<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/NCT03807115</url>
  </required_header>
  <id_info>
    <org_study_id>CPSR-REPAR Research Award</org_study_id>
    <nct_id>NCT03807115</nct_id>
  </id_info>
  <brief_title>Effects of an Educational Intervention on Rehabilitation Clinicians' Practices for Health-related Outcomes After Stroke</brief_title>
  <official_title>Effects of an Innovative Continuing Professional Development Intervention on Rehabilitation Clinicians' Practices to Improve Walking and Independence in Activities of Daily Living After Stroke: a Pilot Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>McGill University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Heart and Stroke Foundation of Canada - Canadian Partnership for Stroke Recovery</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Réseau Provincial De Recherche En Adaptation-Réadaptation (REPAR)</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>McGill 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>
      The overall aim of this pilot study is to evaluate the feasibility of a study protocol for a&#xD;
      future stepped wedge cluster randomized clinical trial (c-RCT) that will investigate the&#xD;
      effects of an innovative KT intervention on 1) walking capacity and independence in ADL in&#xD;
      patients undergoing rehabilitation after stroke (patient outcomes); and 2) clinicians'&#xD;
      practice (i.e. use of 4 evidence-based stroke rehabilitation interventions: motor&#xD;
      imagery/mental practice, rhythmic auditory stimulation gait therapy, task oriented training&#xD;
      including fitness and mobility exercises and aerobic training) (provider outcome) aimed at&#xD;
      improving walking capacity. The specific objectives are: 1) To evaluate the feasibility&#xD;
      (effectiveness of clinician recruitment strategies, extent of losses to follow-up across&#xD;
      sites, and data analysis plans) of the study protocol in terms of methodology (stepped wedge&#xD;
      design is an innovative methodology); 2) To estimate intervention effect sizes on study&#xD;
      outcomes (patient and clinician); 3) To evaluate the secondary outcome (clinicians' use of&#xD;
      the 4 interventions) with regard to reliability and validity.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Walking capacity is the major priority for patients after stroke. Strong research evidence&#xD;
      shows that walking capacity can be improved by rehabilitation interventions such as motor&#xD;
      imagery, rhythmic auditory cueing, task-oriented training and aerobic exercise. Despite&#xD;
      strong evidence for the effectiveness of these interventions on walking capacity, many&#xD;
      clinicians (occupational therapists (OTs) and physical therapists (PTs)) do not use these in&#xD;
      their practice. This knowledge translation (KT) pilot study aims to support evidence-based&#xD;
      practice amongst rehabilitation clinicians working in stroke rehabilitation and collect data&#xD;
      to inform a future larger clinical trial that will investigate if having repeated exposure to&#xD;
      an innovative KT intervention will: increase clinicians' use of four targeted rehabilitation&#xD;
      interventions (listed above) and positively affect walking capacity and independence in daily&#xD;
      activities in patients after stroke. The investigators will recruit 2-3 OTs and 2-3 PTs per&#xD;
      site from 6 major inpatient stroke rehabilitation centres across Canada to participate in a&#xD;
      KT intervention consisting of an interactive and readily accessible web-based platform to&#xD;
      deliver evidence-based knowledge on 4 rehabilitation interventions targeting walking&#xD;
      capacity. This will be done via email in short online educational capsules including&#xD;
      strategies for implementing the interventions and tools to promote reflection on current and&#xD;
      future practice. They will then ask clinicians for feedback on: 1) the value of the knowledge&#xD;
      delivered via email; 2) their perceptions about the success of using the guidelines with&#xD;
      specific stroke patients; 3) the barriers they experienced when using the platform; and 4)&#xD;
      the actual benefits for their patients. Through this innovative KT intervention, clinicians&#xD;
      will have an opportunity to reflect upon and subsequently modify their practice to include&#xD;
      evidence-based interventions known to improve walking capacity and functional independence.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Active, not recruiting</last_known_status>
  <start_date type="Actual">February 24, 2020</start_date>
