Quality of Life and Depression in Dialysis Patients (QOLD)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Fresenius Medical Care Korea
ClinicalTrials.gov Identifier:
NCT01668628
First received: May 24, 2012
Last updated: August 21, 2015
Last verified: August 2015
  Purpose
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.

Condition
Chronic Kidney Disease Stage 5

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Quality of Life and Depression in Peritoneal Dialysis Patients and Hemodialysis Patients

Resource links provided by NLM:


Further study details as provided by Fresenius Medical Care Korea:

Primary Outcome Measures:
  • 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 [ Time Frame: Visit 1(zero month) and Visit 2 (12 months after Visit 1) ] [ Designated as safety issue: No ]

    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.



Secondary Outcome Measures:
  • The Association Between Hydration Status and Depression and Quality of Life in Peritoneal Dialysis Patients [ Time Frame: Visit 1(zero month) and Visit 2 (12 months after Visit 1) ] [ Designated as safety issue: No ]

    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.


  • The Association Between Hydration Status and Depression and Quality of Life in Hemodialysis Patients [ Time Frame: Visit 1(zero month) and Visit 2 (12 months after Visit 1) ] [ Designated as safety issue: No ]
    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


Enrollment: 1068
Study Start Date: August 2010
Study Completion Date: June 2014
Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts
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

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

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
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

    1. pacemaker, defibrillator
    2. pregnancy or lactation period
    3. amputation
    4. artificial joint
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01668628

Locations
Korea, Republic of
Seoul St. Mary's Hospital
Seoul, Seocho-gu, Korea, Republic of, 137-701
Sponsors and Collaborators
Fresenius Medical Care Korea
Investigators
Principal Investigator: Yongsoo Kim, M.D., Ph.D. Division of nephrology, The Catholic University of Korea College of Medicine
  More Information

Responsible Party: Fresenius Medical Care Korea
ClinicalTrials.gov Identifier: NCT01668628     History of Changes
Other Study ID Numbers: QOLD_01_052012 
Study First Received: May 24, 2012
Results First Received: June 26, 2015
Last Updated: August 21, 2015
Health Authority: South Korea: Institutional Review Board

Keywords provided by Fresenius Medical Care Korea:
quality of life
depression
BCM (body composition minitor)
hydrational status

Additional relevant MeSH terms:
Kidney Diseases
Renal Insufficiency, Chronic
Renal Insufficiency
Urologic Diseases

ClinicalTrials.gov processed this record on April 27, 2016