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CompletedNCT02085837Updated Jan 5, 2017

Healthy Transitions in Late Stage Kidney Disease

An interventional study of Education and Daily weight measurement and monitoring in Chronic Kidney Disease, sponsored by Northwell Health. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2017-01-05.

Sponsored by Northwell Health · Not applicable, Interventional, and Health services research

Phase
Not applicable
Study type
Interventional
Enrollment
130
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Chronic Kidney Disease
03

In context

Renal Insufficiency, Chronic

3,224 studies on the registry are indexed under Renal Insufficiency, Chronic; 706 are open to participants now.

This study's enrollment of 130 is above the median of 74 across 2,229 interventional studies indexed under Renal Insufficiency, Chronic.

Browse Renal Insufficiency, Chronic studies →

Lead sponsor

Northwell Health is the lead sponsor of 473 studies on the registry; 106 are open to participants now.

Of its 43 completed or terminated interventional studies of FDA-regulated products, 22 (51%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

Exclusion Criteria:

  • Cognitive impairment that is clinically apparent
05

Study design

Phase
Not applicable
Primary purpose
Health services research
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
130 participants (actual)

Study arms

  • 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 · Other: Daily weight measurement and monitoring · Other: Universal Dietary education · Other: Medication review · Other: Focused advanced directive program · Other: Countdown to fistula program

  • No intervention
    Usual Care Group

    Usual care by nephrologist. No additional nursing support services will be provide to this group.

Interventions

  • OtherEducation

    Additional education will be provided by nurses to improve communication and reduce fragmentation of care.

  • OtherDaily weight measurement and monitoring

    Monitor weight to avoid problems related to hypervolemia.

  • OtherUniversal Dietary education

    To improve diet and health

  • OtherMedication review

    Medication will be reviewed by nurses to detect any discrepancies to reduce medication error.

  • OtherFocused advanced directive program

    Education will be provided to increase awareness and encourage patients to have advanced directive.

  • OtherCountdown 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.

06

What researchers measure

Primary outcomes

  1. Hospitalization rate

    Reduction in hospitalization rate in intervention group as compare to control group.

    Time frame: 18 months

Secondary outcomes

  1. Improve hemodialysis access rates

    Percentage of patients with AVF, AVG or catheters

    Time frame: 18 months

  2. Home dialysis

    Increase choice of home dialysis as modality of treatment

    Time frame: 18 months

07

Study locations

1 site
  • Division of Kidney diseases and Hypertension
    Great Neck, New York 11021, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 5, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT02085837
Lead sponsor
Northwell Health
Responsible party
Steven Fishbane (Principal Investigator, Northwell Health) — Principal investigator
First posted
Mar 13, 2014
Start date
Oct 2013
Primary completion
Jul 2014
Completion
Jan 2016
Last update
Jan 5, 2017

Study contacts

Steven Fishbane, MD
principal investigator · Northwell Health

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jan 2017. You cannot join it, but the record below documents what was studied.

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