<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/NCT03238222</url>
  </required_header>
  <id_info>
    <org_study_id>17/LO/0568</org_study_id>
    <secondary_id>R477/0516</secondary_id>
    <nct_id>NCT03238222</nct_id>
  </id_info>
  <brief_title>Motivating Structured Walking Activity in Intermittent Claudication</brief_title>
  <acronym>MOSAIC</acronym>
  <official_title>A Brief Physiotherapist-led Behaviour Change Intervention to Facilitate Walking in Older People With Peripheral Arterial Disease: a Randomised Controlled Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Guy's and St Thomas' NHS Foundation Trust</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>King's College London</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>The Dunhill Medical Trust</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Guy's and St Thomas' NHS Foundation Trust</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>
  </oversight_info>
  <brief_summary>
    <textblock>
      Peripheral arterial disease can cause leg pain or discomfort (called intermittent&#xD;
      claudication (IC)), which limits the ability to walk and carry out everyday activities.&#xD;
      Lifestyle changes, like increasing walking, can lead to improvements, but can be a challenge&#xD;
      to begin and then continue. The aim of this study is to investigate if a physiotherapist-led,&#xD;
      behaviour change treatment effects walking in people with IC. The treatment is designed to&#xD;
      build an understanding of IC and walking exercise and help individuals develop strategies to&#xD;
      increase regular walking. The trial will recruit 192 adults (aged 50 years and over) with IC.&#xD;
      All participants will visit King's College London or their local hospital to complete two&#xD;
      short walking tests and answer questionnaires about their daily activities, beliefs about&#xD;
      their symptoms and treatment, quality of life and the costs of having IC.&#xD;
&#xD;
      Participants will then be randomly assigned to receive either the new treatment or continue&#xD;
      with their usual NHS care. The new treatment involves two 60-minute face-to-face sessions (at&#xD;
      the participant's home or local hospital) and two 20-minute telephone calls with a&#xD;
      physiotherapist who will discuss participants' understanding and beliefs about IC, walking&#xD;
      and help participants to set goals and plans to increase walking over 12 weeks. Participants&#xD;
      will be provided with a step counter (pedometer) and walking record.&#xD;
&#xD;
      After 12 weeks, all participants will attend a second appointment where they will repeat the&#xD;
      walking tests and fill out another set of questionnaires. A final set of questionnaires will&#xD;
      be completed by all participants after 6 months (by post or electronically). Some&#xD;
      participants will be invited to provide feedback on their experience of the treatment and&#xD;
      trial by telephone or a face-to-face interview with a researcher.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">November 10, 2017</start_date>
  <completion_date type="Anticipated">January 9, 2021</completion_date>
  <primary_completion_date type="Anticipated">November 9, 2020</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>Treatment</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>6 Minute Walk Distance</measure>
    <time_frame>3 months</time_frame>
    <description>6 Minute Walking Distance (in metres) measured during a self-paced, standardised 6 Minute Walk Test conducted around a level, 100-foot circuit.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>6 Minute Walk Distance (6MWD)</measure>
    <time_frame>Baseline and 3 months</time_frame>
    <description>6 Minute Walking Distance (in metres) measured during a self-paced, standardised 6 Minute Walk Test conducted around a level, 100-foot circuit.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Self-reported Maximum Walking Distance</measure>
    <time_frame>Baseline, 3 and 6 months</time_frame>
    <description>Single global item</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Self-Reported Walking Ability</measure>
    <time_frame>Baseline, 3 and 6 months</time_frame>
    <description>Walking Estimated-Limitation Calculated by History (WELCH)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Activities of Daily Living</measure>
    <time_frame>Baseline, 3 and 6 months</time_frame>
    <description>Nottingham Extended Activities of Daily Living (NEADL)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Health-Related Quality of Life</measure>
    <time_frame>Baseline, 3 and 6 months</time_frame>
