Knee OsteoarthritisNCT06283147
Risk Assessment and Management Program (RAMP) on Knee Osteoarthritis in Primary Care
A study testing Risk assessment and Management Programme - Knee Osteoarthritis in people with Knee Osteoarthritis, run by Chinese University of Hong Kong at 1 site in Hong Kong.
Trial summary
The goal of this clinical trial is to determine the clinical effectiveness of a Chronic Care Model (CCM) named Risk Assessment and Management Program on Knee OA (RAMP-Knee OA) in adults with knee Osteoarthritis (Knee OA) at 52 weeks. Participants will be screened for eligibility to participate. Read more about this study
- Who is it for?
- Ages 45 years and older
- Conditions the study is for
- Knee Osteoarthritis
- What is being tested?
- Risk assessment and Management Programme - Knee Osteoarthritis
- Type of treatment
- Injection or infusion, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 228 participants
- Where
- 1 siteHong Kong
- Study dates
- 8 Apr 2024to 30 Jun 2026
- Phase
- Interventional
- 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 45 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of Knee OA based on clinical criteria of the American Rheumatology College
- Moderate to severe Knee pain for 3 months or longer (average score of 4 or greater on a 0-10 pain scale in the past 3 months)
Who cannot join
- Participants with potential serious knee pathology (e.g. inflammatory arthritis, acute trauma, malignancy)
- Previous Knee replacement
- Scheduled knee joint replacement surgery within 1 year
- Participants who are unable to reliably participate (e.g. those who do not speak Chinese or unable to attend study intervention)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Risk Assessment and Management Program (RAMP) on Knee Osteoarthritis in Primary Care- a One-year Pragmatic Randomized Controlled Trial
The goal of this clinical trial is to determine the clinical effectiveness of a Chronic Care Model (CCM) named Risk Assessment and Management Program on Knee OA (RAMP-Knee OA) in adults with knee Osteoarthritis (Knee OA) at 52 weeks.
Participants will be screened for eligibility to participate. After confirming eligibility, participants will complete the baseline assessment and be randomized into one of the following groups (n=114 for each group):
- RAMP Knee-OA group
- Usual care group
Outcomes will be measured at baseline, week 16, week 32, and week 52.
Read the detailed description
The goal of this clinical trial is to determine the clinical effectiveness of a Chronic Care Model (CCM) named Risk Assessment and Management Program on Knee OA (RAMP-Knee OA) in adults with knee Osteoarthritis (Knee OA) at 52 weeks. RAMP-knee OA is designed based on the validated framework of CCM, which identifies six important components including self-management support, clinical information systems, delivery system redesign, decision support, health care organization, and community resources.
The main questions the study aims to answer are:
In comparison with people undergoing usual care, whether:
- Participants in the RAMP-Knee OA group will report greater improvement in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) pain subscale
- Participants in the RAMP-Knee OA group will report greater improvement in physical function, self-management efficacy, lower limb muscle mass, psychosocial health, and quality of life
Participants will be screened for eligibility to participate. After confirming eligibility, participants will complete the baseline assessment and be randomized into one of the following groups (n=114 for each group):
- RAMP Knee-OA group: Participants will be referred to the RAMP-Knee OA clinic operated by a Registered Nurse, which will be a face-to-face consultation scheduled every 4 months following patients' usual clinic appointments. A total of 4 sessions will be provided for each enrolled participant over one year. The content of the Programme centers around arthritis education, structure-land base exercise, and weight management, with the additional component of counseling support and dietary advice on musculoskeletal health.
- Usual care group: Participants allocated to the usual care group will continue with their standard usual care (follow-up appointment at General Out Patient Clinic (GOPC) is typically every 4 months). The management approach for knee OA and other chronic diseases will be solely at the discretion of the attending physicians.
Outcomes will be measured at baseline, week 16, week 32, and week 52. Demographic data and knee pain duration will be collected at baseline assessment. Outcomes to measure include the severity of knee pain, physical function, level of physical activity, self-efficacy, level of anxiety and depression, insomnia, loneliness, health-related quality of life, and lower limb muscle mass. The use of co-intervention, analgesics, and other over-the-counter drugs will be recorded.
The baseline characteristics of the two groups will be compared using the independent samples t-test or the Mann-Whitney test for continuous variables and chi-square test for categorical variables.
- Conditions
- Knee Osteoarthritis
- Being tested
- Risk assessment and Management Programme - Knee Osteoarthritis
- Keywords
- Risk assessment and Management Programme, Chronic Care Model
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Risk assessment and Management Programme - Knee OsteoarthritisBehavioural
(i) Arthritis education: Topics will cover the 21 key messages identified in International Consensus List of Essential Statements for Osteoarthritis "What Do People With Knee or Hip Osteoarthritis Need to Know"
(ii) Structured land-based exercise: We have selected strengthening, flexibility training (stretching), and aerobic exercise as our key components because they are most applicable in primary care settings.
(iii) Weight Management: Weight management will be offered for participants with a BMI ≥ 23 kg/m2.
(iv) Counselling support for psychosocial health: counselling support will be provided for those with mild to moderate anxiety and depression, insomnia and loneliness identified in the risk assessment.
(v) Dietary advice: Online dietary education for musculoskeletal health (with reference to local context) will be provided. The dietitian will also provide support regarding specific dietary advice on weight management.
| Study group | Role | What they receive |
|---|---|---|
| RAMP Knee OA | Experimental | Patients allocated to the intervention group will continue their "usual care" at the GOPCs, plus enrolment into the RAMP-Knee OA program. Receives: Behavioral: Risk assessment and Management Programme - Knee Osteoarthritis |
| Usual Care group | No intervention | Patients allocated to the usual care arm will continue receiving their "usual care" at the GOPCs without any additional intervention. "Usual care" typically refers to the established and commonly provided treatments, interventions, and practices that patients would receive in routine clinical practice for their particular condition or disease. For GOPCs in Hong Kong, the follow-up period for all chronic diseases is typically every 4 months. Each consultation at GOPC has an average duration of 3-5 minutes, during which physicians will address all chronic diseases, including knee OA. Physicians may provide brief healthcare advice, prescribe chronic medications and analgesics if necessary, and refer patients to physiotherapy if indicated. The management approach for knee OA and other chronic diseases will be solely at the discretion of the attending physicians. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Knee pain
Knee pain as measured by the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)
Measured: Baseline, week 16, week 32, week 52
Secondary outcomes (11)
Physical Function
Physical function measured by WOMAC function subscale
Measured: Baseline, week 16, week 32, week 52
Physical function
Physical function measured by 30-second chair and stand performance test
Measured: Baseline, week 16, week 32, week 52
Lower limb muscle mass
Lower limb muscle mass measured by bio-impedance analysis
Measured: Baseline, week 16, week 32, week 52
Level of physical activity
Level of physical activity measured by Chinese International Physical Activity Questionnaire (Short form)
Measured: Baseline, week 16, week 32, week 52
Self-Management efficacy
Self-management efficacy measure by Pain-Self Efficacy questionnaire
Measured: Baseline, week 16, week 32, week 52
Level of Anxiety
Anxiety measured by Generalized Anxiety Disorder -7
Measured: Baseline, week 16, week 32, week 52
Level of Depression
Depression measured by Patient Health Questionnaire -9
Measured: Baseline, week 16, week 32, week 52
Insomnia
Insomnia measured by 7 item Insomnia Severity Index
Measured: Baseline, week 16, week 32, week 52
Loneliness
Loneliness measured by 6 item De Jong Gierveld Loneliness Scale
Measured: Baseline, week 16, week 32, week 52
Health related Quality of Life
Health related Quality of life measured by Euroquol- 5D-5L
Measured: Baseline, week 16, week 32, week 52
Demographic data
Demographic data such as height, weight, BMI, age, sex, knee pain duration, chronic comorbid conditions, chronic medications
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Feb 2024
- Study start8 Apr 2024
- Primary completion30 May 2026
- Study completion30 Jun 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Knee OsteoarthritisStudies of the same condition, open and under way.
- More trials run by Chinese University of Hong KongThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The study is a 52-week, two-arm, parallel, doubled-blinded randomized clinical trial, evaluating the clinical efficacy of RAMP-Knee OA (N=114) versus usual care (N=114) on self-reported knee pain and other secondary outcomes.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 228 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chinese University of Hong Kong
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Regina Wing Shan Sit, Chinese University of Hong Kong
- Investigators
- Regina Wing Shan SIT, M.D., Principal investigator, Jockey Club School of Public Health and Primary Care, Chinese University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06283147
- Sponsor's protocol ID
- 2023.530
- Status last verified
- Jan 2026
- First submitted
- 22 Feb 2024
- Last updated
- 2 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Sit RW, Yip BH, Choi SY, Wong MC, Law SW, Lam CY, Hunter D, Wong SY. Risk Assessment and Management Program (RAMP) on knee osteoarthritis in primary care-a one-year pragmatic randomized controlled trial. Trials. 2026 Feb 3;27(1):187. doi: 10.1186/s13063-026-09469-x.
PubMed 41629997
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Risk Assessment and Management Program (RAMP) on Knee Osteoarthritis in Primary Care- a One-year Pragmatic Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06283147
- Acronym / sponsor ID
- 2023.530
- Conditions
- Knee Osteoarthritis
- Keywords
- Risk assessment and Management Programme, Chronic Care Model
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 228 participants (actual)
- Lead sponsor
- Chinese University of Hong KongUniversity, hospital or other
- Study start
- 8 Apr 2024 (actual)
- Primary completion
- 30 May 2026 (actual)
- Study completion
- 30 Jun 2026 (actual)
- First posted
- 28 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this clinical trial is to determine the clinical effectiveness of a Chronic Care Model (CCM) named Risk Assessment and Management Program on Knee OA (RAMP-Knee OA) in adults with knee Osteoarthritis (Knee OA) at 52 weeks.
Participants will be screened for eligibility to participate. After confirming eligibility, participants will complete the baseline assessment and be randomized into one of the following groups (n=114 for each group):
- RAMP Knee-OA group
- Usual care group
Outcomes will be measured at baseline, week 16, week 32, and week 52.
Detailed description
The goal of this clinical trial is to determine the clinical effectiveness of a Chronic Care Model (CCM) named Risk Assessment and Management Program on Knee OA (RAMP-Knee OA) in adults with knee Osteoarthritis (Knee OA) at 52 weeks. RAMP-knee OA is designed based on the validated framework of CCM, which identifies six important components including self-management support, clinical information systems, delivery system redesign, decision support, health care organization, and community resources.
The main questions the study aims to answer are:
In comparison with people undergoing usual care, whether:
- Participants in the RAMP-Knee OA group will report greater improvement in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) pain subscale
- Participants in the RAMP-Knee OA group will report greater improvement in physical function, self-management efficacy, lower limb muscle mass, psychosocial health, and quality of life
Participants will be screened for eligibility to participate. After confirming eligibility, participants will complete the baseline assessment and be randomized into one of the following groups (n=114 for each group):
- RAMP Knee-OA group: Participants will be referred to the RAMP-Knee OA clinic operated by a Registered Nurse, which will be a face-to-face consultation scheduled every 4 months following patients' usual clinic appointments. A total of 4 sessions will be provided for each enrolled participant over one year. The content of the Programme centers around arthritis education, structure-land base exercise, and weight management, with the additional component of counseling support and dietary advice on musculoskeletal health.
- Usual care group: Participants allocated to the usual care group will continue with their standard usual care (follow-up appointment at General Out Patient Clinic (GOPC) is typically every 4 months). The management approach for knee OA and other chronic diseases will be solely at the discretion of the attending physicians.
Outcomes will be measured at baseline, week 16, week 32, and week 52. Demographic data and knee pain duration will be collected at baseline assessment. Outcomes to measure include the severity of knee pain, physical function, level of physical activity, self-efficacy, level of anxiety and depression, insomnia, loneliness, health-related quality of life, and lower limb muscle mass. The use of co-intervention, analgesics, and other over-the-counter drugs will be recorded.
