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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00692419
First Posted: June 6, 2008
Last Update Posted: April 27, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
Dialysis Clinic, Inc.
Liberty Dialysis, LLC
DaVita Dialysis
Information provided by (Responsible Party):
VA Office of Research and Development
  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: Symptom management nurse intervention Behavioral: Feedback intervention

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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 VA Office of Research and Development:

Primary Outcome Measures:
  • Change in Pain, Sexual Dysfunction, and Depression Symptoms [ Time Frame: 12 months ]
    The primary outcome of this study is the change in symptom scores during the intervention phase of the study


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: Symptom management nurse intervention
This arm of the study will have a symptom management nurse facilitate the management of pain, sexual dysfunction and depression. The nurse will work with the patient's renal provider to implement appropriate symptom alleviating treatment. The intervention is patient specific and entirely dependent on the treatment recommendation made by the symptom management nurse.
Behavioral: Symptom management nurse 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: Feedback intervention
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. The intervention on symptoms is at the discretion of the renal provider. The interventions implemented were patient specific and consisted of therapies the patient's renal provider decided to implement.
Behavioral: Feedback 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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00692419


Locations
United States, Pennsylvania
VA Pittsburgh Healthcare System University Drive Division, Pittsburgh, PA
Pittsburgh, Pennsylvania, United States, 15240
Sponsors and Collaborators
VA Office of Research and Development
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: VA Office of Research and Development
ClinicalTrials.gov Identifier: NCT00692419     History of Changes
Other Study ID Numbers: IIR 07-190
First Submitted: June 4, 2008
First Posted: June 6, 2008
Results First Submitted: October 30, 2014
Results First Posted: November 19, 2014
Last Update Posted: April 27, 2015
Last Verified: September 2014

Keywords provided by VA Office of Research and Development:
pain
sexual dysfunction
depression
symptoms

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