Healthy Transitions in Late Stage Kidney Disease
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.
1 other identifier
interventional
130
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Oct 2013
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2013
CompletedFirst Submitted
Initial submission to the registry
March 7, 2014
CompletedFirst Posted
Study publicly available on registry
March 13, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2016
CompletedJanuary 5, 2017
January 1, 2017
9 months
March 7, 2014
January 3, 2017
Conditions
Outcome Measures
Primary Outcomes (1)
Hospitalization rate
Reduction in hospitalization rate in intervention group as compare to control group.
18 months
Secondary Outcomes (2)
Improve hemodialysis access rates
18 months
Home dialysis
18 months
Study Arms (2)
Healthy Transitions Group
EXPERIMENTAL* 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 Group
NO INTERVENTIONUsual care by nephrologist. No additional nursing support services will be provide to this group.
Interventions
Additional education will be provided by nurses to improve communication and reduce fragmentation of care.
Monitor weight to avoid problems related to hypervolemia.
Medication will be reviewed by nurses to detect any discrepancies to reduce medication error.
Education will be provided to increase awareness and encourage patients to have advanced directive.
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.
Eligibility Criteria
You may qualify if:
- Stage 4-5 Chronic Kidney Disease (CKD), defined as estimated glomerular filtration rate (eGFR) between 0-30 ml/minute
- years of age or older
You may not qualify if:
- Cognitive impairment that is clinically apparent
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Northwell Healthlead
Study Sites (1)
Division of Kidney diseases and Hypertension
Great Neck, New York, 11021, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Steven Fishbane, MD
Northwell Health
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- HEALTH SERVICES RESEARCH
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
March 7, 2014
First Posted
March 13, 2014
Study Start
October 1, 2013
Primary Completion
July 1, 2014
Study Completion
January 1, 2016
Last Updated
January 5, 2017
Record last verified: 2017-01