<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/NCT04440215</url>
  </required_header>
  <id_info>
    <org_study_id>MP-04-2020-519</org_study_id>
    <nct_id>NCT04440215</nct_id>
  </id_info>
  <brief_title>Optimizing Patient Adherence to Stroke Rehabilitation Treatment</brief_title>
  <acronym>Telestroke</acronym>
  <official_title>Optimizing Patient Adherence to Stroke Rehabilitation Treatment: a Telerehabilitation Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Université de Sherbrooke</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Université de Montréal</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Laval University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Canadian Institutes of Health Research (CIHR)</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Université de Sherbrooke</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>
      Stroke impacts nearly 400,000 Canadians annually. Three quarters of stroke survivors will&#xD;
      live with minor to severe impairments or disabilities; which require rehabilitation care.&#xD;
      Strong evidence supports beginning rehabilitation as soon as the patient's medical status has&#xD;
      stabilized and continuing following discharge from acute care. Access to optimal services is&#xD;
      hampered, however, by travel distances to access rehabilitation, the lack of opportunities&#xD;
      for structured and formal interprofessional communication among service providers, and&#xD;
      failures to engage the patient and family members in a structured decision making process.&#xD;
      Moreover, adherence to rehabilitation treatments has been shown to be suboptimal. Many&#xD;
      patients refuse their outpatient rehabilitation treatments outright or decrease the duration&#xD;
      and/or frequency of their treatments over time.&#xD;
&#xD;
      The aim of this proposed mixed methods pragmatic clinical trial is to evaluate an&#xD;
      intervention that provides patients who have experienced stroke the opportunity to return&#xD;
      home safely after their acute hospital stay, to encourage patient (and family) engagement in&#xD;
      their rehabilitation care, and to overcome challenges of access to patient-centered&#xD;
      interprofessional rehabilitation care.&#xD;
&#xD;
      The proposed intervention will entail 220 patients (and family) to receive rehabilitation&#xD;
      care through remote, live treatment sessions with an interdisciplinary group of clinicians&#xD;
      (called telerehabilitation) versus standard of care (n = 110 patients). Five rehabilitation&#xD;
      teams will be trained to develop rehabilitation treatment plans that engage the patient and&#xD;
      family, while taking advantage of a telerehabilitation platform to engage the patient/family.&#xD;
      Grounded in findings gathered through a Canadian Institute of Health Research (CIHR) funded&#xD;
      pilot study, the primary study objective is to evaluate process, clinical outcomes and costs&#xD;
      of telerehabilitation in comparison with usual care. Through qualitative interviews with&#xD;
      patients and family as well as clinicians, a second objective of this pragmatic, controlled&#xD;
      trial is to explore and describe contextual factors (both personal and environmental) that&#xD;
      will help the delivery of care, and improve patient's outcomes while fully using technology&#xD;
      to deliver stroke rehabilitation care.&#xD;
&#xD;
      This study represents a unique, highly relevant opportunity to minimize both knowledge and&#xD;
      practice gaps, while producing robust, indepth data on the factors related to the&#xD;
      effectiveness of telerehabilitation.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Stroke impacts nearly 400,000 Canadians annually. Three quarters of stroke survivors will&#xD;
      live with minor to severe impairments or disabilities; which require rehabilitation care&#xD;
      representing &gt;$3.6 billion in Canadian healthcare expenditure every year. Strong evidence&#xD;
      supports beginning rehabilitation as soon as the patient's medical status has stabilized and&#xD;
      continuing following discharge from acute care, ideally in the patient's community. Access to&#xD;
      optimal services is hampered, however, by travel distances to access rehabilitation, the lack&#xD;
      of opportunities for structured and formal interprofessional communication among service&#xD;
      providers, and failures to engage the patient and family members in a structured decision&#xD;
      making process. Even when travel is not a barrier, adherence to rehabilitation treatments has&#xD;
      been shown to be suboptimal. Many patients refuse their outpatient rehabilitation treatments&#xD;
      outright or decrease the duration and/or frequency of their treatments over time.&#xD;
&#xD;
      The aim of this proposed mixed methods pragmatic clinical trial is to evaluate an&#xD;
      intervention that provides patients who have experienced stroke the opportunity to return&#xD;
      home safely after their acute hospital stay, to encourage patient (and family) engagement in&#xD;
      their rehabilitation care, and to overcome challenges of access to patient-centered&#xD;
      interprofessional rehabilitation care.&#xD;
&#xD;
