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Developing Tools for Dialysis Decision Support

Developing Tools for Dialysis Decision Support

Status
Active, not recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06597279
Enrollment
25
Registered
2024-09-19
Start date
2024-11-21
Completion date
2026-09-30
Last updated
2025-08-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Kidney Diseases

Brief summary

The aim of this study is to evaluate the impact of a web-based dialysis decision support tool on decisional conflict, and values-treatment concordance and other decisional outcomes in individuals with advanced chronic kidney disease, and to assess the tool's acceptability and usability.

Detailed description

This study employs a pre-post design to assess the impact of a web-based dialysis decision support tool on patients with advanced chronic kidney disease and their caregivers. Participants will complete baseline surveys assessing demographics, knowledge of kidney failure treatments, and decisional conflict during a nephrology clinic visit. Following the visit, participants will access the decision support tool, with follow-up support provided by the study coordinator. One to four weeks after the baseline visit, participants will complete follow-up surveys to re-evaluate knowledge, decisional conflict, values-treatment concordance, and the quality of shared decision-making. Additionally, telephone interviews will be conducted to explore participants' understanding of treatment options and gather feedback on the decision support tool.

Interventions

BEHAVIORALWeb-based dialysis decision support tool

The intervention in this study is the Kidney Care Roadmap, a web-based dialysis decision support tool designed to assist patients with advanced chronic kidney disease and their caregivers.

Sponsors

VA Palo Alto Health Care System
Lead SponsorFED

Study design

Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE

Intervention model description

This is a non-randomized controlled trial using historical control as a comparator. It involves comparing outcomes from a group of participants receiving the current intervention with outcomes from a previously treated group (historical control) that did not receive the intervention.

Eligibility

Sex/Gender
ALL
Age
65 Years to No maximum
Healthy volunteers
No

Inclusion criteria

1. Age >=65 2. Estimated GFR <25 ml/min/1.73m2 3. English speaking 4. Not a candidate for kidney transplant based on nephrologist assessment. Family/caregiver inclusion criteria: 1. age >=21 2. English speaking

Exclusion criteria

a. Patients with cognitive impairment will be excluded; however their family member or caregiver is eligible to participate.

Design outcomes

Primary

MeasureTime frameDescription
Treatment choice1 monthProportion of patients who are undecided about treatment choice.
Values treatment concordance1 monthChange in values treatment concordance.
Confidence in treatment decision1 monthConfidence in kidney failure treatment decision
Decisional Conflict Scale (DCS)1 monthChange in the decisional conflict scale (DCS) score from baseline to follow-up. Scores range from 0 \[no decisional conflict\] to 100 \[extremely high decisional conflict\].

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026