Knee Arthroplasty Activity Trial

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Interventional
Eligible Ages	40 Years - 85 Years
Gender	All

More Inclusion & Exclusion Criteria

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

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT04107649
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.	N/A
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	Brigham and Women's Hospital
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	Elena Losina, Ph.D.
Principal Investigator Affiliation	Brigham and Women's Hospital
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Other
Overall Status	Recruiting
Countries	United States
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Knee Osteoarthritis, Total Knee Replacement

Additional Details

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).

Arms & Interventions

Arms

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, having regular check-in calls with study staff over the intervention period, wearing and returning waist-worn activity trackers at 5 time points over two years, and completing 6 study surveys.

Experimental: Arm2

Participants in this arm receive usual post-operative care, complete all basic study activities (as described in arm 1) and receive the wrist-based activity tracker intervention.

Experimental: Arm3

Participants in this arm receive usual post-operative care, complete all basic study activities (as described in arm 1), receive wrist-based activity tracker intervention, and receive the TAC(MI)+FI.

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 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.

Behavioral: - 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.

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Northwestern Memorial Hospital, Chicago, Illinois

Status

Recruiting

Address

Northwestern Memorial Hospital

Chicago, Illinois, 60611

Site Contact

Marcella Oliver

[email protected]

312-503-6071

University of Kansas Medical Center, Kansas City, Kansas

Status