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Empowering Patients on Choices for Renal Replacement Therapy (Aim 2)

Empowering Patients on Choices for Renal Replacement Therapy (Aim 2)

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02440659
Acronym
EPOCH-RRT
Enrollment
2946
Registered
2015-05-12
Start date
2015-02-28
Completion date
2015-12-31
Last updated
2017-05-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Kidney Disease

Keywords

Chronic Kidney Disease, Hemodialysis, Peritoneal Dialysis

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).

Interventions

None listed

Sponsors

University of Michigan
CollaboratorOTHER
Henry Ford Health System
CollaboratorOTHER
National Kidney Foundation, United States
CollaboratorOTHER
American Association of Kidney Patients
CollaboratorOTHER
Patient-Centered Outcomes Research Institute
CollaboratorOTHER
Arbor Research Collaborative for Health
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

Inclusion criteria

* 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).

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frameDescription
Patient's Quality of LifeBaseline% of patients very much or extremely affected by dialysis

Countries

United States

Participant flow

Participants by arm

ArmCount
Hemodialysis (HD)
Patients who have chronic kidney disease (CKD) and are currently on hemodialysis.
1,346
Peritoneal Dialysis (PD)
Patients who have chronic kidney disease (CKD) and are currently on peritoneal dialysis.
614
Total1,960

Baseline characteristics

CharacteristicTotalPeritoneal Dialysis (PD)Hemodialysis (HD)
Age, Continuous62.06 years
STANDARD_DEVIATION 14.66
59.90 years
STANDARD_DEVIATION 14.92
63.04 years
STANDARD_DEVIATION 14.44
Age, Customized
<=18 years
0 participants0 participants0 participants
Age, Customized
>=65 years
878 participants229 participants649 participants
Age, Customized
Between 18 and 65 years
1070 participants384 participants686 participants
Region of Enrollment
United States
1960 participants614 participants1346 participants
Sex/Gender, Customized
Female
853 participants282 participants571 participants
Sex/Gender, Customized
Male
1097 participants331 participants766 participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
— / —— / —
other
Total, other adverse events
0 / 00 / 0
serious
Total, serious adverse events
0 / 00 / 0

Outcome results

Primary

Patient's Quality of Life

% of patients very much or extremely affected by dialysis

Time frame: Baseline

ArmMeasureGroupValue (NUMBER)
Hemodialysis (HD)Patient's Quality of LifeRelying on myself34 % of patients
Hemodialysis (HD)Patient's Quality of LifeDoing what I want in my free time35 % of patients
Hemodialysis (HD)Patient's Quality of LifeSpending time with people I care about34 % of patients
Hemodialysis (HD)Patient's Quality of LifeDoing activities that I am interested in28 % of patients
Hemodialysis (HD)Patient's Quality of LifeTraveling out of town45 % of patients
Hemodialysis (HD)Patient's Quality of LifeMaintaining a normal lifestyle27 % of patients
Hemodialysis (HD)Patient's Quality of LifeManaging my daily schedule21 % of patients
Hemodialysis (HD)Patient's Quality of LifeKeeping up with chores26 % of patients
Hemodialysis (HD)Patient's Quality of LifeBeing energetic32 % of patients
Hemodialysis (HD)Patient's Quality of LifeExercising22 % of patients
Hemodialysis (HD)Patient's Quality of LifeMaintaining my weight23 % of patients
Hemodialysis (HD)Patient's Quality of LifeDrinking as much water as I want46 % of patients
Hemodialysis (HD)Patient's Quality of LifeEating what I like38 % of patients
Hemodialysis (HD)Patient's Quality of LifeFeeling healthy26 % of patients
Hemodialysis (HD)Patient's Quality of LifeFeeling attractive19 % of patients
Hemodialysis (HD)Patient's Quality of LifeGetting enough sleep26 % of patients
Peritoneal Dialysis (PD)Patient's Quality of LifeGetting enough sleep22 % of patients
Peritoneal Dialysis (PD)Patient's Quality of LifeRelying on myself38 % of patients
Peritoneal Dialysis (PD)Patient's Quality of LifeBeing energetic28 % of patients
Peritoneal Dialysis (PD)Patient's Quality of LifeDoing what I want in my free time27 % of patients
Peritoneal Dialysis (PD)Patient's Quality of LifeEating what I like24 % of patients
Peritoneal Dialysis (PD)Patient's Quality of LifeSpending time with people I care about21 % of patients
Peritoneal Dialysis (PD)Patient's Quality of LifeExercising20 % of patients
Peritoneal Dialysis (PD)Patient's Quality of LifeDoing activities that I am interested in21 % of patients
Peritoneal Dialysis (PD)Patient's Quality of LifeFeeling attractive17 % of patients
Peritoneal Dialysis (PD)Patient's Quality of LifeTraveling out of town42 % of patients
Peritoneal Dialysis (PD)Patient's Quality of LifeMaintaining my weight21 % of patients
Peritoneal Dialysis (PD)Patient's Quality of LifeMaintaining a normal lifestyle24 % of patients
Peritoneal Dialysis (PD)Patient's Quality of LifeFeeling healthy22 % of patients
Peritoneal Dialysis (PD)Patient's Quality of LifeManaging my daily schedule17 % of patients
Peritoneal Dialysis (PD)Patient's Quality of LifeDrinking as much water as I want24 % of patients
Peritoneal Dialysis (PD)Patient's Quality of LifeKeeping up with chores24 % of patients

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026