Clinical trial NCT06283147: Risk Assessment and Management Program (RAMP) on Knee Osteoarthritis in Primary Care
Official title: Risk Assessment and Management Program (RAMP) on Knee Osteoarthritis in Primary Care- a One-year Pragmatic Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Knee Osteoarthritis
Keywords: Risk assessment and Management Programme
Chronic Care Model
Lead sponsor: Chinese University of Hong Kong
Sponsor class: OTHER
First posted: 2024-02-28
Enrollment: 228
Sex: ALL
Minimum age (years): 45
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: HEALTH_SERVICES_RESEARCH

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. RAMP Knee-OA group
2. 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):

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.

Eligibility criteria: 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)

Primary outcomes:
measure: Knee pain
timeFrame: Baseline, week 16, week 32, week 52
Secondary outcomes:
measure: Physical Function
timeFrame: Baseline, week 16, week 32, week 52
measure: Physical function
timeFrame: Baseline, week 16, week 32, week 52
measure: Lower limb muscle mass
timeFrame: Baseline, week 16, week 32, week 52
measure: Level of physical activity
timeFrame: Baseline, week 16, week 32, week 52
measure: Self-Management efficacy
timeFrame: Baseline, week 16, week 32, week 52
measure: Level of Anxiety
timeFrame: Baseline, week 16, week 32, week 52
measure: Level of Depression
timeFrame: Baseline, week 16, week 32, week 52
measure: Insomnia
timeFrame: Baseline, week 16, week 32, week 52
measure: Loneliness
timeFrame: Baseline, week 16, week 32, week 52
measure: Health related Quality of Life
timeFrame: Baseline, week 16, week 32, week 52
measure: Demographic data
timeFrame: Baseline
Other outcomes:
Locations:
city: Hong Kong
country: Hong Kong
facility: Lek Yuen GOPC
Study officials:
affiliation: Jockey Club School of Public Health and Primary Care, Chinese University of Hong Kong
name: Regina Wing Shan SIT, M.D.
role: PRINCIPAL_INVESTIGATOR
References: