Chronic Kidney Disease Stage 5
Conditions
Keywords
quality of life, depression, BCM (body composition minitor), hydrational status
Brief summary
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.
Detailed description
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
Interventions
None listed
Sponsors
Fresenius Medical Care Korea
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The Association Between Hydration Status and Depression and Quality of Life in Peritoneal Dialysis Patients | 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. |
| The Association Between Hydration Status and Depression and Quality of Life in Hemodialysis Patients | 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 |
Countries
South Korea
Participant flow
Recruitment details
1. Date of the recruitment period : From October 10, 2010 to April 3, 2013 2. Types of location : At the general hospitals
Participants by arm
| Arm | Count |
|---|---|
| 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 | 349 |
| Prevalent PD Patients Prevalent peritoneal dialysis(PD) patients who are under peritoneal dialysis treatment more than 6 months | 359 |
| Prevalent HD Patients Prevalent hemodialysis(HD) patients who are under hemodialysis treatment more than 6 months | 367 |
| Total | 1,075 |
Baseline characteristics
| Characteristic | Incident PD Patients | Prevalent PD Patients | Prevalent HD Patients | Total |
|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 70 Participants | 74 Participants | 70 Participants | 214 Participants |
| Age, Categorical Between 18 and 65 years | 279 Participants | 285 Participants | 297 Participants | 861 Participants |
| Age, Continuous | 51.7 years STANDARD_DEVIATION 11.6 | 51.9 years STANDARD_DEVIATION 11.6 | 51.0 years STANDARD_DEVIATION 11.5 | 51.5 years STANDARD_DEVIATION 11.6 |
| Sex: Female, Male Female | 209 Participants | 180 Participants | 189 Participants | 578 Participants |
| Sex: Female, Male Male | 140 Participants | 179 Participants | 178 Participants | 497 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 0 / 349 | 3 / 359 | 1 / 367 |
| serious Total, serious adverse events | 37 / 349 | 50 / 359 | 21 / 367 |
Outcome results
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.
Time frame: Visit 1(zero month) and Visit 2 (12 months after Visit 1)
Population: 5 subjects in Incident PD patients and 2 subjects in Prevalent HD patients are excluded due to protocol violation.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Incident PD Patients | 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 | Change in Mental health score | 0.46 units on a scale | Standard Deviation 13.39 |
| Incident PD Patients | 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 | Change in Physical health score | 1.22 units on a scale | Standard Deviation 19.53 |
| Incident PD Patients | 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 | Change in Kidney disease component score | -1.34 units on a scale | Standard Deviation 11.46 |
| Incident PD Patients | 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 | Change in BDI score | 1.12 units on a scale | Standard Deviation 8.74 |
| Prevalent PD Patients | 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 | Change in BDI score | 0.60 units on a scale | Standard Deviation 7.9 |
| Prevalent PD Patients | 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 | Change in Kidney disease component score | -0.50 units on a scale | Standard Deviation 10.03 |
| Prevalent PD Patients | 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 | Change in Physical health score | -1.50 units on a scale | Standard Deviation 17.95 |
| Prevalent PD Patients | 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 | Change in Mental health score | -1.27 units on a scale | Standard Deviation 12.04 |
| Prevalent HD Patients | 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 | Change in Physical health score | 1.62 units on a scale | Standard Deviation 17.44 |
| Prevalent HD Patients | 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 | Change in Mental health score | 0.32 units on a scale | Standard Deviation 11.98 |
| Prevalent HD Patients | 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 | Change in Kidney disease component score | -0.95 units on a scale | Standard Deviation 10.5 |
| Prevalent HD Patients | 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 | Change in BDI score | -0.08 units on a scale | Standard Deviation 7.33 |
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
Time frame: Visit 1(zero month) and Visit 2 (12 months after Visit 1)
