The Study of Physical Activity Rewards After Knee Surgery

Study Overview
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Brief Summary
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The objectives of this research are to conduct a proof of concept randomized controlled trial with 200 patients undergoing primary total knee replacement (TKR) at Brigham and Women's Hospital (BWH). The trial will compare levels of physical activity in subjects in the behavioral and economic interventions versus Usual Care post TKR.

Detailed Description
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Physical activity (PA) has been shown to improve pain and function in persons with knee osteoarthritis (OA), reduce obesity, and prevent the onset and progression of heart disease, diabetes, and chronic pulmonary disease. The US Department of Human and Health Services (DHHS) guidelines recommend that adults engage in >150 minutes of moderate physical activity per week. However, adherence to PA guidelines is poor in the general population, particularly in persons with knee OA. Total knee replacement (TKR) is widely used in patients with symptomatic, advanced knee OA. While the vast majority of persons undergoing TKR experience considerable reduction in pain and improvement in functional capacity, far fewer take this opportunity to become more physically active. Since physical activity has a direct relationship with quality of life and with prevention and amelioration of many chronic conditions, many TKR recipients do not derive maximum benefits from the procedure. The focus of this proposal is to conduct a proof of concept RCT to establish the efficacy of a behavioral economics-based intervention that would facilitate engagement in physical activity and improve adherence to PA guidelines in the growing population of TKR recipients. We address the innovative hypothesis that the period following TKR presents a window of opportunity to fundamentally change attitudes and beliefs regarding PA, and that tangible economic incentives will effectively induce behavior change and facilitate adherence to PA guidelines.

Conditions
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Osteoarthritis, Degenerative Joint Disease

Intervention / Treatment
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* Behavioral: Motivational Interviewing (MI)
* Other: Financial Incentives


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Scheduled to undergo primary TKA at BWH Osteoarthritis is the principal underlying diagnosis Age >=40 at the projected date of TKA English-speaking Willing and able to access the internet to complete study related questionnaires Exclusion Criteria: Osteoarthritis is not the principal underlying diagnosis (e.g. inflammatory arthritis) Dementia (can not fill out forms) Psychological issues that preclude participation, as identified by participating surgeons Does not have access to a computer and/or the internet. Non-English speaker (instruments are not validated in Spanish); very few non-English speakers (<5%) are otherwise eligible Age <40 at the projected date of TKA (TKA is usually due to major trauma, juvenile onset or congenital disease) Lives in a nursing home (difficult to track costs) Implantation of Unicompartamental Knee Arthroscopy (different clinical features and different costs) Bilateral TKA in same admission (simultaneous), staged or within 6 months Uses a wheelchair or walker to ambulate Has been told by a physician that he/she has a heart condition and should only do physical activity recommended by a doctor Has pain in his/her chest when doing physical activity Loses balance because of dizziness Loses consciousness Unable/unwilling to wear Fitbit® accelerometer for 5 or more days during baseline visit

Ages Eligible for Study
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Minimum Age: 40 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Usual Care<br>Participants randomized to the Usual Care group will receive the current standard post-operative TKR care. | |
| Active Comparator: Motivational Interviewing (MI)<br>Participants randomized to the MI Intervention group will receive up to 14 telephone calls from a Health Educator for 9 months post-TKR. | Behavioral: Motivational Interviewing (MI)<br>* The motivational interviewing arms of SPARKS will consist of Health Educators trained in Motivational Interviewing (MI) techniques contacting participants at regular intervals over the course of the nine months following participants' total knee replacement (TKR).<br>|
| Active Comparator: Financial Incentives (FI)<br>Participants randomized to the FI Intervention group will receive financial incentives for completing physical activity logs weekly/bi-weekly and achieving pre-specified physical activity goals over the course of the study. | Other: Financial Incentives<br>* The financial intervention arms of SPARKS will provide compensation to participants for completing physical activity logs weekly/bi-weekly and reaching pre-specified physical activity goals.<br>|
| Active Comparator: Motivational Inverterviewing (MI) + Financial Incentives (FI)<br>Participants randomized to the FI + MI Intervention group will receive financial incentives for completing physical activity logs weekly/bi-weekly and achieving pre-specified physical activity goals as well as receive up to 14 telephone calls from a Health Educator for 9 months post-TKR. | Behavioral: Motivational Interviewing (MI)<br>* The motivational interviewing arms of SPARKS will consist of Health Educators trained in Motivational Interviewing (MI) techniques contacting participants at regular intervals over the course of the nine months following participants' total knee replacement (TKR).<br>Other: Financial Incentives<br>* The financial intervention arms of SPARKS will provide compensation to participants for completing physical activity logs weekly/bi-weekly and reaching pre-specified physical activity goals.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| number of steps | The primary outcome is the average number of steps over 7 days as measured by accelerometer at 6 months post-TKR. | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adherence to PA guidelines | The secondary outcome will be adherence to PA guidelines, defined by the DHHS as >150 minutes of moderate or greater intensity PA occurring in bouts of 10 minutes or more per week. | 6-months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Osteoarthritis, Total Knee Replacement, total Knee Arthroplasty, Post-operative recovery TKR, Physical Activity, Motivational Interviewing, Financial Incentives