<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/NCT04435873</url>
  </required_header>
  <id_info>
    <org_study_id>SP124 Home Experience</org_study_id>
    <nct_id>NCT04435873</nct_id>
  </id_info>
  <brief_title>Assessing Patient-Reported Experience of Care for Home Dialysis (ASPIRED)</brief_title>
  <official_title>Assessing Patient-Reported Experience of Care for Home Dialysis (ASPIRED)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Satellite Healthcare</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>University of Washington</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Satellite Healthcare</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>
      Home dialysis modalities, including peritoneal dialysis (PD) and home hemodialysis (HHD),&#xD;
      represent alternatives to conventional in-center hemodialysis (HD) that for some patients may&#xD;
      be better aligned with preferences regarding the integration of dialysis treatments into&#xD;
      their lives. Assessment of patient experience and satisfaction with care among individuals&#xD;
      undergoing maintenance dialysis in the United States is a national health care priority and&#xD;
      mandated by Congress. While validated instruments (ICH CAHPS) are in use to assess patient&#xD;
      experience with in-center HD, currently no validated instruments are available to measure&#xD;
      patient-reported experience in home dialysis.&#xD;
&#xD;
      This Home Patient Experience Survey Validation Study is an in-house research study conducted&#xD;
      in partnership with the University of Washington.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Assessment of patient experience and satisfaction with care among individuals undergoing&#xD;
      maintenance dialysis in the United States is a national health care priority and mandated by&#xD;
      Congress. No validated instruments are available to measure the patient-reported experience&#xD;
      of care in-home dialysis patients. Such tools are needed as more patients are expected to&#xD;
      choose home dialysis therapies in the future. This study aims to validate a home patient&#xD;
      experience survey instrument.&#xD;
&#xD;
      This is a cross-sectional validation to determine the measurement properties of a new home&#xD;
      dialysis patient experience survey instrument. Satellite Healthcare home dialysis patients&#xD;
      will be approached by mail or by phone to complete the survey.&#xD;
&#xD;
      The aim of this study is to perform field testing for this newly developed instrument for the&#xD;
      purposes of instrument validation and to determine survey instrument measurement properties.&#xD;
      This will include the evaluation of any multi-item scales as well as an overall score.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">July 17, 2020</start_date>
  <completion_date type="Actual">May 6, 2021</completion_date>
  <primary_completion_date type="Actual">November 2, 2020</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Other</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Evaluation of the measurement model</measure>
    <time_frame>through survey completion, an average of 6 months</time_frame>
    <description>The evaluation will encompass the survey burden, presence of a floor or ceiling effect for any item, test-retest reliability, development of multi-item subscales, internal consistency and reliability, center level reliability of the items and composites, and construct validity.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Survey response rate</measure>
    <time_frame>through survey completion, an average of 6 months</time_frame>
    <description>Percent (%) of participants contacted who complete survey instrument</description>
  </secondary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">513</enrollment>
  <condition>Home Dialysis</condition>
  <condition>End Stage Renal Disease</condition>
  <arm_group>
    <arm_group_label>Mail Survey Participants</arm_group_label>
    <description>Approximately 1200 home patients will receive mail surveys. Of these, one thousand and twenty (1,020) patients will be asked to complete the survey once. One hundred and eighty (180) patients will be asked to complete the survey twice.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Telephone Survey Participants</arm_group_label>
    <description>Three hundred (300) home patients will be surveyed by phone. Of those, one hundred and twenty will be asked to complete the survey once. One hundred and eighty patients will be asked to complete the phone surveys on two separate occasions.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Survey using &quot;Your Home Dialysis Care Experience&quot; tool.</intervention_name>
    <description>Validation of a new survey instrument to capture the experience of care by home dialysis patients.</description>
    <arm_group_label>Mail Survey Participants</arm_group_label>
    <arm_group_label>Telephone Survey Participants</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Target population is composed of those individuals receiving Home Dialysis care at&#xD;
        Satellite Healthcare facilities,&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients receiving care for home dialysis at a facility that provides care for &gt;= 3&#xD;
             patients at the time of cohort identification.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Age &lt; 18 years&#xD;
&#xD;
          -  Patients receiving care for home dialysis at the facility for less than 3 months&#xD;
&#xD;
          -  Institutionalized (senior nursing facility/multi-resident facility) or Hospice care&#xD;
             patients&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Satellite WellBound of Daly City</name>
      <address>
        <city>Daly City</city>
        <state>California</state>
        <zip>94014</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Satellite Wellbound of Emeryville</name>
      <address>
        <city>Emeryville</city>
        <state>California</state>
        <zip>94608</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Satellite Dialysis Folsom</name>
      <address>
        <city>Folsom</city>
        <state>California</state>
        <zip>95630</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Satellite Wellbound of Fremont</name>
      <address>
        <city>Fremont</city>
        <state>California</state>
        <zip>94538</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Satellite Healthcare Gilroy</name>
      <address>
        <city>Gilroy</city>
        <state>California</state>
        <zip>95020</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Satellite Healthcare Larkspur</name>
      <address>
        <city>Greenbrae</city>
        <state>California</state>
        <zip>94904</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Satellite Healthcare Laguna Hills</name>
      <address>
        <city>Laguna Hills</city>
        <state>California</state>
        <zip>92653</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Satellite Healthcare Merced</name>
      <address>
        <city>Merced</city>
        <state>California</state>
        <zip>95384</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Satellite WellBound of Milpitas</name>
      <address>
        <city>Milpitas</city>
        <state>California</state>
        <zip>95035</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Satellite WellBound of Modesto</name>
      <address>
        <city>Modesto</city>
        <state>California</state>
        <zip>95354</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Satellite WellBound of North Modesto</name>
      <address>
        <city>Modesto</city>
        <state>California</state>
        <zip>95356</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Satellite WellBound of Mountain View</name>
      <address>
        <city>Mountain View</city>
        <state>California</state>
        <zip>94040</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Satellite Healthcare Orange</name>
      <address>
        <city>Orange</city>
        <state>California</state>
        <zip>92868</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Satellite Healthcare South Gate</name>
      <address>
        <city>S. Gate</city>
        <state>California</state>
        <zip>90280</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Satellite WellBound of Sacramento</name>
      <address>
        <city>Sacramento</city>
        <state>California</state>
        <zip>95821</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Satellite WellBound of Sacramento University</name>
      <address>
        <city>Sacramento</city>
        <state>California</state>
        <zip>95825</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Satellite Healthcare Sacramento</name>
      <address>
        <city>Sacramento</city>
        <state>California</state>
        <zip>95834</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Satellite Healthcare San Carlos</name>
      <address>
        <city>San Carlos</city>
        <state>California</state>
        <zip>94070</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Satellite WellBound of San Francisco</name>
      <address>
        <city>San Francisco</city>
        <state>California</state>
        <zip>94109</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Satellite WellBound of San Jose</name>
      <address>
        <city>San Jose</city>
        <state>California</state>
        <zip>95125</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Satellite WellBound of San Leandro</name>
      <address>
        <city>San Leandro</city>
        <state>California</state>
        <zip>94577</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Satellite WellBound of San Mateo</name>
      <address>
        <city>San Mateo</city>
        <state>California</state>
        <zip>94403</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Satellite WellBound of Santa Cruz</name>
      <address>
        <city>Santa Cruz</city>
        <state>California</state>
        <zip>95062</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Satellite WellBound of Santa Rosa</name>
      <address>
        <city>Santa Rosa</city>
        <state>California</state>
        <zip>95407</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Satellite WellBound of Stockton</name>
      <address>
        <city>Stockton</city>
        <state>California</state>
        <zip>95219</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Satellite Healthcare Tracy</name>
      <address>
        <city>Tracy</city>
        <state>California</state>
        <zip>95377</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Satellite Healthcare Turlock West</name>
      <address>
        <city>Turlock</city>
        <state>California</state>
        <zip>95380</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Satellite WellBound of Vallejo</name>
      <address>
        <city>Vallejo</city>
        <state>California</state>
        <zip>94590</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Satellite Wellbound of Memphis</name>
