Quality of Life and Depression in Dialysis Patients (QOLD)

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

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.

Study Overview

• Status: Completed
• Conditions: Chronic Kidney Disease Stage 5

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

• Study Type: Observational
• Enrollment (Actual): 1068

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seocho-gu
    • Seoul, Seocho-gu, Korea, Republic of, 137-701
      • Seoul St. Mary's Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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

Description

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 Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort
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
Prevalent PD patients; Prevalent peritoneal dialysis(PD) patients who are under peritoneal dialysis treatment more than 6 months
Prevalent HD patients; Prevalent hemodialysis(HD) patients who are under hemodialysis treatment more than 6 months

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)
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)

Collaborators and Investigators

• Sponsor: Fresenius Medical Care Korea
• Investigators: Principal Investigator: Yongsoo Kim, M.D., Ph.D., Division of nephrology, The Catholic University of Korea College of Medicine

Study record dates

Study Major Dates

• Study Start: August 1, 2010
• Primary Completion (Actual): June 1, 2014
• Study Completion (Actual): June 1, 2014

Study Registration Dates

• First Submitted: May 24, 2012
• First Submitted That Met QC Criteria: August 16, 2012
• First Posted (Estimate): August 20, 2012

Study Record Updates

• Last Update Posted (Estimate): September 24, 2015
• Last Update Submitted That Met QC Criteria: August 21, 2015
• Last Verified: August 1, 2015

More Information

Terms related to this study

• Keywords: quality of life; depression; BCM (body composition minitor); hydrational status
• Additional Relevant MeSH Terms: Behavioral Symptoms; Urologic Diseases; Renal Insufficiency; Depression; Kidney Diseases; Renal Insufficiency, Chronic
• Other Study ID Numbers: QOLD_01_052012