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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01530945
First Posted: February 10, 2012
Last Update Posted: September 4, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
National Institute of Nursing Research (NINR)
Information provided by (Responsible Party):
University of North Carolina, Chapel Hill
  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:


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

Primary Outcome Measures:
  • Symptoms, physical functioning, psychosocial needs, spiritual well-being, cognitive functioning [ Time Frame: 12 months ]

Enrollment: 227
Study Start Date: March 2012
Study Completion Date: July 2015
Primary Completion Date: July 2015 (Final data collection date for primary outcome measure)
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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 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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01530945


Locations
United States, North Carolina
UNC Hospitals and outpatient dialysis clinics
Chapel Hill, North Carolina, United States, 27514
Sponsors and Collaborators
University of North Carolina, Chapel Hill
National Institute of Nursing Research (NINR)
Investigators
Principal Investigator: Mi-Kyung Song, PhD, RN, FAAN University of North Carolina, Chapel Hill
  More Information

Responsible Party: University of North Carolina, Chapel Hill
ClinicalTrials.gov Identifier: NCT01530945     History of Changes
Other Study ID Numbers: R01NR013359 ( U.S. NIH Grant/Contract )
First Submitted: February 7, 2012
First Posted: February 10, 2012
Last Update Posted: September 4, 2015
Last Verified: September 2015

Additional relevant MeSH terms:
Kidney Diseases
Kidney Failure, Chronic
Urologic Diseases
Renal Insufficiency, Chronic
Renal Insufficiency