Mapping Multidimensional Illness Trajectories of Patients With End-stage Kidney Disease

This study is currently recruiting participants.

Verified May 2013 by University of North Carolina, Chapel Hill

Sponsor:

Collaborator:

National Institute of Nursing Research (NINR)

Information provided by (Responsible Party):

University of North Carolina, Chapel Hill

ClinicalTrials.gov Identifier:

NCT01530945

First received: February 7, 2012

Last updated: May 6, 2013

Last verified: May 2013

History of Changes

Purpose

Patients with end-stage kidney disease (ESKD) must manage not only the demands of dialysis and comorbid conditions but also associated symptoms and acute life-threatening events that contribute to functional limitations and increased risk of mortality. Yet little is known about the trajectories of quality of life dimensions in patients with ESKD when they experience acute life-threatening episodes, to guide palliative care for this population. In this prospective, descriptive study, we will identify trajectories of symptoms, physical functioning, psychosocial needs, and emotional and spiritual well-being in 200 patients with ESKD who are at a high risk of experiencing acute life-threatening events and mortality within 12 months.

Condition
End Stage Kidney Disease

Study Type:	Observational
Study Design:	Observational Model: Cohort Time Perspective: Prospective
Official Title:	Mapping Multidimensional Illness Trajectories of Patients With ESKD

Resource links provided by NLM:

MedlinePlus related topics: Kidney Failure

U.S. FDA Resources

Further study details as provided by University of North Carolina, Chapel Hill:

Primary Outcome Measures:

Symptoms, physical functioning, psychosocial needs, spiritual well-being [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Estimated Enrollment:	250
Study Start Date:	March 2012
Estimated Study Completion Date:	July 2015
Estimated Primary Completion Date:	July 2015 (Final data collection date for primary outcome measure)

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No
Sampling Method:	Non-Probability Sample

Study Population

ESKD patients who have been on dialysis

Criteria

Inclusion Criteria:

aged 18 years or older;
receiving either HD or PD
on dialysis either < 3 months or ≥ 6 months with a Charlson Comorbidity Index (CCI) score ≥ 5

Exclusion Criteria:

Patients who are enrolled in hospice or too sick to participate in questionnaire completion will not be eligible.
Kidney transplant candidates will be excluded because their illness trajectories after transplant are likely to differ.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01530945

Contacts

Contact: Mi-Kyung Song, PhD

919-843-9496

songm@email.unc.edu

Locations

United States, North Carolina
UNC Hospitals and outpatient dialysis clinics	Recruiting
Chapel Hill, North Carolina, United States, 27514
Contact: Mi-Kyung Song, PhD 919-843-9496 songm@email.unc.edu
Principal Investigator: Mi-Kyung Song, PhD
Sub-Investigator: Sandra Ward, PhD
Sub-Investigator: Gerald Hladik, MD
Sub-Investigator: Eric Bair, PhD

Sponsors and Collaborators

University of North Carolina, Chapel Hill

National Institute of Nursing Research (NINR)

More Information

No publications provided

Responsible Party:	University of North Carolina, Chapel Hill
ClinicalTrials.gov Identifier:	NCT01530945 History of Changes
Other Study ID Numbers:	R01NR013359, R01NR013359
Study First Received:	February 7, 2012
Last Updated:	May 6, 2013
Health Authority:	United States: Institutional Review Board United States: Federal Government

Additional relevant MeSH terms:

Kidney Diseases
Kidney Failure, Chronic
Urologic Diseases
Renal Insufficiency, Chronic
Renal Insufficiency

ClinicalTrials.gov processed this record on June 18, 2013

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