SMILE: Pain, Sexual Dysfunction, and Depression in Hemodialysis Patients

• Sponsor: US Department of Veterans Affairs (U.S. Fed)
• Overall Status: Completed
• CT.gov ID: NCT00692419
• Collaborator: Dialysis Clinic, Inc. (Industry), Liberty Dialysis, LLC (Other), DaVita Dialysis (Industry)
• Enrollment: 315
• Location: 1
• Arms: 2
• Duration (Months): 38
• Patients Per Site Per Month: 8.3

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
End Stage Renal Disease; Sexual Dysfunction, Physiological; Pain; Depression	Behavioral: Symptom management nurse intervention; Behavioral: Feedback intervention	N/A

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 Design

• Study Type: Interventional
• Actual Enrollment: 315 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Pain, Sexual Dysfunction and Depression in Hemodialysis Patients
• Study Start Date: Nov 1, 2008
• Actual Primary Completion Date: Apr 1, 2011
• Actual Study Completion Date: Jan 1, 2012

Arms and Interventions

Arm	Intervention/Treatment
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

Outcome Measures

Primary Outcome Measures

1. Change in Pain, Sexual Dysfunction, and Depression Symptoms [12 months]

   The primary outcome of this study is the change in symptom scores during the intervention phase of the study

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Locations

	Site	City	State	Country	Postal Code
1	VA Pittsburgh Healthcare System University Drive Division, Pittsburgh, PA	Pittsburgh	Pennsylvania	United States	15240

Sponsors and Collaborators

• US 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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: US Department of Veterans Affairs
• ClinicalTrials.gov Identifier: NCT00692419
• Other Study ID Numbers: IIR 07-190
• First Posted: Jun 6, 2008
• Last Update Posted: Apr 27, 2015
• Last Verified: Sep 1, 2014

• Keywords provided by US Department of Veterans Affairs: pain; sexual dysfunction; depression; symptoms
• Additional relevant MeSH terms: Kidney Failure, Chronic; Sexual Dysfunction, Physiological; Depression; Depressive Disorder

Study Results

Participant Flow

Pre-assignment Detail	the number of patients recruited into the study beginning at the time of the observation phase (315) differs from the number of patients who continued in the study and were included in the intervention phase of the study (220)

Arm/Group Title	Arm 1	Arm 2
Arm/Group Description	This arm of the study will have a symptom management nurse facilitate the management of pain, sexual dysfunction and depression 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	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 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
Period Title: Overall Study
STARTED	100	120
COMPLETED	84	102
NOT COMPLETED	16	18

Baseline Characteristics

Arm/Group Title	Symptom Management Intervention	Feedback Intervention	Total
Arm/Group Description	This arm of the study will have a symptom management nurse facilitate the management of pain, sexual dysfunction and depression 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	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 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	Total of all reporting groups
Overall Participants	100	120	220
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	62.6 (14.3)	63.9 (12.0)	63.2 (13.5)
Sex: Female, Male (Count of Participants)
Female	44 44%	55 45.8%	99 45%
Male	56 56%	65 54.2%	121 55%

Outcome Measures

1. Primary Outcome

Title	Change in Pain, Sexual Dysfunction, and Depression Symptoms
Description	The primary outcome of this study is the change in symptom scores during the intervention phase of the study
Time Frame	12 months

Outcome Measure Data

Analysis Population Description

change in pain score during intervention period. In adjusted models, we used mixed effects linear regression to compare changes in symptom scores between the two study arms over the duration of the intervention, and to compare symptom scores among individual patients across the observation and intervention phases.

Arm/Group Title	Management Arm Change in Pain Score	Feedback Group - Change in Pain Score	Management Group - Change in ED Score	Feedback Group - Change in ED Score	Management Group - Change in Depression Score	Feedback Arm Change in Depression Score
Arm/Group Description	Management arm change in pain score of the Short Form McGill Pain Questionnaire (SF-MPQ) during the intervention. The SF-MPQ includes 15 pain descriptors that are rated from 0 (no pain) to 3 (severe pain), with a summary score of 0-45. Higher scores represent more pain.	Feedback group - change in pain score of the Short Form McGill Pain Questionnaire (SF-MPQ) during the intervention. The SF-MPQ includes 15 pain descriptors that are rated from 0 (no pain) to 3 (severe pain), with a summary score of 0-45. Higher scores represent more pain.	Management group - change in ED score on the Sexual Health Inventory for Men (SHIM) questionnaire during the intervention. We scored the SHIM from 5-25 with lower scores denoting more severe ED. We considered patients with SHIM scores <22 to have ED.	Feedback group - change in ED score on the Sexual Health Inventory for Men (SHIM) questionnaire during the intervention. We scored the SHIM from 5-25 with lower scores denoting more severe ED. We considered patients with SHIM scores <22 to have ED.	Management group - change in depression score on the Patient Health Questionnaire 9 (PHQ-9) during the intervention. The PHQ-9 is scored from 1 to 27, with higher scores denoting more severe depression. We considered patients with PHQ-9 scores ≥10 to have depression.	Feedback arm change in depression score on the Patient Health Questionnaire 9 (PHQ-9) during the intervention. The PHQ-9 is scored from 1 to 27, with higher scores denoting more severe depression. We considered patients with PHQ-9 scores ≥10 to have depression.
Measure Participants	100	120	100	120	100	120
Mean (Standard Error) [units on a scale]	-3.12 (0.54)	-3.7 (0.51)	0.62 (0.34)	0.71 (0.32)	-1.99 (0.54)	-2.29 (0.49)

Adverse Events

Arm/Group Title	Arm 1		Arm 2
Arm/Group Description	This arm of the study will have a symptom management nurse facilitate the management of pain, sexual dysfunction and depression 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		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 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
All Cause Mortality
	Arm 1		Arm 2
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Arm 1		Arm 2
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	19/100 (19%)		15/120 (12.5%)
General disorders
death	19/100 (19%)	19	15/120 (12.5%)	15
Other (Not Including Serious) Adverse Events
	Arm 1		Arm 2
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	2/100 (2%)		1/120 (0.8%)
Nervous system disorders
medication side effect	2/100 (2%)	100	1/120 (0.8%)	120

Limitations/Caveats

Individual providers were overseeing the care of patients from both study arms. The sample size was relatively small. Single geographic area. No control arm. Symptoms assessed during dialysis. No formal assessment of treatment compliance.

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.