<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT01668628</url>
  </required_header>
  <id_info>
    <org_study_id>QOLD_01_052012</org_study_id>
    <nct_id>NCT01668628</nct_id>
  </id_info>
  <brief_title>Quality of Life and Depression in Dialysis Patients</brief_title>
  <acronym>QOLD</acronym>
  <official_title>Quality of Life and Depression in Peritoneal Dialysis Patients and Hemodialysis Patients</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Fresenius Medical Care Korea</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Fresenius Medical Care Korea</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The aim of this study is to evaluate quality of life (QOL) and depression in peritoneal&#xD;
      dialysis patients compare to hemodialysis patients and assess hydration effect on QOL and&#xD;
      depression over time.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      In dialysis patients, low QOL and depression affects clinical outcomes such as morbidity and&#xD;
      mortality.&#xD;
&#xD;
      Therefore at the point of treating dialysis patients, It is important to provide not only&#xD;
      physical health but also psychosocial health.&#xD;
&#xD;
      QOL could be decided by physical health (i.e. sign and symptom, laboratory results, death)&#xD;
      and psychological health (i.e. fatigue, pain, consciousness of health and satisfaction).&#xD;
&#xD;
      And also generally it is well known that physical and psychological functions in dialysis&#xD;
      patients are decreased.&#xD;
&#xD;
      And especially depression is common disease in dialysis patients. It is also well known that&#xD;
      about from 25 to 50 percent of dialysis patients have depression which could result in low&#xD;
      QOL moreover hospitalization, complication, and mortality.&#xD;
&#xD;
      But there is no QOL and depression study with hydration status. Therefore the investigators&#xD;
      would like to explore it.&#xD;
&#xD;
      The objective of the study is to evaluate quality of life (QOL) and depression in dialysis&#xD;
      patients and assess the hydration effect on QOL and depression over time&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>August 2010</start_date>
  <completion_date type="Actual">June 2014</completion_date>
  <primary_completion_date type="Actual">June 2014</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <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</measure>
    <time_frame>Visit 1(zero month) and Visit 2 (12 months after Visit 1)</time_frame>
    <description>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.&#xD;
KDQOL SF 1.3 and BDI are validated questionnaires to assess HRQOL and depression, respectively.&#xD;
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).&#xD;
HRQOL is assessed by three components; physical health score, mental health score and kidney disease health score.&#xD;
Physical health score, mental health score and kidney disease health score are averaged scores of subscales.&#xD;
The range of each score and each subscale are 0 - 100, and higher values indicate better HRQOL status.&#xD;
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.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>The Association Between Hydration Status and Depression and Quality of Life in Peritoneal Dialysis Patients</measure>
    <time_frame>Visit 1(zero month) and Visit 2 (12 months after Visit 1)</time_frame>
    <description>Hydration status is checked via BCM(body composition monitor) at Visit 1 and Visit 2 period, as a Overhydration(OH) value.&#xD;
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.&#xD;
Physical health score, mental health score and kidney disease health score are averaged scores of subscales.&#xD;
The range of each score and each subscale are 0 - 100, and higher values indicate better HRQOL status.&#xD;
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.&#xD;
The outcome measure is the averaged scores at Visit 1 between the Normohydration group and Overhydration group.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The Association Between Hydration Status and Depression and Quality of Life in Hemodialysis Patients</measure>
    <time_frame>Visit 1(zero month) and Visit 2 (12 months after Visit 1)</time_frame>
    <description>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</description>
  </secondary_outcome>
  <number_of_groups>3</number_of_groups>
  <enrollment type="Actual">1068</enrollment>
  <condition>Chronic Kidney Disease Stage 5</condition>
  <arm_group>
    <arm_group_label>Incident PD patients</arm_group_label>
    <description>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</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Prevalent PD patients</arm_group_label>
    <description>Prevalent peritoneal dialysis(PD) patients who are under peritoneal dialysis treatment more than 6 months</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Prevalent HD patients</arm_group_label>
    <description>Prevalent hemodialysis(HD) patients who are under hemodialysis treatment more than 6 months</description>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        1. Incident PD patients group : 250 subjects, First treatment for ESRD by any peritoneal&#xD;
             dialysis modality within 30 days prior to or following enrollment (patients may be&#xD;
             enrolled prior to commencing first treatment if there is clear indication that the&#xD;
             treatment modality is CAPD or APD and they consent in advance to enter the study) and&#xD;
             patients who don't have any experience of dialysis treatment before this study&#xD;
&#xD;
