xml: <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/NCT06005623</url>
    </required_header>
    <id_info>
      <org_study_id>OUH KneeActivity</org_study_id>
      <nct_id>NCT06005623</nct_id>
    </id_info>
    <brief_title>Motivational Feedback Following Total or Unicompartmental Knee Arthroplasty</brief_title>
    <acronym>KneeActivity</acronym>
    <official_title>Levels of Physical Activity and Quality of Life by Activity Tracking and Motivational Feed-back Following Knee Replacement Surgery - Randomized Controlled Trial Nested in a Prospective Cohort (KneeActivity)</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Odense University Hospital</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>University of Southern Denmark</agency>
        <agency_class>Other</agency_class>
      </collaborator>
      <collaborator>
        <agency>Gigtforeningen</agency>
        <agency_class>Other</agency_class>
      </collaborator>
      <collaborator>
        <agency>Region of Southern Denmark</agency>
        <agency_class>Other</agency_class>
      </collaborator>
      <collaborator>
        <agency>Vejle Hospital</agency>
        <agency_class>Other</agency_class>
      </collaborator>
    </sponsors>
    <source>Odense University Hospital</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 goal of this randomized controlled trial (RCT) nested in a prospective cohort study is to&#xD;
        investigate whether physical activity (PA) following total knee arthroplasty (TKA) or&#xD;
        unicompartmental knee arthroplasty (UKA) can be optimized by the use of an activity tracking&#xD;
        device including motivational feedback in comparison with activity tracking without feedback.&#xD;
        Furthermore, the project will investigate the predictive value of PA level prior to TKA/UKA&#xD;
        for the length of stay, return to work, and quality of life.&#xD;
  &#xD;
        The main hypothese of the study are:&#xD;
  &#xD;
        RCT study:&#xD;
  &#xD;
          -  Using an activity tracking device, including motivational feed-back on PA show a&#xD;
             superior short-term effect on increased PA (Total counts; primary outcome measure),&#xD;
             physical functioning, return to work, and quality of life in comparison with no&#xD;
             motivational feed-back from the activity tracker, defined as 'care as usual', in TKA and&#xD;
             UKA patients&#xD;
  &#xD;
          -  Using an activity tracking device, including motivational feedback, will have a superior&#xD;
             effect on step counts, activity types and pain compared to the standard care, in TKA and&#xD;
             UKA patients&#xD;
  &#xD;
        Prospective cohort:&#xD;
  &#xD;
          -  PA prior to TKA or UKA can work as a predictive measure for function and quality of life&#xD;
             following surgery&#xD;
  &#xD;
          -  PA prior to TKA or UKA can work as a predictive measure for the length of hospital stay&#xD;
             and return to work&#xD;
  &#xD;
        Patients will be randomized to activity tracking and motivational feed-back by gamification&#xD;
        for patient self-mobilization (Intervention-group) or 'care-as-usual' including activity&#xD;
        tracking without motivational feed-back (Control-group). Patients not eligible and/or willing&#xD;
        to participate in the RCT study, will be offered to participate in a prospective&#xD;
        non-interventional cohort study.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Background:&#xD;
  &#xD;
        Worldwide over a million patients receive a TKA or UKA each year and in Denmark more than&#xD;
        10,000 TKA and UKA's are performed annually, and the lifetime risk of symptomatic&#xD;
        osteoarthritis (OA) of the knees are 45%. Despite being considered a successful intervention,&#xD;
        15-25% of patients following TKA are not satisfied with their output, which to some degree&#xD;
        may be associated with reduced daily physical activity (PA). Few scientific studies have&#xD;
        examined how daily PA is affected by TKA and how it might affect rehabilitation. It is&#xD;
        unknown if a focus on increased PA in everyday life after return from hospital might improve&#xD;
        rehabilitation and patient satisfaction. The current study addresses this 'gap' in science&#xD;
        with high-level clinical evidence, to investigate if a novel technology on motivational&#xD;
