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

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: Active, not recruiting
• Conditions: Knee Osteoarthritis
• Intervention / Treatment: Behavioral: Risk assessment and Management Programme - Knee Osteoarthritis

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: Interventional
• Enrollment (Estimated): 228
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• 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

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

Outcome Measure	Measure Description	Time Frame
Knee pain	Knee pain as measured by the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)	Baseline, week 16, week 32, week 52

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Physical Function	Physical function measured by WOMAC function subscale	Baseline, week 16, week 32, week 52
Physical function	Physical function measured by 30-second chair and stand performance test	Baseline, week 16, week 32, week 52
Lower limb muscle mass	Lower limb muscle mass measured by bio-impedance analysis	Baseline, week 16, week 32, week 52
Level of physical activity	Level of physical activity measured by Chinese International Physical Activity Questionnaire (Short form)	Baseline, week 16, week 32, week 52
Self-Management efficacy	Self-management efficacy measure by Pain-Self Efficacy questionnaire	Baseline, week 16, week 32, week 52
Level of Anxiety	Anxiety measured by Generalized Anxiety Disorder -7	Baseline, week 16, week 32, week 52
Level of Depression	Depression measured by Patient Health Questionnaire -9	Baseline, week 16, week 32, week 52
Insomnia	Insomnia measured by 7 item Insomnia Severity Index	Baseline, week 16, week 32, week 52
Loneliness	Loneliness measured by 6 item De Jong Gierveld Loneliness Scale	Baseline, week 16, week 32, week 52
Health related Quality of Life	Health related Quality of life measured by Euroquol- 5D-5L	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	Baseline

Collaborators and Investigators

• Sponsor: Chinese University of Hong Kong
• Investigators: 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

Study Major Dates

• Study Start (Actual): April 8, 2024
• Primary Completion (Estimated): November 30, 2025
• Study Completion (Estimated): April 1, 2026

Study Registration Dates

• First Submitted: February 22, 2024
• First Submitted That Met QC Criteria: February 22, 2024
• First Posted (Actual): February 28, 2024

Study Record Updates

• Last Update Posted (Actual): June 26, 2025
• Last Update Submitted That Met QC Criteria: June 22, 2025
• Last Verified: August 1, 2024

More Information

Terms related to this study

• Keywords: Chronic Care Model; Risk assessment and Management Programme
• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Arthritis; Joint Diseases; Rheumatic Diseases; Osteoarthritis; Osteoarthritis, Knee
• Other Study ID 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