NCT00692419

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
315

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Nov 2008

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 4, 2008

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 6, 2008

Completed
5 months until next milestone

Study Start

First participant enrolled

November 1, 2008

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2011

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2012

Completed
2.9 years until next milestone

Results Posted

Study results publicly available

November 19, 2014

Completed
Last Updated

April 27, 2015

Status Verified

September 1, 2014

Enrollment Period

2.4 years

First QC Date

June 4, 2008

Results QC Date

October 30, 2014

Last Update Submit

April 6, 2015

Conditions

End Stage Renal DiseaseSexual Dysfunction, PhysiologicalPainDepression

Keywords

painsexual dysfunctiondepressionsymptoms

Outcome Measures

Primary Outcomes (1)

  • Change in Pain, Sexual Dysfunction, and Depression Symptoms

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

    12 months

Study Arms (2)

Symptom management nurse intervention

EXPERIMENTAL

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

Feedback intervention

ACTIVE COMPARATOR

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

Interventions

Symptom management nurse interventionBEHAVIORAL

A symptom management nurse will facilitate the management of pain, sexual dysfunction and depression in patients enrolled in one arm of the study

Symptom management nurse intervention
Feedback interventionBEHAVIORAL

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

Feedback intervention

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Our target population is male and female hemodialysis patients age 18 years or greater who are English speakers.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

VA Pittsburgh Healthcare System University Drive Division, Pittsburgh, PA

Pittsburgh, Pennsylvania, 15240, United States

Location

Related Publications (11)

  • 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.

    PMID: 20601163RESULT

  • 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.

    PMID: 23458106RESULT

  • 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.

    PMID: 23352380RESULT

  • 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.

    PMID: 24357510RESULT

  • 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.

    PMID: 25081360RESULT

  • 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.

    PMID: 22339326RESULT

  • 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.

    PMID: 22580787RESULT

  • 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.

    PMID: 23024159RESULT

  • 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.

    PMID: 21551025RESULT

  • 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.

    PMID: 25403142RESULT

  • Campbell ZC, Dawson JK, Kirkendall SM, McCaffery KJ, Jansen J, Campbell KL, Lee VW, Webster AC. Interventions for improving health literacy in people with chronic kidney disease. Cochrane Database Syst Rev. 2022 Dec 6;12(12):CD012026. doi: 10.1002/14651858.CD012026.pub2.

    PMID: 36472416DERIVED

MeSH Terms

Conditions

Kidney Failure, ChronicSexual Dysfunction, PhysiologicalPainDepression

Condition Hierarchy (Ancestors)

Renal Insufficiency, ChronicRenal InsufficiencyKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsGenital DiseasesNeurologic ManifestationsSigns and SymptomsBehavioral SymptomsBehavior

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.

Results Point of Contact

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

Study Officials

  • Steven D. Weisbord, MD MSc

    VA Pittsburgh Healthcare System University Drive Division, Pittsburgh, PA

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
FED
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 4, 2008

First Posted

June 6, 2008

Study Start

November 1, 2008

Primary Completion

April 1, 2011

Study Completion

January 1, 2012

Last Updated

April 27, 2015

Results First Posted

November 19, 2014

Record last verified: 2014-09

Locations

US(1)