        feed-back regarding PA can be introduced to assist patients with a better rehabilitation&#xD;
        following TKA or UKA.&#xD;
  &#xD;
        Aim:&#xD;
  &#xD;
        The aim of this randomized controlled trial (RCT) nested in a prospective cohort is to&#xD;
        investigate whether PA following TKA or UKA can be optimized by the use of an activity&#xD;
        tracking device including motivational feedback in comparison with activity tracking without&#xD;
        feedback. Furthermore, a prospective cohort will investigate the predictive value of PA level&#xD;
        prior to TKA/UKA for the post-surgical length of stay, return to work, and quality of life.&#xD;
  &#xD;
        Trial design overview:&#xD;
  &#xD;
        Design:&#xD;
  &#xD;
        Randomized, blinded, two-arm, multi center trial. 150 patients scheduled for TKA or UKA will&#xD;
        be recruited through Odense University Hospital (Svendborg and Odense) and Vejle Hospital.&#xD;
        Patients will be randomized to 12 weeks of activity tracking and motivational feed-back by&#xD;
        gamification for patient self-mobilization (Intervention group) or 'care-as-usual' including&#xD;
        activity tracking without motivational feed-back (control group).&#xD;
  &#xD;
        Patients that are not eligible and/or willing to participate in the RCT study will be offered&#xD;
        to participate in a prospective non-interventional cohort study where the main outcome are&#xD;
        self-reported disability, generel health, return to work, pain medication, overall experience&#xD;
        with TKA or UKA.&#xD;
  &#xD;
        SENS Motion:&#xD;
  &#xD;
        SENS Motion (SENS Innovation ApS, Copenhagen, Denmark) is a wireless medical accelerometer&#xD;
        for collecting objectively PA data. SENS Motion has developed a patient app with&#xD;
        gamification/motivational feed-back to enhance PA. SENS Motion is CE marked as a medical&#xD;
        device. SENS Motion has no right to unpublished study data and is neither financially nor&#xD;
        personally involved in this trial. None in the study group is related to SENS Motion.&#xD;
  &#xD;
        Blinding:&#xD;
  &#xD;
        The primary investigator will be blinded to allocation and will not participate in&#xD;
        randomization of patients. The statistical analysis will be performed on allocation codes&#xD;
        only and thus the data analysts will be blinded in relation to intervention allocation.&#xD;
        Blinding to intervention of patients, surgeon, and nurses (healthcare providers) will not be&#xD;
        possible due to the nature of the intervention.&#xD;
  &#xD;
        Randomizing and database:&#xD;
  &#xD;
        Randomization is performed internet-based using REDCap Randomize, allocated 1:1. The&#xD;
        randomization itself takes place right after the surgery. The randomization is performed as a&#xD;
        block randomization in blocks of 2, 4 and 6. No stratifications are applied to the&#xD;
        randomization, and the primary investigator is blinded regarding the permuted blocking&#xD;
        strategy. A data manager, with no clinical involvement in the trial, prepares the&#xD;
        randomization sequence. The allocation is concealed in a password-protected computer file.&#xD;
  &#xD;
        Compliance:&#xD;
  &#xD;
        Patients in the control group will have the app installed on their smartphones without&#xD;
        motivational feedback, solely for transferring data from the activity tracker. To prevent&#xD;
        data loss, weekly SMS messages will remind both intervention and control groups to open their&#xD;
        SENS app during the week. No standard for adherence in app interventions has been established&#xD;
        previously. The implementation aims for a 70% adherence rate, indicating that the&#xD;
        intervention group will interact with the app and obtain motivational feedback for 5 out of 7&#xD;
        days weekly.&#xD;
  &#xD;
        All patients will receive written information on how to attach the sensor, use the app&#xD;
        (without a tablet), and use the tablet with motivational feedback. Moreover, all patients&#xD;
        will receive a link to a YouTube video presenting the project and providing instructions on&#xD;
        how to use the equipment.&#xD;
  &#xD;
        Time points Assessment will be performed at baseline two weeks prior to surgery and&#xD;