Population: Only prevalent hemodialysis dialysis participants with complete baseline hydration status and scale scores were assessed for this Outcome Measure.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Incident PD Patients | The Association Between Hydration Status and Depression and Quality of Life in Hemodialysis Patients | Baseline physical health score | 56.28 units on a scale | Standard Deviation 15.01 |
| Incident PD Patients | The Association Between Hydration Status and Depression and Quality of Life in Hemodialysis Patients | Baseline BDI score | 16.06 units on a scale | Standard Deviation 8.81 |
| Incident PD Patients | The Association Between Hydration Status and Depression and Quality of Life in Hemodialysis Patients | Baseline mental health score | 49.93 units on a scale | Standard Deviation 10.69 |
| Incident PD Patients | The Association Between Hydration Status and Depression and Quality of Life in Hemodialysis Patients | Baseline kidney disease component score | 67.46 units on a scale | Standard Deviation 9.34 |
| Prevalent PD Patients | The Association Between Hydration Status and Depression and Quality of Life in Hemodialysis Patients | Baseline physical health score | 51.97 units on a scale | Standard Deviation 18.39 |
| Prevalent PD Patients | The Association Between Hydration Status and Depression and Quality of Life in Hemodialysis Patients | Baseline kidney disease component score | 65.51 units on a scale | Standard Deviation 10.65 |
| Prevalent PD Patients | The Association Between Hydration Status and Depression and Quality of Life in Hemodialysis Patients | Baseline mental health score | 47.86 units on a scale | Standard Deviation 12.29 |
| Prevalent PD Patients | The Association Between Hydration Status and Depression and Quality of Life in Hemodialysis Patients | Baseline BDI score | 16.57 units on a scale | Standard Deviation 9.56 |
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.
Time frame: Visit 1(zero month) and Visit 2 (12 months after Visit 1)
Population: PD participants with OH value, HRQOL scores and BDI scores at visit 1 and visit 2 were assessed for this Outcome Measure.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Incident PD Patients | The Association Between Hydration Status and Depression and Quality of Life in Peritoneal Dialysis Patients | Baseline physical health score | 55.5 units on a scale | Standard Deviation 16.2 |
| Incident PD Patients | The Association Between Hydration Status and Depression and Quality of Life in Peritoneal Dialysis Patients | Baseline mental health score | 50.1 units on a scale | Standard Deviation 10.6 |
| Incident PD Patients | The Association Between Hydration Status and Depression and Quality of Life in Peritoneal Dialysis Patients | Baseline kidney disease component score | 69.3 units on a scale | Standard Deviation 9.6 |
| Incident PD Patients | The Association Between Hydration Status and Depression and Quality of Life in Peritoneal Dialysis Patients | Baseline BDI score | 15.1 units on a scale | Standard Deviation 9.5 |
| Prevalent PD Patients | The Association Between Hydration Status and Depression and Quality of Life in Peritoneal Dialysis Patients | Baseline BDI score | 16.7 units on a scale | Standard Deviation 9.6 |
| Prevalent PD Patients | The Association Between Hydration Status and Depression and Quality of Life in Peritoneal Dialysis Patients | Baseline physical health score | 51.5 units on a scale | Standard Deviation 16.5 |
| Prevalent PD Patients | The Association Between Hydration Status and Depression and Quality of Life in Peritoneal Dialysis Patients | Baseline kidney disease component score | 67.0 units on a scale | Standard Deviation 9.6 |
| Prevalent PD Patients | The Association Between Hydration Status and Depression and Quality of Life in Peritoneal Dialysis Patients | Baseline mental health score | 47.5 units on a scale | Standard Deviation 11.1 |
Comparison: Student's t-test: Comparison of baseline physical health score between Normohydration group and Overhydration group.p-value: 0.008t-test, 2 sided
Comparison: Student's t test: Comparison of baseline mental health score between Normohydration group and Overhydration group.p-value: 0.008t-test, 2 sided
Comparison: Student's t test: Comparison of baseline kidney disease component score between Normohydration group and Overhydration groupp-value: 0.008t-test, 2 sided
Comparison: Student's t test: Comparison of baseline BDI score between Normohydration group and Overhydration group.p-value: 0.157t-test, 2 sided