Risk Assessment and Management Program (RAMP) on Knee Osteoarthritis in Primary Care

June 22, 2025 updated by: Regina Wing Shan Sit, Chinese University of Hong Kong

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):

  1. RAMP Knee-OA group
  2. Usual care group

Outcomes will be measured at baseline, week 16, week 32, and week 52.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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):

  1. 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.
  2. 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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
228

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

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

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Hong Kong
      • Hong Kong, Hong Kong
        • Lek Yuen GOPC

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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)

Exclusion Criteria:

  • 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)

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

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: RAMP Knee OA
Patients allocated to the intervention group will continue their "usual care" at the GOPCs, plus enrolment into the RAMP-Knee OA program.
Behavioral: 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.
No Intervention: Usual Care group
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 the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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)
Baseline, week 16, week 32, week 52

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Physical Function
Time Frame: Baseline, week 16, week 32, week 52
Physical function measured by WOMAC function subscale
Baseline, week 16, week 32, week 52
Physical function
Time Frame: Baseline, week 16, week 32, week 52
Physical function measured by 30-second chair and stand performance test
Baseline, week 16, week 32, week 52
Lower limb muscle mass
Time Frame: Baseline, week 16, week 32, week 52
Lower limb muscle mass measured by bio-impedance analysis
Baseline, week 16, week 32, week 52
Level of physical activity
Time Frame: Baseline, week 16, week 32, week 52
Level of physical activity measured by Chinese International Physical Activity Questionnaire (Short form)
Baseline, week 16, week 32, week 52
Self-Management efficacy
Time Frame: Baseline, week 16, week 32, week 52
Self-management efficacy measure by Pain-Self Efficacy questionnaire
Baseline, week 16, week 32, week 52
Level of Anxiety
Time Frame: Baseline, week 16, week 32, week 52
Anxiety measured by Generalized Anxiety Disorder -7
Baseline, week 16, week 32, week 52
Level of Depression
Time Frame: Baseline, week 16, week 32, week 52
Depression measured by Patient Health Questionnaire -9
Baseline, week 16, week 32, week 52
Insomnia
Time Frame: Baseline, week 16, week 32, week 52
Insomnia measured by 7 item Insomnia Severity Index
Baseline, week 16, week 32, week 52
Loneliness
Time Frame: Baseline, week 16, week 32, week 52
Loneliness measured by 6 item De Jong Gierveld Loneliness Scale
Baseline, week 16, week 32, week 52
Health related Quality of Life
Time Frame: Baseline, week 16, week 32, week 52
Health related Quality of life measured by Euroquol- 5D-5L
Baseline, week 16, week 32, week 52
Demographic data
Time Frame: Baseline
Demographic data such as height, weight, BMI, age, sex, knee pain duration, chronic comorbid conditions, chronic medications
Baseline

Collaborators and Investigators

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Chinese University of Hong Kong

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Regina Wing Shan SIT, M.D., Jockey Club School of Public Health and Primary Care, Chinese University of Hong Kong

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 (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 8, 2024

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 30, 2025

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 1, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 22, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 22, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 28, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 26, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 22, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2023.530

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

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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