CONNACT OA Knee Cohort (CONNACT)

June 25, 2021 updated by: Bryan Tan, Tan Tock Seng Hospital

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.

Study Overview

Status

Not yet recruiting

Study Type

Observational

Enrollment (Anticipated)

500

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

  • Name: Pei Gin Ong
  • Phone Number: 63577713

Study Locations

      • Singapore, Singapore
        • Tan Tock Seng Hospital
        • Contact:
      • Singapore, Singapore
        • Khoo Teck Puat Hospital
        • Contact:
          • Lih Yen Ng
      • Singapore, Singapore
        • St Luke's Eldercare (AMK Polyclinic, Hougang Central, Nee Soon Central)
        • Contact:
          • Jennifer Goh

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

46 years to 99 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Knee Osteoarthritis patients for conservative treatment

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Knee Injury and Osteoarthritis Outcomes Score (KOOS-12)
Time Frame: Baseline
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)
Time Frame: Change from Baseline to 3 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.
Change from Baseline to 3 months
Knee Injury and Osteoarthritis Outcomes Score (KOOS-12)
Time Frame: Change from Baseline to 6 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.
Change from Baseline to 6 months
Knee Injury and Osteoarthritis Outcomes Score (KOOS-12)
Time Frame: 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.
Change from Baseline to 12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Knee Injury and Osteoarthritis Outcomes Score (KOOS) subscales - Pain, Function, QoL
Time Frame: Baseline
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.
Baseline
Knee Injury and Osteoarthritis Outcomes Score (KOOS) subscales - Pain, Function, QoL
Time Frame: Change from Baseline to 3 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.
Change from Baseline to 3 months
Knee Injury and Osteoarthritis Outcomes Score (KOOS) subscales - Pain, Function, QoL
Time Frame: Change from Baseline to 6 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.
Change from Baseline to 6 months
Knee Injury and Osteoarthritis Outcomes Score (KOOS) subscales - Pain, Function, QoL
Time Frame: 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.
Change from Baseline to 12 months
EuroQol-5 Dimensions (EQ-5D)
Time Frame: Baseline
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.
Baseline
EuroQol-5 Dimensions (EQ-5D)
Time Frame: Change from Baseline to 3 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.
Change from Baseline to 3 months
EuroQol-5 Dimensions (EQ-5D)
Time Frame: Change from Baseline to 6 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.
Change from Baseline to 6 months
EuroQol-5 Dimensions (EQ-5D)
Time Frame: 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.
Change from Baseline to 12 months
Patient Health Questionnaire 4 (PHQ-4)
Time Frame: Baseline

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.

Baseline
Patient Health Questionnaire 4 (PHQ-4)
Time Frame: Change from Baseline to 3 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.

Change from Baseline to 3 months
Patient Health Questionnaire 4 (PHQ-4)
Time Frame: Change from Baseline to 6 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.

Change from Baseline to 6 months
Patient Health Questionnaire 4 (PHQ-4)
Time Frame: 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.

Change from Baseline to 12 months
Pain, Enjoyment, General Activity Scale (PEG)
Time Frame: Baseline
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.
Baseline
Pain, Enjoyment, General Activity Scale (PEG)
Time Frame: Change from Baseline to 3 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.
Change from Baseline to 3 months
Pain, Enjoyment, General Activity Scale (PEG)
Time Frame: Change from Baseline to 6 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.
Change from Baseline to 6 months
Pain, Enjoyment, General Activity Scale (PEG)
Time Frame: 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.
Change from Baseline to 12 months

