Clinical trial NCT04544904: The Technology, Exercise Programming, and Activity Prescription for Enhanced Mobility (TEAM) Study
Official title: Novel Uses of Technology for Individuals With Mild to Moderate Hip or Knee Osteoarthritis: The Technology, Exercise Programming, and Activity Prescription for Enhanced Mobility (TEAM) Study
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Osteo Arthritis Knee
Osteoarthritis
Hip Arthritis
Keywords: exercise
physical activity
medicine
Lead sponsor: Western University, Canada
Sponsor class: OTHER
First posted: 2020-09-10
Enrollment: 192
Sex: ALL
Minimum age (years): 40
Maximum age (years): 74
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Many individuals with osteoarthritis (OA) (up to 45%) are referred to an orthopaedic surgeon for a joint replacement prematurely or will not be candidates for surgery. These individuals need appropriate (non-operative) care to help reduce their pain and enhance their mobility. We are studying the use of innovative technology to help physicians give physical activity advice for patients to become more active and provide free online resources to help patients understand OA self-management and exercise, especially when they have barriers to accessing formal care. Individuals with OA that are referred to a specialized clinic will receive one of three interventions: usual care (handout on resources), a physical activity prescription by a doctor, or the prescription and a link to a free web-based platform (website) on non-operative management of OA with patient education and exercise videos. Our goal is to help with non-operative management strategies to improve quality of life, reduce pain, improve mobility, and possibly delay or prevent a joint replacement.

Osteoarthritis is a condition where people feel joint pain or stiffness. Joints are the body parts where two bones join together with softer material (cartilage) between them. In osteoarthritis, this cartilage wears down. It is the biggest cause for disability worldwide. Helping people with osteoarthritis starts with education, physical activity, and physiotherapy. Doctors can also prescribe braces, injections or medications. For severe osteoarthritis when nothing else helps, surgery can be done to replace the joint.

Doctors often refer patients for surgery too soon. Skipping steps of care may mean unnecessary surgery and longer wait times. The Musculoskeletal Rapid Access Clinic (now called Clinic) in London was set up to solve these problems. They screen patients before referring them to a surgeon, and do not refer almost half of patients. Our goal is to support these patients with new ways to make their non-surgical treatment better.

The first way is through physical activity 'prescription'. It works well for other chronic conditions and patients say it helps. We don't know how well it works for people with osteoarthritis. Most doctors have little time, training or experience for prescribing physical activity. Technology can make it easier for doctors and patients. We have designed a tool to help doctors prescribe physical activity and a smartphone app to track patient activity. We have also created a free website. This includes patient education, exercise videos, and virtual physiotherapy. This can be important for individuals who can't access in-person care.

Detailed 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-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:

1. Does the use of novel technology (PARx) affect patient reported outcomes in individuals with mild to moderate hip or knee OA?
2. Does PARx influence activity levels in individuals with mild to moderate hip or knee OA?
3. 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?
4. 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.

Eligibility criteria: Inclusion Criteria:

* 40-74 years of age
* Screened by the Southwest Musculoskeletal RAC as "mild to moderate OA" using clinical and radiographic criteria

Exclusion Criteria:

* Concomitant end-stage OA (awaiting/prior TJA)
* Inflammatory arthritis (rheumatoid, psoriatic, or disease-modifying anti-rheumatic drug exposure)
* Unstable medical conditions that would preclude physical activity prescription (e.g. unstable angina, uncontrolled Type 2 Diabetes)
* Not able/willing to follow up for the study period
* Does not have access to the internet
* Cannot communicate in English.

Primary outcomes:
measure: height
timeFrame: Baseline
measure: height
timeFrame: 2 months
measure: height
timeFrame: 6 months
measure: height
timeFrame: 12 months
measure: body mass index (derived)
timeFrame: Baseline
measure: body mass index (derived)
timeFrame: 2 months
measure: body mass index (derived)
timeFrame: 6 months
measure: body mass index (derived)
timeFrame: 12 months
measure: abdominal circumference
timeFrame: Baseline
measure: abdominal circumference
timeFrame: 2 months
measure: abdominal circumference
timeFrame: 6 months
measure: abdominal circumference
timeFrame: 12 months
measure: weight
timeFrame: Baseline
measure: weight
timeFrame: 2 months
measure: weight
timeFrame: 6 months
measure: weight
timeFrame: 12 months
measure: PA Evaluation
timeFrame: Baseline
measure: PA Evaluation
timeFrame: 2 months
measure: PA Evaluation
timeFrame: 6 months
measure: PA Evaluation
timeFrame: 12 months
measure: Functional Assessment 30 second sit-to-stand test
timeFrame: Baseline
measure: Functional Assessment 30 second sit-to-stand test
timeFrame: 2 months
measure: Functional Assessment 30 second sit-to-stand test
timeFrame: 6 months
measure: Functional Assessment 30 second sit-to-stand test
timeFrame: 12 months
measure: Functional Assessment 40-meter fast-paced walk test
timeFrame: Baseline
measure: Functional Assessment 40-meter fast-paced walk test
timeFrame: 2 months
measure: Functional Assessment 40-meter fast-paced walk test
timeFrame: 6 months
measure: Functional Assessment 40-meter fast-paced walk test
timeFrame: 12 months
measure: Hip Disability and OA Outcome Score (HOOS)
timeFrame: Baseline
measure: Hip Disability and OA Outcome Score (HOOS)
timeFrame: 2 months
measure: Hip Disability and OA Outcome Score (HOOS)
timeFrame: 6 months
measure: Hip Disability and OA Outcome Score (HOOS)
timeFrame: 12 months
measure: Knee OA Outcome Score (KOOS)
timeFrame: Baseline
measure: Knee OA Outcome Score (KOOS)
timeFrame: 2 months
measure: Knee OA Outcome Score (KOOS)
timeFrame: 6 months
measure: Knee OA Outcome Score (KOOS)
timeFrame: 12 months
measure: Intermittent and Constant OA Pain (ICOAP)
timeFrame: Baseline
measure: Intermittent and Constant OA Pain (ICOAP)
timeFrame: 2 months
measure: Intermittent and Constant OA Pain (ICOAP)
timeFrame: 6 months
measure: Intermittent and Constant OA Pain (ICOAP)
timeFrame: 12 months
measure: Patient Global Assessment of Health Status (PGA)
timeFrame: Baseline
measure: Patient Global Assessment of Health Status (PGA)
timeFrame: 2 months
measure: Patient Global Assessment of Health Status (PGA)
timeFrame: 6 months
measure: Patient Global Assessment of Health Status (PGA)
timeFrame: 12 months
measure: Patient Acceptable Symptom State (PASS)
timeFrame: Baseline
measure: Patient Acceptable Symptom State (PASS)
timeFrame: 2 months
measure: Patient Acceptable Symptom State (PASS)
timeFrame: 6 months
measure: Patient Acceptable Symptom State (PASS)
timeFrame: 12 months
measure: Arthritis Self-Efficacy Questionnaire
timeFrame: Baseline
measure: Arthritis Self-Efficacy Questionnaire
timeFrame: 2 months
measure: Arthritis Self-Efficacy Questionnaire
timeFrame: 6 months
measure: Arthritis Self-Efficacy Questionnaire
timeFrame: 12 months
measure: Center for the Epidemiological studies - Depression Scale (CES-D)
timeFrame: Baseline
measure: Center for the Epidemiological studies - Depression Scale (CES-D)
timeFrame: 2 months
measure: Center for the Epidemiological studies - Depression Scale (CES-D)
timeFrame: 6 months
measure: Center for the Epidemiological studies - Depression Scale (CES-D)
