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Quality of Life and Depression in Dialysis Patients (QOLD)

21 augustus 2015 bijgewerkt door: Fresenius Medical Care Korea

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.

Studie Overzicht

Toestand

Voltooid

Conditie

Gedetailleerde beschrijving

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

Studietype

Observationeel

Inschrijving (Werkelijk)

1068

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studie Locaties

  • Korea, republiek van
    • Seocho-gu
      • Seoul, Seocho-gu, Korea, republiek van, 137-701
        • Seoul St. Mary'S Hospital

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

18 jaar tot 75 jaar (Volwassen, Oudere volwassene)

Accepteert gezonde vrijwilligers

Nee

Geslachten die in aanmerking komen voor studie

Allemaal

Bemonsteringsmethode

Niet-waarschijnlijkheidssteekproef

Studie Bevolking

  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

Beschrijving

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

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

Cohorten en interventies

Groep / 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

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
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
Tijdsspanne: 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.
Visit 1(zero month) and Visit 2 (12 months after Visit 1)

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
The Association Between Hydration Status and Depression and Quality of Life in Peritoneal Dialysis Patients
Tijdsspanne: 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.
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
Tijdsspanne: 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
Visit 1(zero month) and Visit 2 (12 months after Visit 1)

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

Fresenius Medical Care Korea

Onderzoekers

  • Hoofdonderzoeker: Yongsoo Kim, M.D., Ph.D., Division of nephrology, The Catholic University of Korea College of Medicine

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start

1 augustus 2010

Primaire voltooiing (Werkelijk)

1 juni 2014

Studie voltooiing (Werkelijk)

1 juni 2014

Studieregistratiedata

Eerst ingediend

24 mei 2012

Eerst ingediend dat voldeed aan de QC-criteria

16 augustus 2012

Eerst geplaatst (Schatting)

20 augustus 2012

Updates van studierecords

Laatste update geplaatst (Schatting)

24 september 2015

Laatste update ingediend die voldeed aan QC-criteria

21 augustus 2015

Laatst geverifieerd

1 augustus 2015

Meer informatie

Termen gerelateerd aan deze studie

Trefwoorden

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • QOLD_01_052012

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