<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/NCT03013192</url>
  </required_header>
  <id_info>
    <org_study_id>27655</org_study_id>
    <nct_id>NCT03013192</nct_id>
  </id_info>
  <brief_title>Three Month Automated Messaging Intervention</brief_title>
  <official_title>Effect of a Three Month Automated Messaging Intervention on Patient Compliance to Physical Therapy Regimens and on Clinical Outcomes</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>St. Louis University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>St. Louis 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>
      Patients who are prescribed physical therapy exercises for their shoulder will have increased&#xD;
      compliance to their PT exercises, an increased ASES score, and will have increased range of&#xD;
      motion (or reach maximum range of motion earlier) at the end of the 3 month&#xD;
      EpxPhysicalTherapy intervention.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Patient compliance to their prescribed physical therapy (PT) exercises is reported to be&#xD;
      22-40% in various studies. Further, Vasey et al. found that about 8% of patients do not even&#xD;
      schedule a follow up PT appointment after it is prescribed. Low adherence presents a problem&#xD;
      since long term completion of prescribed home exercises has been correlated with improved&#xD;
      health outcomes. Sluijs et al. found that low adherence to PT exercises can be primarily&#xD;
      attributed to three factors: (1) the barriers patients perceive and encounter, (2) the lack&#xD;
      of positive feedback, and (3) the degree of helplessness. An automated phone/texting system&#xD;
      can help with these three points by increasing positive feedback, increasing compliance, and&#xD;
      monitoring patient progress. The system can continually remind the patient that their end&#xD;
      goal is possible, which will decrease their feeling of helplessness in their condition.&#xD;
&#xD;
      Provide an introduction and background information. Describe past experimental and/or&#xD;
      clinical findings leading to the formulation of the study, if applicable. Investigator&#xD;
      Initiated studies must cite references in the response provided or attach a bibliography.&#xD;
      *?HELP?*&#xD;
&#xD;
      Patient compliance to their prescribed physical therapy (PT) exercises is reported to be&#xD;
      22-40% in various studies [1-4]. Further, Vasey et al. found that about 8% of patients do not&#xD;
      even schedule a follow up PT appointment after it is prescribed [5]. Low adherence presents a&#xD;
      problem since long term completion of prescribed home exercises has been correlated with&#xD;
      improved health outcomes. Sluijs et al. found that low adherence to PT exercises can be&#xD;
      primarily attributed to three factors: (1) the barriers patients perceive and encounter, (2)&#xD;
      the lack of positive feedback, and (3) the degree of helplessness [2]. An automated&#xD;
      phone/texting system can help with these three points by increasing positive feedback,&#xD;
      increasing compliance, and monitoring patient progress. The system can continually remind the&#xD;
      patient that their end goal is possible, which will decrease their feeling of helplessness in&#xD;
      their condition.&#xD;
&#xD;
      The American Shoulder and Elbow Surgeons (ASES) created a survey form that evaluates the&#xD;
      shoulder function of a patient. The survey is scored out of 100 points (100 being best&#xD;
      possible shoulder function and 0 being worst possible shoulder function). The form can be&#xD;
      filled out on an iPad online, and the score recorded by a member of the medical team. This&#xD;
      screening form has been validated by numerous studies, and has been specifically validated&#xD;
      for patients with non-operative rotator cuff pain/abnormalities (the population that this&#xD;
      study is proposing to study).&#xD;
&#xD;
      Telemedicine shows promise in improving the outcomes of orthopedic interventions. Medication&#xD;
      adherence and patient outcomes have been shown to improve in interventions that include&#xD;
      reminders. Also, because the adoption of cell phones is nearly ubiquitous worldwide and the&#xD;
      vast majority of cell phone users text message, a text-message-based intervention seems&#xD;
      particularly promising.&#xD;
&#xD;
      Many studies have shown that SMS text messaging has increased treatment compliance. PT&#xD;
      adherence to prescribed exercises seems to be limited by compliance, so Epharmix along with&#xD;
      several orthopedic surgeons set out to develop an intervention. The result,&#xD;
      EpxPhysicalTherapy (EpxPT), is an automated system that ensures that patients have both&#xD;
      scheduled their physical therapy appointment and have performed their home exercises. It also&#xD;
      sends motivational text messages to the patient to encourage the participant to perform their&#xD;
      exercises since a lack of positive reinforcement has been correlated with decreased&#xD;
      compliance. When a patient identifies that they have been unable to schedule a PT appointment&#xD;
      or have not completed their exercises for multiple days in a row, an alert is sent to the&#xD;
      healthcare team.&#xD;
&#xD;
      The system was designed to deliver either voice or text-based automated messages to patients&#xD;
      in a way that avoids an additional burden on the healthcare team. EpxPT offers numerous&#xD;
      advantages to strictly app-based or text message-based systems in both older and&#xD;
      underprivileged patient populations. Older patients, who may be more comfortable with voice&#xD;
      messages, have that option, and patients without a smartphone will still be able to receive&#xD;
      the intervention.&#xD;
&#xD;
      Patients identified to be eligible for this study and have consented will be randomly&#xD;
      assigned to one of two groups: Group 1 will receive the standard of care alone (control) and&#xD;
      Group 2 will receive the EpxPT intervention. In Group 2, EpxPT will remind the patient to&#xD;
      schedule their first PT appointment. Group 2 patients will also be asked if they have&#xD;
      completed their prescribed PT exercises every other day. They will then be sent a&#xD;
      motivational text messages or voice call in order to highlight the importance of completing&#xD;
      their PT regimen. Group 2 patient compliance will be tracked through the text responses&#xD;
      recorded in the Epharmix database. Both Group 1 and Group 2 patients will be seen at a follow&#xD;
      up appointment once a month for three months. At this appointment, patients in both groups&#xD;
      will be asked about their PT compliance (this will be the measurement of compliance for Group&#xD;
      1), and range of motion and a ASES score will be measured.&#xD;
&#xD;
        -  Aim 1: To compare control and intervention group compliance to their prescribed physical&#xD;
           therapy home exercise regimen&#xD;
&#xD;
        -  Aim 2: To compare control and intervention group shoulder range of motion after a 3&#xD;
           month intervention&#xD;
&#xD;
        -  Aim 3: To compare control and intervention group ASES scores after a 3 month&#xD;
           intervention&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    IRB and institutional re-assessment&#xD;
  </why_stopped>
  <start_date type="Actual">September 1, 2017</start_date>
  <completion_date type="Actual">December 19, 2018</completion_date>
  <primary_completion_date type="Actual">December 19, 2018</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>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Compliance with PT</measure>
    <time_frame>3 months</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>American Shoulder And Elbow Surgeons Score</measure>
    <time_frame>3 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Shoulder range of motion</measure>
    <time_frame>3 months</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">13</enrollment>
  <condition>Rotator Cuff Tendinopathy</condition>
  <arm_group>
    <arm_group_label>Control</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>No text message reminders, usual patient protocol</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Intervention (text messaging)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Text message reminders for PT</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Text message reminder</intervention_name>
    <description>Patients will receive automated text message reminders regarding their physical therapy</description>
    <arm_group_label>Intervention (text messaging)</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Anterior or lateral shoulder tenderness&#xD;
&#xD;
          -  Positive clinical signs of rotator cuff impingement&#xD;
&#xD;
          -  X-ray with no fractures, glenohumeral arthritis, or dislocation&#xD;
&#xD;
          -  Prescribed shoulder PT for their shoulder&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  None&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>40 Years</minimum_age>
    <maximum_age>90 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Saint Louis University</name>
      <address>
        <city>Saint Louis</city>
        <state>Missouri</state>
        <zip>63110</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>September 2019</verification_date>
  <study_first_submitted>January 4, 2017</study_first_submitted>
  <study_first_submitted_qc>January 5, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 6, 2017</study_first_posted>
  <last_update_submitted>September 11, 2019</last_update_submitted>
  <last_update_submitted_qc>September 11, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">September 13, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>St. Louis University</investigator_affiliation>
    <investigator_full_name>Scott Kaar, MD</investigator_full_name>
    <investigator_title>Associate Professor</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Tendinopathy</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/NCT03013192
org study id: 27655
nct id: NCT03013192
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Patients who are prescribed physical therapy exercises for their shoulder will have increased
      compliance to their PT exercises, an increased ASES score, and will have increased range of
      motion (or reach maximum range of motion earlier) at the end of the 3 month
      EpxPhysicalTherapy intervention.
Patient compliance to their prescribed physical therapy (PT) exercises is reported to be
      22-40% in various studies. Further, Vasey et al. found that about 8% of patients do not even
      schedule a follow up PT appointment after it is prescribed. Low adherence presents a problem
      since long term completion of prescribed home exercises has been correlated with improved
      health outcomes. Sluijs et al. found that low adherence to PT exercises can be primarily
      attributed to three factors: (1) the barriers patients perceive and encounter, (2) the lack
      of positive feedback, and (3) the degree of helplessness. An automated phone/texting system
      can help with these three points by increasing positive feedback, increasing compliance, and
      monitoring patient progress. The system can continually remind the patient that their end
      goal is possible, which will decrease their feeling of helplessness in their condition.

      Provide an introduction and background information. Describe past experimental and/or
      clinical findings leading to the formulation of the study, if applicable. Investigator
      Initiated studies must cite references in the response provided or attach a bibliography.
      *?HELP?*

      Patient compliance to their prescribed physical therapy (PT) exercises is reported to be
      22-40% in various studies [1-4]. Further, Vasey et al. found that about 8% of patients do not
      even schedule a follow up PT appointment after it is prescribed [5]. Low adherence presents a
      problem since long term completion of prescribed home exercises has been correlated with
      improved health outcomes. Sluijs et al. found that low adherence to PT exercises can be
      primarily attributed to three factors: (1) the barriers patients perceive and encounter, (2)
      the lack of positive feedback, and (3) the degree of helplessness [2]. An automated
      phone/texting system can help with these three points by increasing positive feedback,
      increasing compliance, and monitoring patient progress. The system can continually remind the
      patient that their end goal is possible, which will decrease their feeling of helplessness in
      their condition.

      The American Shoulder and Elbow Surgeons (ASES) created a survey form that evaluates the
      shoulder function of a patient. The survey is scored out of 100 points (100 being best
      possible shoulder function and 0 being worst possible shoulder function). The form can be
      filled out on an iPad online, and the score recorded by a member of the medical team. This
      screening form has been validated by numerous studies, and has been specifically validated
      for patients with non-operative rotator cuff pain/abnormalities (the population that this
      study is proposing to study).

      Telemedicine shows promise in improving the outcomes of orthopedic interventions. Medication
      adherence and patient outcomes have been shown to improve in interventions that include
      reminders. Also, because the adoption of cell phones is nearly ubiquitous worldwide and the
      vast majority of cell phone users text message, a text-message-based intervention seems
      particularly promising.

      Many studies have shown that SMS text messaging has increased treatment compliance. PT
      adherence to prescribed exercises seems to be limited by compliance, so Epharmix along with
      several orthopedic surgeons set out to develop an intervention. The result,
      EpxPhysicalTherapy (EpxPT), is an automated system that ensures that patients have both
      scheduled their physical therapy appointment and have performed their home exercises. It also
      sends motivational text messages to the patient to encourage the participant to perform their
      exercises since a lack of positive reinforcement has been correlated with decreased
      compliance. When a patient identifies that they have been unable to schedule a PT appointment
      or have not completed their exercises for multiple days in a row, an alert is sent to the
      healthcare team.

      The system was designed to deliver either voice or text-based automated messages to patients
      in a way that avoids an additional burden on the healthcare team. EpxPT offers numerous
      advantages to strictly app-based or text message-based systems in both older and
      underprivileged patient populations. Older patients, who may be more comfortable with voice
      messages, have that option, and patients without a smartphone will still be able to receive
      the intervention.

      Patients identified to be eligible for this study and have consented will be randomly
      assigned to one of two groups: Group 1 will receive the standard of care alone (control) and
      Group 2 will receive the EpxPT intervention. In Group 2, EpxPT will remind the patient to
      schedule their first PT appointment. Group 2 patients will also be asked if they have
      completed their prescribed PT exercises every other day. They will then be sent a
      motivational text messages or voice call in order to highlight the importance of completing
      their PT regimen. Group 2 patient compliance will be tracked through the text responses
      recorded in the Epharmix database. Both Group 1 and Group 2 patients will be seen at a follow
      up appointment once a month for three months. At this appointment, patients in both groups
      will be asked about their PT compliance (this will be the measurement of compliance for Group
      1), and range of motion and a ASES score will be measured.

        -  Aim 1: To compare control and intervention group compliance to their prescribed physical
           therapy home exercise regimen

        -  Aim 2: To compare control and intervention group shoulder range of motion after a 3
           month intervention

        -  Aim 3: To compare control and intervention group ASES scores after a 3 month
           intervention
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Compliance with PT
time frame: 3 months
measure: American Shoulder And Elbow Surgeons Score
time frame: 3 months
measure: Shoulder range of motion
time frame: 3 months
arm group label: Control
arm group type: No Intervention
description: No text message reminders, usual patient protocol
arm group label: Intervention (text messaging)
arm group type: Experimental
description: Text message reminders for PT
intervention type: Other
intervention name: Text message reminder
description: Patients will receive automated text message reminders regarding their physical therapy
arm group label: Intervention (text messaging)
criteria: 
gender: All
minimum age: 40 Years
maximum age: 90 Years
healthy volunteers: No
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: St. Louis University
investigator full name: Scott Kaar, MD
investigator title: Associate Professor
mesh term: Tendinopathy
sharing ipd: No