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Barriers to Peritoneal Dialysis Selection

The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2012 by MetroHealth Medical Center.
Recruitment status was  Not yet recruiting
Sponsor:
Information provided by (Responsible Party):
Suma Prakash, MD, MetroHealth Medical Center
ClinicalTrials.gov Identifier:
NCT01517841
First received: January 20, 2012
Last updated: January 24, 2012
Last verified: January 2012

January 20, 2012
January 24, 2012
January 2012
January 2013   (final data collection date for primary outcome measure)
Barriers to making a dialysis modality decision [ Time Frame: 1 year ] [ Designated as safety issue: No ]
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.
Same as current
Complete list of historical versions of study NCT01517841 on ClinicalTrials.gov Archive Site
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Barriers to Peritoneal Dialysis Selection
Barriers to Selection and Initiation of Peritoneal Dialysis in the United States

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.
Not Provided
Observational
Observational Model: Cohort
Time Perspective: Prospective
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Non-Probability Sample

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

Chronic Kidney Disease
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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.
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Not yet recruiting
180
April 2013
January 2013   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
United States
 
NCT01517841
IRB11-00542
No
Suma Prakash, MD, MetroHealth Medical Center
Suma Prakash, MD
Not Provided
Principal Investigator: Suma Prakash, MD MetroHealth Medical Center
MetroHealth Medical Center
January 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP