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Sponsors and Collaborators: |
Department of Veterans Affairs Dialysis Clinics, Inc. Liberty Dialysis DaVita Dialysis |
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Information provided by: | Department of Veterans Affairs |
ClinicalTrials.gov Identifier: | NCT00692419 |
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 |
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End Stage Renal Disease Sexual Dysfunctions, Physiologic Pain Depression |
Behavioral: Renal Symptom Management Nurse Practitioner Intervention Behavioral: Feedback of Symptoms Intervention |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study |
Official Title: | Pain, Sexual Dysfunction and Depression in Hemodialysis Patients |
Estimated Enrollment: | 245 |
Study Start Date: | November 2008 |
Estimated Study Completion Date: | July 2011 |
Estimated Primary Completion Date: | April 2010 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental
This arm of the study will have a symptom management nurse practitioner facilitate the management of pain, sexual dysfunction and depression
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Behavioral: Renal Symptom Management Nurse Practitioner Intervention
A symptom management nurse practitioner will facilitate the management of pain, sexual dysfunction and depression in patients enrolled in one arm of the study
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2: Active Comparator
This arm of the study will have a 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
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Behavioral: Feedback of Symptoms Intervention
Pain, sexual dysfunction and depression will be assessed monthly with 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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Background:
Of the many symptoms that frequently affect patients on hemodialysis, pain, sexual dysfunction, and depression are among the most prevalent, severe, and highly correlated with impaired quality of life. These observations are particularly noteworthy with the emergence of data documenting the safety and efficacy of pharmacologic therapy for these three symptoms. Nonetheless, preliminary studies suggest that even when severe, these symptoms remain untreated or under-treated in patients on chronic hemodialysis. The reasons for the inadequate implementation of therapy have not been clearly elucidated, but our research has demonstrated that renal providers are largely unaware of the presence and severity of pain, sexual dysfunction, and depression in their hemodialysis patients. Although increasing provider awareness of these symptoms would seem to be a necessary step for the provision of therapy, it is not clear that simply informing clinicians would be sufficient to improve treatment.
Objectives:
Objective: The broad objective of this 3-year project is to determine the most effective strategy for the management of pain, sexual dysfunction, and depression in patients on chronic hemodialysis.
Methods:
Research Design: In a randomized clinical trial of 245 patients receiving hemodialysis at 8 dialysis units, we will compare two symptom management strategies: (a) providing feedback on patients' symptoms to renal providers along with evidence-based algorithms for their treatment and; (b) using a renal symptom management nurse practitioner to identify and facilitate treatment of these symptoms.
Methodology: After enrollment, baseline data will be collected from all patients during a 6-month observation period. Pain, sexual dysfunction, depression, quality of life, and satisfaction with care will be assessed monthly during this observation period using validated symptom assessment instruments. Our assessment of sexual function will focus on erectile dysfunction in men, and decreased libido, arousal, dyspareunia, and satisfaction in women. We will also conduct monthly assessments of patients' attendance at dialysis, compliance with treatment duration, emergency room visits, and hospitalizations.
After the 6-month observational phase, we will launch a 12-month intervention phase to compare two interventions. During this phase, we will continue monthly assessments of pain, sexual dysfunction, depression, quality of life, and satisfaction with care. Patients will be randomized into one of two arms based on the day of their dialysis shift. In the first arm, the "feedback intervention," renal providers will receive data on the presence and severity of patients' pain, sexual dysfunction, and depression along with algorithms for the treatment of these symptoms (For sexual dysfunction, providers will receive a treatment algorithm for erectile dysfunction and a recommendation to refer women with this symptom for gynecologic care). Treatment decisions will be left at the discretion of the provider(s). In the second arm, the "management intervention," a renal symptom management nurse practitioner will assess and facilitate the treatment of pain, sexual dysfunction, and depression. In this arm, treatment of sexual dysfunction in men will focus on erectile dysfunction, while the symptom management nurse practitioner will facilitate referral of women with sexual dysfunction for gynecological care given the lack of pharmacologic therapy. We will continue to track attendance and compliance with dialysis, emergency room visits, and hospitalizations on a monthly basis during the intervention phase.
Status:
The project team is engaged in start-up activities.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Our target population is men and women age > 18 years who are English speakers.
Exclusion Criteria:
Contact: Steven D Weisbord, MD MSc | (412) 360-3911 | steven.weisbord@va.gov |
United States, Pennsylvania | |
VA Pittsburgh Healthcare System | Recruiting |
Pittsburgh, Pennsylvania, United States, 15240 | |
Contact: Steven D Weisbord, MD MSc 412-360-3911 steven.weisbord@va.gov | |
Principal Investigator: Steven D. Weisbord, MD MSc |
Principal Investigator: | Steven D. Weisbord, MD MSc | VA Pittsburgh Healthcare System |
Responsible Party: | Department of Veterans Affairs ( Weisbord, Steven - Principal Investigator ) |
Study ID Numbers: | IIR 07-190 |
Study First Received: | June 4, 2008 |
Last Updated: | November 21, 2008 |
ClinicalTrials.gov Identifier: | NCT00692419 |
Health Authority: | United States: Federal Government |
pain sexual dysfunction depression symptoms |
Renal Insufficiency Depression Urologic Diseases Renal Insufficiency, Chronic Mental Disorders Mood Disorders |
Kidney Failure, Chronic Pain Kidney Diseases Depressive Disorder Behavioral Symptoms Kidney Failure |