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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 )

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
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
Hide 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
Arm/Group Title Symptom Management Intervention Feedback Intervention Total
Hide 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
Hide 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%
1.Primary Outcome
Title Change in Pain, Sexual Dysfunction, and Depression Symptoms
Hide Description The primary outcome of this study is the change in symptom scores during the intervention phase of the study
Time Frame 12 months
Hide Outcome Measure Data
Hide 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
Hide 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)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Arm 1 Arm 2
Hide 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   --/--      --/--    
Hide 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.
Hide 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
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.
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
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:
Layout table for additonal information
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