Chronic Kidney DiseaseEPOCH-RRTNCT02440659
Empowering Patients on Choices for Renal Replacement Therapy (Aim 2)
An observational study of Chronic Kidney Disease, run by Arbor Research Collaborative for Health at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Chronic Kidney Disease
- How many people
- 2,946 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2015to 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
- Healthy volunteers accepted
- Adult, Older adult
Study population: Adult patients currently consented in the Dialysis Outcomes and Practice Patterns Study (DOPPS) or the Peritoneal Outcomes and Practice Patterns Study (PDOPPS).
Who may be able to join
- Individuals 18 years of age or older.
- Currently consented in the Dialysis Outcomes and Practice Patterns Study - (DOPPS) or the Peritoneal Outcomes and Practice Patterns Study (PDOPPS).
Who cannot join
- Individuals under 18 years of age.
- Individuals unable to provide informed consent.
Trial locations and contacts
1 site in 1 country.
United States1 site
Arbor Research Collaborative for Health
Ann Arbor, Michigan, 48104
About this study
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 two is based on preliminary results of Aim one interviews, and in collaboration with the Patient Advisory Panel, the investigators developed a brief questionnaire to be administered to participants in the Dialysis Outcomes and Practice Patterns Study (DOPPS) and Peritoneal Dialysis Outcomes and Practice Patterns Study (PDOPPS). Two separate versions of the questionnaire were created to reflect unique aspects of in-center hemodialysis (HD) and peritoneal dialysis (PD).
- 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 |
|---|---|---|
| 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.
Patient's Quality of Life
% of patients very much or extremely affected by dialysis
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2015 (estimated)
- Study startFeb 2015
- Primary completionAug 2015
- 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
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 2,946 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
- NCT02440659
- Sponsor's protocol ID
- 1109201303132
- Acronym
- EPOCH-RRT
- Status last verified
- Apr 2017
- First submitted
- 9 Apr 2015
- Last updated
- 10 May 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Empowering Patients on Choices for Renal Replacement Therapy (Aim 2)
- ClinicalTrials.gov ID
- NCT02440659
- Acronym / sponsor ID
- EPOCH-RRT / 1109201303132
- Conditions
- Chronic Kidney Disease
- Keywords
- Chronic Kidney Disease, Hemodialysis, Peritoneal Dialysis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 2,946 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
- Feb 2015
- Primary completion
- Aug 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 12 May 2015 (estimated)
- Results
- Posted 4 Oct 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 two is based on preliminary results of Aim one interviews, and in collaboration with the Patient Advisory Panel, the investigators developed a brief questionnaire to be administered to participants in the Dialysis Outcomes and Practice Patterns Study (DOPPS) and Peritoneal Dialysis Outcomes and Practice Patterns Study (PDOPPS). Two separate versions of the questionnaire were created to reflect unique aspects of in-center hemodialysis (HD) and peritoneal dialysis (PD).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients currently consented in the Dialysis Outcomes and Practice Patterns Study (DOPPS) or the Peritoneal Outcomes and Practice Patterns Study (PDOPPS).
Key inclusion criteria (2 listed)
- Individuals 18 years of age or older.
- Currently consented in the Dialysis Outcomes and Practice Patterns Study - (DOPPS) or the Peritoneal Outcomes and Practice Patterns Study (PDOPPS).
Key exclusion criteria (2 listed)
- Individuals under 18 years of age.
- Individuals unable to provide informed consent.
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
Patient's Quality of Life
Time frame: Baseline
% of patients very much or extremely affected by dialysis
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 May 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related trials for Chronic Kidney Disease
Active, not recruitingPhase 2
Safety and Efficacy of Empagliflozin in Hemodialysis
End Stage Renal Disease
RecruitingPhase 3
Study to Assess the Efficacy, Pharmacokinetics, Safety and Tolerability of Atrasentan in Pediatric Patients With Primary IgAN
Berger Disease, Bergers Disease
Recruiting
Investigating Vascular Properties of HEMI and SPG Signals in Individuals With or at Risk for Chronic Kidney Disease
Chronic Kidney Disease, Hypertension (HTN)
Not yet recruiting
Hypothermic Kidney Machine Perfusion With Omnisol
End Stage Renal Disease (ESRD), Kidney Transplant
Not yet recruiting
An Individuation Intervention to Reduce Socioeconomic Disparities in Chronic Kidney Disease Care
Chronic Kidney Diseases
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 2 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 10 May 2017. 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 4 Oct 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?
Patient's Quality of Life (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 10 May 2017.