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/NCT05996328</url>
    </required_header>
    <id_info>
      <org_study_id>2025</org_study_id>
      <nct_id>NCT05996328</nct_id>
    </id_info>
    <brief_title>CSP #2025 - Geriatric OUt-of-hospital Randomized MEal Trial in Heart Failure: Veterans Affairs (GOURMET-VA)</brief_title>
    <acronym>GOURMET-VA</acronym>
    <official_title>CSP #2025 - Geriatric OUt-of-hospital Randomized MEal Trial in Heart Failure: Veterans Affairs (GOURMET-VA)</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>VA Office of Research and Development</agency>
        <agency_class>U.S. Fed</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>VA Office of Research and Development</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>
      <is_us_export>No</is_us_export>
    </oversight_info>
    <brief_summary>
      <textblock>
        The purpose of this multi-center clinical trial is to study the efficacy and safety of&#xD;
        providing nutritional support added to the study-defined standard of care which consists of&#xD;
        standardized dietary education and a single dietary counseling session shortly after&#xD;
        discharge, versus study-defined standard of care alone.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">April 1, 2024</start_date>
    <completion_date type="Anticipated">September 30, 2026</completion_date>
    <primary_completion_date type="Anticipated">April 30, 2026</primary_completion_date>
    <phase>N/A</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>Randomized</allocation>
      <intervention_model>Parallel Assignment</intervention_model>
      <intervention_model_description>Two-arm study: active intervention vs study-defined standard of care</intervention_model_description>
      <primary_purpose>Supportive Care</primary_purpose>
      <masking>Double (Investigator, Outcomes Assessor)</masking>
      <masking_description>Due to the nature of the intervention, participants, dietitians, and site coordinators can't be blinded. However, the investigators and outcome assessors will be blinded</masking_description>
    </study_design_info>
    <primary_outcome>
      <measure>Number of pairwise comparisons with wins of Clinical Benefit, evaluated a hierarchical composite of days alive out of hospital and =5-point difference in the change of health-related quality of life</measure>
      <time_frame>within 6 weeks post-index hospital discharge</time_frame>
      <description>All patients randomized to intervention are compared to all patients randomized to placebo within strata. In each comparison with any two patients, a patient will win by achieving a superior clinical outcome which is determined by sequentially assessing the following criteria with evaluation halted when distinct advantage for either patient is shown:&#xD;
  Days alive out of hospital at 6 weeks: shorter days is worse; tied, if same days alive out of hospital. Move to evaluation of 2 if tied.&#xD;
  Change of The Kansas City Cardiomyopathy Questionnaire Clinical Summary (KCCQ-CS) at 6 weeks from baseline: the threshold for the difference is greater or equal to 5 for a win; tied, if difference is less than 5.&#xD;
  The KCCQ-CS ranges from 0 to 100, where a higher score reflects a better outcome.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>DAOH at 6 months post-discharge</measure>
      <time_frame>6 months post-discharge</time_frame>
      <description>This outcome was selected to determine whether home-delivered meals, augmented by enhanced dietary counseling, during a high-risk period have durable effects on readmission burden.</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">1400</enrollment>
    <condition>Heart Failure</condition>
    <arm_group>
      <arm_group_label>Control</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>Study-defined standard of care</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Home-delivered meals and short-term dietary counseling</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Home-delivered, low-sodium, nutritionally robust meals for 6 weeks plus two additional remotely delivered dietary counseling sessions in addition to the study-defined standard of care.</description>
    </arm_group>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Home-delivered meals and short-term dietary counseling</intervention_name>
      <description>Home-delivered, low-sodium, nutritionally robust meals for 6 weeks plus two additional remotely delivered dietary counseling sessions in addition to the study-defined standard of care.</description>
      <arm_group_label>Home-delivered meals and short-term dietary counseling</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Study -defined standard of care</intervention_name>
      <description>study-defined standard of care consists of standardized dietary education and a single dietary counseling session shortly after discharge</description>
      <arm_group_label>Control</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  aged 60 years&#xD;
  &#xD;
            -  Veterans enrolled in a VHA facility&#xD;
  &#xD;
            -  Hospitalized ( 24 hours) with new HF or worsening chronic HF&#xD;
  &#xD;
            -  Dentition, swallowing function, etc. sufficient to safely consume food and liquid of&#xD;
               standard composition and texture (i.e., no pureed food, no thickened liquids needed)&#xD;
  &#xD;
            -  Able and willing to provide informed consent and perform study activities&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Food allergies or intolerances that cannot be accommodated by study diet&#xD;
  &#xD;
            -  On dialysis or estimated glomerular filtration rate &lt;30 at randomization&#xD;
  &#xD;
            -  Serum potassium (non-hemolyzed) &gt;6.0 mmol/L during index hospitalization&#xD;
  &#xD;
            -  Heart transplant or active transplant listing&#xD;
  &#xD;
            -  Left ventricular assist device present or anticipated &lt;6 months&#xD;
  &#xD;
            -  Malignancy or other non-cardiac condition limiting life expectancy to &lt;12 months&#xD;
  &#xD;
            -  Planned admission to a skilled nursing facility following hospital discharge, or&#xD;
               discharge to other location/situation where Veteran does not have control over diet&#xD;
  &#xD;
            -  Lack of space to store food for a week or equipment to prepare food&#xD;
  &#xD;
            -  Severe cognitive impairment (SLUMS score &lt;20, or &lt;19 if less than high school&#xD;
               education completed)&#xD;
  &#xD;
            -  Severe food insecurity (5 or 6 points on the USDA 6-item Food Insecurity Screen)&#xD;
  &#xD;
            -  Body mass index &gt;50 kg/m2&#xD;
  &#xD;
            -  Other medical, psychiatric, behavioral, or logistical condition which, in the clinical&#xD;
               judgement of the site investigator, makes it unlikely the patient can effectively&#xD;
               participate in or complete the study&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>60 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Scott L. Hummel, MD</last_name>
      <role>Study Chair</role>
      <affiliation>VA Ann Arbor Healthcare System, Ann Arbor, MI</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Yuan Huang</last_name>
      <phone>(203) 737-7966</phone>
      <email>Yuan.Huang1@va.gov</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Shirley Joyner</last_name>
      <phone>(203) 932-5711</phone>
      <email>Shirley.Joyner@va.gov</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>VA Connecticut Healthcare System West Haven Campus, West Haven, CT</name>
        <address>
          <city>West Haven</city>
          <state>Connecticut</state>
          <zip>06516-2770</zip>
          <country>United States</country>
        </address>
      </facility>
    </location>
    <location>
      <facility>
        <name>VA Ann Arbor Healthcare System, Ann Arbor, MI</name>
        <address>
          <city>Ann Arbor</city>
          <state>Michigan</state>
          <zip>48105-2303</zip>
          <country>United States</country>
        </address>
      </facility>
      <contact>
        <last_name>Scott L Hummel, MD</last_name>
        <email>Scott.Hummel@va.gov</email>
      </contact>
      <investigator>
        <last_name>Scott L. Hummel, MD</last_name>
        <role>Study Chair</role>
      </investigator>
    </location>
    <location_countries>
      <country>United States</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 9, 2023</study_first_submitted>
    <study_first_submitted_qc>August 9, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 18, 2023</study_first_posted>
    <last_update_submitted>August 9, 2023</last_update_submitted>
    <last_update_submitted_qc>August 9, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 18, 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>Heart Failure</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>Yes</sharing_ipd>
      <ipd_description>Digital data underlying primary scientific publications from this study will be held as part of a data sharing resource maintained by the Cooperative Studies Program (VA-CSP). These data may be available to the public and other VA and non-VA researchers under certain conditions and consistent with the informed consent and CSP policy which prioritize protecting subjects' privacy and confidentiality to the fullest extent possible</ipd_description>
    </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/NCT05996328
  org study id: 2025
  nct id: NCT05996328
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  is us export: No
  The purpose of this multi-center clinical trial is to study the efficacy and safety of
        providing nutritional support added to the study-defined standard of care which consists of
        standardized dietary education and a single dietary counseling session shortly after
        discharge, versus study-defined standard of care alone.
  allocation: Randomized
  intervention model: Parallel Assignment
  intervention model description: Two-arm study: active intervention vs study-defined standard of care
  primary purpose: Supportive Care
  masking: Double (Investigator, Outcomes Assessor)
  masking description: Due to the nature of the intervention, participants, dietitians, and site coordinators can't be blinded. However, the investigators and outcome assessors will be blinded
  measure: Number of pairwise comparisons with wins of Clinical Benefit, evaluated a hierarchical composite of days alive out of hospital and =5-point difference in the change of health-related quality of life
  time frame: within 6 weeks post-index hospital discharge
  description: All patients randomized to intervention are compared to all patients randomized to placebo within strata. In each comparison with any two patients, a patient will win by achieving a superior clinical outcome which is determined by sequentially assessing the following criteria with evaluation halted when distinct advantage for either patient is shown:
  Days alive out of hospital at 6 weeks: shorter days is worse; tied, if same days alive out of hospital. Move to evaluation of 2 if tied.
  Change of The Kansas City Cardiomyopathy Questionnaire Clinical Summary (KCCQ-CS) at 6 weeks from baseline: the threshold for the difference is greater or equal to 5 for a win; tied, if difference is less than 5.
  The KCCQ-CS ranges from 0 to 100, where a higher score reflects a better outcome.
  measure: DAOH at 6 months post-discharge
  time frame: 6 months post-discharge
  description: This outcome was selected to determine whether home-delivered meals, augmented by enhanced dietary counseling, during a high-risk period have durable effects on readmission burden.
  arm group label: Control
  arm group type: Active Comparator
  description: Study-defined standard of care
  arm group label: Home-delivered meals and short-term dietary counseling
  arm group type: Experimental
  description: Home-delivered, low-sodium, nutritionally robust meals for 6 weeks plus two additional remotely delivered dietary counseling sessions in addition to the study-defined standard of care.
  intervention type: Other
  intervention name: Home-delivered meals and short-term dietary counseling
  description: Home-delivered, low-sodium, nutritionally robust meals for 6 weeks plus two additional remotely delivered dietary counseling sessions in addition to the study-defined standard of care.
  arm group label: Home-delivered meals and short-term dietary counseling
  intervention type: Other
  intervention name: Study -defined standard of care
  description: study-defined standard of care consists of standardized dietary education and a single dietary counseling session shortly after discharge
  arm group label: Control
  criteria: 
  gender: All
  minimum age: 60 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Scott L. Hummel, MD
  role: Study Chair
  affiliation: VA Ann Arbor Healthcare System, Ann Arbor, MI
  last name: Yuan Huang
  phone: (203) 737-7966
  email: Yuan.Huang1@va.gov
  last name: Shirley Joyner
  phone: (203) 932-5711
  email: Shirley.Joyner@va.gov
  facility: 
  facility: 
  contact: 
  investigator: 
  country: United States
  responsible party type: Sponsor
  mesh term: Heart Failure
  sharing ipd: Yes
  ipd description: Digital data underlying primary scientific publications from this study will be held as part of a data sharing resource maintained by the Cooperative Studies Program (VA-CSP). These data may be available to the public and other VA and non-VA researchers under certain conditions and consistent with the informed consent and CSP policy which prioritize protecting subjects' privacy and confidentiality to the fullest extent possible