Health Literacy Level, Kidney Disease, Chronic, Renal Dialysis
Conditions
Keywords
clinical pharmacist, end stage renal disease
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.
Interventions
BEHAVIORALPharmacist intervention
Patient will have an interview with a clinical pharmacist to explain the role of each medication. The pharmacist will also explain the best moment to take each medication.
Sponsors
Centre Hospitalier de Vichy
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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.
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| Assessment 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 |
| Phosphatemia evolution | 12 months | concentration of phosphate in blood plasma |
| Calcemia evolution | 12 months | concentration of calcium in blood plasma |
| 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 texts |
| 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. |
| PTH evolution | 12 months | concentration of PTH in blood plasma |
Countries
France
Contacts
Primary ContactAurélien PIRAUD
Outcome results
None listed