Knee Arthroplasty Activity Trial

Knee Osteoarthritis Clinical Trial

— KArAT  

Official title:

Knee Arthroplasty Activity Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04107649
• Other study ID #: 2019P002700
• Status: Recruiting
• Phase: N/A
• Start date: April 27, 2023
• Est. completion date: June 15, 2028

Study information

• Verified date: April 2024
• Source: Brigham and Women's Hospital
• Contact: Elena Losina, Ph.D., MSC
• Phone: 617-732-5338
• Email: elosina[@]bwh.harvard.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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 controlled 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 do the same and also receive a wrist-based physical activity tracker intervention. Participants in the third arm will receive a telephonic active coaching (motivational interviewing) and financial incentives (for reaching physical activity goals) (TAC(MI)+FI) based intervention, as well as a wrist-based physical activity tracker intervention. The second and third arms will be eligible to receive lottery-based financial rewards for wearing a wrist-worn activity tracker for twenty-four months during the study.

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 people 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

Arm 3: Usual post-TKR care + Wrist-based physical activity tracker wear + Telephonic Active Coaching (Motivational Interviewing) + Financial Incentives (TAC(MI)+FI).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 600
• Est. completion date: June 15, 2028
• Est. primary completion date: June 15, 2028
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 85 Years

Eligibility

Inclusion Criteria:

• Age 40-85 years

• English-speaking

• Scheduled to undergo primary, unilateral total knee replacement (TKR) at one of the 4 recruitment centers

• OA is principal underlying indication for TKR

• During an accelerometer run-in period lasting one week at baseline (prior to surgery), subjects must show that they can comply with waist-worn physical activity tracker protocols by wearing the activity tracker for =4/7 days of the week for =10 hours/day

• Regular access to a personal computer, laptop, tablet, or smartphone for wrist-worn activity tracker syncing

• Satisfying average baseline steps/day criteria (calculated from waist-worn activity tracker data from the run-in period)

Exclusion Criteria:

• Non-English speaking

• Residence in nursing home

• Diagnosis of dementia, epilepsy, Parkinson's Disease, or diabetes with peripheral neuropathy

• Inflammatory arthritis (rheumatoid arthritis, ankylosing spondylitis, psoriatic arthritis, reactive arthritis, systemic lupus erythematosus, polymyalgia)

• Psychological issues that preclude participation

• Inpatient or other musculoskeletal surgery scheduled within six months following index primary TKR

• Uses a wheelchair to ambulate (subjects who use a cane will be eligible)

• Surgeon-documented other reason for study exclusion

• Subject does not have regular access to a device capable of receiving email or text messages

Related Conditions & MeSH terms

• Knee Osteoarthritis
• Osteoarthritis
• Osteoarthritis, Knee
• Total Knee Replacement

Intervention

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 6-13 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 $95 in bonus rewards.
• Wrist based activity tracker wear
Activity tracking data will be collected on a weekly basis. Participants who receive this intervention are eligible to be entered into a lottery to win one of two $25 rewards for every week they wear their wrist-based activity tracker >10 hours for >4/7 days a week, beginning 6-weeks after 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), having check-in calls with study staff weekly from weeks 1-13 after surgery and every other week for weeks 14-31, 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 be eligible to receive up to $235 for completing these activities over the course of two years.

Locations

Country	Name	City	State
United States	Brigham and Women's Hospital	Boston	Massachusetts
United States	University at Buffalo	Buffalo	New York
United States	Northwestern Memorial Hospital	Chicago	Illinois
United States	University of Kansas Medical Center	Kansas City	Kansas
United States	University of Nebraska Medical Center	Omaha	Nebraska

Sponsors (5)

Lead Sponsor	Collaborator
Brigham and Women's Hospital	Northwestern Memorial Hospital, University at Buffalo, University of Kansas Medical Center, University of Nebraska

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Durability of changes in activity levels	Changes in subjects' activity levels at 12-, 18-, and 24-months post-TKR as measured by the ActiGraph.	2 weeks pre-TKR to 24 months post-TKR
Other	Change in pain and functional status	Change in subjects' pain and functional status at 8-, 12-, 18-, and 24-months post-TKR as measured by the questionnaire.	2 weeks pre-TKR to 24 months post-TKR
Other	Change in quality of life	Change in subjects' quality of life at 8-, 12-, 18-, and 24-months post-TKR as measured by the questionnaire.	2 weeks pre-TKR to 24 months post-TKR
Other	Change in performance measures	Change in subjects' performance at 32 weeks post-TKR as measured by performance tests.	2 weeks pre-TKR to 6 months post-TKR
Other	Change in cost	Change in subjects' medical costs at 8-, 12-, 18-, and 24-months post-TKR as measured by the questionnaire.	2 weeks pre-TKR to 24 months post-TKR
Primary	Proportion of Subjects Engaged in at least 150 min/week of moderate-to-vigorous physical activity (MVPA).	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.	32-weeks post-TKR
Secondary	Change in average daily step count	Change in subjects' average daily step count from pre-TKR to 32-weeks post-TKR as measured by the ActiGraph.	2-week pre-TKR to 32-weeks post-TKR
Secondary	Change in weekly minutes of moderate-to-vigorous activity (MVPA)	Change in the number of minutes per week that subjects spend engaged in MVPA from pre-TKR to 32-weeks post-TKR as measured by the ActiGraph.	2 week pre-TKR to 32-weeks post-TKR
Secondary	Change in average daily sedentary time	Change in subjects' daily sedentary time from pre-TKR to 32-weeks post-TKR as measured by the ActiGraph.	2 weeks pre-TKR to 32-weeks post-TKR