          2. Prevalent PD patients : 250 subjects, Prevalent peritoneal dialysis(PD) patients who&#xD;
             are under peritoneal dialysis treatment more than 6 months&#xD;
&#xD;
          3. Prevalent HD patients : 250 subjects, Prevalent hemodialysis(HD) patients who are&#xD;
             under hemodialysis treatment more than 6 months&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Dialysis patients, age from 18 years to 75 years&#xD;
&#xD;
          -  Incident continuous ambulatory peritoneal dialysis(CAPD) or automated peritoneal&#xD;
             dialysis(APD) patients who don't have any experience of dialysis treatment before this&#xD;
             study&#xD;
&#xD;
          -  Prevalent peritoneal dialysis(PD) patients who are getting peritoneal dialysis&#xD;
             treatment more than 6 months&#xD;
&#xD;
          -  Prevalent hemodialysis (HD) patients who are getting haemodialysis treatment more than&#xD;
             6 months&#xD;
&#xD;
          -  The subjects who are eligible for 1 year follow up&#xD;
&#xD;
          -  Written informed consent before any trial related activities&#xD;
&#xD;
          -  Eligible patients to complete questionnaire&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Prognosis for survival less than 3 months&#xD;
&#xD;
          -  Kidney transplantation less than 15 months&#xD;
&#xD;
          -  Ineligible patients for questionnaire&#xD;
&#xD;
          -  Any malignancies and ascites&#xD;
&#xD;
          -  Any condition which could interfere with the patient's ability to comply with the&#xD;
             study protocol&#xD;
&#xD;
          -  Ineligible to measure BCM&#xD;
&#xD;
               1. pacemaker, defibrillator&#xD;
&#xD;
               2. pregnancy or lactation period&#xD;
&#xD;
               3. amputation&#xD;
&#xD;
               4. artificial joint&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Yongsoo Kim, M.D., Ph.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Division of nephrology, The Catholic University of Korea College of Medicine</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Seoul St. Mary's Hospital</name>
      <address>
        <city>Seoul</city>
        <state>Seocho-gu</state>
        <zip>137-701</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Korea, Republic of</country>
  </location_countries>
  <verification_date>August 2015</verification_date>
  <study_first_submitted>May 24, 2012</study_first_submitted>
  <study_first_submitted_qc>August 16, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 20, 2012</study_first_posted>
  <results_first_submitted>June 26, 2015</results_first_submitted>
  <results_first_submitted_qc>August 21, 2015</results_first_submitted_qc>
  <results_first_posted type="Estimate">September 24, 2015</results_first_posted>
  <last_update_submitted>August 21, 2015</last_update_submitted>
  <last_update_submitted_qc>August 21, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">September 24, 2015</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>quality of life</keyword>
  <keyword>depression</keyword>
  <keyword>BCM (body composition minitor)</keyword>
  <keyword>hydrational status</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Kidney Diseases</mesh_term>
    <mesh_term>Renal Insufficiency, Chronic</mesh_term>
    <mesh_term>Depression</mesh_term>
  </condition_browse>

  <clinical_results>

    <participant_flow>
      <recruitment_details>Date of the recruitment period : From October 10, 2010 to April 3, 2013&#xD;
Types of location : At the general hospitals</recruitment_details>
      <group_list>
        <group group_id="P1">
          <title>Incident Peritoneal Dialysis(PD) Patients</title>
          <description>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</description>
        </group>
        <group group_id="P2">
          <title>Prevalent Peritoneal Dialysis (PD) Patients</title>
          <description>Prevalent peritoneal dialysis(PD) patients who are under peritoneal dialysis treatment more than 6 months</description>
        </group>
        <group group_id="P3">
          <title>Prevalent Hemodialysis (HD) Patients</title>
          <description>Prevalent hemodialysis(HD) patients who are under hemodialysis treatment more than 6 months</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="349">5 subjects had been excluded due to protocol violation and then data of the rest were anlayzed.</participants>
                <participants group_id="P2" count="359"/>
                <participants group_id="P3" count="367">2 subjects had been excluded due to protocol violation and then data of the rest were anlayzed.</participants>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="347"/>
                <participants group_id="P2" count="359"/>
                <participants group_id="P3" count="367"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Incident PD Patients</title>
          <description>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</description>
        </group>
        <group group_id="B2">
          <title>Prevalent PD Patients</title>
          <description>Prevalent peritoneal dialysis(PD) patients who are under peritoneal dialysis treatment more than 6 months</description>
        </group>
        <group group_id="B3">
          <title>Prevalent HD Patients</title>
          <description>Prevalent hemodialysis(HD) patients who are under hemodialysis treatment more than 6 months</description>
        </group>
        <group group_id="B4">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="349"/>
            <count group_id="B2" value="359"/>
            <count group_id="B3" value="367"/>
            <count group_id="B4" value="1075"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>&lt;=18 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Between 18 and 65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="279"/>
                    <measurement group_id="B2" value="285"/>
                    <measurement group_id="B3" value="297"/>
                    <measurement group_id="B4" value="861"/>
                  </measurement_list>
                </category>
                <category>
                  <title>&gt;=65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="70"/>
                    <measurement group_id="B2" value="74"/>
                    <measurement group_id="B3" value="70"/>
                    <measurement group_id="B4" value="214"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="51.7" spread="11.6"/>
                    <measurement group_id="B2" value="51.9" spread="11.6"/>
                    <measurement group_id="B3" value="51.0" spread="11.5"/>
                    <measurement group_id="B4" value="51.5" spread="11.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="209"/>
                    <measurement group_id="B2" value="180"/>
                    <measurement group_id="B3" value="189"/>
                    <measurement group_id="B4" value="578"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="140"/>
                    <measurement group_id="B2" value="179"/>
                    <measurement group_id="B3" value="178"/>
                    <measurement group_id="B4" value="497"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>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</title>
        <description>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.&#xD;
KDQOL SF 1.3 and BDI are validated questionnaires to assess HRQOL and depression, respectively.&#xD;
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).&#xD;
HRQOL is assessed by three components; physical health score, mental health score and kidney disease health score.&#xD;
Physical health score, mental health score and kidney disease health score are averaged scores of subscales.&#xD;
The range of each score and each subscale are 0 - 100, and higher values indicate better HRQOL status.&#xD;
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.</description>
        <time_frame>Visit 1(zero month) and Visit 2 (12 months after Visit 1)</time_frame>
        <population>5 subjects in Incident PD patients and 2 subjects in Prevalent HD patients are excluded due to protocol violation.</population>
        <group_list>
          <group group_id="O1">
            <title>Incident PD Patients</title>
            <description>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</description>
          </group>
          <group group_id="O2">
            <title>Prevalent PD Patients</title>
            <description>Prevalent peritoneal dialysis(PD) patients who are under peritoneal dialysis treatment more than 6 months</description>
          </group>
          <group group_id="O3">
            <title>Prevalent HD Patients</title>
            <description>Prevalent hemodialysis(HD) patients who are under hemodialysis treatment more than 6 months</description>
          </group>
        </group_list>
        <measure>
          <title>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</title>
          <description>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.&#xD;
KDQOL SF 1.3 and BDI are validated questionnaires to assess HRQOL and depression, respectively.&#xD;
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).&#xD;
HRQOL is assessed by three components; physical health score, mental health score and kidney disease health score.&#xD;
Physical health score, mental health score and kidney disease health score are averaged scores of subscales.&#xD;
The range of each score and each subscale are 0 - 100, and higher values indicate better HRQOL status.&#xD;
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.</description>
          <population>5 subjects in Incident PD patients and 2 subjects in Prevalent HD patients are excluded due to protocol violation.</population>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="347"/>
                <count group_id="O2" value="359"/>
                <count group_id="O3" value="367"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Change in Physical health score</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.22" spread="19.53"/>
                    <measurement group_id="O2" value="-1.50" spread="17.95"/>
                    <measurement group_id="O3" value="1.62" spread="17.44"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change in Mental health score</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.46" spread="13.39"/>
                    <measurement group_id="O2" value="-1.27" spread="12.04"/>
                    <measurement group_id="O3" value="0.32" spread="11.98"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change in Kidney disease component score</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-1.34" spread="11.46"/>
                    <measurement group_id="O2" value="-0.50" spread="10.03"/>
                    <measurement group_id="O3" value="-0.95" spread="10.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change in BDI score</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.12" spread="8.74"/>
                    <measurement group_id="O2" value="0.60" spread="7.90"/>
                    <measurement group_id="O3" value="-0.08" spread="7.33"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>The Association Between Hydration Status and Depression and Quality of Life in Peritoneal Dialysis Patients</title>
        <description>Hydration status is checked via BCM(body composition monitor) at Visit 1 and Visit 2 period, as a Overhydration(OH) value.&#xD;
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.&#xD;
Physical health score, mental health score and kidney disease health score are averaged scores of subscales.&#xD;
The range of each score and each subscale are 0 - 100, and higher values indicate better HRQOL status.&#xD;
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.&#xD;
The outcome measure is the averaged scores at Visit 1 between the Normohydration group and Overhydration group.</description>
        <time_frame>Visit 1(zero month) and Visit 2 (12 months after Visit 1)</time_frame>
        <population>PD participants with OH value, HRQOL scores and BDI scores at visit 1 and visit 2 were assessed for this Outcome Measure.</population>
        <group_list>
          <group group_id="O1">
            <title>Normohydration Group</title>
            <description>Peritoneal dialysis patients with baseline -2L&lt;OH value &lt;+2L</description>
          </group>
          <group group_id="O2">
            <title>Overhydration Group</title>
            <description>Peritoneal dialysis patients with baseline OH value &gt;+2L</description>
          </group>
        </group_list>
        <measure>
          <title>The Association Between Hydration Status and Depression and Quality of Life in Peritoneal Dialysis Patients</title>
          <description>Hydration status is checked via BCM(body composition monitor) at Visit 1 and Visit 2 period, as a Overhydration(OH) value.&#xD;
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.&#xD;
Physical health score, mental health score and kidney disease health score are averaged scores of subscales.&#xD;
The range of each score and each subscale are 0 - 100, and higher values indicate better HRQOL status.&#xD;
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.&#xD;
The outcome measure is the averaged scores at Visit 1 between the Normohydration group and Overhydration group.</description>
          <population>PD participants with OH value, HRQOL scores and BDI scores at visit 1 and visit 2 were assessed for this Outcome Measure.</population>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="266"/>
                <count group_id="O2" value="215"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline physical health score</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="55.5" spread="16.2"/>
                    <measurement group_id="O2" value="51.5" spread="16.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Baseline mental health score</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="50.1" spread="10.6"/>
                    <measurement group_id="O2" value="47.5" spread="11.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Baseline kidney disease component score</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="69.3" spread="9.6"/>
                    <measurement group_id="O2" value="67.0" spread="9.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Baseline BDI score</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="15.1" spread="9.5"/>
                    <measurement group_id="O2" value="16.7" spread="9.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Student's t-test: Comparison of baseline physical health score between Normohydration group and Overhydration group.</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>0.008</p_value>
            <method>t-test, 2 sided</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Student's t test: Comparison of baseline mental health score between Normohydration group and Overhydration group.</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>0.008</p_value>
            <method>t-test, 2 sided</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Student's t test: Comparison of baseline kidney disease component score between Normohydration group and Overhydration group</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>0.008</p_value>
            <method>t-test, 2 sided</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Student's t test: Comparison of baseline BDI score between Normohydration group and Overhydration group.</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>0.157</p_value>
            <method>t-test, 2 sided</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>The Association Between Hydration Status and Depression and Quality of Life in Hemodialysis Patients</title>
        <description>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</description>
        <time_frame>Visit 1(zero month) and Visit 2 (12 months after Visit 1)</time_frame>
        <population>Only prevalent hemodialysis dialysis participants with complete baseline hydration status and scale scores were assessed for this Outcome Measure.</population>
        <group_list>
          <group group_id="O1">
            <title>Normohydration Group</title>
            <description>Hemodialysis patients with baseline -2L&lt;OH value &lt;+2L</description>
          </group>
          <group group_id="O2">
            <title>Overhydration Group</title>
            <description>Hemodialysis patients with baseline OH value &gt;+2L</description>
          </group>
        </group_list>
        <measure>
          <title>The Association Between Hydration Status and Depression and Quality of Life in Hemodialysis Patients</title>
          <description>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</description>
          <population>Only prevalent hemodialysis dialysis participants with complete baseline hydration status and scale scores were assessed for this Outcome Measure.</population>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="198"/>
                <count group_id="O2" value="159"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline physical health score</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="56.28" spread="15.01"/>
                    <measurement group_id="O2" value="51.97" spread="18.39"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Baseline mental health score</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="49.93" spread="10.69"/>
                    <measurement group_id="O2" value="47.86" spread="12.29"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Baseline kidney disease component score</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="67.46" spread="9.34"/>
                    <measurement group_id="O2" value="65.51" spread="10.65"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Baseline BDI score</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="16.06" spread="8.81"/>
                    <measurement group_id="O2" value="16.57" spread="9.56"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Visit 1(zero month) and Visit 2 (12 months after Visit 1)</time_frame>
      <group_list>
        <group group_id="E1">
          <title>Incident PD Patients</title>
          <description>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</description>
        </group>
        <group group_id="E2">
          <title>Prevalent PD Patients</title>
          <description>Prevalent peritoneal dialysis(PD) patients who are under peritoneal dialysis treatment more than 6 months</description>
        </group>
        <group group_id="E3">
          <title>Prevalent HD Patients</title>
          <description>Prevalent hemodialysis(HD) patients who are under hemodialysis treatment more than 6 months</description>
        </group>
      </group_list>
      <serious_events>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="37" subjects_at_risk="349"/>
                <counts group_id="E2" subjects_affected="50" subjects_at_risk="359"/>
                <counts group_id="E3" subjects_affected="21" subjects_at_risk="367"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>Death</sub_title>
                <counts group_id="E1" events="12" subjects_affected="12" subjects_at_risk="349"/>
                <counts group_id="E2" events="21" subjects_affected="21" subjects_at_risk="359"/>
                <counts group_id="E3" events="13" subjects_affected="13" subjects_at_risk="367"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Peritonitis</sub_title>
                <counts group_id="E1" events="19" subjects_affected="19" subjects_at_risk="349"/>
                <counts group_id="E2" events="22" subjects_affected="22" subjects_at_risk="359"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="367"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Renal and urinary disorders</title>
            <event_list>
              <event>
                <sub_title>Admission</sub_title>
                <counts group_id="E1" events="6" subjects_affected="6" subjects_at_risk="349"/>
                <counts group_id="E2" events="7" subjects_affected="7" subjects_at_risk="359"/>
                <counts group_id="E3" events="8" subjects_affected="8" subjects_at_risk="367"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="349"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="359"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="367"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Surgical and medical procedures</title>
            <event_list>
              <event>
                <sub_title>Kidney transplantation</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="349"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="359"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="367"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Dr. Hye Eun Yoon</name_or_title>
      <organization>The Catholic University of Korea</organization>
      <phone>82-32-280-5886</phone>
      <email>berrynana@catholic.ac.kr</email>
    </point_of_contact>
  </clinical_results>
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT01668628
org study id: QOLD_01_052012
nct id: NCT01668628
lead sponsor: 
has dmc: No
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
observational model: Cohort
time perspective: Prospective
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)
description: 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.
measure: 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)
description: 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.
measure: 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)
description: 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
arm group label: Incident PD patients
description: 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
arm group label: Prevalent PD patients
description: Prevalent peritoneal dialysis(PD) patients who are under peritoneal dialysis treatment more than 6 months
arm group label: Prevalent HD patients
description: Prevalent hemodialysis(HD) patients who are under hemodialysis treatment more than 6 months
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 75 Years
healthy volunteers: No
last name: Yongsoo Kim, M.D., Ph.D.
role: Principal Investigator
affiliation: Division of nephrology, The Catholic University of Korea College of Medicine
facility: 
country: Korea, Republic of
responsible party type: Sponsor
mesh term: Kidney Diseases
mesh term: Renal Insufficiency, Chronic
mesh term: Depression
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 