Quality of Life and Depression in Dialysis Patients

NCT01668628 | Completed Results

• 1 other identifier: QOLD_01_052012
• Study Type: observational
• Target: 1,068
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Kidney Disease Stage 5

Keywords

quality of life; depression; BCM (body composition minitor); hydrational status

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• The Association Between Hydration Status and Depression and Quality of Life in Peritoneal Dialysis Patients

  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

  Visit 1(zero month) and Visit 2 (12 months after Visit 1)

Study Arms (3)

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

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Fresenius Medical Care Korea: lead

Study Sites (1)

Seoul St. Mary's Hospital

Seoul, Seocho-gu, 137-701, South Korea

Location

MeSH Terms

Conditions

Renal Insufficiency, Chronic; Depression

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Behavioral Symptoms; Behavior

Results Point of Contact

• Title: Dr. Hye Eun Yoon
• Organization: The Catholic University of Korea

berrynana@catholic.ac.kr

82-32-280-5886

Study Officials

• Yongsoo Kim, M.D., Ph.D.

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

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 24, 2012
• First Posted: August 20, 2012
• Study Start: August 1, 2010
• Primary Completion: June 1, 2014
• Study Completion: June 1, 2014
• Last Updated: September 24, 2015
• Results First Posted: September 24, 2015

Record last verified: 2015-08

Locations

KR (1)