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/NCT06033924</url>
    </required_header>
    <id_info>
      <org_study_id>E3965-R</org_study_id>
      <nct_id>NCT06033924</nct_id>
    </id_info>
    <brief_title>Telehealth Delivered Home-based Walking for Vets With Peripheral Artery Disease</brief_title>
    <acronym>TREK-PAD</acronym>
    <official_title>Telehealth Delivered Home-based Walking for Vets With Peripheral Artery Disease (TREK-PAD)</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>Yes</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>
        Walking is beneficial for adults with peripheral arterial disease. Benefits include the&#xD;
        ability to walk for longer periods and general well being (quality of life). This study will&#xD;
        look at two types of delivery methods for a home-based walking program. The walking program&#xD;
        includes step count goals, information on healthy walking and motivational messages. The two&#xD;
        delivery methods include a web-based delivery and an telehealth delivery. Participants are&#xD;
        randomized to either one of the delivery methods or usual care. After 12 weeks participants&#xD;
        in the web based or telehealth based groups maybe re-randomized to receive a combination of&#xD;
        both web-based and telehealth for a second 12 week period. After 24 weeks, everyone is&#xD;
        followed for an additional 12 weeks, so the total time a participant is in the study is 36&#xD;
        weeks. At baseline, 12, 24 and 36 weeks we ask participant to walk (slowly) on a treadmill,&#xD;
        perform a six-minute walk test, and several questionnaires on quality of life. Vouchers are&#xD;
        provided at each study visit. All participants who complete the study also keep their&#xD;
        pedometer.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Objectives: The purpose of this proposed study is to evaluate two delivery methods of&#xD;
        home-based walking among Veterans with PAD, using an innovative sequential multiple&#xD;
        assignments, randomized trial (SMART) design to compare a web-based delivered walking&#xD;
        program, and a video telehealth delivered walking program versus usual care among Veterans&#xD;
        with PAD.&#xD;
  &#xD;
        Design &amp; Outcomes: Using a randomized control trial design with sequential multiple&#xD;
        assignments, participants will be randomized to 1 of 3 arms; a web-based delivered (WBD)&#xD;
        walking program, (ii) a video telehealth delivered (VTD) walking program, or (iii) usual care&#xD;
        (UC) only.&#xD;
  &#xD;
        Intervention &amp; Duration: The interventions include i) the web-based delivered (WBD) walking&#xD;
        program and (ii) the video telehealth delivered (VTD) walking program. All participants,&#xD;
        irrespective of study assignment, will receive two in-person visits with an exercise&#xD;
        physiologist prior to randomization. After 12 weeks, participants in the WBD arm who do not&#xD;
        respond will be further randomized to receive WBD + VTD or WBD only, and participants in the&#xD;
        VTD arm who do not respond will be further randomized to receive VTD + WBD or VTD only.&#xD;
        Nonresponse will be defined as a &lt;15% increase in maximal walk distance compared to baseline&#xD;
        (measured with a validated treadmill protocol at 12 weeks). The interventions will then&#xD;
        continue for an additional 12 weeks (for a total of 24 weeks of the intervention). After the&#xD;
        24-week visit, participants will be followed for an additional 12 weeks to examine&#xD;
        longer-term responses for a total participant study duration of 36 weeks.&#xD;
  &#xD;
        Outcomes include maximal and pain-free walking distance, and health-related quality of life&#xD;
        (HRQOL) will be measured at all visits (i.e., baseline, 12-, 24-, and 36 weeks). The primary&#xD;
        outcome of interest is a change in maximal walking distance from baseline to 12 weeks.&#xD;
        Secondary outcomes include the change in maximal walking distance at 24 and 36 weeks and a&#xD;
        change in pain-free walking distance and HRQOL at 12-, 24- and 36 weeks. Primary and&#xD;
        secondary outcomes will be measured in all participants.&#xD;
  &#xD;
        Sample Size &amp; Population: A total of 225 Veterans with peripheral artery disease will be&#xD;
        enrolled.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">January 1, 2024</start_date>
    <completion_date type="Anticipated">October 29, 2027</completion_date>
    <primary_completion_date type="Anticipated">October 29, 2027</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>
      <primary_purpose>Supportive Care</primary_purpose>
      <masking>Single (Participant)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Change in maximal walking distance</measure>
      <time_frame>baseline to 12 weeks</time_frame>
      <description>measured using the Gardener-Sinner protocol treadmill test, a validated protocol for measuring maximal and claudication free walking distance among patients with PAD, used in clinical care</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Change in maximal walking distance</measure>
      <time_frame>baseline to 24 weeks</time_frame>
      <description>measured using the Gardener-Sinner protocol treadmill test, a validated protocol for measuring maximal and claudication free walking distance among patients with PAD, used in clinical care</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change in maximal walking distance</measure>
      <time_frame>baseline to 36 weeks</time_frame>
      <description>measured using the Gardener-Sinner protocol treadmill test, a validated protocol for measuring maximal and claudication free walking distance among patients with PAD, used in clinical care</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change in claudication free walking distance</measure>
      <time_frame>baseline to 12 weeks</time_frame>
      <description>measured using the Gardener-Sinner protocol treadmill test, a validated protocol for measuring maximal and claudication free walking distance among patients with PAD, used in clinical care</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change in claudication free walking distance</measure>
      <time_frame>baseline to 24 weeks</time_frame>
      <description>measured using the Gardener-Sinner protocol treadmill test, a validated protocol for measuring maximal and claudication free walking distance among patients with PAD, used in clinical care</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change in claudication free walking distance</measure>
      <time_frame>baseline to 36 weeks</time_frame>
      <description>measured using the Gardener-Sinner protocol treadmill test, a validated protocol for measuring maximal and claudication free walking distance among patients with PAD, used in clinical care</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change in PAD-specific health-related quality of life</measure>
      <time_frame>baseline to 12 weeks</time_frame>
      <description>measured using a disease specific validated questionnaire - the Peripheral Artery Questionnaire (PAQ) which uses scale scores of 0 to 100, with high numbers indicating better outcomes.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change in PAD-specific health-related quality of life</measure>
      <time_frame>baseline to 24 weeks</time_frame>
      <description>measured using a disease specific validated questionnaire - the Peripheral Artery Questionnaire (PAQ) which uses scale scores of 0 to 100, with high numbers indicating better outcomes.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change in PAD-specific health-related quality of life</measure>
      <time_frame>baseline to 36 weeks</time_frame>
      <description>measured using a disease specific validated questionnaire - the Peripheral Artery Questionnaire (PAQ) which uses scale scores of 0 to 100, with high numbers indicating better outcomes.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change in general health-quality of life</measure>
      <time_frame>baseline to 12 weeks</time_frame>
      <description>Measuring using the Patient-Reported Outcomes Measurement Information System (PROMIS). The PROMIS 29 include 4 questions form each of 7 domains (depression, anxiety, physical function, pain interference, fatigue, sleep disturbance, and ability's to participate in social roles and activities. The PROMIS-29 yields scores for each of the domains above and a total score.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change in general health-quality of life</measure>
      <time_frame>baseline to 24 weeks</time_frame>
      <description>Measuring using the Patient-Reported Outcomes Measurement Information System (PROMIS). The PROMIS 29 include 4 questions form each of 7 domains (depression, anxiety, physical function, pain interference, fatigue, sleep disturbance, and ability's to participate in social roles and activities. The PROMIS-29 yields scores for each of the domains above and a total score.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change in general health-quality of life</measure>
      <time_frame>baseline to 36 weeks</time_frame>
      <description>Measuring using the Patient-Reported Outcomes Measurement Information System (PROMIS). The PROMIS 29 include 4 questions form each of 7 domains (depression, anxiety, physical function, pain interference, fatigue, sleep disturbance, and ability's to participate in social roles and activities. The PROMIS-29 yields scores for each of the domains above and a total score.</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">225</enrollment>
    <condition>Peripheral Artery Disease</condition>
    <arm_group>
      <arm_group_label>Internet-based Walking Program</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Weekly automated goals are delivered via email to the participant; goals are based on previous week's step count accumulation</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Telehealth Counseling Walking Program</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Weekly telehealth calls to assess compliance to exercise prescription and discuss various topics related to adoption and adherence to the walking program</description>
    </arm_group>
    <intervention>
      <intervention_type>Behavioral</intervention_type>
      <intervention_name>Walking Program</intervention_name>
      <description>Walking program: is delivered either via an internet-based web site or via telehealth counseling for 12 weeks. Among participants who do not increase their step counts (&gt;15%), these non-responders will be rerandomized to received the combination of internet and telehealth or either along for an additional 12-weeks (total intervention time is 24-weeks). A follow-up phase of 12-weeks will be completed for a total participant duration of 36 weeks.</description>
      <arm_group_label>Internet-based Walking Program</arm_group_label>
      <arm_group_label>Telehealth Counseling Walking Program</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Men and women&#xD;
  &#xD;
            -  Diagnosis of lower extremity PAD due to atherosclerosis&#xD;
  &#xD;
            -  Claudication with walking defined as stage 1-3 on the Rutherford Scale&#xD;
  &#xD;
            -  Medical clearance from the patient's primary care provider or vascular care provider&#xD;
  &#xD;
            -  Ability to walk at least one city block&#xD;
  &#xD;
            -  Self-reported sedentary behaviors defined as &lt; 150 minutes per week of physical&#xD;
               activity&#xD;
  &#xD;
            -  Access to a phone and/or email &amp; Internet&#xD;
  &#xD;
            -  Competent to provide informed consent&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Life expectancy of less than six months&#xD;
  &#xD;
            -  Comorbidities that limit walking to a severe degree (i.e., wheelchair-bound)&#xD;
  &#xD;
            -  Resident of a nursing home&#xD;
  &#xD;
            -  Recent enrollment in an exercise program or performing 150 minutes per week or more of&#xD;
               exercise&#xD;
  &#xD;
            -  Planned revascularization or amputation in the next two months&#xD;
  &#xD;
            -  Recent CVD events (&lt; 3 months) including stroke/TIA, MI, UA, PCI/CABG&#xD;
  &#xD;
            -  Unstable cardiac conditions (severe valve disease, NYHA class III-IV heart failure,&#xD;
               untreated complex congenital heart disease, or complex arrhythmias)&#xD;
  &#xD;
            -  Current substance abuse&#xD;
  &#xD;
            -  Psychiatric disorder which limits the patient's ability to follow the study protocol,&#xD;
               Pregnancy&#xD;
  &#xD;
            -  Inability to speak and read English&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>21 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Elizabeth A Jackson, MD</last_name>
      <role>Principal Investigator</role>
      <affiliation>Birmingham VA Medical Center, Birmingham, AL</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Elizabeth A Jackson, MD</last_name>
      <phone>(205) 933-8101</phone>
      <email>elizabeth.jackson2@va.gov</email>
    </overall_contact>
    <location>
      <facility>
        <name>Birmingham VA Medical Center, Birmingham, AL</name>
        <address>
          <city>Birmingham</city>
          <state>Alabama</state>
          <zip>35233-1927</zip>
          <country>United States</country>
        </address>
      </facility>
      <contact>
        <last_name>Elizabeth A Jackson, MD</last_name>
        <phone>205-933-8101</phone>
        <email>elizabeth.jackson2@va.gov</email>
      </contact>
      <investigator>
        <last_name>Elizabeth A Jackson, MD</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location>
      <facility>
        <name>VA Palo Alto Health Care System, Palo Alto, CA</name>
        <address>
          <city>Palo Alto</city>
          <state>California</state>
          <zip>94304-1207</zip>
          <country>United States</country>
        </address>
      </facility>
      <contact>
        <last_name>Jonathan N Myers, PhD</last_name>
        <phone>123-456-7890</phone>
        <email>jonathan.myers@va.gov</email>
      </contact>
    </location>
    <location>
      <facility>
        <name>Rocky Mountain Regional VA Medical Center, Aurora, CO</name>
