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

September 2, 2015 updated by: University of North Carolina, Chapel Hill

Mapping Multidimensional Illness Trajectories of Patients With ESKD

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.

Study Overview

Status

Completed

Study Type

Observational

Enrollment (Actual)

227

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • North Carolina
      • Chapel Hill, North Carolina, United States, 27514
        • UNC Hospitals and outpatient dialysis clinics

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

ESKD patients who have been on dialysis

Description

Inclusion Criteria:

  • aged 18 years or older;
  • receiving either Hemodialysis or Peritoneal dialysis
  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Symptoms, physical functioning, psychosocial needs, spiritual well-being, cognitive functioning
Time Frame: 12 months
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Mi-Kyung Song, PhD, RN, FAAN, University of North Carolina, Chapel Hill

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2012

Primary Completion (Actual)

July 1, 2015

Study Completion (Actual)

July 1, 2015

Study Registration Dates

First Submitted

February 7, 2012

First Submitted That Met QC Criteria

February 9, 2012

First Posted (Estimate)

February 10, 2012

Study Record Updates

Last Update Posted (Estimate)

September 4, 2015

Last Update Submitted That Met QC Criteria

September 2, 2015

Last Verified

September 1, 2015

More Information

Terms related to this study

Other Study ID Numbers

  • R01NR013359 (U.S. NIH Grant/Contract)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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