NCT07364292

Brief Summary

International guidelines for kidney failure emphasize the importance of aligning renal replacement therapy (RRT) modality selection with individuals' preferences through high-quality, structured education. However, observational qualitative studies suggest that pre-dialysis education remains inconsistently delivered, with substantial centre-to-centre variation in the content and organization of Belgian pre-dialysis programs despite a shared healthcare policy. Multiple barriers to home-based therapies have been repeatedly reported at both the unit and patient levels, including nursing shortages, limited availability of trained staff, financial constraints, high rates of unplanned dialysis initiation, distress at treatment start, low health literacy, and an increasingly frail and comorbid patient population. Yet, a minority of dialysis units appear able to mitigate these barriers more effectively than others. This discrepancy raises concern that centre-oriented priorities (unit throughput, cost-effectiveness, technical performance) may still outweigh patient-centred goals (supporting life priorities and meaningful shared decision-making). This study aims to explore nephrologists' beliefs, knowledge, and attitudes regarding shared decision-making in dialysis modality selection and their potential influence on the adoption of alternative RRT modalities beyond in-centre hemodialysis. Q methodology will be used to capture and compare shared viewpoints and patterns of disagreement across participants.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
25

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Mar 2024

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 28, 2024

Completed
2 months until next milestone

Study Start

First participant enrolled

March 15, 2024

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 15, 2025

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2025

Completed
24 days until next milestone

First Posted

Study publicly available on registry

January 23, 2026

Completed
Last Updated

January 23, 2026

Status Verified

January 1, 2026

Enrollment Period

1.5 years

First QC Date

January 28, 2024

Last Update Submit

January 15, 2026

Conditions

Keywords

shared-decision-makingdialysis modality selectionkidney failurehome-based therapies

Outcome Measures

Primary Outcomes (1)

  • Number of distinct Q-methodology viewpoints (factors) identified from nephrologists' Q-sorts related to shared decision-making in dialysis modality choice, as derived from Q-factor analysis.

    Q-sort data will be collected using a forced-ranking of predefined actions in response to clinical vignettes. The primary quantitative endpoint is the number of interpretable factors extracted from participants' Q-sorts using principal component factor analysis with varimax rotation. Results will be reported as: * Number of factors identified (count), * Number (%) of participants significantly loading on each factor (p \< 0.01) * Factor loadings (correlation coefficients) per factor reported as mean (SD) and range.

    Time Frame: Once, at the baseline study visit (single Q-sort session), up to 90' per participant

Secondary Outcomes (1)

  • Number and content of overarching themes and sub-themes identified from semi-structured interviews relevant to dialysis-decision making.

    Once, during the baseline session (up to 30 minutes per participant)

Study Arms (1)

nephrologists

OTHER

no other arm

Behavioral: Q methodology

Interventions

Q methodologyBEHAVIORAL

Q- sorting operation is done during a face-to-face meeting of the participant and the interviewer. Participants rank-order a set of statements or opinions into a grid. They rank the importance of statements relative to all others. A specific characteristic of Q Sort is that participants are forced to prioritize amongst statements. During the ranking procedure, they must explain their reasoning process on their positioning of their cards ("thinking-aloud" their reasoning). This audiotaping of the thinking aloud during the actual completion of the Q-Sort allows to not only gain insights in the perceptions of the participants, but also in their underlying reasoning, emotions, and motivation.

nephrologists

Eligibility Criteria

Age30 Years - 67 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • nephrologists professionnaly active

You may not qualify if:

  • non active or retired nephrologists
  • nephrologist who do not have regular contact with ESKD patients or who do not engage in treatment discussion

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

HUB Erasme

Brussels, Belgium

Location

Related Publications (3)

  • Allen K, Shaw KL, Spry JL, Dikomitis L, Coyle D, Damery S, Fotheringham J, Lambie M, Williams IP, Davies S. How does organisational culture facilitate uptake of home dialysis? An ethnographic study of kidney centres in England. BMJ Open. 2024 Dec 27;14(12):e085754. doi: 10.1136/bmjopen-2024-085754.

    PMID: 39732481BACKGROUND
  • Brown EA, Brivio GB, Van Biesen W. Towards a better uptake of home dialysis in Europe: understanding the present and looking to the future. Clin Kidney J. 2024 Jun 5;17(Suppl 1):i3-i12. doi: 10.1093/ckj/sfae082. eCollection 2024 May.

    PMID: 38846418BACKGROUND
  • Cortvrindt C, Van Biesen W, Gambino G, Clause AL. Factors influencing renal replacement therapy modality choice from the nephrologist's perspective. J Nephrol. 2024 Apr;37(3):635-645. doi: 10.1007/s40620-024-01915-w. Epub 2024 Mar 21.

MeSH Terms

Conditions

Kidney Failure, ChronicRenal Insufficiency

Condition Hierarchy (Ancestors)

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

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
SINGLE GROUP
Model Details: explanatory study using mixed method qualitative data analysed systematically by quantitative method (Q method)
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Medical doctor in nephrology

Study Record Dates

First Submitted

January 28, 2024

First Posted

January 23, 2026

Study Start

March 15, 2024

Primary Completion

September 15, 2025

Study Completion

December 30, 2025

Last Updated

January 23, 2026

Record last verified: 2026-01

Locations