KArAT: Knee Arthroplasty Activity Trial
Study Details
Study Description
Brief Summary
Total knee replacement (TKR) is a common and costly procedure widely used to relieve pain and improve function in patients with symptomatic advanced knee osteoarthritis (OA). As of 2013, the annual incidence of TKR was over 680,000 surgeries and annual costs exceeded $11 billion. Growing evidence suggests that while pain and functional status improve following TKR, physical activity (PA) typically does not surpass pre-TKR levels. Engagement in PA can meaningfully improve quality of life (QoL), pain, and function. Given the large investment in TKR, the effectiveness and cost-effectiveness of TKR could be substantially increased if TKR recipients became more physically active.
The Knee Arthroplasty Activity Trial (KArAT) is a randomized control trial and participants will be randomly assigned to one of three arms. Participants across all arms will receive usual post-operative care for TKR surgery. Participants in the first arm will complete basic study activities, such as responding to surveys and attending two in-person clinic visits. Participants in the second arm will receive a wrist-based physical activity tracker intervention and receive phone calls from study staff about improving their general well being. Participants in the third arm will receive a telephonic active coaching (motivational interviewing) and financial incentives (TAC(MI)+FI) based intervention, as well as a wrist-based physical activity tracker intervention. The second and third arms will receive financial rewards for wearing a wrist-worn activity tracker for twelve months during the study.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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N/A |
Detailed Description
The investigators have designed the KArAT trial with two specific aims. First, to conduct a parallel three-arm RCT to establish the efficacy and sustainability of the effect of personalized intervention built on the principles of behavioral science and behavioral economics in improving PA among sedentary person who have undergone TKR. Our second aim is to establish the cost-effectiveness and budget impact of TAC(MI)+FI to improve PA in persons who have undergone TKR.
The three arms will include:
Arm 1: Usual post-TKR care
Arm 2: Usual post-TKR care + Wrist-based physical activity tracker wear + Phone calls about general well being
Arm 3: Usual post-TKR care + Wrist-based physical activity tracker wear + Telephonic Active Coaching (Motivational Interviewing) + Financial Incentives (TAC(MI)+FI).
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Other: Arm1 Participants in this arm receive usual post-operative care and complete all basic study activities, which include: attending 2 in-clinic visits at designated time-points, wearing and returning waist-worn activity trackers at 5 time points over two years, and completing 6 study surveys. |
Other: Basic Study Activities
Basic study activities begin two-weeks before TKR and end approximately 24-months after TKR. Basic study activities include: two in-person visits at the local clinic site (2 weeks before TKR and 32-weeks after TKR), completing 6 surveys, and wearing an ActiGraph activity tracker (waist-worn) for five one-week periods throughout the study (2-weeks before-TKR, 32-weeks post-TKR, one-year post-TKR, 18-months post-TKR, two-years post-TKR). All participants will wear a wrist-worn activity tracker simultaneously with the ActiGraph 2-weeks before-TKR. All participants will be eligible to receive up to $235 for completing these activities over the course of two years.
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| Experimental: Arm2 Participants in this arm receive usual post-operative care, complete all basic study activities, receive the wrist-based activity tracker intervention, and receive regular calls from study personnel about improving their general well being. |
Behavioral: Wrist based activity tracker wear
Participants who receive this intervention are eligible to receive $5/week for wearing a wrist-based activity tracker daily for 48-weeks ($240 total), beginning 6-weeks after surgery. Activity tracking data will be collected on a weekly basis.
Behavioral: Phone calls to provide information about general well being
From weeks 5-13 after surgery, participants receive weekly calls to provide educational information about improving general well-being. These calls occur once every other week for weeks 14-31 following surgery.
Other: Basic Study Activities
Basic study activities begin two-weeks before TKR and end approximately 24-months after TKR. Basic study activities include: two in-person visits at the local clinic site (2 weeks before TKR and 32-weeks after TKR), completing 6 surveys, and wearing an ActiGraph activity tracker (waist-worn) for five one-week periods throughout the study (2-weeks before-TKR, 32-weeks post-TKR, one-year post-TKR, 18-months post-TKR, two-years post-TKR). All participants will wear a wrist-worn activity tracker simultaneously with the ActiGraph 2-weeks before-TKR. All participants will be eligible to receive up to $235 for completing these activities over the course of two years.
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| Experimental: Arm3 Participants in this arm receive usual post-operative care, complete all basic study activities, and receive the TAC(MI)+FI and wrist-based activity tracker interventions. |
Behavioral: Telephonic Active Coaching (Motivational Interviewing) + Financial Incentives
As part of TAC(MI)+FI, participants speak with a health coach at Brigham and Women's Hospital once a week via telephone for weeks 5-13 following surgery, and once every other week for weeks 14-31 after surgery. Participants in this arm can receive financial rewards for achieving weekly physical activity goals, as well as bonus rewards for achieving goals multiple weeks in a row. Over the course of this 6-month long TAC(MI)+FI intervention period, these participants are able to receive up to $680 for meeting physical activity goals, and up to $180 in bonus rewards.
