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

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.
 
ClinicalTrials.gov Identifier: NCT00692419
Recruitment Status : Completed
First Posted : June 6, 2008
Results First Posted : November 19, 2014
Last Update Posted : April 27, 2015
Sponsor:
Collaborators:
Dialysis Clinic, Inc.
Liberty Dialysis, LLC
DaVita Dialysis
Information provided by (Responsible Party):
VA Office of Research and Development ( US Department of Veterans Affairs )

Tracking Information
First Submitted Date  ICMJE June 4, 2008
First Posted Date  ICMJE June 6, 2008
Results First Submitted Date  ICMJE October 30, 2014
Results First Posted Date  ICMJE November 19, 2014
Last Update Posted Date April 27, 2015
Study Start Date  ICMJE November 2008
Actual Primary Completion Date April 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 17, 2014)
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
Original Primary Outcome Measures  ICMJE
 (submitted: June 4, 2008)
reduction in pain, sexual dysfunction, and depression symptoms [ Time Frame: 12 months ]
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Pain, Sexual Dysfunction, and Depression in Hemodialysis Patients
Official Title  ICMJE Pain, Sexual Dysfunction and Depression in Hemodialysis Patients
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 suggest that more than 35,000 veterans currently receive chronic hemodialysis. Although life-sustaining, hemodialysis is associated with substantial morbidity and mortality. Numerous studies have sought to identify interventions that reduce the mortality of patients dependent on hemodialysis, yet recent clinical trials of dialysis dose, dialysis membrane, and lipid lowering therapy have failed to demonstrate survival benefits. With the recognition that providers have limited means beyond renal transplantation to prolong the lives of patients on hemodialysis, investigators are beginning to refocus their research efforts on identifying interventions to improve patients' quality of life, which is substantially impaired in this population. Several major factors that contribute to poor quality of life have been identified, including the large burden of physical and emotional symptoms in this patient population.

Of the many symptoms that 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 recent data documenting the safety and efficacy of pharmacologic therapy for these symptoms. Nonetheless, preliminary studies suggest that even when severe, these symptoms are untreated or under-treated in patients on hemodialysis. The reasons for the sub-optimal treatment have not been clearly elucidated, but the investigators research 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 important for the provision of therapy, it is not clear that simply informing clinicians would be sufficient to improve treatment.

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. The investigators postulate that merely informing renal providers of patients' pain, sexual dysfunction, and depression and providing them with evidence-based treatment algorithms will not significantly improve the management of these symptoms. Rather, optimal symptom management will require assessment and treatment of these symptoms by a dedicated renal symptom management nurse. In a randomized clinical trial of not more than 350 patients receiving hemodialysis at 9 dialysis units, the investigators 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 to identify and facilitate treatment of these symptoms. This study involves the nurse and the research assistant bringing treatment plans and algorithms to the attention of the renal providers and does not involve any treatment by the research assistant and nurse themselves. By determining the most effective approach to the management of overall pain, sexual dysfunction, and depression, the investigators hope to introduce a patient-centered management approach to improve the quality of life of patients receiving chronic hemodialysis.

METHODS: Overview of Study Design The investigators have proposed a randomized, clinical trial to compare two strategies for the treatment of pain, sexual dysfunction, and depression in patients on chronic hemodialysis. The investigators have recruited 315 patients from nine local VA and non-VA dialysis units.

After enrollment, baseline data was collected from 289 patients, and an observation period of at least 2 months but not longer than 12 months ensued. Pain, sexual dysfunction, and depression were assessed monthly during this observation period, which allowed us to establish the stability of symptoms in study patients and obtain a valid estimate of the impact of the investigators interventions on these domains. Additionally, quality of life, overall symptom burden and satisfaction with care was assessed every 3 months. The investigators assessment of sexual function focused on ED in men, and decreased libido, arousal, dyspareunia, and satisfaction in women. The investigators also conducted monthly assessments of patients' attendance at dialysis, compliance with treatment duration, emergency room visits, and hospitalizations.

After the observational phase, the investigators launched a 12-month intervention phase to compare two interventions. During this phase, the investigators continue these same assessments of pain, sexual dysfunction, depression, quality of life, overall symptom burden and satisfaction with care. The investigators continue to track attendance and compliance with dialysis, emergency room visits, and hospitalizations on a monthly basis. Patients are randomized into one of two study arms by day of dialysis treatment (Monday, Wednesday, and Friday versus Tuesday, Thursday, and Saturday). Sites that only treat patients on a Monday/Wednesday/Friday dialysis schedule are randomized by the time of the dialysis shift within the day, patients on the a.m. shift are randomized to one arm of the study and those on the p.m. shift to the other. One group is randomized to a "feedback intervention" in which 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 ED and a recommendation to refer women with this symptom for gynecologic care). Treatment decisions will be left at the discretion of the provider(s). The other group has a renal symptom management nurse assess and facilitate the treatment of pain, sexual dysfunction, and depression (management intervention).In this arm, treatment of sexual dysfunction in men will focus on ED, while the symptom management nurse will facilitate referral of women with sexual dysfunction for gynecological care given the lack of pharmacologic therapy.

Study Status: Intervention Phase is completed, analysis is ongoing.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • End Stage Renal Disease
  • Sexual Dysfunction, Physiological
  • Pain
  • Depression
Intervention  ICMJE
  • 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
  • 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
Study Arms  ICMJE
  • 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.
    Intervention: Behavioral: Symptom management nurse intervention
  • 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.
    Intervention: Behavioral: Feedback intervention
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: January 14, 2011)
315
Original Estimated Enrollment  ICMJE
 (submitted: June 4, 2008)
245
Actual Study Completion Date  ICMJE January 2012
Actual Primary Completion Date April 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00692419
Other Study ID Numbers  ICMJE IIR 07-190
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party VA Office of Research and Development ( US Department of Veterans Affairs )
Study Sponsor  ICMJE US Department of Veterans Affairs
Collaborators  ICMJE
  • Dialysis Clinic, Inc.
  • Liberty Dialysis, LLC
  • DaVita Dialysis
Investigators  ICMJE
Principal Investigator: Steven D. Weisbord, MD MSc VA Pittsburgh Healthcare System University Drive Division, Pittsburgh, PA
PRS Account VA Office of Research and Development
Verification Date September 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP