<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/NCT04505891</url>
  </required_header>
  <id_info>
    <org_study_id>20-004204</org_study_id>
    <nct_id>NCT04505891</nct_id>
  </id_info>
  <brief_title>Enhanced Kidney Follow-up for AKI Survivors in Care Transitions</brief_title>
  <official_title>Enhanced Kidney Follow-up for AKI Survivors in Care Transitions (The ACT Study): Impact on Patient Reported Outcomes</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Mayo Clinic</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Mayo Clinic</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>
      The purpose of this study is to assess the ability of education and outpatient kidney care&#xD;
      follow-up in order to improve patient knowledge about acute kidney injury (AKI).&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">August 17, 2020</start_date>
  <completion_date type="Actual">December 21, 2021</completion_date>
  <primary_completion_date type="Actual">December 21, 2021</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Sequential Assignment</intervention_model>
    <primary_purpose>Health Services Research</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Modified Kidney Knowledge Survey (mKIKS)</measure>
    <time_frame>14-days after last study contact</time_frame>
    <description>Assesses participants' objective knowledge about AKI causes, risk factors, and management. The minimum score is 0, maximum score is 15, higher scores indicate greater knowledge.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Brief health literacy screen</measure>
    <time_frame>30-days post hospitalization</time_frame>
    <description>A 4-item tool to assess health literacy. Minimum score of 0, maximum score 20, higher scores indicate higher health literacy</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Patient-Reported Outcomes Measurement Information System (PROMIS) Global Health 10</measure>
    <time_frame>30-days post hospitalization</time_frame>
    <description>Based on the provided responses, an overall summary score, and two subset scores - Global health physical and Global health mental can be calculated. Raw summed score are converted into T-scores. Higher scores indicate better health.</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">49</enrollment>
  <condition>Acute Kidney Injury</condition>
  <arm_group>
    <arm_group_label>Usual care</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Education alone</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Education and follow-up</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Education</intervention_name>
    <description>Kidney health education will be delivered prior to discharge by trained nurse educators.</description>
    <arm_group_label>Education alone</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Education and follow-up</intervention_name>
    <description>In patients allocated to the education and follow-up arm, education along with a a post-discharge healthcare visit from a multidisciplinary care team will be performed.</description>
    <arm_group_label>Education and follow-up</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  KDIGO Stage 3 AKI&#xD;
&#xD;
          -  Primary care provider at Mayo Rochester.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patient with need for dialysis at discharge from hospital or hospice.&#xD;
&#xD;
          -  Enrolled in the Primary Care Transition Program.&#xD;
&#xD;
          -  Non-English speaking.&#xD;
&#xD;
          -  Cognitive impairment.&#xD;
&#xD;
          -  Dementia.&#xD;
&#xD;
          -  Mini-Cog score of less than 3.&#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>Erin F Barreto, PharmD, RPh</last_name>
    <role>Principal Investigator</role>
    <affiliation>Mayo Clinic</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Mayo Clinic in Rochester</name>
      <address>
        <city>Rochester</city>
        <state>Minnesota</state>
        <zip>55905</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <link>
    <url>https://www.mayo.edu/research/clinical-trials</url>
    <description>Mayo Clinic Clinical Trials</description>
  </link>
  <verification_date>January 2022</verification_date>
  <study_first_submitted>August 4, 2020</study_first_submitted>
  <study_first_submitted_qc>August 6, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">August 10, 2020</study_first_posted>
  <last_update_submitted>January 3, 2022</last_update_submitted>
  <last_update_submitted_qc>January 3, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">January 5, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Mayo Clinic</investigator_affiliation>
    <investigator_full_name>Erin Barreto</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <keyword>transitions of care</keyword>
  <keyword>education</keyword>
  <keyword>patient reported outcomes</keyword>
  <keyword>chronic kidney disease</keyword>
  <keyword>acute kidney injury</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Acute Kidney Injury</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </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/NCT04505891
org study id: 20-004204
nct id: NCT04505891
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The purpose of this study is to assess the ability of education and outpatient kidney care
      follow-up in order to improve patient knowledge about acute kidney injury (AKI).
allocation: Non-Randomized
intervention model: Sequential Assignment
primary purpose: Health Services Research
masking: None (Open Label)
measure: Modified Kidney Knowledge Survey (mKIKS)
time frame: 14-days after last study contact
description: Assesses participants' objective knowledge about AKI causes, risk factors, and management. The minimum score is 0, maximum score is 15, higher scores indicate greater knowledge.
measure: Brief health literacy screen
time frame: 30-days post hospitalization
description: A 4-item tool to assess health literacy. Minimum score of 0, maximum score 20, higher scores indicate higher health literacy
measure: Patient-Reported Outcomes Measurement Information System (PROMIS) Global Health 10
time frame: 30-days post hospitalization
description: Based on the provided responses, an overall summary score, and two subset scores - Global health physical and Global health mental can be calculated. Raw summed score are converted into T-scores. Higher scores indicate better health.
arm group label: Usual care
arm group type: No Intervention
arm group label: Education alone
arm group type: Active Comparator
arm group label: Education and follow-up
arm group type: Active Comparator
intervention type: Behavioral
intervention name: Education
description: Kidney health education will be delivered prior to discharge by trained nurse educators.
arm group label: Education alone
intervention type: Behavioral
intervention name: Education and follow-up
description: In patients allocated to the education and follow-up arm, education along with a a post-discharge healthcare visit from a multidisciplinary care team will be performed.
arm group label: Education and follow-up
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Erin F Barreto, PharmD, RPh
role: Principal Investigator
affiliation: Mayo Clinic
facility: 
country: United States
url: https://www.mayo.edu/research/clinical-trials
description: Mayo Clinic Clinical Trials
responsible party type: Principal Investigator
investigator affiliation: Mayo Clinic
investigator full name: Erin Barreto
investigator title: Principal Investigator
mesh term: Acute Kidney Injury
sharing ipd: No