Clinical trial NCT04942236: CONNACT OA Knee Cohort
Official title: Collaborative Model of Care Between Orthopaedics and Allied Health Care Professionals (CONNACT) OA Knee Cohort
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Osteoarthritis, Knee
Lead sponsor: Tan Tock Seng Hospital
Sponsor class: OTHER
Collaborators: name: National Healthcare Group, Singapore
name: Khoo Teck Puat Hospital
name: Woodlands Health Campus
First posted: 2021-06-28
Enrollment: 500
Sex: ALL
Minimum age (years): 46
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Knee Osteoarthritis patients for conservative treatment

Brief summary: CONNACT OA knee cohort is a prospective longitudinal cohort study where we aim to collect sociodemographic, psychosocial, clinical, health utilization and cost data in order to better understand the Asian OA knee cohort and investigate for prognostic variables that can potentially influence a patients clinical outcome and treatment decisions.

In addition, the CONNACT OA knee cohort will form the basis for a cohort multiple randomized control trial (cmRCT) study design where multiple interventions can be tested in a randomized fashion. Each intervention is offered to a randomly selected sample of patients eligible for that intervention, who are then compared with the rest of the eligible patients from the cohort that are still being treated as usual.


Eligibility criteria: Inclusion Criteria:

1. Knee Osteoarthritis (based on NICE guidelines)
2. Age \> 45 years
3. Community ambulator with or without walking aid
4. Conversant in English or Chinese

Exclusion Criteria:

1. Alternative diagnosis to Knee OA e.g. referred pain from spine or hip
2. Other forms of knee arthritis e.g. inflammatory, post-traumatic
3. Moderate to severe cognitive impairment e.g. dementia
4. Previous knee arthroplasty
5. Wheelchair bound patients
6. Medical conditions that will medically interfere with rehabilitation involvement e.g. decompensated heart failure, stroke with significant deficit, end stage renal failure

