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/NCT05972070</url>
    </required_header>
    <id_info>
      <org_study_id>ROMTherapy_HBCR_1001</org_study_id>
      <nct_id>NCT05972070</nct_id>
    </id_info>
    <brief_title>Integration of Telemedicine and Home-Based Cardiac Rehabilitation: Feasibility, Efficacy, and Adherence</brief_title>
    <official_title>Integration of Telemedicine and Home-Based Cardiac Rehabilitation: Feasibility, Efficacy, and Adherence</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>ROM Technologies, INC</agency>
        <agency_class>Industry</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>ROM Technologies, INC</source>
    <oversight_info>
      <has_dmc>Yes</has_dmc>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>Yes</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        The aim of this study is to evaluate feasibility, efficacy, and adherence of home-based&#xD;
        cardiac rehabilitation with the integration of telemedicine. Several components will be&#xD;
        assessed such as quality-of-life, nutritional counseling, maximum metabolic activity (MET's),&#xD;
        diabetic management, tobacco cessation, lipid, blood pressure, and psychosocial management.&#xD;
        These tasks will be accomplished through concurrent conversations between patients and their&#xD;
        therapist's utilizing telemedicine with observed exercise training.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        The focus of this study is to determine the feasibility, efficacy, and adherence of&#xD;
        home-based cardiac rehabilitation with the integration of telemedicine. The study consists of&#xD;
        an initial review, rehabilitation sessions, nutrition consultation, and risk stratification.&#xD;
        Once the patient is cleared for the rehabilitation program, they will be assigned a cardiac&#xD;
        rehab specialist and begin the 36 rehabilitation sessions. The sessions include pre-session&#xD;
        questions, surveys, pre-, during, and post vitals, exercise protocol, and off-the-device&#xD;
        exercises.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">June 1, 2023</start_date>
    <completion_date type="Anticipated">November 30, 2023</completion_date>
    <primary_completion_date type="Anticipated">October 31, 2023</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>Session attended</measure>
      <time_frame>12 weeks (End of treatment)</time_frame>
      <description>Measure the number of sessions attended to determine the ease of patients to utilize home-based cardiac rehab integrated with telemedicine (non-inferiority to historical controls)</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Sessions completed</measure>
      <time_frame>12 weeks(End of treatment)</time_frame>
      <description>Measure the number of sessions completed to determine compliance of patients to utilize home-based cardiac rehab integrated with telemedicine</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Duke Activity Status Index (DASI)</measure>
      <time_frame>Baseline, 12 weeks (End of Treatment)</time_frame>
      <description>Estimate of functional capacity</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Patient Health Questionnaire(PHQ)</measure>
      <time_frame>Baseline, 12 weeks (End of Treatment)</time_frame>
      <description>Quality of Life assessment</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Short Physical Performance Battery</measure>
      <time_frame>Baseline, 12 weeks (End of Treatment)</time_frame>
      <description>Lower extremity functional assessment</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Short Form-36</measure>
      <time_frame>Baseline, 12 weeks (End of Treatment)</time_frame>
      <description>Quality of Life assessment</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Laboratory assessment</measure>
      <time_frame>Baseline, 12 weeks (End of Treatment)</time_frame>
      <description>To determine if there is an improvement in low density lipoprotein, triglycerides,</description>
    </secondary_outcome>
    <number_of_groups>1</number_of_groups>
    <enrollment type="Anticipated">500</enrollment>
    <condition>Myocardial Infarction</condition>
    <condition>Percutaneous Transluminal Coronary Angioplasty</condition>
    <condition>Coronary Artery Bypass</condition>
    <condition>Stable Angina</condition>
    <condition>Heart Failure</condition>
    <condition>Valve Disease, Heart</condition>
    <condition>Cardiac Rehabilitation</condition>
    <condition>Stent</condition>
    <arm_group>
      <arm_group_label>Cardiac patients</arm_group_label>
      <description>Adult patients who have undergone surgical or percutaneous coronary revascularization due to atherosclerotic coronary artery disease.</description>
    </arm_group>
    <intervention>
      <intervention_type>Device</intervention_type>
      <intervention_name>ROMTech Portable Connect</intervention_name>
      <description>The ROMTech PortableConnect Rehab System is a continuous rehabilitative exercise therapy device that uses assisted movement to measure, evaluate, exercise, re-educate and strengthen muscles, and to increase joint range of motion.</description>
      <arm_group_label>Cardiac patients</arm_group_label>
      <other_name>ROMTech PC</other_name>
      <other_name>ROMTech PortableConnect Rehab System</other_name>
    </intervention>
    <biospec_retention>Samples Without DNA</biospec_retention>
    <biospec_descr>
      <textblock>
        Blood sample&#xD;
      </textblock>
    </biospec_descr>
    <eligibility>
      <study_pop>
        <textblock>
          Adult patients who have undergone surgical or percutaneous coronary revascularization due&#xD;
          to atherosclerotic coronary artery disease.&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Non-Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            1. Over the age of 18&#xD;
  &#xD;
            2. NYHA Functional Class I, II,&#xD;
  &#xD;
            3. Recent (within 60 days) status post coronary artery revascularization for&#xD;
               atherosclerotic coronary artery disease (coronary artery bypass grafting or&#xD;
               percutaneous coronary revascularization with stent implantation)&#xD;
  &#xD;
            4. Candidate for traditional center-based cardiac rehabilitation&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            1. Under the age of 18&#xD;
  &#xD;
            2. Adults lacking capacity to consent.&#xD;
  &#xD;
            3. NYHA Functional Class III, IV&#xD;
  &#xD;
            4. Acute coronary syndrome&#xD;
  &#xD;
            5. Systolic heart failure (LV EF &lt;40%)&#xD;
  &#xD;
            6. Status post cardiac surgery for structural heart disease or heart transplant&#xD;
  &#xD;
            7. Percutaneous coronary angioplasty&#xD;
  &#xD;
            8. Adults lacking capacity to consent.&#xD;
  &#xD;
            9. Pregnant women&#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_contact>
      <last_name>LaToya T. King</last_name>
      <phone>2035184735</phone>
      <email>Latoya.King@romtech.com</email>
    </overall_contact>
    <location>
      <facility>
        <name>ROMTech</name>
        <address>
          <city>Brookfield</city>
          <state>Connecticut</state>
          <zip>06804</zip>
          <country>United States</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>LaToya T King</last_name>
        <phone>203-518-4735</phone>
        <email>Latoya.King@romtech.com</email>
      </contact>
      <investigator>
        <last_name>John Stulak, MD</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location_countries>
      <country>United States</country>
    </location_countries>
    <verification_date>July 2023</verification_date>
    <study_first_submitted>July 3, 2023</study_first_submitted>
    <study_first_submitted_qc>July 24, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 2, 2023</study_first_posted>
    <last_update_submitted>July 24, 2023</last_update_submitted>
    <last_update_submitted_qc>July 24, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 2, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>Cardiac rehabilitation</keyword>
    <keyword>Home based cardiac rehabilitation</keyword>
    <keyword>Telemedicine and Home-Based Cardiac Rehabilitation</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Myocardial Infarction</mesh_term>
      <mesh_term>Angina, Stable</mesh_term>
      <mesh_term>Heart Valve Diseases</mesh_term>
      <mesh_term>Infarction</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/NCT05972070
  org study id: ROMTherapy_HBCR_1001
  nct id: NCT05972070
  lead sponsor: 
  has dmc: Yes
  is fda regulated drug: No
  is fda regulated device: Yes
  The aim of this study is to evaluate feasibility, efficacy, and adherence of home-based
        cardiac rehabilitation with the integration of telemedicine. Several components will be
        assessed such as quality-of-life, nutritional counseling, maximum metabolic activity (MET's),
        diabetic management, tobacco cessation, lipid, blood pressure, and psychosocial management.
        These tasks will be accomplished through concurrent conversations between patients and their
        therapist's utilizing telemedicine with observed exercise training.
  The focus of this study is to determine the feasibility, efficacy, and adherence of
        home-based cardiac rehabilitation with the integration of telemedicine. The study consists of
        an initial review, rehabilitation sessions, nutrition consultation, and risk stratification.
        Once the patient is cleared for the rehabilitation program, they will be assigned a cardiac
        rehab specialist and begin the 36 rehabilitation sessions. The sessions include pre-session
        questions, surveys, pre-, during, and post vitals, exercise protocol, and off-the-device
        exercises.
  observational model: Cohort
  time perspective: Prospective
  measure: Session attended
  time frame: 12 weeks (End of treatment)
  description: Measure the number of sessions attended to determine the ease of patients to utilize home-based cardiac rehab integrated with telemedicine (non-inferiority to historical controls)
  measure: Sessions completed
  time frame: 12 weeks(End of treatment)
  description: Measure the number of sessions completed to determine compliance of patients to utilize home-based cardiac rehab integrated with telemedicine
  measure: Duke Activity Status Index (DASI)
  time frame: Baseline, 12 weeks (End of Treatment)
  description: Estimate of functional capacity
  measure: Patient Health Questionnaire(PHQ)
  time frame: Baseline, 12 weeks (End of Treatment)
  description: Quality of Life assessment
  measure: Short Physical Performance Battery
  time frame: Baseline, 12 weeks (End of Treatment)
  description: Lower extremity functional assessment
  measure: Short Form-36
  time frame: Baseline, 12 weeks (End of Treatment)
  description: Quality of Life assessment
  measure: Laboratory assessment
  time frame: Baseline, 12 weeks (End of Treatment)
  description: To determine if there is an improvement in low density lipoprotein, triglycerides,
  arm group label: Cardiac patients
  description: Adult patients who have undergone surgical or percutaneous coronary revascularization due to atherosclerotic coronary artery disease.
  intervention type: Device
  intervention name: ROMTech Portable Connect
  description: The ROMTech PortableConnect Rehab System is a continuous rehabilitative exercise therapy device that uses assisted movement to measure, evaluate, exercise, re-educate and strengthen muscles, and to increase joint range of motion.
  arm group label: Cardiac patients
  other name: ROMTech PC
  other name: ROMTech PortableConnect Rehab System
  Blood sample
  study pop: 
  sampling method: Non-Probability Sample
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  last name: LaToya T. King
  phone: 2035184735
  email: Latoya.King@romtech.com
  facility: 
  status: Recruiting
  contact: 
  investigator: 
  country: United States
  responsible party type: Sponsor
  mesh term: Myocardial Infarction
  mesh term: Angina, Stable
  mesh term: Heart Valve Diseases
  mesh term: Infarction