Impact of Hospital Pharmacist Intervention on Medication Management in Dialysis Patients (IPhaDia)

November 14, 2024 updated by: Centre Hospitalier de Vichy

Impact of Hospital Pharmacist Intervention on Medication Management in Dialysis Patients After Assessment of Health Literacy Level

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

70

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • France
      • Vichy, France, 0320
        • Centre Hospitalier de Vichy
        • Contact:
        • Contact:
        • Contact:
          • Jessica PIGNARD, Doctor
        • Contact:
          • Romane HUET, Doctor
        • Contact:
          • Mathilde TAMAIN, Doctor

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Controle Arm
Control arm: will have no specific intervention
Experimental: Intervention Arm
Intervention arm: 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.
Behavioral: Pharmacist 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Level of understanding and treatment management
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
12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
level of health literacy
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
12 months
Assessment of patient-reported compliance with medication
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
12 months
Kalemia evolution
Time Frame: 12 months
concentration of potassium in blood plasma
12 months
Phosphatemia evolution
Time Frame: 12 months
concentration of phosphate in blood plasma
12 months
Calcemia evolution
Time Frame: 12 months
concentration of calcium in blood plasma
12 months
PTH evolution
Time Frame: 12 months
concentration of PTH in blood plasma
12 months
Vitamine D evolution
Time Frame: 12 months
concentration of vitamine D in blood plasma
12 months
Quality of life
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.
12 months
Assessment of compliance with medication
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".
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre Hospitalier de Vichy

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

November 15, 2024

Primary Completion (Estimated)

November 30, 2026

Study Completion (Estimated)

February 28, 2027

Study Registration Dates

First Submitted

November 12, 2024

First Submitted That Met QC Criteria

November 14, 2024

First Posted (Estimated)

November 18, 2024

Study Record Updates

Last Update Posted (Estimated)

November 18, 2024

Last Update Submitted That Met QC Criteria

November 14, 2024

Last Verified

November 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CHV-2024-10

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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