NCT01952600

Brief 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 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
215

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jun 2013

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2013

Completed
27 days until next milestone

First Submitted

Initial submission to the registry

June 28, 2013

Completed
3 months until next milestone

First Posted

Study publicly available on registry

September 30, 2013

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2013

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2015

Completed
8 months until next milestone

Results Posted

Study results publicly available

August 8, 2016

Completed
Last Updated

September 20, 2016

Status Verified

August 1, 2016

Enrollment Period

6 months

First QC Date

June 28, 2013

Results QC Date

June 24, 2016

Last Update Submit

August 10, 2016

Conditions

Keywords

Chronic Kidney DiseaseHemodialysisPeritoneal Dialysis

Outcome Measures

Primary Outcomes (1)

  • 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.

    Baseline

Study Arms (3)

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.

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Adult patients residing in the United States with advanced chronic kidney disease or on dialysis.

You may qualify if:

  • 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.

You may not qualify if:

  • Individuals under 18 years of age.
  • Individuals unable to provide informed consent.
  • Individuals who do not have chronic kidney disease.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Arbor Research Collaborative for Health

Ann Arbor, Michigan, 48104, United States

Location

Related Links

MeSH Terms

Conditions

Renal Insufficiency, Chronic

Condition Hierarchy (Ancestors)

Renal InsufficiencyKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Results Point of Contact

Title
Dr. Francesca Tentori
Organization
Arbor Research Collaborative for Health

Study Officials

  • Francesca Tentori, MD, MS

    Arbor Research Collaborative for Health

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
observational
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 28, 2013

First Posted

September 30, 2013

Study Start

June 1, 2013

Primary Completion

December 1, 2013

Study Completion

December 1, 2015

Last Updated

September 20, 2016

Results First Posted

August 8, 2016

Record last verified: 2016-08

Locations