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/NCT05989659</url>
    </required_header>
    <id_info>
      <org_study_id>2022_2973</org_study_id>
      <nct_id>NCT05989659</nct_id>
    </id_info>
    <brief_title>Transitioning to Home or In-center Dialysis</brief_title>
    <acronym>TRANSIT-CARE</acronym>
    <official_title>Transitioning Patients With Advanced Chronic Kidney Disease to Home or In-center Dialysis: Understanding the Experience and Quality of Life for Patients and Their Caregivers</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Ciusss de L'Est de l'Île de Montréal</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>Canadian Institutes of Health Research (CIHR)</agency>
        <agency_class>Other</agency_class>
      </collaborator>
      <collaborator>
        <agency>The Kidney Foundation of Canada</agency>
        <agency_class>Other</agency_class>
      </collaborator>
    </sponsors>
    <source>Ciusss de L'Est de l'Île de Montréal</source>
    <oversight_info>
      <has_dmc>No</has_dmc>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        For people with advanced kidney disease, deciding which type of dialysis is best can be&#xD;
        challenging. Studies have shown that quality of life is very important to patients. It is&#xD;
        thought that the quality of life of people receiving their dialysis at home may be better&#xD;
        than the one of people receiving dialysis in a hospital. However, how the start of dialysis&#xD;
        changes the quality of life of people who choose home dialysis in comparison to people&#xD;
        choosing dialysis in a hospital is still unknown.&#xD;
  &#xD;
        TRANSIT-CARE is a prospective mixed methods study following adult with advanced kidney&#xD;
        disease who progress to dialysis and receive home or hospital-based dialysis. This study aims&#xD;
        to examine the trajectory and change in patients' quality of life and their frailty status&#xD;
        (health, mobility and function) before start of dialysis and up to 12-month after start.&#xD;
        Differences between people doing home dialysis and hospital-based dialysis will be assesses&#xD;
        taking into account people's characteristics including their gender and socio-demographics&#xD;
        characteristics. The study will include questionnaires to measure quality of life and tools&#xD;
        to evaluate frailty. Additionally, semi-structured interviews will be done with a diverse&#xD;
        group of patients and caregivers before and after the initiation of dialysis to better&#xD;
        understand their experience of transitioning to dialysis.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Home dialysis has been encouraged due to its clinical benefits and lower costs, leading to&#xD;
        increased use in recent years, even among patients with a high comorbidity burden and frailty&#xD;
        severity. Health-related quality of life (HRQoL) is reduced in patients receiving dialysis,&#xD;
        although patients treated with home dialysis may have relatively better patient-reported&#xD;
        outcome measures (PROMs), than those on in-center dialysis. As the home dialysis population&#xD;
        expands to include patients with a high frailty severity, it is unknown if these benefits are&#xD;
        preserved. More importantly, data lacks on how the transition to home or in-center dialysis&#xD;
        is experienced by patients and caregivers and whether changes in HRQoL and frailty impact&#xD;
        this experience.&#xD;
  &#xD;
        Objectives&#xD;
  &#xD;
          1. Determine and compare the trajectory of HRQoL, frailty and caregiver burden during the&#xD;
             chronic kidney disease (CKD)-to-dialysis transition. (QUANTI)&#xD;
  &#xD;
          2. Examine the experience of participants during their progression from CKD to dialysis.&#xD;
             (QUALI)&#xD;
  &#xD;
          3. Understand how HRQoL, frailty, and dialysis modality influence patients' and caregivers'&#xD;
             experience of transition. (QUANTI+QUALI)&#xD;
  &#xD;
        Design and Research Plan TRANSIT-CARE is a 5-year multicenter mixed-methods study of patients&#xD;
        with advanced CKD and their caregivers across 12 Canadian centers, with active&#xD;
        patient-partner engagement.&#xD;
  &#xD;
        QUANTITATIVE Participant will be followed every 3-months (from estimated glomerular&#xD;
        filtration rate [eGFR] &lt;12 mL/min/1.73m2) and up to 12-month after dialysis start (4-week,&#xD;
        3-, 6-,12-month).&#xD;
  &#xD;
        Target recruitment: 420 patients / 165 caregivers. Dialysis modality will be defined as the&#xD;
        chosen modality at baseline visit, and dichotomized as home dialysis (peritoneal or home&#xD;
        hemodialysis) and in-center dialysis.&#xD;
  &#xD;
        Changes in PROMs and frailty will be assessed using multivariable mixed linear spline&#xD;
        regression analysis with each measure used as a continuous variable adjusted for baseline&#xD;
        scores, chosen dialysis modality (exposure), dialysis start (time-dependent variable) and&#xD;
        prespecified potential confounders.&#xD;
  &#xD;
        QUALITATIVE Semi-structured interviews will be conducted with 30 patients and 30 caregivers&#xD;
        (from three centers) before and after dialysis initiation.&#xD;
  &#xD;
        Thematic analysis will be used to identify patient and caregiver perceptions of home and&#xD;
        in-center dialysis, their reactions to dialysis initiation (e.g., feelings of empowerment or&#xD;
        loss, life disruption) and perceived burden for caregivers.&#xD;
  &#xD;
        Data integration Data from the qualitative and quantitative components will be integrated at&#xD;
        time of analysis using tables and joint displays.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">January 1, 2023</start_date>
    <completion_date type="Anticipated">December 30, 2027</completion_date>
    <primary_completion_date type="Anticipated">December 30, 2026</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 in Kidney Disease Quality of Life - 36 (KDQOL-36) - Patients</measure>
      <time_frame>From study inclusion until 12-months after dialysis start.</time_frame>
      <description>Scale from 0-100 (0=poor , 100 = excellent )</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Change in 'Zarit' burden Interview (ZBI) - Caregivers</measure>
      <time_frame>From study inclusion until 12-months after dialysis start.</time_frame>
      <description>Scale 0-88 (0=no/little burden, 88 = severe burden)</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Change in Fried Frailty phenotype</measure>
      <time_frame>From study inclusion until 12-months after dialysis start.</time_frame>
      <description>5 components (slowness, weakness, weight loss, low physical activity, exhaustion) with classification as no-frail, pre-frail or frail</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change in Clinical Frailty Scale</measure>
      <time_frame>From study inclusion until 12-months after dialysis start.</time_frame>
      <description>Scale 1 (very fit) to 9 (terminally ill)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change in Hospital Anxiety and Depression - Patients</measure>
      <time_frame>From study inclusion until 12-months after dialysis start.</time_frame>
      <description>14-item scale (7 anxiety, 7 depression) with score ≥8 used as cut-off for increased risk of depression and anxiety</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change in Short-form (SF)-36 - Caregivers</measure>
      <time_frame>From study inclusion until 12-months after dialysis start.</time_frame>
      <description>Scale from 0-100 (0=poor , 100 = excellent )</description>
    </secondary_outcome>
    <other_outcome>
      <measure>Semi-structured interviews with patients and caregivers</measure>
      <time_frame>First interview between study start and dialysis initiation / Second interview between dialysis start and up to 12-month after dialysis start.</time_frame>
      <description>2 interviews with patients and caregivers</description>
    </other_outcome>
    <number_of_groups>4</number_of_groups>
    <enrollment type="Anticipated">420</enrollment>
    <condition>Chronic Kidney Diseases</condition>
    <arm_group>
      <arm_group_label>Patient - Home Dialysis</arm_group_label>
      <description>Patients transitioning to home dialysis</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Patient - Facility Hemodialysis</arm_group_label>
      <description>Patients transitioning to facility hemodialysis</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Caregivers - Home dialysis</arm_group_label>
      <description>Caregivers of patients transitioning to home dialysis</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Caregivers - Facility Hemodialysis</arm_group_label>
      <description>Caregivers of patients transitioning to facility hemodialysis</description>
    </arm_group>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Exposure: Home dialysis or facility-hemodialysis</intervention_name>
      <description>Initiation of dialysis with home dialysis (peritoneal dialysis or home hemodialysis) or facility-hemodialysis</description>
      <arm_group_label>Caregivers - Facility Hemodialysis</arm_group_label>
      <arm_group_label>Caregivers - Home dialysis</arm_group_label>
      <arm_group_label>Patient - Facility Hemodialysis</arm_group_label>
      <arm_group_label>Patient - Home Dialysis</arm_group_label>
    </intervention>
    <eligibility>
      <study_pop>
        <textblock>
          Adults followed in advanced chronic kidney disease clinics and their caregivers will be&#xD;
          recruited from 12 academic centers across Canada&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Non-Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            1. Adults followed in advanced CKD clinic,&#xD;
  &#xD;
            2. estimated glomerular filtration rate (eGFR) &lt;12 mL/min/1.73m2 103,&#xD;
  &#xD;
            3. Have chosen their dialysis modality,&#xD;
  &#xD;
            4. Understand English or French.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            1. Orientation toward conservative treatment,&#xD;
  &#xD;
            2. Planned kidney transplantation &lt; 6 months,&#xD;
  &#xD;
            3. Unable to provide consent due to severe cognitive or psychiatric disease,&#xD;
  &#xD;
            4. Previous treatment with dialysis &gt; 3 months,&#xD;
  &#xD;
            5. Life expectancy &lt; 6 months&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Annie-Claire Nadeau-Fredette, MD</last_name>
      <role>Principal Investigator</role>
      <affiliation>CIUSSS de l'Est-de-l'Ile-de-Montréal</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Karine Chaussé</last_name>
      <phone>514-252-3400</phone>
      <phone_ext>3722</phone_ext>
      <email>karine.chausse.cemtl@ssss.gouv.qc.ca</email>
    </overall_contact>
    <location>
      <facility>
        <name>Hôpital Maisonneuve-Rosemont</name>
        <address>
          <city>Montréal</city>
          <state>Quebec</state>
          <zip>H1T 2M4</zip>
          <country>Canada</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Annie-Claire Nadeau-Fredette, MD</last_name>
        <phone>514-252-3400</phone>
        <phone_ext>6141</phone_ext>
        <email>ac.nadeau-fredette@umontreal.ca</email>
      </contact>
      <contact_backup>
        <last_name>Karine Chaussé</last_name>
        <phone>514-242-3400</phone>
        <phone_ext>3722</phone_ext>
        <email>karine.chausse.cemtl@ssss.gouv.qc.ca</email>
      </contact_backup>
    </location>
    <location_countries>
      <country>Canada</country>
    </location_countries>
    <verification_date>July 2023</verification_date>
    <study_first_submitted>July 28, 2023</study_first_submitted>
    <study_first_submitted_qc>August 4, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 14, 2023</study_first_posted>
    <last_update_submitted>August 4, 2023</last_update_submitted>
    <last_update_submitted_qc>August 4, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 14, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>Chronic Kidney Disease</keyword>
    <keyword>Quality of Life</keyword>
    <keyword>Frailty</keyword>
    <keyword>Home Dialysis</keyword>
    <keyword>Peritoneal Dialysis</keyword>
    <keyword>Home Hemodialysis</keyword>
    <keyword>Hemodialysis</keyword>
    <keyword>Mixed Methods</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>
    </condition_browse>
    <!-- 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/NCT05989659
  org study id: 2022_2973
  nct id: NCT05989659
  lead sponsor: 
  collaborator: 
  collaborator: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  For people with advanced kidney disease, deciding which type of dialysis is best can be
        challenging. Studies have shown that quality of life is very important to patients. It is
        thought that the quality of life of people receiving their dialysis at home may be better
        than the one of people receiving dialysis in a hospital. However, how the start of dialysis
        changes the quality of life of people who choose home dialysis in comparison to people
        choosing dialysis in a hospital is still unknown.
  
        TRANSIT-CARE is a prospective mixed methods study following adult with advanced kidney
        disease who progress to dialysis and receive home or hospital-based dialysis. This study aims
        to examine the trajectory and change in patients' quality of life and their frailty status
        (health, mobility and function) before start of dialysis and up to 12-month after start.
        Differences between people doing home dialysis and hospital-based dialysis will be assesses
        taking into account people's characteristics including their gender and socio-demographics
        characteristics. The study will include questionnaires to measure quality of life and tools
        to evaluate frailty. Additionally, semi-structured interviews will be done with a diverse
        group of patients and caregivers before and after the initiation of dialysis to better
        understand their experience of transitioning to dialysis.
  Home dialysis has been encouraged due to its clinical benefits and lower costs, leading to
        increased use in recent years, even among patients with a high comorbidity burden and frailty
        severity. Health-related quality of life (HRQoL) is reduced in patients receiving dialysis,
        although patients treated with home dialysis may have relatively better patient-reported
        outcome measures (PROMs), than those on in-center dialysis. As the home dialysis population
        expands to include patients with a high frailty severity, it is unknown if these benefits are
        preserved. More importantly, data lacks on how the transition to home or in-center dialysis
        is experienced by patients and caregivers and whether changes in HRQoL and frailty impact
        this experience.
  
        Objectives
  
          1. Determine and compare the trajectory of HRQoL, frailty and caregiver burden during the
             chronic kidney disease (CKD)-to-dialysis transition. (QUANTI)
  
          2. Examine the experience of participants during their progression from CKD to dialysis.
             (QUALI)
  
          3. Understand how HRQoL, frailty, and dialysis modality influence patients' and caregivers'
             experience of transition. (QUANTI+QUALI)
  
        Design and Research Plan TRANSIT-CARE is a 5-year multicenter mixed-methods study of patients
        with advanced CKD and their caregivers across 12 Canadian centers, with active
        patient-partner engagement.
  
        QUANTITATIVE Participant will be followed every 3-months (from estimated glomerular
        filtration rate [eGFR] <12 mL/min/1.73m2) and up to 12-month after dialysis start (4-week,
        3-, 6-,12-month).
  
        Target recruitment: 420 patients / 165 caregivers. Dialysis modality will be defined as the
        chosen modality at baseline visit, and dichotomized as home dialysis (peritoneal or home
        hemodialysis) and in-center dialysis.
  
        Changes in PROMs and frailty will be assessed using multivariable mixed linear spline
        regression analysis with each measure used as a continuous variable adjusted for baseline
        scores, chosen dialysis modality (exposure), dialysis start (time-dependent variable) and
        prespecified potential confounders.
  
        QUALITATIVE Semi-structured interviews will be conducted with 30 patients and 30 caregivers
        (from three centers) before and after dialysis initiation.
  
        Thematic analysis will be used to identify patient and caregiver perceptions of home and
        in-center dialysis, their reactions to dialysis initiation (e.g., feelings of empowerment or
        loss, life disruption) and perceived burden for caregivers.
  
        Data integration Data from the qualitative and quantitative components will be integrated at
        time of analysis using tables and joint displays.
  observational model: Cohort
  time perspective: Prospective
  measure: Change in Kidney Disease Quality of Life - 36 (KDQOL-36) - Patients
  time frame: From study inclusion until 12-months after dialysis start.
  description: Scale from 0-100 (0=poor , 100 = excellent )
  measure: Change in 'Zarit' burden Interview (ZBI) - Caregivers
  time frame: From study inclusion until 12-months after dialysis start.
  description: Scale 0-88 (0=no/little burden, 88 = severe burden)
  measure: Change in Fried Frailty phenotype
  time frame: From study inclusion until 12-months after dialysis start.
  description: 5 components (slowness, weakness, weight loss, low physical activity, exhaustion) with classification as no-frail, pre-frail or frail
  measure: Change in Clinical Frailty Scale
  time frame: From study inclusion until 12-months after dialysis start.
  description: Scale 1 (very fit) to 9 (terminally ill)
  measure: Change in Hospital Anxiety and Depression - Patients
  time frame: From study inclusion until 12-months after dialysis start.
  description: 14-item scale (7 anxiety, 7 depression) with score ≥8 used as cut-off for increased risk of depression and anxiety
  measure: Change in Short-form (SF)-36 - Caregivers
  time frame: From study inclusion until 12-months after dialysis start.
  description: Scale from 0-100 (0=poor , 100 = excellent )
  measure: Semi-structured interviews with patients and caregivers
  time frame: First interview between study start and dialysis initiation / Second interview between dialysis start and up to 12-month after dialysis start.
  description: 2 interviews with patients and caregivers
  arm group label: Patient - Home Dialysis
  description: Patients transitioning to home dialysis
  arm group label: Patient - Facility Hemodialysis
  description: Patients transitioning to facility hemodialysis
  arm group label: Caregivers - Home dialysis
  description: Caregivers of patients transitioning to home dialysis
  arm group label: Caregivers - Facility Hemodialysis
  description: Caregivers of patients transitioning to facility hemodialysis
  intervention type: Other
  intervention name: Exposure: Home dialysis or facility-hemodialysis
  description: Initiation of dialysis with home dialysis (peritoneal dialysis or home hemodialysis) or facility-hemodialysis
  arm group label: Caregivers - Facility Hemodialysis
  arm group label: Caregivers - Home dialysis
  arm group label: Patient - Facility Hemodialysis
  arm group label: Patient - Home Dialysis
  study pop: 
  sampling method: Non-Probability Sample
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Annie-Claire Nadeau-Fredette, MD
  role: Principal Investigator
  affiliation: CIUSSS de l'Est-de-l'Ile-de-Montréal
  last name: Karine Chaussé
  phone: 514-252-3400
  phone ext: 3722
  email: karine.chausse.cemtl@ssss.gouv.qc.ca
  facility: 
  status: Recruiting
  contact: 
  contact backup: 
  country: Canada
  responsible party type: Sponsor
  mesh term: Kidney Diseases
  mesh term: Renal Insufficiency, Chronic