NCT07535320

Brief Summary

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
500

participants targeted

Target at P75+ for all trials

Timeline
20mo left

Started Dec 2025

Typical duration for all trials

Geographic Reach
1 country

2 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress19%
Dec 2025Dec 2027

First Submitted

Initial submission to the registry

August 25, 2025

Completed
4 months until next milestone

Study Start

First participant enrolled

December 16, 2025

Completed
4 months until next milestone

First Posted

Study publicly available on registry

April 17, 2026

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2027

Last Updated

April 17, 2026

Status Verified

December 1, 2025

Enrollment Period

2 years

First QC Date

August 25, 2025

Last Update Submit

April 9, 2026

Conditions

Keywords

NephrologyHome DialysisChronic Kidney DiseaseDiscrete Choice Experiment

Outcome Measures

Primary Outcomes (1)

  • Preference coefficients for renal replacement therapy attributes, including monthly financial allowance, estimated using a discrete choice experiment

    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)

Study Arms (1)

Choice of dialysis

Patients with an end-stage renal disease who need to make a choice concerning their prefered dialysis' modality

Other: Questionnaire

Interventions

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).

Choice of dialysis

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with chronic kidney disease in the advanced stage

You may qualify if:

  • 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)

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

CHU de Caen

Caen, 14000, France

RECRUITING

CHU

Caen, 14000, France

RECRUITING

MeSH Terms

Conditions

Renal Insufficiency, Chronic

Interventions

Surveys and Questionnaires

Condition Hierarchy (Ancestors)

Renal InsufficiencyKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Data CollectionEpidemiologic MethodsInvestigative TechniquesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public Health

Central Study Contacts

Clémence Tomadesso, Mrs

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
OTHER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 25, 2025

First Posted

April 17, 2026

Study Start

December 16, 2025

Primary Completion (Estimated)

December 31, 2027

Study Completion (Estimated)

December 31, 2027

Last Updated

April 17, 2026

Record last verified: 2025-12

Locations