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Trial record 1 of 1 for:    NCT02235571
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iChoose Decision Kidney Aid for End-Stage Renal Disease Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02235571
Recruitment Status : Completed
First Posted : September 10, 2014
Last Update Posted : October 6, 2017
Sponsor:
Collaborators:
Columbia University
Northwestern University
Satellite Healthcare
Norman S. Coplon Extramural Grant Program
Information provided by (Responsible Party):
Rachel Patzer, PhD, Emory University

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.


Condition or disease Intervention/treatment Phase
End-Stage Kidney Disease Kidney Failure, Chronic Kidney Transplantation Behavioral: iChoose Kidney Decision Aid Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 470 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: iChoose Kidney Decision Aid for Treatment Options Among End-Stage Renal Disease (ESRD) Patients
Study Start Date : September 2014
Actual Primary Completion Date : September 2017
Actual Study Completion Date : September 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
No Intervention: Control
These subjects are receiving standard patient education
Experimental: iChoose Kidney Decision Aid
These subjects receive iChoose Kidney Decision Aid along with standard patient education
Behavioral: iChoose 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.




Primary Outcome Measures :
  1. Effectiveness of the iChoose Kidney intervention to improve knowledge and shared decision-making between patients and physicians regarding ESRD treatment options. [ Time Frame: Up to 19 months ]
    Patient knowledge of the survival benefit of transplant and the patient's individualized mortality risk


Secondary Outcome Measures :
  1. Patient access to transplant [ Time Frame: Up to 19 months ]
    Evaluation completion, waitlisting, transplant


Other Outcome Measures:
  1. Patient treatment preferences [ Time Frame: Up to 19 months ]
    Patient preference for transplant vs. dialysis



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02235571


Locations
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United States, Georgia
Emory Transplant Center
Atlanta, Georgia, United States, 30322
United States, Illinois
Northwestern University (Kovler Transplant Center)
Chicago, Illinois, United States
United States, New York
Columbia University Medical Center
New York, New York, United States
Sponsors and Collaborators
Emory University
Columbia University
Northwestern University
Satellite Healthcare
Norman S. Coplon Extramural Grant Program
Investigators
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Principal Investigator: Rachel Patzer, PhD, MPH Emory University
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Rachel Patzer, PhD, Assistant Professor, Emory University
ClinicalTrials.gov Identifier: NCT02235571    
Other Study ID Numbers: IRB00076067
First Posted: September 10, 2014    Key Record Dates
Last Update Posted: October 6, 2017
Last Verified: October 2017
Additional relevant MeSH terms:
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Kidney Diseases
Kidney Failure, Chronic
Renal Insufficiency
Urologic Diseases
Renal Insufficiency, Chronic