Risk Assessment and Management Program (RAMP) on knee osteoarthritis in primary care-a one-year pragmatic randomized...

Knee osteoarthritis (OA) is the most common chronic arthritis and is a leading cause of pain and disability. Chronic care model (CCM) has been proved successful in Hong Kong primary care setting. This study aims to assess the clinical effectiveness of a CCM, named Assessment and Management Program on Knee Osteoarthritis (RAMP-Knee OA), compared to usual care in adults with knee OA.

The study is a 52-week, two-arm, parallel, open-label 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. Measurement instruments will be tested at baseline, 16, 32, and 52 weeks. The primary outcome will be the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC; 5-point Likert) pain at 52 weeks. Secondary outcomes include a set of biopsychosocial parameters: Physical function will be measured subjectively by WOMAC function subscale and objectively by the 30-second chair and stand performance test. Lower limb muscle mass will be measured by bioimpedance analysis. Physical activity level will be measured by the Chinese International Physical Activity Questionnaire (Short form). Self-management efficacy will be measured by Pain-Self Efficacy questionnaire. Generalized Anxiety Disorder-7 (GAD-7) and Patient Health Questionnaire-9 (PHQ-9) will be used to measure anxiety and depression, respectively. Insomnia will be measured by the 7-item Insomnia Severity Index (ISI), and loneliness will be measured by the 6-item De Jong Gierveld Loneliness Scale. EuroQuol-5D questionnaire will be used to measure health-related quality of life. Both primary and secondary outcomes at different points will be conducted using analysis of covariance, adjusting for baseline values. Secondary analyses include adjustments for potential confounders and exploration of interaction effects of treatment and the potential moderators.

The findings will address the evidence-to-practice gap for the implementation of a CCM that incorporates a comprehensive risk assessment, care protocol, self-management support, and scheduled health assessments in Hong Kong.

ClinicalTrials.gov, 1 NCT06283147. Registered on 22 February 2024.