<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/NCT02230280</url>
  </required_header>
  <id_info>
    <org_study_id>STPILOT-134162</org_study_id>
    <nct_id>NCT02230280</nct_id>
  </id_info>
  <brief_title>My Stroke Team (MYST): Stroke App Pilot Study</brief_title>
  <official_title>Strengthening Community-Based Stroke Care: A Pilot Study of a Community Navigation and Rehabilitation Intervention That Includes a Mobile Health Solution</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>McMaster University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>McMaster University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Most stroke survivors live with other chronic health conditions that can negatively affect&#xD;
      their recovery and overall health and well-being. Although stroke care has improved, there&#xD;
      are still many challenges to the delivery of community-based stroke care. These challenges&#xD;
      include: poor coordination of care across health care providers and settings; limited&#xD;
      communication among health care providers; limited use of evidence-based treatment&#xD;
      guidelines; difficulties navigating community services and supports; and limited client and&#xD;
      family caregiver involvement in making healthcare decisions. The investigators developed a&#xD;
      new mobile health (mHealth) application, My Stroke Team (MYST), to address these challenges&#xD;
      to improve the overall quality of stroke care at home. This study will expand this work to:&#xD;
      1) explore the feasibility and acceptability of this mobile tool, 2) determine its impact and&#xD;
      usability for home care providers, stroke survivors, and their family caregivers, and 3)&#xD;
      determine its impact on the costs of use of health services.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Research Questions:&#xD;
&#xD;
        1. What is the feasibility and acceptability of the MYST app within the context of a&#xD;
           6-month community navigation and rehabilitation intervention from the perspectives of&#xD;
           health care providers, clients, and family caregivers?&#xD;
&#xD;
        2. What are the MYST app usage patterns by various subgroups of end-users (e.g., clients,&#xD;
           health-care providers, age groups of HCPs, stroke survivors and family caregivers)?&#xD;
&#xD;
        3. What is the effect of the intervention on stroke survivors' health-related quality of&#xD;
           life, community re-integration, physical functioning, depression, anxiety,&#xD;
           self-efficacy, and costs of use of health services, from a societal perspective?&#xD;
&#xD;
        4. What is the effect of the intervention on family caregivers' health-related quality of&#xD;
           life, caregiver strain, depression, anxiety, and costs of use of health services from a&#xD;
           societal perspective?&#xD;
&#xD;
        5. What is the effect of the intervention on HCP outcomes (interprofessional&#xD;
           collaboration)?&#xD;
&#xD;
      Methods:&#xD;
&#xD;
      Due to the complexity of evaluating health services interventions, a mixed methods design&#xD;
      will be used to evaluate the multi-component intervention. A pragmatic pre-test post-test&#xD;
      single site study design will be used to evaluate the intervention. By pragmatic, the&#xD;
      investigators mean the intervention will be implemented under real-world conditions,&#xD;
      including reliance on existing staff at the participating site. Assessments will be made at&#xD;
      baseline (pre-test) and immediately following the six-month intervention period (post-test).&#xD;
      Descriptive qualitative methods will be used to explore the feasibility and acceptability of&#xD;
      the intervention.&#xD;
&#xD;
      Outcomes will be assessed at baseline and 6 months. Summary descriptive measures will be&#xD;
      reported for all variables.&#xD;
&#xD;
      Expected Outcomes:&#xD;
&#xD;
      It is expected that stroke survivors with multiple chronic conditions, their family&#xD;
      caregivers and healthcare providers will find the MYST app acceptable and feasible.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">May 8, 2017</start_date>
  <completion_date type="Actual">April 30, 2018</completion_date>
  <primary_completion_date type="Actual">April 30, 2018</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Health Services Research</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Changes in health-related quality of life (HRQoL) for both stroke survivors and caregivers as measured by the SF-12</measure>
    <time_frame>Baseline and the end of the intervention (6 months from baseline)</time_frame>
    <description>The Short-Form 12(SF-12) Health Survey will be administered to stroke survivors and caregivers to measure health-related quality of life</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Feasibility of the mobile application as part of the intervention.</measure>
    <time_frame>At the end of the intervention (6 months)</time_frame>
    <description>Participants' perspectives on the feasibility of the mobile application will be assessed qualitatively through focus groups (HCPs) and interviews (stroke survivors and family caregivers).</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Changes in the degree of physical functioning related to stroke.</measure>
    <time_frame>Baseline and the end of the intervention (6 months from baseline)</time_frame>
    <description>The Stroke Impact Scale (SIS)-16 will be administered to stroke survivors at baseline and 6 months, to assess physical functioning related to stroke</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in the prevalence and severity of depression symptoms in stroke survivors and family caregivers.</measure>
    <time_frame>Baseline and the end of the intervention (6 months from baseline)</time_frame>
    <description>The Centre for Epidemiological Studies Depression Scale (CES-D-10) will be used to assess the prevalence and the severity of depression symptoms.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in the degree of strain of family caregiver.</measure>
    <time_frame>Baseline and the end of the intervention (6months from baseline)</time_frame>
    <description>The Modified Caregiver Strain Index(CSI) will be administered to every stroke survivor's family caregiver at baseline and at 6 months to assess change in burden associated with caregiving</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in prevalence and severity of anxiety.</measure>
    <time_frame>Baseline and end of intervention (6 months from baseline)</time_frame>
    <description>The Generalized Anxiety Disorder Screener-7 (GAD-7) scale will be used to assess changes in the degree of anxiety of stroke survivors at baseline and 6 months from baseline.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in the self efficacy of stroke survivors.</measure>
    <time_frame>Baseline and end of the intervention (6 months from baseline)</time_frame>
    <description>The Stanford's 6-item Self-Efficacy for Managing Chronic Disease Scale (SE-MCD) will be administered to stroke survivors to assess changes in self efficacy at baseline and end of the study.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in the community integration of stroke patients.</measure>
    <time_frame>Baseline and end of the intervention (6 months from baseline)</time_frame>
    <description>The Reintegration to Normal Living Index (RNLI) will be administered to stroke survivors to assess degree of community reintegration post-stroke.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in the costs of use of health services by stroke survivors and family caregivers</measure>
    <time_frame>Baseline and end of intervention (6 months from baseline)</time_frame>
    <description>The costs of use of all types of health services from baseline to six months will be determined using the Health and Social Services Utilization Inventory (HSSUI).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in team functioning.</measure>
    <time_frame>At three months into the intervention study and upon completion of the study (16 months)</time_frame>
    <description>The Collaborative Practice Assessment Tool will be administered to home care providers to assess changes in team functioning.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in level of integration between home care providers.</measure>
    <time_frame>At three months into the intervention study and upon completion of the study (16 months)</time_frame>
    <description>The Team Climate Inventory will be administered to home care providers to assess changes in their level of integration.</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">30</enrollment>
  <condition>Stroke</condition>
  <condition>Comorbidity</condition>
  <condition>Chronic Disease</condition>
  <arm_group>
    <arm_group_label>The intervention cohort.</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>A community transition and rehabilitation intervention that includes a mobile health solution</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Strengthening Community-Based Stroke Care: A Pilot Study of a Community Navigation and Rehabilitation Intervention that Includes a Mobile Health Solution</intervention_name>
    <description>Participants will be offered regular in-home visits over the 6-month study period in addition to usual outpatient rehabilitation services. The health care providers will have access to a mobile health application (MYST) to share real-time information and access community resources and best practice guidelines.</description>
    <arm_group_label>The intervention cohort.</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Participants are newly referred for outpatient rehabilitation with a confirmed&#xD;
             diagnosis of stroke (first ever or recurrent) within the past 12 months, and are not&#xD;
             planning to move away from the community in the next 6 months. Participants have at&#xD;
             least 2 predetermined comorbid conditions, and must have the capacity to provide&#xD;
             informed consent, either independently or by substitute decision maker.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Participants will be excluded if they are unable to read and understand English and do&#xD;
             not have access to a translator.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>55 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Maureen Markle-Reid, RN, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>McMaster University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Hamilton Health Sciences</name>
      <address>
        <city>Hamilton</city>
        <state>Ontario</state>
        <zip>L8S 4L8</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Canada</country>
  </location_countries>
  <verification_date>March 2019</verification_date>
  <study_first_submitted>August 28, 2014</study_first_submitted>
  <study_first_submitted_qc>September 2, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 3, 2014</study_first_posted>
  <last_update_submitted>March 5, 2019</last_update_submitted>
  <last_update_submitted_qc>March 5, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">March 6, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>McMaster University</investigator_affiliation>
    <investigator_full_name>Maureen Markle-Reid</investigator_full_name>
    <investigator_title>Associate Professor and Canada Research Chair</investigator_title>
  </responsible_party>
  <keyword>Mobile health technology</keyword>
  <keyword>Multiple chronic conditions</keyword>
  <keyword>Older adults</keyword>
  <keyword>Home and community care</keyword>
  <keyword>Effectiveness</keyword>
  <keyword>Cost analysis</keyword>
  <keyword>Interprofessional Stroke Rehabilitation</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Stroke</mesh_term>
    <mesh_term>Chronic Disease</mesh_term>
  </condition_browse>
  <!-- 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/NCT02230280
org study id: STPILOT-134162
nct id: NCT02230280
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Most stroke survivors live with other chronic health conditions that can negatively affect
      their recovery and overall health and well-being. Although stroke care has improved, there
      are still many challenges to the delivery of community-based stroke care. These challenges
      include: poor coordination of care across health care providers and settings; limited
      communication among health care providers; limited use of evidence-based treatment
      guidelines; difficulties navigating community services and supports; and limited client and
      family caregiver involvement in making healthcare decisions. The investigators developed a
      new mobile health (mHealth) application, My Stroke Team (MYST), to address these challenges
      to improve the overall quality of stroke care at home. This study will expand this work to:
      1) explore the feasibility and acceptability of this mobile tool, 2) determine its impact and
      usability for home care providers, stroke survivors, and their family caregivers, and 3)
      determine its impact on the costs of use of health services.
Research Questions:

        1. What is the feasibility and acceptability of the MYST app within the context of a
           6-month community navigation and rehabilitation intervention from the perspectives of
           health care providers, clients, and family caregivers?

        2. What are the MYST app usage patterns by various subgroups of end-users (e.g., clients,
           health-care providers, age groups of HCPs, stroke survivors and family caregivers)?

        3. What is the effect of the intervention on stroke survivors' health-related quality of
           life, community re-integration, physical functioning, depression, anxiety,
           self-efficacy, and costs of use of health services, from a societal perspective?

        4. What is the effect of the intervention on family caregivers' health-related quality of
           life, caregiver strain, depression, anxiety, and costs of use of health services from a
           societal perspective?

        5. What is the effect of the intervention on HCP outcomes (interprofessional
           collaboration)?

      Methods:

      Due to the complexity of evaluating health services interventions, a mixed methods design
      will be used to evaluate the multi-component intervention. A pragmatic pre-test post-test
      single site study design will be used to evaluate the intervention. By pragmatic, the
      investigators mean the intervention will be implemented under real-world conditions,
      including reliance on existing staff at the participating site. Assessments will be made at
      baseline (pre-test) and immediately following the six-month intervention period (post-test).
      Descriptive qualitative methods will be used to explore the feasibility and acceptability of
      the intervention.

      Outcomes will be assessed at baseline and 6 months. Summary descriptive measures will be
      reported for all variables.

      Expected Outcomes:

      It is expected that stroke survivors with multiple chronic conditions, their family
      caregivers and healthcare providers will find the MYST app acceptable and feasible.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Health Services Research
masking: None (Open Label)
measure: Changes in health-related quality of life (HRQoL) for both stroke survivors and caregivers as measured by the SF-12
time frame: Baseline and the end of the intervention (6 months from baseline)
description: The Short-Form 12(SF-12) Health Survey will be administered to stroke survivors and caregivers to measure health-related quality of life
measure: Feasibility of the mobile application as part of the intervention.
time frame: At the end of the intervention (6 months)
description: Participants' perspectives on the feasibility of the mobile application will be assessed qualitatively through focus groups (HCPs) and interviews (stroke survivors and family caregivers).
measure: Changes in the degree of physical functioning related to stroke.
time frame: Baseline and the end of the intervention (6 months from baseline)
description: The Stroke Impact Scale (SIS)-16 will be administered to stroke survivors at baseline and 6 months, to assess physical functioning related to stroke
measure: Change in the prevalence and severity of depression symptoms in stroke survivors and family caregivers.
time frame: Baseline and the end of the intervention (6 months from baseline)
description: The Centre for Epidemiological Studies Depression Scale (CES-D-10) will be used to assess the prevalence and the severity of depression symptoms.
measure: Change in the degree of strain of family caregiver.
time frame: Baseline and the end of the intervention (6months from baseline)
description: The Modified Caregiver Strain Index(CSI) will be administered to every stroke survivor's family caregiver at baseline and at 6 months to assess change in burden associated with caregiving
measure: Change in prevalence and severity of anxiety.
time frame: Baseline and end of intervention (6 months from baseline)
description: The Generalized Anxiety Disorder Screener-7 (GAD-7) scale will be used to assess changes in the degree of anxiety of stroke survivors at baseline and 6 months from baseline.
measure: Change in the self efficacy of stroke survivors.
time frame: Baseline and end of the intervention (6 months from baseline)
description: The Stanford's 6-item Self-Efficacy for Managing Chronic Disease Scale (SE-MCD) will be administered to stroke survivors to assess changes in self efficacy at baseline and end of the study.
measure: Change in the community integration of stroke patients.
time frame: Baseline and end of the intervention (6 months from baseline)
description: The Reintegration to Normal Living Index (RNLI) will be administered to stroke survivors to assess degree of community reintegration post-stroke.
measure: Change in the costs of use of health services by stroke survivors and family caregivers
time frame: Baseline and end of intervention (6 months from baseline)
description: The costs of use of all types of health services from baseline to six months will be determined using the Health and Social Services Utilization Inventory (HSSUI).
measure: Change in team functioning.
time frame: At three months into the intervention study and upon completion of the study (16 months)
description: The Collaborative Practice Assessment Tool will be administered to home care providers to assess changes in team functioning.
measure: Change in level of integration between home care providers.
time frame: At three months into the intervention study and upon completion of the study (16 months)
description: The Team Climate Inventory will be administered to home care providers to assess changes in their level of integration.
arm group label: The intervention cohort.
arm group type: Other
description: A community transition and rehabilitation intervention that includes a mobile health solution
intervention type: Other
intervention name: Strengthening Community-Based Stroke Care: A Pilot Study of a Community Navigation and Rehabilitation Intervention that Includes a Mobile Health Solution
description: Participants will be offered regular in-home visits over the 6-month study period in addition to usual outpatient rehabilitation services. The health care providers will have access to a mobile health application (MYST) to share real-time information and access community resources and best practice guidelines.
arm group label: The intervention cohort.
criteria: 
gender: All
minimum age: 55 Years
maximum age: N/A
healthy volunteers: No
last name: Maureen Markle-Reid, RN, PhD
role: Principal Investigator
affiliation: McMaster University
facility: 
country: Canada
responsible party type: Principal Investigator
investigator affiliation: McMaster University
investigator full name: Maureen Markle-Reid
investigator title: Associate Professor and Canada Research Chair
mesh term: Stroke
mesh term: Chronic Disease