xml: <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/NCT06019871</url>
    </required_header>
    <id_info>
      <org_study_id>15032023</org_study_id>
      <nct_id>NCT06019871</nct_id>
    </id_info>
    <brief_title>The Danish Symptomburden Study Among Patients With Advanced Kidney Disease</brief_title>
    <official_title>Danish Cohort for Patients Over 75 Years of Age With Chronic Kidney Disease Stage Five Who Are on Dialysis Treatment or on a Conservative Kidney Management Pathway</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>University of Aarhus</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>University of Aarhus</source>
    <oversight_info>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        Patients with chronic kidney disease stage five have a high symptom burden regardless of&#xD;
        whether they are treated with dialysis or without dialysis, a conservative kidney management&#xD;
        pathway (CKM). Previously, there has not been a validated tool in Danish to collect&#xD;
        information about symptoms. The Integrated Palliative Outcome Scale Renal (IPOS-Renal) has&#xD;
        now been validated and translated into Danish. IPOS-Renal aims to identify symptoms among&#xD;
        patients with chronic kidney disease stage five.&#xD;
  &#xD;
        The purpose of the study is to investigate whether there is a correlation between treatment -&#xD;
        dialysis (haemodialysis or peritoneal dialysis) or CKM for patients &gt;75 years of age with&#xD;
        chronic kidney disease stage V and their symptom burden measured with IPOS-Renal. In&#xD;
        addition, it is investigated whether there is a correlation between treatment - dialysis or&#xD;
        CKM for patients &gt;75 years of age with chronic kidney disease stage V and their mortality.&#xD;
  &#xD;
        The study will be conducted as an observational prospective cohort study over a two-year&#xD;
        period, and based on a power calculation, it is expected to include 341 patients with data&#xD;
        originating from 11 hospitals in Denmark. Comparison of change in symptom burden over time&#xD;
        measured by IPOS-Renal for the two forms of treatment will be examined as continuous data,&#xD;
        and then the t-test or Mann-Whitney test will be used. A cox proportional hazard regression&#xD;
        analysis will be used to examine mortality for patients in dialysis treatment and patients on&#xD;
        CKM pathway.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Background In chronic kidney disease stage five, patients must decide whether they want to&#xD;
        start treatment with dialysis or a conservative kidney management pathway (CKM). It is a&#xD;
        major decision for patients and their relatives, which concerns survival, quality of life,&#xD;
        symptom burden and time spent in hospital. Patients with chronic kidney disease stage five&#xD;
        have a high symptom burden, regardless of whether they are treated with dialysis or on CKM&#xD;
        pathway. Systematic observation and recording of the symptoms should take place and&#xD;
        alleviated to the extent possible. The patients experience a number of different symptoms&#xD;
        including fatigue, nausea, dyspnoea, reduced level of physical function, pain and&#xD;
        restlessness in the legs. A systematic review based on 25 primary studies found that there is&#xD;
        an increased mortality in patients on an CKM pathway compared to patients on dialysis. But at&#xD;
        the same time, benefits are seen in relation to increased quality of life, reduced symptom&#xD;
        burden and fewer hospitalizations if the patient is on CKM pathway. Another study reports&#xD;
        that patients in dialysis treatment have a higher symptom burden, lower well-being and poorer&#xD;
        quality of life than patients who have opted out of dialysis.&#xD;
  &#xD;
        In Denmark, symptoms experienced by patients with chronic kidney disease stage five are not&#xD;
        systematically recorded, as there has not previously been a tool to collect Patient Reported&#xD;
        Outcomes . The Integrated Palliative Outcome Scale Renal (IPOS-Renal) for patients with&#xD;
        chronic kidney disease stage five is a validated screening tool to systematically investigate&#xD;
        which symptoms patients with chronic kidney disease stage five report. Routinely collecting&#xD;
        data about the patient's symptoms is the first step to improve care and treatment for&#xD;
        patients with stage five chronic kidney disease. The validation and translation of the Danish&#xD;
        IPOS-Renal was carried out in 2019-2020 by principal investigator. The implementation of&#xD;
        IPOS-Renal can help to provide an increased focus on symptom management and quality of life&#xD;
        among patients with chronic kidney disease stage five. IPOS-Renal gives patients the&#xD;
        opportunity to be further involved in their disease and health, as the patients themselves&#xD;
        have the opportunity to complete the questionnaire. IPOS-Renal takes less than 10 minutes to&#xD;
        complete. IPOS-Renal contains a total of 11 questions concerning the most common physical&#xD;
        symptoms for patients with chronic kidney failure. In addition, IPOS-Renal also contains&#xD;
        questions about the patient's mental and existential needs, social needs and practical needs.&#xD;
  &#xD;
        Purpose The purpose of the current study is to investigate whether there is a correlation&#xD;
        between patients &gt;75 years of age with chronic kidney disease stage five in treatment with -&#xD;
        dialysis or on a CKM pathway and their symptom burden measured with the IPOS-Renal score. In&#xD;
        addition, it is investigated whether there is a correlation between patients &gt;75 years of age&#xD;
        with chronic kidney disease stage five in treatment with - dialysis or on a CKM pathway and&#xD;
        their mortality.&#xD;
  &#xD;
        Hypotheses I. Patients on a CKM pathway have greater improvement in their symptom burden&#xD;
        measured with IPOS-Renal than patients in dialysis treatment. II. Patients in dialysis&#xD;
        treatment have a lower mortality rate than patients on a CKM pathway.&#xD;
  &#xD;
        Materials and methods The project will be carried out as an observational prospective cohort&#xD;
