<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/NCT02225535</url>
  </required_header>
  <id_info>
    <org_study_id>Bio13-241</org_study_id>
    <nct_id>NCT02225535</nct_id>
  </id_info>
  <brief_title>Investigation of a Physiotherapist and Nurse Practitioner Intervention for Chronic Low Back Disorders Delivered Through Telehealth</brief_title>
  <official_title>Advancing Interprofessional Primary Health Care Services in Rural Settings for People With Chronic Low Back Disorders: Investigation of a Physiotherapist and Nurse Practitioner Intervention Delivered Through Telehealth</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Saskatchewan</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Saskatchewan Health Research Foundation</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Ralston Brothers Grant (Kelsey Trail Health Region)</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Saskatchewan</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this project is to compare &quot;usual care&quot; for chronic low back disorders in a&#xD;
      rural setting (nurse practitioner/NP) to two different means of integrating Physical Therapy&#xD;
      (PT) into a rural health care team:&#xD;
&#xD;
        1. in-person PT assessment, where the PT travels from an urban center&#xD;
&#xD;
        2. interprofessional Telehealth assessment where the local NP is joined by a PT via&#xD;
           Telehealth.&#xD;
&#xD;
      The project will evaluate health, systems and process outcomes, comparative effectiveness and&#xD;
      costs of the three methods of assessment. The hypothesis is that an interprofessional&#xD;
      Telehealth assessment with be as effective as an in-person PT assessment, but more effective&#xD;
      than usual care.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The study design will include two intervention groups and a control group with 20&#xD;
      participants in each group: 1. interprofessional videoconferencing intervention, 2. in-person&#xD;
      PT and, 3. &quot;usual-care&quot; provided by a NP. Due to the interprofessional nature of the&#xD;
      intervention, the NP involved in the telehealth-based intervention group may alter their&#xD;
      &quot;usual care&quot; practice; therefore, the control group participants will be drawn from the&#xD;
      practices of 2 NPs not involved in the Telehealth intervention providing services out of a&#xD;
      different clinic. Each PT and the NP alone will complete a standardized online diagnostic&#xD;
      classification tool.Participants will be randomly assigned to one of the three groups.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>July 2014</start_date>
  <completion_date type="Actual">January 2016</completion_date>
  <primary_completion_date type="Actual">January 2016</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>Double (Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Short term impact of patient/provider satisfaction</measure>
    <time_frame>up to 2 weeks after assessment</time_frame>
    <description>questionnaire</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Short term outcome of patient experience with Telehealth</measure>
    <time_frame>up to 2 weeks</time_frame>
    <description>qualitative questionnaire</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Medium term outcome of patient and provider satisfaction</measure>
    <time_frame>3 months</time_frame>
    <description>questionnaire</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Short term impact of patient function</measure>
    <time_frame>up to 2 weeks after assessment</time_frame>
    <description>Modified Oswestry Disability questionnaire</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Short term impact on pain</measure>
    <time_frame>up to 2 weeks after assessment</time_frame>
    <description>Numeric Pain Rating Scale - questionnaire</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Short term impact on quality of life</measure>
    <time_frame>up to 2 weeks after assessment</time_frame>
    <description>Euro-Qol health survey instrument (EQ-5D)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Medium term impact on pain</measure>
    <time_frame>3 months</time_frame>
    <description>Numeric Pain Rating Scale - questionnaire</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Medium term impact on quality of life</measure>
    <time_frame>3 months</time_frame>
    <description>Euro-Qol health survey instrument (EQ-5D)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Medium impact on patient function</measure>
    <time_frame>3 months</time_frame>
    <description>Modified Oswestry Disability Index questionnaire</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Cost effectiveness of each of 3 arms of study</measure>
    <time_frame>6 months</time_frame>
    <description>patient diaries</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Long term outcome on patient/provider satisfaction</measure>
    <time_frame>6 months</time_frame>
    <description>questionnaire</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Long term impact on quality of life</measure>
    <time_frame>6 months</time_frame>
    <description>Euro-Qol health survey instrument (EQ-5D)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Long term impact on function</measure>
    <time_frame>6 months</time_frame>
    <description>Modified Oswestry Disability Index questionnaire</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Long term impact on pain</measure>
    <time_frame>6 months</time_frame>
    <description>Numeric Pain Rating Scale</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Barriers and facilitators to use of Telehealth</measure>
    <time_frame>2 weeks</time_frame>
    <description>questionnaire</description>
  </other_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">64</enrollment>
  <condition>Chronic Low Back Pain</condition>
  <arm_group>
    <arm_group_label>Usual Care (NP)</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Rural NP with client in-person, usual care</description>
  </arm_group>
  <arm_group>
    <arm_group_label>PT in-person</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Urban PT travels to rural area to manage patient's back pain in-person.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>PT/NP Telehealth</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Intervention: Rural NP is joined by PT via Telehealth for interprofessional videoconference with patient</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>NP face to face management of Chronic Low Back Pain</intervention_name>
    <description>usual NP management of chronic low back disorder</description>
    <arm_group_label>Usual Care (NP)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>PT face to face management of Chronic Low Back Pain</intervention_name>
    <description>Includes manual therapy, education, exercise</description>
    <arm_group_label>PT in-person</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Interprofessional Videoconferencing for Chronic Low Back Pain</intervention_name>
    <description>Includes manual therapy, education, exercise.</description>
    <arm_group_label>PT/NP Telehealth</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  adult 18-80&#xD;
&#xD;
          -  low back pain and/or related leg pain affecting function, &gt;3 months duration&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  clients within a third party payer insurance coverage system&#xD;
&#xD;
          -  clients with primarily neck or thoracic pain&#xD;
&#xD;
          -  clients with language or comprehension difficulties that would limit completion of&#xD;
             paperwork&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Brenna Bath, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>School of Physical Therapy, University of Saskatchewan</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of Saskatchewan</name>
      <address>
        <city>Saskatoon</city>
        <state>Saskatchewan</state>
        <zip>S7J4W3</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Canada</country>
  </location_countries>
  <verification_date>October 2018</verification_date>
  <study_first_submitted>July 31, 2014</study_first_submitted>
  <study_first_submitted_qc>August 22, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 26, 2014</study_first_posted>
  <last_update_submitted>October 10, 2018</last_update_submitted>
  <last_update_submitted_qc>October 10, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">October 11, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Saskatchewan</investigator_affiliation>
    <investigator_full_name>Brenna Bath</investigator_full_name>
    <investigator_title>Assistant Professor, School of Physical Therapy</investigator_title>
  </responsible_party>
  <keyword>low back pain</keyword>
  <keyword>telehealth</keyword>
  <keyword>videoconferencing</keyword>
  <keyword>access to physical therapy</keyword>
  <keyword>interprofessional care</keyword>
  <keyword>rural health</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Back Pain</mesh_term>
    <mesh_term>Low Back Pain</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/NCT02225535
org study id: Bio13-241
nct id: NCT02225535
lead sponsor: 
collaborator: 
collaborator: 
has dmc: No
The purpose of this project is to compare "usual care" for chronic low back disorders in a
      rural setting (nurse practitioner/NP) to two different means of integrating Physical Therapy
      (PT) into a rural health care team:

        1. in-person PT assessment, where the PT travels from an urban center

        2. interprofessional Telehealth assessment where the local NP is joined by a PT via
           Telehealth.

      The project will evaluate health, systems and process outcomes, comparative effectiveness and
      costs of the three methods of assessment. The hypothesis is that an interprofessional
      Telehealth assessment with be as effective as an in-person PT assessment, but more effective
      than usual care.
The study design will include two intervention groups and a control group with 20
      participants in each group: 1. interprofessional videoconferencing intervention, 2. in-person
      PT and, 3. "usual-care" provided by a NP. Due to the interprofessional nature of the
      intervention, the NP involved in the telehealth-based intervention group may alter their
      "usual care" practice; therefore, the control group participants will be drawn from the
      practices of 2 NPs not involved in the Telehealth intervention providing services out of a
      different clinic. Each PT and the NP alone will complete a standardized online diagnostic
      classification tool.Participants will be randomly assigned to one of the three groups.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Investigator, Outcomes Assessor)
measure: Short term impact of patient/provider satisfaction
time frame: up to 2 weeks after assessment
description: questionnaire
measure: Short term outcome of patient experience with Telehealth
time frame: up to 2 weeks
description: qualitative questionnaire
measure: Medium term outcome of patient and provider satisfaction
time frame: 3 months
description: questionnaire
measure: Short term impact of patient function
time frame: up to 2 weeks after assessment
description: Modified Oswestry Disability questionnaire
measure: Short term impact on pain
time frame: up to 2 weeks after assessment
description: Numeric Pain Rating Scale - questionnaire
measure: Short term impact on quality of life
time frame: up to 2 weeks after assessment
description: Euro-Qol health survey instrument (EQ-5D)
measure: Medium term impact on pain
time frame: 3 months
description: Numeric Pain Rating Scale - questionnaire
measure: Medium term impact on quality of life
time frame: 3 months
description: Euro-Qol health survey instrument (EQ-5D)
measure: Medium impact on patient function
time frame: 3 months
description: Modified Oswestry Disability Index questionnaire
measure: Cost effectiveness of each of 3 arms of study
time frame: 6 months
description: patient diaries
measure: Long term outcome on patient/provider satisfaction
time frame: 6 months
description: questionnaire
measure: Long term impact on quality of life
time frame: 6 months
description: Euro-Qol health survey instrument (EQ-5D)
measure: Long term impact on function
time frame: 6 months
description: Modified Oswestry Disability Index questionnaire
measure: Long term impact on pain
time frame: 6 months
description: Numeric Pain Rating Scale
measure: Barriers and facilitators to use of Telehealth
time frame: 2 weeks
description: questionnaire
arm group label: Usual Care (NP)
arm group type: Placebo Comparator
description: Rural NP with client in-person, usual care
arm group label: PT in-person
arm group type: Active Comparator
description: Urban PT travels to rural area to manage patient's back pain in-person.
arm group label: PT/NP Telehealth
arm group type: Active Comparator
description: Intervention: Rural NP is joined by PT via Telehealth for interprofessional videoconference with patient
intervention type: Other
intervention name: NP face to face management of Chronic Low Back Pain
description: usual NP management of chronic low back disorder
arm group label: Usual Care (NP)
intervention type: Other
intervention name: PT face to face management of Chronic Low Back Pain
description: Includes manual therapy, education, exercise
arm group label: PT in-person
intervention type: Other
intervention name: Interprofessional Videoconferencing for Chronic Low Back Pain
description: Includes manual therapy, education, exercise.
arm group label: PT/NP Telehealth
criteria: 
gender: All
minimum age: 18 Years
maximum age: 80 Years
healthy volunteers: No
last name: Brenna Bath, PhD
role: Principal Investigator
affiliation: School of Physical Therapy, University of Saskatchewan
facility: 
country: Canada
responsible party type: Principal Investigator
investigator affiliation: University of Saskatchewan
investigator full name: Brenna Bath
investigator title: Assistant Professor, School of Physical Therapy
mesh term: Back Pain
mesh term: Low Back Pain