AzTrials
AzTrials

Osteoarthritis, KneeCONNACTNCT04942236

CONNACT OA Knee Cohort

An observational study of Osteoarthritis, Knee, run by Tan Tock Seng Hospital at 3 sites in Singapore.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
Search all trials

Trial 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… Read more about this study

Who is it for?
Ages 46 to 99 years
Conditions the study is for
Osteoarthritis, Knee
How many people
500 participants
Where
3 sitesSingapore
Study dates
30 Jun 2021to 31 Dec 2024
Phase
Observational
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 46 to 99 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: Knee Osteoarthritis patients for conservative treatment

Who may be able to join

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

Who cannot join

  • 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

Trial locations and contacts

3 sites in 1 country.

Bryan Tan contact

63577713

bryan_tan@whc.sg

Pei Gin Ong contact

63577713

Singapore3 sites
  • Khoo Teck Puat Hospital

    Singapore

    Lih Yen Ng

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

    Singapore

    Jennifer Goh

  • Tan Tock Seng Hospital

    Singapore

    Bryan Tan, 63577713, bryan_tan@whc.sg

Other trials in Singapore

About this study

Official title: Collaborative Model of Care Between Orthopaedics and Allied Health Care Professionals (CONNACT) OA Knee Cohort

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.

Medical subject headings
Osteoarthritis, Knee

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Baseline

  2. 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.

    Measured: Change from Baseline to 3 months

  3. 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.

    Measured: Change from Baseline to 6 months

  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.

    Measured: Change from Baseline to 12 months

Secondary outcomes (16)
  1. Knee Injury and Osteoarthritis Outcomes Score (KOOS) subscales - Pain, Function, QoL

    The three subscales of KOOS-12 are scored separately: KOOS Pain (4 items); KOOS Function (4 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 three 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: Baseline

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

    The three subscales of KOOS-12 are scored separately: KOOS Pain (4 items); KOOS Function (4 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 three 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: Change from Baseline to 3 months

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

    The three subscales of KOOS-12 are scored separately: KOOS Pain (4 items); KOOS Function (4 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 three 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: Change from Baseline to 6 months

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

    The three subscales of KOOS-12 are scored separately: KOOS Pain (4 items); KOOS Function (4 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 three 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: Change from Baseline to 12 months

  5. EuroQol-5 Dimensions (EQ-5D)

    EuroQol-5 Dimensions (EQ-5D) consists 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 selecting 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: Baseline

  6. EuroQol-5 Dimensions (EQ-5D)

    EuroQol-5 Dimensions (EQ-5D) consists 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 selecting 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: Change from Baseline to 3 months

  7. EuroQol-5 Dimensions (EQ-5D)

    EuroQol-5 Dimensions (EQ-5D) consists 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 selecting 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: Change from Baseline to 6 months

  8. EuroQol-5 Dimensions (EQ-5D)

    EuroQol-5 Dimensions (EQ-5D) consists 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 selecting 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: Change from Baseline to 12 months

  9. 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 suggest anxiety. Total score ≥3 for last 2 questions suggest depression.

    Measured: Baseline

  10. 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 suggest anxiety. Total score ≥3 for last 2 questions suggest depression.

    Measured: Change from Baseline to 3 months

  11. 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 suggest anxiety. Total score ≥3 for last 2 questions suggest depression.

    Measured: Change from Baseline to 6 months

  12. 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 suggest anxiety. Total score ≥3 for last 2 questions suggest depression.

    Measured: Change from Baseline to 12 months

  13. 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: Baseline

  14. 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: Change from Baseline to 3 months

  15. 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: Change from Baseline to 6 months

  16. 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: Change from Baseline to 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Jun 2021
  2. Study start30 Jun 2021 (estimated)
  3. Primary completion31 Dec 2023 (estimated)
  4. Study completion31 Dec 2024 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
500 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04942236
Sponsor's protocol ID
WHC/2020-00076
Acronym
CONNACT
Status last verified
Jun 2021
First submitted
8 Jun 2021
Last updated
28 Jun 2021
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • 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.

    PubMed 39488423
  • 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.

    PubMed 36750930

Questions about this trial

What is this clinical trial studying?

An observational study of Osteoarthritis, Knee, run by Tan Tock Seng Hospital at 3 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 4 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 28 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 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?

Contact Bryan Tan (63577713, bryan_tan@whc.sg), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Knee Injury and Osteoarthritis Outcomes Score (KOOS-12) (time frame: Baseline). The study lists 4 primary outcomes in all. 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 NCT04942236, which also lists 2 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 28 Jun 2021.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in