Quality of Life and Depression in Dialysis Patients

Chronic Kidney Disease Stage 5 Clinical Trial

— QOLD  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01668628
• Other study ID #: QOLD_01_052012
• Status: Completed
• Phase: N/A
• First received: May 24, 2012
• Last updated: August 21, 2015
• Start date: August 2010
• Est. completion date: June 2014

Study information

• Verified date: August 2015
• Source: Fresenius Medical Care Korea
• Contact: n/a
• Is FDA regulated: No
• Health authority: South Korea: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1068
• Est. completion date: June 2014
• Est. primary completion date: June 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Chronic Kidney Disease Stage 5
• Kidney Diseases
• Renal Insufficiency, Chronic

Locations

Country	Name	City	State
Korea, Republic of	Seoul St. Mary's Hospital	Seoul	Seocho-gu

Sponsors (1)

Lead Sponsor	Collaborator
Fresenius Medical Care Korea

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
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	Health-related quality of life (HRQOL) is assessed via KDQOL SF 1.3 and depression is assessed via BDI at the visit 1 and Visit 2 period.; KDQOL SF 1.3 and BDI are validated questionnaires to assess HRQOL and depression, respectively.; Visit 2 period is followed 12 months after Visit 1 period. The outcome measure is the difference in averaged scores between Visit 1 and Visit 2; It is calculated as (Score at visit 2 - Score at visit 1).; HRQOL is assessed by three components; physical health score, mental health score and kidney disease health score.; Physical health score, mental health score and kidney disease health score are averaged scores of subscales.; The range of each score and each subscale are 0 - 100, and higher values indicate better HRQOL status.; The BDI score is a summed score of each component of BDI questionnaire, and the range is 5 to 63. Higher BDI scores are considered to represent more severe depression symptoms.	Visit 1(zero month) and Visit 2 (12 months after Visit 1)	No
Secondary	The Association Between Hydration Status and Depression and Quality of Life in Peritoneal Dialysis Patients	Hydration status is checked via BCM(body composition monitor) at Visit 1 and Visit 2 period, as a Overhydration(OH) value.; Health-related quality of life (HRQOL) is measured via scores of KDQOL SF1.3. Depression was assessed using Beck Depression Inventory (BDI) score. Visit 2 period is followed 12 months after Visit 1 period. HRQOL is assessed by three components; physical health score, mental health score and kidney disease health score.; Physical health score, mental health score and kidney disease health score are averaged scores of subscales.; The range of each score and each subscale are 0 - 100, and higher values indicate better HRQOL status.; The BDI score is a summed score of each component of BDI questionnaire, and the range is 5 to 63. Higher BDI scores are considered to represent more severe depression symptoms.; The outcome measure is the averaged scores at Visit 1 between the Normohydration group and Overhydration group.	Visit 1(zero month) and Visit 2 (12 months after Visit 1)	No
Secondary	The Association Between Hydration Status and Depression and Quality of Life in Hemodialysis Patients	Quality of life was measured via scores of KDQOL SF1.3. Hydration status was measured via body composition monitor as an Overhydration (OH) value Depression was assessed using Beck depression inventory (BDI) score	Visit 1(zero month) and Visit 2 (12 months after Visit 1)	No