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| ID | Type | Description | Link |
|---|---|---|---|
| R21AR063913 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) | NIH |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Usual Care | No Intervention | Participants randomized to the Usual Care group will receive the current standard post-operative TKR care. | |
| Motivational Interviewing (MI) | Active Comparator | Participants randomized to the MI Intervention group will receive up to 14 telephone calls from a Health Educator for 9 months post-TKR. |
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| Financial Incentives (FI) | Active Comparator | 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. |
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| Motivational Inverterviewing (MI) + Financial Incentives (FI) | Active Comparator | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Motivational Interviewing (MI) | Behavioral | 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). |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Elena Losina, PhD | Brigham and Women's Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Brigham and Women's Hospital | Boston | Massachusetts | 02115 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28732147 | Result | Losina E, Collins JE, Deshpande BR, Smith SR, Michl GL, Usiskin IM, Klara KM, Winter AR, Yang HY, Selzer F, Katz JN. Financial Incentives and Health Coaching to Improve Physical Activity Following Total Knee Replacement: A Randomized Controlled Trial. Arthritis Care Res (Hoboken). 2018 May;70(5):732-740. doi: 10.1002/acr.23324. Epub 2018 Apr 12. | |
| 27585441 | Derived | Usiskin IM, Yang HY, Deshpande BR, Collins JE, Michl GL, Smith SR, Klara KM, Selzer F, Katz JN, Losina E. Association between activity limitations and pain in patients scheduled for total knee arthroplasty. BMC Musculoskelet Disord. 2016 Sep 1;17(1):378. doi: 10.1186/s12891-016-1233-2. |
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| ID | Term |
|---|---|
| D010003 | Osteoarthritis |
| D007592 | Joint Diseases |
| D009043 | Motor Activity |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
| D001519 | Behavior |
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| ID | Term |
|---|---|
| D062405 | Motivational Interviewing |
| ID | Term |
|---|---|
| D037001 | Directive Counseling |
| D003376 | Counseling |
| D008605 | Mental Health Services |
| D004191 | Behavioral Disciplines and Activities |
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| Financial Incentives | Other | 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. |
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| D006296 | Health Services |
| D005159 | Health Care Facilities Workforce and Services |