Knee Arthroplasty Activity 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.

Conditions

• Knee Osteoarthritis
• Total Knee Replacement

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.

Sponsors & Collaborators

• Northwestern Memorial Hospital

  collaborator OTHER

• University of Kansas Medical Center

  collaborator OTHER

• University at Buffalo

  collaborator OTHER

• University of Nebraska

  collaborator OTHER

• Brigham and Women's Hospital

  lead OTHER

Principal Investigators

• Elena Losina, Ph.D. · Brigham and Women's Hospital

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Model

PARALLEL

Eligibility

Min Age

40 Years

Max Age

85 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2023-04-27

Primary Completion

2028-06-15

Completion

2028-06-15

Countries

• United States

Study Locations