Clinical trial NCT01668628: Quality of Life and Depression in Dialysis Patients
Official title: Quality of Life and Depression in Peritoneal Dialysis Patients and Hemodialysis Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Chronic Kidney Disease Stage 5
Keywords: quality of life
depression
BCM (body composition minitor)
hydrational status
Lead sponsor: Fresenius Medical Care Korea
Sponsor class: INDUSTRY
First posted: 2012-08-20
Enrollment: 1068
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 1. Incident PD patients group : 250 subjects, First treatment for ESRD by any peritoneal dialysis modality within 30 days prior to or following enrollment (patients may be enrolled prior to commencing first treatment if there is clear indication that the treatment modality is CAPD or APD and they consent in advance to enter the study) and patients who don't have any experience of dialysis treatment before this study
2. Prevalent PD patients : 250 subjects, Prevalent peritoneal dialysis(PD) patients who are under peritoneal dialysis treatment more than 6 months
3. Prevalent HD patients : 250 subjects, Prevalent hemodialysis(HD) patients who are under hemodialysis treatment more than 6 months

Brief 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.

Detailed description: In dialysis patients, low QOL and depression affects clinical outcomes such as morbidity and mortality.

Therefore at the point of treating dialysis patients, It is important to provide not only physical health but also psychosocial health.

QOL could be decided by physical health (i.e. sign and symptom, laboratory results, death) and psychological health (i.e. fatigue, pain, consciousness of health and satisfaction).

And also generally it is well known that physical and psychological functions in dialysis patients are decreased.

And especially depression is common disease in dialysis patients. It is also well known that about from 25 to 50 percent of dialysis patients have depression which could result in low QOL moreover hospitalization, complication, and mortality.

But there is no QOL and depression study with hydration status. Therefore the investigators would like to explore it.

The objective of the study is to evaluate quality of life (QOL) and depression in dialysis patients and assess the 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

  1. pacemaker, defibrillator
  2. pregnancy or lactation period
  3. amputation
  4. artificial joint

Primary outcomes:
measure: 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
timeFrame: Visit 1(zero month) and Visit 2 (12 months after Visit 1)
Secondary outcomes:
measure: The Association Between Hydration Status and Depression and Quality of Life in Peritoneal Dialysis Patients
timeFrame: Visit 1(zero month) and Visit 2 (12 months after Visit 1)
measure: The Association Between Hydration Status and Depression and Quality of Life in Hemodialysis Patients
timeFrame: Visit 1(zero month) and Visit 2 (12 months after Visit 1)
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul St. Mary's Hospital
state: Seocho-gu
Study officials:
affiliation: Division of nephrology, The Catholic University of Korea College of Medicine
name: Yongsoo Kim, M.D., Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: