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Barriers to Peritoneal Dialysis Selection

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ClinicalTrials.gov Identifier: NCT01517841
Recruitment Status : Completed
First Posted : January 25, 2012
Last Update Posted : June 14, 2018
Sponsor:
Information provided by (Responsible Party):
Ash Sehgal, MetroHealth Medical Center

Brief 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.

Condition or disease
Chronic Kidney Disease

Study Type : Observational
Actual Enrollment : 55 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Barriers to Selection and Initiation of Peritoneal Dialysis in the United States
Actual Study Start Date : August 2012
Actual Primary Completion Date : June 2013
Actual Study Completion Date : December 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Kidney Diseases

Group/Cohort
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.



Primary Outcome Measures :
  1. Barriers to making a dialysis modality decision [ Time Frame: 1 year ]
    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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   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.
Criteria

Inclusion Criteria:

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

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01517841


Locations
United States, Ohio
MetroHealth Medical Center- Center for Reducing Health Disparities
Cleveland, Ohio, United States, 44109
Sponsors and Collaborators
MetroHealth Medical Center
Investigators
Principal Investigator: Suma Prakash, MD MetroHealth Medical Center

Responsible Party: Ash Sehgal, Professor, MetroHealth Medical Center
ClinicalTrials.gov Identifier: NCT01517841     History of Changes
Other Study ID Numbers: IRB11-00542
First Posted: January 25, 2012    Key Record Dates
Last Update Posted: June 14, 2018
Last Verified: June 2018

Keywords provided by Ash Sehgal, MetroHealth Medical Center:
peritoneal dialysis
modality choice
kidney disease

Additional relevant MeSH terms:
Kidney Diseases
Renal Insufficiency, Chronic
Urologic Diseases
Renal Insufficiency