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Quality of Life and Depression in Dialysis Patients (QOLD)

This study is currently recruiting participants.
Verified March 2013 by Fresenius Medical Care Korea
Sponsor:
Information provided by (Responsible Party):
Fresenius Medical Care Korea
ClinicalTrials.gov Identifier:
NCT01668628
First received: May 24, 2012
Last updated: March 7, 2013
Last verified: March 2013
History of Changes
  Purpose

The aim of this study is to evaluate QOL (quality of life) 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:

U.S. FDA Resources

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: 28 momths ] [ Designated as safety issue: No ]

    QOL is assessed via KDQOL SF 1.3 and depression is assessed via BDI at the visit 1 and Visit 2 period.

    Visit 2 period is followed 12 months after Visit 1 period.



Secondary Outcome Measures:
  • Association between QOL(quality of life) and depression [ Time Frame: 28 months ] [ Designated as safety issue: No ]

    QOL is assessed via KDQOL SF 1.3 and depression is assessed via BDI at the visit 1 and Visit 2 period.

    Visit 2 period is followed 12 months after Visit 1 period.


  • Comparison KDQOL and BDI score of peritoneal dialysis(PD) group with hemodialysis(HD) group [ Time Frame: 28 months ] [ Designated as safety issue: No ]
  • Hydration and nutrition status by BCM(Body composition monitor) [ Time Frame: 28 months ] [ Designated as safety issue: No ]

    Hydration and nutritional status is checked via BCM(body composition monitor) at Visit 1 and Visit 2 period.

    (Overhydration(OH), total body water(TBW), extracellular water(ECW), intracellular water(ICW), Lean tissue Index(LTI), Fat tissue index(FTI))



Estimated Enrollment: 750
Study Start Date: August 2010
Estimated Study Completion Date: June 2014
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts
Incident PD patients
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
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 QOL(quality of life) and depression in peritoneal dialysis patients compare to hemodialysis patients and assess 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01668628

Contacts
Contact: Yumi Cho 82-2-2112-8842 yu-mi.cho@fmc-asia.com

Locations
Korea, Republic of
Seoul St. Mary's Hospital Recruiting
Seoul, Seocho-gu, Korea, Republic of, 137-701
Contact: Cho Yumi     82-2-2112-8842     yu-mi.cho@fmc-asia.com    
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

No publications provided

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
Last Updated: March 7, 2013
Health Authority: South Korea: Institutional Review Board

Keywords provided by Fresenius Medical Care Korea:
quality of life
depression
BCM
hydrational status

Additional relevant MeSH terms:
Depression
Depressive Disorder
Kidney Diseases
Renal Insufficiency, Chronic
Kidney Failure, Chronic
 Behavioral Symptoms
Mood Disorders
Mental Disorders
Urologic Diseases
Renal Insufficiency

ClinicalTrials.gov processed this record on May 22, 2013