ACTIVE_NOT_RECRUITING

Knee Arthroplasty Activity Trial

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Knee Arthroplasty Activity Trial

Quick Facts

Study Start:2023-04-27
Study Completion:2028-06-15
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:ACTIVE_NOT_RECRUITING

Study ID

NCT04107649

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:40 Years to 85 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Age 40-85 years
  2. * English-speaking
  3. * Scheduled to undergo primary, unilateral total knee replacement (TKR) at one of the 4 recruitment centers
  4. * OA is principal underlying indication for TKR
  5. * 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
  6. * Regular access to a personal computer, laptop, tablet, or smartphone for wrist-worn activity tracker syncing
  7. * Satisfying average baseline steps/day criteria (calculated from waist-worn activity tracker data from the run-in period)
  1. * Non-English speaking
  2. * Residence in nursing home
  3. * Diagnosis of dementia, epilepsy, Parkinson's Disease, or diabetes with peripheral neuropathy
  4. * Inflammatory arthritis (rheumatoid arthritis, ankylosing spondylitis, psoriatic arthritis, reactive arthritis, systemic lupus erythematosus, polymyalgia)
  5. * Psychological issues that preclude participation
  6. * Inpatient or other musculoskeletal surgery scheduled within six months following index primary TKR
  7. * Uses a wheelchair to ambulate (subjects who use a cane will be eligible)
  8. * Surgeon-documented other reason for study exclusion
  9. * Subject does not have regular access to a device capable of receiving email or text messages

Contacts and Locations

Principal Investigator

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

Study Locations (Sites)

Northwestern Memorial Hospital
Chicago, Illinois, 60611
United States
University of Kansas Medical Center
Kansas City, Kansas, 66160
United States
Brigham and Women's Hospital
Boston, Massachusetts, 02115
United States
University of Nebraska Medical Center
Omaha, Nebraska, 68198
United States
University at Buffalo
Buffalo, New York, 14215
United States

Collaborators and Investigators

Sponsor: Brigham and Women's Hospital

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

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-04-27
Study Completion Date2028-06-15

Study Record Updates

Study Start Date2023-04-27
Study Completion Date2028-06-15

Terms related to this study

Keywords Provided by Researchers

  • Physical Activity
  • Total Knee Replacement
  • Knee Osteoarthritis

Additional Relevant MeSH Terms

  • Knee Osteoarthritis
  • Total Knee Replacement