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

NCT06283147 | Active Not Recruiting

• 1 other identifier: 2023.530
• Study Type: interventional
• Target: 228
• Locations: 1 country
• Sites: 1

Brief 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. After confirming eligibility, participants will complete the baseline assessment and be randomized into one of the following groups (n=114 for each group):

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

Conditions

Knee Osteoarthritis

Keywords

Risk assessment and Management Programme; Chronic Care Model

Outcome Measures

Primary Outcomes (1)

• Knee pain

  Knee pain as measured by the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)

  Baseline, week 16, week 32, week 52

Secondary Outcomes (11)

• Physical Function

  Baseline, week 16, week 32, week 52

• Physical function

  Baseline, week 16, week 32, week 52

• Lower limb muscle mass

  Baseline, week 16, week 32, week 52

• Level of physical activity

  Baseline, week 16, week 32, week 52

• Self-Management efficacy

  Baseline, week 16, week 32, week 52

Study Arms (2)

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.

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.

Interventions

Risk assessment and Management Programme - Knee Osteoarthritis BEHAVIORAL

(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.

RAMP Knee OA

Eligibility Criteria

• Age: 45 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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)

Sponsors & Collaborators

• Chinese University of Hong Kong: lead

Study Sites (1)

Lek Yuen GOPC

Hong Kong, Hong Kong

Location

Related Publications (1)

• 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. doi: 10.1186/s13063-026-09469-x. Online ahead of print.

  PMID: 41629997 DERIVED

MeSH Terms

Conditions

Osteoarthritis, Knee

Interventions

Risk Assessment

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Intervention Hierarchy (Ancestors)

Risk; Probability; Statistics as Topic; Epidemiologic Methods; Investigative Techniques; Risk Management; Organization and Administration; Health Services Administration; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Epidemiologic Measurements; Public Health; Environment and Public Health

Study Officials

• Regina Wing Shan SIT, M.D.

  Jockey Club School of Public Health and Primary Care, Chinese University of Hong Kong

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: All data collection will be performed by trained research assistants blinded to the allocation status of the patients, and statistician will analyse data without referring to allocation information.
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor Regina Wing Shan Sit

Model Details: 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.

Study Record Dates

• First Submitted: February 22, 2024
• First Posted: February 28, 2024
• Study Start: April 8, 2024
• Primary Completion: November 30, 2025
• Study Completion: April 1, 2026
• Last Updated: June 26, 2025

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

HK (1)