Back to resultsHealthy Transitions in Late Stage Kidney Disease
Primary Purpose
Chronic Kidney Disease
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Education
Daily weight measurement and monitoring
Universal Dietary education
Medication review
Focused advanced directive program
Countdown to fistula program
Sponsored by
About this trial
This is an interventional health services research trial for Chronic Kidney Disease
Eligibility 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
Sites / Locations
- Division of Kidney diseases and Hypertension
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Healthy Transitions Group
Usual Care Group
Arm Description
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
Usual care by nephrologist. No additional nursing support services will be provide to this group.
Outcomes
Primary Outcome Measures
Hospitalization rate
Reduction in hospitalization rate in intervention group as compare to control group.
Secondary Outcome Measures
Improve hemodialysis access rates
Percentage of patients with AVF, AVG or catheters
Home dialysis
Increase choice of home dialysis as modality of treatment
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02085837
Brief Title
Healthy Transitions in Late Stage Kidney Disease
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.
Study Type
Interventional
2. Study Status
Record Verification Date
January 2017
Overall Recruitment Status
Completed
Study Start Date
October 2013 (undefined)
Primary Completion Date
July 2014 (Actual)
Study Completion Date
January 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Northwell Health
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Kidney Disease
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
130 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Healthy Transitions Group
Arm Type
Experimental
Arm Description
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
Arm Title
Usual Care Group
Arm Type
No Intervention
Arm Description
Usual care by nephrologist. No additional nursing support services will be provide to this group.
Intervention Type
Other
Intervention Name(s)
Education
Intervention Description
Additional education will be provided by nurses to improve communication and reduce fragmentation of care.
Intervention Type
Other
Intervention Name(s)
Daily weight measurement and monitoring
Intervention Description
Monitor weight to avoid problems related to hypervolemia.
Intervention Type
Other
Intervention Name(s)
Universal Dietary education
Intervention Description
To improve diet and health
Intervention Type
Other
Intervention Name(s)
Medication review
Intervention Description
Medication will be reviewed by nurses to detect any discrepancies to reduce medication error.
Intervention Type
Other
Intervention Name(s)
Focused advanced directive program
Intervention Description
Education will be provided to increase awareness and encourage patients to have advanced directive.
Intervention Type
Other
Intervention Name(s)
Countdown to fistula program
Intervention Description
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.
Primary Outcome Measure Information:
Title
Hospitalization rate
Description
Reduction in hospitalization rate in intervention group as compare to control group.
Time Frame
18 months
Secondary Outcome Measure Information:
Title
Improve hemodialysis access rates
Description
Percentage of patients with AVF, AVG or catheters
Time Frame
18 months
Title
Home dialysis
Description
Increase choice of home dialysis as modality of treatment
Time Frame
18 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Steven Fishbane, MD
Organizational Affiliation
Northwell Health
Official's Role
Principal Investigator
Facility Information:
Facility Name
Division of Kidney diseases and Hypertension
City
Great Neck
State/Province
New York
ZIP/Postal Code
11021
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Healthy Transitions in Late Stage Kidney Disease
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