timeFrame: 12 months
measure: Visual Analogue Scale to Evaluate Fatigue Severity (VAS-F)
timeFrame: Baseline
measure: Visual Analogue Scale to Evaluate Fatigue Severity (VAS-F)
timeFrame: 2 months
measure: Visual Analogue Scale to Evaluate Fatigue Severity (VAS-F)
timeFrame: 6 months
measure: Visual Analogue Scale to Evaluate Fatigue Severity (VAS-F)
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: London
country: Canada
facility: Fowler Kennedy Sports Medicine Clinic
state: Ontario
Study officials:
affiliation: Western University
name: Jane Thornton, MD PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Bombardier, C., G. Hawker, and D. Mosher, The Impact of Arthritis in Canada: Today and Over the Next 30 Years. 2011, Arthritis Alliance of Canada: Canadian Arthritis Network.
citation: McAlindon TE, Bannuru RR, Sullivan MC, Arden NK, Berenbaum F, Bierma-Zeinstra SM, Hawker GA, Henrotin Y, Hunter DJ, Kawaguchi H, Kwoh K, Lohmander S, Rannou F, Roos EM, Underwood M. OARSI guidelines for the non-surgical management of knee osteoarthritis. Osteoarthritis Cartilage. 2014 Mar;22(3):363-88. doi: 10.1016/j.joca.2014.01.003. Epub 2014 Jan 24.
citation: King LK, Marshall DA, Faris P, Woodhouse LJ, Jones CA, Noseworthy T, Bohm E, Dunbar MJ, Hawker GA; BEST-Knee Research Team. Use of Recommended Non-surgical Knee Osteoarthritis Management in Patients prior to Total Knee Arthroplasty: A Cross-sectional Study. J Rheumatol. 2020 Aug 1;47(8):1253-1260. doi: 10.3899/jrheum.190467. Epub 2019 Nov 15.
citation: Malian, S.J., Predictors of appropriate referral to total knee arthroplasty: a validation study, in Health and Rehabilitation Sciences. 2015, Western University: Electronic Thesis and Dissertation Repository. p. 75.
citation: Churchill L, Malian SJ, Chesworth BM, Bryant D, MacDonald SJ, Marsh JD, Giffin JR. The development and validation of a multivariable model to predict whether patients referred for total knee replacement are suitable surgical candidates at the time of initial consultation. Can J Surg. 2016 Dec;59(6):407-414. doi: 10.1503/cjs.004316.
citation: Pedersen BK, Saltin B. Exercise as medicine - evidence for prescribing exercise as therapy in 26 different chronic diseases. Scand J Med Sci Sports. 2015 Dec;25 Suppl 3:1-72. doi: 10.1111/sms.12581.
citation: Lewis BS, Lynch WD. The effect of physician advice on exercise behavior. Prev Med. 1993 Jan;22(1):110-21. doi: 10.1006/pmed.1993.1008.
citation: Andersen RE, Blair SN, Cheskin LJ, Bartlett SJ. Encouraging patients to become more physically active: the physician's role. Ann Intern Med. 1997 Sep 1;127(5):395-400. doi: 10.7326/0003-4819-127-5-199709010-00010. No abstract available.
citation: Flores Mateo G, Granado-Font E, Ferre-Grau C, Montana-Carreras X. Mobile Phone Apps to Promote Weight Loss and Increase Physical Activity: A Systematic Review and Meta-Analysis. J Med Internet Res. 2015 Nov 10;17(11):e253. doi: 10.2196/jmir.4836.
citation: Skou ST, Odgaard A, Rasmussen JO, Roos EM. Group education and exercise is feasible in knee and hip osteoarthritis. Dan Med J. 2012 Dec;59(12):A4554.
citation: Skou ST, Simonsen ME, Odgaard A, Roos EM. Predictors of long-term effect from education and exercise in patients with knee and hip pain. Dan Med J. 2014 Jul;61(7):A4867.
citation: Skou ST, Roos EM. Good Life with osteoArthritis in Denmark (GLA:D): evidence-based education and supervised neuromuscular exercise delivered by certified physiotherapists nationwide. BMC Musculoskelet Disord. 2017 Feb 7;18(1):72. doi: 10.1186/s12891-017-1439-y.
