NCT02440659

Brief 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. 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).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
2,946

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Feb 2015

Shorter than P25 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

February 1, 2015

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

April 9, 2015

Completed
1 month until next milestone

First Posted

Study publicly available on registry

May 12, 2015

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2015

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2015

Completed
10 months until next milestone

Results Posted

Study results publicly available

October 4, 2016

Completed
Last Updated

May 10, 2017

Status Verified

April 1, 2017

Enrollment Period

6 months

First QC Date

April 9, 2015

Results QC Date

June 24, 2016

Last Update Submit

April 4, 2017

Conditions

Keywords

Chronic Kidney DiseaseHemodialysisPeritoneal Dialysis

Outcome Measures

Primary Outcomes (1)

  • Patient's Quality of Life

    % of patients very much or extremely affected by dialysis

    Baseline

Study Arms (2)

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 VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Adult patients currently consented in the Dialysis Outcomes and Practice Patterns Study (DOPPS) or the Peritoneal Outcomes and Practice Patterns Study (PDOPPS).

You may qualify if:

  • 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).

You may not qualify if:

  • Individuals under 18 years of age.
  • Individuals unable to provide informed consent.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Arbor Research Collaborative for Health

Ann Arbor, Michigan, 48104, United States

Location

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
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
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 9, 2015

First Posted

May 12, 2015

Study Start

February 1, 2015

Primary Completion

August 1, 2015

Study Completion

December 1, 2015

Last Updated

May 10, 2017

Results First Posted

October 4, 2016

Record last verified: 2017-04

Locations