    <description>Vascular Quality of Life Questionnaire-6 (VascuQol-6)</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Treatment Cognitions</measure>
    <time_frame>Baseline, 3 and 6 months</time_frame>
    <description>Theory of Planned Behaviour Questionnaire</description>
  </other_outcome>
  <other_outcome>
    <measure>Illness Cognitions</measure>
    <time_frame>Baseline, 3 and 6 months</time_frame>
    <description>Brief Illness Perceptions Questionnaire (BIPQ)</description>
  </other_outcome>
  <other_outcome>
    <measure>Walking Adherence</measure>
    <time_frame>Baseline, 3 and 6 months</time_frame>
    <description>Exercise Adherence Rating Scale</description>
  </other_outcome>
  <other_outcome>
    <measure>Resource Use</measure>
    <time_frame>Baseline, 3 and 6 months</time_frame>
    <description>Client Service Receipt Inventory</description>
  </other_outcome>
  <other_outcome>
    <measure>Health Related Quality of Life</measure>
    <time_frame>Baseline, 3 and 6 months</time_frame>
    <description>Euroqol- 5D-5L</description>
  </other_outcome>
  <other_outcome>
    <measure>Pain Free Walking Ability</measure>
    <time_frame>Baseline and 3 months</time_frame>
    <description>Patient-reported pain free walking time (seconds) and distance (metres) during the 6 Minute Walk Test</description>
  </other_outcome>
  <other_outcome>
    <measure>Maximal Walking Ability</measure>
    <time_frame>Baseline and 3 months</time_frame>
    <description>The maximum time (seconds) and distance (metres) walked before stopping during a 6 Minute Walk Test</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">192</enrollment>
  <condition>Peripheral Arterial Disease</condition>
  <condition>Intermittent Claudication</condition>
  <condition>Peripheral Vascular Disease</condition>
  <arm_group>
    <arm_group_label>MOSAIC Treatment</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>MOSAIC treatment plus Usual NHS Care. MOSAIC treatment comprises 2 x 60-minute individual face-to-face consultations (weeks 1 &amp; 2) and 2 x 20-minute follow-up telephone calls (weeks 6 &amp; 12) with a trained physiotherapist.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Usual Care Comparison</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Usual NHS care for people with intermittent claudication typically consists of an initial assessment, drug therapy and simple advice to walk provided by a vascular specialist and delivered in the vascular outpatient clinic.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>MOSAIC</intervention_name>
    <description>MOSAIC comprises 2 x 60-minute individual face-to-face consultations (weeks 1 &amp; 2) and 2 x 20-minute follow-up telephone calls (weeks 6 &amp; 12) delivered at a convenient time and location of participant's choice (local NHS Trust or participant's home). All sessions are delivered by a trained Band 6/7 physiotherapist. All participants randomized to receive MOSAIC will be provided with a pedometer and a patient manual which will include information on intermittent claudication, risk factors, walking guidelines, goal setting, problem solving and action planning worksheets and a walking diary.</description>
    <arm_group_label>MOSAIC Treatment</arm_group_label>
    <other_name>Motivating Structured walking Activity in IC</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  ≥50 years of age;&#xD;
&#xD;
          -  established PAD (Ankle Brachial Pressure Index ≤0.90 and/or radiographic evidence or&#xD;
             clinician reported diagnosis) and IC (presence of symptoms reported on the San Diego&#xD;
             Claudication Questionnaire)&#xD;
&#xD;
          -  able to participate in MOSAIC&#xD;
&#xD;
          -  able and willing to provide informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Unstable IC (self-reported change in symptoms during previous 3 months)&#xD;
&#xD;
          -  walking &gt;90 minutes/week (reported on Brief International Physical Activity&#xD;
             Questionnaire&#xD;
&#xD;
          -  contraindications to walking exercise (e.g., unstable angina) confirmed by their&#xD;
             vascular specialist&#xD;
&#xD;
          -  have completed any prescribed supervised exercise sessions in the previous 6 months or&#xD;
             been offered prescribed exercise sessions in the next 6 months.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>50 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Sanjay Patel</last_name>
    <role>Principal Investigator</role>
    <affiliation>Guy's and St Thomas' NHS Foundation Trust</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Julie S Bieles, PhD</last_name>
    <phone>02078486321</phone>
    <email>julie.s.bieles@kcl.ac.uk</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Lindsay Bearne, PhD</last_name>
    <phone>0207 848 6283</phone>
    <email>lindsay.bearne@kcl.ac.uk</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Dartford and Gravesham NHS Trust (GSTT PIC site)</name>
      <address>
        <city>Dartford</city>
        <state>Kent</state>
        <country>United Kingdom</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Maidstone and Tunbridge Wells NHS Trust (GSTT PIC site)</name>
      <address>
        <city>Maidstone</city>
        <state>Kent</state>
        <country>United Kingdom</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Ashford &amp; St Peter's NHS Foundation Trust</name>
      <address>
        <city>Ashford</city>
        <state>Surrey</state>
        <country>United Kingdom</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Guy's &amp; St Thomas NHS Foundation Trust</name>
      <address>
        <city>London</city>
        <country>United Kingdom</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>King's College Hospital NHS Foundation Trust</name>
      <address>
        <city>London</city>
        <country>United Kingdom</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Lewisham and Greenwich NHS Trust (GSTT PIC site)</name>
      <address>
        <city>London</city>
        <country>United Kingdom</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Royal Free London NHS Foundation Trust</name>
      <address>
        <city>London</city>
        <country>United Kingdom</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>St George's University Hospital NHS Foundation Trust</name>
      <address>
        <city>London</city>
        <country>United Kingdom</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>The Royal London Hospital, Barts Heatth NHS Trust</name>
      <address>
        <city>London</city>
        <country>United Kingdom</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location_countries>
    <country>United Kingdom</country>
  </location_countries>
  <verification_date>December 2019</verification_date>
  <study_first_submitted>August 1, 2017</study_first_submitted>
  <study_first_submitted_qc>August 1, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 3, 2017</study_first_posted>
  <last_update_submitted>December 10, 2019</last_update_submitted>
  <last_update_submitted_qc>December 10, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">December 11, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Walking</keyword>
  <keyword>Six-Minute Walk Distance</keyword>
  <keyword>Illness Perceptions</keyword>
  <keyword>Theory of Planned Behaviour</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Peripheral Arterial Disease</mesh_term>
    <mesh_term>Peripheral Vascular Diseases</mesh_term>
    <mesh_term>Vascular Diseases</mesh_term>
    <mesh_term>Intermittent Claudication</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


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/NCT03238222
org study id: 17/LO/0568
secondary id: R477/0516
nct id: NCT03238222
lead sponsor: 
collaborator: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
Peripheral arterial disease can cause leg pain or discomfort (called intermittent
      claudication (IC)), which limits the ability to walk and carry out everyday activities.
      Lifestyle changes, like increasing walking, can lead to improvements, but can be a challenge
      to begin and then continue. The aim of this study is to investigate if a physiotherapist-led,
      behaviour change treatment effects walking in people with IC. The treatment is designed to
      build an understanding of IC and walking exercise and help individuals develop strategies to
      increase regular walking. The trial will recruit 192 adults (aged 50 years and over) with IC.
      All participants will visit King's College London or their local hospital to complete two
      short walking tests and answer questionnaires about their daily activities, beliefs about
      their symptoms and treatment, quality of life and the costs of having IC.

      Participants will then be randomly assigned to receive either the new treatment or continue
      with their usual NHS care. The new treatment involves two 60-minute face-to-face sessions (at
      the participant's home or local hospital) and two 20-minute telephone calls with a
      physiotherapist who will discuss participants' understanding and beliefs about IC, walking
      and help participants to set goals and plans to increase walking over 12 weeks. Participants
      will be provided with a step counter (pedometer) and walking record.

      After 12 weeks, all participants will attend a second appointment where they will repeat the
      walking tests and fill out another set of questionnaires. A final set of questionnaires will
      be completed by all participants after 6 months (by post or electronically). Some
      participants will be invited to provide feedback on their experience of the treatment and
      trial by telephone or a face-to-face interview with a researcher.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Outcomes Assessor)
measure: 6 Minute Walk Distance
time frame: 3 months
description: 6 Minute Walking Distance (in metres) measured during a self-paced, standardised 6 Minute Walk Test conducted around a level, 100-foot circuit.
measure: 6 Minute Walk Distance (6MWD)
time frame: Baseline and 3 months
description: 6 Minute Walking Distance (in metres) measured during a self-paced, standardised 6 Minute Walk Test conducted around a level, 100-foot circuit.
measure: Self-reported Maximum Walking Distance
time frame: Baseline, 3 and 6 months
description: Single global item
measure: Self-Reported Walking Ability
time frame: Baseline, 3 and 6 months
description: Walking Estimated-Limitation Calculated by History (WELCH)
measure: Activities of Daily Living
time frame: Baseline, 3 and 6 months
description: Nottingham Extended Activities of Daily Living (NEADL)
measure: Health-Related Quality of Life
time frame: Baseline, 3 and 6 months
description: Vascular Quality of Life Questionnaire-6 (VascuQol-6)
measure: Treatment Cognitions
time frame: Baseline, 3 and 6 months
description: Theory of Planned Behaviour Questionnaire
measure: Illness Cognitions
time frame: Baseline, 3 and 6 months
description: Brief Illness Perceptions Questionnaire (BIPQ)
measure: Walking Adherence
time frame: Baseline, 3 and 6 months
description: Exercise Adherence Rating Scale
measure: Resource Use
time frame: Baseline, 3 and 6 months
description: Client Service Receipt Inventory
measure: Health Related Quality of Life
time frame: Baseline, 3 and 6 months
description: Euroqol- 5D-5L
measure: Pain Free Walking Ability
time frame: Baseline and 3 months
description: Patient-reported pain free walking time (seconds) and distance (metres) during the 6 Minute Walk Test
measure: Maximal Walking Ability
time frame: Baseline and 3 months
description: The maximum time (seconds) and distance (metres) walked before stopping during a 6 Minute Walk Test
arm group label: MOSAIC Treatment
arm group type: Experimental
description: MOSAIC treatment plus Usual NHS Care. MOSAIC treatment comprises 2 x 60-minute individual face-to-face consultations (weeks 1 & 2) and 2 x 20-minute follow-up telephone calls (weeks 6 & 12) with a trained physiotherapist.
arm group label: Usual Care Comparison
arm group type: No Intervention
description: Usual NHS care for people with intermittent claudication typically consists of an initial assessment, drug therapy and simple advice to walk provided by a vascular specialist and delivered in the vascular outpatient clinic.
intervention type: Behavioral
intervention name: MOSAIC
description: MOSAIC comprises 2 x 60-minute individual face-to-face consultations (weeks 1 & 2) and 2 x 20-minute follow-up telephone calls (weeks 6 & 12) delivered at a convenient time and location of participant's choice (local NHS Trust or participant's home). All sessions are delivered by a trained Band 6/7 physiotherapist. All participants randomized to receive MOSAIC will be provided with a pedometer and a patient manual which will include information on intermittent claudication, risk factors, walking guidelines, goal setting, problem solving and action planning worksheets and a walking diary.
arm group label: MOSAIC Treatment
other name: Motivating Structured walking Activity in IC
criteria: 
gender: All
minimum age: 50 Years
maximum age: N/A
healthy volunteers: No
last name: Sanjay Patel
role: Principal Investigator
affiliation: Guy's and St Thomas' NHS Foundation Trust
last name: Julie S Bieles, PhD
phone: 02078486321
email: julie.s.bieles@kcl.ac.uk
last name: Lindsay Bearne, PhD
phone: 0207 848 6283
email: lindsay.bearne@kcl.ac.uk
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
country: United Kingdom
responsible party type: Sponsor
mesh term: Peripheral Arterial Disease
mesh term: Peripheral Vascular Diseases
mesh term: Vascular Diseases
mesh term: Intermittent Claudication
sharing ipd: Undecided