citation: Maksymowych WP, Richardson R, Mallon C, van der Heijde D, Boonen A. Evaluation and validation of the patient acceptable symptom state (PASS) in patients with ankylosing spondylitis. Arthritis Rheum. 2007 Feb 15;57(1):133-9. doi: 10.1002/art.22469.
citation: Agarwal P, Kithulegoda N, Bouck Z, Bosiak B, Birnbaum I, Reddeman L, Steiner L, Altman L, Mawson R, Propp R, Thornton J, Ivers N. Feasibility of an Electronic Health Tool to Promote Physical Activity in Primary Care: Pilot Cluster Randomized Controlled Trial. J Med Internet Res. 2020 Feb 14;22(2):e15424. doi: 10.2196/15424.
citation: Keating XD, Zhou K, Liu X, Hodges M, Liu J, Guan J, Phelps A, Castro-Pinero J. Reliability and Concurrent Validity of Global Physical Activity Questionnaire (GPAQ): A Systematic Review. Int J Environ Res Public Health. 2019 Oct 26;16(21):4128. doi: 10.3390/ijerph16214128.
citation: Dobson F, Hinman RS, Hall M, Terwee CB, Roos EM, Bennell KL. Measurement properties of performance-based measures to assess physical function in hip and knee osteoarthritis: a systematic review. Osteoarthritis Cartilage. 2012 Dec;20(12):1548-62. doi: 10.1016/j.joca.2012.08.015. Epub 2012 Aug 31.
citation: Klassbo M, Larsson E, Mannevik E. Hip disability and osteoarthritis outcome score. An extension of the Western Ontario and McMaster Universities Osteoarthritis Index. Scand J Rheumatol. 2003;32(1):46-51. doi: 10.1080/03009740310000409.
citation: Roos EM, Lohmander LS. The Knee injury and Osteoarthritis Outcome Score (KOOS): from joint injury to osteoarthritis. Health Qual Life Outcomes. 2003 Nov 3;1:64. doi: 10.1186/1477-7525-1-64.
citation: Hawker GA, Davis AM, French MR, Cibere J, Jordan JM, March L, Suarez-Almazor M, Katz JN, Dieppe P. Development and preliminary psychometric testing of a new OA pain measure--an OARSI/OMERACT initiative. Osteoarthritis Cartilage. 2008 Apr;16(4):409-14. doi: 10.1016/j.joca.2007.12.015.
citation: Hawker GA, Stewart L, French MR, Cibere J, Jordan JM, March L, Suarez-Almazor M, Gooberman-Hill R. Understanding the pain experience in hip and knee osteoarthritis--an OARSI/OMERACT initiative. Osteoarthritis Cartilage. 2008 Apr;16(4):415-22. doi: 10.1016/j.joca.2007.12.017. Epub 2008 Mar 4.
citation: Scott PJ, Huskisson EC. Measurement of functional capacity with visual analogue scales. Rheumatol Rehabil. 1977 Nov;16(4):257-9. doi: 10.1093/rheumatology/16.4.257.
citation: Balestroni G, Bertolotti G. [EuroQol-5D (EQ-5D): an instrument for measuring quality of life]. Monaldi Arch Chest Dis. 2012 Sep;78(3):155-9. doi: 10.4081/monaldi.2012.121. Italian.
citation: Lorig K, Chastain RL, Ung E, Shoor S, Holman HR. Development and evaluation of a scale to measure perceived self-efficacy in people with arthritis. Arthritis Rheum. 1989 Jan;32(1):37-44. doi: 10.1002/anr.1780320107.
citation: Radloff, L.S., The CES-D Scale:A Self-Report Depression Scale for Research in the General Population. Applied Psychological Measurement, 1977. 1(3): p. 385-401.
citation: Lee KA, Hicks G, Nino-Murcia G. Validity and reliability of a scale to assess fatigue. Psychiatry Res. 1991 Mar;36(3):291-8. doi: 10.1016/0165-1781(91)90027-m.
citation: Glasgow RE, Vogt TM, Boles SM. Evaluating the public health impact of health promotion interventions: the RE-AIM framework. Am J Public Health. 1999 Sep;89(9):1322-7. doi: 10.2105/ajph.89.9.1322.
citation: Braun, V. and V. Clarke, Using thematic analysis in psychology. Qualitative Research in Psychology, 2006. 3(2): p. 77-101.