Renal DialysisIPhaDiaNCT06692231
Impact of Hospital Pharmacist Intervention on Medication Management in Dialysis Patients
A study testing Pharmacist intervention in people with Renal Dialysis and Health Literacy Level, run by Centre Hospitalier de Vichy at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Renal Dialysis, Health Literacy Level, Kidney Disease, Chronic
- What is being tested?
- Pharmacist intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteFrance
- Study dates
- 15 Nov 2024to 28 Feb 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site
Centre hospitalier de Vichy
Vichy, France, 0320
Aurélien PIRAUD, (+33) 04 70 97 13 14, aurelien.piraud@ch-vichy.fr
Jessica PIGNARD, Doctor, (+33) 04.70.97.29.57, jessica.pignard@ch-vichy.fr
About this study
Official title: 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.
- Being tested
- Pharmacist intervention
- Keywords
- clinical pharmacist, end stage renal disease
- Medical subject headings
- Renal Insufficiency, Chronic, Kidney Failure, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pharmacist interventionBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Pharmacist intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 12 months
Secondary outcomes (9)
level of health literacy
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
Measured: 12 months
Assessment of patient-reported compliance with medication
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
Measured: 12 months
Kalemia evolution
concentration of potassium in blood plasma
Measured: 12 months
Phosphatemia evolution
concentration of phosphate in blood plasma
Measured: 12 months
Calcemia evolution
concentration of calcium in blood plasma
Measured: 12 months
PTH evolution
concentration of PTH in blood plasma
Measured: 12 months
Vitamine D evolution
concentration of vitamine D in blood plasma
Measured: 12 months
Quality of life
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.
Measured: 12 months
Assessment of compliance with medication
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".
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2024
- Study start15 Nov 2024 (estimated)
- Primary completion30 Nov 2026 (estimated)
- Study completion28 Feb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Renal DialysisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier de Vichy
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06692231
- Sponsor's protocol ID
- CHV-2024-10
- Acronym
- IPhaDia
- Status last verified
- Nov 2024
- First submitted
- 12 Nov 2024
- Last updated
- 18 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Hospital Pharmacist Intervention on Medication Management in Dialysis Patients After Assessment of Health Literacy Level
- ClinicalTrials.gov ID
- NCT06692231
- Acronym / sponsor ID
- IPhaDia / CHV-2024-10
- Keywords
- clinical pharmacist, end stage renal disease
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Centre Hospitalier de VichyUniversity, hospital or other
- Study start
- 15 Nov 2024 (estimated)
- Primary completion
- 30 Nov 2026 (estimated)
- Study completion
- 28 Feb 2027 (estimated)
- First posted
- 18 Nov 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Controle Arm | No intervention | –Control arm: will have no specific intervention |
| Intervention Arm | Experimental | Behavioral: Pharmacist interventionIntervention 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pharmacist interventionPatient 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. | Behavioural | Intervention Arm |
Primary outcome
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
9 secondary outcomes
level of health literacy
Time frame: 12 months
Assessment of patient-reported compliance with medication
Time frame: 12 months
Kalemia evolution
Time frame: 12 months
Phosphatemia evolution
Time frame: 12 months
Calcemia evolution
Time frame: 12 months
PTH evolution
Time frame: 12 months
Vitamine D evolution
Time frame: 12 months
Quality of life
Time frame: 12 months
Assessment of compliance with medication
Time frame: 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Nov 2024.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pharmacist intervention in people with Renal Dialysis and Health Literacy Level, run by Centre Hospitalier de Vichy at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 18 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Aurélien PIRAUD ((+33 ) 04 70 97 13 14, aurelien.piraud@ch-vichy.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Level of understanding and treatment management (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Nov 2024.