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

End Stage Kidney Disease Clinical Trial

Official title:

Mapping Multidimensional Illness Trajectories of Patients With ESKD

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01530945
• Other study ID #: R01NR013359
• Secondary ID: R01NR013359
• Status: Completed
• Phase: N/A
• First received: February 7, 2012
• Last updated: September 2, 2015
• Start date: March 2012
• Est. completion date: July 2015

Study information

• Verified date: September 2015
• Source: University of North Carolina, Chapel Hill
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review BoardUnited States: Federal Government
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 227
• Est. completion date: July 2015
• Est. primary completion date: July 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• End Stage Kidney Disease
• Kidney Diseases
• Kidney Failure, Chronic

Locations

Country	Name	City	State
United States	UNC Hospitals and outpatient dialysis clinics	Chapel Hill	North Carolina

Sponsors (2)

Lead Sponsor	Collaborator
University of North Carolina, Chapel Hill	National Institute of Nursing Research (NINR)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Symptoms, physical functioning, psychosocial needs, spiritual well-being, cognitive functioning		12 months	No