Other Names:
Behavioral: Wrist based activity tracker wear
Participants who receive this intervention are eligible to receive $5/week for wearing a wrist-based activity tracker daily for 48-weeks ($240 total), beginning 6-weeks after surgery. Activity tracking data will be collected on a weekly basis.
Other: Basic Study Activities
Basic study activities begin two-weeks before TKR and end approximately 24-months after TKR. Basic study activities include: two in-person visits at the local clinic site (2 weeks before TKR and 32-weeks after TKR), completing 6 surveys, and wearing an ActiGraph activity tracker (waist-worn) for five one-week periods throughout the study (2-weeks before-TKR, 32-weeks post-TKR, one-year post-TKR, 18-months post-TKR, two-years post-TKR). All participants will wear a wrist-worn activity tracker simultaneously with the ActiGraph 2-weeks before-TKR. All participants will be eligible to receive up to $235 for completing these activities over the course of two years.
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Outcome Measures
Primary Outcome Measures
- Proportion of Subjects Engaged in at least 150 min/week of moderate-to-vigorous physical activity (MVPA). [32-weeks post-TKR]
The primary outcome of this trial is the proportion of subjects who meet or surpass the PA threshold of 150 minutes per week of at least moderate physical activity, which is defined as 3 metabolic equivalents (METs), at 32 weeks post-TKR.
Secondary Outcome Measures
- Sustainability of the effect of the TAC(MI)+FI intervention [24-months post-TKR]
The proportion of subjects who meet or surpass the PA threshold of 150 minutes per week of at least moderate physical activity at 24 months post-TKR.
- Change in average daily step count [2-week pre-TKR to 32-weeks post-TKR]
Change in subjects' average daily step count from pre-TKR to 32-weeks post-TKR.
- Change in weekly minutes of moderate-to-vigorous activity (MVPA) [2 week pre-TKR to 32-weeks post-TKR]
Change in the number of minutes per week that subjects spend engaged in MVPA from pre_TKR to 32-weeks post-TKR.
- Change in average daily sedentary time [2 weeks pre-TKR to 32-weeks post-TKR]
Change in subjects' daily sedentary time from pre-TKR to 32-weeks post-TKR.
Eligibility Criteria
Criteria
Inclusion Criteria:
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Age 40-85 years
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English-speaking
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Scheduled to undergo primary, unilateral total knee replacement (TKR) at one of the 5 recruitment centers
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OA is principal underlying indication for TKR
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During an accelerometer run-in period lasting one week at baseline (prior to surgery), subjects must show that they can comply with wrist-worn and waist-worn physical activity tracker protocols: (1) subject wears both activity trackers for ≥4/7 days of the week for ≥10 hours/day, (2) subject uploads wrist-worn activity tracker data and returns waist-worn activity tracker after accelerometer run-in period
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Regular access to a personal computer, laptop, tablet, or smartphone for wrist-worn activity tracker syncing
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Average baseline steps/day (calculated from waist-worn activity tracker data from the run-in period)<5,000
Exclusion Criteria:
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Non-English speaking
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Residence in nursing home
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Diagnosis of dementia, epilepsy, Parkinson's Disease, or diabetes with peripheral neuropathy
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Inflammatory arthritis (rheumatoid arthritis, reactive arthritis, systemic lupus erythematosus, polymyalgia)
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Psychological issues that preclude participation
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Inpatient or other musculoskeletal surgery scheduled within six months following index primary TKR
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Surgeon-documented other reason for study exclusion
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Northwestern Memorial Hospital | Chicago | Illinois | United States | 60611 |
| 2 | University of Kansas Medical Center | Kansas City | Kansas | United States | 66160 |
| 3 | Brigham and Women's Hospital | Boston | Massachusetts | United States | 02115 |
| 4 | University at Buffalo | Buffalo | New York | United States | 14215 |
| 5 | The Cleveland Clinic | Cleveland | Ohio | United States | 44195 |
| 6 | University of South Carolina - Palmetto Health | Columbia | South Carolina | United States | 29203 |
Sponsors and Collaborators
- Brigham and Women's Hospital
- Northwestern Memorial Hospital
- The Cleveland Clinic
- University of Kansas Medical Center
- University of South Carolina
- University at Buffalo
Investigators
- Principal Investigator: Elena Losina, Ph.D., Brigham and Women's Hospital
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 2019P002700