Chronic Kidney DiseaseEPOCH-RRTNCT01952600
Empowering Patients On Choices for Renal Replacement Therapy (Aim 1)
An observational study of Chronic Kidney Disease, run by Arbor Research Collaborative for Health at 1 site in United States.
Trial summary
The EPOCH-RRT study seeks to fill knowledge gaps by gaining more understanding of chronic kidney disease (CKD) patients' priorities; assessing the comparative benefits of hemodialysis (HD) versus peritoneal dialysis (PD), with respect to these priorities; and providing tailored information to assist patients with… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Kidney Disease
- How many people
- 215 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2013to Dec 2015
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
Study population: Adult patients residing in the United States with advanced chronic kidney disease or on dialysis.
Who may be able to join
- Individuals 18 years of age or older.
- Individuals with advanced chronic kidney disease or on dialysis (in-center, hemodialysis, or peritoneal dialysis) for at least three months.
Who cannot join
- Individuals under 18 years of age.
- Individuals unable to provide informed consent.
- Individuals who do not have chronic kidney disease.
Trial locations and contacts
1 site in 1 country.
United States1 site
Arbor Research Collaborative for Health
Ann Arbor, Michigan, 48104
About this study
The EPOCH-RRT study seeks to fill knowledge gaps by gaining more understanding of chronic kidney disease (CKD) patients' priorities; assessing the comparative benefits of hemodialysis (HD) versus peritoneal dialysis (PD), with respect to these priorities; and providing tailored information to assist patients with identifying the best dialysis modality fit for their own unique circumstances and perspectives.
The outcomes most relevant to patients ("patient-centered") extend beyond those traditionally assessed in clinical research, with the relative importance varying across patient groups. A tailored decision aid based on these findings can improve patient decision-making processes regarding choice of dialysis modality.
Read the detailed description
Empowering Patients On Choices for Renal Replacement Therapy (EPOCH-RRT)study seeks to identify factors that matter the most to patients with kidney disease and study how they are impacted by different types of dialysis. The inclusion of patients, caregivers, and patient advocacy organizations as research partners will assure that the study addresses questions of greatest relevance to patients facing the need for dialysis.
Aim One of EPOCH-RRT identifies outcomes that are most important to different groups of advanced CKD and dialysis patients through qualitative methods applied for conducting in-depth interviews.
- Conditions
- Chronic Kidney Disease
- Keywords
- Chronic Kidney Disease, Hemodialysis, Peritoneal Dialysis
- Medical subject headings
- Renal Insufficiency, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Chronic Kidney Disease (CKD) | Patients who have advanced chronic kidney disease, but are not currently on either hemodialysis (HD) or peritoneal dialysis (PD). | |
| Hemodialysis (HD) | Patients who have chronic kidney disease (CKD) and are currently on hemodialysis. | |
| Peritoneal Dialysis (PD) | Patients who have chronic kidney disease (CKD) and are currently on peritoneal dialysis. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Factors That Are Most Important to Patients
Differences in factors most important to patients were compared across chronic kidney disease, hemodialysis, and peritoneal dialysis patients.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Sep 2013 (estimated)
- Study startJun 2013
- Primary completionDec 2013
- Study completionDec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Chronic Kidney DiseaseStudies of the same condition, open and under way.
