- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01530945
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
Conditions
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
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North Carolina
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Chapel Hill, North Carolina, United States, 27514
- UNC Hospitals and outpatient dialysis clinics
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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.
Collaborators
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
Additional Relevant MeSH Terms
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.