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Empowering Patients On Choices for Renal Replacement Therapy (Aim 1)

Empowering Patients On Choices for Renal Replacement Therapy (Aim 1)

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT01952600
Acronym
EPOCH-RRT
Enrollment
215
Registered
2013-09-30
Start date
2013-06-30
Completion date
2015-12-31
Last updated
2016-09-20

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

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.

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

Time perspective
PROSPECTIVE

Eligibility

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

Inclusion criteria

* 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.

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frameDescription
Factors That Are Most Important to PatientsBaselineDifferences in factors most important to patients were compared across chronic kidney disease, hemodialysis, and peritoneal dialysis patients.

Countries

United States

Participant flow

Participants by arm

ArmCount
Chronic Kidney Disease (CKD)
Patients who have advanced chronic kidney disease, but are not currently on either hemodialysis (HD) or peritoneal dialysis (PD).
65
Hemodialysis (HD)
Patients who have chronic kidney disease (CKD) and are currently on hemodialysis.
77
Peritoneal Dialysis (PD)
Patients who have chronic kidney disease (CKD) and are currently on peritoneal dialysis.
38
Total180

Baseline characteristics

CharacteristicHemodialysis (HD)Peritoneal Dialysis (PD)Chronic Kidney Disease (CKD)Total
Age, Categorical
<=18 years
0 Participants0 Participants0 Participants0 Participants
Age, Categorical
>=65 years
22 Participants7 Participants34 Participants63 Participants
Age, Categorical
Between 18 and 65 years
55 Participants31 Participants31 Participants117 Participants
Age, Continuous56.14 years
STANDARD_DEVIATION 16.65
50.37 years
STANDARD_DEVIATION 14.81
63.40 years
STANDARD_DEVIATION 56.14
57.54 years
STANDARD_DEVIATION 16.76
Region of Enrollment
United States
77 participants38 participants65 participants180 participants
Sex: Female, Male
Female
36 Participants20 Participants43 Participants99 Participants
Sex: Female, Male
Male
41 Participants18 Participants22 Participants81 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
EG002
affected / at risk
deaths
Total, all-cause mortality
— / —— / —— / —
other
Total, other adverse events
0 / 650 / 770 / 38
serious
Total, serious adverse events
0 / 650 / 770 / 38

Outcome results

Primary

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.

Time frame: Baseline

ArmMeasureGroupValue (NUMBER)
Chronic Kidney Disease (CKD)Factors That Are Most Important to PatientsKeeping as much independence as possible98 % of patients
Chronic Kidney Disease (CKD)Factors That Are Most Important to PatientsQuality and quantity of life100 % of patients
Chronic Kidney Disease (CKD)Factors That Are Most Important to PatientsFlexibility in daily schedule90 % of patients
Chronic Kidney Disease (CKD)Factors That Are Most Important to PatientsImportant to do dialysis at home67 % of patients
Chronic Kidney Disease (CKD)Factors That Are Most Important to PatientsPlanned schedule at dialysis center68 % of patients
Chronic Kidney Disease (CKD)Factors That Are Most Important to PatientsSafer to do dialysis at a medical place55 % of patients
Chronic Kidney Disease (CKD)Factors That Are Most Important to PatientsAbility to go to school and work43 % of patients
Chronic Kidney Disease (CKD)Factors That Are Most Important to PatientsConcern about the way you look43 % of patients
Chronic Kidney Disease (CKD)Factors That Are Most Important to PatientsSpending time with patients at dialysis center21 % of patients
Chronic Kidney Disease (CKD)Factors That Are Most Important to PatientsWorry about how dialysis will affect others43 % of patients
Hemodialysis (HD)Factors That Are Most Important to PatientsSpending time with patients at dialysis center52 % of patients
Hemodialysis (HD)Factors That Are Most Important to PatientsKeeping as much independence as possible93 % of patients
Hemodialysis (HD)Factors That Are Most Important to PatientsSafer to do dialysis at a medical place74 % of patients
Hemodialysis (HD)Factors That Are Most Important to PatientsPlanned schedule at dialysis center76 % of patients
Hemodialysis (HD)Factors That Are Most Important to PatientsQuality and quantity of life89 % of patients
Hemodialysis (HD)Factors That Are Most Important to PatientsWorry about how dialysis will affect others33 % of patients
Hemodialysis (HD)Factors That Are Most Important to PatientsConcern about the way you look32 % of patients
Hemodialysis (HD)Factors That Are Most Important to PatientsFlexibility in daily schedule0 % of patients
Hemodialysis (HD)Factors That Are Most Important to PatientsAbility to go to school and work0 % of patients
Hemodialysis (HD)Factors That Are Most Important to PatientsImportant to do dialysis at home0 % of patients
Peritoneal Dialysis (PD)Factors That Are Most Important to PatientsConcern about the way you look42 % of patients
Peritoneal Dialysis (PD)Factors That Are Most Important to PatientsImportant to do dialysis at home89 % of patients
Peritoneal Dialysis (PD)Factors That Are Most Important to PatientsPlanned schedule at dialysis center0 % of patients
Peritoneal Dialysis (PD)Factors That Are Most Important to PatientsSafer to do dialysis at a medical place0 % of patients
Peritoneal Dialysis (PD)Factors That Are Most Important to PatientsSpending time with patients at dialysis center0 % of patients
Peritoneal Dialysis (PD)Factors That Are Most Important to PatientsAbility to go to school and work71 % of patients
Peritoneal Dialysis (PD)Factors That Are Most Important to PatientsKeeping as much independence as possible97 % of patients
Peritoneal Dialysis (PD)Factors That Are Most Important to PatientsWorry about how dialysis will affect others29 % of patients
Peritoneal Dialysis (PD)Factors That Are Most Important to PatientsQuality and quantity of life92 % of patients
Peritoneal Dialysis (PD)Factors That Are Most Important to PatientsFlexibility in daily schedule94 % of patients

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