Trial Outcomes & Findings for Quality of Life and Depression in Dialysis Patients (NCT NCT01668628)

Results Overview

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.

Recruitment status

COMPLETED

Target enrollment

1068 participants

Primary outcome timeframe

Visit 1(zero month) and Visit 2 (12 months after Visit 1)

Results posted on

2015-09-24

Participant Flow

1. Date of the recruitment period : From October 10, 2010 to April 3, 2013 2. Types of location : At the general hospitals

Participant milestones

Participant milestones
Measure	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	Prevalent Peritoneal Dialysis (PD) Patients Prevalent peritoneal dialysis(PD) patients who are under peritoneal dialysis treatment more than 6 months	Prevalent Hemodialysis (HD) Patients Prevalent hemodialysis(HD) patients who are under hemodialysis treatment more than 6 months
Overall Study STARTED	349	359	367
Overall Study COMPLETED	347	359	367
Overall Study NOT COMPLETED	2	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Quality of Life and Depression in Dialysis Patients

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Incident PD Patients n=349 Participants 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	Prevalent PD Patients n=359 Participants Prevalent peritoneal dialysis(PD) patients who are under peritoneal dialysis treatment more than 6 months	Prevalent HD Patients n=367 Participants Prevalent hemodialysis(HD) patients who are under hemodialysis treatment more than 6 months	Total n=1075 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Age, Categorical Between 18 and 65 years	279 Participants n=5 Participants	285 Participants n=7 Participants	297 Participants n=5 Participants	861 Participants n=4 Participants
Age, Categorical >=65 years	70 Participants n=5 Participants	74 Participants n=7 Participants	70 Participants n=5 Participants	214 Participants n=4 Participants
Age, Continuous	51.7 years STANDARD_DEVIATION 11.6 • n=5 Participants	51.9 years STANDARD_DEVIATION 11.6 • n=7 Participants	51.0 years STANDARD_DEVIATION 11.5 • n=5 Participants	51.5 years STANDARD_DEVIATION 11.6 • n=4 Participants
Sex: Female, Male Female	209 Participants n=5 Participants	180 Participants n=7 Participants	189 Participants n=5 Participants	578 Participants n=4 Participants
Sex: Female, Male Male	140 Participants n=5 Participants	179 Participants n=7 Participants	178 Participants n=5 Participants	497 Participants n=4 Participants

PRIMARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure	Incident PD Patients n=347 Participants 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	Prevalent PD Patients n=359 Participants Prevalent peritoneal dialysis(PD) patients who are under peritoneal dialysis treatment more than 6 months	Prevalent HD Patients n=367 Participants 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 Change in Physical health score	1.22 units on a scale Standard Deviation 19.53	-1.50 units on a scale Standard Deviation 17.95	1.62 units on a scale Standard Deviation 17.44
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	-1.27 units on a scale Standard Deviation 12.04	0.32 units on a scale Standard Deviation 11.98
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	0.60 units on a scale Standard Deviation 7.90	-0.08 units on a scale Standard Deviation 7.33
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	-0.50 units on a scale Standard Deviation 10.03	-0.95 units on a scale Standard Deviation 10.5

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure	Incident PD Patients n=266 Participants 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	Prevalent PD Patients n=215 Participants 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
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	47.5 units on a scale Standard Deviation 11.1	—
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	51.5 units on a scale Standard Deviation 16.5	—
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	67.0 units on a scale Standard Deviation 9.6	—
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	16.7 units on a scale Standard Deviation 9.6	—

SECONDARY outcome

Timeframe: 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.

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

Outcome measures

Outcome measures
Measure	Incident PD Patients n=198 Participants 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	Prevalent PD Patients n=159 Participants 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
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	51.97 units on a scale Standard Deviation 18.39	—
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	47.86 units on a scale Standard Deviation 12.29	—
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	65.51 units on a scale Standard Deviation 10.65	—
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	16.57 units on a scale Standard Deviation 9.56	—

Adverse Events

Incident PD Patients

Serious events: 37 serious events

Other events: 0 other events

Deaths: 0 deaths

Prevalent PD Patients

Serious events: 50 serious events

Other events: 3 other events

Deaths: 0 deaths

Prevalent HD Patients

Serious events: 21 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Incident PD Patients n=349 participants at risk 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 n=359 participants at risk Prevalent peritoneal dialysis(PD) patients who are under peritoneal dialysis treatment more than 6 months	Prevalent HD Patients n=367 participants at risk Prevalent hemodialysis(HD) patients who are under hemodialysis treatment more than 6 months
Infections and infestations Peritonitis	5.4% 19/349 • Number of events 19 • Visit 1(zero month) and Visit 2 (12 months after Visit 1)	6.1% 22/359 • Number of events 22 • Visit 1(zero month) and Visit 2 (12 months after Visit 1)	0.00% 0/367 • Visit 1(zero month) and Visit 2 (12 months after Visit 1)
Cardiac disorders Death	3.4% 12/349 • Number of events 12 • Visit 1(zero month) and Visit 2 (12 months after Visit 1)	5.8% 21/359 • Number of events 21 • Visit 1(zero month) and Visit 2 (12 months after Visit 1)	3.5% 13/367 • Number of events 13 • Visit 1(zero month) and Visit 2 (12 months after Visit 1)
Renal and urinary disorders Admission	1.7% 6/349 • Number of events 6 • Visit 1(zero month) and Visit 2 (12 months after Visit 1)	1.9% 7/359 • Number of events 7 • Visit 1(zero month) and Visit 2 (12 months after Visit 1)	2.2% 8/367 • Number of events 8 • Visit 1(zero month) and Visit 2 (12 months after Visit 1)

Other adverse events

Other adverse events
Measure	Incident PD Patients n=349 participants at risk 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 n=359 participants at risk Prevalent peritoneal dialysis(PD) patients who are under peritoneal dialysis treatment more than 6 months	Prevalent HD Patients n=367 participants at risk Prevalent hemodialysis(HD) patients who are under hemodialysis treatment more than 6 months
Surgical and medical procedures Kidney transplantation	0.00% 0/349 • Visit 1(zero month) and Visit 2 (12 months after Visit 1)	0.84% 3/359 • Number of events 3 • Visit 1(zero month) and Visit 2 (12 months after Visit 1)	0.27% 1/367 • Number of events 1 • Visit 1(zero month) and Visit 2 (12 months after Visit 1)

Additional Information

Dr. Hye Eun Yoon

The Catholic University of Korea

Phone: 82-32-280-5886

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place