Recruitment

Recruitment Status
Not yet recruiting
Estimated Enrollment
165

Summary

Conditions
  • Hip Arthritis
  • Osteo Arthritis Knee
  • Osteoarthritis
Type
Interventional
Phase
Not Applicable
Design
Allocation: RandomizedIntervention Model: Parallel AssignmentMasking: None (Open Label)Primary Purpose: Treatment

Participation Requirements

Age
Between 40 years and 74 years
Gender
Both males and females

Description

Osteoarthritis (OA) is the leading cause of disability worldwide and affects more than 4.4 million Canadians. Current evidence-based guidelines for OA management recommend weight management, patient education, physical activity, physiotherapy (PT), bracing, viscosupplementation, and anti-inflammator...

Osteoarthritis (OA) is the leading cause of disability worldwide and affects more than 4.4 million Canadians. Current evidence-based guidelines for OA management recommend weight management, patient education, physical activity, physiotherapy (PT), bracing, viscosupplementation, and anti-inflammatory/pain medications prior to joint replacement surgery. Unfortunately, current practice trends are not consistent with these guidelines, as nearly half of patients with OA referred to orthopedic surgeons do not require total joint arthroplasty (TJA) at the time of initial consultation. Through the Southwest Musculoskeletal Rapid Access Clinic (RAC), approximately ten referrals (20%) are rejected each day due to OA criteria not met, and a further 20% are assessed as non-operative. We aim to identify individuals with 'mild to moderate' OA and optimize their first-line non-operative management, starting with physical activity and education. Physical activity prescriptions are effective in increasing patient levels of physical activity, and 93% of patients surveyed want advice on physical activity from their physicians; but it is underused. Physicians cite lack of time and inadequate training as barriers. Electronic screening of physical activity behaviours can save time for physicians, and the use of digital health tools can improve physical activity levels. Patient education and physiotherapist-led group exercise therapy programs have shown to delay progression of knee OA symptoms and improve pain and function; however, two of the most significant barriers to accessing exercise programming is the cost (~approximate $425-475 per 6-8-week session) and accessibility to attend the exercise session (proximity to facility, remote/rural communities, etc.). The Need for a Solution that targets both Providers and Patients Screening for baseline physical activity levels and including educational components significantly increase intervention effectiveness. We have previously tested the feasibility of implementing an e-health tool to support physical activity counselling by physicians during patients' periodic health review. We will adapt and implement this tool, Physical Activity and App Prescription (PARx) to screen and provide tailored resources for physical activity in the setting of OA. We will use tablet computers and email, directly linked with the electronic medical record (EMR), to engage patients in contemplating their own physical activity levels, start conversations with their healthcare providers (in this case, primary care physicians with additional training in sport and exercise medicine), and support customized, patient-centered health care. After patients enter their information, they will receive evidence-based behavioural change supports to help them meet their goals. The automated algorithm assesses current activity level, risk factors/comorbidities and readiness for change. Based on the answers provided, patients are risk-stratified and tailored resources will be provided to the patient and to their clinician in the form of decision support tools embedded in the EMR. This will include the novel implementation of an exercise tracking platform via the smartphone app (myrecovery.ai). The web-based platform Joint Management (JM) is a free, readily accessible evidenced-based resource focusing on non-operative management strategies for mild to moderate hip and knee OA. The platform will include exercise programming (videos, pictures, and descriptions of the exercises) and patient education (benefits of exercise, lifestyle modifications, nutrition, injections, etc.), to assist the patient engage in self-management. JM will also include the option for (paid) virtual access to PTs, who can provide individualized support, recommendations and exercise programming via the platform. RATIONALE: Creating customized physical activity plans with automated reminders and other supports addresses the problem of self-efficacy in providers by developing an evidence-based automated method, while also addressing the issue of patient adherence by using tailored behaviour change techniques, through assessing readiness for change, and helping patients create new habits. The motivation for JM is to create a free, online evidence-based OA education and exercise programming resource for those that are not able to afford or access community-based exercise programs. The virtual PT option will help optimize patient's experience with the web-based platform, offering support and personalized recommendations regarding management of their condition and exercise programming tailored to their specific abilities, preferences, and needs. Why this is Innovative: The evidence for using patient-reported measures and functional outcomes to guide quality improvement for personalized OA care in a systematic manner is in an early stage, meaning that this project can not only impact healthcare delivery and translate new knowledge into medical practice but help position Western University as a leader in this area. The novel technologies (PARx and JM) are innovative tools informed by patient priorities and co-designed with our patient partners, specifically geared towards 1) developing new and more personalized treatment approaches, 2) developing more effective self-management tools, and 3) reducing disparities in vulnerable and hard-to-reach populations. To this end, we will share our findings broadly with our patient partners and reach out to these harder-to-reach groups in particular. EXPECTED OUTCOMES: Health Outcomes: We expect to increase patients' physical activity and improve outcomes for individuals with mild to moderate OA. We aim to optimize non-operative management of OA symptoms and therefore possibly delay and/or prevent the need for TJA. Academic Outcomes: We expect to develop a model of physical activity prescription and patient education that can be scaled up for implementation in primary care. Societal Outcomes: Both novel technologies have the potential to be implemented across Canada, targeting modifying disease progression and, ideally, delaying or preventing TJA. Innovative Technology 1: Physical Activity (PA) and App Prescription (Rx) (PARx) Physical Activity and App Prescription (PARx): Tablet/email software (REDCap) is used to collect physical activity data from patient input and prompt intervention by providers. The automated algorithm assesses current activity level, risk factors/comorbidities and readiness for change. Based upon their answers, patients will be risk-stratified and tailored resources will be provided to them in the form of a personalized prescription and free smartphone app (myrecovery.ai) to track activity levels. Innovative Technology 2: Joint Management (JM) Joint Management (JM): This is a free online evidence-based OA education and exercise programming resource for those that are not able to afford or access community-based exercise programs, with a virtual physiotherapy (PT) option to offer support and personalized recommendations. OBJECTIVES: The objective of the proposed study is to 1) determine if PARx and JM will improve pain, increase physical activity levels, and improve functional outcomes in patients with mild to moderate hip or knee OA RESEARCH QUESTIONS: Does the use of novel technology (PARx) affect patient reported outcomes in individuals with mild to moderate hip or knee OA? Does PARx influence activity levels in individuals with mild to moderate hip or knee OA? Does the use of novel technology (PARx and JM) affect patient reported and functional outcomes in individuals with mild to moderate hip or knee OA? What are the experiences and perceptions of patients and physicians during this process? SPECIFIC AIMS: Measure and compare A1) patient reported outcomes (pain, joint stiffness, disability, quality of life, disease knowledge, self-efficacy, depression, and fatigue), A2) physical activity levels, and A3) functional outcomes with those that have access (PARx and JM) and those that do not have access (usual care) to the technology. Determine A4) participant and physician experiences. HYPOTHESES: We hypothesize that access to technology-facilitated physical activity prescription (PARx) and access to the web-based platform (JM) will H1) improve patient reported outcomes (pain, joint stiffness, disability, quality of life, disease knowledge, self-efficacy, depression, and fatigue), H2) increase PA levels, and H3) improve functional outcomes in individuals with mild to moderate hip or knee OA compared to usual care. We hypothesize that access to JM will result in a greater improvement than PARx alone.

Tracking Information

NCT #
NCT04544904
Collaborators
Not Provided
Investigators
Not Provided