<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/NCT03809975</url>
  </required_header>
  <id_info>
    <org_study_id>NTF_JUL2017_I_C2_CQR_01</org_study_id>
    <secondary_id>2018/00408</secondary_id>
    <nct_id>NCT03809975</nct_id>
  </id_info>
  <brief_title>Collaborative Model of Care Between Orthopaedics and Allied Healthcare Professionals Trial (CONnACT)</brief_title>
  <official_title>Collaborative Model of Care Between Orthopaedics and Allied Healthcare Professionals Trial (CONnACT)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Tan Tock Seng Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>University of Southern Denmark</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Nanyang Technological University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Singapore General Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>University of Sydney</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Tan Tock Seng 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>
      Osteoarthritis knee is the leading cause of chronic disability among older adults. Our&#xD;
      current model of care is doctor-centric and inefficient leading to suboptimal use of allied&#xD;
      health intervention for effective lifestyle and behaviour changes resulting in potentially,&#xD;
      unnecessary surgery.&#xD;
&#xD;
      The study is designed using an effectiveness-implementation hybrid study design utilizing a&#xD;
      mixed methods approach. The hybrid study has dual aims. The primary aim is to evaluate the&#xD;
      clinical effectiveness (pain, function and quality of life) of a 12-week multidisciplinary&#xD;
      (Orthopaedics, Physiotherapy, Dietetics, Psychology) personalized, community-based program&#xD;
      for patients with knee osteoarthritis through a randomized-controlled trial. The secondary&#xD;
      aim is to obtain data that will inform the context for implementation and guide future wider&#xD;
      scale application. The investigators hypothesize that this multidisciplinary program is&#xD;
      clinically more effective in the treatment of knee osteoarthritis at 12 months compared to&#xD;
      standard care.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      BACKGROUND With a rapidly aging population, osteoarthritis is expected to become the 4th&#xD;
      leading cause of global disability by 2020. Established guidelines for knee osteoarthritis&#xD;
      strongly advocate lifestyle changes, such with exercises and weight loss as first line of&#xD;
      treatment, whilst reserving surgery as the last resort. Our current model of care is&#xD;
      doctor-centric and inefficient leading to suboptimal use of allied health intervention for&#xD;
      effective lifestyle and behaviour changes resulting in potentially, unnecessary surgery.&#xD;
      Redesigning the model of care by moving away from costly surgical treatment through the&#xD;
      optimization and synergizing of proven non-surgical treatments is key to deliver value-based&#xD;
      care.&#xD;
&#xD;
      AIMS AND HYPOTHESIS Primary Aim and Hypothesis. Evaluate the clinical effectiveness (pain,&#xD;
      function and quality of life) at 12 months of a personalized, community based 3-month&#xD;
      multidisciplinary program (Orthopaedics, Physiotherapist, Dietitian and Psychologist) as&#xD;
      compared with usual care for patients with knee osteoarthritis. The investigators hypothesize&#xD;
      that patients with knee osteoarthritis who undergo a personalized, community based 3-month&#xD;
      multidisciplinary program will have better pain, function and quality of life scores at 12&#xD;
      months post initiation of program compared to patients who undergo usual care.&#xD;
&#xD;
      Secondary Aim. Evaluate the cost effectiveness of a personalized, community based 3-month&#xD;
      multidisciplinary program (Orthopaedic, Physiotherapist, Dietitian and Psychologist) for&#xD;
      patients with knee osteoarthritis. Qualitative assessment of the acceptability, feasibility&#xD;
      and scalability of such a program&#xD;
&#xD;
      METHODOLOGY The study will be conducted as a single centre, single-blinded, gender&#xD;
      stratified, block permutated randomized controlled trial using a mixed method approach&#xD;
      (quantitative and qualitative), comparing a proposed new multidisciplinary personalized&#xD;
      community-based model of care and the current model of care.&#xD;
&#xD;
      Patients with suspected knee osteoarthritis who are referred from the Polyclinics in the&#xD;
      primary healthcare setting to the Tan Tock Seng Hospital Orthopaedic Specialist Outpatient&#xD;
      Clinic. Patients will then be evaluated based on the inclusion and exclusion criteria and&#xD;
      subsequently invited to join the study if eligible. Consent for participation into the study&#xD;
      will be obtained prior to randomization. Randomization will be done via gender stratified&#xD;
      permutated block randomization.&#xD;
&#xD;
      ECONOMIC EVALUATION An economic evaluation from a societal perspective will be undertaken to&#xD;
      determine the cost effectiveness of the intervention. The incremental cost effectiveness&#xD;
      ratio of this multidisciplinary non-surgical community-based program for knee osteoarthritis&#xD;
      compared to routine care will be determined. Cost data will be collected via questionnaires&#xD;
      and hospital databases to estimate both the direct medical, direct non-medical and indirect&#xD;
      cost. Indirect cost of health-related productivity loss due to knee osteoarthritis will be&#xD;
      calculated using a human capital approach. The primary measure of health benefit will be&#xD;
      Quality of Life Years measure using the EQ-5D.&#xD;
&#xD;
      QUALITATIVE COMPONENT The qualitative component of our study will employ several qualitative&#xD;
      methods such as focus group discussions and individual interviews with a variety of subjects&#xD;
      including both patients and stakeholders. The focus will on identifying the potential&#xD;
      barriers and facilitators to implementing and upscaling the intervention.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Active, not recruiting</overall_status>
  <start_date type="Actual">September 18, 2018</start_date>
  <completion_date type="Anticipated">December 31, 2021</completion_date>
  <primary_completion_date type="Actual">February 1, 2021</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>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Knee Injury and Osteoarthritis Outcomes Score (KOOS4)</measure>
    <time_frame>Assessed at baseline, 3 months, 6 months, 12 months</time_frame>
    <description>Change in disease specific pain and functional outcome scores between patients undergoing the multidisciplinary community program and the current model of care will be evaluated. A composite score of the following subscales will be calculated using the averaged score - Pain, Symptoms, Activities of Daily Living and Quality of Life will be calculated. Scores between 0 and 100 represent the percentage of total possible score achieved, with zero representing extreme knee problems and 100 representing no knee problems.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Knee Injury and Osteoarthritis Outcomes Score (KOOS) subscales - Pain, Symptoms, Activities of Daily Living, Sports/Recreational Activities, Quality of Life</measure>
    <time_frame>Assessed at baseline, 3 months, 6 months, 12 months</time_frame>
    <description>The five patient-relevant subscales of KOOS are scored separately: KOOS Pain (9 items); KOOS Symptoms (7 items); KOOS ADL (17 items); KOOS Sport/Rec (5 items); KOOS QOL (4 items). A Likert scale is used and all items have five possible answer options scored from 0 (No Problems) to 4 (Extreme Problems) and each of the five scores is calculated as the sum of the items included. Scores are transformed to a 0-100 scale, with zero representing extreme knee problems and 100 representing no knee problems</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>EuroQol-5 Dimensions (EQ-5D)</measure>
    <time_frame>Assessed at baseline, 3 months, 6 months, 12 months</time_frame>
    <description>EuroQol-5 Dimensions (EQ-5D) which consist of 2 dimensions, the EQ-5D descriptive system and the EQ visual analogue scale (EQ VAS). The descriptive system comprises five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems and extreme problems. The patient is asked to indicate his/her health state by ticking the box next to the most appropriate statement in each of the five dimensions. This decision results in a 1-digit number that expresses the level selected for that dimension. The digits for the five dimensions can be combined into a 5-digit number that describes the patient's health state. The EQ VAS records the patient's self-rated health on a vertical visual analogue scale, where the endpoints are labelled 'The best health you can imagine' and 'The worst health you can imagine'. The VAS will be used as a quantitative measure of health outcome.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Functional Assessment - 30s chair stand test</measure>
    <time_frame>Assessed at baseline, 3 months, 6 months, 12 months</time_frame>
    <description>To test leg strength and endurance. Total number of repetitions completed in 30 seconds is recorded.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Functional Assessment - 40m fast-paced walk test</measure>
    <time_frame>Assessed at baseline, 3 months, 6 months, 12 months</time_frame>
    <description>Measure of patient's walking speed. Time taken to complete 40 meters walk will be recorded in seconds.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Functional Assessment - 4 stairs climb test</measure>
    <time_frame>Assessed at baseline, 3 months, 6 months, 12 months</time_frame>
    <description>To assess the strength, balance and agility through ascending and descending a set number of steps. Time to ascend and descend steps (excluding turning around time) is recorded separately in seconds. Overall time taken (including the turn around time) to ascend and descend stairs is also recorded.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Functional Assessment - Timed up and go test</measure>
    <time_frame>Assessed at baseline, 3 months, 6 months, 12 months</time_frame>
    <description>To assess patient's mobility and balance through the patient's ability to rise from a seated position to walk around a cone 3 meters away and return to the seated position. Time taken to perform the test in fast walking pace will be recorded in seconds.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Patient Health Questionnaire 4 (PHQ-4)</measure>
    <time_frame>Assessed at baseline, 3 months, 6 months, 12 months</time_frame>
    <description>Measurement for depression and anxiety rated on a 4 point Likert-type scale. 0 refers to 'Not at all'; 3 refers 'Nearly everyday'. Total score is determined by adding together the scores of each of the 4 items. Scores are rated as normal (0-2), mild (3-5), moderate (6-8), and severe (9-12).&#xD;
Total score ≥3 for first 2 questions suggests anxiety. Total score ≥3 for last 2 questions suggests depression.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Patient Activation Measure (PAM)</measure>
    <time_frame>Assessed at baseline, 3 months, 6 months, 12 months</time_frame>
    <description>Measures patients on a 0-100 scale and can segment patients into one of four activation levels along an empirically derived continuum. Each activation level reveals insight into an array of health-related characteristics, including attitudes, motivators, behaviors, and outcomes.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pain, Enjoyment, General Activity Scale (PEG)</measure>
    <time_frame>Assessed at baseline, 3 months, 6 months, 12 months</time_frame>
    <description>Measures the pain intensity and interference level using a three-item scale. Scale of 0 to 10 is used for each item. 0 refers 'no pain'; 10 refers 'worse pain'. Add the responses to the three questions, then divide by three to get a mean score (out of 10) on overall impact of points.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Body Mass Index (BMI)</measure>
    <time_frame>Assessed at baseline, 3 months, 6 months, 12 months</time_frame>
    <description>Assessed if patient achieved weight loss during the study period. Weight and height of patient will be measured in m and kg respectively. Weight and height will be combined to report BMI in kg/m^2</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Total Knee Replacement</measure>
    <time_frame>Assessed at 3 months, 6 months, 12 months</time_frame>
    <description>Indicates if the patient undergoes a total knee replacement at any time during the study period.</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Cumulative Analgesia Consumption Score (CACS)</measure>
    <time_frame>Assessed at baseline, 3 months, 6 months, 12 months</time_frame>
    <description>Objective measurement of patient's analgesics average weekly consumption based on the quantity multiplied by the category of analgesic medication according to the WHO pain relief ladder(1 point - non-opioid, 2 points - mild opioid, 3 points - strong opioid) in order to calculate a total score.</description>
  </other_outcome>
  <other_outcome>
    <measure>Semi-Quantitative Food Frequency Questionnaire (FFQ)</measure>
    <time_frame>Assessed at baseline, 3 months, 6 months, 12 months</time_frame>
    <description>Understand the eating habits and dietary choice over time. 64 question questionnaire looking at the frequency of food consumption in different food group on a 5 point scale ranging from less than 3 times a month to more than once a day.</description>
  </other_outcome>
  <other_outcome>
    <measure>Sports Injury Rehabilitation Adherence Scale (SIRAS)</measure>
    <time_frame>Assessed after each physiotherapist session</time_frame>
    <description>A measurement of the patient's compliance level to exercises done by the attending therapist. 3 question questionnaire with an answering scale of 1 to 5. Total score is derived from adding the 3 scores up.</description>
  </other_outcome>
  <other_outcome>
    <measure>Global perceived effect (GPE)</measure>
    <time_frame>Assessed at 3 months, 6 months, 12 months</time_frame>
    <description>Patient will be asked to rate their overall recovery on a 7-point Likert scale. 1 refers to 'Very much improved'; 7 refers to 'Very much deteriorated'.</description>
  </other_outcome>
  <other_outcome>
    <measure>Patient Acceptable Symptom State (PASS)</measure>
    <time_frame>Assessed at 3 months, 6 months, 12 months</time_frame>
    <description>A single-question used to assess patient's satisfaction in the treatment. Response will be either yes or no.&quot;When you think of your knee function, will you consider your current condition as satisfying? By knee function, you should take into account your activities of daily living, sport and recreational activities, your pain and other symptoms and your quality of life&quot;</description>
  </other_outcome>
  <other_outcome>
    <measure>Patient-reported Treatment failure</measure>
    <time_frame>Assessed at 3 months, 6 months, 12 months</time_frame>
    <description>Patient who answers 'no' to PASS will be ask to determine if they consider the treatment to have failed. Response will be 'yes' or 'no'. &quot;Would you consider your current state as being so unsatisfactory that you consider the treatment to have failed?&quot;</description>
  </other_outcome>
  <other_outcome>
    <measure>Costs</measure>
    <time_frame>Assessed at 3 months, 6 months, 12 months</time_frame>
    <description>Cost questionnaire measuring the direct and indirect costs</description>
  </other_outcome>
  <other_outcome>
    <measure>Adverse Events</measure>
    <time_frame>Assessed at 3 months, 6 months,12 months</time_frame>
    <description>Adverse events (AE) and serious adverse events (SAE) will be recorded at all follow-ups by asking the participants about potential AEs using open-probe questioning to ensure that all AEs are recorded. AEs will be categorized into index knee or other sites and will be recorded and assessed for severity independent of whether or not there is a causal relationship with study treatments.</description>
  </other_outcome>
  <other_outcome>
    <measure>University of California, Los Angeles(UCLA) activity score</measure>
    <time_frame>Assessed at baseline, 3 months, 6 months and 12 months</time_frame>
    <description>1 question survey to understands patient physical activity level from a scale of 1(wholly inactive) to 10(regular participation in impact sports).</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">114</enrollment>
  <condition>Osteoarthritis</condition>
  <arm_group>
    <arm_group_label>Control Arm</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Current model of care&#xD;
Patients will undergo the current standard of care in the Orthopaedic Outpatient Clinic in Tan Tock Seng Hospital. Patients will undergo routine consultation with an orthopaedic surgeon and will be provided with standard treatment as necessitated based on the assessment of the orthopaedic surgeon. Subsequent follow up appointments will be scheduled at the discretion of the orthopaedic surgeon. Patients will be referred to the physiotherapists, dietitian and psychologists as necessary for regular or adhoc sessions at the discretion of the allied health professional.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Intervention Arm</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Multidisciplinary Community Program&#xD;
Community based, personalized, structured, 12-week multidisciplinary program that includes Orthopaedics, Physiotherapy, Dietitics, Psychology interventions. This intervention involves the use of formal assessment such as BMI and psychological questionnaires to determine the need for dietetics or psychological intervention. In addition, there are educational sessions to improve patient's understanding of osteoarthritis and improve their activation level. An optional support group session will be arranged at approx. 3-4 months after completion of the 12-week intervention program to improve sustainability of treatment effect.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Multidisciplinary Community Program</intervention_name>
    <description>Patient will undergoes 12 weeks of structured and personalized multidisciplinary community-based program, which consists of Physiotherapy, Dietetics and Psychology sessions. Patients will also attend 2 educational sessions. Physiotherapy and educational sessions are mandatory for all participants, while the need for dietetics and psychological interventions are determine using individual's BMI measurements and psychological questionnaires.&#xD;
Inclusion criteria:&#xD;
Dietetics: 23.5 &lt; BMI &lt;32.5; Psychology: PEG &gt; 4 or PHQ-4 &gt; 5 or PAM level &lt; 3</description>
    <arm_group_label>Intervention Arm</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Current model of care</intervention_name>
    <description>No controlled set of treatment assigned to patient. It is based totally on the discretion of the attending clinicians. It will generally contain an unspecific number of physiotherapy sessions. Other allied health involvement such as dietetics and psychological interventions will be on an ad hoc basis. In some cases, the orthopaedic surgeon may recommend for surgery.</description>
    <arm_group_label>Control Arm</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria&#xD;
&#xD;
          1. National Institute for Health and Care Excellence (NICE) clinical criteria for knee&#xD;
             osteoarthritis&#xD;
&#xD;
          2. Radiographic severity of knee osteoarthritis - Kellgren Lawrence Score &gt; 1&#xD;
&#xD;
          3. Knee Injury and Osteoarthritis Outcome Score (KOOS4) ≤ 75&#xD;
&#xD;
          4. Independent community ambulator with or without walking aid&#xD;
&#xD;
          5. Age ≥ 45 years old&#xD;
&#xD;
          6. Conversant in English/Chinese&#xD;
&#xD;
          7. Subject will need to fulfill all the inclusion criteria for eligibility.&#xD;
&#xD;
        Exclusion Criteria&#xD;
&#xD;
          1. Alternative diagnosis to knee osteoarthritis e.g. referred pain from the spine or hip&#xD;
&#xD;
          2. Secondary arthritis e.g. inflammatory, post-traumatic&#xD;
&#xD;
          3. Inability to comply with study protocol e.g. cognitive impairment&#xD;
&#xD;
          4. Previous knee arthroplasty on the symptomatic knee&#xD;
&#xD;
          5. Wheelchair bound patients&#xD;
&#xD;
          6. Any other medical condition that study team determines may interfere with study&#xD;
             involvement&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>45 Years</minimum_age>
    <maximum_age>99 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Bryan Tan, MBBS, MRCS</last_name>
    <role>Principal Investigator</role>
    <affiliation>Tan Tock Seng Hospital</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Soren Skou, PT, PhD</last_name>
    <role>Study Chair</role>
    <affiliation>University of Southern Denmark</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Josip Car, MD, PhD</last_name>
    <role>Study Chair</role>
    <affiliation>Nanyang Technological University</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Julian Thumboo, MBBS, FRCP</last_name>
    <role>Study Chair</role>
    <affiliation>Singapore General Hospital</affiliation>
  </overall_official>
  <overall_official>
    <last_name>David Hunter, MBBS, PhD</last_name>
    <role>Study Chair</role>
    <affiliation>University of Sydney</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>St Luke Eldercare (AMK)</name>
      <address>
        <city>Singapore</city>
        <country>Singapore</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Tan Tock Seng Hospital</name>
      <address>
        <city>Singapore</city>
        <country>Singapore</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Singapore</country>
  </location_countries>
  <verification_date>October 2021</verification_date>
  <study_first_submitted>January 15, 2019</study_first_submitted>
  <study_first_submitted_qc>January 17, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 18, 2019</study_first_posted>
  <last_update_submitted>October 6, 2021</last_update_submitted>
  <last_update_submitted_qc>October 6, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">October 8, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Tan Tock Seng Hospital</investigator_affiliation>
    <investigator_full_name>Bryan Tan</investigator_full_name>
    <investigator_title>Senior Resident</investigator_title>
  </responsible_party>
  <keyword>Knee</keyword>
  <keyword>Osteoarthritis</keyword>
  <keyword>Model of care</keyword>
  <keyword>Multi-disciplinary</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Osteoarthritis</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</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/NCT03809975
org study id: NTF_JUL2017_I_C2_CQR_01
secondary id: 2018/00408
nct id: NCT03809975
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Osteoarthritis knee is the leading cause of chronic disability among older adults. Our
      current model of care is doctor-centric and inefficient leading to suboptimal use of allied
      health intervention for effective lifestyle and behaviour changes resulting in potentially,
      unnecessary surgery.

      The study is designed using an effectiveness-implementation hybrid study design utilizing a
      mixed methods approach. The hybrid study has dual aims. The primary aim is to evaluate the
      clinical effectiveness (pain, function and quality of life) of a 12-week multidisciplinary
      (Orthopaedics, Physiotherapy, Dietetics, Psychology) personalized, community-based program
      for patients with knee osteoarthritis through a randomized-controlled trial. The secondary
      aim is to obtain data that will inform the context for implementation and guide future wider
      scale application. The investigators hypothesize that this multidisciplinary program is
      clinically more effective in the treatment of knee osteoarthritis at 12 months compared to
      standard care.
BACKGROUND With a rapidly aging population, osteoarthritis is expected to become the 4th
      leading cause of global disability by 2020. Established guidelines for knee osteoarthritis
      strongly advocate lifestyle changes, such with exercises and weight loss as first line of
      treatment, whilst reserving surgery as the last resort. Our current model of care is
      doctor-centric and inefficient leading to suboptimal use of allied health intervention for
      effective lifestyle and behaviour changes resulting in potentially, unnecessary surgery.
      Redesigning the model of care by moving away from costly surgical treatment through the
      optimization and synergizing of proven non-surgical treatments is key to deliver value-based
      care.

      AIMS AND HYPOTHESIS Primary Aim and Hypothesis. Evaluate the clinical effectiveness (pain,
      function and quality of life) at 12 months of a personalized, community based 3-month
      multidisciplinary program (Orthopaedics, Physiotherapist, Dietitian and Psychologist) as
      compared with usual care for patients with knee osteoarthritis. The investigators hypothesize
      that patients with knee osteoarthritis who undergo a personalized, community based 3-month
      multidisciplinary program will have better pain, function and quality of life scores at 12
      months post initiation of program compared to patients who undergo usual care.

      Secondary Aim. Evaluate the cost effectiveness of a personalized, community based 3-month
      multidisciplinary program (Orthopaedic, Physiotherapist, Dietitian and Psychologist) for
      patients with knee osteoarthritis. Qualitative assessment of the acceptability, feasibility
      and scalability of such a program

      METHODOLOGY The study will be conducted as a single centre, single-blinded, gender
      stratified, block permutated randomized controlled trial using a mixed method approach
      (quantitative and qualitative), comparing a proposed new multidisciplinary personalized
      community-based model of care and the current model of care.

      Patients with suspected knee osteoarthritis who are referred from the Polyclinics in the
      primary healthcare setting to the Tan Tock Seng Hospital Orthopaedic Specialist Outpatient
      Clinic. Patients will then be evaluated based on the inclusion and exclusion criteria and
      subsequently invited to join the study if eligible. Consent for participation into the study
      will be obtained prior to randomization. Randomization will be done via gender stratified
      permutated block randomization.

      ECONOMIC EVALUATION An economic evaluation from a societal perspective will be undertaken to
      determine the cost effectiveness of the intervention. The incremental cost effectiveness
      ratio of this multidisciplinary non-surgical community-based program for knee osteoarthritis
      compared to routine care will be determined. Cost data will be collected via questionnaires
      and hospital databases to estimate both the direct medical, direct non-medical and indirect
      cost. Indirect cost of health-related productivity loss due to knee osteoarthritis will be
      calculated using a human capital approach. The primary measure of health benefit will be
      Quality of Life Years measure using the EQ-5D.

      QUALITATIVE COMPONENT The qualitative component of our study will employ several qualitative
      methods such as focus group discussions and individual interviews with a variety of subjects
      including both patients and stakeholders. The focus will on identifying the potential
      barriers and facilitators to implementing and upscaling the intervention.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Outcomes Assessor)
measure: Knee Injury and Osteoarthritis Outcomes Score (KOOS4)
time frame: Assessed at baseline, 3 months, 6 months, 12 months
description: Change in disease specific pain and functional outcome scores between patients undergoing the multidisciplinary community program and the current model of care will be evaluated. A composite score of the following subscales will be calculated using the averaged score - Pain, Symptoms, Activities of Daily Living and Quality of Life will be calculated. Scores between 0 and 100 represent the percentage of total possible score achieved, with zero representing extreme knee problems and 100 representing no knee problems.
measure: Knee Injury and Osteoarthritis Outcomes Score (KOOS) subscales - Pain, Symptoms, Activities of Daily Living, Sports/Recreational Activities, Quality of Life
time frame: Assessed at baseline, 3 months, 6 months, 12 months
description: The five patient-relevant subscales of KOOS are scored separately: KOOS Pain (9 items); KOOS Symptoms (7 items); KOOS ADL (17 items); KOOS Sport/Rec (5 items); KOOS QOL (4 items). A Likert scale is used and all items have five possible answer options scored from 0 (No Problems) to 4 (Extreme Problems) and each of the five scores is calculated as the sum of the items included. Scores are transformed to a 0-100 scale, with zero representing extreme knee problems and 100 representing no knee problems
measure: EuroQol-5 Dimensions (EQ-5D)
time frame: Assessed at baseline, 3 months, 6 months, 12 months
description: EuroQol-5 Dimensions (EQ-5D) which consist of 2 dimensions, the EQ-5D descriptive system and the EQ visual analogue scale (EQ VAS). The descriptive system comprises five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems and extreme problems. The patient is asked to indicate his/her health state by ticking the box next to the most appropriate statement in each of the five dimensions. This decision results in a 1-digit number that expresses the level selected for that dimension. The digits for the five dimensions can be combined into a 5-digit number that describes the patient's health state. The EQ VAS records the patient's self-rated health on a vertical visual analogue scale, where the endpoints are labelled 'The best health you can imagine' and 'The worst health you can imagine'. The VAS will be used as a quantitative measure of health outcome.
measure: Functional Assessment - 30s chair stand test
time frame: Assessed at baseline, 3 months, 6 months, 12 months
description: To test leg strength and endurance. Total number of repetitions completed in 30 seconds is recorded.
measure: Functional Assessment - 40m fast-paced walk test
time frame: Assessed at baseline, 3 months, 6 months, 12 months
description: Measure of patient's walking speed. Time taken to complete 40 meters walk will be recorded in seconds.
measure: Functional Assessment - 4 stairs climb test
time frame: Assessed at baseline, 3 months, 6 months, 12 months
description: To assess the strength, balance and agility through ascending and descending a set number of steps. Time to ascend and descend steps (excluding turning around time) is recorded separately in seconds. Overall time taken (including the turn around time) to ascend and descend stairs is also recorded.
measure: Functional Assessment - Timed up and go test
time frame: Assessed at baseline, 3 months, 6 months, 12 months
description: To assess patient's mobility and balance through the patient's ability to rise from a seated position to walk around a cone 3 meters away and return to the seated position. Time taken to perform the test in fast walking pace will be recorded in seconds.
measure: Patient Health Questionnaire 4 (PHQ-4)
time frame: Assessed at baseline, 3 months, 6 months, 12 months
description: Measurement for depression and anxiety rated on a 4 point Likert-type scale. 0 refers to 'Not at all'; 3 refers 'Nearly everyday'. Total score is determined by adding together the scores of each of the 4 items. Scores are rated as normal (0-2), mild (3-5), moderate (6-8), and severe (9-12).
Total score ≥3 for first 2 questions suggests anxiety. Total score ≥3 for last 2 questions suggests depression.
measure: Patient Activation Measure (PAM)
time frame: Assessed at baseline, 3 months, 6 months, 12 months
description: Measures patients on a 0-100 scale and can segment patients into one of four activation levels along an empirically derived continuum. Each activation level reveals insight into an array of health-related characteristics, including attitudes, motivators, behaviors, and outcomes.
measure: Pain, Enjoyment, General Activity Scale (PEG)
time frame: Assessed at baseline, 3 months, 6 months, 12 months
description: Measures the pain intensity and interference level using a three-item scale. Scale of 0 to 10 is used for each item. 0 refers 'no pain'; 10 refers 'worse pain'. Add the responses to the three questions, then divide by three to get a mean score (out of 10) on overall impact of points.
measure: Body Mass Index (BMI)
time frame: Assessed at baseline, 3 months, 6 months, 12 months
description: Assessed if patient achieved weight loss during the study period. Weight and height of patient will be measured in m and kg respectively. Weight and height will be combined to report BMI in kg/m^2
measure: Total Knee Replacement
time frame: Assessed at 3 months, 6 months, 12 months
description: Indicates if the patient undergoes a total knee replacement at any time during the study period.
measure: Cumulative Analgesia Consumption Score (CACS)
time frame: Assessed at baseline, 3 months, 6 months, 12 months
description: Objective measurement of patient's analgesics average weekly consumption based on the quantity multiplied by the category of analgesic medication according to the WHO pain relief ladder(1 point - non-opioid, 2 points - mild opioid, 3 points - strong opioid) in order to calculate a total score.
measure: Semi-Quantitative Food Frequency Questionnaire (FFQ)
time frame: Assessed at baseline, 3 months, 6 months, 12 months
description: Understand the eating habits and dietary choice over time. 64 question questionnaire looking at the frequency of food consumption in different food group on a 5 point scale ranging from less than 3 times a month to more than once a day.
measure: Sports Injury Rehabilitation Adherence Scale (SIRAS)
time frame: Assessed after each physiotherapist session
description: A measurement of the patient's compliance level to exercises done by the attending therapist. 3 question questionnaire with an answering scale of 1 to 5. Total score is derived from adding the 3 scores up.
measure: Global perceived effect (GPE)
time frame: Assessed at 3 months, 6 months, 12 months
description: Patient will be asked to rate their overall recovery on a 7-point Likert scale. 1 refers to 'Very much improved'; 7 refers to 'Very much deteriorated'.
