Quality of Life and Depression in Dialysis Patients (QOLD)
Quality of Life and Depression in Peritoneal Dialysis Patients and Hemodialysis Patients
Visão geral do estudo
Status
Condições
Descrição detalhada
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
Tipo de estudo
Inscrição (Real)
Contactos e Locais
Locais de estudo
-
-
Seocho-gu
-
Seoul, Seocho-gu, Republica da Coréia, 137-701
- Seoul St. Mary'S Hospital
-
-
Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
Método de amostragem
População do estudo
- 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
- Prevalent PD patients : 250 subjects, Prevalent peritoneal dialysis(PD) patients who are under peritoneal dialysis treatment more than 6 months
- Prevalent HD patients : 250 subjects, Prevalent hemodialysis(HD) patients who are under hemodialysis treatment more than 6 months
Descrição
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
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
Coortes e Intervenções
Grupo / Coorte |
|---|
|
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
|
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
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
Prazo: 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)
|
Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
The Association Between Hydration Status and Depression and Quality of Life in Peritoneal Dialysis Patients
Prazo: 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
Prazo: 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)
|
Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Yongsoo Kim, M.D., Ph.D., Division of nephrology, The Catholic University of Korea College of Medicine
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo
Conclusão Primária (Real)
Conclusão do estudo (Real)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Estimativa)
Atualizações de registro de estudo
Última Atualização Postada (Estimativa)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- QOLD_01_052012
Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .