End-Stage Kidney DiseaseNCT02235571
iChoose Decision Kidney Aid for End-Stage Renal Disease Patients
A study testing iChoose Kidney Decision Aid in people with End-Stage Kidney Disease and Kidney Failure, Chronic, run by Emory University at 3 sites in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- End-Stage Kidney Disease, Kidney Failure, Chronic, Kidney Transplantation
- What is being tested?
- iChoose Kidney Decision Aid
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 470 participants
- Where
- 3 sitesUnited States
- Study dates
- Sep 2014to Sep 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Severe cognitive or visual impairment
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Emory Transplant Center
Atlanta, Georgia, 30322
Northwestern University (Kovler Transplant Center)
Chicago, Illinois
Columbia University Medical Center
New York, New York
About this study
Official title: iChoose Kidney Decision Aid for Treatment Options Among End-Stage Renal Disease (ESRD) Patients
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.
- Being tested
- iChoose Kidney Decision Aid
- Medical subject headings
- Kidney Failure, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
iChoose Kidney Decision AidBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Control | No intervention | These subjects are receiving standard patient education |
| iChoose Kidney Decision Aid | Experimental | These subjects receive iChoose Kidney Decision Aid along with standard patient education Receives: Behavioral: iChoose Kidney Decision Aid |
What is being measured
The primary outcome is the main question the study is designed to answer.
Effectiveness of the iChoose Kidney intervention to improve knowledge and shared decision-making between patients and physicians regarding ESRD treatment options.
Patient knowledge of the survival benefit of transplant and the patient's individualized mortality risk
Measured: Up to 19 months
Secondary outcomes (1)
Patient access to transplant
Evaluation completion, waitlisting, transplant
Measured: Up to 19 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Sep 2014 (estimated)
- Study startSep 2014
- Primary completionSep 2017
- Study completionSep 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for End-Stage Kidney DiseaseStudies of the same condition, open and under way.
- More trials run by Emory UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 470 participants (actual)
Sponsor and investigators
- Lead sponsor
- Emory University
- Sponsor type
- University, hospital or other
- Collaborators
- Columbia University, Northwestern University, Satellite Healthcare, Norman S. Coplon Extramural Grant Program
- Responsible party
- Principal investigator, Rachel Patzer, PhD, Emory University
- Investigators
- Rachel Patzer, PhD, MPH, Principal investigator, Emory University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02235571
- Sponsor's protocol ID
- IRB00076067
- Status last verified
- Oct 2017
- First submitted
- 6 Sep 2014
- Last updated
- 6 Oct 2017
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Patzer RE, McPherson L, Basu M, Mohan S, Wolf M, Chiles M, Russell A, Gander JC, Friedewald JJ, Ladner D, Larsen CP, Pearson T, Pastan S. Effect of the iChoose Kidney decision aid in improving knowledge about treatment options among transplant candidates: A randomized controlled trial. Am J Transplant. 2018 Aug;18(8):1954-1965. doi: 10.1111/ajt.14693. Epub 2018 Mar 26.
PubMed 29446209
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- iChoose Kidney Decision Aid for Treatment Options Among End-Stage Renal Disease (ESRD) Patients
- ClinicalTrials.gov ID
- NCT02235571
- Acronym / sponsor ID
- IRB00076067
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 470 participants (actual)
- Lead sponsor
- Emory UniversityUniversity, hospital or other
- Collaborators
- Columbia University, Northwestern University, Satellite Healthcare, Norman S. Coplon Extramural Grant Program
- Study start
- Sep 2014
- Primary completion
- Sep 2017 (actual)
- Study completion
- Sep 2017 (actual)
- First posted
- 10 Sep 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | –These subjects are receiving standard patient education |
| iChoose Kidney Decision Aid | Experimental | Behavioral: iChoose Kidney Decision AidThese subjects receive iChoose Kidney Decision Aid along with standard patient education |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (1 listed)
- Severe cognitive or visual impairment
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| iChoose Kidney Decision AidProviders 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. | Behavioural | iChoose Kidney Decision Aid |
Primary outcome
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
1 secondary outcome
Patient access to transplant
Time frame: Up to 19 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Oct 2017.
- Derived from this study: PubMed 29446209Patzer RE, McPherson L, Basu M, Mohan S, Wolf M, Chiles M, Russell A, Gander JC, Friedewald JJ, Ladner D, Larsen CP, Pearson T, Pastan S. Effect of the iChoose Kidney decision aid in improving knowledge about treatment options among transplant candidates: A randomized controlled trial. Am J Transplant. 2018 Aug;18(8):1954-1965. doi: 10.1111/ajt.14693. Epub 2018 Mar 26.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rachel Patzer, PhD, MPH principal investigator
Emory University
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing iChoose Kidney Decision Aid in people with End-Stage Kidney Disease and Kidney Failure, Chronic, run by Emory University at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Oct 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02235571, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Oct 2017.