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/NCT05985395</url>
    </required_header>
    <id_info>
      <org_study_id>0914-21-FB</org_study_id>
      <nct_id>NCT05985395</nct_id>
    </id_info>
    <brief_title>HEART Camp Connect: A Feasibility Study</brief_title>
    <official_title>HEART Camp Connect: A Feasibility Study</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>University of Nebraska</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>University of Nebraska</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>
        This study builds on the tested and refined HEART Camp intervention which has been shown to&#xD;
        improve long-term adherence to exercise in individuals diagnosed with heart failure. HEART&#xD;
        Camp Connect enhances HEART Camp by delivering the coaching via videoconference and providing&#xD;
        access to hospital-based exercise facilities and online exercise programming. This&#xD;
        prospective study uses a 2-group, randomized repeated measures experimental design with 3&#xD;
        data collection points baseline, Month 3, and Month 6.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Potential participants will be approached at a Heart Failure clinic at an academic medical&#xD;
        center. As a secondary recruitment strategy, we will use a database that identifies patients&#xD;
        who previously indicated their willingness to be contacted for clinical research.&#xD;
  &#xD;
        Study personnel will obtain informed consent in person in a private room or over the phone&#xD;
        facilitated by the academic medical center electronic consent process. Once consented,&#xD;
        participants will complete cardiopulmonary exercise testing (CPET) to guide individual&#xD;
        exercise prescriptions and protect against risks associated with exercise. CPET results that&#xD;
        preclude safe exercise training (arrhythmia) or those with CPET results indicating&#xD;
        cardio-respiratory fitness (females with maximum oxygen consumption ≥ 21ml/kg/min and males&#xD;
        with oxygen consumption ≥ 24 ml/kg/min) will be withdrawn from the study.&#xD;
  &#xD;
        Participants will be given instruction on the use of the heart rate monitor. Participants&#xD;
        will wear their monitor exercise sessions for heart rate monitoring. Participants will also&#xD;
        receive educational training via videos on topics such as exercising with heart failure, how&#xD;
        medications impact exercise, and nutrition.&#xD;
  &#xD;
        Participants will be instructed to wear a heart rate monitor and strive to meet a goal of 150&#xD;
        minutes of moderate-intensity exercise per week. Minutes toward adherence goals for the study&#xD;
        will be calculated as time spent participating in a moderate-intensity activity and&#xD;
        determined by their CPET results and personalized exercise prescription.&#xD;
  &#xD;
        Each participant will be given access to an Omaha-based exercise coach that he/she will meet&#xD;
        with weekly over Zoom for 30 minutes. Coaches will discuss exercise over the past week&#xD;
        including problems, issues, concerns. Goals will be set, reviewed, assessed, and revised each&#xD;
        week. For virtual exercise, all participants will access a Virtual Wellness Center.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">March 28, 2022</start_date>
    <completion_date type="Anticipated">September 15, 2023</completion_date>
    <primary_completion_date type="Anticipated">September 15, 2023</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>Single Group Assignment</intervention_model>
      <primary_purpose>Health Services Research</primary_purpose>
      <masking>Single (Outcomes Assessor)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>The number of potential participants without smart devices</measure>
      <time_frame>baseline to 3 months</time_frame>
      <description>Adherence to exercise&#xD;
  Procedures identify connectivity issues, the number of potential participants without smart devices, and evaluating orientation to Polar watch, rating of perceived exertion and digital diaries</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>The number of potential participants without smart devices</measure>
      <time_frame>baseline to 6 months</time_frame>
      <description>Adherence to exercise&#xD;
  Procedures identify connectivity issues, the number of potential participants without smart devices, and evaluating orientation to Polar watch, rating of perceived exertion and digital diaries</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>The number of potential participants without smart devices</measure>
      <time_frame>3 months to 6 months</time_frame>
      <description>Adherence to exercise&#xD;
  Procedures identify connectivity issues, the number of potential participants without smart devices, and evaluating orientation to Polar watch, rating of perceived exertion and digital diaries</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">50</enrollment>
    <condition>Heart Failure With Preserved Ejection Fraction</condition>
    <arm_group>
      <arm_group_label>HEART Camp Connect</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Participants will have access to a virtual exercise platform or membership to a medical exercise facility. Participants will meet with a virtual exercise coach via Zoom on a weekly basis.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Usual Care</arm_group_label>
      <arm_group_type>No Intervention</arm_group_type>
      <description>Participants will have access to a virtual exercise platform or membership to a medical exercise facility.</description>
    </arm_group>
    <intervention>
      <intervention_type>Behavioral</intervention_type>
      <intervention_name>HEART Camp Connect</intervention_name>
      <description>Once eligible and enrolled, participants will complete 150 minutes of moderate-intensity exercise a week with help of a virtual exercise coach.</description>
      <arm_group_label>HEART Camp Connect</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Diagnosis of heart failure (HF) with an ejection fraction (EF) ≥50%&#xD;
  &#xD;
            -  Age ≥18 years&#xD;
  &#xD;
            -  English-speaking&#xD;
  &#xD;
            -  Echocardiogram in prior 12 months&#xD;
  &#xD;
            -  Stable pharmacologic therapy in past 30 days&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Score&lt;6 on a diagnostic algorithm&#xD;
  &#xD;
            -  Life-limiting illness precluding study completion&#xD;
  &#xD;
            -  Clinical evidence of decompensated HF&#xD;
  &#xD;
            -  Unstable angina or marked shortness of breath on exertion at &lt;2 metabolic equivalents&#xD;
  &#xD;
            -  Myocardial infarction, coronary artery bypass surgery, or biventricular pacemaker &lt;6&#xD;
               weeks&#xD;
  &#xD;
            -  Orthopedic or neuromuscular disorders preventing participation in aerobic exercise&#xD;
  &#xD;
            -  Cardiopulmonary exercise test results that preclude safe exercise&#xD;
  &#xD;
            -  Unwilling/unable to complete pre-randomization procedures&#xD;
  &#xD;
            -  Pregnancy&#xD;
  &#xD;
            -  Implantable cardioverter-defibrillator&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Windy Alonso, PhD, RN</last_name>
      <role>Principal Investigator</role>
      <affiliation>University of Nebraska</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Windy Alonso, PhD, RN</last_name>
      <phone>402-559-8342</phone>
      <email>windy.alonso@unmc.edu</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Bunny Pozehl, PhD, APRN-NP</last_name>
      <phone>402-559-3182</phone>
      <email>bpozehl@unmc.edu</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>University of Nebraska Medical Center</name>
        <address>
          <city>Omaha</city>
          <state>Nebraska</state>
          <zip>68198-5330</zip>
          <country>United States</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Windy Alonso, PhD, RN</last_name>
        <phone>402-559-8342</phone>
        <email>windy.alonso@unmc.edu</email>
      </contact>
    </location>
    <location_countries>
      <country>United States</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 2, 2023</study_first_submitted>
    <study_first_submitted_qc>August 9, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 14, 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 14, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>exercise training</keyword>
    <keyword>adherence</keyword>
    <keyword>coaching</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Heart Failure</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/NCT05985395
  org study id: 0914-21-FB
  nct id: NCT05985395
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  This study builds on the tested and refined HEART Camp intervention which has been shown to
        improve long-term adherence to exercise in individuals diagnosed with heart failure. HEART
        Camp Connect enhances HEART Camp by delivering the coaching via videoconference and providing
        access to hospital-based exercise facilities and online exercise programming. This
        prospective study uses a 2-group, randomized repeated measures experimental design with 3
        data collection points baseline, Month 3, and Month 6.
  Potential participants will be approached at a Heart Failure clinic at an academic medical
        center. As a secondary recruitment strategy, we will use a database that identifies patients
        who previously indicated their willingness to be contacted for clinical research.
  
        Study personnel will obtain informed consent in person in a private room or over the phone
        facilitated by the academic medical center electronic consent process. Once consented,
        participants will complete cardiopulmonary exercise testing (CPET) to guide individual
        exercise prescriptions and protect against risks associated with exercise. CPET results that
        preclude safe exercise training (arrhythmia) or those with CPET results indicating
        cardio-respiratory fitness (females with maximum oxygen consumption ≥ 21ml/kg/min and males
        with oxygen consumption ≥ 24 ml/kg/min) will be withdrawn from the study.
  
        Participants will be given instruction on the use of the heart rate monitor. Participants
        will wear their monitor exercise sessions for heart rate monitoring. Participants will also
        receive educational training via videos on topics such as exercising with heart failure, how
        medications impact exercise, and nutrition.
  
        Participants will be instructed to wear a heart rate monitor and strive to meet a goal of 150
        minutes of moderate-intensity exercise per week. Minutes toward adherence goals for the study
        will be calculated as time spent participating in a moderate-intensity activity and
        determined by their CPET results and personalized exercise prescription.
  
        Each participant will be given access to an Omaha-based exercise coach that he/she will meet
        with weekly over Zoom for 30 minutes. Coaches will discuss exercise over the past week
        including problems, issues, concerns. Goals will be set, reviewed, assessed, and revised each
        week. For virtual exercise, all participants will access a Virtual Wellness Center.
  allocation: Randomized
  intervention model: Single Group Assignment
  primary purpose: Health Services Research
  masking: Single (Outcomes Assessor)
  measure: The number of potential participants without smart devices
  time frame: baseline to 3 months
  description: Adherence to exercise
  Procedures identify connectivity issues, the number of potential participants without smart devices, and evaluating orientation to Polar watch, rating of perceived exertion and digital diaries
  measure: The number of potential participants without smart devices
  time frame: baseline to 6 months
  description: Adherence to exercise
  Procedures identify connectivity issues, the number of potential participants without smart devices, and evaluating orientation to Polar watch, rating of perceived exertion and digital diaries
  measure: The number of potential participants without smart devices
  time frame: 3 months to 6 months
  description: Adherence to exercise
  Procedures identify connectivity issues, the number of potential participants without smart devices, and evaluating orientation to Polar watch, rating of perceived exertion and digital diaries
  arm group label: HEART Camp Connect
  arm group type: Experimental
  description: Participants will have access to a virtual exercise platform or membership to a medical exercise facility. Participants will meet with a virtual exercise coach via Zoom on a weekly basis.
  arm group label: Usual Care
  arm group type: No Intervention
  description: Participants will have access to a virtual exercise platform or membership to a medical exercise facility.
  intervention type: Behavioral
  intervention name: HEART Camp Connect
  description: Once eligible and enrolled, participants will complete 150 minutes of moderate-intensity exercise a week with help of a virtual exercise coach.
  arm group label: HEART Camp Connect
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: Accepts Healthy Volunteers
  last name: Windy Alonso, PhD, RN
  role: Principal Investigator
  affiliation: University of Nebraska
  last name: Windy Alonso, PhD, RN
  phone: 402-559-8342
  email: windy.alonso@unmc.edu
  last name: Bunny Pozehl, PhD, APRN-NP
  phone: 402-559-3182
  email: bpozehl@unmc.edu
  facility: 
  status: Recruiting
  contact: 
  country: United States
  responsible party type: Sponsor
  mesh term: Heart Failure