CONNACT OA Knee Cohort

Not yet recruiting

• Conditions: Osteoarthritis, Knee

• Registration Number: NCT04942236
• Lead Sponsor: Tan Tock Seng Hospital

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2021-06
• Study First Submitted: 2021-06-08
• Study First Submitted QC: 2021-06-25
• Last Update Submitted: 2021-06-25
• Study First Posted: 2021-06-28
• Last Update Posted: 2021-06-28
• Study Start: 2021-06-30
• Primary Completion: 2023-12-31
• Study Completion: 2024-12-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 500

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Knee Injury and Osteoarthritis Outcomes Score (KOOS-12)	Change from Baseline to 12 months	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.

Secondary Outcome Measures

Name	Time	Method
Patient Health Questionnaire 4 (PHQ-4)	Change from Baseline to 12 months	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.
Knee Injury and Osteoarthritis Outcomes Score (KOOS) subscales - Pain, Function, QoL	Change from Baseline to 12 months	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.
EuroQol-5 Dimensions (EQ-5D)	Change from Baseline to 12 months	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.
Pain, Enjoyment, General Activity Scale (PEG)	Change from Baseline to 12 months	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.

Trial Locations

Locations (3)

Khoo Teck Puat Hospital; 🇸🇬 Singapore, Singapore

St Luke's Eldercare (AMK Polyclinic, Hougang Central, Nee Soon Central); 🇸🇬 Singapore, Singapore

Tan Tock Seng Hospital; 🇸🇬 Singapore, Singapore