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

NCT01530945 | Completed

• 1 other identifier: R01NR013359
• Study Type: observational
• Target: 227
• Locations: 1 country
• Sites: 1

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.

Conditions

End Stage Kidney Disease

Outcome Measures

Primary Outcomes (1)

• Symptoms, physical functioning, psychosocial needs, spiritual well-being, cognitive functioning

  12 months

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

ESKD patients who have been on dialysis

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of North Carolina, Chapel Hill: lead
• National Institute of Nursing Research (NINR): collaborator

Study Sites (1)

UNC Hospitals and outpatient dialysis clinics

Chapel Hill, North Carolina, 27514, United States

Location

MeSH Terms

Conditions

Kidney Failure, Chronic

Condition Hierarchy (Ancestors)

Renal Insufficiency, Chronic; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Mi-Kyung Song, PhD, RN, FAAN

  University of North Carolina, Chapel Hill

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 7, 2012
• First Posted: February 10, 2012
• Study Start: March 1, 2012
• Primary Completion: July 1, 2015
• Study Completion: July 1, 2015
• Last Updated: September 4, 2015

Record last verified: 2015-09

Locations

US (1)