  <completion_date type="Anticipated">December 31, 2021</completion_date>
  <primary_completion_date type="Anticipated">October 15, 2021</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>Crossover Assignment</intervention_model>
    <intervention_model_description>This is a pilot stepped-wedge c-RCT. Data collection will take place over 16 weeks at 6 sites. Patient chart data (Functional Independence Measure (FIM), Functional Ambulation Category (FAC), 6-Minute-Walk-Test) will be collected weekly at all sites. Weeks 1-12: Participants at sites 1-6 will submit a weekly Calculation of Indicators (COI). Weeks 1-12: Sites 1 and 2 will receive 4 weekly online intervention packages and submit Information Assessment Method (IAM) and COI questionnaires for 12 weeks. Weeks 5-12: Sites 3 and 4 will receive 4 weekly online intervention packages and submit IAM and COI questionnaires for 8 weeks. Weeks 9-12: Sites 5 and 6 will receive 4 weekly online intervention packages and submit IAM and COI questionnaires for a total of 4 weeks. The longest exposure to the intervention will be 3 months and the minimum will be 1 month as per stepped-wedge c-RCT design. All participants will complete a My Guideline Implementation Barometer (MGIB) questionnaire at month 4.</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Six minute walk test (walking ability)</measure>
    <time_frame>1-3 months</time_frame>
    <description>Measurement of the total distance walked over six minutes on a hard, flat surface</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Functional Independence Measure</measure>
    <time_frame>1-3 months</time_frame>
    <description>7-level measurement of functional independence (1=total assist; 7=complete independence)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Functional Ambulation Category</measure>
    <time_frame>1-3 months</time_frame>
    <description>6-point measurement of functional ambulation (0=nonfunctional ambulation; 5=ambulator independent)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Information Assessment Method</measure>
    <time_frame>1-3 months</time_frame>
    <description>Clinician-reported feedback on weekly delivery and retrieval of health information provided in educational capsules</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Clinician-reported feedback on caseload (Calculation of Indicators)</measure>
    <time_frame>1-3 months</time_frame>
    <description>Number of patients with stroke treated per week</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Clinician-reported feedback on delivery of interventions (Calculation of Indicators)</measure>
    <time_frame>1-3 months</time_frame>
    <description>Duration of interventions delivered per stroke patient per week (in 5 minute increments)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Clinician-reported feedback on confidence level in ability to deliver interventions (Calculation of Indicators)</measure>
    <time_frame>1-3 months</time_frame>
    <description>Confidence level in ability to deliver interventions on 10-point scale (0=not at all confident; 10=extremely confident)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>My Guidelines Implementation Barometer</measure>
    <time_frame>1-3 months</time_frame>
    <description>Clinician-reported feedback on application of guideline recommendations in clinical practice, barriers to implementation and expected health benefits. Clinicians will be asked to list the factors that influenced the use of those recommendations in their practice.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">37</enrollment>
  <condition>Stroke</condition>
  <condition>Knowledge, Attitudes, Practice</condition>
  <condition>Physical Disability</condition>
  <condition>Motor Skills Disorders</condition>
  <arm_group>
    <arm_group_label>Intervention</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Arm: Intervention: Implementation of stroke mobility guidelines</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Arm: Control: Usual care</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Implementation of stroke mobility guidelines</intervention_name>
    <description>Delivery of weekly online educational capsules on 4 evidence-based stroke recommendations (motor imagery/mental practice, rhythmic auditory stimulation gait therapy, task-oriented training including fitness and mobility exercises, and aerobic training) plus feedback on participant's awareness, agreement, satisfaction with, and perceived value of the content, perceived implementation success and facilitators and barriers encountered.</description>
    <arm_group_label>Intervention</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Occupational therapists and physical therapists with a minimum of 1 year clinical&#xD;
