Healthy Transitions in Late Stage Kidney Disease

Chronic Kidney Disease Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02085837
• Other study ID #: 13-033
• Status: Completed
• Phase: N/A
• First received: March 7, 2014
• Last updated: January 3, 2017
• Start date: October 2013
• Est. completion date: January 2016

Study information

• Verified date: January 2017
• Source: Northwell Health
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 130
• Est. completion date: January 2016
• Est. primary completion date: July 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Health Services Research

Related Conditions & MeSH terms

• Chronic Kidney Disease
• Kidney Diseases
• Renal Insufficiency, Chronic

Intervention

Other:
• Education
Additional education will be provided by nurses to improve communication and reduce fragmentation of care.
• Daily weight measurement and monitoring
Monitor weight to avoid problems related to hypervolemia.
• Universal Dietary education
To improve diet and health
• Medication review
Medication will be reviewed by nurses to detect any discrepancies to reduce medication error.
• Focused advanced directive program
Education will be provided to increase awareness and encourage patients to have advanced directive.
• 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.

Locations

Country	Name	City	State
United States	Division of Kidney diseases and Hypertension	Great Neck	New York

Sponsors (1)

Lead Sponsor	Collaborator
Northwell Health

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Hospitalization rate	Reduction in hospitalization rate in intervention group as compare to control group.	18 months	No
Secondary	Improve hemodialysis access rates	Percentage of patients with AVF, AVG or catheters	18 months	No
Secondary	Home dialysis	Increase choice of home dialysis as modality of treatment	18 months	No