Trial Outcomes & Findings for Pain, Sexual Dysfunction, and Depression in Hemodialysis Patients (NCT NCT00692419)

NCT ID: NCT00692419

Last Updated: 2015-04-27

Results Overview

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

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 315 participants
• Primary outcome timeframe: 12 months
• Results posted on: 2015-04-27

Participant Flow

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)

Participant milestones

Measure	Arm 1 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	Arm 2 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
Overall Study STARTED	100	120
Overall Study COMPLETED	84	102
Overall Study NOT COMPLETED	16	18

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Pain, Sexual Dysfunction, and Depression in Hemodialysis Patients

Baseline characteristics by cohort

Measure	Symptom Management Intervention n=100 Participants 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	Feedback Intervention n=120 Participants 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 n=220 Participants Total of all reporting groups
Age, Continuous	62.6 years STANDARD_DEVIATION 14.3 • n=5 Participants	63.9 years STANDARD_DEVIATION 12.0 • n=7 Participants	63.2 years STANDARD_DEVIATION 13.5 • n=5 Participants
Sex: Female, Male Female	44 Participants n=5 Participants	55 Participants n=7 Participants	99 Participants n=5 Participants
Sex: Female, Male Male	56 Participants n=5 Participants	65 Participants n=7 Participants	121 Participants n=5 Participants

PRIMARY outcome

Timeframe: 12 months

Population: 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.

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

Outcome measures

Measure	Management Arm Change in Pain Score n=100 Participants 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 n=120 Participants 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 n=100 Participants 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 n=120 Participants 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 n=100 Participants 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 n=120 Participants 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.
Change in Pain, Sexual Dysfunction, and Depression Symptoms	-3.12 units on a scale Standard Error 0.54	-3.7 units on a scale Standard Error 0.51	0.62 units on a scale Standard Error 0.34	0.71 units on a scale Standard Error 0.32	-1.99 units on a scale Standard Error 0.54	-2.29 units on a scale Standard Error 0.49

Adverse Events

Arm 1

Serious events: 19 serious events

Other events: 2 other events

Deaths: 0 deaths

Arm 2

Serious events: 15 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Measure	Arm 1 n=100 participants at risk 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	Arm 2 n=120 participants at risk 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
General disorders death	19.0% 19/100 • Number of events 19	12.5% 15/120 • Number of events 15

Other adverse events

Measure	Arm 1 n=100 participants at risk 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	Arm 2 n=120 participants at risk 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
Nervous system disorders medication side effect	2.0% 2/100 • Number of events 100	0.83% 1/120 • Number of events 120

Additional Information

Steven D. Weisbord MD

VA Pittsburgh Healthcare System, Center for Health Equity Research and Promotion

Phone: 412-360-3911

Email: steven.weisbord@va.gov

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place