Overview
Symptomatic osteoarthritis (OA) of the knee affects approximately one-fifth (\~300K) of Singaporeans aged 50 years or older, with the disease prevalence increasing with age. Patients with advanced knee OA and severe disability often require a total knee replacement (TKR) surgery. With an ageing population and the high prevalence of obesity, the annual number of TKR is projected to rise. Thus, innovative care models are urgently needed to improve patient outcomes, while managing or reducing the economic burden of this common and costly public health problem.
Unmet Need: Conservative treatment through physiotherapy rehabilitation is a key intervention but significant access limitations result in unnecessary TKRs. For patients with knee OA, consensus guidelines are unanimous in recommending education, exercise, and weight management (if required) as first-line intervention. Physiotherapy rehabilitation incorporates these 3 first-line interventions and is a widely advocated and evidence-based component of OA intervention. Despite this, international evidence suggests that these core interventions are often under-utilized, with only 20-40% of community-dwelling older adults with knee OA receiving them. Locally and worldwide, suboptimal care from rehabilitation non-attendance is prevalent and costly: available research suggests that at least a quarter of TKRs could have been avoided with optimal care. Thus, to reduce the economic burden of OA, there is a need to develop innovative and flexible rehabilitation strategies.
mHealth-based program is a likely solution to address this unmet need, but local contextualization is needed. Against this background, a mobile health (mHealth)-based OA self-management program may be a feasible solution to deliver guideline-based interventions, with minimal involvement by healthcare professionals. Whilst several app- or web-based OA self-management programs are available, few have undergone rigorous RCT evaluation, and still fewer provide detailed instructions to enable self-directed exercise (in particular, muscle strengthening exercises) - despite the evidence that exercise is the cornerstone of knee OA management. Furthermore, the reach and adoption of these programs in Singapore is limited as they are designed for English-speaking patients from Western cultures. Hence, whilst there are potential benefits in harnessing technology-enabled programs, these data emphasize the need for local co-design and adaptation to suit the Singapore context and to facilitate adoption.
Thus, we have, through an iterative user-centered design process, developed Managing Osteoarthritis of the Knee using Therapist Technology Optimized Rehabilitation (MOKneeTOR), a blended digital rehabilitation program integrating an initial face-to-face physiotherapy assessment and a mobile health (mHealth)-enabled exercise and self-management program designed to promote first-line interventions (education, exercise, and weight management where indicated) for patients with knee osteoarthritis.
Description
Study Hypotheses
Primary hypothesis: The MOKneeTOR program will be non-inferior to hospital-based physiotherapy rehabilitation at 3 and at 6 months in improving physical function (fast gait speed).
Secondary hypothesis: The MOKneeTOR program will be more cost-effective than hospital-based physiotherapy rehabilitation in reducing total OA-related costs.
Approach and Methods
This will be an assessor-blinded, parallel design, non-inferiority randomized controlled trial, with assessments done at baseline, 3 months, and 6 months after randomization. The protocol conforms to the CONSORT guidelines for eHealth interventions and non-inferiority RCTs.
Participants
Study participants will be recruited from a large pool of patients who are referred by orthopaedic surgeons for conservative physiotherapy management in Singapore General Hospital (SGH). Informed, written consent by each participant will be obtained. Study treatments, but not the study hypotheses, will be disclosed to participants; therefore, participants will be unaware of the hypothesized direction of effect.
Randomization To maintain allocation concealment, randomization will be undertaken only after completion of baseline outcome assessment. Participants will be randomized using minimal sufficient balance (MSB) randomization, a covariate-adaptive randomization method designed to ensure covariate balance on the key variables of age, sex, treating physiotherapists, and baseline knee pain intensity. The first 20 patients will be allocated in a 1:1 ratio to MOKneeTOR program or outpatient physiotherapy rehabilitation program using simple randomization, after which the computer-generated MSB algorithm will be activated. To support an exploration of potential mechanisms through which our MOKneeTOR mobile app improves management adherence, participants randomized to the MOKneeTOR program will undergo a second randomization (1:1) to receive either (i) MOKneeTOR with the standard MOKneeTOR app configuration or (ii) MOKneeTOR with enhanced personalization of the MOKneeTOR app (e.g., personalized UI such as tailored caricature, preferred colour scheme and customizable chatbot settings that allow patients to choose between concise or detailed replies). Notably, this 2:1:1 design will optimize our ability to assess the overall effects of the MOKneeTOR program relative to outpatient physiotherapy rehabilitation program while also allow an exploration of potential mechanistic effects of the MOKneeTOR app.
Participants randomized to MOKneeTOR program may optionally nominate one adult support person (SP) (e.g., family member/friend) to receive access to an SP version of the MOKneeTOR mobile app. The SP app is a subset of the patient app and is intended to (i) improve SP's knee OA knowledge and (ii) support SP's efforts in supporting the participant's self-management. The SP app displays the participant's progress summaries (exercise and physical activity frequency) and delivers informational and encouragement messages to the SP. Participation of an SP is optional and does not affect the participant's clinical care or trial participation.
Eligibility
Inclusion Criteria:
- All patients who meet the knee OA clinical criteria (aged ≥45 years, activity-related knee pain, and ≤30 min knee joint stiffness in the morning) will be included,
- an owner of a smartphone,
- an education level of at least 8 years,
- a willingness to be randomized to either MOKneeTOR program or outpatient rehabilitation program,
- an ability to complete baseline assessment.
Exclusion Criteria:
- lower limb joint replacement surgery anticipated within the next 6 months,
- rheumatoid arthritis and other systemic arthritis,
- a previous history of stroke and other major neurological conditions,
- significant back or other non-knee pain,
- pregnant women