- 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
- Observational
- Time perspective
- Prospective
- Enrolment
- 215 participants (actual)
Sponsor and investigators
- Lead sponsor
- Arbor Research Collaborative for Health
- Sponsor type
- University, hospital or other
- Collaborators
- University of Michigan, Henry Ford Health System, National Kidney Foundation, United States, American Association of Kidney Patients, Patient-Centered Outcomes Research Institute
- Responsible party
- Sponsor
- Investigators
- Francesca Tentori, MD, MS, Principal investigator, Arbor Research Collaborative for Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01952600
- Sponsor's protocol ID
- 110920130510
- Acronym
- EPOCH-RRT
- Status last verified
- Aug 2016
- First submitted
- 28 Jun 2013
- Last updated
- 20 Sep 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Empowering Patients On Choices for Renal Replacement Therapy (Aim 1)
- ClinicalTrials.gov ID
- NCT01952600
- Acronym / sponsor ID
- EPOCH-RRT / 110920130510
- Conditions
- Chronic Kidney Disease
- Keywords
- Chronic Kidney Disease, Hemodialysis, Peritoneal Dialysis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 215 participants (actual)
- Lead sponsor
- Arbor Research Collaborative for HealthUniversity, hospital or other
- Collaborators
- University of Michigan, Henry Ford Health System, National Kidney Foundation, United States, American Association of Kidney Patients, Patient-Centered Outcomes Research Institute
- Study start
- Jun 2013
- Primary completion
- Dec 2013 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 30 Sep 2013 (estimated)
- Results
- Posted 8 Aug 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The EPOCH-RRT study seeks to fill knowledge gaps by gaining more understanding of chronic kidney disease (CKD) patients' priorities; assessing the comparative benefits of hemodialysis (HD) versus peritoneal dialysis (PD), with respect to these priorities; and providing tailored information to assist patients with identifying the best dialysis modality fit for their own unique circumstances and perspectives.
The outcomes most relevant to patients ("patient-centered") extend beyond those traditionally assessed in clinical research, with the relative importance varying across patient groups. A tailored decision aid based on these findings can improve patient decision-making processes regarding choice of dialysis modality.
Detailed description
Empowering Patients On Choices for Renal Replacement Therapy (EPOCH-RRT)study seeks to identify factors that matter the most to patients with kidney disease and study how they are impacted by different types of dialysis. The inclusion of patients, caregivers, and patient advocacy organizations as research partners will assure that the study addresses questions of greatest relevance to patients facing the need for dialysis.
Aim One of EPOCH-RRT identifies outcomes that are most important to different groups of advanced CKD and dialysis patients through qualitative methods applied for conducting in-depth interviews.
Study design
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Chronic Kidney Disease (CKD) | – | –Patients who have advanced chronic kidney disease, but are not currently on either hemodialysis (HD) or peritoneal dialysis (PD). |
| Hemodialysis (HD) | – | –Patients who have chronic kidney disease (CKD) and are currently on hemodialysis. |
| Peritoneal Dialysis (PD) | – | –Patients who have chronic kidney disease (CKD) and are currently on peritoneal dialysis. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients residing in the United States with advanced chronic kidney disease or on dialysis.
Key inclusion criteria (2 listed)
- Individuals 18 years of age or older.
- Individuals with advanced chronic kidney disease or on dialysis (in-center, hemodialysis, or peritoneal dialysis) for at least three months.
Key exclusion criteria (3 listed)
- Individuals under 18 years of age.
- Individuals unable to provide informed consent.
- Individuals who do not have chronic kidney disease.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Factors That Are Most Important to Patients
Time frame: Baseline
Differences in factors most important to patients were compared across chronic kidney disease, hemodialysis, and peritoneal dialysis patients.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Sep 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Arbor Research Collaborative for Health is committed to improving patient care through research that shapes medical policies and practice.Link provided by the sponsor.
- The University of Michigan Division of Nephrology is internationally recognized for its excellence in clinical care, rich educational offerings, and diverse research programs.Link provided by the sponsor.
- University of Michigan Center for Managing Chronic Disease aims to build the capacity for effective chronic disease prevention and management.Link provided by the sponsor.
- The National Kidney Foundation is a voluntary nonprofit health organization dedicated to preventing kidney disease.Link provided by the sponsor.
- The American Association of Kidney Patients is dedicated to improving the lives of kidney patients and their families by helping them deal with the physical, emotional, and social impact of kidney disease.Link provided by the sponsor.
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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.
Francesca Tentori, MD, MS principal investigator
Arbor Research Collaborative for Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Kidney Disease, run by Arbor Research Collaborative for Health at 1 site 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 2 inclusion and 3 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 20 Sep 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Yes. Results are posted in the registry (first posted 8 Aug 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Factors That Are Most Important to Patients (time frame: Baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 20 Sep 2016.