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/NCT06040398</url>
    </required_header>
    <id_info>
      <org_study_id>15474</org_study_id>
      <nct_id>NCT06040398</nct_id>
    </id_info>
    <brief_title>The JUMPSTART Program: Encouraging Early Mobilization and Optimizing Recovery of TAVR Patients' Post-hospital Discharge</brief_title>
    <official_title>The JUMPSTART Program: Encouraging Early Mobilization and Optimizing Recovery of TAVR Patients' Post-hospital Discharge</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Hamilton Health Sciences Corporation</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>Edwards Lifesciences</agency>
        <agency_class>Industry</agency_class>
      </collaborator>
      <collaborator>
        <agency>McMaster University</agency>
        <agency_class>Other</agency_class>
      </collaborator>
    </sponsors>
    <source>McMaster University</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>
        A virtual, self-directed, and tailored early mobilization program called JUMPSTART, that aims&#xD;
        to bridge cardiac rehabilitation intake for post-TAVR patients has been developed at the&#xD;
        Hamilton General Hospital. The program includes a series of exercise videos at varying levels&#xD;
        of intensity, designed for patients to follow at home, post-discharge. JUMPSTART is currently&#xD;
        being offered as part of clinical care. In this new pilot study, the study team plans to&#xD;
        develop and test new strategies to optimize recruitment and participation, develop additional&#xD;
        JUMPSTART materials and evaluate outcomes through follow-up surveys and&#xD;
        registry/administrative data at Hamilton General Hospital.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Post-TAVR patients who have successfully completed a pre-discharge ambulation assessment and&#xD;
        are deemed eligible for discharge will be eligible to participate. Potential participants&#xD;
        will be introduced to the study in the pre-TAVR clinic by the nurse practitioner or their&#xD;
        delegate. Participants who agree to be contacted for research purposes will provide written&#xD;
        consent in the pre-TAVR clinic when they meet with the nurse practitioner. Confirmation of&#xD;
        eligibility for the research study will be conducted post-TAVR by the nurse practitioner. The&#xD;
        JUMPSTART program will be offered to all eligible patients as part of standard clinical care,&#xD;
        regardless of their consent to participate in the research study. No data will be collected&#xD;
        for the purposes of the research study from patients who do not provide consent. The primary&#xD;
        outcomes will be adoption (the number of eligible post-TAVR patients who participate in the&#xD;
        JUMPSTART early mobilization program), and a preliminary comparison of quality of life&#xD;
        (measured using the Toronto Aortic Stenosis Quality of Life Questionnaire) between people who&#xD;
        do and do not participate in the JUMPSTART program.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">March 1, 2023</start_date>
    <completion_date type="Anticipated">March 31, 2024</completion_date>
    <primary_completion_date type="Anticipated">February 28, 2024</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>Effectiveness (quality of life)</measure>
      <time_frame>Baseline and 3 months post-TAVR procedure.</time_frame>
      <description>Changes in Toronto Aortic Stenosis QoL Questionnaire (TASQ) scores will be compared among study participants who did the JUMPSTART program, and those that didn't. The TASQ consists of 16 statements. Most statements are answered via 7-point Likert scale, where a higher score represents worse outcomes.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Adoption</measure>
      <time_frame>14 days post-TAVR procedure.</time_frame>
      <description>Number of eligible patients who participate in the JUMPSTART program.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Adoption</measure>
      <time_frame>3 months post-TAVR procedure.</time_frame>
      <description>Number of eligible patients who participate in the JUMPSTART program. Target = 70% adoption rate.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Reach</measure>
      <time_frame>12 months (post-study start date).</time_frame>
      <description>Assessed by dividing the total eligible number of TAVR patients who agree to enter the JUMPSTART program by the total eligible number of TAVR patients who underwent the TAVR procedure at the Hamilton General Hospital.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Effectiveness (cardiac rehab attendance)</measure>
      <time_frame>3 months post-TAVR procedure.</time_frame>
      <description>Measurement of the percentage of post-TAVR patients who have attended a cardiac rehab orientation session by 3 months post-TAVR procedure.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Effectiveness (acceptability)</measure>
      <time_frame>14 days and 3 months post-TAVR procedure.</time_frame>
      <description>Acceptability will be measured by self-reported questionnaire in consenting participants, administered via telephone interview or online survey (REDCap). Participants are asked to provide their level of satisfaction with the exercise videos and instructional handout on a scale of 1-7, where 1 = very unsatisfied and 7 = very satisfied.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Effectiveness (feasibility)</measure>
      <time_frame>14 days and 3 months post-TAVR procedure.</time_frame>
      <description>Feasibility will be measured by self-reported questionnaire in consenting participants, administered via telephone interview or online survey (REDCap). Participants are asked about ease in following the exercise videos, and challenges associated with doing the exercises.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Adoption (barriers and facilitators)</measure>
      <time_frame>14 days and 3 months post-TAVR procedure.</time_frame>
      <description>Barriers and facilitators will be assessed by questionnaire administered via telephone interview or online survey (REDCap). No response scales are used, the data collected is qualitative in nature. Implementation strategies will be tailored to these barriers and facilitators using an iterative process.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Implementation (fidelity)</measure>
      <time_frame>Assessed at 4 months (post-study start date), 8 months, and 12 months.</time_frame>
      <description>Meetings/focus groups with research team and hospital staff to review whether implementation has taken place as planned (e.g., fidelity of the recruitment process, data collection), and to discuss pre-discharge testing and whether patients are given JUMPSTART materials both at the pre-TAVR clinic and prior to discharge.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Maintenance</measure>
      <time_frame>Assessed at 4 months (post-study start date), 8 months, and 12 months.</time_frame>
      <description>Meetings/focus groups with research team to review study participation rates and to discuss barriers to participation. Program sustainability and plans for imbedding the program into routine care/practice will also be discussed.</description>
    </secondary_outcome>
    <number_of_groups>1</number_of_groups>
    <enrollment type="Anticipated">150</enrollment>
    <condition>Aortic Valve Stenosis</condition>
    <condition>Transcatheter Aortic Valve Replacement</condition>
    <arm_group>
      <arm_group_label>TAVR Patients</arm_group_label>
      <description>All outpatients undergoing TAVR and managed through the overnight-model pathway at the Hamilton General Hospital will be eligible for participation.</description>
    </arm_group>
    <intervention>
      <intervention_type>Behavioral</intervention_type>
      <intervention_name>JUMPSTART exercise program</intervention_name>
      <description>The intervention is an early mobilization protocol (JUMPSTART). Four interactive exercise videos, at different intensity levels, include a variety of stretches and exercises designed to improve the full body mobilization of post-TAVR patients. Videos have been developed in consultation with a physiotherapist and cardiac rehabilitation specialist and have been piloted for initial acceptability by patients at the Hamilton General Hospital. The videos will be freely accessible to all eligible patients and their caregivers (regardless of participation in the research study) online (www.hhscebi.ca/projects/jumpstart). A written version of the exercise program, with photographs and detailed instructions, will also be made available. Additional exercise videos will be developed based on patients' needs and feedback received.</description>
      <arm_group_label>TAVR Patients</arm_group_label>
    </intervention>
    <eligibility>
      <study_pop>
        <textblock>
          The population of post-TAVR patients is growing larger and ranges in age from 65 to 95&#xD;
          years.&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Non-Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Outpatients who have undergone a TAVR procedure at the Hamilton General Hospital&#xD;
  &#xD;
            -  Patients who are managed through the overnight-model pathway&#xD;
  &#xD;
            -  Patients who successfully completed ambulation assessment&#xD;
  &#xD;
            -  Patients who are deemed eligible for discharge&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Patients who are hospitalized after the procedure (inpatients)&#xD;
  &#xD;
            -  Patients who had an axillary approach for TAVR&#xD;
  &#xD;
            -  Patients who had a pacemaker temporarily left in at the end of case, and&#xD;
  &#xD;
            -  Patients who received a permanent pacemaker in the last month&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>N/A</minimum_age>
      <maximum_age>N/A</maximum_age>
    </eligibility>
    <overall_official>
      <last_name>Madhu K Natarajan, MD</last_name>
      <role>Principal Investigator</role>
      <affiliation>Hamilton Health Sciences and McMaster University</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Marija Corovic, MPH</last_name>
      <phone>(905) 525-9140</phone>
      <email>corovicm@mcmaster.ca</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Karen Mosleh, MSc</last_name>
      <phone>(905) 525-9140</phone>
      <email>spithokd@mcmaster.ca</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>Hamilton Health Sciences (McMaster Children's Hospital and Hamilton General Hospital)</name>
        <address>
          <city>Hamilton</city>
          <state>Ontario</state>
          <country>Canada</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Administrative Office</last_name>
        <phone>905-521-2100</phone>
      </contact>
    </location>
    <location_countries>
      <country>Canada</country>
    </location_countries>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>July 12, 2023</study_first_submitted>
    <study_first_submitted_qc>September 13, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 15, 2023</study_first_posted>
    <last_update_submitted>September 13, 2023</last_update_submitted>
    <last_update_submitted_qc>September 13, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 15, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Hamilton Health Sciences Corporation</investigator_affiliation>
      <investigator_full_name>Madhu K. Natarajan</investigator_full_name>
      <investigator_title>Interventional and Structural Cardiologist; Professor, McMaster University</investigator_title>
    </responsible_party>
    <keyword>early mobilization</keyword>
    <keyword>exercise program</keyword>
    <keyword>cardiac care</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Aortic Valve Stenosis</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/NCT06040398
  org study id: 15474
  nct id: NCT06040398
  lead sponsor: 
  collaborator: 
  collaborator: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  A virtual, self-directed, and tailored early mobilization program called JUMPSTART, that aims
        to bridge cardiac rehabilitation intake for post-TAVR patients has been developed at the
        Hamilton General Hospital. The program includes a series of exercise videos at varying levels
        of intensity, designed for patients to follow at home, post-discharge. JUMPSTART is currently
        being offered as part of clinical care. In this new pilot study, the study team plans to
        develop and test new strategies to optimize recruitment and participation, develop additional
        JUMPSTART materials and evaluate outcomes through follow-up surveys and
        registry/administrative data at Hamilton General Hospital.
  Post-TAVR patients who have successfully completed a pre-discharge ambulation assessment and
        are deemed eligible for discharge will be eligible to participate. Potential participants
        will be introduced to the study in the pre-TAVR clinic by the nurse practitioner or their
        delegate. Participants who agree to be contacted for research purposes will provide written
        consent in the pre-TAVR clinic when they meet with the nurse practitioner. Confirmation of
        eligibility for the research study will be conducted post-TAVR by the nurse practitioner. The
        JUMPSTART program will be offered to all eligible patients as part of standard clinical care,
        regardless of their consent to participate in the research study. No data will be collected
        for the purposes of the research study from patients who do not provide consent. The primary
        outcomes will be adoption (the number of eligible post-TAVR patients who participate in the
        JUMPSTART early mobilization program), and a preliminary comparison of quality of life
        (measured using the Toronto Aortic Stenosis Quality of Life Questionnaire) between people who
        do and do not participate in the JUMPSTART program.
  observational model: Cohort
  time perspective: Prospective
  measure: Effectiveness (quality of life)
  time frame: Baseline and 3 months post-TAVR procedure.
  description: Changes in Toronto Aortic Stenosis QoL Questionnaire (TASQ) scores will be compared among study participants who did the JUMPSTART program, and those that didn't. The TASQ consists of 16 statements. Most statements are answered via 7-point Likert scale, where a higher score represents worse outcomes.
  measure: Adoption
  time frame: 14 days post-TAVR procedure.
  description: Number of eligible patients who participate in the JUMPSTART program.
  measure: Adoption
  time frame: 3 months post-TAVR procedure.
  description: Number of eligible patients who participate in the JUMPSTART program. Target = 70% adoption rate.
  measure: Reach
  time frame: 12 months (post-study start date).
  description: Assessed by dividing the total eligible number of TAVR patients who agree to enter the JUMPSTART program by the total eligible number of TAVR patients who underwent the TAVR procedure at the Hamilton General Hospital.
  measure: Effectiveness (cardiac rehab attendance)
  time frame: 3 months post-TAVR procedure.
  description: Measurement of the percentage of post-TAVR patients who have attended a cardiac rehab orientation session by 3 months post-TAVR procedure.
  measure: Effectiveness (acceptability)
  time frame: 14 days and 3 months post-TAVR procedure.
  description: Acceptability will be measured by self-reported questionnaire in consenting participants, administered via telephone interview or online survey (REDCap). Participants are asked to provide their level of satisfaction with the exercise videos and instructional handout on a scale of 1-7, where 1 = very unsatisfied and 7 = very satisfied.
  measure: Effectiveness (feasibility)
  time frame: 14 days and 3 months post-TAVR procedure.
  description: Feasibility will be measured by self-reported questionnaire in consenting participants, administered via telephone interview or online survey (REDCap). Participants are asked about ease in following the exercise videos, and challenges associated with doing the exercises.
  measure: Adoption (barriers and facilitators)
  time frame: 14 days and 3 months post-TAVR procedure.
  description: Barriers and facilitators will be assessed by questionnaire administered via telephone interview or online survey (REDCap). No response scales are used, the data collected is qualitative in nature. Implementation strategies will be tailored to these barriers and facilitators using an iterative process.
  measure: Implementation (fidelity)
  time frame: Assessed at 4 months (post-study start date), 8 months, and 12 months.
  description: Meetings/focus groups with research team and hospital staff to review whether implementation has taken place as planned (e.g., fidelity of the recruitment process, data collection), and to discuss pre-discharge testing and whether patients are given JUMPSTART materials both at the pre-TAVR clinic and prior to discharge.
  measure: Maintenance
  time frame: Assessed at 4 months (post-study start date), 8 months, and 12 months.
  description: Meetings/focus groups with research team to review study participation rates and to discuss barriers to participation. Program sustainability and plans for imbedding the program into routine care/practice will also be discussed.
  arm group label: TAVR Patients
  description: All outpatients undergoing TAVR and managed through the overnight-model pathway at the Hamilton General Hospital will be eligible for participation.
  intervention type: Behavioral
  intervention name: JUMPSTART exercise program
  description: The intervention is an early mobilization protocol (JUMPSTART). Four interactive exercise videos, at different intensity levels, include a variety of stretches and exercises designed to improve the full body mobilization of post-TAVR patients. Videos have been developed in consultation with a physiotherapist and cardiac rehabilitation specialist and have been piloted for initial acceptability by patients at the Hamilton General Hospital. The videos will be freely accessible to all eligible patients and their caregivers (regardless of participation in the research study) online (www.hhscebi.ca/projects/jumpstart). A written version of the exercise program, with photographs and detailed instructions, will also be made available. Additional exercise videos will be developed based on patients' needs and feedback received.
  arm group label: TAVR Patients
  study pop: 
  sampling method: Non-Probability Sample
  criteria: 
  gender: All
  minimum age: N/A
  maximum age: N/A
  last name: Madhu K Natarajan, MD
  role: Principal Investigator
  affiliation: Hamilton Health Sciences and McMaster University
  last name: Marija Corovic, MPH
  phone: (905) 525-9140
  email: corovicm@mcmaster.ca
  last name: Karen Mosleh, MSc
  phone: (905) 525-9140
  email: spithokd@mcmaster.ca
  facility: 
  status: Recruiting
  contact: 
  country: Canada
  responsible party type: Principal Investigator
  investigator affiliation: Hamilton Health Sciences Corporation
  investigator full name: Madhu K. Natarajan
  investigator title: Interventional and Structural Cardiologist; Professor, McMaster University
  mesh term: Aortic Valve Stenosis