Quality of Life and Depression in Dialysis Patients

NCT ID: NCT01668628

Last Updated: 2015-09-24

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

1068 participants

Study Classification

OBSERVATIONAL

Study Start Date

2010-08-31

Study Completion Date

2014-06-30

Brief Summary

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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

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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

Conditions

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Chronic Kidney Disease Stage 5

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Incident PD patients

First treatment for end stage of renal disease (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 continuous ambulatory peritoneal dialysis (CAPD) or automated peritoneal dilaysis (APD) and they consent in advance to enter the study) and patients who don't have any experience of dialysis treatment before this study

No interventions assigned to this group

Prevalent PD patients

Prevalent peritoneal dialysis(PD) patients who are under peritoneal dialysis treatment more than 6 months

No interventions assigned to this group

Prevalent HD patients

Prevalent hemodialysis(HD) patients who are under hemodialysis treatment more than 6 months

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Fresenius Medical Care Korea

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Yongsoo Kim, M.D., Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Division of nephrology, The Catholic University of Korea College of Medicine

Locations

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Seoul St. Mary's Hospital

Seoul, Seocho-gu, South Korea

Site Status

Countries

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South Korea

Other Identifiers

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QOLD_01_052012

Identifier Type: -

Identifier Source: org_study_id

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