      <address>
        <city>Memphis</city>
        <state>Tennessee</state>
        <zip>38117</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Satellite WellBound of South Austin</name>
      <address>
        <city>Austin</city>
        <state>Texas</state>
        <zip>78744</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Satellite WellBound of Austin</name>
      <address>
        <city>Austin</city>
        <state>Texas</state>
        <zip>78758</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Satellite Healthcare Laredo South</name>
      <address>
        <city>Laredo</city>
        <state>Texas</state>
        <zip>78040</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>May 2021</verification_date>
  <study_first_submitted>June 12, 2020</study_first_submitted>
  <study_first_submitted_qc>June 16, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 17, 2020</study_first_posted>
  <last_update_submitted>November 30, 2021</last_update_submitted>
  <last_update_submitted_qc>November 30, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">December 2, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>ESRD</keyword>
  <keyword>Dialysis</keyword>
  <keyword>Patient Experience</keyword>
  <keyword>Home Dialysis</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Kidney Failure, Chronic</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
    <ipd_description>A de-identified data set of responses will be shared with the Kidney Research Institute at the University of Washington.</ipd_description>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</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/NCT04435873
org study id: SP124 Home Experience
nct id: NCT04435873
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Home dialysis modalities, including peritoneal dialysis (PD) and home hemodialysis (HHD),
      represent alternatives to conventional in-center hemodialysis (HD) that for some patients may
      be better aligned with preferences regarding the integration of dialysis treatments into
      their lives. Assessment of patient experience and satisfaction with care among individuals
      undergoing maintenance dialysis in the United States is a national health care priority and
      mandated by Congress. While validated instruments (ICH CAHPS) are in use to assess patient
      experience with in-center HD, currently no validated instruments are available to measure
      patient-reported experience in home dialysis.

      This Home Patient Experience Survey Validation Study is an in-house research study conducted
      in partnership with the University of Washington.
Assessment of patient experience and satisfaction with care among individuals undergoing
      maintenance dialysis in the United States is a national health care priority and mandated by
      Congress. No validated instruments are available to measure the patient-reported experience
      of care in-home dialysis patients. Such tools are needed as more patients are expected to
      choose home dialysis therapies in the future. This study aims to validate a home patient
      experience survey instrument.

      This is a cross-sectional validation to determine the measurement properties of a new home
      dialysis patient experience survey instrument. Satellite Healthcare home dialysis patients
      will be approached by mail or by phone to complete the survey.

      The aim of this study is to perform field testing for this newly developed instrument for the
      purposes of instrument validation and to determine survey instrument measurement properties.
      This will include the evaluation of any multi-item scales as well as an overall score.
observational model: Other
time perspective: Prospective
measure: Evaluation of the measurement model
time frame: through survey completion, an average of 6 months
description: The evaluation will encompass the survey burden, presence of a floor or ceiling effect for any item, test-retest reliability, development of multi-item subscales, internal consistency and reliability, center level reliability of the items and composites, and construct validity.
measure: Survey response rate
time frame: through survey completion, an average of 6 months
description: Percent (%) of participants contacted who complete survey instrument
arm group label: Mail Survey Participants
description: Approximately 1200 home patients will receive mail surveys. Of these, one thousand and twenty (1,020) patients will be asked to complete the survey once. One hundred and eighty (180) patients will be asked to complete the survey twice.
arm group label: Telephone Survey Participants
description: Three hundred (300) home patients will be surveyed by phone. Of those, one hundred and twenty will be asked to complete the survey once. One hundred and eighty patients will be asked to complete the phone surveys on two separate occasions.
intervention type: Other
intervention name: Survey using "Your Home Dialysis Care Experience" tool.
description: Validation of a new survey instrument to capture the experience of care by home dialysis patients.
arm group label: Mail Survey Participants
arm group label: Telephone Survey Participants
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
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country: United States
responsible party type: Sponsor
mesh term: Kidney Failure, Chronic
sharing ipd: Undecided
ipd description: A de-identified data set of responses will be shared with the Kidney Research Institute at the University of Washington.