        randomization, following the intervention (14 weeks post baseline) (the primary endpoint) and&#xD;
        a long term follow-up at 12 months post baseline.&#xD;
  &#xD;
        Sample size:&#xD;
  &#xD;
        Sample size is estimated using total accelerometer counts per day from a previous publication&#xD;
        on TKA patients. Between-group difference in change score of 50.500 activity counts per day&#xD;
        representing ≈ 1/3 standard deviation and a change of ≈17% is considered clinically relevant.&#xD;
        To achieve a statistical power of 80% (β=0.80), using a standard deviation of 101.000 counts&#xD;
        per day pre- and post-intervention, and allowing the detection of statistically significant&#xD;
        differences at an α level of 0.05 (two-tailed testing), a sample size of n = 62 is estimated&#xD;
        for each group. Allowing for dropout a recruitment of 150 patients (in total) is planned.&#xD;
  &#xD;
        Main comparative analyses between groups will be performed by using an intention-to-treat&#xD;
        analysis. Between-group mean differences and 95% confidence intervals will be estimated with&#xD;
        a general linear model in which the patients baseline score is entered as a covariate and&#xD;
        adjusted for potential baseline differences (age, sex, BMI). In addition to the&#xD;
        intention-to-treat analysis, a per-protocol analysis will be also be conducted.&#xD;
  &#xD;
        Ethics:&#xD;
  &#xD;
        The study has been submitted to the regional Committee for Medical Research Ethics, which has&#xD;
        assessed the project as &quot;not subject to notification&quot;, Project-ID: S-20222000 - 171. Finally,&#xD;
        The Danish Medicines Agency has declared no need for further permission to carry out the&#xD;
        study.&#xD;
  &#xD;
        Qualitative study:&#xD;
  &#xD;
        A qualitative study using iterations where patients and healthcare professionals through&#xD;
        interviews provided input for improvements of the current technology was initiated to tailor&#xD;
        the technological maturation of the SENS App for the current patient group. Evaluation and&#xD;
        patient involvement will be based on interviews of ten patients. Feed-back from the focus&#xD;
        group will be implemented in an updated app-version. The first iteration was in augus t2021,&#xD;
        the second was in feburary 2023, the last iteration is planed in september 2023.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">September 1, 2023</start_date>
    <completion_date type="Anticipated">September 1, 2025</completion_date>
    <primary_completion_date type="Anticipated">September 1, 2025</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>
      <intervention_model_description>Multicenter randomized (1:1) parallel-group intervention study with blinded statistical analysis towards group allocation. Patients will be randomized to activity tracking and motivational feed-back by gamification for patient self-mobilization (INT) or 'care-as-usual' including activity tracking without motivational feed-back (CON).</intervention_model_description>
      <primary_purpose>Prevention</primary_purpose>
      <masking>Single (Investigator)</masking>
      <masking_description>Data will be analyzed by the PhD student blinded towards group allocation.</masking_description>
    </study_design_info>
    <primary_outcome>
      <measure>Between-group change score of total daily PA (accelerometer counts)</measure>
      <time_frame>Baseline and 12 weeks</time_frame>
      <description>PA will be evaluated by SENS Motion as described above. The primary outcome measure is the between-group change score of total daily PA (accelerometer counts) from baseline to 12 weeks following discharge. Accelerometer counts per day is a cumulative and validated variable based on raw accelerometer data in 3 planes and is a proxy for total daily PA</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Physical active minuts (Between-group change)</measure>
      <time_frame>Baseline and 12 weeks</time_frame>
      <description>Physical active minutes per day measured with SENS motion.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Physical activity (Between-group change)</measure>
      <time_frame>Baseline, 12 weeks and 12 months</time_frame>
      <description>Patient-reported physical activity will be assessed using the International Physical Activity Questionnaire - Short Form (IPAQ-SF). The IPAQ-SF measures activity over the past week in four different intensity levels, including 1) vigorous activities, 2) moderate activities, 3) walking, and 4) sitting. Higher value equals higher level of activity.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Patient satisfaction and patient reported outcome measures (Between-group change)</measure>
      <time_frame>Baseline, 12 weeks and 12 months</time_frame>
      <description>The OKS (Oxford Knee Score) is a validated 12-item questionnaire evaluate outcomes following TKA. It was translated into Danish in 2009, its validity in Danish has not been confirmed. The questionnaire generates scores ranging from 0-48, with a score of 4 representing the best outcome post-TKA. Each item response is graded between 0-4. A Danish study found that the minimal important change is 8.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Quality of Life (Between-group change)</measure>
      <time_frame>Baseline, 12 weeks and 12 months</time_frame>
      <description>The EQ-5D-5L (European Quality of Life - 5 Dimensions) is a validated survey for measuring HRQoL It consists of five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. The outcome is reported on a scale of 1-5 where 1 is no problems and 5 is extrem problems. The EQ-5D-5L is validated in knee OA patients referred for knee replacement surgery [43].</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Return to work in day-surgery (Between-group change)</measure>
      <time_frame>12 weeks, 12 months</time_frame>
      <description>For patients active in the labor market, time on sick leave before returning to work (full time or part time) will be assessed by a questionnaire.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Global Perceived Effect (GPE) (Between-group change)</measure>
      <time_frame>12 weeks, 12 months</time_frame>
      <description>Global Perceives Effect questions will be used for measuring the participants' overall experience with the TKA or UKA. A 5-point likert scale using the following answers will be used &quot;Much worse&quot;, &quot;Little worse&quot;, &quot;The same&quot;, &quot;Little better&quot;, and &quot;Much better.</description>
    </secondary_outcome>
    <other_outcome>
      <measure>Activity types (Between-group change)</measure>
      <time_frame>Baseline and 12 weeks</time_frame>
      <description>Activity types evaluated by SENS motion i.e. time spent sleeping/resting, standing, walking, and cycling will be evaluated.</description>
    </other_outcome>
    <other_outcome>
      <measure>Post-OP pain (Between-group change)</measure>
      <time_frame>12 weeks</time_frame>
      <description>The patients receive weekly text message (SMS) with a question about their knee-pain. They will be asked to rate their pain on a NRS scale from 0-10, where 0 corresponds to no pain and 10 correspoinds to worst imaginable pain.</description>
    </other_outcome>
    <other_outcome>
      <measure>Use of POST-op pain medication (Between-group change)</measure>
      <time_frame>12 weeks</time_frame>
      <description>Patients will receive a SMS with a question about their use of pain medication the last week. The SMS have 3 options: 1. No use of pain medication, 2. non-prescription medicine (e.g. Panodil, Pamol, Ibumetin), and 3. strong-painkillers (e.g. Morphine, Tramadol).</description>
    </other_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">150</enrollment>
    <condition>Knee Arthropathy</condition>
    <arm_group>
      <arm_group_label>Intervention</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Activity tracking and motivational feed-back by gamification.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Care as usual</arm_group_label>
      <arm_group_type>No Intervention</arm_group_type>
      <description>Activity tracking without motivational feed-back</description>
    </arm_group>
    <intervention>
      <intervention_type>Device</intervention_type>
      <intervention_name>SENS Motion + Motivational Feedback</intervention_name>
      <description>To weeks prior to surgery and in a 12-week period following discharge after TKA/UKA patients will be equipped with a discrete patch and built-in accelerometer (SENS Motion, Denmark, Copenhagen) attached on the thigh of the leg not undergoing surgery.&#xD;
  Following discharge after TKA/UKA patients randomized to the intervention-group will receive the app (&quot;SENS motion&quot;). On their provided app, patients will be able to choose between two tabs. Tab 1 will allow patients to view predefined goals, all of which are locations in a self-selected city. The sensor will measure the physical activity and daily rhythm of the patient, and accelerometer counts will be converted into daily steps, which will be visible to the patients. In Tab 2, patients will be able to see graphical representations of their daily activity as well as their history during the period in which they have worn the accelerometer. The graphical representations include: Daily steps, physical active minutes, and type of activity.</description>
      <arm_group_label>Intervention</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            1. Age: 40-85 years&#xD;
  &#xD;
            2. patients scheduled for primary TKA or UKA&#xD;
  &#xD;
            3. understanding both verbal and written Danish language.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            1. Difficulty adhering to the study protocol&#xD;
  &#xD;
            2. Refusal of standard care&#xD;
  &#xD;
            3. Known- or newly diagnosed malignancy or palliative care&#xD;
  &#xD;
            4. Participation in an interventional clinical trial during the last 3 months potentially&#xD;
               interacting with the aims of the current study.&#xD;
  &#xD;
            5. Do not own a smartphone&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>40 Years</minimum_age>
      <maximum_age>85 Years</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Cecilie D Skov, MD</last_name>
      <role>Principal Investigator</role>
      <affiliation>Odense University Hospital and Institute of Clinical Research, SDU</affiliation>
    </overall_official>
    <overall_official>
      <last_name>Anders Holsgaard-Larsen, Professor</last_name>
      <role>Study Director</role>
      <affiliation>Odense University Hospital and Institute of Clinical Research, SDU</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Cecilie Dollerup Skov, MD</last_name>
      <phone>+4560913839</phone>
      <email>Cecilie.Dolerup.Skov3@rsyd.dk</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Anders Holsgaard-Larsen, Professor</last_name>
      <email>AHLarsen@health.sdu.dk</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>Odense University Hospital</name>
        <address>
          <city>Odense</city>
          <country>Denmark</country>
        </address>
      </facility>
      <contact>
        <last_name>Cecilie D Skov, MD</last_name>
        <phone>+0045 60913839</phone>
        <email>cecilie.dollerup.skov3@rsyd.dk</email>
      </contact>
      <investigator>
        <last_name>Anders Holsgaard-Larsen, Professor</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location>
      <facility>
        <name>Odense University Hospital</name>
        <address>
          <city>Svendborg</city>
          <country>Denmark</country>
        </address>
      </facility>
      <investigator>
        <last_name>Martin Lindberg-Larsen, MD</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location>
      <facility>
        <name>Lillebaelt Hospital</name>
        <address>
          <city>Vejle</city>
          <country>Denmark</country>
        </address>
      </facility>
      <investigator>
        <last_name>Claus Varnum, MD</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location_countries>
      <country>Denmark</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 15, 2023</study_first_submitted>
    <study_first_submitted_qc>August 15, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 22, 2023</study_first_posted>
    <last_update_submitted>August 22, 2023</last_update_submitted>
    <last_update_submitted_qc>August 22, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 24, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Odense University Hospital</investigator_affiliation>
      <investigator_full_name>Anders Holsgaard Larsen</investigator_full_name>
      <investigator_title>Professor, PhD</investigator_title>
    </responsible_party>
    <keyword>Physical activity</keyword>
    <keyword>Motivational Feedback</keyword>
    <keyword>Rehabilitation</keyword>
    <keyword>Tele-Health</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Joint 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>
  
