Pain, Sexual Dysfunction, and Depression in Hemodialysis Patients (SMILE)

This study has been completed.
Sponsor:
Collaborators:
Dialysis Clinic, Inc.
Liberty Dialysis, LLC
DaVita Dialysis
Information provided by (Responsible Party):
Department of Veterans Affairs
ClinicalTrials.gov Identifier:
NCT00692419
First received: June 4, 2008
Last updated: April 18, 2014
Last verified: April 2014
  Purpose

This study is seeking to identify the most effective strategy to manage pain, sexual dysfunction, and depression in patients receiving chronic hemodialysis therapy.


Condition Intervention
End Stage Renal Disease
Sexual Dysfunction, Physiological
Pain
Depression
Behavioral: Renal Symptom Management Nurse Practitioner Intervention
Behavioral: Feedback of Symptoms Intervention

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Pain, Sexual Dysfunction and Depression in Hemodialysis Patients

Resource links provided by NLM:


Further study details as provided by Department of Veterans Affairs:

Primary Outcome Measures:
  • reduction in pain, sexual dysfunction, and depression symptoms [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Enrollment: 315
Study Start Date: November 2008
Study Completion Date: January 2012
Primary Completion Date: April 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm 1
This arm of the study will have a symptom management nurse facilitate the management of pain, sexual dysfunction and depression
Behavioral: Renal Symptom Management Nurse Practitioner Intervention
A symptom management nurse will facilitate the management of pain, sexual dysfunction and depression in patients enrolled in one arm of the study
Active Comparator: Arm 2
This arm of the study will have pain, sexual dysfunction and depression assessed monthly with feedback given to renal providers on the presence and severity of these symptoms. Treatment will be left at the discretion of the renal provider
Behavioral: Feedback of Symptoms Intervention
Pain, sexual dysfunction and depression will be assessed monthly and feedback will be given to renal providers on the presence and severity of these symptoms. Treatment will be left at the discretion of the renal provider

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Our target population is male and female hemodialysis patients age 18 years or greater who are English speakers.

Exclusion Criteria:

  • 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.
  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: NCT00692419

Locations
United States, Pennsylvania
Center for Health Equity Research and Promotion
Pittsburgh, Pennsylvania, United States, 15206
Sponsors and Collaborators
Dialysis Clinic, Inc.
Liberty Dialysis, LLC
DaVita Dialysis
Investigators
Principal Investigator: Steven D. Weisbord, MD MSc VA Pittsburgh Healthcare System University Drive Division, Pittsburgh, PA
  More Information

Publications:

Responsible Party: Department of Veterans Affairs
ClinicalTrials.gov Identifier: NCT00692419     History of Changes
Other Study ID Numbers: IIR 07-190
Study First Received: June 4, 2008
Last Updated: April 18, 2014
Health Authority: United States: Federal Government

Keywords provided by Department of Veterans Affairs:
pain
sexual dysfunction
depression
symptoms

Additional relevant MeSH terms:
Depression
Depressive Disorder
Kidney Diseases
Kidney Failure, Chronic
Sexual Dysfunctions, Psychological
Sexual Dysfunction, Physiological
Behavioral Symptoms
Mood Disorders
Mental Disorders
Urologic Diseases
Renal Insufficiency, Chronic
Renal Insufficiency
Sexual and Gender Disorders
Genital Diseases, Male
Genital Diseases, Female

ClinicalTrials.gov processed this record on July 10, 2014