Barriers to Peritoneal Dialysis Selection

Sponsor
MetroHealth Medical Center (Other)
Overall Status
Completed
CT.gov ID
NCT01517841
Collaborator
(none)
55
1
16
3.4

Study Details

Study Description

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 Intervention/Treatment Phase

    Study Design

    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 :
    Aug 1, 2012
    Actual Primary Completion Date :
    Jun 1, 2013
    Actual Study Completion Date :
    Dec 1, 2013

    Arms and Interventions

    Arm Intervention/Treatment
    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.

    Outcome Measures

    Primary Outcome Measures

    1. Barriers to making a dialysis modality decision [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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Locations

    Site City State Country Postal Code
    1 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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Ash Sehgal, Professor, MetroHealth Medical Center
    ClinicalTrials.gov Identifier:
    NCT01517841
    Other Study ID Numbers:
    • IRB11-00542
    First Posted:
    Jan 25, 2012
    Last Update Posted:
    Jun 14, 2018
    Last Verified:
    Jun 1, 2018
    Keywords provided by Ash Sehgal, Professor, MetroHealth Medical Center
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Jun 14, 2018