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CompletedNCT01517841Updated Jun 14, 2018

Barriers to Peritoneal Dialysis Selection

An observational study in Chronic Kidney Disease, sponsored by MetroHealth Medical Center. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2018-06-14.

Sponsored by MetroHealth Medical Center · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
55
Ages
18 Years and older
Sex
All
01

Study summary

The purpose of this study is to understand what prevents chronic kidney disease patients from making a timely decision about dialysis modality options. This understanding will allow us to develop and implement interventions to assist patients in this turning point so that they can make the right decision for them in a timely enough manner so that each patient can start dialysis in the safest and best way for them. 200 later stage chronic kidney disease patients (20% or less of kidney function remaining) will be asked to participate in the study with the goal of having 150 patients participate in the study.

Hypotheses:

  1. 50 % of patients will have made a modality decision when interviewed and patients in the action stage of behavior will be more likely to make a modality selection than patients in earlier stages of behavior change. Barriers to modality selection will act at several levels including patient, provider and health system level and will vary by behavioral stage of change
  2. 10-15% of patients might choose home dialysis. Knowledge, self efficacy in terms of CKD, education, and income will likely be barriers to home dialysis choice.
02

Conditions studied

  • Chronic Kidney Disease

Keywords

  • peritoneal dialysis
  • modality choice
  • kidney disease
03

In context

Kidney Diseases

3,840 studies on the registry are indexed under Kidney Diseases; 500 are open to participants now.

This study's enrollment of 55 is below the median of 192 across 1,033 observational studies indexed under Kidney Diseases.

Browse Kidney Diseases studies →

Lead sponsor

MetroHealth Medical Center is the lead sponsor of 101 studies on the registry; 19 are open to participants now.

Of its 12 completed or terminated interventional studies of FDA-regulated products, 7 (58%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

The study population will consist of patients with late stage CKD and ESRD patients who are cared for by nephrologists at MetroHealth Medical Center.

Inclusion criteria

  • All patients of age greater than or equal to 18 years at MHMC who are late stage CKD

Exclusion criteria

Exclusion Criteria:

  • Patients who have acute renal failure and then recover renal function to levels of eGFR (estimated glomerular filtration rate) 20 mL/min/1.73m2 and in whom the nephrologist feels will not progress to ESRD in 2 years
  • Patients who are not candidates for peritoneal dialysis
  • Pregnant women
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
55 participants (actual)

Groups and cohorts

  • Chronic kidney disease

    Patients with chronic kidney disease (20% or less kidney function remaining. Patients with end stage renal disease who are currently receiving dialysis.

06

What researchers measure

Primary outcomes

  1. Barriers to making a dialysis modality decision

    Determine the proportion of patients that made a dialysis modality decision and determine the barriers to being able to make a decision. Determine the proportion of patients choosing home dialysis and barriers associated with choice of home dialysis therapy.

    Time frame: 1 year

07

Study locations

1 site
  • MetroHealth Medical Center- Center for Reducing Health Disparities
    Cleveland, Ohio 44109, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 14, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01517841
Lead sponsor
MetroHealth Medical Center
Responsible party
Ash Sehgal (Professor, MetroHealth Medical Center) — Principal investigator
First posted
Jan 25, 2012
Start date
Aug 2012
Primary completion
Jun 2013
Completion
Dec 2013
Last update
Jun 14, 2018

Study contacts

Suma Prakash, MD
principal investigator · MetroHealth Medical Center

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jun 2018. You cannot join it, but the record below documents what was studied.

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