<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/NCT03035682</url>
  </required_header>
  <id_info>
    <org_study_id>2016.11RE</org_study_id>
    <nct_id>NCT03035682</nct_id>
  </id_info>
  <brief_title>The Impact of a mHealth Application on Outpatient Physical Therapy HEP Adherence and Outcomes: A RCT</brief_title>
  <official_title>The Impact of a mHealth Application on Outpatient Physical Therapy HEP Adherence and Outcomes: A Randomized Clinical Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Aultman Health Foundation</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Aultman Health Foundation</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to determine the impact a mobile health application has on&#xD;
      adherence to a physical therapy home exercise program and its effect on functional outcomes.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Outpatient physical therapy is an integral aspect in combating the impairment and dysfunction&#xD;
      associated with musculoskeletal injuries. Healthcare and insurance restrictions are leading&#xD;
      to reduced clinic visits, encouraging efficient and effective treatments and focusing a&#xD;
      greater demand on education, proactive wellness and home exercise maintenance. Home exercise&#xD;
      prescription has long been a fundamental aspect to a physical therapy routine or regimen. It&#xD;
      is well established that exercise protocols can positively impact pain, fitness levels,&#xD;
      physical function and measures of life quality (Forkan, Pumper, Smyth, Wirkkala, A Ciol, &amp;&#xD;
      Shumway-Cook, 2006). It is also recognized that treatment outcomes may be negatively impacted&#xD;
      by non-adherence to the prescribed exercise recommendation in rehabilitation (Holden,&#xD;
      Haywood, Portia, Gee, &amp; Mclean, 2014). Research historically suggests that levels of&#xD;
      non-adherence to exercise prescription range from 50-70% (Bassett, 2003; Sluijs, Kok, &amp; van&#xD;
      der Zee, 1993), and likely increase as time passes. Investigating non-adherence demonstrates&#xD;
      a myriad of influencing factors. These factors can be characterized as motivators and&#xD;
      barriers. With the explosion of mobile communications access and increasing number of active&#xD;
      device users, healthcare is embarking on the concept of mobile health management. Mobile&#xD;
      health interventions have been found to have a positive impact in the arenas of medication&#xD;
      compliance, weight loss, chronic disease management and postoperative complication (Lee,&#xD;
      2016; Ronghua, Li, (2015).The implementation of a mobile health application in physical&#xD;
      therapy outpatient management has not been well established. It is time to investigate the&#xD;
      impact of using a mobile health application on a prescribed physical therapy treatment&#xD;
      regimen for the enhancement of HEP adherence and functional outcome assessment.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 23, 2017</start_date>
  <completion_date type="Actual">December 12, 2019</completion_date>
  <primary_completion_date type="Actual">July 23, 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>Adherence Exercise Logs: Adherence = exercise reps completed (x) sets completed (x) times per day completed (x) days per week completed divided by total number of (reps) (sets) (time per day) (days per week) assigned to the HEP regimen for each patient</measure>
    <time_frame>Weekly during course of patient standard treatment. Logs will be assessed over each 7 day period after initial treatment session and collected up to a period of 24 weeks or discharge from therapy intervention for any reason, which ever may occur first.</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Self -report Adherence Question: Both groups will complete a single question assessment regarding their perceived level of adherence to the prescribed home exercise plan.</measure>
    <time_frame>Completed at 1 week after inital exam , at discharge from PT as defined by a period up to 24 weeks or discontinuation of therapy intervention for any reason, which ever may occur first, and 3 month follow-up. 6month follow-up if subject agreeable.</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Numeric Pain Rating Scale (NPRS) 0-10 scale.</measure>
    <time_frame>Outcome will be completed at initial exam, at discharge from PT as defined by a period up to 24 weeks or discontinuation of therapy intervention for any reason, which ever may occur first.</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Patient-Specific Functional Scale (PSFS)</measure>
    <time_frame>Outcome will be completed at initial exam, at discharge from PT as defined by a period up to 24 weeks or discontinuation of therapy intervention for any reason, which ever may occur first.</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The Global Rating of Change Scale (GROC)</measure>
    <time_frame>At patient discharge from PT as defined by a period up to 24 weeks or discontinuation of therapy intervention for any reason, which ever may occur first, and at 3 month follow-up. 6month follow-up if subject agreeable.</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">104</enrollment>
  <condition>Orthopedic Disorder</condition>
  <condition>Musculoskeletal Injury</condition>
  <arm_group>
    <arm_group_label>Traditional Group</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>The control group will receive traditional PT services as deemed clinically appropriate via examination to include traditional home exercise prescription.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Augmented Media Group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The Augmented Media group will receive traditional PT services as deemed clinically appropriate via examination and include home exercise prescription via a mobile health application.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Augmented Media Group</intervention_name>
    <description>The intervention group will receive traditional PT services deemed clinically appropriate via examination plus home exercise prescription augmented via a mobile health application. The augmented media group will receive digital exercise prescription via a mobile health application source (Physitrack) that includes: high definition video and pictures, education material and written instruction, reminder notification and in-app logging of completion.</description>
    <arm_group_label>Augmented Media Group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Traditional Group</intervention_name>
    <description>The Traditional Group will receive traditional PT services deemed clinically appropriate via examination plus traditional home exercise prescription.</description>
    <arm_group_label>Traditional Group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Any musculoskeletal pathology: spine, UE, LE&#xD;
&#xD;
          2. Age18 or older&#xD;
&#xD;
          3. Primary language is English. Ability to read, write and understand the English&#xD;
             language&#xD;
&#xD;
          4. Ownership of mobile smart phone&#xD;
&#xD;
          5. Functional and cognitive ability to operate/manipulate a mobile media application&#xD;
&#xD;
          6. Willingness to use their data package for support/use of mobile application&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        Following the initial screening criteria, the study population will be scrutinized for&#xD;
        exclusion.&#xD;
&#xD;
        Exclusion criteria:&#xD;
&#xD;
          1. History of neurological pathology with neurological impairments&#xD;
&#xD;
          2. Impaired cognition&#xD;
&#xD;
          3. Difficulty with operation and manipulation of mobile application&#xD;
&#xD;
          4. Difficulty with directions as set forth by the intake The exclusion criteria will be&#xD;
             screened by written intake and a traditional medical history by the primary&#xD;
             researcher. Subject enrollment will commence after eligibility is met and informed&#xD;
             consent received.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>100 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Robert A Elson, MPT</last_name>
    <role>Principal Investigator</role>
    <affiliation>Aultman Health Foundation</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Aultman Hospital - West Physical Therapy</name>
      <address>
        <city>Canton</city>
        <state>Ohio</state>
        <zip>44710</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>August 2020</verification_date>
  <study_first_submitted>January 18, 2017</study_first_submitted>
  <study_first_submitted_qc>January 26, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 30, 2017</study_first_posted>
  <last_update_submitted>August 23, 2020</last_update_submitted>
  <last_update_submitted_qc>August 23, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">August 25, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Aultman Health Foundation</investigator_affiliation>
    <investigator_full_name>Robert Elson PT</investigator_full_name>
    <investigator_title>Physical Therapist</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Musculoskeletal Diseases</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/NCT03035682
org study id: 2016.11RE
nct id: NCT03035682
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The purpose of this study is to determine the impact a mobile health application has on
      adherence to a physical therapy home exercise program and its effect on functional outcomes.
Outpatient physical therapy is an integral aspect in combating the impairment and dysfunction
      associated with musculoskeletal injuries. Healthcare and insurance restrictions are leading
      to reduced clinic visits, encouraging efficient and effective treatments and focusing a
      greater demand on education, proactive wellness and home exercise maintenance. Home exercise
      prescription has long been a fundamental aspect to a physical therapy routine or regimen. It
      is well established that exercise protocols can positively impact pain, fitness levels,
      physical function and measures of life quality (Forkan, Pumper, Smyth, Wirkkala, A Ciol, &
      Shumway-Cook, 2006). It is also recognized that treatment outcomes may be negatively impacted
      by non-adherence to the prescribed exercise recommendation in rehabilitation (Holden,
      Haywood, Portia, Gee, & Mclean, 2014). Research historically suggests that levels of
      non-adherence to exercise prescription range from 50-70% (Bassett, 2003; Sluijs, Kok, & van
      der Zee, 1993), and likely increase as time passes. Investigating non-adherence demonstrates
      a myriad of influencing factors. These factors can be characterized as motivators and
      barriers. With the explosion of mobile communications access and increasing number of active
      device users, healthcare is embarking on the concept of mobile health management. Mobile
      health interventions have been found to have a positive impact in the arenas of medication
      compliance, weight loss, chronic disease management and postoperative complication (Lee,
      2016; Ronghua, Li, (2015).The implementation of a mobile health application in physical
      therapy outpatient management has not been well established. It is time to investigate the
      impact of using a mobile health application on a prescribed physical therapy treatment
      regimen for the enhancement of HEP adherence and functional outcome assessment.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Adherence Exercise Logs: Adherence = exercise reps completed (x) sets completed (x) times per day completed (x) days per week completed divided by total number of (reps) (sets) (time per day) (days per week) assigned to the HEP regimen for each patient
time frame: Weekly during course of patient standard treatment. Logs will be assessed over each 7 day period after initial treatment session and collected up to a period of 24 weeks or discharge from therapy intervention for any reason, which ever may occur first.
measure: Self -report Adherence Question: Both groups will complete a single question assessment regarding their perceived level of adherence to the prescribed home exercise plan.
time frame: Completed at 1 week after inital exam , at discharge from PT as defined by a period up to 24 weeks or discontinuation of therapy intervention for any reason, which ever may occur first, and 3 month follow-up. 6month follow-up if subject agreeable.
measure: Numeric Pain Rating Scale (NPRS) 0-10 scale.
time frame: Outcome will be completed at initial exam, at discharge from PT as defined by a period up to 24 weeks or discontinuation of therapy intervention for any reason, which ever may occur first.
measure: Patient-Specific Functional Scale (PSFS)
time frame: Outcome will be completed at initial exam, at discharge from PT as defined by a period up to 24 weeks or discontinuation of therapy intervention for any reason, which ever may occur first.
measure: The Global Rating of Change Scale (GROC)
time frame: At patient discharge from PT as defined by a period up to 24 weeks or discontinuation of therapy intervention for any reason, which ever may occur first, and at 3 month follow-up. 6month follow-up if subject agreeable.
arm group label: Traditional Group
arm group type: Active Comparator
description: The control group will receive traditional PT services as deemed clinically appropriate via examination to include traditional home exercise prescription.
arm group label: Augmented Media Group
arm group type: Experimental
description: The Augmented Media group will receive traditional PT services as deemed clinically appropriate via examination and include home exercise prescription via a mobile health application.
intervention type: Other
intervention name: Augmented Media Group
description: The intervention group will receive traditional PT services deemed clinically appropriate via examination plus home exercise prescription augmented via a mobile health application. The augmented media group will receive digital exercise prescription via a mobile health application source (Physitrack) that includes: high definition video and pictures, education material and written instruction, reminder notification and in-app logging of completion.
arm group label: Augmented Media Group
intervention type: Other
intervention name: Traditional Group
description: The Traditional Group will receive traditional PT services deemed clinically appropriate via examination plus traditional home exercise prescription.
arm group label: Traditional Group
criteria: 
gender: All
minimum age: 18 Years
maximum age: 100 Years
healthy volunteers: No
last name: Robert A Elson, MPT
role: Principal Investigator
affiliation: Aultman Health Foundation
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Aultman Health Foundation
investigator full name: Robert Elson PT
investigator title: Physical Therapist
mesh term: Musculoskeletal Diseases
sharing ipd: No