Healthy Transitions in Late Stage Kidney Disease

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2014 by North Shore Long Island Jewish Health System
Sponsor:
Information provided by (Responsible Party):
North Shore Long Island Jewish Health System
ClinicalTrials.gov Identifier:
NCT02085837
First received: March 7, 2014
Last updated: NA
Last verified: March 2014
History: No changes posted
  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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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 North Shore Long Island Jewish Health System:

Primary Outcome Measures:
  • Hospitalization rate [ Time Frame: 18 months ] [ Designated as safety issue: No ]
    Reduction in hospitalization rate in intervention group as compare to control group.


Secondary Outcome Measures:
  • Improve arterio-venous (AV) fistula rate [ Time Frame: 18 months ] [ Designated as safety issue: No ]
    A comprehensive stepwise program to ensure AV fistula placement in all appropriate patients.

  • Home dialysis [ Time Frame: 18 months ] [ Designated as safety issue: No ]
    Increase choice of home dialysis as modality of treatment


Estimated Enrollment: 300
Study Start Date: October 2013
Estimated Study Completion Date: April 2016
Estimated Primary Completion Date: April 2016 (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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02085837

Contacts
Contact: Steven Fishbane, MD 516-465-8200 sfishbane@nshs.edu
Contact: Vipulbhai Sakhiya 516-465-8841 vsakhiya@nshs.edu

Locations
United States, New York
Division of Kidney diseases and Hypertension Recruiting
Great Neck, New York, United States, 11021
Contact: Steven Fishbane, MD         
Contact: Vipulbhai Sakhiya         
Principal Investigator: Steven Fishbane, MD         
Sponsors and Collaborators
North Shore Long Island Jewish Health System
Investigators
Principal Investigator: Steven Fishbane, MD North Shore Long Island Jewish Health System
  More Information

No publications provided

Responsible Party: North Shore Long Island Jewish Health System
ClinicalTrials.gov Identifier: NCT02085837     History of Changes
Other Study ID Numbers: 13-033
Study First Received: March 7, 2014
Last Updated: March 7, 2014
Health Authority: United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on September 18, 2014