        study of patients with chronic kidney disease stage five in dialysis treatment or on a CKM&#xD;
        pathway. Data originate from patients from 11 hospitals in Denmark: Aalborg University&#xD;
        Hospital, Regionshospitalet Gødstrup, Sydvestjysk Sygehus, Kolding Hospital, Gegehus&#xD;
        Sønderjylland Sønderborg, Rigshospitalet, Sjællands University Hospital Roskilde, Nykøbing&#xD;
        Falster Hospital, Herlev Hospital, North Zealand Hospital and Aarhus University Hospital. In&#xD;
        the current study, baseline information is defined at the patient's first response to the&#xD;
        questionnaire. After that, the questionnaire is answered every 6 months for two years or&#xD;
        until death.&#xD;
  &#xD;
        Study population The patients will be included right after they have made their decision&#xD;
        about treatment - dialysis (haemodialysis or peritoneal dialysis) or CKM pathway. In&#xD;
        addition, patients must meet inclusion criteria. The patients will be observed for at least&#xD;
        two years or until death. The study started on 15.03.2023, and it is expected to be completed&#xD;
        on 14.03.2025.&#xD;
  &#xD;
        Data collection and procedure All patients who meet the inclusion criteria and have chosen&#xD;
        treatment can be included in the project. Upon inclusion in the project, a declaration of&#xD;
        consent is signed. After this, the patient or with the help of relatives or a health&#xD;
        professional will fill in the first questionnaire IPOS-Renal at baseline and then every 6&#xD;
        months. The completed questionnaire is sent by post to primary investigator, or scanned in&#xD;
        and sent via e-mail. When 5 months have passed, primary investigator sends a reminder that a&#xD;
        new questionnaire must be answered in 1 month (+/- 14 days). This takes place 6, 12, 18 and&#xD;
        24 months after inclusion.&#xD;
  &#xD;
        Demographic data will be collected at baseline: age, sex, eGFR, comorbidities, frailty,&#xD;
        social conditions, housing conditions, education level, ethnicity and quality of life. Data&#xD;
        is collected by principal investigator, who is also responsible for data management. The&#xD;
        principal investigator is employed by Department of Renal Medicine at Aarhus University&#xD;
        Hospital. Data will be entered and stored in REDCap.&#xD;
  &#xD;
        Power calculation Power calculation is based on published data for the hypothesis II, that&#xD;
        patients in dialysis treatment have lower mortality than patients on a CKM pathway. Published&#xD;
        international data have shown that the hazard ratio (HR) for patients in dialysis treatment&#xD;
        compared to patients on a CKM pathway is around 0.5. In a Danish study, the distribution of&#xD;
        the patients is seen, thus 90% of patients are in dialysis treatment, while 10% of patients&#xD;
        are on a CKM pathway. Internationally, there are studies with patient distributions where up&#xD;
        to 60% of the patients are in dialysis treatment, while 40% of the patients are on CKM&#xD;
        pathway. This power calculation is based on an assumption of a patient distribution where 80%&#xD;
        of patients are in dialysis treatment and 20% of patients are on a CKM pathway. The Danish&#xD;
        Nephrology Society finds a mortality of 30% for patients &gt;70 years of age. Based on this, it&#xD;
        is calculated that a sample size of a total of 341 patients would provide a power of &gt;80% and&#xD;
        could show an HR of 0.5. The project expects to be able to include 341 patients over a period&#xD;
        of two years.&#xD;
  &#xD;
        Power calculation was also performed for hypothesis I; Patients on a CKM pathway have a&#xD;
        greater improvement in their symptom burden measured with IPOS-Renal than patients in&#xD;
        dialysis. This hypothesis required a smaller sample size to achieve a power of &gt;80%. The&#xD;
        sample size of 341 patients will therefore also be sufficient to be able to identify&#xD;
        differences for this hypothesis.&#xD;
  &#xD;
        Statistical considerations The statistical analyses will be performed and processed in STATA&#xD;
        17.0. All hypotheses are tested at a significance level of 0.05. Demographic data for&#xD;
        baseline characteristics are presented with mean and standard deviation (SD) for continuous&#xD;
        data that can be described by a normal distribution. Continuous data, which cannot be&#xD;
        described with a normal distribution, are presented with median and interquartile range&#xD;
        (IQR). Categorical data is described with number (n) and proportion in percent (%). Scores&#xD;
        for primary outcomes are presented with mean and SD if the data is normally distributed.&#xD;
        Continuous variables are compared by t-test or Mann-Whitney test. While categorical variables&#xD;
        will be compared by chi2 test. Change in symptom burden over time measured by IPOS-Renal will&#xD;
        be continuous data collected at 6 months, 12 months, 18 months and 24 months for patients in&#xD;
        dialysis treatment and patients on a CKM pathway, respectively. The results of the two&#xD;
        different patient groups are then compared by t-test or Mann-Whitney test. A cox proportional&#xD;
        hazard regression analysis will be used in relation to calculating the mortality during the&#xD;
        follow-up period for the group of patients in dialysis treatment and patients on CKM pathway,&#xD;
        respectively.&#xD;
  &#xD;
        Critical considerations The study has some methodological limitations. Since data is&#xD;
        collected through self-reported questionnaires, there is a risk of information bias, which&#xD;
        can be seen in either an over- or under-reporting of symptom burden. We also expect to see a&#xD;
        difference between the two patient groups in relation to age, frailty and comorbidity.&#xD;
        Attempts will be made to take these differences into account in the statistical analyses. We&#xD;
        expect the group of patients in dialysis treatment to be the largest. At the same time, we&#xD;
        expect that this group will have a lower mortality and a greater burden of symptoms measured&#xD;
        with IPOS-Renal compared to patients on the CKM pathway. On the contrary, we expect that the&#xD;
        patients on a CKM pathway have higher mortality and lower symptom burden measured with&#xD;
        IPOS-Renal compared to patients on dialysis. The study's strength of 80% is considered a&#xD;
        strength for the study, and one must assume that the results found are not based on chance,&#xD;
        but contain the real true values.&#xD;
  &#xD;
        Ethical considerations Informed written consent will be obtained from all patients prior to&#xD;
        the study. Participation in the study will be based on consent to care and treatment in&#xD;
        accordance with the health legislation, chapter 5, section 15. According to the Scientific&#xD;
        Ethics Committee, it is not required to report the study. This study will be conducted in&#xD;
        accordance with the ethical principles of medical research involving human subjects based on&#xD;
        the World Medical Association Declaration of Helsinki to protect patients' rights.&#xD;
  &#xD;
        On 05.01.2022, the Danish Data Protection Authority has given permission for the registration&#xD;
        of sensitive personal data in the research project, Case no. 788266.&#xD;
  &#xD;
        Information relating to experimental subjects is protected in accordance with the General&#xD;
        Data Protection Regulation and patient rights according to the health legislation.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">March 15, 2023</start_date>
    <completion_date type="Anticipated">September 15, 2025</completion_date>
    <primary_completion_date type="Anticipated">September 15, 2025</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>IPOS score</measure>
      <time_frame>after six months, after 12 months, after 18 months and after 24 months</time_frame>
      <description>A score between zero and 40. A high score means a high symptom burden</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Mortality</measure>
      <time_frame>For two years</time_frame>
      <description>Death or a live uptil two years</description>
    </secondary_outcome>
    <number_of_groups>2</number_of_groups>
    <enrollment type="Anticipated">341</enrollment>
    <condition>Chronic Kidney Diseases</condition>
    <arm_group>
      <arm_group_label>Decided for conservative kidney management</arm_group_label>
      <description>Patient with advanced kidney disease and decided for conservative kidney management</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Decided for dialysis</arm_group_label>
      <description>Patient with advanced kidney disease and decided for dialysis</description>
    </arm_group>
    <intervention>
      <intervention_type>Procedure</intervention_type>
      <intervention_name>Dialysis</intervention_name>
      <description>Patients who have decided for dialysis either center haemo-dialysis or peritoneal dialysis</description>
      <arm_group_label>Decided for dialysis</arm_group_label>
    </intervention>
    <eligibility>
      <study_pop>
        <textblock>
          The patients will be included right after they have made their decision about treatment -&#xD;
          dialysis (haemodialysis or peritoneal dialysis) or CKM pathway. In addition, patients must&#xD;
          meet inclusion criteria. The patients will be observed for at least two years or until&#xD;
          death. The study is expected to start on 15.03.2023, and it is expected to be completed on&#xD;
          15.09.2025.&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Non-Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Patients with chronic kidney disease stage V&#xD;
  &#xD;
            -  Patients &gt;75 years&#xD;
  &#xD;
            -  Patients who have decided on future treatment with either dialysis (haemodialysis or&#xD;
               peritoneal dialysis) or a CKM pathway&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Patients who do not meet the inclusion criteria&#xD;
  &#xD;
            -  Patients eligible for kidney transplantation&#xD;
  &#xD;
            -  Patients who have decided on home haemodialysis&#xD;
  &#xD;
            -  Patients who do not wish to participate in the study&#xD;
  &#xD;
            -  Patients who are unable to participate in the study due to cognitive impairment&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>75 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
    </eligibility>
    <overall_official>
      <last_name>Jeanette Finderup</last_name>
      <role>Principal Investigator</role>
      <affiliation>Aarhus University Hospital</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Finderup</last_name>
      <phone>004578452525</phone>
      <email>jeajee@rm.dk</email>
    </overall_contact>
    <location>
      <facility>
        <name>Aarhus University Hospital, Department of Renal Medicine</name>
        <address>
          <city>Aarhus N</city>
          <country>Denmark</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Finderup</last_name>
      </contact>
    </location>
    <location_countries>
      <country>Denmark</country>
    </location_countries>
    <verification_date>March 2023</verification_date>
    <study_first_submitted>March 6, 2023</study_first_submitted>
    <study_first_submitted_qc>August 25, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 31, 2023</study_first_posted>
    <last_update_submitted>September 11, 2023</last_update_submitted>
    <last_update_submitted_qc>September 11, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 13, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <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>
    </condition_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT06019871
  org study id: 15032023
  nct id: NCT06019871
  lead sponsor: 
  is fda regulated drug: No
  is fda regulated device: No
  Patients with chronic kidney disease stage five have a high symptom burden regardless of
        whether they are treated with dialysis or without dialysis, a conservative kidney management
        pathway (CKM). Previously, there has not been a validated tool in Danish to collect
        information about symptoms. The Integrated Palliative Outcome Scale Renal (IPOS-Renal) has
        now been validated and translated into Danish. IPOS-Renal aims to identify symptoms among
        patients with chronic kidney disease stage five.
  
        The purpose of the study is to investigate whether there is a correlation between treatment -
        dialysis (haemodialysis or peritoneal dialysis) or CKM for patients >75 years of age with
        chronic kidney disease stage V and their symptom burden measured with IPOS-Renal. In
        addition, it is investigated whether there is a correlation between treatment - dialysis or
        CKM for patients >75 years of age with chronic kidney disease stage V and their mortality.
  
        The study will be conducted as an observational prospective cohort study over a two-year
        period, and based on a power calculation, it is expected to include 341 patients with data
        originating from 11 hospitals in Denmark. Comparison of change in symptom burden over time
        measured by IPOS-Renal for the two forms of treatment will be examined as continuous data,
        and then the t-test or Mann-Whitney test will be used. A cox proportional hazard regression
        analysis will be used to examine mortality for patients in dialysis treatment and patients on
        CKM pathway.
  Background In chronic kidney disease stage five, patients must decide whether they want to
        start treatment with dialysis or a conservative kidney management pathway (CKM). It is a
        major decision for patients and their relatives, which concerns survival, quality of life,
        symptom burden and time spent in hospital. Patients with chronic kidney disease stage five
        have a high symptom burden, regardless of whether they are treated with dialysis or on CKM
        pathway. Systematic observation and recording of the symptoms should take place and
        alleviated to the extent possible. The patients experience a number of different symptoms
        including fatigue, nausea, dyspnoea, reduced level of physical function, pain and
        restlessness in the legs. A systematic review based on 25 primary studies found that there is
        an increased mortality in patients on an CKM pathway compared to patients on dialysis. But at
        the same time, benefits are seen in relation to increased quality of life, reduced symptom
        burden and fewer hospitalizations if the patient is on CKM pathway. Another study reports
        that patients in dialysis treatment have a higher symptom burden, lower well-being and poorer
        quality of life than patients who have opted out of dialysis.
  
        In Denmark, symptoms experienced by patients with chronic kidney disease stage five are not
        systematically recorded, as there has not previously been a tool to collect Patient Reported
        Outcomes . The Integrated Palliative Outcome Scale Renal (IPOS-Renal) for patients with
        chronic kidney disease stage five is a validated screening tool to systematically investigate
        which symptoms patients with chronic kidney disease stage five report. Routinely collecting
        data about the patient's symptoms is the first step to improve care and treatment for
        patients with stage five chronic kidney disease. The validation and translation of the Danish
        IPOS-Renal was carried out in 2019-2020 by principal investigator. The implementation of
        IPOS-Renal can help to provide an increased focus on symptom management and quality of life
        among patients with chronic kidney disease stage five. IPOS-Renal gives patients the
        opportunity to be further involved in their disease and health, as the patients themselves
        have the opportunity to complete the questionnaire. IPOS-Renal takes less than 10 minutes to
        complete. IPOS-Renal contains a total of 11 questions concerning the most common physical
        symptoms for patients with chronic kidney failure. In addition, IPOS-Renal also contains
        questions about the patient's mental and existential needs, social needs and practical needs.
  
        Purpose The purpose of the current study is to investigate whether there is a correlation
        between patients >75 years of age with chronic kidney disease stage five in treatment with -
        dialysis or on a CKM pathway and their symptom burden measured with the IPOS-Renal score. In
        addition, it is investigated whether there is a correlation between patients >75 years of age
        with chronic kidney disease stage five in treatment with - dialysis or on a CKM pathway and
        their mortality.
  
        Hypotheses I. Patients on a CKM pathway have greater improvement in their symptom burden
        measured with IPOS-Renal than patients in dialysis treatment. II. Patients in dialysis
        treatment have a lower mortality rate than patients on a CKM pathway.
  
        Materials and methods The project will be carried out as an observational prospective cohort
        study of patients with chronic kidney disease stage five in dialysis treatment or on a CKM
        pathway. Data originate from patients from 11 hospitals in Denmark: Aalborg University
        Hospital, Regionshospitalet Gødstrup, Sydvestjysk Sygehus, Kolding Hospital, Gegehus
        Sønderjylland Sønderborg, Rigshospitalet, Sjællands University Hospital Roskilde, Nykøbing
        Falster Hospital, Herlev Hospital, North Zealand Hospital and Aarhus University Hospital. In
        the current study, baseline information is defined at the patient's first response to the
        questionnaire. After that, the questionnaire is answered every 6 months for two years or
        until death.
  
        Study population The patients will be included right after they have made their decision
        about treatment - dialysis (haemodialysis or peritoneal dialysis) or CKM pathway. In
        addition, patients must meet inclusion criteria. The patients will be observed for at least
        two years or until death. The study started on 15.03.2023, and it is expected to be completed
        on 14.03.2025.
  
        Data collection and procedure All patients who meet the inclusion criteria and have chosen
        treatment can be included in the project. Upon inclusion in the project, a declaration of
        consent is signed. After this, the patient or with the help of relatives or a health
        professional will fill in the first questionnaire IPOS-Renal at baseline and then every 6
        months. The completed questionnaire is sent by post to primary investigator, or scanned in
        and sent via e-mail. When 5 months have passed, primary investigator sends a reminder that a
        new questionnaire must be answered in 1 month (+/- 14 days). This takes place 6, 12, 18 and
        24 months after inclusion.
  
        Demographic data will be collected at baseline: age, sex, eGFR, comorbidities, frailty,
        social conditions, housing conditions, education level, ethnicity and quality of life. Data
        is collected by principal investigator, who is also responsible for data management. The
        principal investigator is employed by Department of Renal Medicine at Aarhus University
        Hospital. Data will be entered and stored in REDCap.
  
        Power calculation Power calculation is based on published data for the hypothesis II, that
        patients in dialysis treatment have lower mortality than patients on a CKM pathway. Published
        international data have shown that the hazard ratio (HR) for patients in dialysis treatment
        compared to patients on a CKM pathway is around 0.5. In a Danish study, the distribution of
        the patients is seen, thus 90% of patients are in dialysis treatment, while 10% of patients
        are on a CKM pathway. Internationally, there are studies with patient distributions where up
        to 60% of the patients are in dialysis treatment, while 40% of the patients are on CKM
        pathway. This power calculation is based on an assumption of a patient distribution where 80%
        of patients are in dialysis treatment and 20% of patients are on a CKM pathway. The Danish
        Nephrology Society finds a mortality of 30% for patients >70 years of age. Based on this, it
        is calculated that a sample size of a total of 341 patients would provide a power of >80% and
        could show an HR of 0.5. The project expects to be able to include 341 patients over a period
        of two years.
  
        Power calculation was also performed for hypothesis I; Patients on a CKM pathway have a
        greater improvement in their symptom burden measured with IPOS-Renal than patients in
        dialysis. This hypothesis required a smaller sample size to achieve a power of >80%. The
        sample size of 341 patients will therefore also be sufficient to be able to identify
        differences for this hypothesis.
  
        Statistical considerations The statistical analyses will be performed and processed in STATA
        17.0. All hypotheses are tested at a significance level of 0.05. Demographic data for
        baseline characteristics are presented with mean and standard deviation (SD) for continuous
        data that can be described by a normal distribution. Continuous data, which cannot be
        described with a normal distribution, are presented with median and interquartile range
        (IQR). Categorical data is described with number (n) and proportion in percent (%). Scores
        for primary outcomes are presented with mean and SD if the data is normally distributed.
        Continuous variables are compared by t-test or Mann-Whitney test. While categorical variables
        will be compared by chi2 test. Change in symptom burden over time measured by IPOS-Renal will
        be continuous data collected at 6 months, 12 months, 18 months and 24 months for patients in
        dialysis treatment and patients on a CKM pathway, respectively. The results of the two
        different patient groups are then compared by t-test or Mann-Whitney test. A cox proportional
        hazard regression analysis will be used in relation to calculating the mortality during the
        follow-up period for the group of patients in dialysis treatment and patients on CKM pathway,
        respectively.
  
        Critical considerations The study has some methodological limitations. Since data is
        collected through self-reported questionnaires, there is a risk of information bias, which
        can be seen in either an over- or under-reporting of symptom burden. We also expect to see a
        difference between the two patient groups in relation to age, frailty and comorbidity.
        Attempts will be made to take these differences into account in the statistical analyses. We
        expect the group of patients in dialysis treatment to be the largest. At the same time, we
        expect that this group will have a lower mortality and a greater burden of symptoms measured
        with IPOS-Renal compared to patients on the CKM pathway. On the contrary, we expect that the
        patients on a CKM pathway have higher mortality and lower symptom burden measured with
        IPOS-Renal compared to patients on dialysis. The study's strength of 80% is considered a
        strength for the study, and one must assume that the results found are not based on chance,
        but contain the real true values.
  
        Ethical considerations Informed written consent will be obtained from all patients prior to
        the study. Participation in the study will be based on consent to care and treatment in
        accordance with the health legislation, chapter 5, section 15. According to the Scientific
        Ethics Committee, it is not required to report the study. This study will be conducted in
        accordance with the ethical principles of medical research involving human subjects based on
        the World Medical Association Declaration of Helsinki to protect patients' rights.
  
        On 05.01.2022, the Danish Data Protection Authority has given permission for the registration
        of sensitive personal data in the research project, Case no. 788266.
  
        Information relating to experimental subjects is protected in accordance with the General
        Data Protection Regulation and patient rights according to the health legislation.
  observational model: Cohort
  time perspective: Prospective
  measure: IPOS score
  time frame: after six months, after 12 months, after 18 months and after 24 months
  description: A score between zero and 40. A high score means a high symptom burden
  measure: Mortality
  time frame: For two years
  description: Death or a live uptil two years
  arm group label: Decided for conservative kidney management
  description: Patient with advanced kidney disease and decided for conservative kidney management
  arm group label: Decided for dialysis
  description: Patient with advanced kidney disease and decided for dialysis
  intervention type: Procedure
  intervention name: Dialysis
  description: Patients who have decided for dialysis either center haemo-dialysis or peritoneal dialysis
  arm group label: Decided for dialysis
  study pop: 
  sampling method: Non-Probability Sample
  criteria: 
  gender: All
  minimum age: 75 Years
  maximum age: N/A
  last name: Jeanette Finderup
  role: Principal Investigator
  affiliation: Aarhus University Hospital
  last name: Finderup
  phone: 004578452525
  email: jeajee@rm.dk
  facility: 
  status: Recruiting
  contact: 
  country: Denmark
  responsible party type: Sponsor
  mesh term: Kidney Diseases
  mesh term: Renal Insufficiency, Chronic
  sharing ipd: No