NCT01517841

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. 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
55

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Aug 2012

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 20, 2012

Completed
5 days until next milestone

First Posted

Study publicly available on registry

January 25, 2012

Completed
6 months until next milestone

Study Start

First participant enrolled

August 1, 2012

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2013

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2013

Completed
Last Updated

June 14, 2018

Status Verified

June 1, 2018

Enrollment Period

10 months

First QC Date

January 20, 2012

Last Update Submit

June 12, 2018

Conditions

Keywords

peritoneal dialysismodality choicekidney disease

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (1)

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 Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • All patients of age greater than or equal to 18 years at MHMC who are late stage CKD

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

MetroHealth Medical Center- Center for Reducing Health Disparities

Cleveland, Ohio, 44109, United States

Location

MeSH Terms

Conditions

Renal Insufficiency, ChronicKidney Diseases

Condition Hierarchy (Ancestors)

Renal InsufficiencyUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Suma Prakash, MD

    MetroHealth Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

January 20, 2012

First Posted

January 25, 2012

Study Start

August 1, 2012

Primary Completion

June 1, 2013

Study Completion

December 1, 2013

Last Updated

June 14, 2018

Record last verified: 2018-06

Locations