NCT Number: NCT06692231
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.
Trial opening soon.
Get Notified18 year and older
All sexes
Interventional
Not applicable
Vichy, France, 0320
Aurélien PIRAUD
CONTACT
(+33) 04 70 97 13 14
Jessica PIGNARD, Doctor
CONTACT
(+33) 04.70.97.29.57
Jessica PIGNARD, Doctor
CONTACT
Mathilde TAMAIN, Doctor
CONTACT
Romane HUET, Doctor
CONTACT
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 12 months
concentration of potassium in blood plasma
Time frame: 12 months
concentration of phosphate in blood plasma
Time frame: 12 months
concentration of calcium in blood plasma
Time frame: 12 months
concentration of PTH in blood plasma
Time frame: 12 months
concentration of vitamine D in blood plasma
Time frame: 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.
Time frame: 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".
Contact information is provided by the study sponsor or research team.
Centre Hospitalier de Vichy
Other
Impact of Hospital Pharmacist Intervention on Medication Management in Dialysis Patients After Assessment of Health Literacy Level
Acronym: IPhaDia
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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