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CompletedNCT06529887EnquêteXPUpdated Jul 31, 2024

What Does the Patient Experience Represent for Patients and Caregivers in Dialysis?

An observational study in Experience, Life, Dialysis and Patient Engagement, sponsored by Calydial. Completed at 4 sites in France. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-07-31.

Sponsored by Calydial · Observational

Study type
Observational
Model
Other
Time perspective
Prospective
Enrollment
160
Ages
18 Years and older
Sex
All
01

Study summary

The primary objective of this work is to describe the vision, representations, and beliefs of professionals and patients regarding the role and place of the user during their care journey at the Calydial renal health facility.

Methodology: a mixed qualitative and quantitative research.

  • Qualitative research: semi-structured interviews with patients and caregivers. The objective is to define the meaning of the patient experience from the perspectives of patients and caregivers.
  • Single-center prospective quantitative study: design of two questionnaires (one for patients and one for caregivers). The objectives of the questionnaires are to:

    • Evaluate the feelings, experiences, and representations/beliefs of the patient experience by caregivers and patients.
    • Assess the understanding of the patient experience by caregivers and patients.
    • Compare the patient experience based on the following parameters: age of patients, gender, treatment duration, treatment location, treatment modality, patient autonomy.
    • Measure the gap between patient and caregiver perspectives to identify/adjust actions.
Read the detailed description

Patient experience encompasses all interactions a healthcare organization has with a patient and their family, potentially influencing their perceptions throughout their healthcare journey. These interactions are shaped both by the policies implemented by the facility and by the personal history and culture of each patient. Patient experience is a subjective concept that can be standardized and objectified. Even if standardized, known as a care pathway, it will still be experienced differently by each patient (depending on whether they are optimistic or pessimistic, live alone or not, and whether they reside in a rural or urban area).

The objective of our work is to evaluate the experience of our care pathway, the factors influencing patient experience, and the caregiver experience. Our facility comprises several units located in the south of Lyon and the north of Isère, providing care for chronic kidney disease at all stages. Our work focused on patients with stage 5 chronic kidney disease treated with hemodialysis (center, medically assisted dialysis unit, and self-dialysis) and home dialysis (hemodialysis and peritoneal dialysis).

The primary objective of this work is to describe the vision, representations, and beliefs of professionals and patients regarding the role and place of the user during their care journey at the Calydial renal health facility.

Methodology: mixed qualitative and quantitative research.

  • Qualitative research: semi-structured interviews with patients and caregivers. The objective is to define the meaning of the patient experience from the perspectives of patients and caregivers.
  • Single-center prospective quantitative study: design of two questionnaires (one for patients and one for caregivers).

The objectives of the questionnaires are to:

  • Evaluate the feelings, experiences, and representations/beliefs of the patient experience by caregivers and patients.
  • Assess the understanding of the patient experience by caregivers and patients.
  • Compare the patient experience based on the following parameters: age of patients, gender, treatment duration, treatment location, treatment modality, patient autonomy.
  • Measure the gap between patient and caregiver perspectives to identify/adjust actions.

Study population The patient and caregiver questionnaires are offered to all patients and caregivers at Calydial.

Inclusions The study population will consist of hemodialysis patients agreeing to respond to the questionnaire during their visit for a dialysis session.

Inclusion criteria:

  • Patient aged 18 years or older
  • On hemodialysis for more than 3 months in one of the participating centers
  • Regardless of the etiology of renal disease

Exclusion criteria:

  • Person refusing to participate in the study
  • Person unable to read or understand French well enough to complete the questionnaires
  • Inability to express consent to participate in the study
  • Cognitive disorders deemed incompatible with study participation by the investigator
  • Psychiatric disorders deemed incompatible with study participation by the investigator
  • Person protected by law
  • Patient under legal protection (safeguard of justice, curatorship, and guardianship)

Study procedure This study is observational and exploratory (non-interventional research), single-center, conducted using a self-administered questionnaire via electronic tablet. The sponsor and investigators commit to conducting this research in accordance with the protocol, Good Clinical Practice guidelines, current legislative and regulatory provisions in France and internationally (particularly the General Data Protection Regulation GDPR).