             experience, working in an in-patient stroke rehabilitation centre in Canada.&#xD;
&#xD;
          -  Sites will be eligible if they do not have an existing format knowledge translation&#xD;
             initiative directed at enhancing practice in mobility training, have at least 10&#xD;
             people with stroke on their unit on a regular basis, and have an interdisciplinary&#xD;
             team consisting of 2-3 occupational therapists and 2-3 physical therapists.&#xD;
&#xD;
          -  Patients with a documented walking deficit (documented in patient's chart) and which&#xD;
             are on the caseload of a minimum of one participating clinician.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Occupational or physical therapists who are currently participating in another&#xD;
             knowledge translation study directed at enhancing practice in mobility training.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Aliki Thomas, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>McGill University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Nanaimo General Hospital</name>
      <address>
        <city>Nanaimo</city>
        <state>British Columbia</state>
        <zip>V9S 2B7</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Riverview Health Centre</name>
      <address>
        <city>Winnipeg</city>
        <state>Manitoba</state>
        <zip>R3L 2P4</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Nova Scotia Health Authority</name>
      <address>
        <city>Halifax</city>
        <state>Nova Scotia</state>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>St. John's Rehab - Sunnybrook Hospital</name>
      <address>
        <city>North York</city>
        <state>Ontario</state>
        <zip>M2M 2G1</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Bridgepoint Rehabilitation Hospital</name>
      <address>
        <city>Toronto</city>
        <state>Ontario</state>
        <zip>M4M 2B5</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Wascana Rehabilitation Centre</name>
      <address>
        <city>Regina</city>
        <state>Saskatchewan</state>
        <zip>S4S 0A5</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Canada</country>
  </location_countries>
  <reference>
    <citation>Mayo NE, Wood-Dauphinee S, Cote R, Durcan L, Carlton J. Activity, participation, and quality of life 6 months poststroke. Arch Phys Med Rehabil. 2002 Aug;83(8):1035-42. doi: 10.1053/apmr.2002.33984.</citation>
    <PMID>12161823</PMID>
  </reference>
  <reference>
    <citation>Korner-Bitensky N, Desrosiers J, Rochette A. A national survey of occupational therapists' practices related to participation post-stroke. J Rehabil Med. 2008 Apr;40(4):291-7. doi: 10.2340/16501977-0167.</citation>
    <PMID>18382825</PMID>
  </reference>
  <reference>
    <citation>Salbach NM, Veinot P, Rappolt S, Bayley M, Burnett D, Judd M, Jaglal SB. Physical therapists' experiences updating the clinical management of walking rehabilitation after stroke: a qualitative study. Phys Ther. 2009 Jun;89(6):556-68. doi: 10.2522/ptj.20080249. Epub 2009 Apr 16.</citation>
    <PMID>19372171</PMID>
  </reference>
  <reference>
    <citation>Salbach NM, Veinot P, Jaglal SB, Bayley M, Rolfe D. From continuing education to personal digital assistants: what do physical therapists need to support evidence-based practice in stroke management? J Eval Clin Pract. 2011 Aug;17(4):786-93. doi: 10.1111/j.1365-2753.2010.01456.x. Epub 2010 Oct 12.</citation>
    <PMID>21040248</PMID>
  </reference>
  <reference>
    <citation>Rochette A, Korner-Bitensky N, Desrosiers J. Actual vs best practice for families post-stroke according to three rehabilitation disciplines. J Rehabil Med. 2007 Sep;39(7):513-9. doi: 10.2340/16501977-0082.</citation>
    <PMID>17724549</PMID>
  </reference>
  <verification_date>February 2021</verification_date>
  <study_first_submitted>December 21, 2018</study_first_submitted>
  <study_first_submitted_qc>January 14, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 16, 2019</study_first_posted>
  <last_update_submitted>February 22, 2021</last_update_submitted>
  <last_update_submitted_qc>February 22, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">February 23, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>McGill University</investigator_affiliation>
    <investigator_full_name>Aliki Thomas</investigator_full_name>
    <investigator_title>Associate Professor</investigator_title>
  </responsible_party>
  <keyword>Stroke</keyword>
  <keyword>Rehabilitation</keyword>
  <keyword>Knowledge translation intervention</keyword>
  <keyword>Walking capacity</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Stroke</mesh_term>
    <mesh_term>Motor Skills Disorders</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</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/NCT03807115
org study id: CPSR-REPAR Research Award
nct id: NCT03807115
lead sponsor: 
collaborator: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The overall aim of this pilot study is to evaluate the feasibility of a study protocol for a
      future stepped wedge cluster randomized clinical trial (c-RCT) that will investigate the
      effects of an innovative KT intervention on 1) walking capacity and independence in ADL in
      patients undergoing rehabilitation after stroke (patient outcomes); and 2) clinicians'
      practice (i.e. use of 4 evidence-based stroke rehabilitation interventions: motor
      imagery/mental practice, rhythmic auditory stimulation gait therapy, task oriented training
      including fitness and mobility exercises and aerobic training) (provider outcome) aimed at
      improving walking capacity. The specific objectives are: 1) To evaluate the feasibility
      (effectiveness of clinician recruitment strategies, extent of losses to follow-up across
      sites, and data analysis plans) of the study protocol in terms of methodology (stepped wedge
      design is an innovative methodology); 2) To estimate intervention effect sizes on study
      outcomes (patient and clinician); 3) To evaluate the secondary outcome (clinicians' use of
      the 4 interventions) with regard to reliability and validity.
Walking capacity is the major priority for patients after stroke. Strong research evidence
      shows that walking capacity can be improved by rehabilitation interventions such as motor
      imagery, rhythmic auditory cueing, task-oriented training and aerobic exercise. Despite
      strong evidence for the effectiveness of these interventions on walking capacity, many
      clinicians (occupational therapists (OTs) and physical therapists (PTs)) do not use these in
      their practice. This knowledge translation (KT) pilot study aims to support evidence-based
      practice amongst rehabilitation clinicians working in stroke rehabilitation and collect data
      to inform a future larger clinical trial that will investigate if having repeated exposure to
      an innovative KT intervention will: increase clinicians' use of four targeted rehabilitation
      interventions (listed above) and positively affect walking capacity and independence in daily
      activities in patients after stroke. The investigators will recruit 2-3 OTs and 2-3 PTs per
      site from 6 major inpatient stroke rehabilitation centres across Canada to participate in a
      KT intervention consisting of an interactive and readily accessible web-based platform to
      deliver evidence-based knowledge on 4 rehabilitation interventions targeting walking
      capacity. This will be done via email in short online educational capsules including
      strategies for implementing the interventions and tools to promote reflection on current and
      future practice. They will then ask clinicians for feedback on: 1) the value of the knowledge
      delivered via email; 2) their perceptions about the success of using the guidelines with
      specific stroke patients; 3) the barriers they experienced when using the platform; and 4)
      the actual benefits for their patients. Through this innovative KT intervention, clinicians
      will have an opportunity to reflect upon and subsequently modify their practice to include
      evidence-based interventions known to improve walking capacity and functional independence.
allocation: Randomized
intervention model: Crossover Assignment
intervention model description: This is a pilot stepped-wedge c-RCT. Data collection will take place over 16 weeks at 6 sites. Patient chart data (Functional Independence Measure (FIM), Functional Ambulation Category (FAC), 6-Minute-Walk-Test) will be collected weekly at all sites. Weeks 1-12: Participants at sites 1-6 will submit a weekly Calculation of Indicators (COI). Weeks 1-12: Sites 1 and 2 will receive 4 weekly online intervention packages and submit Information Assessment Method (IAM) and COI questionnaires for 12 weeks. Weeks 5-12: Sites 3 and 4 will receive 4 weekly online intervention packages and submit IAM and COI questionnaires for 8 weeks. Weeks 9-12: Sites 5 and 6 will receive 4 weekly online intervention packages and submit IAM and COI questionnaires for a total of 4 weeks. The longest exposure to the intervention will be 3 months and the minimum will be 1 month as per stepped-wedge c-RCT design. All participants will complete a My Guideline Implementation Barometer (MGIB) questionnaire at month 4.
primary purpose: Treatment
masking: None (Open Label)
measure: Six minute walk test (walking ability)
time frame: 1-3 months
description: Measurement of the total distance walked over six minutes on a hard, flat surface
measure: Functional Independence Measure
time frame: 1-3 months
description: 7-level measurement of functional independence (1=total assist; 7=complete independence)
measure: Functional Ambulation Category
time frame: 1-3 months
description: 6-point measurement of functional ambulation (0=nonfunctional ambulation; 5=ambulator independent)
measure: Information Assessment Method
time frame: 1-3 months
description: Clinician-reported feedback on weekly delivery and retrieval of health information provided in educational capsules
measure: Clinician-reported feedback on caseload (Calculation of Indicators)
time frame: 1-3 months
description: Number of patients with stroke treated per week
measure: Clinician-reported feedback on delivery of interventions (Calculation of Indicators)
time frame: 1-3 months
description: Duration of interventions delivered per stroke patient per week (in 5 minute increments)
measure: Clinician-reported feedback on confidence level in ability to deliver interventions (Calculation of Indicators)
time frame: 1-3 months
description: Confidence level in ability to deliver interventions on 10-point scale (0=not at all confident; 10=extremely confident)
measure: My Guidelines Implementation Barometer
time frame: 1-3 months
description: Clinician-reported feedback on application of guideline recommendations in clinical practice, barriers to implementation and expected health benefits. Clinicians will be asked to list the factors that influenced the use of those recommendations in their practice.
arm group label: Intervention
arm group type: Other
description: Arm: Intervention: Implementation of stroke mobility guidelines
arm group label: Control
arm group type: No Intervention
description: Arm: Control: Usual care
intervention type: Other
intervention name: Implementation of stroke mobility guidelines
description: Delivery of weekly online educational capsules on 4 evidence-based stroke recommendations (motor imagery/mental practice, rhythmic auditory stimulation gait therapy, task-oriented training including fitness and mobility exercises, and aerobic training) plus feedback on participant's awareness, agreement, satisfaction with, and perceived value of the content, perceived implementation success and facilitators and barriers encountered.
arm group label: Intervention
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Aliki Thomas, PhD
role: Principal Investigator
affiliation: McGill University
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
country: Canada
citation: Mayo NE, Wood-Dauphinee S, Cote R, Durcan L, Carlton J. Activity, participation, and quality of life 6 months poststroke. Arch Phys Med Rehabil. 2002 Aug;83(8):1035-42. doi: 10.1053/apmr.2002.33984.
PMID: 12161823
citation: Korner-Bitensky N, Desrosiers J, Rochette A. A national survey of occupational therapists' practices related to participation post-stroke. J Rehabil Med. 2008 Apr;40(4):291-7. doi: 10.2340/16501977-0167.
PMID: 18382825
citation: Salbach NM, Veinot P, Rappolt S, Bayley M, Burnett D, Judd M, Jaglal SB. Physical therapists' experiences updating the clinical management of walking rehabilitation after stroke: a qualitative study. Phys Ther. 2009 Jun;89(6):556-68. doi: 10.2522/ptj.20080249. Epub 2009 Apr 16.
PMID: 19372171
citation: Salbach NM, Veinot P, Jaglal SB, Bayley M, Rolfe D. From continuing education to personal digital assistants: what do physical therapists need to support evidence-based practice in stroke management? J Eval Clin Pract. 2011 Aug;17(4):786-93. doi: 10.1111/j.1365-2753.2010.01456.x. Epub 2010 Oct 12.
PMID: 21040248
citation: Rochette A, Korner-Bitensky N, Desrosiers J. Actual vs best practice for families post-stroke according to three rehabilitation disciplines. J Rehabil Med. 2007 Sep;39(7):513-9. doi: 10.2340/16501977-0082.
PMID: 17724549
responsible party type: Principal Investigator
investigator affiliation: McGill University
investigator full name: Aliki Thomas
investigator title: Associate Professor
mesh term: Stroke
mesh term: Motor Skills Disorders
sharing ipd: No