Pain, Sexual Dysfunction, and Depression in Hemodialysis Patients (SMILE)
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|ClinicalTrials.gov Identifier: NCT00692419|
Recruitment Status : Completed
First Posted : June 6, 2008
Results First Posted : November 19, 2014
Last Update Posted : April 27, 2015
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|Condition or disease||Intervention/treatment||Phase|
|End Stage Renal Disease Sexual Dysfunction, Physiological Pain Depression||Behavioral: Symptom management nurse intervention Behavioral: Feedback intervention||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||315 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Pain, Sexual Dysfunction and Depression in Hemodialysis Patients|
|Study Start Date :||November 2008|
|Actual Primary Completion Date :||April 2011|
|Actual Study Completion Date :||January 2012|
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
- 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
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|Ages Eligible for Study:||18 Years and older (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
- Our target population is male and female hemodialysis patients age 18 years or greater who are English speakers.
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00692419
|United States, Pennsylvania|
|VA Pittsburgh Healthcare System University Drive Division, Pittsburgh, PA|
|Pittsburgh, Pennsylvania, United States, 15240|
|Principal Investigator:||Steven D. Weisbord, MD MSc||VA Pittsburgh Healthcare System University Drive Division, Pittsburgh, PA|
|Responsible Party:||US Department of Veterans Affairs|
|Other Study ID Numbers:||
|First Posted:||June 6, 2008 Key Record Dates|
|Results First Posted:||November 19, 2014|
|Last Update Posted:||April 27, 2015|
|Last Verified:||September 2014|
Kidney Failure, Chronic
Sexual Dysfunction, Physiological
Renal Insufficiency, Chronic