Completed

QOLDQuality of Life and Depression in Peritoneal Dialysis Patients and Hemodialysis Patients

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What is being collected

Data Collection

Collected from today forward - Prospective
Who is being recruted

Urogenital Diseases+12

+ Behavior

+ Behavioral Symptoms

From 18 to 75 Years
See all eligibility criteria
How is the trial designed

Cohort

Tracking disease incidence in order to identify risk factors and understand disease progression over time.
Observational
Study Start: August 2010
See protocol details

Summary

Principal SponsorFresenius Medical Care Korea
Last updated: September 24, 2015
Sourced from a government-validated database.Claim as a partner

Study start date: August 1, 2010

Actual date on which the first participant was enrolled.

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

Principal SponsorFresenius Medical Care Korea
Last updated: September 24, 2015
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

1068 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Cohort

These studies follow a group of individuals with common characteristics (such as a condition or birth year) over a specific period to study health outcomes or exposures.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 18 to 75 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Urogenital DiseasesBehaviorBehavioral SymptomsChronic DiseaseFemale Urogenital Diseases and Pregnancy ComplicationsKidney DiseasesPathologic ProcessesPathological Conditions, Signs and SymptomsUrologic DiseasesDisease AttributesRenal InsufficiencyFemale Urogenital DiseasesMale Urogenital DiseasesDepressionRenal Insufficiency, Chronic

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

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

3 intervention groups are designated in this study

This study does not include a placebo group 

Treatment Groups

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Seoul St. Mary's Hospital

Seoul, South KoreaOpen Seoul St. Mary's Hospital in Google Maps
CompletedOne Study Center