Rates of Hospitalization in Home Care Assisted Peritoneal Dialysis

February 6, 2009 updated by: Sunnybrook Health Sciences Centre

Home Care Assisted Peritoneal Dialysis: The Impact of Expanding Eligibility for Peritoneal Dialysis on Rates of Hospitalization

We have developed and implemented a program that offers home care assistance to patients wishing to perform home peritoneal dialysis, but are unable to do it for themselves. This study is being conducted to ensure the safety of this dialysis program and specifically, to see if the risk of being hospitalized is increased when this therapy is provided to patients.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

The cost of caring for patients with kidney failure is growing at an alarming rate and accounts for up to 7% of health care expenditures in developed countries. The majority of the cost is due to in-centre hemodialysis (HD) because of high operating costs and the capital investment required to build new dialysis units. In recent years, there has been a shortage of in-centre HD beds and it has become a priority to increase the number of patients being treated in their place of residence with therapies like peritoneal dialysis (PD). Unfortunately, many patients are unable to perform their own dialysis at home, a trend that will become more and more common as the population ages. We developed and implemented a program of home care assisted PD at Sunnybrook Health Sciences Centre where health care workers go into the home to assist patients with their treatment. The program has been a success and has garnered national attention. As a result, it has been adopted province-wide as part of the "Provincial PD Joint Initiative" and the Manitoba Renal Program is currently implementing a similar program to increase the use of PD.

However, based on preliminary data, we are concerned that patients treated with home care assisted PD may have higher rates of hospitalization when compared to traditional forms of treatment (23.5 days per year of follow-up compared to 13 days per year of follow-up. If this is true it could have a significant impact on patient quality-of-life, cost-savings associated with PD, and resource allocation and planning in regional dialysis programs. This is of particular concern given that the provincial initiative has a goal of increasing the proportion of patients being treated with PD from the current 18% to 30% by 2010.

The primary objective of this study is to determine if patients treated with home care assisted peritoneal dialysis are more likely to be hospitalized when compared to those treated with in-centre hemodialysis.

The secondary objective of this study is to compare the occurrence of important outcome events including the need for access-related procedures, technique survival, and death in patients on home care assisted peritoneal dialysis compared to in-centre hemodialysis.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Ontario
      • Toronto, Ontario, Canada, M4N 3M5
        • Sunnybrook Health Sciences Centre

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. 18 years of age or older
  2. End-stage kidney disease in the opinion of the attending nephrologist
  3. Deemed eligible for both home assisted PD and traditional in-centre HD following a multidisciplinary assessment, regardless of what therapy is chosen

Exclusion Criteria:

  1. History of kidney transplant or expected to receive a transplant in the next 3 months
  2. Expected to transfer to another regional dialysis program following the initiation of dialysis

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Time Perspectives: Prospective

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Sunnybrook Health Sciences Centre

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
London Health Sciences Centre

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Robert R Quinn, MD, Sunnybrook Health Sciences Centre
  • Principal Investigator: Matthew J Oliver, MD, MHS, Sunnybrook Health Sciences Centre

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 1, 2007

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 1, 2009

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 1, 2009

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 9, 2007

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 9, 2007

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 11, 2007

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 9, 2009

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 6, 2009

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2007

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 07-22

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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