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Barriers to Peritoneal Dialysis Selection

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified January 2012 by Suma Prakash, MD, MetroHealth Medical Center.
Recruitment status was:  Not yet recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01517841
First Posted: January 25, 2012
Last Update Posted: January 25, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Suma Prakash, MD, MetroHealth Medical Center
  Purpose

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
Chronic Kidney Disease

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Barriers to Selection and Initiation of Peritoneal Dialysis in the United States

Resource links provided by NLM:


Further study details as provided by Suma Prakash, MD, MetroHealth Medical Center:

Primary Outcome Measures:
  • 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.


Estimated Enrollment: 180
Study Start Date: January 2012
Estimated Study Completion Date: April 2013
Estimated Primary Completion Date: January 2013 (Final data collection date for primary outcome measure)
Groups/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.

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
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
  Contacts and Locations
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 Not yet recruiting
Cleveland, Ohio, United States, 44109
Contact: Anna McGrail       amcgrail@metrohealth.org   
Sponsors and Collaborators
Suma Prakash, MD
Investigators
Principal Investigator: Suma Prakash, MD MetroHealth Medical Center
  More Information

Responsible Party: Suma Prakash, MD, Dr. Suma Prakash, MetroHealth Medical Center
ClinicalTrials.gov Identifier: NCT01517841     History of Changes
Other Study ID Numbers: IRB11-00542
First Submitted: January 20, 2012
First Posted: January 25, 2012
Last Update Posted: January 25, 2012
Last Verified: January 2012

Keywords provided by Suma Prakash, MD, MetroHealth Medical Center:
peritoneal dialysis
modality choice
kidney disease

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