      The proposed intervention will entail 220 patients (and family) to receive rehabilitation&#xD;
      care through remote, live treatment sessions with an interdisciplinary group of clinicians&#xD;
      (called telerehabilitation) versus standard of care (n = 110 patients). Five rehabilitation&#xD;
      teams will be trained to develop rehabilitation treatment plans that engage the patient and&#xD;
      family, while taking advantage of a telerehabilitation platform to engage the patient/family.&#xD;
      Grounded in findings gathered through a CIHR funded pilot study, the primary study objective&#xD;
      is to evaluate process, clinical outcomes and costs of telerehabilitation in comparison with&#xD;
      usual care. Through qualitative interviews with patients and family as well as clinicians, a&#xD;
      second objective of this pragmatic, controlled trial is to explore and describe contextual&#xD;
      factors (both personal and environmental) that will help the delivery of care, and improve&#xD;
      patient's outcomes while fully using technology to deliver stroke rehabilitation care.&#xD;
&#xD;
      This application has been developed by an interdisciplinary team of researchers, local&#xD;
      healthcare providers from each region involved, two patient partners who have experienced&#xD;
      stroke, provincial network stakeholders, and decision makers, all engaged in the successful&#xD;
      implementation of stroke guidelines and jurisdictional strategic plans. A panel of Canadian&#xD;
      health system knowledge users rounds out the team, to enhance the proposed intervention, to&#xD;
      communicate the relevance and anticipated use of the findings within their province, and to&#xD;
      foster adaptation of improved stroke care elsewhere. Finally, the study has been endorsed by&#xD;
      several knowledge users from the Quebec Ministry of Health as well as the Quebec Heart and&#xD;
      Stroke Foundation. Considering contrasts between rehabilitation practices and the Canadian&#xD;
      Stroke recommendations and the lack of relevant, robust data, this study represents a unique,&#xD;
      highly relevant opportunity to minimize both knowledge and practice gaps, while producing&#xD;
      robust, indepth data on the factors related to the effectiveness of telerehabilitation.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">July 10, 2020</start_date>
  <completion_date type="Anticipated">December 1, 2024</completion_date>
  <primary_completion_date type="Anticipated">December 1, 2023</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Sequential Assignment</intervention_model>
    <intervention_model_description>An interrupted time series design. It consists of observing the same dependent variable over time, with a break in the series of observations corresponding to the introduction of an intervention.</intervention_model_description>
    <primary_purpose>Health Services Research</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Patient adherence to stroke rehabilitation plan (Patient journal)</measure>
    <time_frame>Through intervention completion (up to 12 weeks)</time_frame>
    <description>Time spent (in minutes) doing any stroke rehabilitation exercises (online + offline). This includes (but is not limited to) physical, writing and speech therapy, and mental health-related exercises recommended by the rehabilitation professional.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in patient adherence to stroke rehabilitation plan</measure>
    <time_frame>Change from baseline and 4-, 6-, 12-week post-recruitment</time_frame>
    <description>StREAM questionnaire which is a 12-item questionnaire coted on a 4-point Likert scale which measure patients' adherence to a rehabilitation program.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Patient adherence to stroke rehabilitation plan (Professional perception)</measure>
    <time_frame>Through intervention completion (up to 12 weeks)</time_frame>
    <description>Health care professional perception of the participants' adherence to the rehabilitation program, evaluated on a 10-point scale.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Sociodemographic questionnaire</measure>
    <time_frame>At recruitment (baseline)</time_frame>
    <description>Home questionnaire including information about sex, age, clinical information about stroke</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in functional recovery and independence</measure>
    <time_frame>Change from baseline and 12-week post-recruitment</time_frame>
    <description>The modified 5-level Functional Independence Measure (FIM; 18 items) will be used. This measurement tool explores an individual's physical, psychological and social function. The tool is used to assess a patient's level of disability as well as change in patient status in response to rehabilitation or medical intervention. A lower score reflects greater disability.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in reintegration into normal social activities</measure>
    <time_frame>Change from baseline and 12-week post-recruitment</time_frame>
    <description>The Reintegration to Normal Living Index (RNLI; 11 items) will be used to assess the degree to which the participants perceived their normal social activities have been impacted by the stroke event. A higher score indicates more difficulty to reintegrate normal living.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in depression state</measure>
    <time_frame>Change from baseline and 12-week post-recruitment</time_frame>
    <description>The Beck Depression Inventory (Beck; 21 items) will be used to measure the severity of depression. The inventory is composed of items relating to depressive symptoms. A higher score indicates higher depression state.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Use of healthcare services</measure>
    <time_frame>within 12 week and 6 month post recruitment</time_frame>
    <description>This outcome, defined as expenses related to services and long-term complications, including hospitalization and physician visits is measured with 3 different tools: 1) Section A - Use of healthcare services (16 items) of the questionnaire developed by the Institut National de Santé Publique du Québec (INSPQ), 2) information collected daily by the participant in a calendar and 3) Health administrative provincial data on use of public health services received.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Adverse events</measure>
    <time_frame>Through intervention completion (up to 12 weeks)</time_frame>
    <description>Presence of adverse events related to rehabilitation (pain, dizziness, fatigue, number of falls)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Perception of interprofessional care shared decision making (Patient POV)</measure>
    <time_frame>12 weeks after recruitment</time_frame>
    <description>The Collaboration and Satisfaction About Care Decision tool (9 items) will be used. This questionnaire will be completed by the health care professionals involved in the study.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Perception of interprofessional care shared decision making (Clinical team POV)</measure>
    <time_frame>Through study completion (up to 5 years)</time_frame>
    <description>The Assessment of Interprofessional Team Collaboration Scale, short version (AITCS; 23 items) will be used. This questionnaire will be completed by the health care professionals involved in the study.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Statistics related to the telerehabilitation platform use</measure>
    <time_frame>Through intervention period (up to 3 years)</time_frame>
    <description>Home questionnaire on telerehabilitation platform utilisation (who, when, duration).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Presence of intervention plan in the patient file</measure>
    <time_frame>12 weeks after recruitment</time_frame>
    <description>A &quot;Yes&quot; or &quot;No&quot; answer to the presence of an intervention plan in the patient file</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Specific shared decision making (SDM) behaviours during decision-making (Questionnaire)</measure>
    <time_frame>At the start of the rehabilitation period</time_frame>
    <description>A composite questionnaire (SURE, 4 questions; Assumed role for decision-making, 1 question; CollaboRATE, 3 questions; Quality in decision-making, 6 questions) will be used to assess the extent to which practitioners involve patients in decision making processes. Patients will be given this questionnaire following the meeting to establish their rehabilitation plan.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Specific shared decision making (SDM) behaviours during decision-making (Interviews)</measure>
    <time_frame>At the start of the rehabilitation period</time_frame>
    <description>A randomized sample of 60 patients will be selected (50% control, 50% intervention). The meetings to establish their treatment plan will be recorded and analyzed using qualitative methods, in order to document the dynamics of the decision-making process. This qualitative section of the study will help enrich and contextualize the quantitative data collected for the other outcomes.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">330</enrollment>
  <condition>Stroke Rehabilitation</condition>
  <condition>Telerehabilitation</condition>
  <condition>Decision Making, Shared</condition>
  <arm_group>
    <arm_group_label>Control</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Usual rehabilitation care (no telerehabilitation, interdisciplinary meetings not systematically organized and/or not involving a complete team of professionals)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Telerehabilitation</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>A mix of home or rehabilitation center visits, telerehabilitation and interprofessional shared decision making process.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Telerehabilitation and team meetings and team care plans</intervention_name>
    <description>A mix of home or rehabilitation center visits and telerehabilitation will be planned by the rehabilitation team for a maximum of 16 weeks. Moreover, for each participant enrolled, a multidisciplinary meeting will be organised. The patient/family will participate in the meeting and the decision making process using the telerehabilitation platform. The team will generate an interprofessional individualized treatment plan, aiming for an interprofessional shared decision making process.</description>
    <arm_group_label>Telerehabilitation</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Usual care</intervention_name>
    <description>Rehabilitation teams will be instructed to provide care as they have been doing previously. Currently, this translates into no telerehabilitation, and interdisciplinary meetings not systematically organized and/or not involving a complete team of professionals.</description>
    <arm_group_label>Control</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Have had stroke event (haemorrhagic or ischemic)&#xD;
&#xD;
          -  Are considered to be safe for home discharge by the acute/ in-patient care team (i.e.&#xD;
             mild to moderate Functional Independence Measure score)&#xD;
&#xD;
          -  Have a relative or informal caregiver who is present in the home should physical&#xD;
             rehabilitation treatments are required;&#xD;
&#xD;
          -  Can speak French or English.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Having severe cognitive decline prior to the stroke event&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Isabelle Gaboury, PhD</last_name>
    <phone>514-452-9078</phone>
    <email>isabelle.gaboury@usherbrooke.ca</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Francois Bordeleau, MSc</last_name>
    <phone>514-550-0601</phone>
    <email>francois.bordeleau@usherbrooke.ca</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Centre de réadaptation en déficience physique - Installation Châteauguay</name>
      <address>
        <city>Châteauguay</city>
        <state>Quebec</state>
        <zip>J6J 4G7</zip>
        <country>Canada</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Diane Aspirot</last_name>
      <email>diane.aspirot.cisssmo16@ssss.gouv.qc.ca</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Centre de réadaptation en déficience physique - Installation Granby</name>
      <address>
        <city>Granby</city>
        <state>Quebec</state>
        <zip>J2G 5L9</zip>
        <country>Canada</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Nadine Morin</last_name>
      <phone>450-777-4641</phone>
      <phone_ext>300</phone_ext>
      <email>nadine.morin.cisssmo16@ssss.gouv.qc.ca</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Centre de réadaptation en déficiences physique - Installation Saint-Hubert</name>
      <address>
        <city>Longueuil</city>
        <state>Quebec</state>
        <zip>J3Y 3N7</zip>
        <country>Canada</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Christine Mills</last_name>
      <phone>(450) 676-7447</phone>
      <phone_ext>2272</phone_ext>
      <email>christine.mills.cisssmo16@ssss.gouv.qc.ca</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Centre de réadaptation en déficience physique - Installation Longueuil</name>
      <address>
        <city>Longueuil</city>
        <state>Quebec</state>
        <zip>J4J 1T2</zip>
        <country>Canada</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Sophie Laniel</last_name>
      <phone>(450) 676-7447</phone>
      <phone_ext>2279</phone_ext>
      <email>sophie.laniel.cisssmo16@ssss.gouv.qc.ca</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Centre de réadaptation en déficience physique - Installation Saint-Hyacinthe</name>
      <address>
        <city>Saint-Hyacinthe</city>
        <state>Quebec</state>
        <zip>J2T 1N2</zip>
        <country>Canada</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Nadine Morin</last_name>
      <phone>450-774-5003</phone>
      <phone_ext>2246</phone_ext>
      <email>nadine.morin.cisssmo16@ssss.gouv.qc.ca</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Centre de réadaptation en déficience physique - Installation Vaudreuil-Dorion</name>
      <address>
        <city>Vaudreuil-Dorion</city>
        <state>Quebec</state>
        <zip>J7V 7E4</zip>
        <country>Canada</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Diane Aspirot</last_name>
      <email>diane.aspirot.cisssmo16@ssss.gouv.qc.ca</email>
    </contact>
  </location>
  <location_countries>
    <country>Canada</country>
  </location_countries>
  <verification_date>July 2021</verification_date>
  <study_first_submitted>June 12, 2020</study_first_submitted>
  <study_first_submitted_qc>June 18, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 19, 2020</study_first_posted>
  <last_update_submitted>July 15, 2021</last_update_submitted>
  <last_update_submitted_qc>July 15, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">July 21, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Université de Sherbrooke</investigator_affiliation>
    <investigator_full_name>Isabelle Gaboury</investigator_full_name>
    <investigator_title>Professor</investigator_title>
  </responsible_party>
  <keyword>Rehabilitation</keyword>
  <keyword>Stroke</keyword>
  <keyword>Adherence</keyword>
  <keyword>Home</keyword>
  <keyword>Telerehabilitation</keyword>
  <keyword>Interprofessional shared decision making</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Stroke</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/NCT04440215
org study id: MP-04-2020-519
nct id: NCT04440215
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Stroke impacts nearly 400,000 Canadians annually. Three quarters of stroke survivors will
      live with minor to severe impairments or disabilities; which require rehabilitation care.
      Strong evidence supports beginning rehabilitation as soon as the patient's medical status has
      stabilized and continuing following discharge from acute care. Access to optimal services is
      hampered, however, by travel distances to access rehabilitation, the lack of opportunities
      for structured and formal interprofessional communication among service providers, and
      failures to engage the patient and family members in a structured decision making process.
      Moreover, adherence to rehabilitation treatments has been shown to be suboptimal. Many
      patients refuse their outpatient rehabilitation treatments outright or decrease the duration
      and/or frequency of their treatments over time.

      The aim of this proposed mixed methods pragmatic clinical trial is to evaluate an
      intervention that provides patients who have experienced stroke the opportunity to return
      home safely after their acute hospital stay, to encourage patient (and family) engagement in
      their rehabilitation care, and to overcome challenges of access to patient-centered
      interprofessional rehabilitation care.

      The proposed intervention will entail 220 patients (and family) to receive rehabilitation
      care through remote, live treatment sessions with an interdisciplinary group of clinicians
      (called telerehabilitation) versus standard of care (n = 110 patients). Five rehabilitation
      teams will be trained to develop rehabilitation treatment plans that engage the patient and
      family, while taking advantage of a telerehabilitation platform to engage the patient/family.
      Grounded in findings gathered through a Canadian Institute of Health Research (CIHR) funded
      pilot study, the primary study objective is to evaluate process, clinical outcomes and costs
      of telerehabilitation in comparison with usual care. Through qualitative interviews with
      patients and family as well as clinicians, a second objective of this pragmatic, controlled
      trial is to explore and describe contextual factors (both personal and environmental) that
      will help the delivery of care, and improve patient's outcomes while fully using technology
      to deliver stroke rehabilitation care.

      This study represents a unique, highly relevant opportunity to minimize both knowledge and
      practice gaps, while producing robust, indepth data on the factors related to the
      effectiveness of telerehabilitation.
Stroke impacts nearly 400,000 Canadians annually. Three quarters of stroke survivors will
      live with minor to severe impairments or disabilities; which require rehabilitation care
      representing >$3.6 billion in Canadian healthcare expenditure every year. Strong evidence
      supports beginning rehabilitation as soon as the patient's medical status has stabilized and
      continuing following discharge from acute care, ideally in the patient's community. Access to
      optimal services is hampered, however, by travel distances to access rehabilitation, the lack
      of opportunities for structured and formal interprofessional communication among service
      providers, and failures to engage the patient and family members in a structured decision
      making process. Even when travel is not a barrier, adherence to rehabilitation treatments has
      been shown to be suboptimal. Many patients refuse their outpatient rehabilitation treatments
      outright or decrease the duration and/or frequency of their treatments over time.

      The aim of this proposed mixed methods pragmatic clinical trial is to evaluate an
      intervention that provides patients who have experienced stroke the opportunity to return
      home safely after their acute hospital stay, to encourage patient (and family) engagement in
      their rehabilitation care, and to overcome challenges of access to patient-centered
      interprofessional rehabilitation care.

      The proposed intervention will entail 220 patients (and family) to receive rehabilitation
      care through remote, live treatment sessions with an interdisciplinary group of clinicians
      (called telerehabilitation) versus standard of care (n = 110 patients). Five rehabilitation
      teams will be trained to develop rehabilitation treatment plans that engage the patient and
      family, while taking advantage of a telerehabilitation platform to engage the patient/family.
      Grounded in findings gathered through a CIHR funded pilot study, the primary study objective
      is to evaluate process, clinical outcomes and costs of telerehabilitation in comparison with
      usual care. Through qualitative interviews with patients and family as well as clinicians, a
      second objective of this pragmatic, controlled trial is to explore and describe contextual
      factors (both personal and environmental) that will help the delivery of care, and improve
      patient's outcomes while fully using technology to deliver stroke rehabilitation care.

      This application has been developed by an interdisciplinary team of researchers, local
      healthcare providers from each region involved, two patient partners who have experienced
      stroke, provincial network stakeholders, and decision makers, all engaged in the successful
      implementation of stroke guidelines and jurisdictional strategic plans. A panel of Canadian
      health system knowledge users rounds out the team, to enhance the proposed intervention, to
      communicate the relevance and anticipated use of the findings within their province, and to
      foster adaptation of improved stroke care elsewhere. Finally, the study has been endorsed by
      several knowledge users from the Quebec Ministry of Health as well as the Quebec Heart and
      Stroke Foundation. Considering contrasts between rehabilitation practices and the Canadian
      Stroke recommendations and the lack of relevant, robust data, this study represents a unique,
      highly relevant opportunity to minimize both knowledge and practice gaps, while producing
      robust, indepth data on the factors related to the effectiveness of telerehabilitation.
allocation: Non-Randomized
intervention model: Sequential Assignment
intervention model description: An interrupted time series design. It consists of observing the same dependent variable over time, with a break in the series of observations corresponding to the introduction of an intervention.
primary purpose: Health Services Research
masking: None (Open Label)
measure: Patient adherence to stroke rehabilitation plan (Patient journal)
time frame: Through intervention completion (up to 12 weeks)
description: Time spent (in minutes) doing any stroke rehabilitation exercises (online + offline). This includes (but is not limited to) physical, writing and speech therapy, and mental health-related exercises recommended by the rehabilitation professional.
measure: Change in patient adherence to stroke rehabilitation plan
time frame: Change from baseline and 4-, 6-, 12-week post-recruitment
description: StREAM questionnaire which is a 12-item questionnaire coted on a 4-point Likert scale which measure patients' adherence to a rehabilitation program.
measure: Patient adherence to stroke rehabilitation plan (Professional perception)
time frame: Through intervention completion (up to 12 weeks)
description: Health care professional perception of the participants' adherence to the rehabilitation program, evaluated on a 10-point scale.
measure: Sociodemographic questionnaire
time frame: At recruitment (baseline)
description: Home questionnaire including information about sex, age, clinical information about stroke
measure: Change in functional recovery and independence
time frame: Change from baseline and 12-week post-recruitment
description: The modified 5-level Functional Independence Measure (FIM; 18 items) will be used. This measurement tool explores an individual's physical, psychological and social function. The tool is used to assess a patient's level of disability as well as change in patient status in response to rehabilitation or medical intervention. A lower score reflects greater disability.
measure: Change in reintegration into normal social activities
time frame: Change from baseline and 12-week post-recruitment
description: The Reintegration to Normal Living Index (RNLI; 11 items) will be used to assess the degree to which the participants perceived their normal social activities have been impacted by the stroke event. A higher score indicates more difficulty to reintegrate normal living.
measure: Change in depression state
time frame: Change from baseline and 12-week post-recruitment
description: The Beck Depression Inventory (Beck; 21 items) will be used to measure the severity of depression. The inventory is composed of items relating to depressive symptoms. A higher score indicates higher depression state.
measure: Use of healthcare services
time frame: within 12 week and 6 month post recruitment
description: This outcome, defined as expenses related to services and long-term complications, including hospitalization and physician visits is measured with 3 different tools: 1) Section A - Use of healthcare services (16 items) of the questionnaire developed by the Institut National de Santé Publique du Québec (INSPQ), 2) information collected daily by the participant in a calendar and 3) Health administrative provincial data on use of public health services received.
measure: Adverse events
time frame: Through intervention completion (up to 12 weeks)
description: Presence of adverse events related to rehabilitation (pain, dizziness, fatigue, number of falls)
measure: Perception of interprofessional care shared decision making (Patient POV)
time frame: 12 weeks after recruitment
description: The Collaboration and Satisfaction About Care Decision tool (9 items) will be used. This questionnaire will be completed by the health care professionals involved in the study.
measure: Perception of interprofessional care shared decision making (Clinical team POV)
time frame: Through study completion (up to 5 years)
description: The Assessment of Interprofessional Team Collaboration Scale, short version (AITCS; 23 items) will be used. This questionnaire will be completed by the health care professionals involved in the study.
measure: Statistics related to the telerehabilitation platform use
time frame: Through intervention period (up to 3 years)
description: Home questionnaire on telerehabilitation platform utilisation (who, when, duration).
measure: Presence of intervention plan in the patient file
time frame: 12 weeks after recruitment
description: A "Yes" or "No" answer to the presence of an intervention plan in the patient file
measure: Specific shared decision making (SDM) behaviours during decision-making (Questionnaire)
time frame: At the start of the rehabilitation period
description: A composite questionnaire (SURE, 4 questions; Assumed role for decision-making, 1 question; CollaboRATE, 3 questions; Quality in decision-making, 6 questions) will be used to assess the extent to which practitioners involve patients in decision making processes. Patients will be given this questionnaire following the meeting to establish their rehabilitation plan.
measure: Specific shared decision making (SDM) behaviours during decision-making (Interviews)
time frame: At the start of the rehabilitation period
description: A randomized sample of 60 patients will be selected (50% control, 50% intervention). The meetings to establish their treatment plan will be recorded and analyzed using qualitative methods, in order to document the dynamics of the decision-making process. This qualitative section of the study will help enrich and contextualize the quantitative data collected for the other outcomes.
arm group label: Control
arm group type: Other
description: Usual rehabilitation care (no telerehabilitation, interdisciplinary meetings not systematically organized and/or not involving a complete team of professionals)
arm group label: Telerehabilitation
arm group type: Experimental
description: A mix of home or rehabilitation center visits, telerehabilitation and interprofessional shared decision making process.
intervention type: Other
intervention name: Telerehabilitation and team meetings and team care plans
description: A mix of home or rehabilitation center visits and telerehabilitation will be planned by the rehabilitation team for a maximum of 16 weeks. Moreover, for each participant enrolled, a multidisciplinary meeting will be organised. The patient/family will participate in the meeting and the decision making process using the telerehabilitation platform. The team will generate an interprofessional individualized treatment plan, aiming for an interprofessional shared decision making process.
arm group label: Telerehabilitation
intervention type: Other
intervention name: Usual care
description: Rehabilitation teams will be instructed to provide care as they have been doing previously. Currently, this translates into no telerehabilitation, and interdisciplinary meetings not systematically organized and/or not involving a complete team of professionals.
arm group label: Control
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Isabelle Gaboury, PhD
phone: 514-452-9078
email: isabelle.gaboury@usherbrooke.ca
last name: Francois Bordeleau, MSc
phone: 514-550-0601
email: francois.bordeleau@usherbrooke.ca
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
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facility: 
status: Recruiting
contact: 
country: Canada
responsible party type: Principal Investigator
investigator affiliation: Université de Sherbrooke
investigator full name: Isabelle Gaboury
investigator title: Professor
mesh term: Stroke
sharing ipd: No