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N/A N=1,075

Quality of Life and Depression in Dialysis Patients

Chronic Kidney Disease Stage 5

Bottom Line

View on ClinicalTrials.gov: NCT01668628 ↗
Enrolled (actual)
1,075
Serious AEs
10.1%
Results posted
Sep 2015
Primary outcome: Primary: Change of Kidney Disease Quality of Life Short Form 1.3 (KDQOL SF 1.3) Score and Beck Depression Inventory(BDI) Score From Visit 1 Period — 1.22; -1.50; 1.62; 0.46 units on a scale

Study Design & Population

Study type
Observational
Phase
N/A
Interventions
—
Age
Adult, Older Adult · 18+ yrs
Sex
All
Sponsor
Fresenius Medical Care Korea
Primary completion
Jun 2014

Outcome Measures

OutcomeResultp-value
PRIMARY
Change of Kidney Disease Quality of Life Short Form 1.3 (KDQOL SF 1.3) Score and Beck Depression Inventory(BDI) Score From Visit 1 Period		 1.22; -1.50; 1.62; 0.46; -1.27; 0.32 —
SECONDARY
The Association Between Hydration Status and Depression and Quality of Life in Peritoneal Dialysis Patients		 55.5; 51.5; 50.1; 47.5; 69.3; 67.0 0.008 sig
SECONDARY
The Association Between Hydration Status and Depression and Quality of Life in Hemodialysis Patients		 56.28; 51.97; 49.93; 47.86; 67.46; 65.51 —

Summary

The aim of this study is to evaluate quality of life (QOL) and depression in peritoneal dialysis patients compare to hemodialysis patients and assess hydration effect on QOL and depression over time.

Eligibility Criteria

Inclusion Criteria

  • Dialysis patients, age from 18 years to 75 years
  • Incident continuous ambulatory peritoneal dialysis(CAPD) or automated peritoneal dialysis(APD) patients who don't have any experience of dialysis treatment before this study
  • Prevalent peritoneal dialysis(PD) patients who are getting peritoneal dialysis treatment more than 6 months
  • Prevalent hemodialysis (HD) patients who are getting haemodialysis treatment more than 6 months
  • The subjects who are eligible for 1 year follow up
  • Written informed consent before any trial related activities
  • Eligible patients to complete questionnaire

Exclusion Criteria

  • Prognosis for survival less than 3 months
  • Kidney transplantation less than 15 months
  • Ineligible patients for questionnaire
  • Any malignancies and ascites
  • Any condition which could interfere with the patient's ability to comply with the study protocol
  • Ineligible to measure BCM
  • pacemaker, defibrillator
  • pregnancy or lactation period
  • amputation
  • artificial joint
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01668628). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

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