Primary outcomes:
measure: Knee Injury and Osteoarthritis Outcomes Score (KOOS-12)
timeFrame: Baseline
measure: Knee Injury and Osteoarthritis Outcomes Score (KOOS-12)
timeFrame: Change from Baseline to 3 months
measure: Knee Injury and Osteoarthritis Outcomes Score (KOOS-12)
timeFrame: Change from Baseline to 6 months
measure: Knee Injury and Osteoarthritis Outcomes Score (KOOS-12)
timeFrame: Change from Baseline to 12 months
Secondary outcomes:
measure: Knee Injury and Osteoarthritis Outcomes Score (KOOS) subscales - Pain, Function, QoL
timeFrame: Baseline
measure: Knee Injury and Osteoarthritis Outcomes Score (KOOS) subscales - Pain, Function, QoL
timeFrame: Change from Baseline to 3 months
measure: Knee Injury and Osteoarthritis Outcomes Score (KOOS) subscales - Pain, Function, QoL
timeFrame: Change from Baseline to 6 months
measure: Knee Injury and Osteoarthritis Outcomes Score (KOOS) subscales - Pain, Function, QoL
timeFrame: Change from Baseline to 12 months
measure: EuroQol-5 Dimensions (EQ-5D)
timeFrame: Baseline
measure: EuroQol-5 Dimensions (EQ-5D)
timeFrame: Change from Baseline to 3 months
measure: EuroQol-5 Dimensions (EQ-5D)
timeFrame: Change from Baseline to 6 months
measure: EuroQol-5 Dimensions (EQ-5D)
timeFrame: Change from Baseline to 12 months
measure: Patient Health Questionnaire 4 (PHQ-4)
timeFrame: Baseline
measure: Patient Health Questionnaire 4 (PHQ-4)
timeFrame: Change from Baseline to 3 months
measure: Patient Health Questionnaire 4 (PHQ-4)
timeFrame: Change from Baseline to 6 months
measure: Patient Health Questionnaire 4 (PHQ-4)
timeFrame: Change from Baseline to 12 months
measure: Pain, Enjoyment, General Activity Scale (PEG)
timeFrame: Baseline
measure: Pain, Enjoyment, General Activity Scale (PEG)
timeFrame: Change from Baseline to 3 months
measure: Pain, Enjoyment, General Activity Scale (PEG)
timeFrame: Change from Baseline to 6 months
measure: Pain, Enjoyment, General Activity Scale (PEG)
timeFrame: Change from Baseline to 12 months
Other outcomes:
measure: OsteoArthritis Quality Indicator (OA QI)
timeFrame: Baseline
measure: University of California, Los Angeles (UCLA) activity score
timeFrame: Baseline
measure: University of California, Los Angeles (UCLA) activity score
timeFrame: Change from Baseline to 3 months
measure: University of California, Los Angeles (UCLA) activity score
timeFrame: Change from Baseline to 6 months
measure: University of California, Los Angeles (UCLA) activity score
timeFrame: Change from Baseline to 12 months
measure: Global perceived effect (GPE)
timeFrame: 3 months
measure: Global perceived effect (GPE)
timeFrame: 6 months
measure: Global perceived effect (GPE)
timeFrame: 12 months
measure: Patient Acceptable Symptom State (PASS)
timeFrame: 3 months
measure: Patient Acceptable Symptom State (PASS)
timeFrame: 6 months
measure: Patient Acceptable Symptom State (PASS)
timeFrame: 12 months
measure: Self-reported treatment failure
timeFrame: 3 months
measure: Self-reported treatment failure
timeFrame: 6 months
measure: Self-reported treatment failure
timeFrame: 12 months
measure: Cumulative Analgesia Consumption Score (CACS)
timeFrame: 3 months
measure: Cumulative Analgesia Consumption Score (CACS)
timeFrame: 6 months
measure: Cumulative Analgesia Consumption Score (CACS)
timeFrame: 12 months
measure: Short dietary questionnaire
timeFrame: Baseline
measure: Short dietary questionnaire
timeFrame: Change from Baseline to 3 months
measure: Short dietary questionnaire
timeFrame: Change from Baseline to 6 months
measure: Short dietary questionnaire
timeFrame: Change from Baseline to 12 months
measure: Questionnaire measuring the direct and indirect costs
timeFrame: 3 months
measure: Questionnaire measuring the direct and indirect costs
timeFrame: 6 months
measure: Questionnaire measuring the direct and indirect costs
timeFrame: 12 months
measure: Arthritis Self-efficacy scale 8 (ASES-8)
timeFrame: Baseline
measure: Arthritis Self-efficacy scale 8 (ASES-8)
timeFrame: Change from Baseline to 3 months
measure: Arthritis Self-efficacy scale 8 (ASES-8)
timeFrame: Change from Baseline to 6 months
measure: Arthritis Self-efficacy scale 8 (ASES-8)
timeFrame: Change from Baseline to 12 months
measure: Brief Fear of Movement Scale for Osteoarthritis
timeFrame: Baseline
measure: Brief Fear of Movement Scale for Osteoarthritis
timeFrame: Change from Baseline to 3 months
measure: Brief Fear of Movement Scale for Osteoarthritis
timeFrame: Change from Baseline to 6 months
measure: Brief Fear of Movement Scale for Osteoarthritis
timeFrame: Change from Baseline to 12 months
measure: Chronic illness-related shame score (CISS)
timeFrame: Baseline
measure: Chronic illness-related shame score (CISS)
timeFrame: Change from Baseline to 3 months
measure: Chronic illness-related shame score (CISS)
timeFrame: Change from Baseline to 6 months
measure: Chronic illness-related shame score (CISS)
timeFrame: Change from Baseline to 12 months
measure: Multidimensional Scale of Perceived Social Support (MSPSS)
timeFrame: Baseline
measure: Multidimensional Scale of Perceived Social Support (MSPSS)
timeFrame: Change from Baseline to 3 months
measure: Multidimensional Scale of Perceived Social Support (MSPSS)
timeFrame: Change from Baseline to 6 months
measure: Multidimensional Scale of Perceived Social Support (MSPSS)
timeFrame: Change from Baseline to 12 months
measure: Built Environment
timeFrame: Baseline
measure: Built Environment
timeFrame: Change from Baseline to 3 months
measure: Built Environment
timeFrame: Change from Baseline to 6 months
measure: Built Environment
timeFrame: Change from Baseline to 12 months
measure: Religion/Spirituality
timeFrame: Baseline
measure: Religion/Spirituality
timeFrame: Change from Baseline to 3 months
measure: Religion/Spirituality
timeFrame: Change from Baseline to 6 months
measure: Religion/Spirituality
timeFrame: Change from Baseline to 12 months
measure: Oxford Knee Score (OKS)
timeFrame: Baseline
measure: Knee Society Score (KSS) Function
timeFrame: Baseline
Locations:
city: Singapore
country: Singapore
facility: Khoo Teck Puat Hospital
city: Singapore
country: Singapore
facility: St Luke's Eldercare (AMK Polyclinic, Hougang Central, Nee Soon Central)
city: Singapore
country: Singapore
facility: Tan Tock Seng Hospital
Study officials:
affiliation: Tan Tock Seng Hospital
name: Bryan Tan
role: PRINCIPAL_INVESTIGATOR
References: