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iChoose Decision Kidney Aid for End-Stage Renal Disease Patients

iChoose Kidney Decision Aid for Treatment Options Among End-Stage Renal Disease (ESRD) Patients

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02235571
Enrollment
470
Registered
2014-09-10
Start date
2014-09-30
Completion date
2017-09-30
Last updated
2017-10-06

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

Conditions

End-Stage Kidney Disease, Kidney Failure, Chronic, Kidney Transplantation

Brief summary

The investigators developed iChoose Kidney -- a shared decision-making support tool accessible through iPad, iPhone, or the web -- to provide ESRD patients and their providers with a simple, standardized, easily accessible, statistically robust tool for use in the clinic to guide patient education and healthcare decision-making about treatment options of dialysis or kidney transplantation. The iChoose Kidney decision aid provides patients with estimates of their individualized 1 and 3-year risks of mortality on dialysis vs. transplantation, based on previous national data. The tool has the potential to improve communication and decision-making between patients and their healthcare providers and improve access to kidney transplantation among patients with ESRD. This will be a two-arm, randomized study, and will be conducted at 3 large transplant centers with diverse patient populations. One group of patients will receive standard education alone during their scheduled transplant evaluation. The second group will receive the standard education as well have the provider use the iChoose Kidney aid with them. The project timeline will be a total of 24 months inclusive of enrollment, follow-up, data analysis, and outcome evaluation. This study will assess how well the iChoose decision aid works in improving patient knowledge, preferences for treatment, and patient access to transplant. The study will also assess whether providers find the tool useful for providing ways to share information with patients about ways to treat their kidney disease.

Interventions

BEHAVIORALiChoose Kidney Decision Aid

Providers will use a shared decision making tool with patients via iPhone, iPad, or web which explains predicted individualized risk of mortality on dialysis vs. transplant during the evaluation appointment for kidney transplant.

Sponsors

Columbia University
CollaboratorOTHER
Northwestern University
CollaboratorOTHER
Satellite Healthcare
CollaboratorOTHER
Norman S. Coplon Extramural Grant Program
CollaboratorUNKNOWN
Emory University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

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

Inclusion criteria

* Diagnosis of end-stage renal disease (ESRD) and on dialysis for \< 1 year * English-speaking * Subjects coming in for transplant medical evaluation * Age \> 18 years

Exclusion criteria

* Severe cognitive or visual impairment

Design outcomes

Primary

MeasureTime frameDescription
Effectiveness of the iChoose Kidney intervention to improve knowledge and shared decision-making between patients and physicians regarding ESRD treatment options.Up to 19 monthsPatient knowledge of the survival benefit of transplant and the patient's individualized mortality risk

Secondary

MeasureTime frameDescription
Patient access to transplantUp to 19 monthsEvaluation completion, waitlisting, transplant

Other

MeasureTime frameDescription
Patient treatment preferencesUp to 19 monthsPatient preference for transplant vs. dialysis

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 7, 2026