Impact of Hospital Pharmacist Intervention on Medication Management in Dialysis Patients

NCT06692231 | Not Yet Recruiting

• 1 other identifier: CHV-2024-10
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

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.

Conditions

Renal Dialysis; Health Literacy Level; Kidney Disease, Chronic

Keywords

clinical pharmacist; end stage renal disease

Outcome Measures

Primary Outcomes (1)

• Level of understanding and treatment management

  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 Outcomes (9)

• level of health literacy

  12 months

• Assessment of patient-reported compliance with medication

  12 months

• Kalemia evolution

  12 months

• Phosphatemia evolution

  12 months

• Calcemia evolution

  12 months

Study Arms (2)

Controle Arm

NO INTERVENTION

Control arm: will have no specific intervention

Intervention Arm

EXPERIMENTAL

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

Interventions

Pharmacist intervention BEHAVIORAL

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.

Intervention Arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Centre Hospitalier de Vichy: lead

Study Sites (1)

Centre hospitalier de Vichy

Vichy, France, 0320, France

Location

MeSH Terms

Conditions

Renal Insufficiency, Chronic; Kidney Failure, Chronic

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Aurélien PIRAUD

CONTACT

(+33 ) 04 70 97 13 14; aurelien.piraud@ch-vichy.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 12, 2024
• First Posted: November 18, 2024
• Study Start: November 15, 2024
• Primary Completion (Estimated): November 30, 2026
• Study Completion (Estimated): February 28, 2027
• Last Updated: November 18, 2024

Record last verified: 2024-11

Locations

FR (1)