Barriers to Peritoneal Dialysis Selection

Chronic Kidney Disease Clinical Trial

Official title:

Barriers to Selection and Initiation of Peritoneal Dialysis in the United States

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01517841
• Other study ID #: IRB11-00542
• Status: Completed
• Start date: August 2012
• Est. completion date: December 2013

Study information

• Verified date: June 2018
• Source: MetroHealth Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 55
• Est. completion date: December 2013
• Est. primary completion date: June 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Chronic Kidney Disease
• Kidney Diseases
• Renal Insufficiency, Chronic

Locations

Country	Name	City	State
United States	MetroHealth Medical Center- Center for Reducing Health Disparities	Cleveland	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
MetroHealth Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	1 year