Pain, Sexual Dysfunction, and Depression in Hemodialysis Patients - Full Text View

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

This study is ongoing, but not recruiting participants.

First Received on June 4, 2008. Last Updated on December 5, 2011 History of Changes

Sponsor:	Department of Veterans Affairs
Collaborators:	Dialysis Clinic, Inc. Liberty Dialysis, LLC DaVita Dialysis
Information provided by (Responsible Party):	Department of Veterans Affairs
ClinicalTrials.gov Identifier:	NCT00692419

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:

MedlinePlus related topics: Depression Dialysis Kidney Failure Palliative Care

U.S. FDA Resources

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
Estimated Study Completion Date:	January 2012
Primary Completion Date:	April 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: 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: 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

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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

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

Department of Veterans Affairs

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:

Weisbord SD, Shields AM, Mor MK, Sevick MA, Homer M, Peternel J, Porter P, Rollman BL, Palevsky PM, Arnold RM, Fine MJ. Methodology of a randomized clinical trial of symptom management strategies in patients receiving chronic hemodialysis: the SMILE study. Contemp Clin Trials. 2010 Sep;31(5):491-7. Epub 2010 Jul 1.

Green JA, Mor MK, Shields AM, Sevick MA, Palevsky PM, Fine MJ, Arnold RM, Weisbord SD. Prevalence and demographic and clinical associations of health literacy in patients on maintenance hemodialysis. Clin J Am Soc Nephrol. 2011 Jun;6(6):1354-60. Epub 2011 May 5.

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:	December 5, 2011
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 Dysfunction, Physiological
Behavioral Symptoms
Mood Disorders

Mental Disorders
Urologic Diseases
Renal Insufficiency, Chronic
Renal Insufficiency
Genital Diseases, Male
Genital Diseases, Female

ClinicalTrials.gov processed this record on February 09, 2012