An observational study in Chronic Kidney Disease Stage 5, sponsored by Fresenius Medical Care Korea. Completed at 1 site in Korea, Republic of. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2015-09-24.
Sponsored by Fresenius Medical Care Korea · Observational
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
3,840 studies on the registry are indexed under Kidney Diseases; 500 are open to participants now.
This study's enrollment of 1,068 is above the median of 192 across 1,033 observational studies indexed under Kidney Diseases.
Browse Kidney Diseases studies →Fresenius Medical Care Korea is the lead sponsor of 2 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Ineligible to measure BCM
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 peritoneal dialysis(PD) patients who are under peritoneal dialysis treatment more than 6 months
Prevalent hemodialysis(HD) patients who are under hemodialysis treatment more than 6 months
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.
Time frame: Visit 1(zero month) and Visit 2 (12 months after Visit 1)
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.
Time frame: 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
Time frame: Visit 1(zero month) and Visit 2 (12 months after Visit 1)
1. Date of the recruitment period : From October 10, 2010 to April 3, 2013 2. Types of location : At the general hospitals
| Milestone | Incident Peritoneal Dialysis(PD) Patients | Prevalent Peritoneal Dialysis (PD) Patients | Prevalent Hemodialysis (HD) Patients |
|---|---|---|---|
| Started | 349 | 359 | 367 |
| Completed | 347 | 359 | 367 |
| Not completed | 2 | 0 | 0 |
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.
| units on a scale | Incident PD Patients | Prevalent PD Patients | Prevalent HD Patients |
|---|---|---|---|
| Change in Physical health score | 1.22 ± 19.53 | -1.50 ± 17.95 | 1.62 ± 17.44 |
| Change in Mental health score | 0.46 ± 13.39 | -1.27 ± 12.04 | 0.32 ± 11.98 |
| Change in Kidney disease component score | -1.34 ± 11.46 | -0.50 ± 10.03 | -0.95 ± 10.5 |
| Change in BDI score | 1.12 ± 8.74 | 0.60 ± 7.90 | -0.08 ± 7.33 |
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.
| units on a scale | Normohydration Group | Overhydration Group |
|---|---|---|
| Baseline physical health score | 55.5 ± 16.2 | 51.5 ± 16.5 |
| Baseline mental health score | 50.1 ± 10.6 | 47.5 ± 11.1 |
| Baseline kidney disease component score | 69.3 ± 9.6 | 67.0 ± 9.6 |
| Baseline BDI score | 15.1 ± 9.5 | 16.7 ± 9.6 |
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
| units on a scale | Normohydration Group | Overhydration Group |
|---|---|---|
| Baseline physical health score | 56.28 ± 15.01 | 51.97 ± 18.39 |
| Baseline mental health score | 49.93 ± 10.69 | 47.86 ± 12.29 |
| Baseline kidney disease component score | 67.46 ± 9.34 | 65.51 ± 10.65 |
| Baseline BDI score | 16.06 ± 8.81 | 16.57 ± 9.56 |
Collected over Visit 1(zero month) and Visit 2 (12 months after Visit 1). Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Incident PD Patients | — | 37/349 (10.6%) | 0/349 (0%) |
| Prevalent PD Patients | — | 50/359 (13.9%) | 3/359 (0.8%) |
| Prevalent HD Patients | — | 21/367 (5.7%) | 1/367 (0.3%) |
| Event | Incident PD Patients | Prevalent PD Patients | Prevalent HD Patients |
|---|---|---|---|
| PeritonitisInfections and infestations | 19/349 | 22/359 | 0/367 |
| DeathCardiac disorders | 12/349 | 21/359 | 13/367 |
| AdmissionRenal and urinary disorders | 6/349 | 7/359 | 8/367 |
| Event | Incident PD Patients | Prevalent PD Patients | Prevalent HD Patients |
|---|---|---|---|
| Kidney transplantationSurgical and medical procedures | 0/349 | 3/359 | 1/367 |
| Age, Categorical(Participants) | Incident PD Patients | Prevalent PD Patients | Prevalent HD Patients | Total |
|---|---|---|---|---|
| <=18 years | 0 | 0 | 0 | 0 |
| Between 18 and 65 years | 279 | 285 | 297 | 861 |
| >=65 years | 70 | 74 | 70 | 214 |
| Age, Continuous(years) | Incident PD Patients | Prevalent PD Patients | Prevalent HD Patients | Total |
|---|---|---|---|---|
| Mean | 51.7 ± 11.6 | 51.9 ± 11.6 | 51.0 ± 11.5 | 51.5 ± 11.6 |
| Sex: Female, Male(Participants) | Incident PD Patients | Prevalent PD Patients | Prevalent HD Patients | Total |
|---|---|---|---|---|
| Female | 209 | 180 | 189 | 578 |
| Male | 140 | 179 | 178 | 497 |
This study is completed, as verified in Aug 2015. You cannot join it, but the record below documents what was studied.
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Fresenius Medical Care Korea