The study is offered to hemodialysis patients during a dialysis session or consultation. They are informed, and their non-opposition to participation is collected. Their participation consists of:

Responding to an electronic self-assessment questionnaire on the patient experience. A caregiver can assist the patient if necessary. The questionnaire data is pseudonymized.

Providing the following information: age, gender, dialysis modality, dialysis duration, dialysis location, participation in therapeutic education.

Data collected

The quantitative questionnaire for patients will be administered on-site across all dialysis modalities. It includes 4 categories to assess:

  • Patient profile (sociodemographic data)
  • Patient care (dialysis experience, recognizing body reactions, considering opinions, feeling of being heard, etc.)
  • Actions to be implemented (patient participation in ETP workshops, participation in working groups, access to patient associations, considering patient knowledge, etc.)
  • Patient rights (user commission, user projects, patient associations, etc.) The questionnaire will be created using REDCAP software. It will then be tested with 3 patients in a medically assisted dialysis unit and 2 professionals (a clinical research associate and a dietitian). The estimated duration of the questionnaire is 20 to 30 minutes for a patient and about 15 minutes for a professional.

Data analysis An analysis of the sociodemographic and clinical characteristics of the population will be conducted. The proportion of patients included within the total eligible population will be calculated, and the characteristics (sex, age, dialysis duration) of included and eligible non-included patients will be compared to estimate the exhaustiveness and representativeness of the included population.

A descriptive analysis will be carried out to describe the sociodemographic characteristics of the respondents. Subsequently, a comparative analysis will be performed to identify the expectations, needs, and opinions of professionals and patients for quality care. Finally, a multivariate analysis will be conducted to relate sociodemographic variables to the theme of the caregiver-patient relationship.

Analyses will be performed using SAS 9.1 software. A 5% bilateral threshold will be considered for defining statistical significance.

02

Conditions studied

  • Experience, Life
  • Dialysis
  • Patient Engagement
  • Patient Participation
  • Patient Relations, Nurse
  • Patient Satisfaction

Keywords

  • patient central care
  • patient experience
  • Sharing decision making
03

In context

Lead sponsor

Calydial is the lead sponsor of 3 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

Study population

Dialysis patients and professionals working at the Calydial renal health facility

Inclusion criteria

  • Patient aged 18 years or older
  • On hemodialysis for more than 3 months in one of the participating centers
  • Regardless of the etiology of renal disease

Exclusion criteria

Exclusion criteria:

  • Person refusing to participate in the study
  • Person unable to read or understand French well enough to complete the questionnaires
  • Inability to express consent to participate in the study
  • Cognitive disorders deemed incompatible with study participation by the investigator
  • Psychiatric disorders deemed incompatible with study participation by the investigator
  • Person protected by law
  • Patient under legal protection (safeguard of justice, curatorship, and guardianship)
05

Study design

Observational model
Other
Time perspective
Prospective
Enrollment
160 participants (actual)
Patient registry
No

Groups and cohorts

  • Patients

    Dialysis patients (hemodialysis and peritoneal dialysis)

  • Professionnels

    Nurses and nephrologists caring for the patient

06

What researchers measure

Primary outcomes

  1. Understanding the experiences, knowledge, and patient experience

    Semi-structured interviews with 8 patients (all dialysis modalities) and 8 healthcare professionals to define the objectives of the quantitative survey (patient and caregiver questionnaires).

    Time frame: 2 years (2020 and 2021)

  2. Evaluation of the care pathway experiences and factors influencing patient experience from the perspectives of patients and caregivers.

    Quantitative questionnaires for patients (all dialysis modalities) and their caregivers (nephrologists and nurses).

    Time frame: 2 months (february and march 2022)

07

Study locations

4 sites
  • CALYDIAL
    Irigny, 69540, France
  • CALYDIAL
    Pierre-Bénite, 69310, France
  • CALYDIAL
    Vienne, 38200, France
  • CALYDIAL
    Vénissieux, 69694, France
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 31, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06529887
Lead sponsor
Calydial
Collaborators
OZ'IRIS Santé
Responsible party
Sponsor
First posted
Jul 31, 2024
Start date
Feb 7, 2022
Primary completion
Mar 10, 2022
Completion
Mar 10, 2022
Last update
Jul 31, 2024

Study contacts

Agnès CAILLETTE-BEAUDOIN, Dr
study director · Calydial

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Jul 2024. You cannot join it, but the record below documents what was studied.

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