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Healthy Transitions in Late Stage Kidney Disease

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT02085837
First Posted: March 13, 2014
Last Update Posted: January 5, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Steven Fishbane, Northwell Health
  Purpose
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.

Condition Intervention
Chronic Kidney Disease Other: Education Other: Daily weight measurement and monitoring Other: Universal Dietary education Other: Medication review Other: Focused advanced directive program Other: Countdown to fistula program

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: 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.

Resource links provided by NLM:


Further study details as provided by Steven Fishbane, Northwell Health:

Primary Outcome Measures:
  • Hospitalization rate [ Time Frame: 18 months ]
    Reduction in hospitalization rate in intervention group as compare to control group.


Secondary Outcome Measures:
  • Improve hemodialysis access rates [ Time Frame: 18 months ]
    Percentage of patients with AVF, AVG or catheters

  • Home dialysis [ Time Frame: 18 months ]
    Increase choice of home dialysis as modality of treatment


Enrollment: 130
Study Start Date: October 2013
Study Completion Date: January 2016
Primary Completion Date: July 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02085837


Locations
United States, New York
Division of Kidney diseases and Hypertension
Great Neck, New York, United States, 11021
Sponsors and Collaborators
Northwell Health
Investigators
Principal Investigator: Steven Fishbane, MD Northwell Health
  More Information

Responsible Party: Steven Fishbane, Principal Investigator, Northwell Health
ClinicalTrials.gov Identifier: NCT02085837     History of Changes
Other Study ID Numbers: 13-033
First Submitted: March 7, 2014
First Posted: March 13, 2014
Last Update Posted: January 5, 2017
Last Verified: January 2017

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