        <address>
          <city>Aurora</city>
          <state>Colorado</state>
          <zip>80045</zip>
          <country>United States</country>
        </address>
      </facility>
      <contact>
        <last_name>P. Michael Ho, MD</last_name>
        <phone>123-456-7890</phone>
        <email>michael.ho@va.gov</email>
      </contact>
    </location>
    <location_countries>
      <country>United States</country>
    </location_countries>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>September 5, 2023</study_first_submitted>
    <study_first_submitted_qc>September 5, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 13, 2023</study_first_posted>
    <last_update_submitted>September 5, 2023</last_update_submitted>
    <last_update_submitted_qc>September 5, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 13, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>peripheral artery disease</keyword>
    <keyword>physical activity</keyword>
    <keyword>quality of life</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Peripheral Arterial Disease</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </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/NCT06033924
  org study id: E3965-R
  nct id: NCT06033924
  lead sponsor: 
  has dmc: Yes
  is fda regulated drug: No
  is fda regulated device: No
  is us export: No
  Walking is beneficial for adults with peripheral arterial disease. Benefits include the
        ability to walk for longer periods and general well being (quality of life). This study will
        look at two types of delivery methods for a home-based walking program. The walking program
        includes step count goals, information on healthy walking and motivational messages. The two
        delivery methods include a web-based delivery and an telehealth delivery. Participants are
        randomized to either one of the delivery methods or usual care. After 12 weeks participants
        in the web based or telehealth based groups maybe re-randomized to receive a combination of
        both web-based and telehealth for a second 12 week period. After 24 weeks, everyone is
        followed for an additional 12 weeks, so the total time a participant is in the study is 36
        weeks. At baseline, 12, 24 and 36 weeks we ask participant to walk (slowly) on a treadmill,
        perform a six-minute walk test, and several questionnaires on quality of life. Vouchers are
        provided at each study visit. All participants who complete the study also keep their
        pedometer.
  Objectives: The purpose of this proposed study is to evaluate two delivery methods of
        home-based walking among Veterans with PAD, using an innovative sequential multiple
        assignments, randomized trial (SMART) design to compare a web-based delivered walking
        program, and a video telehealth delivered walking program versus usual care among Veterans
        with PAD.
  
        Design & Outcomes: Using a randomized control trial design with sequential multiple
        assignments, participants will be randomized to 1 of 3 arms; a web-based delivered (WBD)
        walking program, (ii) a video telehealth delivered (VTD) walking program, or (iii) usual care
        (UC) only.
  
        Intervention & Duration: The interventions include i) the web-based delivered (WBD) walking
        program and (ii) the video telehealth delivered (VTD) walking program. All participants,
        irrespective of study assignment, will receive two in-person visits with an exercise
        physiologist prior to randomization. After 12 weeks, participants in the WBD arm who do not
        respond will be further randomized to receive WBD + VTD or WBD only, and participants in the
        VTD arm who do not respond will be further randomized to receive VTD + WBD or VTD only.
        Nonresponse will be defined as a <15% increase in maximal walk distance compared to baseline
        (measured with a validated treadmill protocol at 12 weeks). The interventions will then
        continue for an additional 12 weeks (for a total of 24 weeks of the intervention). After the
        24-week visit, participants will be followed for an additional 12 weeks to examine
        longer-term responses for a total participant study duration of 36 weeks.
  
        Outcomes include maximal and pain-free walking distance, and health-related quality of life
        (HRQOL) will be measured at all visits (i.e., baseline, 12-, 24-, and 36 weeks). The primary
        outcome of interest is a change in maximal walking distance from baseline to 12 weeks.
        Secondary outcomes include the change in maximal walking distance at 24 and 36 weeks and a
        change in pain-free walking distance and HRQOL at 12-, 24- and 36 weeks. Primary and
        secondary outcomes will be measured in all participants.
  
        Sample Size & Population: A total of 225 Veterans with peripheral artery disease will be
        enrolled.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Supportive Care
  masking: Single (Participant)
  measure: Change in maximal walking distance
  time frame: baseline to 12 weeks
  description: measured using the Gardener-Sinner protocol treadmill test, a validated protocol for measuring maximal and claudication free walking distance among patients with PAD, used in clinical care
  measure: Change in maximal walking distance
  time frame: baseline to 24 weeks
  description: measured using the Gardener-Sinner protocol treadmill test, a validated protocol for measuring maximal and claudication free walking distance among patients with PAD, used in clinical care
  measure: Change in maximal walking distance
  time frame: baseline to 36 weeks
  description: measured using the Gardener-Sinner protocol treadmill test, a validated protocol for measuring maximal and claudication free walking distance among patients with PAD, used in clinical care
  measure: Change in claudication free walking distance
  time frame: baseline to 12 weeks
  description: measured using the Gardener-Sinner protocol treadmill test, a validated protocol for measuring maximal and claudication free walking distance among patients with PAD, used in clinical care
  measure: Change in claudication free walking distance
  time frame: baseline to 24 weeks
  description: measured using the Gardener-Sinner protocol treadmill test, a validated protocol for measuring maximal and claudication free walking distance among patients with PAD, used in clinical care
  measure: Change in claudication free walking distance
  time frame: baseline to 36 weeks
  description: measured using the Gardener-Sinner protocol treadmill test, a validated protocol for measuring maximal and claudication free walking distance among patients with PAD, used in clinical care
  measure: Change in PAD-specific health-related quality of life
  time frame: baseline to 12 weeks
  description: measured using a disease specific validated questionnaire - the Peripheral Artery Questionnaire (PAQ) which uses scale scores of 0 to 100, with high numbers indicating better outcomes.
  measure: Change in PAD-specific health-related quality of life
  time frame: baseline to 24 weeks
  description: measured using a disease specific validated questionnaire - the Peripheral Artery Questionnaire (PAQ) which uses scale scores of 0 to 100, with high numbers indicating better outcomes.
  measure: Change in PAD-specific health-related quality of life
  time frame: baseline to 36 weeks
  description: measured using a disease specific validated questionnaire - the Peripheral Artery Questionnaire (PAQ) which uses scale scores of 0 to 100, with high numbers indicating better outcomes.
  measure: Change in general health-quality of life
  time frame: baseline to 12 weeks
  description: Measuring using the Patient-Reported Outcomes Measurement Information System (PROMIS). The PROMIS 29 include 4 questions form each of 7 domains (depression, anxiety, physical function, pain interference, fatigue, sleep disturbance, and ability's to participate in social roles and activities. The PROMIS-29 yields scores for each of the domains above and a total score.
  measure: Change in general health-quality of life
  time frame: baseline to 24 weeks
  description: Measuring using the Patient-Reported Outcomes Measurement Information System (PROMIS). The PROMIS 29 include 4 questions form each of 7 domains (depression, anxiety, physical function, pain interference, fatigue, sleep disturbance, and ability's to participate in social roles and activities. The PROMIS-29 yields scores for each of the domains above and a total score.
  measure: Change in general health-quality of life
  time frame: baseline to 36 weeks
  description: Measuring using the Patient-Reported Outcomes Measurement Information System (PROMIS). The PROMIS 29 include 4 questions form each of 7 domains (depression, anxiety, physical function, pain interference, fatigue, sleep disturbance, and ability's to participate in social roles and activities. The PROMIS-29 yields scores for each of the domains above and a total score.
  arm group label: Internet-based Walking Program
  arm group type: Experimental
  description: Weekly automated goals are delivered via email to the participant; goals are based on previous week's step count accumulation
  arm group label: Telehealth Counseling Walking Program
  arm group type: Experimental
  description: Weekly telehealth calls to assess compliance to exercise prescription and discuss various topics related to adoption and adherence to the walking program
  intervention type: Behavioral
  intervention name: Walking Program
  description: Walking program: is delivered either via an internet-based web site or via telehealth counseling for 12 weeks. Among participants who do not increase their step counts (>15%), these non-responders will be rerandomized to received the combination of internet and telehealth or either along for an additional 12-weeks (total intervention time is 24-weeks). A follow-up phase of 12-weeks will be completed for a total participant duration of 36 weeks.
  arm group label: Internet-based Walking Program
  arm group label: Telehealth Counseling Walking Program
  criteria: 
  gender: All
  minimum age: 21 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Elizabeth A Jackson, MD
  role: Principal Investigator
  affiliation: Birmingham VA Medical Center, Birmingham, AL
  last name: Elizabeth A Jackson, MD
  phone: (205) 933-8101
  email: elizabeth.jackson2@va.gov
  facility: 
  contact: 
  investigator: 
  facility: 
  contact: 
  facility: 
  contact: 
  country: United States
  responsible party type: Sponsor
  mesh term: Peripheral Arterial Disease
  sharing ipd: No