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
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.
Single-center prospective quantitative study: design of two questionnaires (one for patients and one for caregivers). The objectives of the questionnaires are to:
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.
The objectives of the questionnaires are to:
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:
Exclusion criteria:
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:
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.
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.
Dialysis patients and professionals working at the Calydial renal health facility
Exclusion criteria:
Dialysis patients (hemodialysis and peritoneal dialysis)
Nurses and nephrologists caring for the patient
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)
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)
Plan to share: No
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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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