  
text: 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/NCT06005623
  org study id: OUH KneeActivity
  nct id: NCT06005623
  lead sponsor: 
  collaborator: 
  collaborator: 
  collaborator: 
  collaborator: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  The goal of this randomized controlled trial (RCT) nested in a prospective cohort study is to
        investigate whether physical activity (PA) following total knee arthroplasty (TKA) or
        unicompartmental knee arthroplasty (UKA) can be optimized by the use of an activity tracking
        device including motivational feedback in comparison with activity tracking without feedback.
        Furthermore, the project will investigate the predictive value of PA level prior to TKA/UKA
        for the length of stay, return to work, and quality of life.
  
        The main hypothese of the study are:
  
        RCT study:
  
          -  Using an activity tracking device, including motivational feed-back on PA show a
             superior short-term effect on increased PA (Total counts; primary outcome measure),
             physical functioning, return to work, and quality of life in comparison with no
             motivational feed-back from the activity tracker, defined as 'care as usual', in TKA and
             UKA patients
  
          -  Using an activity tracking device, including motivational feedback, will have a superior
             effect on step counts, activity types and pain compared to the standard care, in TKA and
             UKA patients
  
        Prospective cohort:
  
          -  PA prior to TKA or UKA can work as a predictive measure for function and quality of life
             following surgery
  
          -  PA prior to TKA or UKA can work as a predictive measure for the length of hospital stay
             and return to work
  
        Patients will be randomized to activity tracking and motivational feed-back by gamification
        for patient self-mobilization (Intervention-group) or 'care-as-usual' including activity
        tracking without motivational feed-back (Control-group). Patients not eligible and/or willing
        to participate in the RCT study, will be offered to participate in a prospective
        non-interventional cohort study.
  Background:
  
        Worldwide over a million patients receive a TKA or UKA each year and in Denmark more than
        10,000 TKA and UKA's are performed annually, and the lifetime risk of symptomatic
        osteoarthritis (OA) of the knees are 45%. Despite being considered a successful intervention,
        15-25% of patients following TKA are not satisfied with their output, which to some degree
        may be associated with reduced daily physical activity (PA). Few scientific studies have
        examined how daily PA is affected by TKA and how it might affect rehabilitation. It is
        unknown if a focus on increased PA in everyday life after return from hospital might improve
        rehabilitation and patient satisfaction. The current study addresses this 'gap' in science
        with high-level clinical evidence, to investigate if a novel technology on motivational
        feed-back regarding PA can be introduced to assist patients with a better rehabilitation
        following TKA or UKA.
  
        Aim:
  
        The aim of this randomized controlled trial (RCT) nested in a prospective cohort is to
        investigate whether PA following TKA or UKA can be optimized by the use of an activity
        tracking device including motivational feedback in comparison with activity tracking without
        feedback. Furthermore, a prospective cohort will investigate the predictive value of PA level
        prior to TKA/UKA for the post-surgical length of stay, return to work, and quality of life.
  
        Trial design overview:
  
        Design:
  
        Randomized, blinded, two-arm, multi center trial. 150 patients scheduled for TKA or UKA will
        be recruited through Odense University Hospital (Svendborg and Odense) and Vejle Hospital.
        Patients will be randomized to 12 weeks of activity tracking and motivational feed-back by
        gamification for patient self-mobilization (Intervention group) or 'care-as-usual' including
        activity tracking without motivational feed-back (control group).
  
        Patients that are not eligible and/or willing to participate in the RCT study will be offered
        to participate in a prospective non-interventional cohort study where the main outcome are
        self-reported disability, generel health, return to work, pain medication, overall experience
        with TKA or UKA.
  
        SENS Motion:
  
        SENS Motion (SENS Innovation ApS, Copenhagen, Denmark) is a wireless medical accelerometer
        for collecting objectively PA data. SENS Motion has developed a patient app with
        gamification/motivational feed-back to enhance PA. SENS Motion is CE marked as a medical
        device. SENS Motion has no right to unpublished study data and is neither financially nor
        personally involved in this trial. None in the study group is related to SENS Motion.
  
        Blinding:
  
        The primary investigator will be blinded to allocation and will not participate in
        randomization of patients. The statistical analysis will be performed on allocation codes
        only and thus the data analysts will be blinded in relation to intervention allocation.
        Blinding to intervention of patients, surgeon, and nurses (healthcare providers) will not be
        possible due to the nature of the intervention.
  
        Randomizing and database:
  
        Randomization is performed internet-based using REDCap Randomize, allocated 1:1. The
        randomization itself takes place right after the surgery. The randomization is performed as a
        block randomization in blocks of 2, 4 and 6. No stratifications are applied to the
        randomization, and the primary investigator is blinded regarding the permuted blocking
        strategy. A data manager, with no clinical involvement in the trial, prepares the
        randomization sequence. The allocation is concealed in a password-protected computer file.
  
        Compliance:
  
        Patients in the control group will have the app installed on their smartphones without
        motivational feedback, solely for transferring data from the activity tracker. To prevent
        data loss, weekly SMS messages will remind both intervention and control groups to open their
        SENS app during the week. No standard for adherence in app interventions has been established
        previously. The implementation aims for a 70% adherence rate, indicating that the
        intervention group will interact with the app and obtain motivational feedback for 5 out of 7
        days weekly.
  
        All patients will receive written information on how to attach the sensor, use the app
        (without a tablet), and use the tablet with motivational feedback. Moreover, all patients
        will receive a link to a YouTube video presenting the project and providing instructions on
        how to use the equipment.
  
        Time points Assessment will be performed at baseline two weeks prior to surgery and
        randomization, following the intervention (14 weeks post baseline) (the primary endpoint) and
        a long term follow-up at 12 months post baseline.
  
        Sample size:
  
        Sample size is estimated using total accelerometer counts per day from a previous publication
        on TKA patients. Between-group difference in change score of 50.500 activity counts per day
        representing ≈ 1/3 standard deviation and a change of ≈17% is considered clinically relevant.
        To achieve a statistical power of 80% (β=0.80), using a standard deviation of 101.000 counts
        per day pre- and post-intervention, and allowing the detection of statistically significant
        differences at an α level of 0.05 (two-tailed testing), a sample size of n = 62 is estimated
        for each group. Allowing for dropout a recruitment of 150 patients (in total) is planned.
  
        Main comparative analyses between groups will be performed by using an intention-to-treat
        analysis. Between-group mean differences and 95% confidence intervals will be estimated with
        a general linear model in which the patients baseline score is entered as a covariate and
        adjusted for potential baseline differences (age, sex, BMI). In addition to the
        intention-to-treat analysis, a per-protocol analysis will be also be conducted.
  
        Ethics:
  
        The study has been submitted to the regional Committee for Medical Research Ethics, which has
        assessed the project as "not subject to notification", Project-ID: S-20222000 - 171. Finally,
        The Danish Medicines Agency has declared no need for further permission to carry out the
        study.
  
        Qualitative study:
  
        A qualitative study using iterations where patients and healthcare professionals through
        interviews provided input for improvements of the current technology was initiated to tailor
        the technological maturation of the SENS App for the current patient group. Evaluation and
        patient involvement will be based on interviews of ten patients. Feed-back from the focus
        group will be implemented in an updated app-version. The first iteration was in augus t2021,
        the second was in feburary 2023, the last iteration is planed in september 2023.
  allocation: Randomized
  intervention model: Parallel Assignment
  intervention model description: Multicenter randomized (1:1) parallel-group intervention study with blinded statistical analysis towards group allocation. Patients will be randomized to activity tracking and motivational feed-back by gamification for patient self-mobilization (INT) or 'care-as-usual' including activity tracking without motivational feed-back (CON).
  primary purpose: Prevention
  masking: Single (Investigator)
  masking description: Data will be analyzed by the PhD student blinded towards group allocation.
  measure: Between-group change score of total daily PA (accelerometer counts)
  time frame: Baseline and 12 weeks
  description: PA will be evaluated by SENS Motion as described above. The primary outcome measure is the between-group change score of total daily PA (accelerometer counts) from baseline to 12 weeks following discharge. Accelerometer counts per day is a cumulative and validated variable based on raw accelerometer data in 3 planes and is a proxy for total daily PA
  measure: Physical active minuts (Between-group change)
  time frame: Baseline and 12 weeks
  description: Physical active minutes per day measured with SENS motion.
  measure: Physical activity (Between-group change)
  time frame: Baseline, 12 weeks and 12 months
  description: Patient-reported physical activity will be assessed using the International Physical Activity Questionnaire - Short Form (IPAQ-SF). The IPAQ-SF measures activity over the past week in four different intensity levels, including 1) vigorous activities, 2) moderate activities, 3) walking, and 4) sitting. Higher value equals higher level of activity.
  measure: Patient satisfaction and patient reported outcome measures (Between-group change)
  time frame: Baseline, 12 weeks and 12 months
  description: The OKS (Oxford Knee Score) is a validated 12-item questionnaire evaluate outcomes following TKA. It was translated into Danish in 2009, its validity in Danish has not been confirmed. The questionnaire generates scores ranging from 0-48, with a score of 4 representing the best outcome post-TKA. Each item response is graded between 0-4. A Danish study found that the minimal important change is 8.
  measure: Quality of Life (Between-group change)
  time frame: Baseline, 12 weeks and 12 months
  description: The EQ-5D-5L (European Quality of Life - 5 Dimensions) is a validated survey for measuring HRQoL It consists of five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. The outcome is reported on a scale of 1-5 where 1 is no problems and 5 is extrem problems. The EQ-5D-5L is validated in knee OA patients referred for knee replacement surgery [43].
  measure: Return to work in day-surgery (Between-group change)
  time frame: 12 weeks, 12 months
  description: For patients active in the labor market, time on sick leave before returning to work (full time or part time) will be assessed by a questionnaire.
  measure: Global Perceived Effect (GPE) (Between-group change)
  time frame: 12 weeks, 12 months
  description: Global Perceives Effect questions will be used for measuring the participants' overall experience with the TKA or UKA. A 5-point likert scale using the following answers will be used "Much worse", "Little worse", "The same", "Little better", and "Much better.
  measure: Activity types (Between-group change)
  time frame: Baseline and 12 weeks
  description: Activity types evaluated by SENS motion i.e. time spent sleeping/resting, standing, walking, and cycling will be evaluated.
  measure: Post-OP pain (Between-group change)
  time frame: 12 weeks
  description: The patients receive weekly text message (SMS) with a question about their knee-pain. They will be asked to rate their pain on a NRS scale from 0-10, where 0 corresponds to no pain and 10 correspoinds to worst imaginable pain.
  measure: Use of POST-op pain medication (Between-group change)
  time frame: 12 weeks
  description: Patients will receive a SMS with a question about their use of pain medication the last week. The SMS have 3 options: 1. No use of pain medication, 2. non-prescription medicine (e.g. Panodil, Pamol, Ibumetin), and 3. strong-painkillers (e.g. Morphine, Tramadol).
  arm group label: Intervention
  arm group type: Experimental
  description: Activity tracking and motivational feed-back by gamification.
  arm group label: Care as usual
  arm group type: No Intervention
  description: Activity tracking without motivational feed-back
  intervention type: Device
  intervention name: SENS Motion + Motivational Feedback
  description: To weeks prior to surgery and in a 12-week period following discharge after TKA/UKA patients will be equipped with a discrete patch and built-in accelerometer (SENS Motion, Denmark, Copenhagen) attached on the thigh of the leg not undergoing surgery.
  Following discharge after TKA/UKA patients randomized to the intervention-group will receive the app ("SENS motion"). On their provided app, patients will be able to choose between two tabs. Tab 1 will allow patients to view predefined goals, all of which are locations in a self-selected city. The sensor will measure the physical activity and daily rhythm of the patient, and accelerometer counts will be converted into daily steps, which will be visible to the patients. In Tab 2, patients will be able to see graphical representations of their daily activity as well as their history during the period in which they have worn the accelerometer. The graphical representations include: Daily steps, physical active minutes, and type of activity.
  arm group label: Intervention
  criteria: 
  gender: All
  minimum age: 40 Years
  maximum age: 85 Years
  healthy volunteers: Accepts Healthy Volunteers
  last name: Cecilie D Skov, MD
  role: Principal Investigator
  affiliation: Odense University Hospital and Institute of Clinical Research, SDU
  last name: Anders Holsgaard-Larsen, Professor
  role: Study Director
  affiliation: Odense University Hospital and Institute of Clinical Research, SDU
  last name: Cecilie Dollerup Skov, MD
  phone: +4560913839
  email: Cecilie.Dolerup.Skov3@rsyd.dk
  last name: Anders Holsgaard-Larsen, Professor
  email: AHLarsen@health.sdu.dk
  facility: 
  contact: 
  investigator: 
  facility: 
  investigator: 
  facility: 
  investigator: 
  country: Denmark
  responsible party type: Principal Investigator
  investigator affiliation: Odense University Hospital
  investigator full name: Anders Holsgaard Larsen
  investigator title: Professor, PhD
  mesh term: Joint Diseases
  sharing ipd: No