The baseline characteristics of the two groups will be compared using the independent samples t-test or the Mann-Whitney test for continuous variables and chi-square test for categorical variables.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- The study is a 52-week, two-arm, parallel, doubled-blinded randomized clinical trial, evaluating the clinical efficacy of RAMP-Knee OA (N=114) versus usual care (N=114) on self-reported knee pain and other secondary outcomes.
| Arm | Type | Receives |
|---|---|---|
| RAMP Knee OA | Experimental | Behavioral: Risk assessment and Management Programme - Knee OsteoarthritisPatients allocated to the intervention group will continue their "usual care" at the GOPCs, plus enrolment into the RAMP-Knee OA program. |
| Usual Care group | No intervention | –Patients allocated to the usual care arm will continue receiving their "usual care" at the GOPCs without any additional intervention. "Usual care" typically refers to the established and commonly provided treatments, interventions, and practices that patients would receive in routine clinical practice for their particular condition or disease. For GOPCs in Hong Kong, the follow-up period for all chronic diseases is typically every 4 months. Each consultation at GOPC has an average duration of 3-5 minutes, during which physicians will address all chronic diseases, including knee OA. Physicians may provide brief healthcare advice, prescribe chronic medications and analgesics if necessary, and refer patients to physiotherapy if indicated. The management approach for knee OA and other chronic diseases will be solely at the discretion of the attending physicians. |
Who may qualify
- Ages
- 45 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Diagnosis of Knee OA based on clinical criteria of the American Rheumatology College
- Moderate to severe Knee pain for 3 months or longer (average score of 4 or greater on a 0-10 pain scale in the past 3 months)
Key exclusion criteria (4 listed)
- Participants with potential serious knee pathology (e.g. inflammatory arthritis, acute trauma, malignancy)
- Previous Knee replacement
- Scheduled knee joint replacement surgery within 1 year
- Participants who are unable to reliably participate (e.g. those who do not speak Chinese or unable to attend study intervention)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Risk assessment and Management Programme - Knee Osteoarthritis(i) Arthritis education: Topics will cover the 21 key messages identified in International Consensus List of Essential Statements for Osteoarthritis "What Do People With Knee or Hip Osteoarthritis Need to Know" (ii) Structured land-based exercise: We have selected strengthening, flexibility training (stretching), and aerobic exercise as our key components because they are most applicable in primary care settings. (iii) Weight Management: Weight management will be offered for participants with a BMI ≥ 23 kg/m2. (iv) Counselling support for psychosocial health: counselling support will be provided for those with mild to moderate anxiety and depression, insomnia and loneliness identified in the risk assessment. (v) Dietary advice: Online dietary education for musculoskeletal health (with reference to local context) will be provided. The dietitian will also provide support regarding specific dietary advice on weight management. | Behavioural | RAMP Knee OA |
Primary outcome
Knee pain
Time frame: Baseline, week 16, week 32, week 52
Knee pain as measured by the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)
11 secondary outcomes
Physical Function
Time frame: Baseline, week 16, week 32, week 52
Physical function
Time frame: Baseline, week 16, week 32, week 52
Lower limb muscle mass
Time frame: Baseline, week 16, week 32, week 52
Level of physical activity
Time frame: Baseline, week 16, week 32, week 52
Self-Management efficacy
Time frame: Baseline, week 16, week 32, week 52
Level of Anxiety
Time frame: Baseline, week 16, week 32, week 52
Level of Depression
Time frame: Baseline, week 16, week 32, week 52
Insomnia
Time frame: Baseline, week 16, week 32, week 52
Loneliness
Time frame: Baseline, week 16, week 32, week 52
Health related Quality of Life
Time frame: Baseline, week 16, week 32, week 52
Demographic data
Time frame: Baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Oct 2026.
- Derived from this study: PubMed 41629997Sit RW, Yip BH, Choi SY, Wong MC, Law SW, Lam CY, Hunter D, Wong SY. Risk Assessment and Management Program (RAMP) on knee osteoarthritis in primary care-a one-year pragmatic randomized controlled trial. Trials. 2026 Feb 3;27(1):187. doi: 10.1186/s13063-026-09469-x.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Regina Wing Shan SIT, M.D. principal investigator
Jockey Club School of Public Health and Primary Care, Chinese University of Hong Kong
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Risk assessment and Management Programme - Knee Osteoarthritis in people with Knee Osteoarthritis, run by Chinese University of Hong Kong at 1 site in Hong Kong.
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 2 inclusion and 4 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: finished, as of the sponsor's last update on 2 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Hong Kong. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Knee pain (time frame: Baseline, week 16, week 32, week 52). 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 NCT06283147, which also lists 1 linked publication.
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 2 Oct 2026.