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
OsteoArthritis Quality Indicator (OA QI)
Time Frame: Baseline
The 17-items OA-QI questionnaire includes quality indicators related to patient education and information, assessment of pain and function, referrals, and pharmacologic treatment for OA. This questionnaire is administer at patient's baseline visit, after consultation with an orthopaedic surgeon, to find out patient-perceived quality of OA management. Using this outcome to investigate the quality of care delivered in primary and secondary care for patients with knee OA.
Baseline
University of California, Los Angeles (UCLA) activity score
Time Frame: Baseline
1 question survey to understands patient physical activity level from a scale of 1 (wholly inactive) to 10 (regular participation in impact sports).
Baseline
University of California, Los Angeles (UCLA) activity score
Time Frame: Change from Baseline to 3 months
1 question survey to understands patient physical activity level from a scale of 1 (wholly inactive) to 10 (regular participation in impact sports).
Change from Baseline to 3 months
University of California, Los Angeles (UCLA) activity score
Time Frame: Change from Baseline to 6 months
1 question survey to understands patient physical activity level from a scale of 1 (wholly inactive) to 10 (regular participation in impact sports).
Change from Baseline to 6 months
University of California, Los Angeles (UCLA) activity score
Time Frame: Change from Baseline to 12 months
1 question survey to understands patient physical activity level from a scale of 1 (wholly inactive) to 10 (regular participation in impact sports).
Change from Baseline to 12 months
Global perceived effect (GPE)
Time Frame: 3 months
Patient will be asked to rate thier overall recovery on a 7-point Likert scale. 1 refers to 'Very much improved'; 7 refers to 'Very much deteriorated'.
3 months
Global perceived effect (GPE)
Time Frame: 6 months
Patient will be asked to rate thier overall recovery on a 7-point Likert scale. 1 refers to 'Very much improved'; 7 refers to 'Very much deteriorated'.
6 months
Global perceived effect (GPE)
Time Frame: 12 months
Patient will be asked to rate thier overall recovery on a 7-point Likert scale. 1 refers to 'Very much improved'; 7 refers to 'Very much deteriorated'.
12 months
Patient Acceptable Symptom State (PASS)
Time Frame: 3 months
A single-question used to assess patient's satisfaction in the treatment. Response will be either yes or no. "When you think of your knee function, will you consider your current condition as satisfying? By knee function, you should take into account your activities of daily living, sport and recreational activities, your pain and other symptoms and your quality of life."
3 months
Patient Acceptable Symptom State (PASS)
Time Frame: 6 months
A single-question used to assess patient's satisfaction in the treatment. Response will be either yes or no. "When you think of your knee function, will you consider your current condition as satisfying? By knee function, you should take into account your activities of daily living, sport and recreational activities, your pain and other symptoms and your quality of life."
6 months
Patient Acceptable Symptom State (PASS)
Time Frame: 12 months
A single-question used to assess patient's satisfaction in the treatment. Response will be either yes or no. "When you think of your knee function, will you consider your current condition as satisfying? By knee function, you should take into account your activities of daily living, sport and recreational activities, your pain and other symptoms and your quality of life."
12 months
Self-reported treatment failure
Time Frame: 3 months
Patient who answers 'no' to PASS will be asked to determine if they consider the treatment to have failed. Response will be 'yes' or 'no'. "Would you consider your current state as being so unsatisfactory that you consider the treatment to have failed?"
3 months
Self-reported treatment failure
Time Frame: 6 months
Patient who answers 'no' to PASS will be asked to determine if they consider the treatment to have failed. Response will be 'yes' or 'no'. "Would you consider your current state as being so unsatisfactory that you consider the treatment to have failed?"
6 months
Self-reported treatment failure
Time Frame: 12 months
Patient who answers 'no' to PASS will be asked to determine if they consider the treatment to have failed. Response will be 'yes' or 'no'. "Would you consider your current state as being so unsatisfactory that you consider the treatment to have failed?"
12 months
Cumulative Analgesia Consumption Score (CACS)
Time Frame: 3 months
Objective measurement of patient's analgesics average weekly consumption based on the quantity multiplied by the category of analgesic medication according to the WHO pain relief ladder (1 point - non-opioid, 2 points - mild opioid, 3 points - strong opioid) in order to calculate a total score.
3 months
Cumulative Analgesia Consumption Score (CACS)
Time Frame: 6 months
Objective measurement of patient's analgesics average weekly consumption based on the quantity multiplied by the category of analgesic medication according to the WHO pain relief ladder (1 point - non-opioid, 2 points - mild opioid, 3 points - strong opioid) in order to calculate a total score.
6 months
Cumulative Analgesia Consumption Score (CACS)
Time Frame: 12 months
Objective measurement of patient's analgesics average weekly consumption based on the quantity multiplied by the category of analgesic medication according to the WHO pain relief ladder (1 point - non-opioid, 2 points - mild opioid, 3 points - strong opioid) in order to calculate a total score.
12 months
Short dietary questionnaire
Time Frame: Baseline
This questionnaire is to assess the eating habits and dietary choices over a period of time. It consists of 9 questions looking at the frequency of consumption in these categories - sugar, fats, fruits and vegetables, and wholegrains - and the degree of mindfulness in eating.
Baseline
Short dietary questionnaire
Time Frame: Change from Baseline to 3 months
This questionnaire is to assess the eating habits and dietary choices over a period of time. It consists of 9 questions looking at the frequency of consumption in these categories - sugar, fats, fruits and vegetables, and wholegrains - and the degree of mindfulness in eating.
Change from Baseline to 3 months
Short dietary questionnaire
Time Frame: Change from Baseline to 6 months
This questionnaire is to assess the eating habits and dietary choices over a period of time. It consists of 9 questions looking at the frequency of consumption in these categories - sugar, fats, fruits and vegetables, and wholegrains - and the degree of mindfulness in eating.
Change from Baseline to 6 months
Short dietary questionnaire
Time Frame: Change from Baseline to 12 months
This questionnaire is to assess the eating habits and dietary choices over a period of time. It consists of 9 questions looking at the frequency of consumption in these categories - sugar, fats, fruits and vegetables, and wholegrains - and the degree of mindfulness in eating.
Change from Baseline to 12 months
Questionnaire measuring the direct and indirect costs
Time Frame: 3 months
Cost questionnaire
3 months
Questionnaire measuring the direct and indirect costs
Time Frame: 6 months
Cost questionnaire
6 months
Questionnaire measuring the direct and indirect costs
Time Frame: 12 months
Cost questionnaire
12 months
Arthritis Self-efficacy scale 8 (ASES-8)
Time Frame: Baseline
This 8-items shortened version of the original 20-item instrument includes two items from the pain subscale, four items from the other symptoms subscale, and two new items that relate to preventing pain and fatigue from interfering with daily activities. The questionnaire measures patients' confidence on a scale of 1 (very uncertain) to 10 (very certain) in their ability to manage symptoms of arthritis. Responses were averaged to yield a score ranging from 1 to 10, the higher number being having greater self-efficacy.
Baseline
Arthritis Self-efficacy scale 8 (ASES-8)
Time Frame: Change from Baseline to 3 months
This 8-items shortened version of the original 20-item instrument includes two items from the pain subscale, four items from the other symptoms subscale, and two new items that relate to preventing pain and fatigue from interfering with daily activities. The questionnaire measures patients' confidence on a scale of 1 (very uncertain) to 10 (very certain) in their ability to manage symptoms of arthritis. Responses were averaged to yield a score ranging from 1 to 10, the higher number being having greater self-efficacy.
Change from Baseline to 3 months
Arthritis Self-efficacy scale 8 (ASES-8)
Time Frame: Change from Baseline to 6 months
