Text Size

Barriers to Peritoneal Dialysis Selection

This study is not yet open for participant recruitment.
Verified January 2012 by MetroHealth Medical Center
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
History of Changes
  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:

U.S. FDA Resources

Further study details as provided by MetroHealth Medical Center:

Primary Outcome Measures:
  • 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.


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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Suma Prakash, MD, Dr. Suma Prakash, MetroHealth Medical Center
ClinicalTrials.gov Identifier: NCT01517841     History of Changes
Other Study ID Numbers: IRB11-00542
Study First Received: January 20, 2012
Last Updated: January 24, 2012
Health Authority: United States: Institutional Review Board

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

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

ClinicalTrials.gov processed this record on May 23, 2013