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

Sponsor
University of North Carolina, Chapel Hill (Other)
Overall Status
Completed
CT.gov ID
NCT01530945
Collaborator
National Institute of Nursing Research (NINR) (NIH)
227
Enrollment
1
Location
40
Duration (Months)
5.7
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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 or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    227 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Mapping Multidimensional Illness Trajectories of Patients With ESKD
    Study Start Date :
    Mar 1, 2012
    Actual Primary Completion Date :
    Jul 1, 2015
    Actual Study Completion Date :
    Jul 1, 2015

    Outcome Measures

    Primary Outcome Measures

    1. Symptoms, physical functioning, psychosocial needs, spiritual well-being, cognitive functioning [12 months]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Locations

    Site City State Country Postal Code
    1 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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    University of North Carolina, Chapel Hill
    ClinicalTrials.gov Identifier:
    NCT01530945
    Other Study ID Numbers:
    • R01NR013359
    • R01NR013359
    First Posted:
    Feb 10, 2012
    Last Update Posted:
    Sep 4, 2015
    Last Verified:
    Sep 1, 2015
    Additional relevant MeSH terms:
    Kidney Diseases
    Kidney Failure, Chronic

    Study Results

    No Results Posted as of Sep 4, 2015