This 8-items shortened version of the original 20-item instrument includes two items from the pain subscale, four items from the other symptoms subscale, and two new items that relate to preventing pain and fatigue from interfering with daily activities. The questionnaire measures patients' confidence on a scale of 1 (very uncertain) to 10 (very certain) in their ability to manage symptoms of arthritis. Responses were averaged to yield a score ranging from 1 to 10, the higher number being having greater self-efficacy.
Change from Baseline to 6 months
Arthritis Self-efficacy scale 8 (ASES-8)
Time Frame: Change from Baseline to 12 months
This 8-items shortened version of the original 20-item instrument includes two items from the pain subscale, four items from the other symptoms subscale, and two new items that relate to preventing pain and fatigue from interfering with daily activities. The questionnaire measures patients' confidence on a scale of 1 (very uncertain) to 10 (very certain) in their ability to manage symptoms of arthritis. Responses were averaged to yield a score ranging from 1 to 10, the higher number being having greater self-efficacy.
Change from Baseline to 12 months
Brief Fear of Movement Scale for Osteoarthritis
Time Frame: Baseline
This scale will be used to assess fear of pain. It is based on the widely used Tampa Scale of Kinesiophobia and contains 6 questions that evaluate fear of pain, movement and re-injury. The patient is asked to indicate 1 (strongly disagree), 2 (disagree), 3 (agree) or 4 (strongly agree) for each item. The higher number represents increasing fear.
Baseline
Brief Fear of Movement Scale for Osteoarthritis
Time Frame: Change from Baseline to 3 months
This scale will be used to assess fear of pain. It is based on the widely used Tampa Scale of Kinesiophobia and contains 6 questions that evaluate fear of pain, movement and re-injury. The patient is asked to indicate 1 (strongly disagree), 2 (disagree), 3 (agree) or 4 (strongly agree) for each item. The higher number represents increasing fear.
Change from Baseline to 3 months
Brief Fear of Movement Scale for Osteoarthritis
Time Frame: Change from Baseline to 6 months
This scale will be used to assess fear of pain. It is based on the widely used Tampa Scale of Kinesiophobia and contains 6 questions that evaluate fear of pain, movement and re-injury. The patient is asked to indicate 1 (strongly disagree), 2 (disagree), 3 (agree) or 4 (strongly agree) for each item. The higher number represents increasing fear.
Change from Baseline to 6 months
Brief Fear of Movement Scale for Osteoarthritis
Time Frame: Change from Baseline to 12 months
This scale will be used to assess fear of pain. It is based on the widely used Tampa Scale of Kinesiophobia and contains 6 questions that evaluate fear of pain, movement and re-injury. The patient is asked to indicate 1 (strongly disagree), 2 (disagree), 3 (agree) or 4 (strongly agree) for each item. The higher number represents increasing fear.
Change from Baseline to 12 months
Chronic illness-related shame score (CISS)
Time Frame: Baseline
This 7-items shame score aim to find out the participants' shame feelings derived from chronic illness-related experiences. Each item is rated on a 5-point Likert (0: Never True; 4: Always True). Higher scores reveal higher levels of shame specifically associated with the experience of having an illness and/or its symptomatology.
Baseline
Chronic illness-related shame score (CISS)
Time Frame: Change from Baseline to 3 months
This 7-items shame score aim to find out the participants' shame feelings derived from chronic illness-related experiences. Each item is rated on a 5-point Likert (0: Never True; 4: Always True). Higher scores reveal higher levels of shame specifically associated with the experience of having an illness and/or its symptomatology.
Change from Baseline to 3 months
Chronic illness-related shame score (CISS)
Time Frame: Change from Baseline to 6 months
This 7-items shame score aim to find out the participants' shame feelings derived from chronic illness-related experiences. Each item is rated on a 5-point Likert (0: Never True; 4: Always True). Higher scores reveal higher levels of shame specifically associated with the experience of having an illness and/or its symptomatology.
Change from Baseline to 6 months
Chronic illness-related shame score (CISS)
Time Frame: Change from Baseline to 12 months
This 7-items shame score aim to find out the participants' shame feelings derived from chronic illness-related experiences. Each item is rated on a 5-point Likert (0: Never True; 4: Always True). Higher scores reveal higher levels of shame specifically associated with the experience of having an illness and/or its symptomatology.
Change from Baseline to 12 months
Multidimensional Scale of Perceived Social Support (MSPSS)
Time Frame: Baseline
This scale is a 12-item questionnaire to identify the patients' perceived adequacy of social support from three sources: family, friends, & significant other. Each item is scored on a scale from 1 to 7 (0 = very strongly disagree, 7 = very strongly agree).
Baseline
Multidimensional Scale of Perceived Social Support (MSPSS)
Time Frame: Change from Baseline to 3 months
This scale is a 12-item questionnaire to identify the patients' perceived adequacy of social support from three sources: family, friends, & significant other. Each item is scored on a scale from 1 to 7 (0 = very strongly disagree, 7 = very strongly agree).
Change from Baseline to 3 months
Multidimensional Scale of Perceived Social Support (MSPSS)
Time Frame: Change from Baseline to 6 months
This scale is a 12-item questionnaire to identify the patients' perceived adequacy of social support from three sources: family, friends, & significant other. Each item is scored on a scale from 1 to 7 (0 = very strongly disagree, 7 = very strongly agree).
Change from Baseline to 6 months
Multidimensional Scale of Perceived Social Support (MSPSS)
Time Frame: Change from Baseline to 12 months
This scale is a 12-item questionnaire to identify the patients' perceived adequacy of social support from three sources: family, friends, & significant other. Each item is scored on a scale from 1 to 7 (0 = very strongly disagree, 7 = very strongly agree).
Change from Baseline to 12 months
Built Environment
Time Frame: Baseline
5-items questionnaire to assess the relationship of one's environment to the health outcomes.
Baseline
Built Environment
Time Frame: Change from Baseline to 3 months
5-items questionnaire to assess the relationship of one's environment to the health outcomes.
Change from Baseline to 3 months
Built Environment
Time Frame: Change from Baseline to 6 months
5-items questionnaire to assess the relationship of one's environment to the health outcomes.
Change from Baseline to 6 months
Built Environment
Time Frame: Change from Baseline to 12 months
5-items questionnaire to assess the relationship of one's environment to the health outcomes.
Change from Baseline to 12 months
Religion/Spirituality
Time Frame: Baseline
2-items questionnaire to find out the effects of having religion/spiritual beliefs on one's health outcomes.
Baseline
Religion/Spirituality
Time Frame: Change from Baseline to 3 months
2-items questionnaire to find out the effects of having religion/spiritual beliefs on one's health outcomes.
Change from Baseline to 3 months
Religion/Spirituality
Time Frame: Change from Baseline to 6 months
2-items questionnaire to find out the effects of having religion/spiritual beliefs on one's health outcomes.
Change from Baseline to 6 months
Religion/Spirituality
Time Frame: Change from Baseline to 12 months
2-items questionnaire to find out the effects of having religion/spiritual beliefs on one's health outcomes.
Change from Baseline to 12 months
Oxford Knee Score (OKS)
Time Frame: Baseline
This 12 items self-reported questionnaire measures patient's pain and level of function. Each item is rated from least to most difficultly or severity. The scoring system ranges from 0 to 4 for each question with 4 representing maximum function and 0 representing poorest function. The lowest (worse) score is 0, and the highest (best) score is 48.
Baseline
Knee Society Score (KSS) Function
Time Frame: Baseline
The 3 items patient-reported portion (Function Score) of the KSS covers the patient's mobility (walking distance and stairs) and potential walking aids. Score range of the KSS is from 0 to 100 points for each portion, with higher scores indicating better outcome.
Baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Bryan Tan, Tan Tock Seng Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

June 30, 2021

Primary Completion (Anticipated)

December 31, 2023

Study Completion (Anticipated)

December 31, 2024

Study Registration Dates

First Submitted

June 8, 2021

First Submitted That Met QC Criteria

June 25, 2021

First Posted (Actual)

June 28, 2021

Study Record Updates

Last Update Posted (Actual)

June 28, 2021

Last Update Submitted That Met QC Criteria

June 25, 2021

Last Verified

June 1, 2021

More Information

Terms related to this study

Other Study ID Numbers

  • WHC/2020-00076

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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