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Quality of Life and Depression in Dialysis Patients (QOLD)

21 août 2015 mis à jour par: 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.

Aperçu de l'étude

Statut

Complété

Les conditions

Description détaillée

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

Type d'étude

Observationnel

Inscription (Réel)

1068

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Lieux d'étude

  • Corée, République de
    • Seocho-gu
      • Seoul, Seocho-gu, Corée, République de, 137-701
        • Seoul St. Mary'S Hospital

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

18 ans à 75 ans (Adulte, Adulte plus âgé)

Accepte les volontaires sains

Non

Sexes éligibles pour l'étude

Tout

Méthode d'échantillonnage

Échantillon non probabiliste

Population étudiée

  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

La description

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

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

Cohortes et interventions

Groupe / Cohorte
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

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
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
Délai: 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)

Mesures de résultats secondaires

Mesure des résultats
Description de la mesure
Délai
The Association Between Hydration Status and Depression and Quality of Life in Peritoneal Dialysis Patients
Délai: 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
Délai: 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)

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Parrainer

Fresenius Medical Care Korea

Les enquêteurs

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

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude

1 août 2010

Achèvement primaire (Réel)

1 juin 2014

Achèvement de l'étude (Réel)

1 juin 2014

Dates d'inscription aux études

Première soumission

24 mai 2012

Première soumission répondant aux critères de contrôle qualité

16 août 2012

Première publication (Estimation)

20 août 2012

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Estimation)

24 septembre 2015

Dernière mise à jour soumise répondant aux critères de contrôle qualité

21 août 2015

Dernière vérification

1 août 2015

Plus d'information

Termes liés à cette étude

Mots clés

Termes MeSH pertinents supplémentaires

Autres numéros d'identification d'étude

  • QOLD_01_052012

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