Healthy Transitions in Late Stage Kidney Disease

January 3, 2017 updated by: Steven Fishbane, Northwell Health

An Open Label Randomized Controlled Study to Compare the Impact of Patient Centered Nursing Services in Addition to a Nephrologist's Usual Patient Care With Usual Nephrologist's Care in Late Stage Chronic Kidney Disease Patients.

Improve health and outcome for people with late stage chronic kidney disease by providing patient centered nursing services in addition to a Nephrologist's routine patient care.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

130

Phase

  • Not Applicable

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

  • United States
    • New York
      • Great Neck, New York, United States, 11021
        • Division of Kidney Diseases and Hypertension

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

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Stage 4-5 Chronic Kidney Disease (CKD), defined as estimated glomerular filtration rate (eGFR) between 0-30 ml/minute
  • 18 years of age or older

Exclusion Criteria:

  • Cognitive impairment that is clinically apparent

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

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Healthy Transitions Group
  • Additional nursing services will be provided to this group in addition to a usual care by Nephrologist.
  • Daily weight measurement and monitoring
  • Medication review
  • Universal dietary education
  • Focused advanced directive program
  • Countdown to fistula program
Other: Education
Additional education will be provided by nurses to improve communication and reduce fragmentation of care.
Other: Daily weight measurement and monitoring
Monitor weight to avoid problems related to hypervolemia.
Other: Universal Dietary education
To improve diet and health
Other: Medication review
Medication will be reviewed by nurses to detect any discrepancies to reduce medication error.
Other: Focused advanced directive program
Education will be provided to increase awareness and encourage patients to have advanced directive.
Other: Countdown to fistula program
To reduce the number of patients starting dialysis with catheter in place, comprehensive stepwise intervention will be provided by nurses to ensure arterio-venous (AV) fistula placement in all appropriate patients, with coordinated follow up and failure recovery processes.
No Intervention: Usual Care Group
Usual care by nephrologist. No additional nursing support services will be provide to this group.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Hospitalization rate
Time Frame: 18 months
Reduction in hospitalization rate in intervention group as compare to control group.
18 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Improve hemodialysis access rates
Time Frame: 18 months
Percentage of patients with AVF, AVG or catheters
18 months
Home dialysis
Time Frame: 18 months
Increase choice of home dialysis as modality of treatment
18 months

Collaborators and Investigators

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

Sponsor

Northwell Health

Investigators

  • Principal Investigator: Steven Fishbane, MD, Northwell Health

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

October 1, 2013

Primary Completion (Actual)

July 1, 2014

Study Completion (Actual)

January 1, 2016

Study Registration Dates

First Submitted

March 7, 2014

First Submitted That Met QC Criteria

March 7, 2014

First Posted (Estimate)

March 13, 2014

Study Record Updates

Last Update Posted (Estimate)

January 5, 2017

Last Update Submitted That Met QC Criteria

January 3, 2017

Last Verified

January 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 13-033

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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