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

Knee Osteoarthritis Clinical Trial

Official title:

Risk Assessment and Management Program (RAMP) on Knee Osteoarthritis in Primary Care- a One-year Pragmatic Randomized Controlled Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06283147
• Other study ID #: 2023.530
• Status: Recruiting
• Phase: N/A
• Start date: April 1, 2024
• Est. completion date: April 1, 2026

Study information

• Verified date: March 2024
• Source: Chinese University of Hong Kong
• Contact: Cheryl Lok Chee Fung, Bachelor
• Phone: 2609 5050
• Email: cheryllcfung[@]cuhk.edu.hk
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 228
• Est. completion date: April 1, 2026
• Est. primary completion date: November 30, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 45 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Knee Osteoarthritis
• Osteoarthritis
• Osteoarthritis, Knee

Intervention

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.

Locations

Country	Name	City	State
Hong Kong	Lek Yuen GOPC	Hong Kong

Sponsors (1)

Lead Sponsor	Collaborator
Chinese University of Hong Kong

Country where clinical trial is conducted

Hong Kong, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Knee pain	Knee pain as measured by the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)	Baseline, week 16, week 32, week 52
Secondary	Physical Function	Physical function measured by WOMAC function subscale	Baseline, week 16, week 32, week 52
Secondary	Physical function	Physical function measured by 30-second chair and stand performance test	Baseline, week 16, week 32, week 52
Secondary	Lower limb muscle mass	Lower limb muscle mass measured by bio-impedance analysis	Baseline, week 16, week 32, week 52
Secondary	Level of physical activity	Level of physical activity measured by Chinese International Physical Activity Questionnaire (Short form)	Baseline, week 16, week 32, week 52
Secondary	Self-Management efficacy	Self-management efficacy measure by Pain-Self Efficacy questionnaire	Baseline, week 16, week 32, week 52
Secondary	Level of Anxiety	Anxiety measured by Generalized Anxiety Disorder -7	Baseline, week 16, week 32, week 52
Secondary	Level of Depression	Depression measured by Patient Health Questionnaire -9	Baseline, week 16, week 32, week 52
Secondary	Insomnia	Insomnia measured by 7 item Insomnia Severity Index	Baseline, week 16, week 32, week 52
Secondary	Loneliness	Loneliness measured by 6 item De Jong Gierveld Loneliness Scale	Baseline, week 16, week 32, week 52
Secondary	Health related Quality of Life	Health related Quality of life measured by Euroquol- 5D-5L	Baseline, week 16, week 32, week 52
Secondary	Demographic data	Demographic data such as height, weight, BMI, age, sex, knee pain duration, chronic comorbid conditions, chronic medications	Baseline