Chronic Kidney Disease Stage 5QOLDNCT01668628
Quality of Life and Depression in Dialysis Patients
An observational study of Chronic Kidney Disease Stage 5, run by Fresenius Medical Care Korea at 1 site in South Korea.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Chronic Kidney Disease Stage 5
- How many people
- 1,068 participants
- Where
- 1 siteSouth Korea
- Study dates
- Aug 2010to Jun 2014
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 1. 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 2. Prevalent PD patients : 250 subjects, Prevalent peritoneal dialysis(PD) patients who are under peritoneal dialysis treatment more than 6 months 3. Prevalent HD patients : 250 subjects, Prevalent hemodialysis(HD) patients who are under hemodialysis treatment more than 6 months
Who may be able to join
- 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
Who cannot join
- 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
Show all 10Show fewer
- pacemaker, defibrillator
- pregnancy or lactation period
- amputation
- artificial joint
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Quality of Life and Depression in Peritoneal Dialysis Patients and Hemodialysis Patients
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.
Read the 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
- Conditions
- Chronic Kidney Disease Stage 5
- Keywords
- quality of life, depression, BCM (body composition minitor), hydrational status
- Medical subject headings
- Renal Insufficiency, Chronic, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Visit 1(zero month) and Visit 2 (12 months after Visit 1)
Secondary outcomes (2)
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.
Measured: 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
Measured: Visit 1(zero month) and Visit 2 (12 months after Visit 1)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Aug 2012 (estimated)
- Study startAug 2010
- Primary completionJun 2014
- Study completionJun 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Chronic Kidney Disease Stage 5Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,068 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fresenius Medical Care Korea
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Yongsoo Kim, M.D., Ph.D., Principal investigator, Division of nephrology, The Catholic University of Korea College of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01668628
- Sponsor's protocol ID
- QOLD_01_052012
- Acronym
- QOLD
- Status last verified
- Aug 2015
- First submitted
- 24 May 2012
- Last updated
- 24 Sep 2015
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Sep 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Quality of Life and Depression in Peritoneal Dialysis Patients and Hemodialysis Patients
- ClinicalTrials.gov ID
- NCT01668628
- Acronym / sponsor ID
- QOLD / QOLD_01_052012
- Conditions
- Chronic Kidney Disease Stage 5
- Keywords
- quality of life, depression, BCM (body composition minitor), hydrational status
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,068 participants (actual)
- Lead sponsor
- Fresenius Medical Care KoreaIndustry (pharma, biotech, devices)
- Study start
- Aug 2010
- Primary completion
- Jun 2014 (actual)
- Study completion
- Jun 2014 (actual)
- First posted
- 20 Aug 2012 (estimated)
- Results
- Posted 24 Sep 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 1. 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 2. Prevalent PD patients : 250 subjects, Prevalent peritoneal dialysis(PD) patients who are under peritoneal dialysis treatment more than 6 months 3. Prevalent HD patients : 250 subjects, Prevalent hemodialysis(HD) patients who are under hemodialysis treatment more than 6 months
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
Time frame: 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.
2 secondary outcomes
The Association Between Hydration Status and Depression and Quality of Life in Peritoneal Dialysis Patients
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
Time frame: Visit 1(zero month) and Visit 2 (12 months after Visit 1)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Sep 2015.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yongsoo Kim, M.D., Ph.D. principal investigator
Division of nephrology, The Catholic University of Korea College of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Kidney Disease Stage 5, run by Fresenius Medical Care Korea at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Sep 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 24 Sep 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 (time frame: Visit 1(zero month) and Visit 2 (12 months after Visit 1)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Sep 2015.