of level of understanding and management of treatment using a survey based on the questionnaire validated by the French Health Authority (HAS).
In order to take better account of the diversity of treatments for dialysis patients, we will use an adaptation of this questionnaire describing more precisely the patient's knowledge of treatments related to phosphocalcic metabolism and potassium.
A score of 7 on this questionnaire means an excellent understanding of the treatment A score of 0 on this questionnaire means the poorest understanding of the treatment
- Secondary Outcome Measures
Name Time Method Phosphatemia evolution 12 months concentration of phosphate in blood plasma
Calcemia evolution 12 months concentration of calcium in blood plasma
PTH evolution 12 months concentration of PTH in blood plasma
Vitamine D evolution 12 months concentration of vitamine D in blood plasma
Quality of life 12 months Patients' quality of life will be assessed using the EQ-5D-5L tool. The EQ-5D descriptive system comprises five dimensions: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression. Each dimension is describe by a five levels scale. (From 0 the worst outcome to 5 the best outcome). A visual analogue scale, where the patient rate is health form 0 to 100, complete this descriptive system.
Assessment of compliance with medication 12 months Call to the patient's usual pharmacy to check that medication retrieval is regular and get the pharmacist's opinion of the patient, by asking the following question: "Based on the last 6 months in your pharmacy's patient file, how would you rate the regularity of this patient's medication retrieval? "Good - Intermediate - Poor".
level of health literacy 12 months Literacy will be assessed measured using the French version of the Short Test of Functional Health Literacy in Adults (STOFHLA).
STOFHLA scale interpretation:
Score 0-16: Inability to read and interpret healthcare texts Score 17-22: Problem reading and interpreting healthcare texts Score 23-36: Can read and interpret most healthcare textsAssessment of patient-reported compliance with medication 12 months The patient-reported compliance will be assed using the GIRERD questionnaire. This tool is made of 6 questions. A score of 0 mean a good compliance and a score ≥3 mean a bad compliance
Kalemia evolution 12 months concentration of potassium in blood plasma
Trial Locations
- Locations (1)
Centre hospitalier de Vichy
🇫🇷Vichy, France