- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07535320
Study of Patient Preferences in Dialysis Treatment Choice: a Discrete Choice Experiment (PREFDOM)
Background Compared to in-center dialysis, home dialysis is associated with better quality of life and lower healthcare system costs. However, barriers remain to its wider adoption. Chronic disease, particularly at an advanced stage, is a major driver of socioeconomic vulnerability. Among dialysis patients, the proportion of individuals covered by France's Universal Health Protection scheme (PUMA) is higher than in the general population. Similarly, those from the most disadvantaged social classes are overrepresented among dialysis patients compared to the overall French population. Dialysis can also lead to job loss. Financial compensation schemes may influence the choice of home dialysis. In France, patients who perform dialysis at home-either independently or with help from a trained family caregiver-are eligible for a "third-person compensatory allowance" (DTP). For some socioeconomically vulnerable patients, eligibility for DTP may influence their decision to opt for home treatment. The DTP is specific to the French healthcare system but could be considered in other countries, particularly within the European Union. Indeed, in most countries with income levels comparable to France, the additional cost of home dialysis is borne by the patient. This study aims to determine whether receiving financial compensation plays a role in choosing a dialysis modality (home-based versus in-center or assisted home dialysis).
Objectives To investigate factors associated with patient preferences regarding renal replacement therapy.
Methods A discrete choice experiment (DCE) was conducted comparing two options: home dialysis (PD and HHD, with DTP) versus in-center hemodialysis (no DTP).
Perspectives If financial compensation influences patients' choices toward home dialysis, the DTP model could be used to address barriers to home-based treatment.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Clémence Tomadesso, Mrs
- Phone Number: +33231063106
- Email: tomadesso-c@chu-caen.fr
Study Locations
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-
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Caen, France, 14000
- Recruiting
- CHU De Caen
-
Contact:
- Sonia Guillouët, PhD
- Phone Number: +33231568291
- Email: sonia.guillouet@unicaen.fr
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Sub-Investigator:
- Ludivine Videloup, RN
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Principal Investigator:
- Sonia Guillouët, PhD
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Caen, France, 14000
- Recruiting
- CHU
-
Contact:
- SONIA GUILLOUET, DR
- Phone Number: +33231563089
- Email: achourakram10@gmail.com
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- Adult patient
- Patient with advanced chronic kidney disease receiving pre-surgery information (presentation of methods)
- Patient enrolled in a social security program
- Patient able to read and understand French
- Patient able to complete the questionnaire (cognitive and sensory)
Exclusion Criteria:
- Minor patients
- Patients transitioning from one method of extrarenal purification to another
- Patients requiring urgent dialysis
- Patients who cannot read or understand French
- Patients under legal protection (guardianship, curatorship, judicial protection)
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Choice of dialysis
Patients with an end-stage renal disease who need to make a choice concerning their prefered dialysis' modality
|
Patients are given a questionnaire. The first part concerns sociodemographic characteristics. The second part concerns the choice of replacement therapy itself. Patients must choose between three possible treatments: "If you had to choose a treatment based on the options provided, which one would you choose? Patients make this choice 13 times (the options change). |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Preference coefficients for renal replacement therapy attributes, including monthly financial allowance, estimated using a discrete choice experiment
Time Frame: Baseline (during the single discrete choice experiment assessment at study enrollment)
|
Participants will complete 13 discrete choice tasks, each requiring selection of one preferred scenario among three renal replacement therapy options. Scenarios are defined by combinations of five attributes: schedule flexibility, nurse availability, dialysis frequency, timing of sessions, and monthly financial allowance. Preferences will be analyzed within a random utility framework using a mixed logit model. The primary outcome is the estimation of marginal utilities (preference coefficients) associated with each attribute level. Particular focus will be placed on the coefficient associated with the monthly financial allowance attribute, to assess its influence on the probability of choosing a home-based treatment modality. This approach allows indirect elicitation of patient preferences without explicit ranking, consistent with economic theory of revealed preferences. |
Baseline (during the single discrete choice experiment assessment at study enrollment)
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Urogenital Diseases
- Pathologic Processes
- Male Urogenital Diseases
- Kidney Diseases
- Urologic Diseases
- Female Urogenital Diseases
- Female Urogenital Diseases and Pregnancy Complications
- Chronic Disease
- Disease Attributes
- Renal Insufficiency
- Pathological Conditions, Signs and Symptoms
- Renal Insufficiency, Chronic
- Health Care Quality, Access, and Evaluation
- Investigative Techniques
- Epidemiologic Methods
- Data Collection
- Health Care Evaluation Mechanisms
- Quality of Health Care
- Public Health
- Environment and Public Health
- Surveys and Questionnaires
Other Study ID Numbers
- 24-0172
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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