Status:
COMPLETED
Pain, Sexual Dysfunction, and Depression in Hemodialysis Patients
Lead Sponsor:
US Department of Veterans Affairs
Collaborating Sponsors:
Dialysis Clinic, Inc.
Liberty Dialysis, LLC
Conditions:
End Stage Renal Disease
Sexual Dysfunction, Physiological
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
This study is seeking to identify the most effective strategy to manage pain, sexual dysfunction, and depression in patients receiving chronic hemodialysis therapy.
Detailed Description
OBJECTIVES: There are currently over 500,000 individuals with end-stage renal disease (ESRD) in the United States, and more than 100,000 new patients develop this condition annually. Recent estimates...
Eligibility Criteria
Inclusion
- Our target population is male and female hemodialysis patients age 18 years or greater who are English speakers.
Exclusion
- We will exclude children because they comprise a minority of the dialysis population and their enrollment would require an adult decision maker's consent.
- We will exclude patients who are significantly cognitively impaired and hence, unable to comprehend study surveys.
- Cognitive function will be assessed at baseline using the mini-Cog, a validated measure of cognitive capacity that we have used previously, and patients with scores \<3 will be excluded.
- Based on our prior studies, we estimate that approximately 5% of patients will be excluded based on this criterion.
- Similarly, non-English speakers will be excluded.
- Finally, patients undergoing active work-up for living donor kidney transplant, and/or considering transfer to peritoneal dialysis will be excluded as they are less likely to remain on hemodialysis for the duration of the study.
Key Trial Info
Start Date :
November 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2012
Estimated Enrollment :
315 Patients enrolled
Trial Details
Trial ID
NCT00692419
Start Date
November 1 2008
End Date
January 1 2012
Last Update
April 27 2015
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
VA Pittsburgh Healthcare System University Drive Division, Pittsburgh, PA
Pittsburgh, Pennsylvania, United States, 15240