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NCT Number: NCT01668628

Quality of Life and Depression in Dialysis 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.

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Key information

Conditions

Chronic Kidney Disease Stage 5 Behavior Behavioral Symptoms Chronic Disease Depression Disease Attributes Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Diseases Male Urogenital Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Renal Insufficiency Renal Insufficiency, Chronic Urogenital Diseases Urologic Diseases

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Seoul St. Mary's Hospital

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

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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
  • pacemaker, defibrillator
  • pregnancy or lactation period
  • amputation
  • artificial joint

Treatment and study plan

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

    Time frame: Visit 1(zero month) and Visit 2 (12 months after Visit 1)

    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 outcomes

  1. 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)

    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.

  2. 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)

    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

Sponsors and collaborators

Lead sponsor

Fresenius Medical Care Korea

Industry

Registry information

Official study title

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

Acronym: QOLD

Important dates

Study start
2010
Primary completion
2014
Study completion
2014
First posted
Aug 20, 2012
Registry last updated
Sep 24, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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