NCT04942236

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
500

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jun 2021

Typical duration for all trials

Geographic Reach
1 country

3 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 8, 2021

Completed
20 days until next milestone

First Posted

Study publicly available on registry

June 28, 2021

Completed
2 days until next milestone

Study Start

First participant enrolled

June 30, 2021

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2023

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2024

Completed
Last Updated

June 28, 2021

Status Verified

June 1, 2021

Enrollment Period

2.5 years

First QC Date

June 8, 2021

Last Update Submit

June 25, 2021

Conditions

Outcome Measures

Primary Outcomes (4)

  • Knee Injury and Osteoarthritis Outcomes Score (KOOS-12)

    Derived from the original 42-item Knee injury and Osteoarthritis Outcome Score (KOOS), KOOS-12 reduces respondent burden by 70% from the original KOOS while providing scale scores for knee-specific Pain, Function and QOL, along with a summary measure of overall knee impact. The KOOS sub scales are scored using the method of summated ratings and transformed to range from 0 to 100, with 0 representing extreme knee problems and 100 representing no knee problem. The KOOS-12 Summary knee impact score is calculated as the average of the KOOS-12 Pain, KOOS-12 Function and KOOS-12 QOL scale scores. It also ranges from 0 to 100, where 0 is the worst possible and 100 is the best possible score.

    Baseline

  • Knee Injury and Osteoarthritis Outcomes Score (KOOS-12)

    Derived from the original 42-item Knee injury and Osteoarthritis Outcome Score (KOOS), KOOS-12 reduces respondent burden by 70% from the original KOOS while providing scale scores for knee-specific Pain, Function and QOL, along with a summary measure of overall knee impact. The KOOS sub scales are scored using the method of summated ratings and transformed to range from 0 to 100, with 0 representing extreme knee problems and 100 representing no knee problem. The KOOS-12 Summary knee impact score is calculated as the average of the KOOS-12 Pain, KOOS-12 Function and KOOS-12 QOL scale scores. It also ranges from 0 to 100, where 0 is the worst possible and 100 is the best possible score.

    Change from Baseline to 3 months

  • Knee Injury and Osteoarthritis Outcomes Score (KOOS-12)

    Derived from the original 42-item Knee injury and Osteoarthritis Outcome Score (KOOS), KOOS-12 reduces respondent burden by 70% from the original KOOS while providing scale scores for knee-specific Pain, Function and QOL, along with a summary measure of overall knee impact. The KOOS sub scales are scored using the method of summated ratings and transformed to range from 0 to 100, with 0 representing extreme knee problems and 100 representing no knee problem. The KOOS-12 Summary knee impact score is calculated as the average of the KOOS-12 Pain, KOOS-12 Function and KOOS-12 QOL scale scores. It also ranges from 0 to 100, where 0 is the worst possible and 100 is the best possible score.

    Change from Baseline to 6 months

  • Knee Injury and Osteoarthritis Outcomes Score (KOOS-12)

    Derived from the original 42-item Knee injury and Osteoarthritis Outcome Score (KOOS), KOOS-12 reduces respondent burden by 70% from the original KOOS while providing scale scores for knee-specific Pain, Function and QOL, along with a summary measure of overall knee impact. The KOOS sub scales are scored using the method of summated ratings and transformed to range from 0 to 100, with 0 representing extreme knee problems and 100 representing no knee problem. The KOOS-12 Summary knee impact score is calculated as the average of the KOOS-12 Pain, KOOS-12 Function and KOOS-12 QOL scale scores. It also ranges from 0 to 100, where 0 is the worst possible and 100 is the best possible score.

    Change from Baseline to 12 months

Secondary Outcomes (16)

  • Knee Injury and Osteoarthritis Outcomes Score (KOOS) subscales - Pain, Function, QoL

    Baseline

  • Knee Injury and Osteoarthritis Outcomes Score (KOOS) subscales - Pain, Function, QoL

    Change from Baseline to 3 months

  • Knee Injury and Osteoarthritis Outcomes Score (KOOS) subscales - Pain, Function, QoL

    Change from Baseline to 6 months

  • Knee Injury and Osteoarthritis Outcomes Score (KOOS) subscales - Pain, Function, QoL

    Change from Baseline to 12 months

  • EuroQol-5 Dimensions (EQ-5D)

    Baseline

  • +11 more secondary outcomes

Other Outcomes (50)

  • OsteoArthritis Quality Indicator (OA QI)

    Baseline

  • University of California, Los Angeles (UCLA) activity score

    Baseline

  • University of California, Los Angeles (UCLA) activity score

    Change from Baseline to 3 months

  • +47 more other outcomes

Eligibility Criteria

Age46 Years - 99 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Knee Osteoarthritis patients for conservative treatment

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Khoo Teck Puat Hospital

Singapore, Singapore

Location

St Luke's Eldercare (AMK Polyclinic, Hougang Central, Nee Soon Central)

Singapore, Singapore

Location

Tan Tock Seng Hospital

Singapore, Singapore

Location

Related Publications (2)

  • Sahrin R, Ng CJY, Lim CJ, Goh ZZS, Pua YH, Tan BY. Exploring the role of the built environment and psychosocial mediators on knee function in knee osteoarthritis patients in Singapore: a cross-sectional study. BMJ Open. 2024 Nov 2;14(11):e082625. doi: 10.1136/bmjopen-2023-082625.

  • Tan BY, Goh ZZS, Lim CJ, Pereira MJ, Yang SY, Tan KG, Tan ACK, Liang P, Abbott JH, Briggs AM, Hunter DJ, Skou ST, Thumboo J, Car J. Singapore KneE osTeoarthritis CoHort (SKETCH): protocol for a multi-centre prospective cohort study. BMC Musculoskelet Disord. 2023 Feb 7;24(1):104. doi: 10.1186/s12891-023-06207-1.

MeSH Terms

Conditions

Osteoarthritis, Knee

Condition Hierarchy (Ancestors)

OsteoarthritisArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Study Officials

  • Bryan Tan

    Tan Tock Seng Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Bryan Tan

CONTACT

Pei Gin Ong

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Consultant

Study Record Dates

First Submitted

June 8, 2021

First Posted

June 28, 2021

Study Start

June 30, 2021

Primary Completion

December 31, 2023

Study Completion

December 31, 2024

Last Updated

June 28, 2021

Record last verified: 2021-06

Locations