measure: Patient Acceptable Symptom State (PASS)
time frame: Assessed at 3 months, 6 months, 12 months
description: A single-question used to assess patient's satisfaction in the treatment. Response will be either yes or no."When you think of your knee function, will you consider your current condition as satisfying? By knee function, you should take into account your activities of daily living, sport and recreational activities, your pain and other symptoms and your quality of life"
measure: Patient-reported Treatment failure
time frame: Assessed at 3 months, 6 months, 12 months
description: Patient who answers 'no' to PASS will be ask to determine if they consider the treatment to have failed. Response will be 'yes' or 'no'. "Would you consider your current state as being so unsatisfactory that you consider the treatment to have failed?"
measure: Costs
time frame: Assessed at 3 months, 6 months, 12 months
description: Cost questionnaire measuring the direct and indirect costs
measure: Adverse Events
time frame: Assessed at 3 months, 6 months,12 months
description: Adverse events (AE) and serious adverse events (SAE) will be recorded at all follow-ups by asking the participants about potential AEs using open-probe questioning to ensure that all AEs are recorded. AEs will be categorized into index knee or other sites and will be recorded and assessed for severity independent of whether or not there is a causal relationship with study treatments.
measure: University of California, Los Angeles(UCLA) activity score
time frame: Assessed at baseline, 3 months, 6 months and 12 months
description: 1 question survey to understands patient physical activity level from a scale of 1(wholly inactive) to 10(regular participation in impact sports).
arm group label: Control Arm
arm group type: Active Comparator
description: Current model of care
Patients will undergo the current standard of care in the Orthopaedic Outpatient Clinic in Tan Tock Seng Hospital. Patients will undergo routine consultation with an orthopaedic surgeon and will be provided with standard treatment as necessitated based on the assessment of the orthopaedic surgeon. Subsequent follow up appointments will be scheduled at the discretion of the orthopaedic surgeon. Patients will be referred to the physiotherapists, dietitian and psychologists as necessary for regular or adhoc sessions at the discretion of the allied health professional.
arm group label: Intervention Arm
arm group type: Experimental
description: Multidisciplinary Community Program
Community based, personalized, structured, 12-week multidisciplinary program that includes Orthopaedics, Physiotherapy, Dietitics, Psychology interventions. This intervention involves the use of formal assessment such as BMI and psychological questionnaires to determine the need for dietetics or psychological intervention. In addition, there are educational sessions to improve patient's understanding of osteoarthritis and improve their activation level. An optional support group session will be arranged at approx. 3-4 months after completion of the 12-week intervention program to improve sustainability of treatment effect.
intervention type: Other
intervention name: Multidisciplinary Community Program
description: Patient will undergoes 12 weeks of structured and personalized multidisciplinary community-based program, which consists of Physiotherapy, Dietetics and Psychology sessions. Patients will also attend 2 educational sessions. Physiotherapy and educational sessions are mandatory for all participants, while the need for dietetics and psychological interventions are determine using individual's BMI measurements and psychological questionnaires.
Inclusion criteria:
Dietetics: 23.5 < BMI <32.5; Psychology: PEG > 4 or PHQ-4 > 5 or PAM level < 3
arm group label: Intervention Arm
intervention type: Other
intervention name: Current model of care
description: No controlled set of treatment assigned to patient. It is based totally on the discretion of the attending clinicians. It will generally contain an unspecific number of physiotherapy sessions. Other allied health involvement such as dietetics and psychological interventions will be on an ad hoc basis. In some cases, the orthopaedic surgeon may recommend for surgery.
arm group label: Control Arm
criteria: 
gender: All
minimum age: 45 Years
maximum age: 99 Years
healthy volunteers: No
last name: Bryan Tan, MBBS, MRCS
role: Principal Investigator
affiliation: Tan Tock Seng Hospital
last name: Soren Skou, PT, PhD
role: Study Chair
affiliation: University of Southern Denmark
last name: Josip Car, MD, PhD
role: Study Chair
affiliation: Nanyang Technological University
last name: Julian Thumboo, MBBS, FRCP
role: Study Chair
affiliation: Singapore General Hospital
last name: David Hunter, MBBS, PhD
role: Study Chair
affiliation: University of Sydney
facility: 
facility: 
country: Singapore
responsible party type: Principal Investigator
investigator affiliation: Tan Tock Seng Hospital
investigator full name: Bryan Tan
investigator title: Senior Resident
mesh term: Osteoarthritis
sharing ipd: Undecided