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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.
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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
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| Measure | Description | Time Frame |
|---|---|---|
| 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 | 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) |
| Measure | Description | Time Frame |
|---|---|---|
| The Association Between Hydration Status and Depression and Quality of Life in Peritoneal Dialysis Patients | 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. |
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Inclusion Criteria:
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
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| Name | Affiliation | Role |
|---|---|---|
| Yongsoo Kim, M.D., Ph.D. | Division of nephrology, The Catholic University of Korea College of Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Seoul St. Mary's Hospital | Seoul | Seocho-gu | 137-701 | South Korea |
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| ID | Title | Description |
|---|---|---|
| FG000 | Incident Peritoneal Dialysis(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 dialysis (APD) and they consent in advance to enter the study) and patients who don't have any experience of dialysis treatment before this study |
| FG001 | Prevalent Peritoneal Dialysis (PD) Patients | Prevalent peritoneal dialysis(PD) patients who are under peritoneal dialysis treatment more than 6 months |
| FG002 | Prevalent Hemodialysis (HD) Patients | Prevalent hemodialysis(HD) patients who are under hemodialysis treatment more than 6 months |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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 dia;ysis (CAPD) or automated peritoneal dialysis (APD) and they consent in advance to enter the study) and patients who don't have any experience of dialysis treatment before this study |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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 | 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. | 5 subjects in Incident PD patients and 2 subjects in Prevalent HD patients are excluded due to protocol violation. | Posted | Mean | Standard Deviation | units on a scale | Visit 1(zero month) and Visit 2 (12 months after Visit 1) |
Visit 1(zero month) and Visit 2 (12 months after Visit 1)
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Peritonitis | Infections and infestations | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Kidney transplantation | Surgical and medical procedures | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Hye Eun Yoon | The Catholic University of Korea | 82-32-280-5886 | berrynana@catholic.ac.kr |
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| ID | Term |
|---|---|
| D051436 | Renal Insufficiency, Chronic |
| D003863 | Depression |
| ID | Term |
|---|---|
| D051437 | Renal Insufficiency |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
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| 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 | 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) |
| BG001 | Prevalent PD Patients | Prevalent peritoneal dialysis(PD) patients who are under peritoneal dialysis treatment more than 6 months |
| BG002 | Prevalent HD Patients | Prevalent hemodialysis(HD) patients who are under hemodialysis treatment more than 6 months |
| BG003 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| ID | Title | Description |
|---|---|---|
| OG000 | 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 dialysis (APD) and they consent in advance to enter the study) and patients who don't have any experience of dialysis treatment before this study |
| OG001 | Prevalent PD Patients | Prevalent peritoneal dialysis(PD) patients who are under peritoneal dialysis treatment more than 6 months |
| OG002 | Prevalent HD Patients | Prevalent hemodialysis(HD) patients who are under hemodialysis treatment more than 6 months |
|
|
| Secondary | The Association Between Hydration Status and Depression and Quality of Life in Peritoneal Dialysis Patients | 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. | PD participants with OH value, HRQOL scores and BDI scores at visit 1 and visit 2 were assessed for this Outcome Measure. | Posted | Mean | Standard Deviation | units on a scale | Visit 1(zero month) and Visit 2 (12 months after Visit 1) |
|
|
|
|
| Secondary | The Association Between Hydration Status and Depression and Quality of Life in Hemodialysis Patients | 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 | Only prevalent hemodialysis dialysis participants with complete baseline hydration status and scale scores were assessed for this Outcome Measure. | Posted | Mean | Standard Deviation | units on a scale | Visit 1(zero month) and Visit 2 (12 months after Visit 1) |
|
|
|
| 37 |
| 349 |
| 0 |
| 349 |
| EG001 | Prevalent PD Patients | Prevalent peritoneal dialysis(PD) patients who are under peritoneal dialysis treatment more than 6 months | 50 | 359 | 3 | 359 |
| EG002 | Prevalent HD Patients | Prevalent hemodialysis(HD) patients who are under hemodialysis treatment more than 6 months | 21 | 367 | 1 | 367 |
| Death | Cardiac disorders | Systematic Assessment |
|
| Admission | Renal and urinary disorders | Systematic Assessment |
|
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| D005261 |
| Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
| Baseline kidney disease component score |
|
| Baseline BDI score |
|
| t-test, 2 sided |
| 0.008 |
| 2-Sided |
| No |
| Superiority or Other |
| Student's t test: Comparison of baseline kidney disease component score between Normohydration group and Overhydration group | t-test, 2 sided | 0.008 | 2-Sided | No | Superiority or Other |
| Student's t test: Comparison of baseline BDI score between Normohydration group and Overhydration group. | t-test, 2 sided | 0.157 | 2-Sided | No | Superiority or Other |
| Baseline kidney disease component score |
|
| Baseline BDI score |
|