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

• 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: US Department of Veterans Affairs
• 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 )

• Study Type: Interventional
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Treatment
• Conditions: End Stage Renal Disease; Sexual Dysfunction, Physiological; Pain; Depression
• Interventions: Behavioral: Symptom management nurse intervention; Behavioral: Feedback intervention
• Enrollment: 315

Participant Flow

Recruitment Details
Pre-assignment Details	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 Number of Baseline Participants		100	120	220
Baseline Analysis Population Description		[Not Specified]
Age, Continuous; Mean (Standard Deviation); Unit of measure: Years
	Number Analyzed	100 participants	120 participants	220 participants
		62.6 (14.3)	63.9 (12.0)	63.2 (13.5)
Sex: Female, Male; Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	100 participants	120 participants	220 participants
	Female	44 44.0%	55 45.8%	99 45.0%
	Male	56 56.0%	65 54.2%	121 55.0%

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.
Overall Number of Participants Analyzed	100	120	100	120	100	120
Mean (Standard Error); Unit of Measure: 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

Time Frame	[Not Specified]
Adverse Event Reporting Description	[Not Specified]
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 (%)		Affected / at Risk (%)
Total	--/--		--/--
Serious Adverse Events
	Arm 1		Arm 2
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	19/100 (19.00%)		15/120 (12.50%)
General disorders
death * [1]	19/100 (19.00%)	19	15/120 (12.50%)	15
* Indicates events were collected by non-systematic assessment; [1] These are the # of deaths. However, none of these deaths were thought related to study participation.
Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events	0%
	Arm 1		Arm 2
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	2/100 (2.00%)		1/120 (0.83%)
Nervous system disorders
medication side effect * [1]	2/100 (2.00%)	100	1/120 (0.83%)	120
* Indicates events were collected by non-systematic assessment; [1] the event was characterized as medication side effect

Limitations and 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.

Results Point of Contact

• Name/Title: Steven D. Weisbord MD
• Organization: VA Pittsburgh Healthcare System, Center for Health Equity Research and Promotion
• Phone: 412-360-3911
• EMail: steven.weisbord@va.gov

Publications of Results:

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. doi: 10.1016/j.cct.2010.06.005. Epub 2010 Jul 1.

Weisbord SD. Sexual dysfunction and quality of life in patients on maintenance dialysis. Semin Dial. 2013 May-Jun;26(3):278-80. doi: 10.1111/sdi.12068. Epub 2013 Mar 5. No abstract available.

Green JA, Mor MK, Shields AM, Sevick MA, Arnold RM, Palevsky PM, Fine MJ, Weisbord SD. Associations of health literacy with dialysis adherence and health resource utilization in patients receiving maintenance hemodialysis. Am J Kidney Dis. 2013 Jul;62(1):73-80. doi: 10.1053/j.ajkd.2012.12.014. Epub 2013 Jan 24.

Mor MK, Sevick MA, Shields AM, Green JA, Palevsky PM, Arnold RM, Fine MJ, Weisbord SD. Sexual function, activity, and satisfaction among women receiving maintenance hemodialysis. Clin J Am Soc Nephrol. 2014 Jan;9(1):128-34. doi: 10.2215/CJN.05470513. Epub 2013 Dec 19.

Weisbord SD, Mor MK, Sevick MA, Shields AM, Rollman BL, Palevsky PM, Arnold RM, Green JA, Fine MJ. Associations of depressive symptoms and pain with dialysis adherence, health resource utilization, and mortality in patients receiving chronic hemodialysis. Clin J Am Soc Nephrol. 2014 Sep 5;9(9):1594-602. doi: 10.2215/CJN.00220114. Epub 2014 Jul 31.

Green JA, Mor MK, Shields AM, Sevik MA, Palevsky PM, Fine MJ, Arnold RM, Weisbord SD. Renal provider perceptions and practice patterns regarding the management of pain, sexual dysfunction, and depression in hemodialysis patients. J Palliat Med. 2012 Feb;15(2):163-7. doi: 10.1089/jpm.2011.0284.

Weisbord SD. Female sexual dysfunction in ESRD: an underappreciated epidemic? Clin J Am Soc Nephrol. 2012 Jun;7(6):881-3. doi: 10.2215/CJN.03870412. Epub 2012 May 10. No abstract available.

Weisbord SD, Mor MK, Green JA, Sevick MA, Shields AM, Zhao X, Rollman BL, Palevsky PM, Arnold RM, Fine MJ. Comparison of symptom management strategies for pain, erectile dysfunction, and depression in patients receiving chronic hemodialysis: a cluster randomized effectiveness trial. Clin J Am Soc Nephrol. 2013 Jan;8(1):90-9. doi: 10.2215/CJN.04450512. Epub 2012 Sep 27.

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. doi: 10.2215/CJN.09761110. Epub 2011 May 5.

Belayev LY, Mor MK, Sevick MA, Shields AM, Rollman BL, Palevsky PM, Arnold RM, Fine MJ, Weisbord SD. Longitudinal associations of depressive symptoms and pain with quality of life in patients receiving chronic hemodialysis. Hemodial Int. 2015 Apr;19(2):216-24. doi: 10.1111/hdi.12247. Epub 2014 Nov 18.

• Responsible Party: VA Office of Research and Development ( US Department of Veterans Affairs )
• ClinicalTrials.gov Identifier: NCT00692419
• 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