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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
University of North Carolina, Chapel Hill
ClinicalTrials.gov Identifier:
NCT01530945
First received: February 7, 2012
Last updated: August 4, 2014
Last verified: August 2014
  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 ] [ 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 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
  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: August 4, 2014
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 September 22, 2014