OsteoarthritisNCT03809975
Collaborative Model of Care Between Orthopaedics and Allied Healthcare Professionals Trial (CONnACT)
A study testing Multidisciplinary Community Program and Current model of care in people with Osteoarthritis, run by Tan Tock Seng Hospital at 2 sites in Singapore.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 45 to 99 years
- Conditions the study is for
- Osteoarthritis
- What is being tested?
- Multidisciplinary Community Program and Current model of care
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 114 participants
- Where
- 2 sitesSingapore
- Study dates
- 18 Sep 2018to 31 Dec 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- National Institute for Health and Care Excellence (NICE) clinical criteria for knee osteoarthritis
- Radiographic severity of knee osteoarthritis - Kellgren Lawrence Score > 1
- Knee Injury and Osteoarthritis Outcome Score (KOOS4) ≤ 75
- Independent community ambulator with or without walking aid
- Age ≥ 45 years old
- Conversant in English/Chinese
- Subject will need to fulfill all the inclusion criteria for eligibility.
Who cannot join
- Alternative diagnosis to knee osteoarthritis e.g. referred pain from the spine or hip
- Secondary arthritis e.g. inflammatory, post-traumatic
- Inability to comply with study protocol e.g. cognitive impairment
- Previous knee arthroplasty on the symptomatic knee
- Wheelchair bound patients
- Any other medical condition that study team determines may interfere with study involvement
Trial locations and contacts
2 sites in 1 country.
Singapore2 sites
St Luke Eldercare (AMK)
Singapore
Tan Tock Seng Hospital
Singapore
About this study
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.
Read the detailed description
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.
- Conditions
- Osteoarthritis
- Being tested
- Multidisciplinary Community Program, Current model of care
- Keywords
- Knee, Osteoarthritis, Model of care, Multi-disciplinary
- Medical subject headings
- Osteoarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Multidisciplinary Community ProgramOther
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
Current model of careOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Control Arm | Active comparator | 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. Receives: Other: Current model of care |
| Intervention Arm | Experimental | 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. Receives: Other: Multidisciplinary Community Program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Knee Injury and Osteoarthritis Outcomes Score (KOOS4)
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.
Measured: Assessed at baseline, 3 months, 6 months, 12 months
Secondary outcomes (11)
Knee Injury and Osteoarthritis Outcomes Score (KOOS) subscales - Pain, Symptoms, Activities of Daily Living, Sports/Recreational Activities, Quality of Life
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
Measured: Assessed at baseline, 3 months, 6 months, 12 months
EuroQol-5 Dimensions (EQ-5D)
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.
Measured: Assessed at baseline, 3 months, 6 months, 12 months
Functional Assessment - 30s chair stand test
To test leg strength and endurance. Total number of repetitions completed in 30 seconds is recorded.
Measured: Assessed at baseline, 3 months, 6 months, 12 months
Functional Assessment - 40m fast-paced walk test
Measure of patient's walking speed. Time taken to complete 40 meters walk will be recorded in seconds.
Measured: Assessed at baseline, 3 months, 6 months, 12 months
Functional Assessment - 4 stairs climb test
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.
Measured: Assessed at baseline, 3 months, 6 months, 12 months
Functional Assessment - Timed up and go test
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.
Measured: Assessed at baseline, 3 months, 6 months, 12 months
Patient Health Questionnaire 4 (PHQ-4)
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.
Measured: Assessed at baseline, 3 months, 6 months, 12 months
Patient Activation Measure (PAM)
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.
Measured: Assessed at baseline, 3 months, 6 months, 12 months
Pain, Enjoyment, General Activity Scale (PEG)
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.
Measured: Assessed at baseline, 3 months, 6 months, 12 months
Body Mass Index (BMI)
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
Measured: Assessed at baseline, 3 months, 6 months, 12 months
Total Knee Replacement
Indicates if the patient undergoes a total knee replacement at any time during the study period.
Measured: Assessed at 3 months, 6 months, 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jan 2019
- Study start18 Sep 2018
- Primary completion1 Feb 2021
- Study completion31 Dec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for OsteoarthritisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 114 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tan Tock Seng Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- University of Southern Denmark, Nanyang Technological University, Singapore General Hospital, University of Sydney
- Responsible party
- Principal investigator, Bryan Tan, Tan Tock Seng Hospital
- Investigators
- Bryan Tan, MBBS, MRCS, Principal investigator, Tan Tock Seng HospitalSoren Skou, PT, PhD, Study chair, University of Southern DenmarkJosip Car, MD, PhD, Study chair, Nanyang Technological UniversityJulian Thumboo, MBBS, FRCP, Study chair, Singapore General HospitalDavid Hunter, MBBS, PhD, Study chair, University of Sydney
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03809975
- Sponsor's protocol ID
- NTF_JUL2017_I_C2_CQR_01
- Other IDs
- 2018/00408, 2018
- Status last verified
- Oct 2021
- First submitted
- 15 Jan 2019
- Last updated
- 8 Oct 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Tan BY, Yang SY, Pereira MJ, Tan CY, Lim CJ, Ng JP, Lee KT, Pua YH, Briggs AM, Hunter DJ, Skou ST, Thumboo J, Car J. Collaborative model of care between orthopaedics and allied healthcare professionals (CONNACT) in knee osteoarthritis: Effectiveness-implementation hybrid randomized controlled trial of a community-based, multidisciplinary, stratified intervention. Osteoarthritis Cartilage. 2024 Aug;32(8):972-981. doi: 10.1016/j.joca.2024.04.018. Epub 2024 May 6.
PubMed 38710437Tan BY, Pereira MJ, Yang SY, Hunter DJ, Skou ST, Thumboo J, Car J. Collaborative model of care between Orthopaedics and allied healthcare professionals in knee osteoarthritis (CONNACT): study protocol for an effectiveness-implementation hybrid randomized control trial. BMC Musculoskelet Disord. 2020 Oct 16;21(1):684. doi: 10.1186/s12891-020-03695-3.
PubMed 33066746Tan BY, Ding BTK, Pereira MJ, Skou ST, Thumboo J, Car J. Collaborative model of care between Orthopaedics and allied healthcare professionals trial (CONNACT) - a feasibility study in patients with knee osteoarthritis using a mixed method approach. BMC Musculoskelet Disord. 2020 Sep 4;21(1):592. doi: 10.1186/s12891-020-03611-9.
PubMed 32887594
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Collaborative Model of Care Between Orthopaedics and Allied Healthcare Professionals Trial (CONnACT)
- ClinicalTrials.gov ID
- NCT03809975
- Acronym / sponsor ID
- NTF_JUL2017_I_C2_CQR_01
- Conditions
- Osteoarthritis
- Keywords
- Knee, Osteoarthritis, Model of care, Multi-disciplinary
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 114 participants (actual)
- Lead sponsor
- Tan Tock Seng HospitalUniversity, hospital or other
- Collaborators
- University of Southern Denmark, Nanyang Technological University, Singapore General Hospital, University of Sydney
- Study start
- 18 Sep 2018 (actual)
- Primary completion
- 1 Feb 2021 (actual)
- Study completion
- 31 Dec 2021 (estimated)
- First posted
- 18 Jan 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control Arm | Active comparator | Other: Current model of careCurrent 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. |
| Intervention Arm | Experimental | Other: Multidisciplinary Community ProgramMultidisciplinary 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. |
Who may qualify
- Ages
- 45 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- National Institute for Health and Care Excellence (NICE) clinical criteria for knee osteoarthritis
- Radiographic severity of knee osteoarthritis - Kellgren Lawrence Score > 1
- Knee Injury and Osteoarthritis Outcome Score (KOOS4) ≤ 75
- Independent community ambulator with or without walking aid
- Age ≥ 45 years old
Key exclusion criteria (6 listed)
- Alternative diagnosis to knee osteoarthritis e.g. referred pain from the spine or hip
- Secondary arthritis e.g. inflammatory, post-traumatic
- Inability to comply with study protocol e.g. cognitive impairment
- Previous knee arthroplasty on the symptomatic knee
- Wheelchair bound patients
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Multidisciplinary Community ProgramPatient 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 | Other | Intervention Arm |
| Current model of careNo 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. | Other | Control Arm |
Primary outcome
Knee Injury and Osteoarthritis Outcomes Score (KOOS4)
Time frame: Assessed at baseline, 3 months, 6 months, 12 months
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.
11 secondary outcomes
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
EuroQol-5 Dimensions (EQ-5D)
Time frame: Assessed at baseline, 3 months, 6 months, 12 months
Functional Assessment - 30s chair stand test
Time frame: Assessed at baseline, 3 months, 6 months, 12 months
Functional Assessment - 40m fast-paced walk test
Time frame: Assessed at baseline, 3 months, 6 months, 12 months
Functional Assessment - 4 stairs climb test
Time frame: Assessed at baseline, 3 months, 6 months, 12 months
Functional Assessment - Timed up and go test
Time frame: Assessed at baseline, 3 months, 6 months, 12 months
Patient Health Questionnaire 4 (PHQ-4)
Time frame: Assessed at baseline, 3 months, 6 months, 12 months
Patient Activation Measure (PAM)
Time frame: Assessed at baseline, 3 months, 6 months, 12 months
Pain, Enjoyment, General Activity Scale (PEG)
Time frame: Assessed at baseline, 3 months, 6 months, 12 months
Body Mass Index (BMI)
Time frame: Assessed at baseline, 3 months, 6 months, 12 months
Total Knee Replacement
Time frame: Assessed at 3 months, 6 months, 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Oct 2021.
- Derived from this study: PubMed 38710437Tan BY, Yang SY, Pereira MJ, Tan CY, Lim CJ, Ng JP, Lee KT, Pua YH, Briggs AM, Hunter DJ, Skou ST, Thumboo J, Car J. Collaborative model of care between orthopaedics and allied healthcare professionals (CONNACT) in knee osteoarthritis: Effectiveness-implementation hybrid randomized controlled trial of a community-based, multidisciplinary, stratified intervention. Osteoarthritis Cartilage. 2024 Aug;32(8):972-981. doi: 10.1016/j.joca.2024.04.018. Epub 2024 May 6.
- Derived from this study: PubMed 33066746Tan BY, Pereira MJ, Yang SY, Hunter DJ, Skou ST, Thumboo J, Car J. Collaborative model of care between Orthopaedics and allied healthcare professionals in knee osteoarthritis (CONNACT): study protocol for an effectiveness-implementation hybrid randomized control trial. BMC Musculoskelet Disord. 2020 Oct 16;21(1):684. doi: 10.1186/s12891-020-03695-3.
- Derived from this study: PubMed 32887594Tan BY, Ding BTK, Pereira MJ, Skou ST, Thumboo J, Car J. Collaborative model of care between Orthopaedics and allied healthcare professionals trial (CONNACT) - a feasibility study in patients with knee osteoarthritis using a mixed method approach. BMC Musculoskelet Disord. 2020 Sep 4;21(1):592. doi: 10.1186/s12891-020-03611-9.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bryan Tan, MBBS, MRCS principal investigator
Tan Tock Seng Hospital
Soren Skou, PT, PhD study chair
University of Southern Denmark
Josip Car, MD, PhD study chair
Nanyang Technological University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Multidisciplinary Community Program and Current model of care in people with Osteoarthritis, run by Tan Tock Seng Hospital at 2 sites in Singapore.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 8 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Singapore. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Knee Injury and Osteoarthritis Outcomes Score (KOOS4) (time frame: Assessed at baseline, 3 months, 6 months, 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03809975, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Oct 2021.